Pipamperon инструкция по применению 40

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Pipamperone

Clinical data
Trade names	Dipiperon
Other names	McN-JR 3345; R-3345
AHFS/Drugs.com	International Drug Names
Routes of administration	Oral
ATC code	N05AD05 (WHO)
Legal status
Legal status	BR: Class C1 (Other controlled substances)[1]
Pharmacokinetic data
Elimination half-life	17-22 hours
Duration of action	0.5-1 hour
Identifiers
IUPAC name 1-[4-(4-fluorophenyl)-4-oxobutyl]-4-piperidin-1-ylpiperidine-4-carboxamide
CAS Number	1893-33-0
PubChem CID	4830
IUPHAR/BPS	92
DrugBank	DB09286
ChemSpider	4664
UNII	5402501F0W
KEGG	D02622
ChEMBL	ChEMBL440294
CompTox Dashboard (EPA)	DTXSID8048369
ECHA InfoCard	100.119.828
Chemical and physical data
Formula	C21H30FN3O2
Molar mass	375.488 g·mol−1
3D model (JSmol)	Interactive image
SMILES Fc1ccc(cc1)C(=O)CCCN3CCC(C(=O)N)(N2CCCCC2)CC3
InChI InChI=1S/C21H30FN3O2/c22-18-8-6-17(7-9-18)19(26)5-4-12-24-15-10-21(11-16-24,20(23)27)25-13-2-1-3-14-25/h6-9H,1-5,10-16H2,(H2,23,27)  Key:AXKPFOAXAHJUAG-UHFFFAOYSA-N
(what is this?)  (verify)

Pipamperone (INN, USAN, BAN), also known as carpiperone and floropipamide or fluoropipamide, and as floropipamide hydrochloride (JAN), is a typical antipsychotic of the butyrophenone family used in the treatment of schizophrenia^[2][3] and as a sleep aid for depression.^[4] It is or has been marketed under brand names including Dipiperon, Dipiperal, Piperonil, Piperonyl, and Propitan.^[3] Pipamperone was discovered at Janssen Pharmaceutica in 1961, and entered clinical trials in the United States in 1963.^[5]

Pharmacology[edit]

Pipamperone acts as an antagonist of the 5-HT_2A,^[6] 5-HT_2B,^[7] 5-HT_2C^[8] D₂,^[6] D₃,^[9] D₄,^[6][10] α₁-adrenergic,^[9] and α₂-adrenergic receptors.^[9] It shows much higher affinity for the 5-HT_2A and D₄ receptors over the D₂ receptor (15-fold in the case of the D₄ receptor, and even higher in the case of the 5-HT_2A receptor),^[6][9][11] being regarded as «highly selective» for the former two sites at low doses.^[11][12] Pipamperone has low and likely insignificant affinity for the H₁ and mACh receptors, as well as for other serotonin and dopamine receptors.^[9]

Pipamperone is considered to have been a forerunner to the atypical antipsychotics, if not an atypical antipsychotic itself, due to its prominent serotonin antagonism.^[13][14][15] It is also used to normalise mood and sleep patterns and has antianxiety effects in neurotic patients.^[16]

Affinity^[17]

Site	pKi
D1	5.61
D2	6.71
D3	6.58
D4	7.95
5 HT1A	5.46
5 HT1B	5.54
5 HT1D	6.14
5 HT1E	5.44
5 HT1F	<5
5-HT2A	8.19
5 HT5	5.35
5 HT7	6.26
α1	7.23
α2A	6.15
α2B	7.08
α2C	6.25

Antidepressant effects[edit]

Low-dose pipamperone (5 mg twice daily) has been found to accelerate and enhance the antidepressant effect of citalopram (40 mg once daily), in a combination (citalopram/pipamperone) referred to as PipCit (code name PNB-01).^[11][18]

See also[edit]

• Clozapine
• Melperone
• Pimozide
• Piritramide
• Risperidone

References[edit]

Content

• Brief information
• What is it and what is it used for?
• What do you need to consider before use?
• How is it used?
• What are the possible side effects?
• How should it be stored?
• What is it and what is it used for?
• What do you need to consider before use?
• How is it used?
• What are the possible side effects?
• How should it be stored?

ATC code N05AD05

Active ingredient	Addictive drug	Psychotropic
Pipamperon	no	no

Date of approval	23.05.2006
Submission status	Pharmacy only
Prescription Status	prescription only
Pharmacological group	Antipsychotics

Brief information

What is it and what is it used for?

Pipamperon HEXAL is used to treat restlessness and agitation. It is used to treat sleep disorders and agitation. The active ingredient is Pipamperone dihydrochloride.

What do you need to consider before use?

Please talk to a doctor or pharmacist before use. If any of the points listed here apply to you, do not take the medicine.

How is it used?

In many cases, a low dose, e.g. B. 40 mg pipamperon sufficient per day.
Otherwise the recommended Initial dose of 40 mg pipamperon 3 times a day.

What are the possible side effects?

The most common side effects are drowsiness and the appearance of the gear phenomenon. Here you will find all information about the rarer side effects.

How should it be stored?

