DOMPERIDONE 10 mg Tabletka Powlekana
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Jak stosować DOMPERIDONE DOK JENERIKI
Treść ulotki
DOMPERIDONE DOC Generici 10 mg tablets
Generic medicine
▼Medicine subject to additional monitoring. This will allow the rapid identification of new
safety information. You can contribute by reporting any adverse effects experienced during
taking this medicine. See the end of section 4 for information on how to report
adverse effects.
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 give it to other people, 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 DOC Generici is and what it is used for
- 2. What you need to know before you take DOMPERIDONE DOC Generici
- 3. How to take DOMPERIDONE DOC Generici
- 4. Possible side effects
- 5. How to store DOMPERIDONE DOC Generici
- 6. Contents of the pack and other information
1. What is DOMPERIDONE DOC Generici and what is it used for
DOMPERIDONE DOC Generici contains the active ingredient domperidone which belongs to a group of
medicines called “dopamine antagonists”.
This medicine is used in adults and children for the treatment of nausea and vomiting (feeling of
unwellness).
2. What you need to know before you take DOMPERIDONE DOC Generici
Do not take DOMPERIDONE DOC Generici:
- if you are allergic to domperidone or to any of the other ingredients of this medicine (listed in section 6);
- if you have a pituitary gland tumor (prolactinoma);
- if you have moderate or severe liver disorder;
- if the ECG (electrocardiogram) shows a heart disorder called “prolonged corrected QT interval”;
- if you have or have had a disorder in which your heart is unable to pump blood around the body as it should (a condition called heart failure);
- if you have a disorder that causes you to have low levels of potassium or magnesium or high levels of potassium in your blood;
- if you are taking certain medicines (See section “Other medicines and DOMPERIDONE Doc Generici”);
- if you suffer from problems with your stomach or intestines (gastrointestinal bleeding, perforation, mechanical obstruction).
Warnings and precautions
Talk to your doctor or pharmacist before taking DOMPERIDONE DOC Generici.
Before taking this medicine contact your doctor if:
- you suffer from liver disorders (impaired or liver failure) (see “Do not use DOMPERIDONE DOC Generici);
- you suffer from kidney disorders (impaired or kidney failure). Ask your doctor for advice if prolonged treatment is required as you may need to take a lower dose of this medicine or take this medicine less often and your doctor may want to check you regularly.
Domperidone 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. 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 section “Other medicines and
DOMPERIDONE DOC Generici”).
Domperidone should be used at the lowest effective dose in adults and children.
While taking domperidone, contact your doctor if you notice heart rhythm disturbances such as palpitations,
difficulty breathing, fainting. In such cases, treatment with domperidone should be stopped.
Other medicines and DOMPERIDONE DOC Generici
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
DOMPERIDONE DOC Generici and apomorphine
Before using DOMPERIDONE DOC Generici 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 DOC Generici if you are taking medicines for the treatment of:
- fungal infections, for example azole antifungals, in particular ketoconazole, fluconazole or voriconazole
- oral;
- bacterial infections, in particular erythromycin, clarithromycin, telithromycin, moxifloxacin, pentamidine
- (these medicines are antibiotics);
- heart problems or high blood pressure (for example amiodarone, dronedarone, quinidine, disopyramide,
- dofetilide, sotalol, diltiazem, verapamil);
- 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 alofantrine);
- AIDS/HIV (protease inhibitors);
- tumors (for example toremifene, vandetanib, vincamine);
Tell your doctor or pharmacist if you are taking medicines for the treatment of infections, heart problems,
AIDS/HIV or for the treatment of Parkinson's disease (levodopa).
It is important that you ask your doctor or pharmacist if Domperidone DOC Generici is safe for you while taking
other medicines, including over-the-counter medicines.
Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, are planning to become pregnant or are breastfeeding
ask your doctor or pharmacist for advice before taking this medicine.
If you are pregnant, take this medicine only if absolutely necessary and under direct medical supervision.
Small amounts of domperidone have been found in breast milk. Domperidone can cause adverse effects on the
heart of the breastfed newborn. Domperidone 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 does not or negligibly alters the ability to drive vehicles or use
machinery.
DOMPERIDONE DOC Generici contains lactose
This medicine contains lactose, a type of sugar. If you have been diagnosed with an intolerance to
certain sugars, contact your doctor before taking this medicine.
3. How to take DOMPERIDONE DOC Generici
Take this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts
consult your doctor or pharmacist.
Follow these instructions strictly, unless your doctor has given you different instructions.
Duration of treatment:
Do not take DOMPERIDONE DOC Generici for more than 7 days.
Adults and adolescents aged 12 years or over and weighing 35 kg or more
Take the medicine at the scheduled time of day.
The usual dose is one tablet taken up to three times a day, preferably before meals.
Do not take more than 3 tablets a day.
Children and adolescents from birth up to a body weight of less than 35 kg
The tablets are not suitable for children weighing less than 35 kg.
Use in people with liver problems
If you suffer from liver problems (moderate or severe hepatic impairment), do not take this medicine
(See section “Do not take DOMPERIDONE DOC Generici”). It is not necessary to modify the dosage
if the liver problems are mild.
Use in people with kidney problems
If you suffer from severe kidney problems (severe renal impairment), your doctor may decide to reduce the dose of
medicine to be taken or the frequency of dosage to 1-2 times a day.
