Introduction

Manidipino cinfa 10 mg tablets EFG

Manidipino hydrochloride

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

Keep this leaflet, as you may need to read it again.
If you have any questions, consult your doctor or pharmacist.
This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
If you experience any side effects, consult your doctor or pharmacist even if they are not listed in this leaflet. See section 4.

1. What is manidipino cinfa and what is it used for

manidipino cinfa contains manidipino hydrochloride as the active ingredient. Manidipino belongs to a group of medications called calcium channel blockers that block the flow of calcium in smooth muscle cells of blood vessels, causing vasodilation and the corresponding reduction in blood pressure.

manidipino cinfa is indicated for the treatment of high blood pressure (essential mild to moderate hypertension).

2. What you need to know before starting to take manidipino cinfa

Do not take manidipino cinfa

If you are allergic to manidipino, to other calcium channel blockers or to any of the other components of this medication (listed in section 6).
If you have severe kidney disease.
If you have heart problems, for example if you have had a myocardial infarction in the last 4 weeks or if you have unstable angina (chest pain due to inadequate oxygen supply to the heart) or if you have heart failure and are not following a specific treatment;
If you have moderate or severe liver disease.

Manidipino should not be administered to children or adolescents under 18 years of age.

Warnings and precautions

Consult your doctor or pharmacist before starting to take manidipino cinfa

If you have some heart problems (for example, left ventricular dysfunction, obstruction of the outflow tract of the left ventricle, right-sided heart failure in patients with untreated sick sinus syndrome not treated with a pacemaker).
If you have heart rhythm disorders.
If you are an elderly person or have any mild liver problem (see section 3 “How to take manidipino cinfa”).
If you are undergoing peritoneal dialysis.

You should also inform your doctor:

If you are pregnant, or think you may be pregnant, if you are trying to become pregnant, or if you are breastfeeding (see section “Pregnancy and Breastfeeding”).

Taking manidipino cinfa with other medications

Inform your doctor or pharmacist if you are taking, have taken recently or may have to take any other medication.

It is especially important to inform your doctor if you are taking any of the following medications:

diuretics (used to eliminate water from the body by increasing urine production) and other medications that reduce blood pressure, such as beta-blockers or other antihypertensive drugs. These medications, in fact, can increase the blood pressure-lowering effect of manidipino;
medications that can influence the metabolism of manidipino's active substance, such as protease inhibitors, cimetidine (used to treat gastric ulcers), or certain antibiotics (used to treat bacterial diseases, such as clarithromycin, erythromycin, and rifampicin), or some antifungals (used to treat fungal infections, such as ketoconazole and itraconazole), or phenytoin, carbamazepine, phenobarbital, terfenadine, astemizole or class III antiarrhythmics used in heart rhythm disorders (such as amiodarone and quinidine);
medications that contain digoxin, used in the treatment of heart rhythm disorders.

If you are taking any of the medications mentioned above, your doctor may prescribe another medication or adjust the dose of manidipino or another medication.

Taking manidipino cinfa with food, drinks and alcohol

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, or are trying to become pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

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

Since manidipino should not be taken during pregnancy, your doctor will recommend that you stop treatment before becoming pregnant or as soon as you know you are pregnant, and will advise on the appropriate treatment.

Breastfeeding

Consult your doctor if you are breastfeeding or before starting breastfeeding. Manidipino should be avoided in women who are breastfeeding, if the manidipino treatment cannot be discontinued, your doctor will advise you to stop breastfeeding.

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

Occasionally, in some patients during treatment for high blood pressure, this medication may cause dizziness. In these cases, you should inform your doctor before engaging in activities such as driving or operating machinery.

Manidipino cinfa contains lactose.

If your doctor has indicated that you have an intolerance to certain sugars, consult with him before taking this medication.

3. How to take manidipino cinfa

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Dose

At the beginning, the recommended dose of manidipino 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).

Manidipino should not be administered to children or adolescents (see section “Do not take manidipino cinfa”).

Dose reduction

If you are elderly, or if you suffer from any kidney or liver disease, your doctor may prescribe a reduced dose.

Administration

Manidipino 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.

Treatment duration

It is essential that you continue taking manidipino until your doctor tells you otherwise. Take exactly the prescribed dose and do not modify it without speaking with your doctor first.

If you take more manidipino cinfa than you should

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.

If you forgot to take manidipino cinfa

If you forgot to take a dose of manidipino, take the next dose as prescribed.

Do not take a double dose to compensate for the missed doses.

If you interrupt the treatment with manidipino cinfa

It is essential that you continue taking manidipino until your doctor tells you otherwise.

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

4. Possible Adverse Effects

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

If side effects occur, they will mainly be mild and temporary. However, some side effects may be serious and require medical attention.

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

Fluid accumulation in tissues causing inflammation (edema), hot flashes, dizziness, nausea, headache, palpitations.

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

Numbness or painful tingling (paresthesia), increased heart rate (tachycardia), decreased blood pressure (hypotension), difficulty breathing (dyspnea), weakness, dry mouth, nausea, vomiting, constipation, gastrointestinal discomfort, skin rash, inflammation of the skin with redness and itching (eczema), transient alterations in laboratory tests of some enzymes (ALT, AST, LDH, GammaGT, ALP, blood urea nitrogen, 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 results in blood tests (e.g., increased bilirubin in blood), jaundice.

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

Myocardial infarction, in patients with pre-existing angina pectoris may experience an increase in frequency, duration, or severity of these attacks, inflammation or alteration of the gums, which require careful dental attention but usually resolve with suspension of treatment.

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

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

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

5. Conservation of manidipino cinfa

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

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

6. Content of the container and additional information

Composition of manidipino cinfa

The active principle is manidipino hydrochloride, 10 mg.
The other components are lactose monohydrate, cornstarch, low-substitution hydroxypropylcellulose, hydroxypropylcellulose, magnesium stearate, and riboflavin (E-101).

Appearance of the product and content of the container

manidipino cinfa 10 mg tablets are presented in the form of scored, round yellow tablets.

Each container contains 28 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620-Huarte (Navarra) – Spain

Responsible for manufacturing

ABIOGEN PHARMA S.P.A

Via Meucci, 36

56121 Ospedaletto, Italy

DOPPEL FARMACEUTICI, S.R.L.

Via Volturno, 48 Quinto De Stampi

I-20089 Rozzano, Milan, Italy

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620-Huarte (Navarra) – Spain

VAMFARMA, S.R.L.

Via Kennedy, 5

26833 Comazzo (LO)

Italy

Last review date of this leaflet:September 2024

Detailed and updated information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/

You can access detailed and updated information about this medication 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/73231/P_73231.html

QR code to:https://cima.aemps.es/cima/dochtml/p/73231/P_73231.html