Patient Information Leaflet

Domperidone Gamir 10 mg, Hard Capsules

Domperidone

Read this 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. Do not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet.See section 4.

1. What is Domperidone Gamir and what is it used for

2. What you need to know before you start taking Domperidone Gamir

3. How to take Domperidone Gamir

4. Possible side effects

5. Storage of Domperidone Gamir

6. Contents of the pack and additional information

This medication is used in adults and adolescents (12 years of age and older and weighing 35 kg or more) to treat nausea (urge to vomit) and vomiting.

Do not take Domperidona Gamir if:

• You are allergic to domperidone or any of the other components of this medication (listed in section 6).
• You have regular stomach bleeding or intense abdominal pain, persistent black stools.
• You have a blocked or perforated intestine.
• You have a pituitary gland tumor (prolactinoma).
• You have moderate or severe liver disease.
• Your ECG (electrocardiogram) shows a heart problem called "prolongation of the corrected QT interval."
• You have or have had a heart problem that prevents your heart from pumping blood to your entire body as it should (known as heart failure).
• You have low levels of potassium or magnesium in your blood or high levels of potassium in your blood.
• You are taking certain medications (see "Other medications and Domperidona Gamir").

Warnings and precautions

Before taking this medication, consult your doctor if you:

• Have liver problems (dysfunction or liver insufficiency) (see "Do not take Domperidona Gamir").
• Have kidney problems (dysfunction or kidney insufficiency). In this case, it is recommended to consult your doctor for prolonged treatment, as you may need a lower dose or take this medication less frequently. Your doctor may want to examine you regularly.

Domperidone may be associated with an increased risk of heart rhythm disorder and cardiac arrest. This risk is more likely in patients over 60 years old or those taking doses above 30 mg/day. The risk also increases when domperidone is administered with certain medications. Inform your doctor or pharmacist if you are taking medications to treat infections (produced by fungi or bacteria) and/or if you have heart problems or HIV/AIDS/ HIV infection (see the section "Other medications and Domperidona Gamir").

Domperidone should be used at the most 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, the treatment with domperidone should be suspended.

Other medications and Domperidona Gamir

Do not take Domperidona Gamir if you are taking medications to treat:

• Infections produced by fungi, e.g., pentamidine or azole antifungals, specifically itraconazole, ketoconazole oral, fluconazole, posaconazole, or voriconazole.
• Infections produced by bacteria, 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).
• Digestive problems (e.g., cisapride, dolasetron, prucalopride).
• Allergies (e.g., mequitazine, mizolastine).
• Malaria (particularly halofantrine, lumefantrine).
• HIV/AIDS infection as ritonavir or saquinavir protease inhibitors.
• Heptatitis C (e.g., telaprevir).
• Cancer (e.g., toremifene, vandetanib, vincamine).

Do not take Domperidona Gamir if you are taking other medications (e.g., bepridil, difemanil, methadone).

Inform your doctor or pharmacist if you are using medications to treat infections, heart problems, or HIV/AIDS/HIV infection or Parkinson's disease.

Domperidona Gamir and apomorphine

Before using Domperidona Gamir and apomorphine, your doctor will ensure that you can take both medications simultaneously. Consult your doctor or specialist for personalized attention. For more information, see the apomorphine prospectus.

It is essential to ask your doctor or pharmacist if Domperidona Gamir is safe for you when using any other medication, including those purchased without a prescription.

Taking Domperidona Gamir with food and drinks

Take Domperidona Gamir before meals, as taking it after meals will slightly delay its absorption.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using this medication.

Pregnancy

The safety of using Domperidona Gamir in pregnant women is unknown.

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

Breastfeeding

Small amounts of domperidone have been detected in breast milk. Domperidone may cause unwanted side effects that affect the baby's heart. Domperidone should be used during breastfeeding only if your doctor considers it clearly necessary. Consult your doctor before taking this medication.

Driving and operating machinery

Some patients have reported feeling dizzy or drowsy after taking Domperidona Gamir. Do not drive or operate machinery until you know how Domperidona Gamir affects you.

Domperidona Gamir contains lactose

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

Follow these administration instructions exactly unless your doctor tells you otherwise.Take Domperidona Gamir before meals, as absorption may be slightly delayed if taken afterwards.

Treatment Duration

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

Adults and Adolescents12 years of age or olderwith a body weight of 35 kg or more

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

Do not take more than three capsules per day.

Take the capsules with some water. Do not chew or break the capsules.

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If You Take More Domperidona Gamir Than You Should

If you have used or taken too much Domperidona 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 called "prolongation of the QT interval".

In case of overdose or accidental ingestion, contact 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 medications may help counteract extrapyramidal effects.

If You Forget to Take Domperidona Gamir

Take your medication as soon as you remember. If it is almost time for your next dose, wait for that time and continue with your regular schedule. Do not take a double dose to make up for the missed dose.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, Domperidone Gamir can cause side effects, although not everyone will experience them.

Rare(may affect up to 1 in 100 people):

• Uncontrolled movements of the face, arms, and legs, excessive trembling, excessive muscle stiffness, or muscle spasms.

Frequency not known(cannot be estimated from 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 facial swelling.
• A severe hypersensitivity reaction that can occur immediately after administration, characterized by hives, itching, shortness of breath, dizziness, and difficulty breathing, among other possible symptoms.
• Cardiovascular system disorders: abnormal heart rhythms (rapid or irregular heartbeat) have been reported; if this occurs, you should stop treatment immediately. Domperidone may be associated with an increased risk of abnormal heart rhythms and cardiac arrest. This risk is more likely in patients over 60 years old or those taking doses above 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 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.

Rare(may affect up to 1 in 100 people)

• Anxiety.
• Agitation.
• Nervousness.
• Loss or decrease of sexual interest.
• Headache.
• Drowsiness.
• Diarrhea.
• Skin rash.
• Itching.
• Hives.
• Breast tenderness.
• Milk secretion from the breasts.
• General feeling of weakness.
• Dizziness.

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

• Eye rolling.
• Stopping of menstrual periods in women.
• Enlargement of breasts in men.
• Inability to urinate.
• Changes in laboratory test results.
• Restless legs syndrome (uncomfortable sensation, with an irresistible desire to move your legs, and sometimes arms and other parts of your body).
• Some patients who have taken Domperidone Gamir in conditions and doses requiring medical supervision, have experienced the following side effects: restlessness, breast swelling, unusual milk secretion, irregular menstrual periods in women, difficulty breastfeeding, depression, hypersensitivity

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

No special storage conditions are required.

Store in the original packaging.

Do not use Domperidona Gamir after the expiration date that appears on the packaging after “CAD” or “EXP”. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medications at your local SIGRE collection point. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Domperidona Gamir.

- The active ingredient is domperidone. Each capsule contains 10 mg of domperidone.

- The other components are: lactose, magnesium stearate, talc, gelatin, titanium dioxide, erythrosine, iron oxide red, iron oxide black.

Appearance of the product and contents of the packaging

Domperidona Gamir is presented in the form of 30 hard, gray capsules with a red cap.

Each package contains 30 capsules.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Viatris Healthcare Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Responsible for manufacturing

ALCALÁ FARMA S.L.

Avenida de Madrid 82

28802 Alcalá de Henares, Madrid - Spain

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

Viatris Pharmaceuticals, S.L.

C/ General Aranaz, 86

28027 - Madrid

Spain

Last review date of this leaflet: February 2020

The detailed information about this medication is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)

(https://www.aemps.gob.es/)