MANIDIPINE COMBIX 20 mg TABLETS

Introduction

Package Leaflet: Information for the User

Manidipino Combix 20 mg Tablets EFG

Manidipino Dihydrochloride

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 Manidipino Combix 20 mg and what is it used for
2. What you need to know before you take Manidipino Combix 20 mg
3. How to take Manidipino Combix 20 mg tablets
4. Possible side effects
5. Storage of Manidipino Combix 20 mg tablets
6. Contents of the pack and other information

1. What is Manidipino Combix 20 mg tablets and what is it used for

Manidipino Combix contains manidipino dihydrochloride as the active substance. Manidipino dihydrochloride belongs to a group of medicines called calcium channel blockers that block the flow of calcium in the smooth muscle cells of blood vessels, causing vasodilation and the corresponding reduction in blood pressure.

Manidipino Combix is indicated for the treatment of essential arterial hypertension from mild to moderate (high blood pressure).

2. What you need to know before you start taking Manidipino Combix 20 mg tablets

Do not take Manidipino Combix

• if you are allergic to manidipino, other calcium channel blockers, or any of the other ingredients of this medicine (listed in section 6).
• if you have severe kidney disease.
• if you have heart problems, for example, if you have had a heart attack in the last 4 weeks or if you suffer from unstable angina (chest pain due to inadequate oxygen supply to the heart) or if you suffer from heart failure and are not undergoing specific treatment.
• if you have moderate or severe liver disease.

Manidipino Combix should not be administered to children and adolescents under 18 years of age.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Manidipino Combix:

• if you have certain heart problems (for example, left ventricular dysfunction, obstruction of the outflow tract of the left ventricle, right-sided heart failure in patients with untreated sick sinus syndrome);
• if you have heart rhythm disturbances;
• if you are an elderly patient or have mild liver problems (see section "How to take Manidipino Combix");
• if you are undergoing peritoneal dialysis.

You should also tell your doctor:

• if you are pregnant, think you may be pregnant, or are planning to become pregnant, or if you are breast-feeding (see section "Pregnancy, breast-feeding, and fertility").

Taking Manidipino Combix with other medicines

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

It is especially important that you tell your doctor if you are taking any of the following medicines:

• diuretics (used to remove water from the body by increasing urine production) and other medicines that reduce blood pressure, such as beta-blockers or other antihypertensive medicines. These medicines can increase the blood pressure-reducing effect of Manidipino Combix;
• medicines that may affect the metabolism of the active substance of Manidipino Combix, such as antiprotease medicines, cimetidine (used to treat stomach ulcers), or certain antibiotics (used to treat bacterial diseases, such as clarithromycin, erythromycin, and rifampicin), or some antifungals (used to treat fungal infections, such as ketoconazole and itraconazole), or phenytoin, carbamazepine, phenobarbital, terfenadine, astemizole, or antiarrhythmic drugs of class III used in heart rate problems (such as amiodarone and quinidine);
• medicines containing digoxin, used in the treatment of heart rhythm disturbances.

If you are taking any of the above-mentioned medicines, your doctor may prescribe another medicine or adjust the dose of Manidipino Combix or another medicine.

Taking Manidipino Combix with food, drinks, and alcohol

Do not take Manidipino Combix with grapefruit juice, as blood pressure may drop too low. Consuming alcohol may enhance the blood pressure-reducing effect of Manidipino Combix.

Pregnancy, breast-feeding, and fertility

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

Pregnancy

Since Manidipino Combix should not be taken during pregnancy, your doctor will advise you to stop treatment before becoming pregnant or as soon as you know you are pregnant, and will advise you on the appropriate treatment.

Breast-feeding

Consult your doctor if you are breast-feeding or before starting breast-feeding. Manidipino Combix should be avoided in breast-feeding women. If treatment with Manidipino Combix cannot be stopped, your doctor will advise you to stop breast-feeding.

Consult your doctor or pharmacist before taking any medicine.

Driving and using machines

Occasionally, in some patients during treatment for high blood pressure, this medicine may cause dizziness. In these cases, you should discuss it with your doctor before performing activities such as driving or operating machinery.

