MANIDIPINE VIR 20 mg TABLETS

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Manidipine VIR 20 mg tablets EFG

Manidipine hydrochloride

Read all of this leaflet carefully before you start taking this medicine.

• 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 symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Contents of the pack:

1. What Manidipine VIR is and what it is used for
2. What you need to know before you take Manidipine VIR
3. How to take Manidipine VIR
4. Possible side effects
5. Storing Manidipine VIR
6. Contents of the pack and further information

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

Manidipine belongs to a group of medicines called selective calcium channel blockers, with a preferentially vascular action.

Manidipine VIR is indicated for the treatment of mild to moderate essential hypertension.

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

Do not take Manidipine VIR

• If you are allergic to manidipine, other dihydropyridines, or any of the other ingredients of this medicine (listed in section 6).
• If you have unstable angina or during the first 4 weeks after a myocardial infarction.
• If you have uncontrolled congestive heart failure.
• If you have severe kidney disease (creatinine clearance <10 ml min).< li>
• If you have moderate to severe liver disease.

Children should not take this medicine.

Warnings and precautions

Consult your doctor or pharmacist before taking Manidipine VIR

• If you have mild liver problems, as the hypotensive effect may be increased (see section 3 "How to take Manidipine VIR").
• In the case of administration to elderly people, your doctor will recommend reducing the dose (see section "How to take Manidipine VIR").
• If you have left ventricular dysfunction.
• If you have left ventricular outflow obstruction.
• If you have isolated right heart failure.
• If you have sinus node dysfunction and do not have a pacemaker implanted.
• If you have stable coronary disease, due to the possibility of increased coronary risk (see section 4 "Possible side effects").
• If you are taking other medicines that inhibit the CYP 3A4 enzyme (such as antiproteases, cimetidine, ketoconazole, itraconazole, erythromycin, or clarithromycin) or inducers of the CYP 3A4 enzyme (such as phenytoin, carbamazepine, phenobarbital, or rifampicin).
• When taking manidipine and other substrates of the CYP 3A4 enzyme (such as terfenadine, astemizole, quinidine, or class III antiarrhythmic drugs, such as amiodarone).
• If you are undergoing peritoneal dialysis.

Interaction of Manidipine VIR with other medicines

Tell your doctor or pharmacist that you are taking, have recently taken, or might take any other medicine for any of the following conditions:

• High blood pressure, such as diuretics and/or beta-blockers.
• Viral and bacterial infections.
• Mental disorders.
• Irregular heart rhythm (such as amiodarone, quinidine, digoxin).
• Allergies (such as terfenadine, astemizole).

Manidipine VIR with food and drinks

Do not drink alcohol or grapefruit juice while taking manidipine.

Pregnancy, breastfeeding, and fertility

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

Driving and using machines

Be careful while driving or operating machinery, as dizziness may occur.

Important information about some of the ingredients of Manidipine VIR

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 VIR

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

Manidipine VIR is administered orally. The tablets should be taken in the morning after breakfast, swallowed without chewing, 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 manidipine is insufficient, your doctor may increase the dose to 20 mg once a day.

If you are elderly or have kidney or liver disease, your doctor may prescribe a lower dose (10 mg once a day).

Your doctor will indicate the duration of your treatment with manidipine VIR. Do not stop treatment before, as you may not have completed the treatment process for your condition.

If you take more Manidipine VIR than you should

If you have taken more manidipine VIR than you should, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount taken.

There is no experience of overdose with this medicine.

If you forget to take Manidipine VIR

In case you forget to take a tablet, take it immediately, continuing with the next tablet the next day, as prescribed.

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

If you stop taking Manidipine VIR

Ask your doctor before stopping this medicine.

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

4. Possible side effects

Like all medicines, Manidipine VIR can cause side effects, although not everybody gets them.

While taking Manidipine VIR, the following side effects may appear:

Frequent (may affect up to 1 in 10 patients): headache, dizziness, vertigo, swelling caused by fluid retention, palpitations, hot flashes.

Uncommon (may affect up to 1 in 100 patients): tingling sensation, weakness or lack of energy, increased heart rate, hypotension, difficulty breathing, nausea, vomiting, constipation, dry mouth, stomach upset, skin rash, skin inflammation (eczema), increased liver enzymes and/or kidney parameters.

Rare (may affect up to 1 in 1,000 patients): somnolence, chest pain, angina pectoris, hypertension, stomach pain, abdominal pain, skin redness, itching, and irritability.

Very rare (may affect up to 1 in 10,000 patients): myocardial infarction, inflammation or alteration of the gums that usually disappear with the suspension of treatment. In isolated cases, patients with pre-existing angina pectoris may experience an increase in frequency, duration, or severity of these attacks.

Frequency not known: muscle pain, breast swelling with or without pain in men (gynecomastia), cloudy liquid (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, even if it is 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. Storing Manidipine VIR

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

Do not use this medicine after the expiry date which is stated on the packaging after "EXP". The expiry date is the last day of the month indicated.

No special storage conditions are required. Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the of the pharmacy. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and further information

Composition of Manidipine VIR

• The active substance is manidipine hydrochloride, 20 mg.
• The other ingredients are lactose, corn starch, low-substituted hydroxypropylcellulose, hydroxypropylcellulose, magnesium stearate, and riboflavin (E-101).

Appearance and packaging of the product

Manidipine VIR 20 mg tablets are presented in the form of scored, oval, yellow tablets.

Each pack contains 28 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

INDUSTRIA QUIMICA Y FARMACEUTICA VIR, S.A.

Laguna, 66-68-70. Poligono Industrial Urtinsa II

28923- Alcorcón (Madrid) Spain

Manufacturer

ABIOGEN PHARMA, S.p.A.

Via Meucci, 36 – Ospedaletto, 56014 Pisa (ITALY)

or

DOPPEL FARMACEUTICI, S.R.L.

Via Volturno, 48 Quinto De Stampi

I-20089 Rozzano, Milan, Italy

or

VAMFARMA S.r.l.

Via Kennedy 5,

26833 Comazzo (LO)

Italy

This leaflet was last revised in September 2024

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