MOTILIUM 10 mg FILM-COATED TABLETS
How to use MOTILIUM 10 mg FILM-COATED TABLETS
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This page provides general information and does not replace a doctor’s consultation. Always consult a doctor before taking any medication. Seek urgent medical care if symptoms are severe.
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Introduction
Package Leaflet: Information for the User
Motilium 10 mg Film-Coated Tablets
Domperidone
Read all of this leaflet carefully before you start taking this medicine.
- Keep this leaflet, you may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
- If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
Contents of the Package Leaflet
- What is Motilium and what is it used for
- What you need to know before you take Motilium
- How to take Motilium
- Possible side effects
- Storage of Motilium
- Contents of the pack and further information
1. What is Motilium and what is it used for
This medicine is used in adults and adolescents (12 years of age and older and weighing 35 kg or more) to treat nausea (feeling sick) and vomiting.
2. What you need to know before you take Motilium
Do not take Motilium
- If you are allergic (hypersensitive) to domperidone or any of the other ingredients of Motilium.
- If you have stomach bleeding or severe abdominal pain or persistent black stools.
- If you have a blocked or perforated intestine.
- If you have a tumor of the pituitary gland (prolactinoma).
- If you have moderate or severe liver disease
- If your ECG (electrocardiogram) shows a heart problem called "prolonged QT interval"
- If you have or have had a problem where your heart does not pump blood to the whole body as it should (this is called heart failure)
- If you have a problem where you have low levels of potassium or magnesium in your blood, or high levels of potassium in your blood
- If you are taking certain medicines (see "Using other medicines")
Warnings and Precautions
Before taking this medicine, talk to your doctor if you:
- have liver problems (liver dysfunction or failure) (see "Do not take Motilium")
- have kidney problems (kidney dysfunction or failure). In this case, it is recommended to ask your doctor for advice in case of prolonged treatment, as you may need a lower dose 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. This risk is more likely in patients over 60 years of age or in those taking doses higher than 30 milligrams per day. The risk also increases when domperidone is given with certain medicines. Tell your doctor or pharmacist if you are taking medicines to treat infections (caused by fungi or bacteria) and/or if you have heart problems or HIV/AIDS (see the section "Using other medicines").
Domperidone should be used at the lowest effective dose.
While taking domperidone, contact your doctor if you experience heart rhythm disorders, such as palpitations, difficulty breathing, or loss of consciousness. In this case, treatment with domperidone should be discontinued.
Adolescents weighing less than 35 kg and children
Motilium should not be given to adolescents aged 12 and over who weigh less than 35 kg, or to children under 12 years of age, as it is not effective in these age groups.
Using other medicines
Do not take Motilium if you are taking medicines to treat:
- fungal infections, e.g. pentamidine or azole antifungals, specifically itraconazole, ketoconazole by mouth, fluconazole, posaconazole, or voriconazole
- bacterial infections, specifically erythromycin, clarithromycin, telithromycin, levofloxacin, moxifloxacin, spiramycin (these are antibiotics)
- heart problems or high blood pressure (e.g. amiodarone, dronedarone, ibutilide, disopyramide, dofetilide, sotalol, hydroquinidine, quinidine)
- psychosis (e.g. haloperidol, pimozide, sertindol)
- depression (e.g. citalopram, escitalopram)
- gastrointestinal disorders (e.g. cisapride, dolasetron, prucalopride)
- allergies (e.g. mequitazine, mizolastine)
- malaria (in particular halofantrine, lumefantrine)
- HIV/AIDS (in particular ritonavir or saquinavir (these are protease inhibitors))
- Hepatitis C (e.g. telaprevir)
- cancer (e.g. toremifene, vandetanib, vincamine).
Do not take Motiliumif you are taking certain other medicines (e.g. bepridil, difemanil, methadone).
Tell your doctor or pharmacist if you are taking medicines to treat infections, heart problems, or HIV/AIDS.
Motilium and Apomorphine
Before using Motilium and apomorphine, your doctor will make sure that you can take both medicines at the same time. Consult your doctor or specialist for personalized care. For more information, see the apomorphine package leaflet.
It is important to ask your doctor or pharmacist if Motilium is safe for you when using any other medicine, even those bought without a prescription.
Taking Motilium with food and drinks
Take Motilium before meals, as if taken after meals, its absorption is slightly delayed.
Pregnancy
It is not known if Motilium is safe to use in pregnant women. If you are pregnant or think you may be pregnant, tell your doctor, who will decide if you can take Motilium.
Breast-feeding
Small amounts of domperidone have been detected in breast milk.
Domperidone may cause unwanted side effects that affect the heart of the breastfed baby. Domperidone should only be used during breastfeeding if your doctor considers it clearly necessary. Consult your doctor for advice before taking this medicine.
