DOMPERIDONE 10 мг Таблетка
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Инструкция по применению DOMPERIDONE ABK
Содержание инструкции
Domperidone ABC 10 mg tablets
Domperidone
Generic medicine
Read this leaflet carefully before using this medicine as it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
- If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
Contents of this leaflet:
- 1. What Domperidone ABC is and what it is used for
- 2. What you need to know before you take Domperidone ABC
- 3. How to take Domperidone ABC
- 4. Possible side effects
- 5. How to store Domperidone ABC
- 6. Contents of the pack and other information
1. What is Domperidone ABC and what it is used for
This medicine is used in adults and adolescents (aged 12 years or older and weighing 35 kg or more) for the treatment of nausea and vomiting (feeling unwell).
2. What you need to know before you take Domperidone ABC
Do not take Domperidone ABCif :
- you are allergic (hypersensitive) to domperidone or any of the other ingredients of Domperidone ABC;
- you have bleeding in the stomach or usually experience severe abdominal pain or persistent black stools;
- you have obstructions or perforations of the intestine;
- you have pituitary gland tumors with prolactin release (prolactinoma);
- you suffer from moderate or severe liver disorder;
- the ECG (electrocardiogram) detects a heart disorder called “prolongation of the QT interval”;
- you suffer from or have suffered from a disorder in which your heart is unable to pump blood into your body as it should (a condition called heart failure);
- you suffer from a disorder that causes you to have low levels of potassium or magnesium or high levels of potassium in your blood;
- you are taking certain medications (See “Taking other medicines”). Warnings and precautionsBefore taking this medicine, contact your doctor if:
- you suffer from liver disorders (impaired or liver failure) (see “Do not take Domperidone ABC”);
- you suffer from kidney disorders (impaired or kidney failure). Consult your doctor for advice in case of prolonged treatment as you may need to take a lower dose of this medicine or take this medicine less often and your doctor may want to visit you regularly.
Domperidone may be associated with an increased risk of heart rhythm disorders and cardiac arrest.
The risk may be more likely in subjects over 60 years of age or who are taking doses greater than 30 mg per day. The risk also increases when domperidone is administered together with other medicines. Tell your doctor or pharmacist if you are taking medicines for the treatment of infections (fungal or bacterial infections) and/or if you have heart problems or AIDS/HIV (see the paragraph “Other medicines and Domperidone ABC”).
Domperidone should be used at the minimum effective dose.
While taking Domperidone ABC, contact your doctor if you notice heart rhythm disturbances such as palpitations, difficulty breathing, loss of consciousness. In such cases, treatment with Domperidone ABC should be discontinued.
Adolescents weighing less than 35 kg and children
Domperidone ABC should not be given to adolescents aged 12 years or older and weighing less than 35 kg or any child under 12 years of age, as it is not effective at this age.
Other medicines and Domperidone ABC
Do not take Domperidone ABC if you are taking medicines for the treatment of:
- fungal infections, for example pentamidine or azole antifungals, in particular oral itraconazole ketoconazole, fluconazole posaconazole or voriconazole;
- bacterial infections, in particular erythromycin, levofloxacin, clarithromycin, telithromycin, moxifloxacin, spiramycin, (these drugs are antibiotics);
- heart problems or high blood pressure (for example amiodarone, dronedarone, ibutilide, hydroquinidine, quinidine, disopyramide, dofetilide, sotalol,);
- psychosis (for example haloperidol, pimozide, sertindole);
- depression (for example citalopram, escitalopram);
- gastro-intestinal disorders (for example cisapride, dolasetron, prucalopride);
- allergy (for example mequitazine, mizolastine);
- malaria (in particular halofantrine, lumefantrine);
- AIDS/HIV for example ritonavir, saquinavir (these are protease inhibitors);
- hepatitis C (for example telaprevir)
- tumors (for example toremifene, vandetanib, vincamine).
