MANIDIPINE VIR 10 mg TABLETS

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Manidipine VIR 10 mg tablets EFG

Manidipine hydrochloride

Read the entire package leaflet carefully before starting to use the medication.

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

Contents of the package leaflet:

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

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

Manidipine belongs to the group of medications called selective calcium channel blockers, with a predominantly vascular action.

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

2. What you need to know before taking Manidipine VIR

Do not use Manidipine VIR

• If you are allergic to manidipine, other dihydropyridines, or any of the other components of this medication (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 medication.

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").
• 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 artery disease, due to the possibility of increased coronary risk (see section 4 "Possible side effects").
• If you are taking other medications 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 antiarrhythmic medications of class III, such as amiodarone).
• If you are undergoing peritoneal dialysis.

Interaction of Manidipine VIR with other medications

Tell your doctor or pharmacist that you are taking, have recently taken, or may need to take any other medication for any of the following conditions:

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

Manidipine VIR with food and beverages

Do not consume alcohol or grapefruit juice during treatment with manidipine.

Pregnancy, breastfeeding, and fertility

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

Driving and using machines

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

Important information about some of the components of Manidipine VIR

This medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

3. How to take Manidipine VIR

Follow the instructions for administration of this medication indicated 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 completing 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 medication and the amount taken.

There is no experience with overdose of this medication.

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 interrupt treatment with Manidipine VIR

Ask your doctor before stopping this medication.

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

4. Possible side effects

Like all medications, Manidipine VIR can cause side effects, although not everyone will experience 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 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, 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 treatment suspension. 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, consult your doctor or pharmacist, even if they are possible side effects not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Manidipine VIR

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

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

No special storage conditions are required. Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need in the of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Contents of the pack and further information

Composition of Manidipine VIR

• The active ingredient is manidipine hydrochloride, 10 mg.
• The other components are lactose, cornstarch, low-substituted hydroxypropylcellulose, hydroxypropylcellulose, magnesium stearate, and riboflavin (E-101).

Appearance of the product and contents of the pack

Manidipine VIR 10 mg tablets are presented in the form of scored, round, 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

The last revision of this package leaflet was in September 2024

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