MANIDIPINE TEVA 20 mg TABLETS

Introduction

Package Leaflet: Information for the User

Manidipine Teva 20 mg Tablets EFG

manidipine 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 pack and other information:

1. What is Manidipine Teva and what is it used for
2. What you need to know before you take Manidipine Teva
3. How to take Manidipine Teva
4. Possible side effects

5 Conservation of Manidipine Teva

1. Contents of the pack and further information

1. What is Manidipine Teva and what is it used for

Manidipine Teva tablets contain 20 mg of the active substance manidipine (as manidipine dihydrochloride), which belongs to a group of medicines called dihydropyridine calcium channel blockers.

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

Manidipine Teva works by relaxing blood vessels, thus reducing blood pressure.

2. What you need to know before you take Manidipine Teva

Do not take Manidipine Teva

• If you are allergic to manidipine or other calcium channel blockers or 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 at night) or during the first 4 weeks after a myocardial infarction.
• If you suffer from untreated congestive heart failure.
• If you suffer from severe renal impairment (creatinine clearance <10ml/min).
• If you suffer from 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 manidipine Teva.

• If you suffer from mild liver problems, as the effects of manidipine may increase (see section 3 "How to take Manidipine Teva")
• If you are an elderly patient, a dose reduction is required (see section 3 "How to take Manidipine Teva")
• If you suffer from heart disease
• If you are taking other medicines (see "Taking Manidipine Teva with other medicines").
• If you are undergoing peritoneal dialysis.

Other medicines and Manidipine Teva

Tell your doctor or pharmacist if 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 lower blood pressure, such as beta-blockers or other antihypertensive drugs. These medicines may increase the blood pressure-lowering effect of manidipine;
• Medicines that may affect the metabolism of the active substance contained in Manidipine Teva, such as protease inhibitors, cimetidine (used to treat gastric 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 (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 conditions.

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

Taking Manidipine Teva with food, drinks, and alcohol

Patient should not take 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

Manidipine Teva should not be used 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 you may experience dizziness.

Manidipine Teva 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 Manidipine Teva

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

If you think that the action of Manidipine Teva is too strong or too weak, consult 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 suffer from renal or hepatic 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 this medicine (see section 2 "Do not take Manidipine Teva").

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

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

If you take more Manidipine Teva than you should

If you (or someone else) swallow a lot of tablets at the same time, or if you think that your child has swallowed some tablets, contact 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 ingested.

If you forget to take Manidipine Teva

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 Manidipine Teva

Before stopping the treatment with Manidipine Teva, 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. The following side effects may occur while taking Manidipine Teva.

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

Frequent (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 on the skin, weakness or lack of energy, rapid heart rate, low blood pressure, difficulty breathing, nausea, vomiting, constipation, dry mouth, gastrointestinal disorders, skin rash, eczema, increased liver enzymes and/or increased renal parameters (your doctor is aware of them).

Rare (may affect up to 1 in 1,000 people):somnolence, dizziness, chest pain, angina, high blood pressure, 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):myocardial infarction, gum inflammation and excessive gum growth that usually disappears with treatment withdrawal. In isolated cases, patients with pre-existing angina may experience an increase in frequency, duration, and severity of these incidents.

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

Reporting of side effects:

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. You can also report side effects directly via the Spanish Medicines Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Conservation of Manidipine Teva

Keep out of 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 further information

Composition of Manidipine Teva

• The active substance is manidipine dihydrochloride.

Each tablet contains 20 mg of manidipine dihydrochloride.

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

Appearance of the product and contents of the pack

The 20 mg tablets are oval, convex, yellow, with a score line in the middle.

Manidipine Teva 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 nº11, Edificio Albatros B 1ª planta

Alcobendas 28108 Madrid

Manufacturer

Abiogen Pharma SpA

Via Antonio Meucci 36, Ospedaletto

56121 Pisa – Italy

or

Doppel Farmaceutici S.r.l.

Via Volturno, 48

20089 Quinto de Stampi, Rozzano, MILANO

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/)