MANIDIPINE CINFA 20 mg TABLETS

Introduction

Package Leaflet: Information for the User

Manidipine Cinfa 20 mg Tablets EFG

Manidipine Hydrochloride

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

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

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

Manidipine Cinfa contains Manidipine Hydrochloride as the active substance. Manidipine belongs to a group of medicines called calcium channel blockers that block the flow of calcium in the smooth muscle cells of blood vessels, causing vasodilation and the corresponding reduction in blood pressure.

Manidipine Cinfa is indicated for the treatment of high blood pressure (essential hypertension, mild to moderate).

2. What you need to know before you take Manidipine Cinfa

Do not take Manidipine Cinfa

• If you are allergic to Manidipine, other calcium channel blockers, or any of the other ingredients of this medicine (listed in section 6).
• If you have severe kidney disease.
• If you have heart problems, for example, if you have had a heart attack in the last 4 weeks or if you suffer from unstable angina (chest pain due to inadequate oxygen supply to the heart) or if you suffer from heart failure and are not receiving specific treatment;
• If you have moderate or severe liver disease.

Manidipine must not be administered to children or adolescents under 18 years of age.

Warnings and Precautions

Consult your doctor or pharmacist before starting to take Manidipine Cinfa

• If you have certain heart problems (for example, left ventricular dysfunction, left ventricular outflow tract obstruction, right-sided heart failure in patients with untreated sick sinus syndrome).
• If you have heart rhythm disturbances.
• If you are elderly or have mild liver or kidney problems (see section 3 "How to take Manidipine Cinfa").
• If you are undergoing peritoneal dialysis.

You should also tell your doctor:

• If you are pregnant, think you may be pregnant, or are planning to become pregnant, or are breast-feeding (see section "Pregnancy and Breast-feeding").

Taking Manidipine Cinfa with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

It is especially important that you tell your doctor if you are taking any of the following medicines:

• Diuretics (used to remove water from the body by increasing urine production) and other medicines that lower blood pressure, such as beta-blockers or other antihypertensive drugs. These medicines can increase the blood pressure-lowering effect of Manidipine;
• Medicines that may affect the metabolism of the active substance of Manidipine, such as protease inhibitors, cimetidine (used to treat stomach ulcers), or certain antibiotics (used to treat bacterial infections, such as clarithromycin, erythromycin, and rifampicin), or certain antifungals (used to treat fungal infections, such as ketoconazole and itraconazole), or phenytoin, carbamazepine, phenobarbital, terfenadine, astemizole, or class III antiarrhythmics used in heart rate problems (such as amiodarone and quinidine);
• Medicines containing digoxin, used to treat heart rhythm disturbances.

If you are taking any of the above medicines, your doctor may prescribe another medicine or adjust the dose of Manidipine or another medicine.

Taking Manidipine Cinfa with food, drinks, and alcohol

Do not take Manidipine with grapefruit juice, as blood pressure may drop too low. Consumption of alcohol may enhance the blood pressure-lowering effect of Manidipine.

Pregnancy and Breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

Consult your doctor if you are pregnant, think you may be pregnant, or are planning to become pregnant.

Since Manidipine should not be taken during pregnancy, your doctor will advise you to stop treatment before becoming pregnant or as soon as you know you are pregnant, and will recommend suitable treatment.

Breast-feeding

Consult your doctor if you are breast-feeding or before starting breast-feeding. Manidipine should be avoided in breast-feeding women; if treatment with Manidipine cannot be discontinued, your doctor will advise you to stop breast-feeding.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

Occasionally, in some patients during treatment for high blood pressure, this medicine may cause dizziness. In these cases, you should discuss it with your doctor before performing activities such as driving or operating machinery.

Manidipine Cinfa contains lactose.

