PATIENT INFORMATION LEAFLET

Manidipino NORMON 20 mg Tablets

Read this 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. Do not pass it on to others even if their symptoms are the same. It may harm them.
• If you think you have suffered a side effect, you can help us by reporting it directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

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

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

Do not use Manidipino NORMON

• If you are allergic (hypersensitive) to manidipino, to other dihidropiridinas or to any of the other components of Manidipino 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)
• If you suffer from moderate to severe liver disease.

Children should not take this medication.

Be especially careful with Manidipino NORMON

• If you have any mild liver problems, as it may increase the hypotensive effect (see section 3 “HOW TO TAKE Manidipino NORMON”).
• In case of administration to elderly people, your doctor will recommend reducing the dose (see section 3 “HOW TO TAKE Manidipino 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 have sinus dysfunction syndrome and do not have an implanted pacemaker.
• If you have stable coronary disease, due to the possibility of increasing coronary risk (see section 4 “POSSIBLE ADVERSE EFFECTS”).
• If you are taking other medications that inhibit the CYP 3A4 enzyme (such as protease inhibitors, cimetidine, ketoconazole, itraconazole, erythromycin or clarithromycin) or with medications that induce the CYP 3A4 enzyme (such as phenytoin, carbamazepine, phenobarbital or rifampicin).
• When taking manidipino and other substrates of the CYP 3A4 enzyme (such as terfenadine, astemizole, quinidine or class III antiarrhythmic drugs, such as amiodarone).
• If you are undergoing peritoneal dialysis.

Use of other medications

Inform 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 rhythm (such as amiodarone, quinidine, digoxin).
• - Allergies (such as terfenadine, astemizole).

Taking Manidipino NORMON with food and drinks

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

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

Pregnancyand lactation

Consult your doctor or pharmacist before using any medication.

Do not use Manidipino NORMON during pregnancy or lactation. If manidipino treatment is necessary, lactation should be interrupted.

Drivingand use of machines

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

Manidipino Normon contains lactose

This medication contains lactose. If your doctor has indicated that you have a certain sugar intolerance, consult with him before taking this medication.

Follow exactly the administration instructions for Manidipino NORMON as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

Manidipino NORMON is administered orally. The tablets should be taken in the morning after breakfast, swallowing them without chewing, along with a little liquid.

Remember to take your medication.

The usual initial dose is 10 mg once a day..If after 2-4 weeks of treatment the antihypertensive effect of manidipino is insufficient, your doctor may increase the dose to 20 mg once a day.

If you are elderly or suffer from any 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 Manidipino NORMON. Do not discontinue treatment before, as you may not have completed the treatment process for your condition.

If you take more Manidipino NORMON than you should

In case you have taken more medication than you should, excessive peripheral vasodilation accompanied by a significant drop in blood pressure and an increase in heart rate may be expected. In this case, rapid symptomatic and cardiovascular support treatment should be initiated.

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

There is no experience with overdoses with this medication.

If you forget to take Manidipino NORMON

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 compensate for the missed doses.

If you interrupt treatment with Manidipino NORMON

Ask your doctor before stopping taking this medication.

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

Like all medications, Manidipino NORMON may produce adverse effects, although not all people will experience them. While taking Manidipino NORMON, the following adverse effects may appear:

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

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

Very rare (in fewer 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.

Unknown frequency (cannot be estimated from available data): muscle pain, breast swelling with or without pain in men (gynecomastia), cloudy fluid (when undergoing dialysis through a tube in the abdomen).

If you consider any of the adverse effects you are experiencing to be severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

Keep out of the reach and sight of children.

Do not use Manidipino NORMON after the expiration date that appears on the packaging after “CAD”. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. In this way, you will help protect the environment.

Composition of Manidipino 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 contents of the package

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

Holder of the marketing authorization and responsible for manufacturing

Holder

LABORATORIOS NORMON, S.A.

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

Responsible for manufacturing

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 has been approved in: September 2024