Do not take Domperidone ABC if you are taking other medicines (for example bepridil, difemanil, methadone).
Tell your doctor or pharmacist if you are taking medicines for the treatment of infections, heart disorders, AIDS/HIV or Parkinson's disease.
Domperidone ABC and apomorphine
Before using Domperidone ABC and apomorphine, your doctor will make sure that your body can tolerate taking both medicines at the same time. Ask for personalized advice from your doctor or a specialist. Read the leaflet of apomorphine.
It is important that you ask your doctor or pharmacist if Domperidone ABC is safe for you while taking other medicines, including over-the-counter medicines.
Domperidone ABC with food and drink
Take Domperidone ABC before meals. If taken after meals, the absorption of the medicine is slightly slowed down.
Pregnancy
It is not known whether the use of Domperidone ABC during pregnancy is harmful.
If you are pregnant or think you may be, tell your doctor before taking Domperidone ABC.
Breastfeeding
Small amounts of domperidone have been detected in breast milk. Domperidone ABC may cause undesirable effects on the heart of the breastfed newborn. Domperidone ABC should be used during breastfeeding only if the doctor considers it strictly necessary. Ask your doctor for advice before taking this medicine.
Driving and using machines
Some patients have reported feeling dizzy or sleepy after taking Domperidone ABC. Do not drive or use machines while taking Domperidone ABC until you know how Domperidone ABC affects you.
Important information about some ingredients of Domperidone ABC
Domperidone ABC contains lactose
If your doctor has diagnosed you with intolerance to certain sugars, contact him before taking this medicine.
Domperidone ABC contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially ‘sodium-free’.
3. How to take Domperidone ABC
Follow these instructions strictly, unless your doctor has given you different instructions.
It is recommended to use Domperidone ABC before meals; if taken after meals, the absorption of the medicine is slightly delayed.
Duration of treatment:
Symptoms usually resolve within 3-4 days of taking this medicine.
Do not take Domperidone ABC for more than 7 days without consulting your doctor.
Adults and adolescents aged 12 years or over and weighing 35 kg or more
The usual dose is one tablet taken up to three times a day, preferably before meals.
Take the tablets with a little water or other liquid. Do not chew them.
Do not take more than three tablets a day.
If you take more Domperidone ABC than you should
If you have taken an excessive amount of Domperidone ABC, contact your doctor, pharmacist or the nearest poison control center immediately. In case of overdose, symptomatic treatment is appropriate. An electrocardiogram may be performed, given the possibility of a cardiac problem called “QT interval prolongation”.
Information for the doctor:close medical supervision of the patient, gastric lavage, use of activated charcoal and supportive therapy are recommended. Anticholinergic anti-Parkinson's medicines may be useful in controlling extrapyramidal disorders.
If you forget to take Domperidone ABC
Take the medicine as soon as you remember. If it is almost time to take the next dose, wait until the time of that dose and then continue as normal. Do not take a double dose to make up for a forgotten dose.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Uncommon(may affect up to 1 in 100 people):
- Involuntary movements of the face or arms or legs, excessive tremor, excessive muscle rigidity or spasm.
Not known(frequency cannot be estimated from the available data):
- Convulsions
- A type of reaction that may occur immediately after administration and is characterised by skin rash, itching, shortness of breath and/or swelling of the face
- A severe hypersensitivity reaction that may occur immediately after administration and is characterised by urticaria, itching, flushing, fainting, and among other possible symptoms, difficulty breathing
- Cardiovascular system disorders have been reported: heart rhythm disorders (fast or irregular heartbeat); if you experience such disorders, you should stop treatment immediately. Domperidone may be associated with an increased risk of heart rhythm disorders and cardiac arrest. This risk may be more likely in patients over 60 years of age or who are taking doses greater than 30 mg per day. Domperidone should be used at the lowest effective dose.
Stop treatment with domperidone and contact your doctor immediatelyif any of the
side effects described above occur.
