Domperidone Gamir 10 mg, hard capsules
Spain
Table of Contents
Patient Information Leaflet
Introduction
Package leaflet: Information for the patient
Domperidone Gamir 10 mg, hard capsules
Domperidone
Read the entire leaflet carefully before you start taking this medicine because it contains important information for you.
- Keep this leaflet, as 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 and must not be given to other people, even if they have the same symptoms as you, since it could harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
Leaflet contents
- What Domperidone Gamir is and what it is used for
- What you need to know before taking Domperidone Gamir
- How to take Domperidone Gamir
- Possible side effects
- How to store Domperidone Gamir
- Contents of the pack and other information
1. What Domperidone Gamir is and what it is used for
This medicine is used in adults and adolescents (12 years of age and older weighing 35 kg or more) to treat nausea (feeling sick) and vomiting.
2. What you need to know before taking Domperidone Gamir
Do not take Domperidone Gamir if:
- You are allergic to domperidone or to any of the other ingredients of this medicine (listed in section 6).
- You have stomach bleeding or regular severe abdominal pain, persistent black stools.
- You have a blocked or perforated intestine.
- You suffer from a tumour of the pituitary gland (prolactinoma).
- You have moderate or severe liver disease.
- Your ECG (electrocardiogram) shows a heart problem called “corrected QT interval prolongation”.
- You have or have had heart problems whereby your heart cannot pump blood properly around the body (known as heart failure).
- You have or have had conditions causing low levels of potassium or magnesium in your blood, or high levels of potassium in your blood.
- You are taking certain medicines (see “Other medicines and Domperidone Gamir”).
- You have or may have a rare tumour of the adrenal gland (phaeochromocytoma), as this could increase your blood pressure.
Warnings and precautions
Before taking this medicine, consult your doctor if you:
- Have liver problems (hepatic dysfunction or failure) (see “Do not take Domperidone Gamir”).
- Have kidney problems (renal dysfunction or failure). In this case, it is advisable to seek medical advice if long-term treatment is needed, as you may require a lower dose or less frequent administration. Your doctor may wish to monitor you regularly.
Domperidone may be associated with an increased risk of heart rhythm disorders and cardiac arrest. This risk is higher in patients over 60 years of age or in those taking doses exceeding 30 mg/day. The risk also increases when domperidone is taken together with certain medicines. Inform 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 AIDS/HIV infection (see section “Other medicines and Domperidone Gamir”).
Domperidone should be used at the lowest effective dose.
While taking domperidone, contact your doctor if you experience heart rhythm disturbances such as palpitations, difficulty breathing, or loss of consciousness. In such cases, treatment with domperidone should be discontinued.
Other medicines and Domperidone Gamir
Do not take Domperidone Gamir if you are taking medicines to treat:
- Fungal infections, e.g.: pentamidine or azole antifungals, specifically itraconazole, oral ketoconazole, 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, sertindole)
- Depression (e.g., citalopram, escitalopram)
- Gastrointestinal disorders (e.g., cisapride, dolasetron, prucalopride)
- Allergies (e.g., mequitazine, mizolastine)
- Malaria (particularly halofantrine, lumefantrine)
- AIDS/HIV infection such as ritonavir or protease inhibitors like saquinavir
- Hepatitis C (e.g., telaprevir)
- Cancer (e.g., toremifene, vandetanib, vincamine)
Do not take Domperidone Gamir if you are taking other medicines (e.g., bepridil, dofetilide, methadone).
Inform your doctor or pharmacist if you are taking medicines for infections, heart problems, AIDS/HIV infection, or Parkinson’s disease.
Domperidone Gamir and apomorphine
Before using Domperidone Gamir and apomorphine together, your doctor will ensure that it is safe for you to take both medicines simultaneously. Consult your doctor or specialist for personalized advice. For further information, refer to the apomorphine package leaflet.
It is important to ask your doctor or pharmacist whether Domperidone Gamir is safe for you when taking any other medicines, including those obtained without a prescription.
Taking Domperidone Gamir with food and drink
Take Domperidone Gamir before meals, as absorption is slightly delayed if taken after meals.
Pregnancy and breastfeeding
Consult your doctor or pharmacist before using this medicine.
Pregnancy
It is unknown whether Domperidone Gamir is safe for use in pregnant women.
If you are pregnant or think you may be pregnant, inform your doctor, who will decide whether you can take Domperidone Gamir.
Breastfeeding
Small amounts of domperidone have been detected in breast milk. Domperidone may cause unwanted side effects affecting the infant’s heart. Domperidone should only be used during breastfeeding if your doctor considers it clearly necessary. Consult your doctor before taking this medicine.
Driving and using machines
Some patients have reported feeling dizzy or drowsy after taking Domperidone Gamir. Do not drive or operate machinery while taking Domperidone Gamir until you know how it affects you.
