Manidipino Kern Pharma 10 mg tablets EFG

Patient Information Leaflet

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Manidipino Kern Pharma 10 mg tablets EFG

Manidipine hydrochloride

Read the entire leaflet carefully before you start using 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 others, 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 Kern Pharma is and what it is used for
2. What you need to know before taking Manidipino Kern Pharma
3. How to take Manidipino Kern Pharma
4. Possible side effects
5. How to store Manidipino Kern Pharma
6. Contents of the pack and other information

1. What Manidipino Kern Pharma is and what it is used for

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

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

2. What you need to know before taking Manidipino Kern Pharma

Do not use Manidipino Kern Pharma

• 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 hepatic disease.

Children must not take this medicine.

Warnings and precautions

Talk to your doctor or pharmacist before starting Manidipino KERN PHARMA.

• If you have mild liver problems, as the hypotensive effect may be increased (see section 3 “How to take Manidipino Kern Pharma”).
• In elderly patients, your doctor may recommend reducing the dose (see section 3 “How to take Manidipino Kern Pharma”).
• 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 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 drugs that inhibit the CYP3A4 enzyme (an enzyme involved in drug metabolism), such as antiproteases, cimetidine, ketoconazole, itraconazole, erythromycin, or clarithromycin, or drugs that induce the CYP3A4 enzyme (such as phenytoin, carbamazepine, phenobarbital, or rifampicin).
• When taking manidipine together with other substrates of the CYP3A4 enzyme (such as terfenadine, astemizole, quinidine, or class III antiarrhythmic drugs like amiodarone).
• If you are undergoing peritoneal dialysis.

Interaction of Manidipino Kern Pharma 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).

Manidipino Kern Pharma 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 might 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 Manidipino Kern Pharma

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 Kern Pharma

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

Manidipino Kern Pharma is administered orally. The tablets should be taken in the morning after breakfast, swallowed whole, without chewing, with a little 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 if you have any kidney or liver disease, your doctor may prescribe you a lower dose (10 mg once daily).

Your doctor will determine the duration of your treatment with Manidipino KERN PHARMA. Do not stop treatment prematurely, as you may not have completed the treatment process for your condition.

If you take more Manidipino Kern Pharma than you should

If you have taken more Manidipino Kern Pharma than you should, consult 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 Kern Pharma

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

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

If you stop taking Manidipino Kern Pharma

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 Kern Pharma can cause adverse effects, although not everyone will experience them.

The following adverse effects may occur while taking Manidipino Kern Pharma:

Common (may affect up to 1 in 10 patients): headache, dizziness, vertigo, swelling due to 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), increase in liver enzymes and/or kidney parameters.

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

Very rare (may affect up to 1 in 1,000 patients): myocardial infarction, inflammation or changes in the gums, which usually resolve 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 (cannot be estimated from available data): muscle pain, breast swelling with or without pain in men (gynecomastia), cloudy fluid (when performing dialysis through a tube in the abdomen).

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

5. Storage of Manidipino Kern Pharma

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 refers to the last day of the month indicated.

No special storage conditions are required.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Manidipino Kern Pharma

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

Appearance of the product and contents of the pack

Manidipino Kern Pharma 10 mg tablets are presented as yellow, round, scored tablets.

Each pack contains 28 tablets.

Marketing Authorization Holder and Manufacturer

Holder

KERN PHARMA, S.L.

Venus, 72. Polígono Industrial Colon II.

08228 Tarrasa (Barcelona)

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

Rozzano, Milan

ITALY

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 medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS): http://www.aemps.es/"