DOMPERIDONE PENSA 10 mg TABLETS

Introduction

Package Leaflet: Information for the User

Domperidone Pensa 10 mg Tablets EFG

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

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

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

2. What you need to know before you take Domperidone Pensa

Do not take Domperidone Pensa

• If you are allergic to domperidone maleate or 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 or 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 "prolonged QT interval".
• If you have a heart condition where your heart is not pumping blood as it should (heart failure).
• If 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 "Taking other medicines").

• If you have or could have a rare tumor of the adrenal gland (pheochromocytoma) because it could raise your blood pressure.

Warnings and Precautions

Before taking this medicine, talk to your doctor if:

• You have liver problems (liver dysfunction or liver failure) (see "Do not take Domperidone Pensa").
• You have kidney problems (kidney dysfunction or kidney failure). It is recommended to ask your doctor for advice in case of prolonged treatment, as you may need to take 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 mg/day. The risk also increases when domperidone is given with certain 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 section "Other medicines and Domperidone Pensa").

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. Treatment with domperidone should be discontinued.

Adolescents weighing less than 35 kg and children

Domperidone 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.

Other medicines and Domperidone Pensa

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

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

• Fungal infections, such as 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, quinidine, disopyramide, dofetilide, sotalol, hydroquinidine).
• Psychosis (e.g., haloperidol, pimozide, sertindol).
• Depression (e.g., citalopram, escitalopram).
• Digestive disorders (e.g., cisapride, dolasetron, prucalopride).
• Allergies (e.g., mequitazine, mizolastine).
• Malaria (in particular, halofantrine, lumefantrine).
• HIV/AIDS (e.g., ritonavir or saquinavir, which are protease inhibitors).
• Hepatitis C (e.g., telaprevir).
• Cancer (e.g., toremifene, vandetanib, vincamine).

Do not take domperidoneif you are taking certain 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 Pensa and apomorphine:

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

Taking Domperidone Pensa with food and drinks

Take Domperidone Pensa before meals, as absorption of this medicine may be slightly delayed if taken after meals.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

It is not known if Domperidone Pensa 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 Pensa.

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 be used during breastfeeding only 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 Pensa. Do not drive or use machines while taking Domperidone Pensa until you know how it affects you.

Domperidone Pensa contains lactose and sodium

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 contains less than 1 mmol of sodium (23 mg) per tablet; this is essentially "sodium-free".

3. How to take Domperidone Pensa

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

Take Domperidone Pensa 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 Pensa for more than 7 days without consulting your doctor.

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

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

Take the tablet with a little water or other liquid. Do not chew the tablet.

Do not take more than three tablets a 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 poison control center immediately. In case of overdose, symptomatic treatment can be given. ECG monitoring may be carried out due to the possibility of a heart problem called 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 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 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 tremor, excessive muscle rigidity or muscle spasm.

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 hypersensitivity 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 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 above side effects.

Other side effects observed with domperidone 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
• Decreased or lost sexual interest
• Drowsiness
• Headache
• Diarrhea
• Skin rash
• Itching
• Hives
• Pain or tenderness in the breasts
• Discharge of milk from the breasts
• General feeling of weakness
• Feeling of dizziness

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

• Rolling of the eyes upwards
• Urination problems
• Enlargement of the breasts in men
• Stopping of menstrual periods
• 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 for conditions and doses that require medical supervision have experienced the following side effects: restlessness, swelling or enlargement of the breasts, unusual discharge 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 it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines and Healthcare Products Agency's (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 Pensa

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

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

Do not use this medicine 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. Return any unused medicine to a pharmacy for disposal. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

Composition of Domperidone Pensa

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

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

Appearance of the product and contents of the pack

Domperidone 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:

APL Swift Services (Malta) Ltd.

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

Malta

or

Aurex B.V.

Baarnsche Dijk 1

3741 LN Baarn

Netherlands

Date of last revision of this leaflet:September 2025

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