DOMPERIDONE 10 mg Таблетки
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Инструкция по применению DOMPERIDONE MYLAN JENERIKS
Содержание инструкции
Domperidone Mylan Generics 10 mg tablets
domperidone
Generic medicine
Read this leaflet carefully before taking 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 their symptoms are the same as yours, as it could be harmful.
- If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
Contents of this leaflet:
- 1. What Domperidone Mylan Generics is and what it is used for
- 2. What you need to know before you take Domperidone Mylan Generics
- 3. How to take Domperidone Mylan Generics
- 4. Possible side effects
- 5. How to store Domperidone Mylan Generics
- 6. Contents of the pack and other information
1. What is Domperidone Mylan Generics and what is it used for
Domperidone Mylan Generics contains the active ingredient domperidone, which belongs to a group of
medicines called prokinetics.
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 Mylan Generics
Do not take Domperidone Mylan Generics if:
- you are allergic to domperidone or any of the other ingredients of this medicine (listed in section 6);
- you have a tumour of the pituitary gland (prolactinoma);
- you have moderate to severe liver problems;
- your ECG (electrocardiogram) shows a heart condition called “prolonged QT interval”;
- you suffer from or have suffered from a condition in which your heart is unable to pump blood around the body as it should (a condition called heart failure);
- you suffer from a condition that causes you to have low levels of potassium or magnesium or high levels of potassium in your blood;
- you are taking certain medicines (see “Other medicines and Domperidone Mylan Generics”);
- you suffer from bleeding, obstruction and perforation of the stomach and/or intestine.
Warnings and precautions
Talk to your doctor or pharmacist before taking Domperidone Mylan Generics.
Before taking this medicine, contact your doctor if:
- you have liver problems (impaired or insufficient liver function) (see the section “Do not take Domperidone Mylan Generics if”);
- you have kidney problems (impaired or insufficient kidney function). Ask your doctor for advice if you require prolonged treatment as it may be necessary to take a lower dose or take this medicine less frequently and your doctor may want to check you regularly.
Domperidone Mylan Generics may be associated with an increased risk of heart rhythm disorders and
cardiac arrest. The risk may be more likely in people over 60 years of age or who are taking doses
greater than 30 mg per day. The risk also increases when domperidone is given with other
medicines. Contact your doctor if you experience heart rhythm disturbances such as palpitations, shortness of breath,
loss of consciousness. In this case, treatment with Domperidone Mylan Generics should be stopped.
Tell your doctor or pharmacist if you are taking medicines for the treatment of infections (fungal or
bacterial infections) and/or suffer from heart problems or AIDS/HIV (see the section “Other medicines and
Domperidone Mylan Generics”).
Domperidone Mylan Generics should be used at the lowest effective dose in adults and children.
Other medicines and Domperidone Mylan Generics
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
Do not take Domperidone Mylan Generics if you are taking medicines for the treatment of:
- fungal infections, for example pentamidine or azole antifungals, in particular itraconazole, ketoconazole, posaconazole, fluconazole or voriconazole by mouth;
- bacterial infections, in particular erythromycin, clarithromycin, telithromycin, levofloxacin, moxifloxacin, spiramycin (these medicines are antibiotics);
- heart problems or high blood pressure (for example amiodarone, dronedarone, quinidine, disopyramide, dofetilide, sotalol, ibutilide, diltiazem, verapamil);
- psychosis (for example haloperidol, pimozide, sertindole);
- depression (for example citalopram, escitalopram);
- gastrointestinal disorders (for example cisapride, dolasetron, prucalopride);
- allergies (for example mequitazine, mizolastine);
- malaria (in particular halofantrine, lumefantrine);
- AIDS/HIV or hepatitis C (protease inhibitors for example ritonavir, saquinavir, telaprevir);
- tumours (for example toremifene, vandetanib, vincamine).
Domperidone Mylan Generics and apomorphine
Before using Domperidone Mylan Generics 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.
Do not take Domperidone Mylan Generics if you are taking other medicines, for example bepridil, difemanil and
methadone.
Tell your doctor or pharmacist if you are taking medicines for the treatment of infections, heart problems or
AIDS/HIV.
Also tell your doctor or pharmacist if you are taking levodopa, azithromycin and roxithromycin.
When antacids or antisecretory drugs are used at the same time, these should not be taken
simultaneously with Domperidone Mylan Generics, for example they should be taken after meals and not before
meals.
Domperidone Mylan Generics with food and drink
Take Domperidone Mylan Generics before meals. If taken after meals, the drug will be absorbed more
slowly.
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding
ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Domperidone Mylan Generics should be used during pregnancy only if absolutely necessary and under
direct medical supervision.
Breastfeeding
Small amounts of domperidone have been detected in breast milk. Domperidone Mylan Generics can cause
undesirable effects, in particular on the heart of the breastfed infant. Domperidone Mylan Generics should
be used during breastfeeding only if your doctor considers it strictly necessary. Ask your doctor for advice
before taking this medicine.
Driving and using machines
This medicine can cause dizziness and drowsiness. Do not drive vehicles or use machines until you are
aware of the effects of Domperidone Mylan Generics on you.
Domperidone Mylan Generics contains lactose and sodium
If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this
medicine.
