MANIDIPINE NORMON 20 mg TABLETS

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Manidipine NORMON 20 mg tablets EFG

Read the entire package leaflet carefully before starting to take the medication.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you consider that any of the side effects you are suffering from is serious or if you notice any side effect not mentioned in this package leaflet, 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 the group of medications 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 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).
• If you suffer from moderate to severe liver disease.

Children should not take this medication.

Be careful with Manidipine NORMON

• If you have mild liver problems, as the hypotensive effect may increase (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 medications that inhibit the CYP 3A4 enzyme (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 CYP 3A4 enzyme substrates (such as terfenadine, astemizole, quinidine, or class III antiarrhythmic medications, such as amiodarone).
• If you are undergoing peritoneal dialysis.

Use of other medications

Tell your doctor or pharmacist if you are using or have recently used other medications, including those purchased without a prescription or medications 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).

Taking Manidipine NORMON with food and drinks

Alcohol consumption should be avoided, as it may enhance the hypotensive effect of this medication.

Do not take grapefruit juice while taking this medication, as the hypotensive effect may increase.

Pregnancyand breastfeeding

Consult your doctor or pharmacist before using any medication.

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

3. How to take Manidipine Normon

Follow the administration instructions of Manidipine NORMON exactly as indicated by your doctor. Consult your doctor or pharmacist if you have any questions.

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 medication.

The initial dose is normally 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 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 medication 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 medication and the amount ingested.

There is no experience with overdose of this medication.

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 stop treatment with Manidipine NORMON

Ask your doctor before stopping this medication.

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

4. Possible side effects

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

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

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

Very rare (in less than 1 out of 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 consider that any of the side effects you are suffering from is serious or if you notice any side effect not mentioned in this package leaflet, 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.

Medications should not be disposed of through wastewater or household waste. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Additional information

Composition of Manidipine NORMON

The active ingredient is manidipine hydrochloride, 20 mg.

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

Appearance of the product and packaging content

Manidipine NORMON 20 mg tablets are presented in the form of scored oval tablets of yellow color. Each package contains 28 tablets.

Marketing authorization holder and manufacturer

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