Manidipino Teva 10 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Manidipino Teva 10 mg tablets EFG

manidipino dihydrochloride

Read the entire 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 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. It may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents:

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

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

Manidipino Teva tablets contain 10 mg of the active substance manidipine (as manidipine dihydrochloride), which belongs to a group of medicines called dihydropyridine calcium channel blockers.

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

Manidipino Teva works by relaxing blood vessels, thereby reducing blood pressure.

2. What you need to know before starting to take Manidipino Teva

Do not take Manidipino Teva

• 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 have unstable angina (chest pain not caused by stress or exercise, or occurring at night) or during the first 4 weeks following a myocardial infarction.
• If you have untreated 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

Talk to your doctor or pharmacist before starting to take Manidipino Teva.

• If you have mild liver problems, as the effects of manidipine may be increased (see section 3 “How to take Manidipino Teva”).
• If you are elderly, a dose reduction may be required (see section 3 “How to take Manidipino Teva”).
• If you have heart disease.
• If you are taking other medicines (see “Taking Manidipino Teva with other medicines”).
• If you are undergoing peritoneal dialysis.

Other medicines and Manidipino Teva

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 medicines that lower blood pressure, such as beta-blockers or other antihypertensive drugs. These medicines may in fact increase the blood pressure-lowering effect of manidipine.
• Medicines that may influence the metabolism of the active substance in Manidipino Teva, such as antiprotease drugs, cimetidine (used to treat gastric ulcers), certain antibiotics (used to treat bacterial infections, 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 conditions.

If you are taking any of the medicines listed above, your doctor may prescribe an alternative medicine or adjust the dose of Manidipino Teva or of the other medicine.

Taking Manidipino Teva 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 plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

Manidipino Teva must not be used 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 you may experience dizziness.

Manidipino Teva contains lactose

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

3. How to take Manidipino Teva

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 is too strong or too weak, consult 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, hepatic and renal impairment

If you are an elderly patient or suffer from renal or hepatic impairment, your doctor may prescribe you a lower dose (10 mg once daily).

Use in children and adolescents

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

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

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

If you take more Manidipino Teva than you should

If you (or someone else) swallow a large number of tablets at the same time, or if you think your child has swallowed any tablets, contact your nearest hospital or 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 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 Manidipino Teva

If you forget a dose, take the next dose at your usual time.

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

If you stop taking Manidipino Teva

Before stopping treatment with Manidipino Teva, consult your doctor.

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

4. Possible adverse effects

Like all medicines, this medicine 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.

The following adverse effects may occur while taking Manidipino Teva.

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): skin tingling sensation, weakness or lack of energy, fast heartbeat, low blood pressure, difficulty breathing, nausea, vomiting, constipation, dry mouth, gastrointestinal disorders, skin rash, eczema, increase in liver enzymes and/or increase in renal parameters (your doctor is aware of these).

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

Frequency not known (frequency cannot be estimated from the available data): abnormal skin redness (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 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 Teva

Keep out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the blister pack and container after 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 collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of Manidipino Teva 10 mg

• The active substance is manidipine dihydrochloride.

Each 10 mg tablet contains manidipine dihydrochloride.

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

Appearance of the product and contents of the pack

The 10 mg tablets are round, convex, yellow in colour, with a central score line.

Manidipino Teva is available in the following pack sizes:

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, nº 11 Edificio Albatros B 1st floor

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 latest 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.es/ "