Manidipino CINFA 10 mg tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

manidipino cinfa 10 mg tablets EFG

Manidipine hydrochloride

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

• 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 personally and must not be given to others, even if they have the same symptoms as you, since it could be harmful to them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if such effects are not listed in this leaflet. See section 4.

Leaflet Contents

1. What manidipino cinfa is and what it is used for
2. What you need to know before taking manidipino cinfa
3. How to take manidipino cinfa
4. Possible adverse effects
5. How to store manidipino cinfa
6. Contents of the pack and other information

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

manidipino cinfa contains manidipino hydrochloride as the active substance. Manidipino belongs to a group of medicines called calcium channel blockers, which block the flow of calcium into the smooth muscle cells of blood vessels, resulting in vasodilation and a consequent reduction in blood pressure.

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

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

• Allergy to manidipine or any of the other ingredients of this medicine (listed in section 6). If you are allergic to any other calcium channel blocker (such as nifedipine, amlodipine, felodipine), talk to your doctor before taking this medicine.

• Severe liver problems. Manidipine is processed by the liver, so if you have severe liver disease, this medicine may not be suitable for you.

• Severe hypotension (low blood pressure). Since manidipine lowers blood pressure, it should be used with caution if you already have low blood pressure.

• Heart problems, such as unstable angina or heart failure. Talk to your doctor if you have any heart condition, as this medicine may not be appropriate in certain cases.

• Kidney problems. Although manidipine is mainly eliminated through the liver, kidney function should still be considered, especially in elderly patients.

• Use in children and adolescents. The safety and effectiveness of manidipine in patients under 18 years of age have not been established.

• Pregnancy and breastfeeding:

  • