DOMPERIDONE GAMIR 10 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the Patient

Domperidone Gamir 10 mg, Hard Capsules

Domperidone

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get 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

1. What is Domperidone Gamir and what is it used for
2. What you need to know before you take Domperidone Gamir
3. How to take Domperidone Gamir
4. Possible side effects
5. Storage of Domperidone Gamir
6. Contents of the pack and further information

1. What is Domperidone Gamir 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 Domperidone Gamir

Do not take Domperidone Gamir if:

• You are allergic to domperidone or any of the other ingredients of this medicine (listed in section 6).
• You have a stomach or intestinal bleeding, or you have a severe abdominal pain of unknown cause.
• You have a blockage or perforation in your intestines.
• You have a tumor of the pituitary gland (prolactinoma).
• You have moderate or severe liver disease.
• Your ECG (electrocardiogram) shows a heart problem known as "prolonged QT interval".
• You have a heart condition where your heart is not pumping properly (heart failure).
• You have low levels of potassium or magnesium in your blood, or you have high levels of potassium in your blood.
• You are taking certain medicines (see "Other medicines and Domperidone Gamir").

Warnings and precautions

Before taking this medicine, tell your doctor if you:

• have liver problems (liver dysfunction or liver failure) (see "Do not take Domperidone Gamir").
• have kidney problems (kidney dysfunction or kidney 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. 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 old or in those taking doses above 30 mg/day. The risk also increases when domperidone is given with certain other medicines. Tell your doctor or pharmacist if you are taking medicines for infections (caused by fungi or bacteria) and/or if you have heart problems or HIV/AIDS (see the 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 disorders, such as palpitations, difficulty breathing, or loss of consciousness. In this case, treatment with domperidone should be discontinued.

Other medicines and Domperidone Gamir

Do not take Domperidone Gamir if you are taking medicines for:

• 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, sertindole)
• 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 protease inhibitors)
• 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, difemanil, methadone).

Tell your doctor or pharmacist if you are taking medicines for infections, heart problems, or HIV/AIDS.

Domperidone Gamir and apomorphine

Before using Domperidone Gamir and apomorphine, your doctor will make sure that you can take both medicines at the same time. Consult your doctor or specialist for personalized advice. For more information, see the apomorphine package leaflet.

It is important to ask your doctor or pharmacist if Domperidone Gamir is safe for you when using any other medicine, including those bought without a prescription.

Taking Domperidone Gamir with food and drinks

Take Domperidone Gamir before meals, as its absorption may be slightly delayed if taken after meals.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using this medicine.

Pregnancy

It is not known if Domperidone Gamir is safe in pregnant women.

If you are pregnant or think you may be pregnant, tell your doctor, who will decide if you can take Domperidone Gamir.

Breastfeeding

Small amounts of domperidone have been detected in breast milk. Domperidone may cause unwanted 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 before taking this medicine.

Driving and using machines

Some patients have reported feeling dizzy or drowsy after taking Domperidone Gamir. Do not drive or use machines while taking Domperidone Gamir until you know how it affects you.

Domperidone Gamir contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

3. How to take Domperidone Gamir

Follow these instructions exactly, unless your doctor has told you otherwise. Take Domperidone Gamir before meals, because if taken after meals, its absorption may be slightly delayed.

Duration of treatment

Symptoms usually resolve 3-4 days after taking this medicine. Do not take Domperidone Gamir for more than 7 days without consulting your doctor.

Adults and adolescents of 12 years of age or older with a body weight of 35 kg or more

The usual dose is one capsule taken up to three times a day, if possible before meals.

Do not take more than three capsules a 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 can be administered. ECG monitoring may be performed due to the possibility of a heart problem known as "prolonged QT interval".

In case of overdose or accidental ingestion, consult the Toxicological Information Service. Phone 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 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 forgotten doses.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Domperidone Gamir 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 tremor, excessive muscle rigidity, or muscle spasms.

Frequency not known(cannot be estimated from the available data)

• Seizures.
• A type of reaction that can occur immediately after administration, 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 old or in those taking doses above 30 mg/day. Domperidone should be used at the lowest effective dose.

Stop treatment with domperidone and contact your doctor immediatelyif you experience any of the side effects described above.

Other side effects observed with Domperidone Gamir 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.
• Restlessness.
• Decreased or lost sexual interest.
• Headache.
• Drowsiness.
• Diarrhea.
• Skin rash.
• Itching.
• Hives.
• Pain or tenderness in the breasts.
• Milk secretion from the breasts.
• General feeling of weakness.
• Feeling of dizziness.

Frequency not known(cannot be estimated from the available data):

• Rolling of the eyes upwards.
• Stop of menstrual periods in women.
• Enlargement of the breasts in men.
• Difficulty urinating.
• 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 Domperidone Gamir for conditions and doses that require medical supervision have experienced the following side effects: restlessness, swelling or enlargement of the breasts, unusual milk secretion from the breasts, irregular menstrual periods in women, difficulty breastfeeding, depression, hypersensitivity.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. You can also report side effects directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: https://www.notificaram.es. By reporting side 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 package.

Do not use Domperidone Gamir after the expiry date which is stated on the carton after "EXP". The expiry date refers to the last day of the month shown.

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 of Domperidone Gamir.

• The active substance is domperidone. Each capsule contains 10 mg of domperidone.
• The other ingredients are: lactose, magnesium stearate, talc, gelatin, titanium dioxide, erythrosine, iron oxide red, iron oxide black.

Appearance of the product and contents of the pack

Domperidone Gamir is presented in the form of 30 hard capsules with a gray body and 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

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.

C/ General Aranaz, 86

28027 - Madrid

Spain

Date of last revision of this leaflet: February 2020

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) https://www.aemps.gob.es/