DOMPERIDONE 10 mg Tabletki Powlekane
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Jak stosować DOMPERIDONE EG
Treść ulotki
Domperidone EG 10 mg tablets
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 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 EG is and what it is used for
- 2. What you need to know before you take Domperidone EG
- 3. How to take Domperidone EG
- 4. Possible side effects
- 5. How to store Domperidone EG
- 6. Contents of the pack and other information
1. What is Domperidone EG and what is it used for
This medicine is used in adults and adolescents (aged 12 years and over 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 EG
Do not take Domperidone EG if:
- you are allergic to domperidone or any of the other ingredients of this medicine (listed in section 6);
- you have bleeding in the stomach or usually experience severe abdominal pain or persistent black stools;
- you have obstructions or perforations of the intestines;
- you have tumors of the pituitary gland (prolactinoma);
- you have moderate or severe liver disorder;
- the ECG (electrocardiogram) shows a heart disorder called “prolongation of the QT interval”;
- 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);
- you have 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 medicines (see “Other medicines and Domperidone EG”).
Warnings and precautions
This medicine should not be used in newborns, infants and children under 12 years of age and in
adolescents weighing less than 35 kg. If Domperidone EG is for a child, refer to your doctor for
the formulation suitable for children.
Before taking this medicine contact your doctor if:
- you suffer from liver disorders (impaired or hepatic failure) (see “Do not take Domperidone EG);
- you suffer from kidney disorders (impaired or renal failure). Consult your doctor for advice if prolonged treatment is necessary as you may need to take a lower dose of this medicine or take this medicine less frequently and your doctor may want to examine 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 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
section “Other medicines and Domperidone EG”).
Domperidone EG should be used at the lowest effective dose in adults and adolescents.
While taking Domperidone EG, contact your doctor if you notice heart rhythm disturbances such as
palpitations, difficulty breathing, fainting. In this case, treatment with Domperidone EG should
be stopped.
Other medicines and Domperidone EG
Do not take Domperidone EG if you are taking medicines for the treatment of:
- fungal infections, for example pentamidine or azole antifungals, in particular itraconazole, oral ketoconazole, fluconazole, posaconazole or voriconazole;
- bacterial infections, in particular erythromycin, clarithromycin, telithromycin, levofloxacin, moxifloxacin, spiramycin (these medicines are antibiotics);
- heart problems or high blood pressure (for example amiodarone, dronedarone, ibutilide, disopyramide, dofetilide, sotalol, hydroquinidine, quinidine);
- psychosis (for example haloperidol, pimozide, sertindole);
- depression (for example citalopram, escitalopram);
- gastro-intestinal disorders (for example cisapride, dolasetron, prucalopride);
- allergies (for example mequitazine, mizolastine);
- malaria (in particular halofantrine, lumefantrine);
- AIDS/HIV for example ritonavir or saquinavir (these are protease inhibitors);
- Hepatitis C (for example telaprevir);
- tumors (for example toremifene, vandetanib, vincamine). Do not take Domperidone EG 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 EG and apomorphine
Before using Domperidone EG 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
It is important that you ask your doctor or pharmacist if Domperidone EG is safe for you while taking
other medicines, including over-the-counter medicines.
Domperidone EG with food and drink
Take Domperidone EG before meals. If taken after meals, the absorption of the medicine is
slightly delayed.
Pregnancy
It is not known whether the use of Domperidone EG during pregnancy is harmful.
If you are pregnant or think you may be pregnant, tell your doctor before taking
Domperidone EG.
Breastfeeding
Small amounts of domperidone have been detected in breast milk. Domperidone EG may cause adverse
effects on the heart of the breastfed infant. Domperidone EG 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
Some patients have reported feeling dizzy or sleepy after taking Domperidone EG.
Do not drive vehicles or use machines while taking Domperidone EG until you know how
Domperidone EG affects you.
Domperidone EG contains lactose, sodium and hydrogenated castor oil
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.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially ‘sodium-free’.
This medicine contains hydrogenated castor oil: it may cause stomach upset and diarrhoea.
3. How to take Domperidone EG
Follow these instructions strictly, unless your doctor has given you different instructions.
Always take Domperidone EG before meals, as absorption of the medicine is slightly delayed if taken after meals.
Duration of treatment:
Symptoms usually resolve within 3-4 days of taking this medicine. Do not take Domperidone EG for more than 7 days without consulting your doctor.
Adults and adolescents aged12 years or over and weighing35 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 3 tablets per
day.
Newborns, infants, children under 12 years of age and adolescents and with a body weight of less than 35
kg
The tablets are not suitable for use in children under 12 years of age or adolescents weighing less than 35 kg. If Domperidone EG is for a child, refer to your doctor for the
suitable formulation for children.
If you take more Domperidone EG than you should
If you have taken an excessive amount of Domperidone EG, contact your doctor, 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 administered. 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 subject, gastric lavage, use of activated charcoal and supportive therapy are recommended. Anticholinergic anti-Parkinsonian
medicines may be useful in controlling extrapyramidal disorders.
If you forget to take Domperidone EG
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 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 trembling, excessive muscle stiffness or muscle spasm.
Not known(frequency cannot be estimated from the available data)
- Convulsions
- A type of reaction that can 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 can occur immediately after administration and is characterised by urticaria, itching, flushing, fainting, and among other possible symptoms, difficulty breathing
- Cardiovascular system disorders: heart rhythm disturbances (fast or irregular heartbeat) have been reported; if such disturbances occur, you must stop treatment immediately. Domperidone may be associated with an increased risk of heart rhythm disturbances 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 in adults and children.
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 EG 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
- Feeling of 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 the results of 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 EG for conditions and dosages requiring 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 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.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 EG
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 EG 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 carboxymethyl cellulose, hydrogenated castor oil, magnesium stearate.
Description of the appearance of Domperidone EG and contents of the pack
Pack of 30 tablets.
Marketing Authorisation Holder
EG S.p.A., Via Pavia, 6 – 20136 Milan
Manufacturer
Francia Farmaceutici S.r.l., Via dei Pestagalli, 7 Milan
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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 EGPostać farmaceutyczna: Tablet, 10 MGSubstancja czynna: domperidoneProducent: ABC FARMACEUTICI S.P.A.Wymaga receptyPostać farmaceutyczna: Coated tablet, 10 MGSubstancja czynna: domperidoneProducent: DOC GENERICI SRLWymaga receptyPostać farmaceutyczna: Tablet, 10 MGSubstancja czynna: domperidoneProducent: MYLAN S.P.A.Wymaga recepty
Odpowiedniki DOMPERIDONE EG w innych krajach
Leki z tą samą substancją czynną dostępne w innych krajach.
Odpowiednik DOMPERIDONE EG w Ukraina
Odpowiednik DOMPERIDONE EG w Hiszpania
Odpowiednik DOMPERIDONE EG w Polska
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DOMPERIDONE EG 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 EG jest domperidone. Informacja ta pomaga rozpoznać leki o tym samym składzie, ale pod różnymi nazwami handlowymi.
DOMPERIDONE EG jest produkowany przez EG S.P.A.. 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 EG 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 EG 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 DOK JENERIKI, 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.