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

3. How to take Manidipine Cinfa

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Dose

Initially, the recommended dose of Manidipine is 10 mg per day. After 2-4 weeks, if the reduction in blood pressure is considered insufficient, your doctor may increase this dose to 20 mg once a day (recommended maintenance dose).

Manidipine must not be administered to children or adolescents (see section "Do not take Manidipine Cinfa").

Dose reduction

If you are elderly or have kidney or liver disease, your doctor may prescribe a reduced dose.

Administration

Manidipine should be taken in the morning after breakfast. The tablet should be swallowed without chewing, with an adequate amount of water.

Try to take your daily dose at the same time each day.

Duration of treatment

It is important that you continue taking Manidipine until your doctor tells you otherwise. Take exactly the prescribed dose and do not modify it without talking to your doctor first.

If you take more Manidipine Cinfa than you should

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.

If you forget to take Manidipine Cinfa

If you forget to take a dose of Manidipine, take the next dose as prescribed.

Do not take a double dose to make up for forgotten doses.

If you stop taking Manidipine Cinfa

It is important that you continue taking Manidipine until your doctor tells you otherwise.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If side effects occur, they are usually mild and temporary. However, some side effects can be serious and require medical attention.

Common side effects(may affect up to 1 in 10 patients):

Fluid accumulation in tissues causing swelling (edema), hot flashes, dizziness, lightheadedness, headache, palpitations.

Uncommon side effects(may affect up to 1 in 100 patients):

Painful tingling or numbness (paresthesia), increased heart rate (tachycardia), low blood pressure (hypotension), difficulty breathing (dyspnea), weakness, dry mouth, nausea, vomiting, constipation, gastrointestinal discomfort, skin rash, skin inflammation with redness and itching (eczema), transient changes in laboratory tests of some enzymes (ALT, AST, LDH, GammaGT, ALP, Urea in blood, and creatinine in blood).

Rare side effects(may affect up to 1 in 1,000 patients):

Irritability, skin redness, itching, stomach pain (gastralgia), abdominal pain, drowsiness, chest pain, chest pain due to inadequate blood supply to the heart (angina pectoris), diarrhea, decreased appetite (anorexia), abnormal blood test results (for example, increased bilirubin in blood), jaundice.

Very rare side effects(may affect up to 1 in 10,000 patients):

Heart attack, in patients with pre-existing angina, they may experience an increase in frequency, duration, or severity of these attacks, gum inflammation or changes, which require careful dental attention but usually resolve with discontinuation of treatment.

Side effects of unknown frequency(cannot be estimated from the available data):

Abnormal skin redness (erythema multiforme), skin disease with abnormal redness and scales (exfoliative dermatitis), muscle pain, breast swelling with or without pain in men (gynecomastia), cloudy fluid (during dialysis through a tube in the abdomen).

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Manidipine Cinfa

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date is the last day of the month shown.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Manidipine Cinfa

• The active substance is Manidipine Hydrochloride, 20 mg.
• The other ingredients are lactose monohydrate, corn starch, low-substituted hydroxypropylcellulose, hydroxypropylcellulose, magnesium stearate, and riboflavin (E-101).

Appearance of the product and pack contents

Manidipine Cinfa 20 mg Tablets are presented as oval, scored, yellow tablets.

Each pack contains 28 tablets.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620-Huarte (Navarra) – Spain

Manufacturer

ABIOGEN PHARMA S.P.A

Via Meucci, 36

56121 Ospedaletto, Italy

Or

DOPPEL FARMACEUTICI, S.R.L.

Via Volturno, 48 Quinto De Stampi

I-20089 Rozzano, Milan, Italy

or

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620-Huarte (Navarra) – Spain

or

VAMFARMA, S.R.L.

Via Kennedy, 5

26833 Comazzo (LO)

Italy

Date of last revision of this leaflet: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.gob.es/

You can access detailed and updated information about this medicine by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/73230/P_73230.html

QR code to: https://cima.aemps.es/cima/dochtml/p/73230/P_73230.html