This medicine contains less than 1mmol (23 mg) of sodium per tablet, that is to say essentially “sodium-free”.
3. How to take Domperidone Mylan Generics
Take this medicine following exactly the instructions of your doctor or pharmacist. If you have doubts
consult your doctor or pharmacist.
Strictly adhere to these instructions, unless your doctor has provided you with different instructions.
Take the minimum effective dose of Domperidone Mylan Generics and for the shortest duration, which allows you to
control nausea and vomiting.
Duration of treatment:
Symptoms usually resolve within 3-4 days of taking this medicine. Do not take Domperidone
Mylan Generics for more than 7 days without consulting your doctor.
Adults and adolescents (aged 12 years and over with a weight of 35 kg or more)
The recommended dose is one tablet taken three times a day, preferably before meals.
Do not take more than 3 tablets a day. If taken after meals, the absorption of the drug is rather
slowed down. Try to take each dose at the scheduled time.
Children and adolescents from birth up to a body weight of less than 35 kg
The tablets are not suitable for children and adolescents weighing less than 35 kg.
Use in people with liver problems
If you suffer from moderate to severe liver problems, do not take this medicine (see the paragraph “Do not
take Domperidone Mylan Generics if”).
Use in people with kidney problems
If you suffer from severe kidney problems, your doctor may decide to reduce the dose or the frequency of dosage to 1-2
times a day.
If you take more Domperidone Mylan Generics than you should
Following the intake of an excessive dose of this medicine, the following symptoms may occur, especially in
newborns and children: agitation, altered state of consciousness, convulsions,
disorientation, drowsiness and difficulty in movements (extrapyramidal manifestations).
If you have taken an excessive amount of Domperidone Mylan Generics, contact your doctor, your
pharmacist or the nearest poison control center immediately, especially if the excessive amount has been taken by a child.
In case of overdose, symptomatic treatment may be adopted. An electrocardiogram (ECG) may be performed, given the possibility of a heart problem called
prolongation of the QT interval.
If you forget to take Domperidone Mylan Generics
If you forget to take a scheduled dose, wait for the time of taking the next dose and then continue
normally. Do not take a double dose to make up for the missed dose.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop treatment with Domperidone Mylan Generics and see your doctor immediately if you
experience any of the following side effects:
Uncommon(may affect up to 1 in 100 people)
- difficulty controlling movements (extrapyramidal disorders).
Not known(frequency cannot be estimated from available data)
- cardiovascular disorders: heart rhythm problems (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 problems and cardiac arrest. This risk may be more likely in people 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;
- convulsions;
- severe allergic reaction that can also cause difficulty breathing (anaphylactic shock, anaphylactic reaction);
- angioedema (swelling of the face, lips, mouth, tongue or throat that can cause difficulty breathing and swallowing).
The following side effects may also occur:
Common(may affect up to 1 in 10 people)
- dry mouth. Uncommon(may affect up to 1 in 100 people)
- loss of sexual desire, anxiety, agitation, nervousness;
- drowsiness, headache, dizziness;
- diarrhoea;
- urticaria, itching, skin rash;
- breast pain and tension;
- abnormal milk production from the breast (galactorrhoea);
- general feeling of weakness (asthenia).
Rare(may affect up to 1 in 1,000 people)
- increased levels of prolactin in the blood;
- stomach and/or intestinal disorders, including transient intestinal cramps.
Very rare(may affect up to 1 in 10,000 people)
- allergic reactions;
Frequency not known(frequency cannot be estimated from available data)
- restless legs syndrome, a disorder characterized by the need to make periodic movements of the legs (worsening of restless legs syndrome in patients with Parkinson's disease);
- upward movement of the eyes (oculogyric crisis);
- inability to urinate;
- development of breast tissue in men (gynecomastia);
- absence of menstruation (amenorrhoea);
- alteration of liver function tests.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. You can also report side effects directly through the national reporting system at: 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 Mylan Generics
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack after “Exp.”.
The expiry date refers to the last day of that month.
Do not store at a temperature above 25°C.
Do not dispose of any medicine in waste water 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 Mylan Generics contains
- The active ingredient is domperidone. Each tablet contains 10 mg of domperidone.
- The other ingredients are: lactose, corn starch, povidone, sodium lauryl sulfate, microcrystalline cellulose, hydrated colloidal silica, sodium carboxymethylcellulose, hydrogenated vegetable oil, magnesium stearate.
Description of the appearance of Domperidone Mylan Generics and contents of the pack
Pack of 30 tablets.
Marketing Authorisation Holder
Mylan S.p.A., Via Vittor Pisani 20, 20124 Milano
Manufacturer
Fine Foods & Pharmaceuticals N.T.M. S.p.A., Via Grignano 43, 24041 Brembate (BG)
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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 MYLAN JENERIKSФорма выпуска: Tablet, 10 MGДействующее вещество: домперидонаПроизводитель: ABC FARMACEUTICI S.P.A.Отпускается по рецептуФорма 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 рецепту
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Действующее вещество DOMPERIDONE MYLAN JENERIKS — домперидона. Эта информация помогает определить лекарства с тем же составом под другими торговыми названиями.
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