Manidipino Combix 20 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Manidipino Combix 20 mg tablets EFG

Manidipine dihydrochloride

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

Leaflet contents:

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

1. What Manidipino Combix 20 mg tablets are and what they are used for

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

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

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

Do not take Manidipino Combix

• if you are allergic to manidipine, to other calcium channel blockers, or to 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 myocardial infarction within the last 4 weeks, or if you suffer from unstable angina (chest pain due to inadequate oxygen supply to the heart), or if you have heart failure and are not receiving specific treatment.
• if you have moderate or severe liver disease.

Manidipino Combix must not be administered to children or adolescents under 18 years of age.

Warnings and precautions

Talk to your doctor or pharmacist before taking Manidipino Combix:

• if you have certain heart problems (for example, left ventricular dysfunction, obstruction of the left ventricular outflow tract, right-sided heart failure in patients with untreated sick sinus syndrome);
• if you have heart rhythm disorders;
• if you are elderly 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, are trying to become pregnant, or are breastfeeding (see section “Pregnancy, breastfeeding and fertility”).

Taking Manidipino Combix with other medicines

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

It is especially important to 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 lower blood pressure, such as beta-blockers or other antihypertensive medicines. These medicines may increase the blood pressure-lowering effect of Manidipino Combix;
• medicines that may affect the metabolism of the active substance in Manidipino Combix, such as antiprotease agents, cimetidine (used to treat gastric ulcers), certain antibiotics (used to treat bacterial infections, such as clarithromycin, erythromycin, and rifampicin), or certain antifungal medicines (used to treat fungal infections, such as ketoconazole and itraconazole), or phenytoin, carbamazepine, phenobarbital, terfenadine, astemizole, or class III antiarrhythmics used for heart rhythm disorders (such as amiodarone and quinidine);
• medicines containing digoxin, used in the treatment of heart disorders.

If you are taking any of the medicines listed above, your doctor may prescribe a different medicine or adjust the dose of Manidipino Combix or of the other medicine.

Taking Manidipino Combix with food, drinks and alcohol

Do not take Manidipino Combix with grapefruit juice, as blood pressure may drop too much. Alcohol consumption may enhance the blood pressure-lowering effect of Manidipino Combix.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using 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 recommend appropriate alternative treatment.

Breastfeeding

Consult your doctor if you are breastfeeding or before starting breastfeeding. Manidipino Combix should be avoided in women who are breastfeeding. If treatment with Manidipino Combix cannot be discontinued, your doctor will advise you to stop breastfeeding.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

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

Manidipino Combix contains lactose

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

3. How to take Manidipino Combix 20 mg tablets

Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor again.

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

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

Use in children and adolescents

Children and adolescents must not take Manidipino Combix (see section “Do not take Manidipino Combix”).

Administration

Manidipino Combix should be taken in the morning after breakfast. The tablet must be swallowed whole, without chewing, with an adequate amount of water. Try to take your daily dose at the same time each 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 change it without first talking to your doctor.

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 at 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 about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Manidipino Combix may cause adverse effects, although not everyone will experience them.

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

Frequent adverse effects (may affect between 1 and 10 out of every 100 patients):

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

Uncommon adverse effects (may affect between 1 and 10 out of every 1,000 patients):

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

Rare adverse effects (may affect between 1 and 10 out of every 10,000 patients):

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

Very rare adverse effects (may affect less than 1 out of every 10,000 patients):

Myocardial infarction, in patients with pre-existing angina pectoris may experience an increase in frequency, duration, or severity of attacks, inflammation or alteration of the gums, which require careful dental care but usually resolve upon discontinuation of treatment.

Adverse effects with unknown frequency (frequency cannot be estimated from the available data):

Muscle pain.

Breast swelling with or without pain in men (gynecomastia).

Abnormal redness of the skin (erythema multiforme), skin disease with abnormal redness and scaling (exfoliative dermatitis).

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

If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse 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 stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE point in your pharmacy. If you have any doubts, 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 Manidipino Combix 20 mg tablets

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

Appearance of the product and contents of the pack

Yellow, oval, biconvex tablets, scored on one side 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 the most recent revision of this leaflet: September 2024

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/