Do not store above 25 ° C. Keep this medicine out of the sight and reach of children.

What is it and what is it used for?

Pipamperon HEXAL is a remedy for the treatment of restlessness and agitation (neuroleptic) from the group of butyrophenones.
Pipamperon HEXAL is used to treat sleep disorders, especially in the elderly, and certain (psychomotor) agitation.

What do you need to consider before use?

Do not take Pipamperon HEXAL

• if you are allergic to pipamperon, related active substances (butyrophenones) or any of the other ingredients of this medicine (listed in section 6).
• in conditions that are associated with a dampening of the central nervous system (e.g. coma, acute alcohol, sleeping pills, painkillers, psychotropic drug poisoning).
• if you have Parkinson’s disease or similar diseases.
• during pregnancy and breastfeeding.

Warnings and Precautions

Sudden deaths in patients receiving antipsychotics
Sudden and unexplained deaths have been reported rarely in psychiatric patients receiving antipsychotic medicines, including Pipamperon HEXAL. It is unclear whether there is a causal relationship with one of the drugs.

Increased mortality in the elderly with dementia disorders
A small increase in the number of deaths has been reported in elderly people with dementia who were treated with antipsychotics compared with those not taking antipsychotics.

Be extra careful when you do

• have an increased risk of stroke or a temporary decrease in the blood supply to the brain.
• or a relative has ever had venous thrombosis (blood clots), as these medicines have been associated with blood clots.

Patients / caregivers should be encouraged to report signs of a possible cerebrovascular event such as sudden relaxation, numbness of the face, arms or legs, and speech and vision disorders to the treating physician immediately. Immediately consider all treatment options or discontinuation of therapy with Pipamperon HEXAL.

Cardiovascular diseases
Caution should be exercised in patients with cardiovascular diseases because of the potential blood pressure lowering effects.
Caution is also required in patients with certain hormone-dependent tumor conditions (prolactin-dependent tumors).

Like other neuroleptics, Pipamperon HEXAL can also extend the so-called QT interval in the ECG. Therefore, caution is advised with:

• low or high blood pressure, turning black in front of the eyes e.g. B. when standing up suddenly, slow heartbeat, potassium deficiency, magnesium deficiency
• certain heart diseases (congenital long QT syndrome or other clinically significant heart damage, in particular circulatory disorders of the coronary arteries, conduction disorders, cardiac arrhythmias)
• simultaneous treatment with drugs that can also prolong the so-called QT interval in the ECG or cause a potassium deficiency (see also «Taking Pipamperon HEXAL with other drugs»)

Neuroleptic Malignant Syndrome
As with other antipsychotics, Pipamperon HEXAL has been associated with cases of neuroleptic malignant syndrome. This is a rare, specific reaction that is characterized by increased temperature (hyperthermia), generalized muscle stiffness (muscle rigidity), vegetative instability, and impaired consciousness. Hyperthermia is often an early sign of this syndrome. In the event of the occurrence of Neuroleptic Malignant Syndrome, antipsychotic therapy should be discontinued immediately and appropriate supportive therapy and careful monitoring should take place.

Tardive dyskinesia
As with all antipsychotic drugs, tardive dyskinesia can occur in some patients on long-term therapy or after therapy has been discontinued. The syndrome is mainly characterized by rhythmic, involuntary movements of the tongue, face, mouth, or jaw. Symptoms can persist and appear to be persistent in some patients. The syndrome can be masked when therapy is resumed, when the dosage is increased, or when switching to another antipsychotic. Treatment should be stopped immediately.

Extrapyramidal symptoms
As with all neuroleptics, extrapyramidal symptoms such as tremors (tremor), muscle stiffness (rigidity), increased salivation (hypersalivation), slowed movement (bradykinesia), unsteady sitting (akathisia) or acute poor posture (dystonia) can occur. The occurrence of extrapyramidal effects is proportional to the dose, but varies greatly from patient to patient. Elderly patients can be particularly sensitive to extrapyramidal symptoms. For this group of patients, a lower dosage and regular blood pressure controls are recommended. Dose reduction, if possible, or administration of anticholinergic medication will help control symptoms.

Seizures / convulsions
Like other neuroleptics, pipamperon can lower the seizure threshold. Your doctor may need to adjust your existing treatment with drugs against epilepsy accordingly.

Serious immunological skin reactions
Very rare cases of severe skin reactions with a widespread rash with peeling skin and blistering of the mouth, eyes and genital organs (toxic epidermal necrolysis and / or Stevens-Johnson syndrome) have been reported.

Endocrine Effects
Hormonal effects of all neuroleptic antipsychotic drugs include hyperprolactinemia, which can cause milk flow in women (galactorrhea), enlargement of the male mammary gland (gynecomastia), and menstrual disorders or absence of menstruation (oligo- or amenorrhea).

More information
Like all antipsychotic substances, Pipamperon HEXAL should not be given alone in the presence of depression. It can be combined with antidepressants to treat conditions where depression is combined with psychosis.

Children and adolescents
Pipamperon HEXAL should only be prescribed to children and adolescents under 18 years of age with special consideration of the risk-benefit ratio.