Driving and using machines
Some patients have reported feeling dizzy or drowsy after taking Motilium. Do not drive or use machines while taking Motilium until you know how it affects you.
Important information about some of the ingredients of Motilium
This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.
This medicine may cause stomach upset and diarrhea because it contains hydrogenated castor oil.
This medicine contains less than 23 milligrams (1 millimole) of sodium per dose, so it is essentially "sodium-free".
3. How to take Motilium
Follow these instructions exactly, unless your doctor has told you otherwise.
Take Motilium before meals, because if taken after meals, its absorption is slightly delayed.
Duration of treatment
Symptoms usually resolve 3-4 days after taking this medicine. Do not take Motilium for more than 7 days without consulting your doctor.
Adults and adolescents 12 years of age and older and weighing 35 kilograms or more
The usual dose is one tablet taken up to three times a day, if possible before meals. Take the tablets with some water or other liquid. Do not chew the tablets. Do not take more than three tablets per day.
If you take moreMotilium than you should
If you have used or taken too much Motilium, contact your doctor, pharmacist, or poison control center immediately. In case of overdose, symptomatic treatment can be given. ECG monitoring may be performed, given the possibility of a heart problem called "prolonged QT interval".
In case of overdose or accidental ingestion, consult the Toxicological Information Service. Telephone 91 562 04 20.
Information for the doctor: it is recommended to closely monitor the patient and take general supportive measures. Anticholinergic antiparkinsonian medicines may help counteract extrapyramidal effects.
If you forget to takeMotilium
Take your medicine as soon as you remember. If it is almost time for your next dose, wait until then and continue with your regular schedule. Do not take a double dose to make up for forgotten doses.
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 and legs, excessive trembling, excessive muscle stiffness or muscle spasms
Frequency not known(cannot be estimated from the available data):
- Seizures
- A type of reaction that can occur immediately after administration and is characterized by skin rash, itching, shortness of breath and/or swelling of the face
- A severe allergic reaction that can occur immediately after administration, characterized by hives, itching, flushing, fainting, and difficulty breathing, among other possible symptoms
- Cardiovascular disorders: heart rhythm disorders (fast or irregular heartbeat) have been reported; if this occurs, you should stop treatment immediately. Domperidone may be associated with an increased risk of heart rhythm disorders and cardiac arrest. This risk is more likely in patients over 60 years of age or in those taking doses higher than 30 milligrams per day. Domperidone should be used at the lowest effective dose.
Stop treatment with domperidone and contact your doctor immediatelyif you experience any of the above side effects.
Other side effects observed with Motilium 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 decreased sexual interest
- Headache
- Drowsiness
- Diarrhea
- Skin rash
- Itching
- Hives
- Breast pain or tenderness
- Breast milk secretion
- General feeling of weakness
- Feeling of dizziness
Frequency not known(cannot be estimated from the available data):
- Eye movement upwards
- Stop of menstrual period in women
- Breast enlargement in men
- Urination difficulties
- Changes in the results of certain laboratory tests
- Restless legs syndrome (uncomfortable feeling, with an irresistible urge to move your legs, and sometimes arms and other parts of your body).
Some patients who have taken Motilium in conditions and doses that require medical supervision have experienced the following side effects:
Restlessness; breast swelling or enlargement, unusual breast secretion, irregular menstrual periods in women, difficulty breastfeeding, depression, hypersensitivity.
Reporting of side effects
If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https//www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.
5. Storage of Motilium
- Keep this medicine out of the sight and reach of children.
- Do not store above 30°C.
- Do not use Motilium after the expiry date stated on the pack. The expiry date "CAD" is the last day of the month indicated, where the first two digits indicate the month and the next ones, the year.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.
6. Contents of the pack and further information
Composition ofMotilium
- The active substance is domperidone.
- The other ingredients are: lactose monohydrate, corn starch, microcrystalline cellulose (E-460), pregelatinized potato starch, povidone, magnesium stearate (E-572), sodium lauryl sulfate, and hydrogenated castor oil, sodium lauryl sulfate, hypromellose (E-464).
Appearance of the product and pack contents
White, glossy, biconvex, film-coated tablet, without defects or roughness. Anonymous on both sides.
The tablets are presented in a blister pack and the pack contains 30 tablets
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
Esteve Pharmaceuticals, S.A.
Passeig de la Zona Franca, 109
08038 Barcelona
Spain
Manufacturer:
TOWA Pharmaceutical Europe, S.L.
c/ de Sant Martí, 75-97 08107 Martorelles (Barcelona)
Spain
This leaflet was approved in May 2019
Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS)http://www.aemps.gob.es/
- Country of registration
- Average pharmacy price2.28 EUR
- Active substance
- Prescription requiredYes
- Manufacturer
- This information is for reference only and does not constitute medical advice. Always consult a doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content.
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