If you take more DOMPERIDONE DOC Generici than you should
Following the intake of an excessive dose of this medicine, the following symptoms may occur:
- agitation;
- altered consciousness;
- convulsions;
- disorientation;
- drowsiness;
- difficulty of movements (extrapyramidal manifestations).
If you have taken an excessive amount of DOMPERIDONE DOC Generici, 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. ECG monitoring may be performed, given the possibility of a heart problem called prolonged QT interval.
If you forget to take DOMPERIDONE DOC Generici
Take the medicine as soon as you remember. If it is almost time to take the next dose, wait until the time of
taking that 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.
The following side effects may occur:
Rare(may affect up to 1 in 1,000 people):
- increased levels of prolactin (a hormone) in the blood;
- gastrointestinal disorders including transient intestinal cramps;
- development of breast tissue in men (gynecomastia);
- absence of menstruation (amenorrhea); production of milk in women who are not pregnant (galactorrhea); Very rare(may affect up to 1 in 10,000 people):
- allergic reactions, including severe ones (anaphylaxis, anaphylactic shock, anaphylactic reaction); urticaria, skin rash and itching;
- swelling of the face, mouth, tongue and throat due to fluid accumulation (angioedema);
- agitation, nervousness;
- difficulty in controlling movement and abnormal muscle movements (extrapyramidal disorders);
- diarrhea;
- alteration of liver function tests (liver function test).
Not known(frequency cannot be estimated from available data)
Cardiovascular system disorders have been reported: heart rhythm disorders (fast or
irregular heartbeat); if you experience such disorders, you should immediately stop treatment.
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.
Nervous system disorders have also been reported: restless legs syndrome (worsened in patients
with Parkinson's disease).
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:
www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa .
By reporting side effects you can help provide more information on the safety of this
medicine.
5. How to store DOMPERIDONE DOC Generici
Keep this medicine out of the sight and reach of children.
Do not take 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.
Store at a temperature not exceeding 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 DOC Generici 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, anhydrous colloidal silica, sodium carboxymethylcellulose, hydrogenated vegetable oil, magnesium stearate.
Description of the appearance of DOMPERIDONE DOC Generici and contents of the pack
Pack of 30 tablets in blisters.
Marketing Authorisation Holder
DOC Generici S.r.l. - Via Turati, 40 - 20121 Milan - Italy
Manufacturer
Francia Farmaceutici S.r.l. - Via dei Pestagalli, 7 – Milan – Italy
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- Kraj rejestracji
- Postać farmaceutycznaCoated tablet, 10 MG
- Kod ATCA03FA03
- Substancja czynna
- Wymaga receptyTak
- Producent
- Te treści mają charakter wyłącznie informacyjny i nie zastępują konsultacji lekarskiej.
- Zamienniki DOMPERIDONE DOK JENERIKIPostać farmaceutyczna: Tablet, 10 MGSubstancja czynna: domperidoneProducent: ABC FARMACEUTICI S.P.A.Wymaga receptyPostać farmaceutyczna: Coated tablet, 10 MGSubstancja czynna: domperidoneProducent: EG S.P.A.Wymaga receptyPostać farmaceutyczna: Tablet, 10 MGSubstancja czynna: domperidoneProducent: MYLAN S.P.A.Wymaga recepty
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DOMPERIDONE DOK JENERIKI wymaga recepty w Włochy. Możesz skonsultować się z lekarzem online, aby sprawdzić, czy ten lek może być odpowiedni w Twojej sytuacji.
Substancją czynną w DOMPERIDONE DOK JENERIKI jest domperidone. Informacja ta pomaga rozpoznać leki o tym samym składzie, ale pod różnymi nazwami handlowymi.
DOMPERIDONE DOK JENERIKI jest produkowany przez DOC GENERICI SRL. Nazwy handlowe i opakowania mogą się różnić w zależności od dystrybutora.
Lekarze, tacy jak Lekarze rodzinni, Psychiatrzy, Dermatolodzy, Kardiolodzy, Endokrynolodzy, Gastroenterolodzy, Pulmonolodzy, Nefrolodzy, Reumatolodzy, Hematolodzy, Zakaźnicy, Alergolodzy, Geriatrzy, Pediatrzy, Onkolodzy, mogą ocenić, czy stosowanie DOMPERIDONE DOK JENERIKI jest odpowiednie w Twoim przypadku, w zależności od sytuacji klinicznej i lokalnych przepisów. Możesz umówić konsultację online, aby omówić objawy i możliwe dalsze kroki.
Polska posiada dobrze rozwiniętą infrastrukturę ochrony zdrowia w dużych miastach, takich jak Warszawa, Kraków, Wrocław i Gdańsk. Apteki są łatwo dostępne i działają zgodnie z obowiązującymi przepisami, zapewniając dostęp do leków na receptę.
Możesz kupić DOMPERIDONE DOK JENERIKI w Warszawie, Krakowie, Wrocławiu lub Gdańsku w każdej aptece, posiadając ważną receptę.
Aby uzyskać receptę, możesz skorzystać z Oladoctor:
Inne leki zawierające tę samą substancję czynną (domperidone) to m.in. DOMPERIDONE ABK, DOMPERIDONE EG, DOMPERIDONE MYLAN JENERIKS. Mogą one różnić się nazwą handlową lub postacią, ale zawierają ten sam składnik terapeutyczny. Przed zmianą lub rozpoczęciem nowego leku skonsultuj się z lekarzem.