Other medicines and Pipamperon HEXAL
Tell your doctor or pharmacist if you are taking / using, have recently taken / used or may take / use any other medicines.
Simultaneous use with other drugs that have a depressant effect on the central nervous system (sleeping pills, sedatives or painkillers, other psychotropic drugs, certain drugs against allergies) can lead to a mutual intensification of the effects and side effects (especially drowsiness and lowering of blood pressure). In particular, the effect of barbiturates or opiates on the respiratory center is increased when pipamperon is used at the same time.

Concomitant use with drugs that lower the brain’s seizure threshold should be avoided.
The combination with certain drugs for the treatment of Parkinson’s disease (dopamine agonists, e.g. levodopa, bromocriptine, lisuride) reduces their effect.

If medicines for high blood pressure (antihypertensive agents) are used at the same time, it should be noted that their antihypertensive effect can be increased.
Simultaneous use of drugs that

• also extend the so-called QT interval in the ECG (e.g. agents for cardiac arrhythmias [antiarrhythmics class IA or III], some antibiotics such as erythromycin, anti-malarial agents, some agents for allergies, agents for the treatment of depression), or
• may lead to a decrease in the level of potassium in the blood (e.g. certain diuretics)
• should be avoided (see also Section 4).

Pipamperon HEXAL with food, drink and alcohol
During treatment with Pipamperon HEXAL you should avoid alcohol, as alcohol changes and intensifies the effect of Pipamperon in an unforeseeable way. In particular, the reactivity is further impaired as a result.

pregnancy and breast feeding period
Ask your doctor or pharmacist for advice before taking this medicine if you are pregnant or breast-feeding, if you suspect you may be pregnant or planning to become pregnant.

You should not use Pipamperon HEXAL during pregnancy and breastfeeding, as there are neither adequate studies on pregnant animals nor experience on the safety of its use in pregnant or breastfeeding women.

If you are of childbearing potential, you should therefore be excluded from pregnancy before starting treatment, and you should use a safe method of contraception during treatment with Pipamperon HEXAL.
The following symptoms may occur in newborn babies of mothers who took Pipamperon HEXAL in the last trimester (last three months of pregnancy): tremors, muscle stiffness and / or weakness, sleepiness, restlessness, breathing difficulties and difficulty breastfeeding. If your baby develops any of these symptoms, you should contact your doctor.

Driving and using machines
Even when used as intended, this medicinal product can change the ability to react to such an extent that the ability to actively participate in road traffic, to operate machines or to work without a secure footing is impaired. This applies even more in combination with alcohol.

Pipamperon HEXAL contains sucrose and lactose
Please take Pipamperon HEXAL only after consulting your doctor if you know that you suffer from an intolerance to certain sugars.

How is it used?

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The dosage and duration of use will be determined by your doctor, taking into account the nature and severity of your illness and your personal reaction to the medicine. In any case, in the case of long-term treatment, the lowest dose required should be determined by regular dose adjustments.
Please follow the instructions of your doctor, otherwise Pipamperon HEXAL cannot work properly.
Unless otherwise prescribed by your doctor, the usual dose is:

adult
In many cases, a low dose, e.g. B. 40 mg pipamperon per day is sufficient.
Otherwise, the recommended starting dose is 40 mg pipamperone three times a day.
The dose can — if necessary — be increased by the doctor up to 120 mg pipamperon 3 times a day. This dose should not be exceeded.

Elderly patients
In elderly patients, it is recommended that lower doses, e.g. B. half of the starting dose for adults, to begin gradually and gradually increase with regular blood pressure monitoring.
The mean dose is 20-40 mg pipamperon 3 times a day. If necessary, higher dosages are also possible.

Children and young people under 18 years of age
Similar to the elderly, adolescents under the age of 18 should receive reduced doses.
Children under 14 years of age are usually given 1 mg pipamperon / kg body weight per day as a starting dose. This dose can be increased by 1 mg / kg body weight / day up to the optimal dose.
In general, a dose of 2-4 mg pipamperon / kg body weight / day is sufficient. If the desired effect cannot be achieved with this dosage, the dose can be increased by the doctor to up to 6 mg / kg body weight / day. The daily dose should be divided into 3 doses.
Due to the high active ingredient content of the tablets, Pipamperon HEXAL juice should be used in the lower dosage range.

type of application
Pipamperon HEXAL can be taken with or between meals.
The tablets are scored and can be divided. To divide, place the tablet on a firm surface with the score facing up. The tablet is divided by pressing gently with the thumb.

If you take more Pipamperon HEXAL than you should
If an overdose is suspected, a doctor must be informed immediately (e.g. poisoning emergency number)!
After an overdose, undesirable side effects such as extrapyramidal symptoms (see section 2 “Warnings and precautions”), agitation up to seizures, low blood pressure, rapid heartbeat, drowsiness, weakness, vomiting and tiredness, which are known to occur even with normal doses, have been reported.

