Leaflet: Information for the user

Manidipino Viatris 10 mg tablets EFG

Read this leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

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

3. How to take Manidipino Viatris.

4. Possible side effects

5. Storage of Manidipino Viatris.

6. Contents of the pack and additional information.

The Manidipino Viatris tablets contain 10 mg of the active ingredient manidipino dihydrochloride, which belongs to a group of medicines called dihydropyridine calcium channel blockers.

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

Manidipino works by relaxing blood vessels and, therefore, reducing blood pressure.

Do not take Manidipino Viatris

• If you are allergic to manidipine, other dihydropyridines, or any other ingredient in this medication (including 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 within the past 4 weeks (myocardial infarction).
• If you have untreated congestive heart failure.
• If you have severe kidney failure (creatinine clearance <10).
• If you have moderate to severe liver failure.
• If you are a child.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Manidipino Viatris

• If you have any liver problems since 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 heart rate due to uncontrolled electrical activity in the heart not controlled with a pacemaker.

Other medications and Manidipino Viatris

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, including those purchased without a prescription, or medications for the following conditions:

• Hypertension, 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.
• Cancer treatment and radiation therapy, such as amifostine.
• HIV treatment, such as protease inhibitors.
• Stomach problems, such as cimetidine.
• Irregular heart rhythm (such as amiodarone, quinidine, digoxin).
• Muscle 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 may reduce 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 if this medication passes into breast milk. If treatment with manidipine is necessary, breastfeeding should be discontinued.

Fertility

There have been reports of alterations in the head of sperm that may make it difficult for patients treated with medications like manidipine.

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 medication.

Driving and operating machinery

This medication may cause drowsiness, so caution should be exercised when driving or operating machinery.

Manidipino Viatris contains lactose

If your doctor has informed you that you have intolerance to some sugars, consult with your doctor before taking this medication.

Always follow exactly the instructions marked by your doctor or pharmacist for taking this medication. You should consult with your doctor or pharmacist if you have any doubts.

If you observe that the action of manidipino is too strong or too weak, consult with your doctor or pharmacist.

Use in children and adolescents

Children and adolescents should not take Manidipino Viatris.

Treatment duration

Your doctor will tell you the duration of treatment. Do not interrupt 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 initial recommended 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 breaking line only serves to break the tablet if you have difficulty swallowing.

Older adults or if you have renal or hepatic insufficiency

If you are an older adult or if you suffer from renal or hepatic insufficiency, 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) ingest a large number of tablets at the same time, or if you think a child has taken some of the tablets, contact the emergency department of the nearest hospital immediately or your doctor. 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 Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Manidipino Viatris

If you forget a dose, take it as soon as possible and take the next ones as prescribed.

Do not take a double dose to compensate for the missed dose.

If you interrupt treatment with Manidipino Viatris

Before stopping taking Manidipino Viatris, contact your doctor.

If you have any doubts about how to take this medication, consult with your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

The following serious side effects may occur during the use of Manidipino Viatris. If they occur, 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 events may be observed.

Other possible side effects

Common(may affect up to 1 in 10 people)

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

Uncommon(may affect up to 1 in 100 people)

• Sensation of tingling in the skin.
• Weakness or lack of energy.
• Increased heart rate.
• Low blood pressure.
• Difficulty breathing.
• Uncomfortable feeling (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)

• Sleep.
• Drowsiness.
• High blood pressure.
• Stomach pain.
• Abdominal pain.
• Skin redness.
• Itching and irritability.
• Increased bilirubin, which may be seen in blood tests.
• Diarrhea.
• Loss of appetite (anorexia).
• Yellowish discoloration 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.

Unknown frequency(cannot be estimated from available data)

• Peeling or shedding of the skin, small spots on the skin.
• Sextrapyramidal syndrome has been reported with other medications, including this medication.
• Muscle pain.
• Inflammation of the breasts, with or without sensitivity, in men (gynecomastia).
• Cloudy liquid (when undergoing dialysis through a tube in the abdomen).

Reporting of side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not take manidipino after the expiration date indicated on the packaging after CAD. The expiration date refers to the last day of the month indicated.

This medication does not require special storage conditions.

Medicines should not be thrown down the drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need.This will help protect the environment.

Content of Manidipino Viatris

The active substance is manidipino dihydrochloride 10 mg.

Each tablet contains 10 mg of dihydrochloride manidipine.

The other components are lactose monohydrate (see section 2 “Manidipino Viatris contains lactose”), cornstarch, hydroxypropylcellulose partially substituted, hydroxypropylcellulose, magnesium stearate, riboflavin.

Appearance of Manidipino Viatris and contents of the package

The tablets are round, convex, yellow in color, with a cutting groove in the middle.

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

Only some package sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Responsible for manufacturing

Abiogen Pharma SpA

Via Meucci 36, Ospedaletto

56014 Pisa – Italy

or

Doppel Farmaceutici S.r.l.

Via Volturno, 48

20089 Quinto de Stampi, Rozzano, Milan

Italy

or

Vamfarma S.r.l.

Via Kennedy, 5

26833 Comazzo

Italy

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

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

This medication has been authorized in the member states of the European Economic Area with the following names:

SpainManidipino Viatris 10 mg tablets EFG

FranceManidipine Viatris 10 mg tablet

Revision date of thisleaflet:November 2024

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) https://www.aemps.gob.es/