Leaflet: information for the user

Domperidone pensa 10 mg tablets EFG

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, and you must 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 isDomperidone pensaand what it is used for

2. What you need to know before starting to takeDomperidone pensa

3. How to takeDomperidone pensa

4. Possible side effects

5. Storage ofDomperidone pensa

6. Contents of the pack and additional information

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

Do not take Domperidona Pensa if you think

• You are allergic to domperidone maleate or any of the other ingredients of this medicine (listed in section 6).
• You have a pituitary gland tumor (prolactinoma).
• You have regular or persistent severe stomach pain or black stools.
• You have a blocked or perforated intestine.
• 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 condition where your heart cannot pump blood to your 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 “Taking other medicines”).

Warnings and Precautions

Before taking this medicine, consult your doctor if:

• You have liver problems (dysfunction or liver insufficiency) (see “Do not take Domperidona Pensa”).
• You have kidney problems (dysfunction or kidney insufficiency). 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 old or those taking doses above 30 mg/day. The risk also increases when domperidone is administered with some 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 medicines and Domperidona Pensa”).

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. Treatment with domperidone should be discontinued.

Adolescents weighing less than 35 kg and children

Domperidone should 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 using, have used recently, or may need to use any other medication.

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

• Fungal infections, such as pentamidine or azole antifungals, specifically itraconazole, ketoconazole oral, 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, or hydroquinidine).
• Psychosis (e.g., haloperidol, pimozide, or sertindole).
• Depression (e.g., citalopram or escitalopram).
• Digestive problems (e.g., cisapride, dolasetron, or prucalopride).
• Allergies (e.g., mequitazine or mizolastine).
• Malaria (particularly halofantrine or lumefantrine).
• HIV/AIDS infection, such as ritonavir or saquinavir (these are protease inhibitors).
• Hepatitis C (e.g., telaprevir).
• Cancer (e.g., toremifene, vandetanib, or vincamine).

Do not take domperidoneif you are taking certain other medications (e.g., bepridil, difemanil, or methadone).

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

Domperidone Pensa and apomorphine:

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

Taking Domperidone Pensa with food and drinks

Take Domperidone Pensa before meals, as taking it after meals may slightly delay the absorption of this medicine.

Pregnancy and breastfeeding

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

Pregnancy

The safety of using Domperidone Pensa in pregnant women is unknown. If you are pregnant or think you may be pregnant, inform your doctor, who will decide whether 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 infant. Domperidone should only be used during breastfeeding if your doctor considers it clearly necessary. Consult your doctor before taking this medicine.

Driving and operating machinery

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

Domperidone Pensa contains lactose and sodium

This medicine contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult them before taking this medicine.

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

Follow these administration instructions exactly unless your doctor tells you otherwise.

Take Domperidona pensa before meals, as taking it afterwards may slightly delay its absorption.

Treatment duration:

Symptoms usually resolve 3-4 days after taking this medication. Do not take Domperidona 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, preferably 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 Domperidona pensa than you should

If you have used or taken too much Domperidona pensa, contact your doctor, pharmacist, or poison control center immediately. In case of overdose, symptomatic treatment may be administered. A heart problem called QT interval prolongation may require ECG monitoring.

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 medications may help counteract extrapyramidal effects.

If you forgot to take Domperidona pensa:

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 doses.

Like all medicines, this medicine may cause side effects, although not everyone will experience them

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

• Uncontrolled movements of the face or arms and legs, excessive tremor, excessive muscle stiffness 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 swelling of the face.
• A severe hypersensitivity reaction that may occur immediately after administration, characterized by urticaria, itching, shortness of breath, dizziness, and difficulty breathing among other possible symptoms.
• Cardiovascular system disorders: arrhythmias (rapid or irregular heartbeat) have been reported; if this occurs, you should stop treatment immediately. Domperidone may be associated with an increased risk of arrhythmias 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 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
• Drowsiness
• Headache
• Diarrhea
• Skin rash
• Itching
• Urticaria
• Breast tenderness
• Milk secretion
• General feeling of weakness
• Dizziness

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

• Eye rolling
• Inability to urinate
• Male breast enlargement
• Stopping of menstrual period
• 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 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 the Vigilance 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 reach and sight of children.

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

Do not use this medication after the expiration date shown on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. 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 pensa

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

The other components (excipients) are: lactose monohydrate, cornstarch, povidone K30 (E1201), sodium laurilsulfate, microcrystalline cellulose (E460), anhydrous colloidal silica (E551), and magnesium stearate (E470B).

Appearance of the product and content of the packaging

Domperidona pensa is presented in the form of biconvex, circular tablets of white color with the inscription “DM10” on one face..Each package contains 30 tablets.

Holder of the marketing authorization

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Responsible for manufacturing:

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

Netherlands

Last review date of this leaflet:May 2022

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/