Manidipino Combix 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 Manidipino Combix 20 mg tablets

Follow exactly the administration instructions of this medicine indicated by your doctor. In case of doubt, consult your doctor again.

Initially, the usual dose of Manidipino Combix is 10 mg per day. After 2-4 weeks, if the reduction in blood pressure is considered insufficient, your doctor may increase this dose to 20 mg once a day (usual maintenance dose).

If you are elderly or have kidney or liver disease, your doctor may prescribe a reduced dose.

Use in children and adolescents

Children and adolescents should not take Manidipino Combix (see section "Do not take Manidipino Combix").

Administration

Manidipino Combix should be taken in the morning after breakfast. The tablet should be swallowed, without chewing, with an adequate amount of water. Try to take your daily dose at the same time every day.

Duration of treatment

It is important that you continue taking Manidipino Combix until your doctor tells you otherwise. Take exactly the prescribed dose and do not modify it without talking to your doctor first.

If you take more Manidipino Combix than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Manidipino Combix

If you forget to take a dose of Manidipino Combix, take the next dose as prescribed. Do not take a double dose to make up for forgotten doses.

It is important that you continue taking Manidipino Combix until your doctor tells you otherwise.

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

4. Possible side effects

Like all medicines, Manidipino Combix can cause side effects, although not everybody gets them.

If side effects occur, they will mainly be mild and temporary. However, some side effects can be serious and require medical attention.

Common side effects(may affect up to 1 in 10 people):

Fluid accumulation in tissues causing swelling (edema), hot flashes, dizziness, lightheadedness, headache, palpitations.

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

Painful tingling or numbness (paresthesia), increased heart rate (tachycardia), low blood pressure (hypotension), difficulty breathing (dyspnea), weakness, dry mouth, nausea, vomiting, constipation, gastrointestinal discomfort, skin rash, skin inflammation with redness and itching (eczema), transient changes in laboratory tests of some enzymes (ALT, AST, LDH, GammaGT, ALP, Urea nitrogen in blood, and creatinine in blood).

Rare side effects(may affect up to 1 in 1,000 people):

Irritability, skin redness, itching, stomach pain (gastralgia), abdominal pain, drowsiness, chest pain, chest pain due to inadequate blood supply to the heart (angina pectoris), diarrhea, decreased appetite (anorexia), abnormal blood test results (for example, increased bilirubin in blood), jaundice.

Very rare side effects(may affect less than 1 in 1,000 people):

Heart attack, in patients with pre-existing angina, they may experience an increase in frequency, duration, or severity of these attacks, gum inflammation or alteration, which requires careful dental attention but usually resolves with treatment discontinuation.

Side effects of unknown frequency(frequency cannot be estimated from the available data):

Muscle pain.

Breast swelling with or without pain in men (gynecomastia)

Abnormal skin redness (erythema multiforme), skin disease with abnormal redness and scales (exfoliative dermatitis)

Cloudy fluid (when performing dialysis through a tube in the abdomen).

If you experience side effects, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet.

Reporting of side effects

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

5. Storage of Manidipino Combix 20 mg tablets

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

No special storage conditions are required.

Do not use this medicine after the expiry date which is 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 or household waste. Return all unused medicines to your pharmacist. This will help to protect the environment.

6. Contents of the pack and other information

Composition of Manidipino Combix 20 mg tablets

• The active substance is manidipino. Each tablet contains 20 mg of manidipino dihydrochloride.
• The other ingredients (excipients) are: lactose monohydrate, cornstarch, low-substituted hydroxypropylcellulose, hydroxypropylcellulose (E463), magnesium stearate (E470b).

Appearance of the product and pack contents

Oval, biconvex tablets, yellow in color, scored on one face and smooth on the other.

OPA/AL/PVC/Al blisters.

Packs of 28 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratorios Combix, S.L.U.

C/ Badajoz 2, Edificio 2

28223 Pozuelo de Alarcón (Madrid)

Spain

Manufacturer

Zydus France

ZAC les Hautes Patures

Parc d’activités des Peupliers

25 Rue des Peupliers

92000 Nanterre

France

or

Centre Spécialités Pharmaceutiques

ZAC des Suzots

35 rue de la Chapelle

63450 Saint Amant Tallende

France

Date of last revision of this leaflet: September 2024

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