Additional reactions have been reported in the event of an overdose: cardiac arrest, cardiac arrhythmia (torsade de pointes), respiratory arrest, coma, swelling of the brain, lack of oxygen, insufficient oxygen supply to the brain, a condition in which the blood contains too much acid, intestinal paralysis with intestinal obstruction, nausea, Diarrhea, aggression, disorientation, paleness, malaise, constriction of the pupils and abnormal gastrointestinal sounds.

Overdose deaths have been reported.

If you forget to take Pipamperon HEXAL
Do not take a double dose to make up for a forgotten dose.

If you stop taking Pipamperon HEXAL
In any case, speak to your doctor if you want to interrupt or prematurely end treatment with Pipamperon HEXAL! Do not end the drug treatment on your own, as this could jeopardize the success of the therapy. If treatment is to be stopped, it is recommended that the dose be reduced gradually.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

What are the possible side effects?

Like all medicines, this medicine can have side effects, although not everybody gets them.
The most common side effects seen in clinical trials were drowsiness and the cogwheel phenomenon.

The frequency of side effects is based on the following categories:

Very common: affects more than 1 in 10 people
Common: affects 1 to 10 users in 100
Uncommon: affects 1 to 10 users in 1,000
Rare: affects 1 to 10 users in 10,000
Very rare: less than 1 user in 10,000
Not known: frequency cannot be estimated from the available data

The following is a list of adverse reactions reported in clinical trials and post-marketing experience.

Very often:

• sleepiness
• Gear phenomenon

Frequently:

• depression
• Increased muscle tone, unsteady sitting, eye cramps, convulsive overstretching of the body, movement disorder
• accelerated heartbeat
• Drop in blood pressure when changing from lying down to standing
• Vomit
• Hives
• muscular spasticity
• Missing menstruation
• Gait disorders, weakness

Very rare:

• Nosebleeds

Not known:

• Decrease in white blood cells
• Hypersensitivity
• increased level of prolactin in the blood
• Convulsions (includes grand mal seizures), neuroleptic malignant syndrome, parkinsonism, syncope, persistent movement disorders, tremors, headache
• See blurred things
• Ventricular fibrillation
• low blood pressure
• Nausea, decreased appetite
• Increase in hepatic enzymes, liver dysfunction, cholestatic hepatitis
• Rash, serious skin changes including blistering and peeling of the skin (Toxic
• epidermal necrolysis)
• Urinary retention
• Milk flow (milky secretion from the woman’s breast), enlargement of the male mammary gland, menstrual disorder, painful permanent erection of the penis
• Fatigue, decreased temperature, edema (includes facial edema and peripheral edema), fever

Cardiac effects such as changes in the cardiac current curve (prolongation of the QT interval on the electrocardiogram (ECG)), cardiac arrhythmias (torsade de pointes, ventricular arrhythmias including ventricular fibrillation, ventricular tachycardia) and cardiac arrest have been reported rarely with antipsychotics. There were also unexplained sudden deaths.

Cases of low blood sodium levels and inadequate ADH secretion syndrome (SIADH) have been reported very rarely in association with antipsychotics.

Cases of increased sweating and salivation have been reported with antipsychotics.

Cases of blood clots in the veins, especially in the legs (with swelling, pain and redness in the legs), which may travel through the bloodstream to the lungs, causing chest pain and difficulty breathing, have been reported with antipsychotics . The frequency is not known. If you experience any of these symptoms, seek medical advice immediately.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this leaflet.
You can also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine.
Federal Institute for Pharmaceuticals and Medical Products
Pharmacovigilance Dept.
Kurt-Georg-Kiesinger Allee 3
D-53175 Bonn
Website: http://www.bfarm.de

How should it be stored?

Keep this medicine out of the sight and reach of children.

Do not store above 25 ° C.

Do not use this medicine after the expiry date which is stated on the container and the carton after “use by”. The expiry date refers to the last day of the month.
Do not dispose drugs in the wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. You help to protect our environment.

Content

• What is it and what is it used for?
• What do you need to consider before use?
• Text for instructions for use Pipamperon-neuraxpharm (tablets)
• Warnings and Precautions
• Text for instructions for use Pipamperon-neuraxpharm (tablets)
• Text for instructions for use Pipamperon-neuraxpharm (tablets)
• Other medicines and Pipamperon-neuraxpharm
• Text for instructions for use Pipamperon-neuraxpharm (tablets)
• Pipamperon-neuraxpharm with food and drink
• pregnancy and breast feeding period
• Driving and using machines
• This medicine contains lactose
• How is it used?
• Text for instructions for use Pipamperon-neuraxpharm (tablets)
• Unless otherwise prescribed by your doctor, the usual dose is:
• type of application
• If you take more Pipamperon-neuraxpharm than you should
• Text for instructions for use Pipamperon-neuraxpharm (tablets)
• If you forget to take Pipamperon-neuraxpharm
• If you stop taking Pipamperon-neuraxpharm
• What are the possible side effects?
• Very common (may affect more than 1 in 10 people)
• Common (may affect up to 1 in 10 people)
• Text for instructions for use Pipamperon-neuraxpharm (tablets)
• Not known (frequency cannot be estimated from the available data)
• Reporting of side effects
• Text for instructions for use Pipamperon-neuraxpharm (tablets)
• How should it be stored?

