MANIDIPINE KERN PHARMA 20 mg TABLETS

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Manidipine Kern Pharma 20 mg tablets EFG

Manidipine hydrochloride

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

• Keep this package leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed to you and you should 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, consult your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet.

Contents of the package leaflet:

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

1. What is Manidipine Kern Pharma and what is it 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 taking Manidipine Kern Pharma

Do not take Manidipine Kern Pharma

• If you are allergic to manidipine, other dihydropyridines, or any of the other ingredients of this medicine (listed in section 6).
• If you have unstable angina or have had a heart attack within the last 4 weeks.
• 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 medicine.

Warnings and precautions

Consult your doctor or pharmacist before starting to take 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 have left ventricular dysfunction.
• If you have left ventricular outflow tract obstruction.
• If you have isolated right heart failure.
• If you have sick sinus syndrome and do not have a pacemaker.
• 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 medicines 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 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 may take any other medicine 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).

Manidipine Kern Pharma with food and drinks

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

Pregnancy, lactation, 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 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 given by your doctor or pharmacist. If in 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 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. Do not stop treatment before completing 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 with overdose of this medicine.

If you forget to take Manidipine Kern Pharma

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 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 about 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 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 1,000 patients): myocardial infarction, gum inflammation or alteration that usually disappears 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 (cannot be estimated from 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 consider that any of the side effects you are experiencing is serious or if you notice any side effect not mentioned in this package leaflet, inform your doctor or pharmacist.

5. Storage of Manidipine Kern Pharma

Keep this medicine out of the sight and reach 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. Return the packaging and any unused medicine to the pharmacy. If in doubt, 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 ingredient is manidipine hydrochloride, 10 mg.
• The other ingredients are lactose, cornstarch, low-substituted hydroxypropylcellulose, hydroxypropylcellulose, magnesium stearate, and riboflavin (E-101).

Appearance of the product and contents of the pack

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

Each pack contains 28 tablets.

Marketing authorization holder and manufacturer

Marketing authorization 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 package leaflet was 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/"