PATIENT INFORMATION LEAFLET

Manidipino VIR 20 mg tablets EFG

Manidipino hydrochloride

Read this 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. Do not give it 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.

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

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

No use Manidipino 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 within the first 4 weeks after a myocardial infarction.
• If you have uncontrolled congestive heart failure.
• If you have severe kidney disease (creatinine clearance <10)
• 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 Manidipino VIR

• If you have mild liver problems, as it may increase the hypotensive effect (see section 3 “How to take Manidipino VIR”).
• In case of administration to elderly people, your doctor will recommend reducing the dose (see section “How to take Manidipino 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 dysfunction syndrome and do not have an implanted pacemaker.
• If you have stable coronary disease, due to the possibility of increased coronary risk (see section 4 ”Possible adverse effects”).
• If you are taking other medications that inhibit the CYP 3A4 enzyme (such as protease inhibitors, cimetidine, ketoconazole, itraconazole, erythromycin, or clarithromycin) or with medications that induce 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 Manidipino VIR with other medications

Inform your doctor or pharmacist that you are taking, have taken recently, 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 rhythm (such as amiodarone, quinidine, digoxin).
• Allergies (such as terfenadine, astemizole).

Manidipino VIR with food and drinks

You should not take alcohol or grapefruit juice during treatment with manidipine.

Pregnancy, breastfeeding, and fertility

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

Driving and operating machinery

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

Important information about some of the components of Manidipino VIR

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

Follow exactly the administration instructions for this medication as indicated 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, along with a small amount of liquid.

The recommended initial dose is 10 mg once a day.

If after 2-4 weeks of treatment the antihypertensive effect of manidipino is insufficient, your doctor may increase the dose to 20 mg once a day.

If you are elderly or suffer from any 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 manidipino VIR. Do not discontinue treatment beforehand, 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 manidipino VIR more than you should, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount taken.

There is no experience of overdose with this medication.

If you forget to take Manidipino VIR

If 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 compensate for the missed doses.

If you interrupt treatment with Manidipino VIR

Ask your doctor before stopping taking this medication.

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

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

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

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

Infrequent (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): drowsiness, chest pain, angina, 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 may experience an increase in frequency, duration, or severity of these attacks.

Unknown frequency: muscle pain, breast swelling with or without pain in men (gynecomastia), cloudy liquid (when performing dialysis through a tube in the abdomen).

Reporting Adverse Effects

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

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

Do not use this medication after the expiration date that appears on the packaging after “Exp”. The expiration date is the last day of the month indicated.

No special storage conditions are required. Do not dispose of medications through drains or trash. Dispose of packaging and unused medications at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Manidipino VIR

• The active ingredient is manidipine hydrochloride, 20 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 packaging

Manidipine VIR 20 mg tablets are presented in the form of oval-shaped scored tablets with a yellow color.

Each package contains 28 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder

INDUSTRIA QUIMICA Y FARMACEUTICA VIR, S.A.

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

28923- Alcorcón (Madrid) Spain

Responsible for manufacturing

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 prospectus was last revised in September 2024

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