ATC code N05AD05

Active ingredient	Addictive drug	Psychotropic
Pipamperon	no	no

Date of approval	01.02.2002
Submission status	Pharmacy only
Prescription Status	prescription only
Pharmacological group	Antipsychotics

What is it and what is it used for?

Pipamperon-neuraxpharm is a remedy for the treatment of restlessness and agitation (neuroleptic) from the group of butyrophenones.

Pipamperon-neuraxpharm is used to treat sleep disorders, especially in the elderly, and certain (psychomotor) agitation.

What do you need to consider before use?

Pipamperon-neuraxpharm must not be taken

if you are allergic to pipamperone, related active substances (butyrophenones) or any of the other ingredients of this medicine (listed in section 6).

Text for instructions for use Pipamperon-neuraxpharm (tablets)

• in conditions that are associated with a depression of the central nervous system (e.g. coma, acute alcohol, sleeping pills, painkillers, psychotropic drugs).
• if you have Parkinson’s disease or similar diseases.
• during pregnancy and breastfeeding.

Warnings and Precautions

Talk to your doctor or pharmacist before taking Pipamperon-neuraxpharm.

Sudden deaths in patients receiving antipsychotics

Sudden and unexplained deaths have been reported rarely in psychiatric patients receiving antipsychotic medicines, including pipamperon. It is unclear whether there is a causal relationship with one of the drugs.

Increased mortality in the elderly with dementia disorders

A small increase in the number of deaths has been reported in elderly people with dementia treated with antipsychotics compared with those not taking antipsychotics.

Be (also) especially careful

• if you have an increased risk of stroke or a temporary decrease in the blood supply to the brain,
• if you or a relative have had a history of venous thrombosis (blood clots), as these medicines have been associated with the occurrence of blood clots.

Patients / caregivers should be encouraged to report signs of a possible cerebrovascular event such as sudden relaxation, numbness of the face, arms or legs, and speech and vision disorders to the treating physician immediately. Immediately consider all treatment options or discontinuation of therapy with Pipamperon-neuraxpharm.

Cardiovascular diseases

Caution should be exercised in patients with cardiovascular diseases because of the potential blood pressure lowering effects.

Caution is also required in patients with certain hormone-dependent tumor conditions (prolactin-dependent tumors).

Like other neuroleptics, Pipamperon can also extend the so-called QT interval in the ECG. Therefore, caution should be exercised

• low or high blood pressure, turning black in front of the eyes e.g. B. when standing up suddenly, slow heartbeat, potassium deficiency, magnesium deficiency,
• certain heart diseases (congenital long QT syndrome or other clinically significant heart damage, in particular circulatory disorders of the coronary arteries, conduction disorders, cardiac arrhythmias),

Text for instructions for use Pipamperon-neuraxpharm (tablets)

simultaneous treatment with drugs that can also prolong the so-called QT interval in the ECG or cause a potassium deficiency (see under «Taking Pipamperon-neuraxpharm together with other drugs»).

Neuroleptic Malignant Syndrome

As with other antipsychotics, pipamperon has been linked to cases of neuroleptic malignant syndrome. This is a rare, specific reaction that is characterized by increased temperature (hyperthermia), generalized muscle stiffness (muscle rigidity), vegetative instability, and impaired consciousness. Hyperthermia is often an early sign of this syndrome. In the event of the occurrence of neuroleptic malignant syndrome, antipsychotic therapy should be discontinued immediately and appropriate supportive therapy and careful monitoring should take place.

Tardive dyskinesia

As with all antipsychotic drugs, tardive dyskinesia can occur in some patients on long-term therapy or after therapy has been discontinued. The syndrome is mainly characterized by rhythmic, involuntary movements of the tongue, face, mouth, or jaw. Symptoms can persist and appear to be persistent in some patients. The syndrome can be masked when therapy is resumed, when the dosage is increased, or when switching to another antipsychotic. Treatment should be stopped immediately.

Extrapyramidal symptoms

As with all neuroleptics, extrapyramidal symptoms such as tremors (tremor), muscle stiffness (rigidity), increased salivation (hypersalivation), slowed movement (bradykinesia), unsteady sitting (akathisia) or acute poor posture (dystonia) can occur. The occurrence of extrapyramidal effects is proportional to the dose, but varies greatly from patient to patient. Elderly patients can be particularly sensitive to extrapyramidal symptoms. For this group of patients, a lower dosage and regular blood pressure controls are recommended. Dose reduction, if possible, or administration of anticholinergic medication will help control symptoms.

Seizures / convulsions

Like other neuroleptics, pipamperon can lower the seizure threshold. Your doctor may need to adjust your existing treatment with drugs against epilepsy accordingly.

Serious immunological skin reactions

Very rare cases of severe skin reactions with a widespread rash with peeling skin and blistering of the mouth, eyes and genital organs (toxic epidermal necrolysis and / or Stevens-Johnson syndrome) have been reported.

