MANIDIPINO KERN PHARMA 10 mg TABLETS

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Manidipine Kern Pharma 10 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 Kern Pharma is and what it is used for
2. What you need to know before you take Manidipine Kern Pharma
3. How to take Manidipine Kern Pharma
4. Possible side effects
5. Storing Manidipine Kern Pharma
6. Contents of the pack and further information

1. What Manidipine Kern Pharma 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 Kern Pharma is indicated for the treatment of mild to moderate essential hypertension.

2. What you need to know before you take Manidipine Kern Pharma

Do not take Manidipine Kern Pharma

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

Children should not take this medicine.

Warnings and precautions

Consult your doctor or pharmacist before taking Manidipine Kern Pharma.

• If you have mild liver problems, as the hypotensive effect may be increased (see section 3 "How to take Manidipine Kern Pharma").
• In the case of administration to elderly people, your doctor will recommend reducing the dose (see section 3 "How to take Manidipine Kern Pharma").
• If you suffer from left ventricular dysfunction.
• If you suffer from left ventricular outflow obstruction.
• If you suffer from isolated right heart failure.
• If you suffer from sick sinus syndrome and do not have a pacemaker implanted.
• If you suffer from 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 enzyme CYP 3A4 (an enzyme that helps to metabolize medicines) (such as antiproteases, cimetidine, ketoconazole, itraconazole, erythromycin, or clarithromycin) or with inducers of the enzyme CYP 3A4 (such as phenytoin, carbamazepine, phenobarbital, or rifampicin).
• When taking manidipine and other substrates of the enzyme CYP 3A4 (such as terfenadine, astemizole, quinidine, or antiarrhythmic drugs of class III, such as amiodarone).
• If you are undergoing peritoneal dialysis.

Interaction of Manidipine Kern Pharma with other medicines

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

Manidipine Kern Pharma with food and drinks

Do 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 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 Kern Pharma

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 Kern Pharma

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

Manidipine Kern Pharma 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 suffer from 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 Kern Pharma. Do not stop treatment before, as you may not have completed the treatment process for your condition.

If you take more Manidipine Kern Pharma than you should

If you have taken more Manidipine Kern Pharma than you should, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone 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 Kern Pharma

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 Kern Pharma

Ask your doctor before stopping treatment with 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 Kern Pharma can cause side effects, although not everybody gets them.

While taking Manidipine Kern Pharma, 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 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, stomach upset, 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 pectoris, hypertension, stomach pain, abdominal pain, skin redness, itching, and irritability.

Very rare (may affect up to 1 in 1,000 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 the frequency, duration, or severity of these attacks.

Frequency not known (cannot be estimated from the available data): muscle pain, breast swelling with or without pain in men (gynecomastia), cloudy liquid (when performing dialysis through a tube in the abdomen).

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

5. Storing Manidipine Kern Pharma

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. Place the packaging and any unused medicine in the at your 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 Kern Pharma

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

Appearance and packaging of the product

Manidipine Kern Pharma 10 mg tablets are presented in the form of scored, round, yellow tablets.

Each pack contains 28 tablets.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

KERN PHARMA, S.L.

Venus, 72. Polígono Industrial Colon II.

08228 Terrassa (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.

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/”