Domperidone Pensa 10 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Domperidone pensa 10 mg tablets EFG

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 you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if these effects are not listed in this leaflet. See section 4.

Leaflet contents

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

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

This medicine is used in adults and adolescents (12 years of age and older with a body weight of 35 kg or more) to treat nausea and vomiting.

2. What you need to know before taking Domperidona pensa

Do not take Domperidona pensa

• If you are allergic to domperidone maleate or to any of the other ingredients of this medicine (listed in section 6).

• If you have a tumor of the pituitary gland (prolactinoma).

• If you have stomach bleeding, regular severe abdominal pain, or persistent black stools.

• If you have a blocked or perforated intestine.

• If you have moderate or severe liver disease.

• If your ECG (electrocardiogram) shows a heart problem called "corrected QT interval prolongation".

• If you have or have had a condition in which your heart cannot pump blood properly throughout the body (known as heart failure).

• If you have a condition causing low levels of potassium or magnesium in your blood, or high levels of potassium in your blood.

• If you are taking certain medicines (see "Taking other medicines").

• If you have or might have a rare tumor of the adrenal gland (pheochromocytoma), 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 liver failure) (see “Do not take Domperidona Pensa”)
• You have kidney problems (renal dysfunction or renal failure). It is advisable to seek medical advice if prolonged treatment is needed, as you may require a lower dose or less frequent dosing. Your doctor may also 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 medications. Inform your doctor or pharmacist if you are taking medicines for infections (caused by fungi or bacteria) and/or if you have heart problems or AIDS/HIV infection (see section “Other medicines and Domperidona Pensa”).

Domperidone should be used at the lowest effective dose.

While taking domperidone, contact your doctor immediately if you experience heart rhythm disturbances such as palpitations, difficulty breathing, or loss of consciousness. Treatment with domperidone should be discontinued.

Adolescents weighing less than 35 kg and children

Domperidone must not be administered to adolescents aged 12 years and older who weigh less than 35 kg, or to children under 12 years of age, as it is not effective in these age groups.

Other medicines and Domperidona Pensa

Inform your doctor or pharmacist if you are currently taking, have recently taken, or might need to take any other medicines.

Do not take Domperidona Pensa if you are taking medicines to treat:

• Fungal infections, such as pentamidine or azole antifungals, specifically itraconazole, oral ketoconazole, fluconazole, posaconazole, or voriconazole.
• Bacterial infections, specifically erythromycin, clarithromycin, telithromycin, levofloxacin, moxifloxacin, or spiramycin (these are antibiotics).
• Heart problems or high blood pressure (e.g., amiodarone, dronedarone, ibutilide, quinidine, disopyramide, dofetilide, sotalol, hydroquinidine).
• 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 saquinavir (these are protease inhibitors).
• Hepatitis C (e.g., telaprevir).
• Cancer (e.g., toremifene, vandetanib, vincamine).

Do not take domperidone if you are taking certain 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.

Domperidona Pensa and apomorphine:

Before taking Domperidona Pensa 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 Domperidona Pensa is safe for you when taking any other medicine, including those obtained without a prescription.

Taking Domperidona Pensa with food and drinks

Take Domperidona Pensa before meals, as absorption of the medicine is slightly delayed if taken after meals.

Pregnancy and breastfeeding

If you are pregnant, breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before taking this medicine.

Pregnancy

It is unknown whether Domperidona Pensa is safe to use in pregnant women. If you are pregnant or think you may be pregnant, inform your doctor, who will decide whether you can take Domperidona Pensa.

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 clearly considered necessary by your doctor. Consult your doctor before taking this medicine.

Driving and using machines

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

Domperidona Pensa contains lactose and sodium

This medicine contains lactose. If your doctor has informed you of an intolerance to certain sugars, consult him or her before taking this medicine.

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; that is, essentially “sodium-free”.

3. How to take Domperidone pensa

Follow these administration instructions exactly unless your doctor has told you otherwise.

Take Domperidone pensa before meals, because if taken after meals, its absorption is slightly delayed.

Duration of treatment:

Symptoms usually resolve within 3–4 days after taking this medicine. Do not take Domperidone pensa 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 tablet taken up to three times a day, preferably before meals.

Take the tablet with some water or another liquid. Do not chew the tablet.

Do not take more than three tablets per day.

If you take more Domperidone pensa than you should

If you have used or taken too much Domperidone pensa, contact your doctor, pharmacist, or a 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 the implementation of general supportive measures. Antiparkinsonian anticholinergic drugs may help counteract extrapyramidal effects.

If you forget to take Domperidone pensa:

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 dosing schedule. Do not take a double dose to make up for a missed dose.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

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

• Involuntary movements of the face or arms and legs, excessive trembling, excessive muscle rigidity, or muscle spasm.

Frequency not known (cannot be estimated from 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 serious hypersensitivity reaction that may occur immediately after administration, characterized by hives, 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 per 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 domperidona 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 decrease in sexual interest
• Drowsiness
• Headache
• Diarrhea
• Skin rash
• Itching
• Hives
• Pain or tenderness in the breasts
• Breast milk secretion
• Feeling of general weakness
• Dizziness

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

• Upward movement of the eyes
• Inability to urinate
• Breast enlargement in men
• Cessation of menstrual periods
• 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 under conditions and 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 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 Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Domperidone pensa

Keep this medicine out of sight and reach of children.

This medicine does not require any special storage temperature. Store in a dry place and in the original packaging.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater drains or in household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Domperidona pensa

The active substance is domperidone. Each tablet contains 10 mg of domperidone as domperidone maleate.

The other components (excipients) are: monohydrate lactose, corn starch, povidone K30 (E1201), sodium lauryl sulfate, microcrystalline cellulose (E460), anhydrous colloidal silicon dioxide (E551), and magnesium stearate (E470B).

Appearance of the product and contents of the pack

Domperidona pensa is presented as white, biconvex, circular tablets with the inscription "DM10" on one side. Each pack contains 30 tablets.

Marketing Authorization Holder

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Manufacturer responsible for production:

APL Swift Services (Malta) Ltd.

HF26, Hal Far Industrial Estate, Hal Far, Birzebbugia BBG 3000

Malta

or

AurexB.V.

Baarnsche Dijk 1

3741 LN Baarn

The Netherlands

Date of the most recent review of this leaflet: September 2025

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