Text for instructions for use Pipamperon-neuraxpharm (tablets)

Endocrine Effects

Hormonal effects of all neuroleptic antipsychotic drugs include hyperprolactinemia, which can cause milk flow in women (galactorrhea), enlargement of the male mammary gland (gynecomastia), and menstrual disorders or absence of menstruation (oligo- or amenorrhea).

More information

Like all antipsychotic substances, Pipamperon-neuraxpharm should not be given alone in the presence of depression. It can be combined with antidepressants to treat conditions where depression is combined with psychosis.

Children and adolescents

Pipamperon-neuraxpharm should only be prescribed to children and adolescents under 18 years of age with special consideration of the risk-benefit ratio.

Other medicines and Pipamperon-neuraxpharm

Tell your doctor or pharmacist if you are taking / using, have recently taken / used or may take / use any other medicines.

Simultaneous use with other drugs that have a depressant effect on the central nervous system (sleeping pills, sedatives or painkillers, other psychotropic drugs, certain drugs against allergies) can lead to a mutual intensification of the effects and side effects (especially drowsiness and lowering of blood pressure). In particular, the effect of barbiturates or opiates on the respiratory center is increased when pipamperon is used at the same time.

Concomitant use with drugs that lower the brain’s seizure threshold should be avoided.

The combination with certain drugs for the treatment of Parkinson’s disease (dopamine agonists, e.g. levodopa, bromocriptine, lisuride) reduces their effect.

If medicines for high blood pressure (antihypertensive agents) are used at the same time, it should be noted that their antihypertensive effect can be increased.

Simultaneous use of drugs that

• also extend the so-called QT interval in the ECG (e.g. agents for cardiac arrhythmias [antiarrhythmics class IA or III], some antibiotics such as erythromycin, anti-malarial agents, some agents for allergies, agents for the treatment of depression), or
• may lead to a decrease in the level of potassium in the blood (e.g. certain diuretics)

should be avoided (see also under 4. «What side effects are possible?»).

Text for instructions for use Pipamperon-neuraxpharm (tablets)

Pipamperon-neuraxpharm with food and drink

You should avoid alcohol during treatment with Pipamperon-neuraxpharm, as alcohol changes and intensifies the effect of Pipamperon in an unforeseeable way. In particular, the reactivity is further impaired as a result.

pregnancy and breast feeding period

Ask your doctor or pharmacist for advice before taking this medicine if you are pregnant or breastfeeding, if you suspect you may be pregnant or planning to become pregnant.

You should not use Pipamperon-neuraxpharm during pregnancy and breastfeeding, as there are neither adequate studies on pregnant animals nor experience on the safety of its use in pregnant or breastfeeding women. If you are of childbearing potential, you should therefore be excluded from pregnancy before starting treatment, and you should use a safe method of contraception during treatment with Pipamperon-neuraxpharm.

Newborn babies of mothers who took Pipamperon in the last trimester (last three months of pregnancy) may experience the following symptoms: tremors, muscle stiffness and / or weakness, sleepiness, restlessness, breathing difficulties, and difficulty breastfeeding. If your baby develops any of these symptoms, you should contact your doctor.

Driving and using machines

Even when used as intended, this medicinal product can change the ability to react to such an extent that the ability to actively participate in road traffic, to operate machines or to work without a secure footing is impaired. This applies even more in combination with alcohol.

This medicine contains lactose

Therefore, please only take Pipamperon-neuraxpharm after consulting your doctor if you know that you suffer from an intolerance to certain sugars.

How is it used?

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

The dosage and duration of use will be determined by your doctor, taking into account the nature and severity of your illness and your personal reaction to the medicine. In any case, in the case of long-term treatment, the lowest dose required should be determined by regular dose adjustments.

Please follow the instructions of your doctor, otherwise Pipamperon-neuraxpharm cannot work properly.

Text for instructions for use Pipamperon-neuraxpharm (tablets)

Unless otherwise prescribed by your doctor, the usual dose is:

adult

In many cases, a low dose, e.g. B. 1 tablet per day (equivalent to 40 mg pipamperon) is sufficient.

Otherwise, the recommended starting dose is 1 tablet three times a day (equivalent to 40 mg pipamperon three times a day).

If necessary, the doctor can increase the dose to 3 tablets three times a day (equivalent to 120 mg pipamperon three times a day). This dose should not be exceeded.

Elderly patients

In elderly patients, it is recommended that lower doses, e.g. B. half of the starting dose for adults, to begin gradually and gradually increase with regular blood pressure monitoring.

The average dose is ½ -1 tablet three times a day (equivalent to 20 — 40 mg pipamperon three times a day). If necessary, higher dosages are also possible.

Children and adolescents under 18 years of age

Similar to the elderly, adolescents under the age of 18 should receive reduced doses.

Children under 14 years of age are usually given 1 mg pipamperon / kg body weight per day as a starting dose. This dose can be increased by 1 mg / kg body weight / day up to the optimal dose.

In general, a dose of 2-4 mg pipamperon / kg body weight per day is sufficient. If the desired effect cannot be achieved with this dosage, the dose can be increased by the doctor to up to 6 mg / kg body weight / day.

The daily dose should be divided into 3 doses.

