MANIDIPINE NORMON 10 mg TABLETS

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Manidipine NORMON 10 mg tablets EFG

Read the entire package leaflet carefully before starting to take 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 for you. Do not give it to others, as it may harm them, even if their symptoms are the same as yours.
• If you experience any of the side effects, or if you notice any side effects not mentioned in this package leaflet, please inform your doctor or pharmacist.

Contents of the package leaflet:

1. WHAT IS MANIDIPINE NORMON AND WHAT IS IT USED FOR
2. BEFORE TAKING MANIDIPINE NORMON
3. HOW TO TAKE MANIDIPINE NORMON
4. POSSIBLE SIDE EFFECTS
5. STORAGE OF MANIDIPINE NORMON
6. ADDITIONAL INFORMATION

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

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

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

2. Before taking Manidipine Normon

Do not use Manidipine NORMON

• If you are allergic (hypersensitive) to manidipine, to other dihydropyridines, or to any of the other components of Manidipine NORMON (see section 6 for the list of components).
• If you suffer from unstable angina pectoris 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.

Be careful with Manidipine NORMON

• If you have mild liver problems, as the hypotensive effect may be increased (see section 3 "HOW TO TAKE Manidipine NORMON").
• In the case of administration to elderly people, your doctor will recommend reducing the dose (see section 3 "HOW TO TAKE Manidipine NORMON").
• 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 CYP 3A4 enzyme (an enzyme that helps metabolize medicines) (such as antiproteases, cimetidine, ketoconazole, itraconazole, erythromycin, or clarithromycin) or with CYP 3A4 enzyme inducers (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.

Use of other medicines

Tell your doctor or pharmacist if you are using or have recently used other medicines, including those obtained without a prescription or 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, quinidine, digoxin).
• - Allergies (such as terfenadine, astemizole).

Taking Manidipine NORMON with food and drinks

Alcohol consumption should be avoided, as it may potentiate the hypotensive effect of this medicine.

Do not take grapefruit juice while taking this medicine, as the hypotensive effect may be increased.

Pregnancyand breastfeeding

Consult your doctor or pharmacist before using any medicine.

Do not use Manidipine NORMON during pregnancy or breastfeeding. If treatment with manidipine is necessary, breastfeeding should be interrupted.

Drivingand using machines

Be careful while driving or operating machinery, as dizziness may occur due to the decrease in blood pressure.

Manidipine Normon contains lactose

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

3. How to take Manidipine Normon

Follow the instructions for administration of Manidipine NORMON indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

Manidipine NORMON is administered orally. The tablets should be taken in the morning after breakfast, swallowed without chewing, with a little liquid.

Remember to take your medicine.

The initial dose is usually 10 mg once a day (one Manidipine NORMON 10 mg tablet orally). 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 NORMON. Do not stop treatment before, as you may not have completed the treatment process for your condition.

If you take more Manidipine NORMON than you should

In case of taking more medicine than you should, it can be expected that excessive peripheral vasodilation will occur, accompanied by a significant drop in blood pressure and an increase in heart rate. In this case, symptomatic and supportive treatment of cardiovascular function should be rapidly initiated.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount ingested.

There is no experience with overdose of this medicine.

If you forget to take Manidipine NORMON

In case of forgetting 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 NORMON

Ask your doctor before stopping this medicine.

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

4. Possible side effects

Like all medicines, Manidipine NORMON can cause side effects, although not everyone gets them. While taking Manidipine NORMON, the following side effects may appear:

Frequent (between 1 and 10 in every 100 patients): headache, dizziness, vertigo, swelling caused by fluid retention, palpitations, hot flashes.

Uncommon (between 1 and 10 in every 1,000 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 (between 1 and 10 in every 10,000 patients): drowsiness, chest pain, angina pectoris, hypertension, stomach pain, abdominal pain, skin redness, itching, and irritability.

Very rare (in less than 1 in every 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 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 experience any of the side effects, or if you notice any side effects not mentioned in this package leaflet, please inform your doctor or pharmacist.

5. Storage of Manidipine Normon

Keep out of the reach and sight of children.

Do not use Manidipine NORMON 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.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Additional information

Composition of Manidipine NORMON

The active substance is manidipine hydrochloride, 10 mg.

The other components are lactose monohydrate, cornstarch, low-substituted hydroxypropylcellulose, hydroxypropylcellulose, magnesium stearate, and riboflavin (E-101).

Appearance of the product and packaging contents

Manidipine NORMON 10 mg tablets are presented in the form of scored, round, yellow tablets. Each package contains 28 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 - 28760 Tres Cantos - Madrid (SPAIN)

Manufacturer

ABIOGEN PHARMA, S.p.A.

Via Meucci, 36 – Ospedaletto, 56014 Pisa (ITALY)

O

GALENICUM HEALTH, S.L.

Avda. Diagonal, 538 4º 1ª

08006 Barcelona, Spain

O

DOPPEL FARMACEUTICI, S.R.L.

Via Volturno, 48 Quinto De Stampi

I-20089 Rozzano, Milan, Italy

O

VAMFARMA, S.R.L.

Via Kenney, 5

26833 Comazzo (LO), Italy

This package leaflet was approved in: September 2024