DOMPERIDONE 10 mg Tabletka Powlekana
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Jak stosować DOMPERIDONE SANDOTS
Treść ulotki
Domperidone Sandoz 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 could 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 Sandoz is and what it is used for
- 2. What you need to know before you take Domperidone Sandoz
- 3. How to take Domperidone Sandoz
- 4. Possible side effects
- 5. How to store Domperidone Sandoz
- 6. Contents of the pack and other information
1. What is Domperidone Sandoz and what is it used for
Domperidone Sandoz 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 sick).
2. What you need to know before you take Domperidone Sandoz
Do not take Domperidone Sandoz:
- if you are allergic to the active ingredient or to any of the other ingredients of this medicine (listed in section 6);
- if you have bleeding in the stomach or regularly experience severe abdominal pain or persistent black stools
- if you have obstructions or perforations of the intestines
- if you have tumors of the pituitary gland that release prolactin (prolactinoma);
- if you have moderate or severe liver disorder;
- if the ECG (electrocardiogram) shows a heart disorder called “prolongation of the 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 “Other medicines and Domperidone Sandoz”); Warnings and precautionsTalk to your doctor or pharmacist before taking Domperidone Sandoz. Before taking this medicine, contact your doctor if:
- you suffer from liver disorders (impaired or hepatic insufficiency) (see “Do not take Domperidone Sandoz);
- you suffer from kidney disorders (impaired or renal insufficiency). Ask your doctor for advice if you are undergoing 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 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 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 section “Other medicines and Domperidone Sandoz”).
Domperidone should be used at the lowest effective dose.
While taking domperidone, contact your doctor if you notice heart rhythm disturbances such as palpitations, difficulty
breathing, fainting. In this case, treatment with domperidone should be stopped.
Adolescents weighing less than 35 kg and children
DOMPERIDONE SANDOZ 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 Sandoz
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
Do not take Domperidone Sandoz 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 oral;
- bacterial infections, in particular erythromycin, clarithromycin, telithromycin, moxifloxacin, levofloxacin, spiramycin (these medicines are antibiotics);
- heart problems or high blood pressure (for example amiodarone, dronedarone, ibutilide, disopyramide, dofetilide, sotalol, hydroquinidine, quinidine, 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 halofantrine, lumefantrine);
- AIDS/HIV (protease inhibitors) (for example ritonavir or saquinavir);
- hepatitis C (for example telaprevir)
- tumors (for example toremifene, vandetanib, vincamine); Do not take Domperidone Sandoz if you are taking other medicines (for example bepridil, diphemanil, methadone). Tell your doctor or pharmacist if you are taking medicines for the treatment of infections, heart disorders or AIDS/HIV or Parkinson's disease.
It is important that you ask your doctor or pharmacist if Domperidone Sandoz is safe for you while taking
other medicines, including over-the-counter medicines.
Domperidone Sandoz and apomorphine
Before using Domperidone Sandoz and apomorphine, your doctor will make sure that your body can tolerate
taking both medicines at the same time. Ask your doctor for personalized advice or a
specialist. Read the leaflet for apomorphine.
Domperidone Sandoz with food and drink
Take Domperidone Sandoz before meals. If taken after meals, the absorption of the
medicine is slightly slowed down.
Pregnancy and breastfeeding
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
It is not known whether the use of Domperidone Sandoz during pregnancy is harmful.
If you are pregnant or think you may be, tell your doctor who will decide whether you can take Domperidone Sandoz
Breastfeeding
Small amounts of domperidone have been detected in breast milk. Domperidone can cause undesirable effects on the
heart of the breastfed newborn. Domperidone should only be used during breastfeeding 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. Do not drive or operate
machinery while taking domperidone until you know how domperidone affects you.
Domperidone Sandoz contains lactose and sodium
This medicine contains lactose, a type of sugar. If you have been diagnosed with intolerance to some
sugars, contact your doctor before taking this medicine.
This medicine contains less than 1 mmol (23mg) of sodium per tablet, i.e. essentially “sodium-free”.
3. How to take Domperidone Sandoz
Take this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts, ask your
doctor or pharmacist.
Strictly adhere to these instructions, unless your doctor has provided you with different instructions.
It is recommended to use Domperidone Sandoz 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 Sandoz
for more than 7 days without consulting your doctor.
Adults and adolescents aged 12 years or over and weighing 35 kg or more
Take the medicine preferably at the same time of day.
The usual dose is one tablet up to three times a day, preferably before meals. Do not take more than three
tablets a day. Take the tablets with a little water or other liquid. Do not chew them.
If you take more Domperidone Sandoz than you should
If you have taken an excessive amount of Domperidone Sandoz, contact your doctor, pharmacist or the nearest
poison control center immediately. In case of overdose, symptomatic treatment is appropriate. Monitoring with an
electrocardiogram should be performed, given the possibility of a cardiac problem called
“QT interval prolongation”.
Information for the doctor:close medical supervision of the subject and general supportive therapy are recommended.
Anticholinergic anti-Parkinson's drugs may be useful in controlling extrapyramidal disorders.
If you forget to take Domperidone Sandoz
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 forgotten dose.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects can occur:
Uncommon(may affect up to 1 in 100 people):
- Involuntary movements of the face or arms or legs, excessive tremor, excessive rigidity or muscle spasm
Not known(frequency cannot be estimated from the available data):
- Convulsions
- A type of reaction that may occur immediately after administration and is characterized by skin rash, itching, shortness of breath and/or swelling of the face
- A serious hypersensitivity reaction that may occur immediately after administration and is characterized by hives, itching, flushing, fainting, and among other possible symptoms, difficulty breathing. Cardiovascular 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 minimum effective dosage. 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 Sandoz 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
- Diarrhea
- Skin rash
- Itching
- Hives
- 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
- Unpleasant sensation in the legs (also called restless legs syndrome)
Some patients who have used Domperidone Sandoz 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 side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system at: wwww.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 Sandoz
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.
Store at a temperature below 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 Sandoz contains
- The active ingredient is domperidone. Each tablet contains 10 mg of domperidone.
- The other ingredients are: lactose monohydrate, corn starch, microcrystalline cellulose, povidone K30, sodium lauryl sulfate, magnesium stearate, anhydrous colloidal silica.
Description of the appearance of Domperidone Sandoz and contents of the pack
White, circular and biconvex tablets with an incision on one side.
PVC/Al blisters containing 30 tablets.
Marketing Authorisation Holder
Sandoz S.p.A., Largo U. Boccioni 1, Origgio (VA) - Italy
Manufacturer
Salutas Pharma GmbH , Otto-von Guericke Alee 1 , Barleben - Germany
LEK d.d., Verovškova 57, 1526 Ljubljana (Slovenia)
LEK d.d. BU Production Lendava, Trimlini 2 D, 9220 Lendava (Slovenia)
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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 SANDOTSPostać 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: Coated tablet, 10 MGSubstancja czynna: domperidoneProducent: EG S.P.A.Wymaga recepty
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DOMPERIDONE SANDOTS 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 SANDOTS jest domperidone. Informacja ta pomaga rozpoznać leki o tym samym składzie, ale pod różnymi nazwami handlowymi.
DOMPERIDONE SANDOTS jest produkowany przez SANDOZ 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 SANDOTS 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 SANDOTS 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 EG. Mogą one różnić się nazwą handlową lub postacią, ale zawierają ten sam składnik terapeutyczny. Przed zmianą lub rozpoczęciem nowego leku skonsultuj się z lekarzem.