Due to the high active ingredient content of the tablets, Pipamperon-neuraxpharm juice should be used in the lower dosage range.

type of application

Pipamperon-neuraxpharm tablets can be taken with or between meals.

If you take more Pipamperon-neuraxpharm than you should

If an overdose is suspected, a doctor must be informed immediately (e.g. poisoning emergency number)!

After an overdose, undesirable side effects such as extrapyramidal symptoms (see section “Warnings and precautions”), agitation up to seizures, low blood pressure, rapid heartbeat, drowsiness, weakness, vomiting and fatigue, which are known to occur even with normal doses, have been reported.

Additional reactions have been reported in the event of an overdose: cardiac arrest, cardiac arrhythmia (torsades de pointes), respiratory arrest, coma,

Text for instructions for use Pipamperon-neuraxpharm (tablets)

Brain swelling, lack of oxygen, insufficient oxygen supply to the brain, a condition in which the blood contains too much acid, intestinal paralysis with intestinal obstruction, nausea, diarrhea, states of aggression, disorientation, paleness, malaise, constriction of the pupils and abnormal gastrointestinal sounds.

Overdose deaths have been reported.

If you forget to take Pipamperon-neuraxpharm

Please do not make up for the missed dose, but continue taking Pipamperon-neuraxpharm as prescribed by your doctor.

If you stop taking Pipamperon-neuraxpharm

In any case, speak to your doctor if you want to interrupt or prematurely end treatment with Pipamperon neuraxpharm! Do not end the drug treatment on your own as this could jeopardize the success of the therapy. If treatment is to be stopped, it is recommended that the dose be reduced gradually.

If you have any further questions on the use of the medicinal product, ask your doctor or pharmacist.

What are the possible side effects?

Like all medicines, this medicine can have side effects, although not everybody gets them.

The most common side effects seen in clinical trials were drowsiness and cogwheel phenomenon.

The following is a list of adverse reactions reported in clinical trials and post-marketing experience.

Very common (may affect more than 1 in 10 people)

• Drowsiness, cogwheel phenomenon

Common (may affect up to 1 in 10 people)

• depression
• Increased muscle tone, unsteady sitting, cramped eyes, convulsive overstretching of the body, movement disorder
• accelerated heartbeat
• Drop in blood pressure when changing from lying down to standing
• Vomit
• Hives
• muscular spasticity
• Missing menstruation
• Gait disorders, weakness

Text for instructions for use Pipamperon-neuraxpharm (tablets)

Not known (frequency cannot be estimated from the available data)

• Decrease in white blood cells
• Hypersensitivity
• increased levels of prolactin in the blood
• Convulsions (includes grand mal seizures), neuroleptic malignant syndrome, parkinsonism, syncope, persistent movement disorders, tremors, headache
• Blurred vision
• Ventricular fibrillation
• low blood pressure
• Nosebleeds
• Nausea, decreased appetite
• Increase in hepatic enzymes, liver dysfunction, cholestatic hepatitis
• Rash, serious skin changes including blistering and peeling of the skin (toxic epidermal necrolysis)
• Urinary retention
• Milk flow (milky secretion from the woman’s breast), enlargement of the male mammary gland, menstrual disorder, painful permanent erection of the penis
• Fatigue, decreased temperature, edema (includes facial edema and peripheral edema), fever

Cardiac effects such as changes in the cardiac current curve (prolongation of the QT interval on the electrocardiogram (ECG)), cardiac arrhythmias (torsades de pointes, ventricular arrhythmias including ventricular fibrillation, ventricular tachycardia) and cardiac arrest have been reported rarely with antipsychotics. There were also unexplained sudden deaths.

Cases of low blood sodium levels and the syndrome of inadequate ADH secretion (SIADH) have been reported very rarely in association with antipsychotics.

Cases of increased sweating and salivation have been reported with antipsychotics.

Cases of blood clots in the veins, especially in the legs (with swelling, pain and redness in the legs), which may travel through the bloodstream to the lungs, causing chest pain and difficulty breathing, have been reported with antipsychotics . The frequency is not known. If you experience any of these symptoms, seek medical advice immediately.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this leaflet.

Text for instructions for use Pipamperon-neuraxpharm (tablets)

You can also report side effects directly to the Federal Institute for Drugs and Medical Devices Dept. Pharmacovigilance

Kurt-Georg-Kiesinger-Allee 3 D-53175 Bonn

Website: www.bfarm.de n.

By reporting side effects you can help provide more information on the safety of this medicine.

How should it be stored?

Keep this medicine out of the reach and sight of children!

Do not use the medicine after the expiry date which is stated on the outer carton and blister packs after «use by:». The expiry date refers to the last day of the month indicated.

Storage conditions:

This medicinal product does not require special storage conditions.

• Так работает Пипамперон
• Когда будет использоваться Пипамперон?
• Вот как применяется Пипамперон
• Каковы побочные эффекты пипамперона?
• Что следует учитывать при приеме пипамперона?
• Как получить лекарства с пипампероном
• С каких пор известен Пипамперон?