Other side effects that have occurred with Domperidone ABC are listed below:
Common(may affect up to 1 in 10 people):
- dry mouth
Uncommon(may affect up to 1 in 100 people):
- anxiety
- agitation
- nervousness
- loss or reduction of libido
- headache
- drowsiness
- diarrhoea
- skin rash
- itching
- urticaria
- painful or tender breasts
- breast milk secretion
- general feeling of weakness
- dizziness
Not known(frequency cannot be estimated from the available data):
- upward movement of the eyes
- interruption of the menstrual cycle in women
- enlarged breasts in men
- inability to urinate
- changes in some laboratory tests.
- Restless legs syndrome (feeling of discomfort, with an irresistible need to move the legs, and sometimes arms and other parts of the body).
Some patients who have used Domperidone ABC for conditions and dosages that require medical
supervision have experienced the following side effects:
Restlessness; swelling or enlargement of the breasts, abnormal secretions from the breasts, irregular
menstrual cycle in women, difficulty breastfeeding, depression, hypersensitivity.
Reporting of suspected adverse reactions
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly via the website:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects you can help provide more information on the safety of
this medicine.
5. How to store Domperidone ABC
Keep the medicine out of sight and reach of children.
Do not take Domperidone ABC after the expiry date stated on the label.
The expiry date “EXP.” refers to the last day of that month, the first two numbers indicate the month,
the following ones the year.
Do not store the tablets at a temperature above 25 °C.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how
to dispose of medicines you no longer use. This will help protect the environment.
6. Contents of the pack and other information
WhatDomperidone ABC contains
The active ingredient is domperidone.
The other ingredients are:
lactose, corn starch, povidone, sodium lauryl sulfate, microcrystalline cellulose, colloidal silicon dioxide,
sodium carboxymethylcellulose, hydrogenated vegetable oil, magnesium stearate
Description of the appearance of Domperidone ABC and contents of the pack
Domperidone ABC 10 mg tablets - Pack of 30 tablets.
Marketing Authorisation Holder
ABC Farmaceutici S.p.A. - Corso Vittorio Emanuele II, 72 – 10121 Turin
Manufacturer
ABC Farmaceutici S.p.A. – Canton Moretti, 29 – San Bernardo d’Ivrea (TO)
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- Страна регистрации
- Форма выпускаTablet, 10 MG
- Код АТХA03FA03
- Действующее вещество
- Отпускается по рецептуДа
- Производитель
- Информация на этой странице носит справочный характер и не является медицинской консультацией. Перед началом приема лекарства обязательно проконсультируйтесь с врачом.
- Аналоги DOMPERIDONE ABKФорма выпуска: Coated tablet, 10 MGДействующее вещество: домперидонаПроизводитель: DOC GENERICI SRLОтпускается по рецептуФорма выпуска: Coated tablet, 10 MGДействующее вещество: домперидонаПроизводитель: EG S.P.A.Отпускается по рецептуФорма выпуска: Tablet, 10 MGДействующее вещество: домперидонаПроизводитель: MYLAN S.P.A.Отпускается по рецепту
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Аналог DOMPERIDONE ABK в Украина
Аналог DOMPERIDONE ABK в Испания
Аналог DOMPERIDONE ABK в Польша
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Действующее вещество DOMPERIDONE ABK — домперидона. Эта информация помогает определить лекарства с тем же составом под другими торговыми названиями.
DOMPERIDONE ABK производится компанией ABC FARMACEUTICI S.P.A.. Упаковка и торговое название могут отличаться в зависимости от дистрибьютора.
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Другие лекарства с тем же действующим веществом (домперидона) включают DOMPERIDONE DOK JENERIKI, DOMPERIDONE EG, DOMPERIDONE MYLAN JENERIKS. Они могут отличаться торговым названием или формой выпуска, но содержат одинаковый терапевтический компонент. Перед изменением лечения рекомендуется проконсультироваться с врачом.
