Manidipino Teva-Ratiopharm 20 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Manidipino Teva-ratiopharm 20 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, 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 could harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of this leaflet:

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

1. What Manidipino Teva-ratiopharm is and what it is used for

Manidipino Teva-ratiopharm contains 20 mg of the active substance manidipine, which belongs to a group of medicines called dihydropyridine calcium channel blockers.

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

Manidipine works by relaxing blood vessels, thereby reducing blood pressure.

2. What you need to know before taking Manidipino Teva-ratiopharm

Do not take Manidipino Teva-ratiopharm

• if you are allergic to manidipine or to other calcium channel blockers or to any of the other ingredients of this medicine (listed in section 6)
• if you suffer from unstable angina (chest pain not caused by stress or exercise, or occurring at night) or during the first 4 weeks after a myocardial infarction
• if you suffer from uncontrolled congestive heart failure
• if you have severe renal impairment (creatinine clearance < 10 ml/min)
• if you have moderate to severe hepatic impairment
• if you are a child or adolescent under 18 years of age

Warnings and precautions

Consult your doctor or pharmacist before starting to take Manidipino Teva-ratiopharm.

• If you have mild liver problems, as the effects of manidipine may be increased (see section 3 “How to take Manidipino Teva-ratiopharm”)
• If you are an elderly patient, a dose reduction may be necessary (see section 3 “How to take Manidipino Teva-ratiopharm”)
• If you suffer from heart disorders
• If you are taking other medicines simultaneously (see “Taking Manidipino Teva-ratiopharm with other medicines”)
• If you are undergoing peritoneal dialysis

Other medicines and Manidipino Teva-ratiopharm

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

It is especially important that you inform 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 antihypertensive medicines such as beta-blockers or other antihypertensive drugs. These medicines may in fact enhance the blood pressure-lowering effect of manidipine;
• Medicines that may influence the metabolism of the active substance in Manidipino Teva-ratiopharm, such as antiprotease drugs, cimetidine (used for treating gastric ulcers), or certain antibiotics (used to treat bacterial diseases, such as clarithromycin, erythromycin and rifampicin), or certain antifungals (used to treat fungal infections, such as ketoconazole and itraconazole), or phenytoin, carbamazepine, phenobarbital (used to treat epilepsy), terfenadine, astemizole (used to treat allergies), quinidine and class III antiarrhythmics used for heart rhythm disorders (such as amiodarone);
• 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 Teva-ratiopharm or of the other medicine.

Taking Manidipino Teva-ratiopharm with food, drinks and alcohol

Patients must not consume alcohol or grapefruit juice during treatment with manidipine.

Pregnancy and breastfeeding

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

Pregnancy

Manidipino Teva-ratiopharm must not be taken during pregnancy.

Breastfeeding

The use of manidipine should be avoided during breastfeeding. If treatment with manidipine is necessary, breastfeeding must be discontinued.

Driving and using machines

Be cautious when driving or operating machinery, as this medicine may cause dizziness.

Manidipino Teva-ratiopharm 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 Teva-ratiopharm

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

If you think that the effect of Manidipino Teva-ratiopharm is too strong or too weak, inform your doctor or pharmacist.

The recommended starting dose is 10 mg once daily.

If after 2-4 weeks of treatment the antihypertensive effect of manidipine is insufficient, your doctor may increase the dose to 20 mg once daily.

Elderly patients, and those with hepatic or renal impairment

If you are elderly or have kidney or liver problems, your doctor may prescribe a lower dose (10 mg once daily).

Use in children and adolescents

Children and adolescents under 18 years of age must not take Manidipino Teva-ratiopharm (see section 2 “Do not take Manidipino Teva-ratiopharm”).

Your doctor will advise you on how long to take the medicine. Do not stop treatment unless your doctor tells you to.

The tablets should be taken in the morning after breakfast, swallowed whole without chewing, with a little liquid.

If you take more Manidipino Teva-ratiopharm than you should

If you (or someone else) have taken several tablets at once, or if you think a child has taken any tablets, contact the nearest hospital Emergency Department or your doctor immediately. As with other calcium channel blockers, overdose may cause excessive peripheral vasodilation leading to low blood pressure and increased heart rate.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take a dose of Manidipino tablets

If you forget a dose, take the next dose as usual.

Do not take a double dose to make up for forgotten doses.

If you stop taking Manidipino Teva-ratiopharm

Before stopping treatment with Manidipino Teva-ratiopharm, consult your doctor.

If you have any further questions about using this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can 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.

The following adverse effects may occur when taking Manidipino Teva-ratiopharm.

Common (may affect up to 1 in 10 people): headache, dizziness, vertigo, swelling due to fluid retention, palpitations, hot flushes.

Uncommon (may affect up to 1 in 100 people): tingling sensation of the skin, weakness or lack of energy, rapid heartbeat, hypotension, difficulty breathing, nausea, vomiting, constipation, dry mouth, gastrointestinal disturbances, rash, eczema, increase in liver enzymes and/or increase in renal parameters (your doctor knows this may occur).

Rare (may affect up to 1 in 1,000 people): somnolence, numbness, chest pain, angina pectoris, hypertension, stomach pain (gastralgia), abdominal pain, diarrhoea, decreased appetite, jaundice, skin redness, itching, irritability, abnormal blood test results (e.g. increased blood bilirubin).

Very rare (may affect up to 1 in 10,000 people): myocardial infarction, inflammation of the gums and gum overgrowth, which usually resolves upon discontinuation of treatment. In isolated cases, patients with pre-existing angina pectoris may experience increased frequency, duration, and severity of these attacks.

Frequency not known (frequency cannot be estimated from the available data): abnormal redness of the skin (erythema multiforme), skin disease with abnormal redness and scaling (exfoliative dermatitis), muscle pain, breast swelling with or without pain in men (gynaecomastia), cloudy fluid (when performing dialysis through a tube in the abdomen).

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, 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 Manidipino Teva-ratiopharm

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the blister and packaging following EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point in your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Manidipino Teva-ratiopharm

The active substance is manidipino dihydrochloride.

Each tablet contains 20 mg of manidipino dihydrochloride.

The other components are: lactose monohydrate, corn starch, low-substituted hydroxypropylcellulose, hydroxypropylcellulose, magnesium stearate, riboflavin.

Appearance of the medicinal product and contents of the pack

Manidipino Teva-ratiopharm 20 mg tablets: yellow, oval, convex, biconvex tablets with a score line.

Manidipino is available in the following pack sizes:

14, 28, 30, 56, 84, 90, 98, 112 tablets

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Holder

Teva Pharma, S.L.U.

C/ Anabel Segura 11, Edificio Albatros B 1ª Planta

Alcobendas 28108 Madrid

Manufacturer

Merckle GmbH

Ludwig-Merckle-Strasse 3

89143 Blaubeuren

Germany

or

Doppel Farmaceutici S.r.l.

Via Volturno, 48

20089 Quinto de Stampi, Rozzano, MILANO

Italy

or

Abiogen Pharma S.p.A.

Via Antonio Meucci, 36 Ospedaletto

56121 Pisa,

Italy

or

Vamfarma S.r.l

Via Kennedy 5, 26833 Comazzo (LO),

Italy

Date of the latest revision of this leaflet: July 2024

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)

You can access detailed and up-to-date information on this medicinal product by scanning with your mobile phone (smartphone) the QR code included in the packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/72352/P_72352.html