MANIDIPINE VIATRIS 10 mg TABLETS

Introduction

Package Leaflet: Information for the User

Manidipino Viatris 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 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 10 mg of the active substance manidipine dihydrochloride, 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 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, 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).< li>
• 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, your doctor may recommend a lower 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 heart rate due to uncontrolled electrical activity in the heart.

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

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

Fertility

It has been reported that changes in sperm head morphology 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 machinery.

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 manidipine is too strong or too weak, talk to 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 daily.

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

The break line is only to help you break 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 daily).

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 your nearest hospital or your doctor immediately. As with other calcium channel blockers, it is expected that an overdose may cause vasodilation, which 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 then 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, talk to 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 on the skin.
• Weakness or lack of energy.
• Increased heart rate.
• Low blood pressure.
• Breathing difficulties.
• Discomfort (nausea).
• Vomiting.
• Constipation.
• Dry mouth.
• Gastrointestinal 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, which 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.
• Enlargement of the breast tissue in men, with or without tenderness (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 or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Spanish Medicines Agency's Pharmacovigilance 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. 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 10 mg.

Each tablet contains 10 mg of manidipine dihydrochloride.

The other ingredients are lactose monohydrate (see section 2 "Manidipino Viatris contains lactose"), corn starch, low-substituted hydroxypropylcellulose, hydroxypropylcellulose, magnesium stearate, riboflavin.

Appearance of Manidipino Viatris and pack contents

The tablets are round, 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 from 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 10 mg tablets EFG

France Manidipine Viatris 10 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/