Активный ингредиент пипамперон используется для бессонницы и беспокойства. Как так называемый «классический нейролептик» первого поколения, он известен довольно давно. Возможные побочные эффекты препарата требуют регулярного контроля со стороны лечащего врача. Дети и беременные женщины должны принимать Пипамперон только после консультации с врачом. Здесь вы можете прочитать все важное о Пипампероне.

Так работает Пипамперон

В головном и спинном мозге (центральной нервной системе) взаимодействие различных веществ-посланников гарантирует, что человек чувствует себя сбалансированным и может соответствующим образом реагировать на определенные ситуации (такие как возбуждение, радость, беспокойство и т. Д.). Для этой цели различные вещества-мессенджеры (такие как дофамин) высвобождаются по мере необходимости нервными клетками, а затем возобновляются и хранятся.

Этот баланс веществ-нарушителей нарушается у людей, которые страдают от нарушений сна или физического дискомфорта.

Действующее вещество пипамперон относится к группе так называемых «классических нейролептиков»: он блокирует определенные места стыковки (рецепторы) дофамина. Восстановление мессенджера приводит к успокоению и улучшению сна.

Прием, расщепление и выведение пипамперона

Активный ингредиент пипамперон быстро всасывается через рот (перорально) из кишечника в кровь. Максимальный эффект достигается примерно через два часа. Затем происходит деградация в печени. Продукты распада затем выводятся с мочой через почки.

Когда будет использоваться Пипамперон?

Показания (показания) Пипамперона включают в себя:

• нарушения сна

Из-за своей высокой эффективности активный ингредиент в основном используется при лечении пожилых пациентов.

Вот как применяется Пипамперон

Так называемый нейролептик пипамперон обычно используется в форме таблеток или сока. Как правило, ежедневное количество активного ингредиента составляет от 40 до 120 мг. Требуемая доза должна быть определена индивидуально для каждого отдельного пациента, с регулярным пересмотром дозировки лечащим врачом. Сок пипамперона и таблетки следует принимать во время еды.

Каковы побочные эффекты пипамперона?

Очень часто, т. Е. У более чем десяти процентов подвергшихся лечению, речь идет о сонливости и так называемом «механическом явлении». Пострадавшие люди больше не могут вытягивать руки и ноги плавными движениями, а лишь рывками в небольших отдельных движениях.

Обычные (от одного до десяти процентов от числа прошедших лечение) имеют следующие побочные эффекты пипамперона: депрессия, высокое кровяное давление, беспокойство, глазная сыпь («окулогирический кризис»), непроизвольные сосательные и чмокающие движения, повышенное слюноотделение, дрожание, учащение пульса, желудочно-кишечный дискомфорт Сыпь, отсутствие менструаций и рост груди у мужчин. Побочные эффекты часто обобщаются под термином «экстрапирамидные двигательные расстройства (EPMS)».

Редко, менее чем у 0,1 процента тех, кто лечится, прием пипамперона вызывает судороги, головные боли и секрецию молочных желез.

Очень редко может возникнуть так называемый «злокачественный нейролептический синдром». Это дрожит и высокая температура. В результате речь идет о распаде мышц, который нужно лечить немедленно. Примерно в 20 процентах случаев этот синдром смертелен, несмотря на лечение.

Что следует учитывать при приеме пипамперона?

Лекарства с пипампероном не должны использоваться у людей с болезнью Паркинсона.

взаимодействия

При одновременном приеме Пипамперон и следующие вещества могут усиливать друг друга:

• Средство от депрессии
• болеутоляющее

Препараты, содержащие пипамперон, уменьшают действие леводопы и бромокриптина. Оба препарата вводятся при болезни Паркинсона.

Принимая Пипамперон в то же время может уменьшить последствия гипотонии.

Вождение и использование машин

Препараты, содержащие пипамперон, могут помешать отзывчивости. Поэтому тем, кто проходит лечение, не рекомендуется активно участвовать в дорожном движении или эксплуатировать тяжелую технику.

Возрастные ограничения

Опыт применения пипамперона у детей ограничен. Поэтому дети и подростки в возрасте до 18 лет могут получать такие лекарства только после строгой оценки риска для здоровья.

Беременность и кормление грудью

Для использования во время беременности и кормления грудью опыта пока очень мало. Беременные женщины и кормящие матери должны принимать лекарства с пипампероном только после консультации с лечащим врачом. Более проверенными альтернативами являются амитриптилин (депрессивные снотворные средства) и дифенгидрамин (снотворное).

Как получить лекарства с пипампероном

Лекарство с пипампероном требует рецепта, потому что успех терапии должен регулярно проверяться врачом. Поэтому они доступны только по рецепту от врача в аптеке.

С каких пор известен Пипамперон?

Действующее вещество пипамперон относится к «классическим нейролептикам», которые уже используются в течение некоторого времени. Большим недостатком являются их сильные побочные эффекты, которые часто сами нуждаются в лечении. Второе поколение нейролептиков (так называемые «атипичные нейролептики») в настоящее время разработано на основе классических нейролептиков. Они вызывают меньше побочных эффектов, чем классические нейролептики, такие как пипамперон.