MANIDIPINO NORMON 10 MG TABLETS EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Manidipino NORMON 10 mg tablets EFG

Read the entire leaflet carefully before you start taking 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 and you should not give it to other people, even if they have the same symptoms, as it may harm them.
• If you consider any of the side effects you experience to be serious, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Leaflet contents:

1. WHAT MANIDIPINO NORMON IS AND WHAT IT IS USED FOR
2. BEFORE YOU TAKE MANIDIPINO NORMON
3. HOW TO TAKE MANIDIPINO NORMON
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE MANIDIPINO NORMON
6. FURTHER INFORMATION

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

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

Manidipino NORMON is indicated for the treatment of mild to moderate essential arterial 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 following a myocardial infarction.
• If you have uncontrolled congestive heart failure.
• If you have severe kidney disease (creatinine clearance <10 ml/min).
• If you have moderate to severe liver disease.

Children must not take this medicine.

Take special care 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 elderly patients, your doctor may recommend a reduced dose (see section 3 “HOW TO TAKE Manidipine Normon”).
• If you have left ventricular dysfunction.
• If you have left ventricular outflow tract obstruction.
• If you have isolated right-sided 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 ADVERSE 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 CYP3A4 substrates (such as terfenadine, astemizole, quinidine, or class III antiarrhythmic drugs like amiodarone).
• If you are undergoing peritoneal dialysis.

Use of other medicines

Inform your doctor or pharmacist if you are using or have recently used any 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, quinidina, 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 medicine.

You must not drink grapefruit juice while taking this medicine, as it may increase the hypotensive effect.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

You must not use Manidipine Normon during pregnancy or breastfeeding. If treatment with manidipine is necessary, breastfeeding should be discontinued.

Driving and using machines

Be cautious when driving or operating machinery, as dizziness may occur due to a drop in blood pressure.

Manidipine Normon contains lactose

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 Normon

Follow exactly the instructions for administration of Manidipino NORMON as given by your doctor. If you have any doubts, consult your doctor or pharmacist.

Manidipino NORMON is administered orally. The tablets should be taken in the morning after breakfast, swallowed whole without chewing, together with some liquid.

Remember to take your medicine.

The usual initial dose is 10 mg once daily (one tablet of Manidipino NORMON 10 mg 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 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 NORMON. Do not stop treatment earlier, as you may not have completed the treatment course for your condition.

If you take more Manidipino NORMON than you should

If you have taken more medicine than you should, excessive peripheral vasodilation may occur, accompanied by a significant drop in blood pressure and increased heart rate. In this case, symptomatic treatment and cardiovascular support must be promptly initiated.

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

There is no experience of overdose with this medicinal product.

If you forget to take Manidipino NORMON

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 forgotten doses.

If you stop taking Manidipino 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 adverse effects

Like all medicines, Manidipino NORMON may produce adverse effects, although not everyone experiences them. The following adverse effects may occur while taking Manidipino NORMON:

Common (between 1 and 10 in 100 patients): headache, dizziness, vertigo, swelling due to fluid retention, palpitations, hot flushes.

Uncommon (between 1 and 10 in 1,000 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), increased liver enzymes and/or kidney parameters.

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

Very rare (less than 1 in 10,000 patients): myocardial infarction, inflammation or alteration of the gums, which usually disappear upon discontinuation 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 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 effect not listed in this leaflet, inform your doctor or pharmacist.

5. Storage of Manidipino Normon

Keep out of the reach and sight of children.

Do not use Manidipino NORMON 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 should not be disposed of via wastewater or household waste. Ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Additional information

Composition of Manidipino NORMON

The active substance is manidipino hydrochloride, 10 mg.

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

Appearance of the medicinal product and contents of the pack

Manidipino NORMON 10 mg tablets are presented as yellow, round, scored tablets. Each pack 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)

OR

GALENICUM HEALTH, S.L.
Avda. Diagonal, 538 4º 1ª
08006 Barcelona, Spain

OR

DOPPEL FARMACEUTICI, S.R.L.
Via Volturno, 48 Quinto De Stampi
I-20089 Rozzano, Milan, Italy

OR

VAMFARMA, S.R.L.
Via Kenney, 5
26833 Comazzo (LO), Italy

This leaflet was last approved in: September 2024