Manidipino Vir 20 mg tablets EFG

Patient Information Leaflet

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Manidipino VIR 20 mg tablets EFG

Manidipine hydrochloride

Read the entire leaflet carefully before you start taking this medicine.

• Keep this leaflet as 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 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.

Leaflet contents:

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

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

Manidipino belongs to the group of medicines known as selective calcium channel blockers, with predominantly vascular action.

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

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

Do not use Manidipine VIR

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

Children must not take this medicine.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Manidipine VIR

• If you have mild liver problems, as the hypotensive effect may be increased (see section 3 “How to take Manidipine VIR”).
• If you are elderly, your doctor may recommend a lower dose (see section “How to take Manidipine VIR”).
• If you have left ventricular dysfunction.
• If you have left ventricular outflow tract obstruction.
• If you have isolated right heart failure.
• If you have sinus node dysfunction syndrome and do not have a pacemaker implanted.
• If you have stable coronary artery disease, due to the possibility of increased coronary risk (see section 4 “Possible side effects”).
• If you are taking concomitant medications that inhibit the CYP3A4 enzyme (an enzyme involved in drug metabolism), such as protease inhibitors, cimetidine, ketoconazole, itraconazole, erythromycin, or clarithromycin, or medications that induce CYP3A4 enzyme activity (such as phenytoin, carbamazepine, phenobarbital, or rifampicin).
• When taking manidipine together with other CYP3A4 substrates (such as terfenadine, astemizole, quinidine, or class III antiarrhythmic drugs like amiodarone).
• If you are undergoing peritoneal dialysis.

Interaction of Manidipine VIR with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines 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, quinidina, digoxin).
• Allergies (such as terfenadine, astemizole).

Manidipine VIR with food and drink

You must not drink alcohol or grapefruit juice during treatment with manidipine.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

Be cautious when driving or operating machinery, as dizziness may occur.

Important information about some of the components of Manidipine VIR

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 VIR

Follow exactly the administration instructions for this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Manidipino VIR is administered orally. The tablets should be taken in the morning after breakfast, swallowed whole without chewing, together with some liquid.

The recommended initial 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.

If you are elderly or suffer from any kidney or liver disease, your doctor may prescribe you a lower dose (10 mg once daily).

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

If you take more Manidipino VIR than you should

If you have taken more Manidipino VIR than you should, 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 taken.

There is no experience of overdose with this medicine.

If you forget to take Manidipino VIR

If you forget to take a tablet, take it as soon as possible, then continue with the next dose the following day as prescribed.

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

If you stop taking Manidipino VIR

Ask your doctor before stopping this medicine.

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

4. Possible adverse effects

Like all medicines, Manidipino VIR may produce adverse effects, although not everyone will experience them.

While taking Manidipino VIR, the following adverse effects may occur:

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

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, gastric discomfort, 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, irritability.

Very rare (may affect up to 1 in 10,000 patients): myocardial infarction, inflammation or alteration of the gums, which usually disappear upon discontinuation 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 fluid (when undergoing dialysis through a tube in the abdomen).

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through 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 VIR

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

Do not use this medicine after the expiry date 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 unused medicines and their containers at a at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of medicines and their packaging that you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Manidipino VIR

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

Appearance of the medicinal product and contents of the pack

Manidipino VIR 20 mg tablets are presented as yellow, oval, scored 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, Spain

or

VAMFARMA S.r.l.

Via Kennedy 5,

26833 Comazzo (LO)

Italy

The last revision of this leaflet was in September 2024

"Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.es/"