Domperidone Gamir contains lactose
This medicine contains lactose. If your doctor has informed you of an intolerance to certain sugars, consult him before taking this medicine.
3. How to take Domperidone Gamir
Follow these administration instructions exactly unless your doctor tells you otherwise. Take Domperidone Gamir before meals, because if taken afterwards, absorption is slightly delayed.
Duration of treatment
Symptoms usually resolve within 3–4 days after taking this medicine. Do not take Domperidone Gamir for longer than 7 days without consulting your doctor.
Adults and adolescents aged 12 years and older with a body weight of 35 kg or more
The usual dose is one capsule taken up to three times daily, preferably before meals.
Do not take more than three capsules per day.
Take the capsules with some water. Do not chew or open the capsules.
If you take more Domperidone Gamir than you should
If you have used or taken too much Domperidone Gamir, contact your doctor, pharmacist, or poison control center immediately. In case of overdose, symptomatic treatment may be administered. ECG monitoring may be performed due to the possibility of a heart problem known as “QT interval prolongation”.
In case of overdose or accidental ingestion, contact the Toxicology Information Service. Telephone 91-562-04-20.
Information for the physician: close observation of the patient is recommended, along with provision of general supportive measures. Antiparkinsonian anticholinergic drugs may help counteract extrapyramidal effects.
If you forget to take Domperidone Gamir
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 a missed dose.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, Domperidone Gamir may produce adverse effects, although not everyone experiences them.
Uncommon (may affect up to 1 in 100 people):
- Involuntary movements of the face, arms, and legs; excessive tremor; excessive muscle rigidity; or muscle spasms.
Frequency not known (cannot be estimated from the available data):
- Seizures.
- A type of reaction that may occur immediately after administration and is characterized by skin rash, itching, shortness of breath, and/or facial swelling.
- A severe hypersensitivity reaction that may occur immediately after administration, characterized by urticaria, itching, flushing, fainting, and difficulty breathing, among other possible symptoms.
- Cardiovascular disorders: disturbances in heart rhythm (fast or irregular heartbeat) have been reported; if this occurs, you must stop treatment immediately. Domperidone may be associated with an increased risk of heart rhythm disturbances and cardiac arrest. This risk is higher in patients over 60 years of age or in those taking doses exceeding 30 milligrams/day. Domperidone should be used at the lowest effective dose.
Stop treatment with domperidone and contact your doctor immediately if you experience any of the adverse effects described above.
Other adverse effects observed with Domperidone Gamir are listed below:
Frequent (may affect up to 1 in 10 people):
- Dry mouth.
Uncommon (may affect up to 1 in 100 people):
- Anxiety.
- Restlessness.
- Nervousness.
- Loss or decrease in sexual interest.
- Headache.
- Somnolence.
- Diarrhea.
- Skin rash.
- Itching.
- Urticaria.
- Pain or tenderness in the breasts.
- Breast milk secretion.
- General feeling of weakness.
- Dizziness.
Frequency not known (cannot be estimated from the available data):
- Upward movement of the eyes.
- Cessation of menstrual periods in women.
- Breast enlargement in men.
- Inability to urinate.
- Changes in the results of certain laboratory tests.
- Restless legs syndrome (uncomfortable sensation with an irresistible urge to move the legs, and sometimes arms and other body parts).
- Some patients who have taken Domperidone Gamir for conditions and at doses requiring medical supervision have experienced the following adverse effects: restlessness, swelling or enlargement of the breasts, unusual breast secretion, irregular menstrual periods in women, difficulty breastfeeding, depression, hypersensitivity.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Domperidone Gamir
Keep this medicine out of the sight and reach of children.
No special storage conditions are required.
Store in the original packaging.
Do not use Domperidone Gamir after the expiry date stated on the packaging after "CAD" or "EXP". The expiry date refers to the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your usual pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Domperidone Gamir.
- The active substance is domperidone. Each capsule contains 10 mg of domperidone.
- The other components are: lactose, magnesium stearate, talc, gelatin, titanium dioxide, erythrosine, red iron oxide, black iron oxide.
Nature of the product and pack contents
Domperidone Gamir is available as 30 hard capsules, grey in colour with a red cap.
Each pack contains 30 capsules.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Viatris Healthcare Limited
Damastown Industrial Park
Mulhuddart, Dublin 15
Dublin
Ireland
Manufacturer
ALCALÁ FARMA S.L.
Avenida de Madrid 82
28802 Alcalá de Henares, Madrid - Spain
For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:
Viatris Pharmaceuticals, S.L.
C/ General Aranaz, 86
28027 - Madrid
Spain
Date of the most recent review of this leaflet: November 2025
Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS): https://www.aemps.gob.es/