MANIDIPINO VIATRIS 20 mg TABLETS

Introduction

Package Leaflet: Information for the User

Manidipino Viatris 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, 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 package leaflet

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

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

Manidipino Viatris tablets contain 20 mg of the active substance manidipine dihydrochloride, which belongs to a group of medicines called dihydropyridine calcium channel blockers.

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

Manidipino acts by relaxing blood vessels and thus reducing blood pressure.

2. What you need to know before you take Manidipino Viatris

Do not take Manidipino Viatris

• If you are allergic to manidipine, other dihydropyridines or any other ingredient of this medicine (listed in section 6).
• If you have unstable angina (chest pain not caused by stress, physical exercise or at night) or have had a heart attack in the last 4 weeks (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.

Warnings and precautions

Consult your doctor or pharmacist before taking Manidipino Viatris

• If you have mild liver problems, as the effects of manidipine may be increased (see section 3 “How to take Manidipino Viatris”).
• If you are an elderly patient, you will be advised to reduce the dose (see section 3 “How to take Manidipino Viatris”).
• If you are undergoing peritoneal dialysis.
• If you have heart problems such as problems with the left side of the heart valves that cause reduced blood flow, heart failure on one side of the heart or a very slow heartbeat due to problems with the electrical activity in the heart that are not controlled with a pacemaker.

Other medicines and Manidipino Viatris

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those obtained without a prescription, or medicines for the following conditions:

• High blood pressure, such as diuretics, beta-blockers or prazosin.
• Viral or bacterial infections, such as ketoconazole, itraconazole, erythromycin, clarithromycin or rifampicin.
• Mental disorders, such as antidepressants and antipsychotics.
• Epilepsy, such as phenytoin, carbamazepine or phenobarbital.
• Chemotherapy and radiotherapy, such as amifostine.
• HIV treatment, such as protease inhibitors.
• Stomach problems, such as cimetidine.
• Irregular heartbeat (such as amiodarone, quinidine, digoxin).
• Stiffness and limited movement in a group of muscles, such as baclofen.
• Allergies (such as terfenadine, astemizole).
• Swelling or increased activity of the immune system or when the pituitary and adrenal glands are not functioning, such as corticosteroids or tetracosactide.
• Enlargement of the prostate gland, such as alfuzosin, doxazosin, tamsulosin or terazosin.

Manidipino Viatris with food and drinks

Do not drink alcohol or grapefruit juice during treatment with manidipine, as both alcohol and grapefruit juice can lower blood pressure.

Pregnancy and breastfeeding

Manidipino should not be taken during pregnancy. The use of manidipino should be avoided during breastfeeding, as it is not known whether this medicine passes into breast milk. If treatment with manidipino is necessary, breastfeeding should be discontinued.

Fertility

It has been reported that alterations in sperm head may occur in patients treated with medicines like manidipine, which may affect fertility.

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, consult your doctor or pharmacist before taking this medicine.

Driving and using machines

This medicine may cause drowsiness, so caution is advised when driving or using machines.

Manidipino Viatris contains lactose

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

3. How to take Manidipino Viatris

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

If you find that the effect of manidipino is too strong or too weak, consult your doctor or pharmacist.

Use in children and adolescents

Children and adolescents should not take Manidipino Viatris.

Duration of treatment

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

Method of administration

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

The recommended initial dose is 10 mg once a day.

If after 2-4 weeks of treatment the antihypertensive effect of manidipino is not sufficient, your doctor may increase the dose to 20 mg once a day.

The break line is only for breaking the tablet if you have difficulty swallowing.

Elderly or if you have renal or hepatic impairment

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

If you take more Manidipino Viatris than you should

If you (or someone else) swallow a large number of tablets all at once, or if you think a child has taken some of the tablets, contact the emergency department of the nearest hospital or your doctor immediately. As with other calcium channel blockers, it is expected that an overdose will produce vasodilation that could lead to a decrease 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 Viatris

If you miss a dose, take it as soon as possible and take the next doses as prescribed.

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

If you stop taking Manidipino Viatris

Before stopping treatment with Manidipino Viatris, consult your doctor.

If you have any further questions on the use of this product, 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 serious side effects may occur during treatment with Manidipino Viatris. If they do, consult your doctor or go to the nearest hospital.

Very rare(may affect up to 1 in 10,000 people)

• Heart attack and in some patients with pre-existing angina, an increase in frequency, duration and severity of these incidents may be observed.

Other possible side effects

Common(may affect up to 1 in 10 people)

• Headache.
• Dizziness.
• Vertigo.
• Swelling caused by fluid retention (edema).
• Fast or irregular heartbeat (palpitations).
• Hot flushes.

Uncommon(may affect up to 1 in 100 people)

• Tingling sensation in the skin.
• Weakness or lack of energy.
• Increased heart rate.
• Low blood pressure.
• Breathing difficulties.
• Nausea.
• Vomiting.
• Constipation.
• Dry mouth.
• Digestive disorders.
• Rashes.
• Eczema.
• Increased liver enzymes and/or increased kidney parameters (may be seen in blood tests).

Rare(may affect up to 1 in 1,000 people)

• Sleepiness.
• Drowsiness.
• High blood pressure.
• Stomach pain.
• Abdominal pain.
• Redness of the skin.
• Itching and irritability.
• Increased bilirubin, which may be seen in blood tests.
• Diarrhea.
• Lack of appetite (anorexia).
• Yellowing of the skin or the white part of the eyes (jaundice).

Very rare(may affect up to 1 in 10,000 people)

• Inflammation or alteration of the gums that usually disappears with the withdrawal of treatment.

Frequency not known(cannot be estimated from the available data)

• Peeling or shedding of the skin, small spots on the skin.
• Extrapyramidal syndrome has been reported with other medicines like this medicine.
• Muscle pain.
• Inflammation of the breasts, with or without sensitivity, in men (gynecomastia).
• Turbid fluid (when performing dialysis through a tube in the abdomen).

Reporting of side effects:

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

5. Storage of Manidipino Viatris

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

Do not take manidipine after the expiry date stated on the pack after EXP. The expiry date refers to 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. Further information

Contents of Manidipino Viatris:

The active substance is manidipine dihydrochloride 20 mg.

Each tablet contains 20 mg of manidipine dihydrochloride

The other ingredients are lactose monohydrate (see section 2 “Manidipino Viatris contains lactose”), corn starch, hypromellose, magnesium stearate, riboflavin.

Appearance of Manidipino Viatris and pack contents

The tablets are oval, convex, yellow, with a break line in the middle.

Manidipino Viatris is available in packs of 14, 28, 30, 56, 84, 90, 98, 112 tablets.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Manufacturer

Abiogen Pharma SpA

Via Meucci 36, Ospedaletto

56014 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

Italy

You can request more information about this medicine by contacting the local representative of the marketing authorisation holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

This medicine has been authorised in the Member States of the European Economic Area under the following names:

Spain Manidipino Viatris 20 mg tablets EFG

France Manidipine Viatris 20 mg tablet

Date of last revision of this leaflet:November 2024

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