MANIDIPINE TEVA-RATIOPHARM 10 mg TABLETS

Introduction

Package Leaflet: Information for the User

Manidipino Teva-ratiopharm 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 pack:

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

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

Manidipino Teva-ratiopharm contains 10 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 acts by relaxing blood vessels, and thus reduces blood pressure.

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

Do not takeManidipino Teva-ratiopharm

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

Warnings and precautions

Consult your doctor or pharmacist before taking 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 have heart problems
• If you are taking other medicines at the same time (see "Taking Manidipino Teva-ratiopharm with other medicines")
• If you are undergoing peritoneal dialysis

Other medicines and Manidipino Teva-ratiopharm

Tell your doctor or pharmacist if you are taking, have recently taken or might 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 drugs. These medicines can increase the blood pressure-lowering effect of manidipine;
• Medicines that may affect the metabolism of the active substance in Manidipino Teva-ratiopharm, such as protease inhibitors, cimetidine (used to treat stomach ulcers), or certain antibiotics (used to treat bacterial infections, such as clarithromycin, erythromycin, and rifampicin), or some 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 in heart rate problems (such as amiodarone)
• Medicines containing digoxin, used to treat heart problems

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

Taking Manidipino Teva-ratiopharm with food, drinks, and alcohol

Patients should not drink 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 have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Manidipino Teva-ratiopharm should not be taken during pregnancy.

Breastfeeding

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

Driving and using machines

Be careful while driving or operating machinery as it may cause dizziness.

Manidipino Teva-ratiopharm contains lactose

If your doctor has told you that you have an intolerance to some sugars, consult with them before taking this medicine.

3. How to take Manidipino Teva-ratiopharm

Follow exactly the administration instructions of this medicine given by your doctor. If you are unsure, consult your doctor or pharmacist again.

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

The recommended initial dose is 10 mg once a day.

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

Elderly patients, renal and hepatic impairment

If you are an elderly patient or have kidney or liver impairment, your doctor may prescribe a lower dose (10 mg once a day).

Use in children and adolescents

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

Your doctor will tell you how long to take the treatment. Do not stop the treatment until your doctor tells you to.

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

If you take more Manidipino Teva-ratiopharm than you should

If you (or someone else) have taken too many tablets at the same time, or if you think a child has taken some tablets, contact the Emergency Department of your nearest hospital or your doctor immediately. As with other calcium channel blockers, in case of overdose, excessive peripheral vasodilation may occur, leading to a drop in blood pressure and an increase in heart rate.

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 taken.

If you forget to take Manidipino Teva-ratiopharm tablets

If you miss 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 on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

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

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

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

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

Very rare(may affect up to 1 in 10,000 people):heart attack, gum inflammation and gum overgrowth, which usually disappears after treatment is stopped. In isolated cases, patients with pre-existing angina may develop increased frequency, duration, and severity of these attacks.

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

Reporting of side effects:

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines Monitoring System: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Manidipino Teva-ratiopharm

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

Do not use this medicine after the expiry date which is stated on the blister and on the carton after EXP. The expiry date is the last day of the month stated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Manidipino Teva-ratiopharm

The active substance is manidipine dihydrochloride.

Each tablet contains 10 mg of manidipine dihydrochloride.

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

Appearance and packaging of the product

Manidipino Teva-ratiopharm 10 mg tablets: round, convex, yellow tablets with a score line.

Manidipino is available in the following packs:

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

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation 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 last revision of this leaflet: July 2024

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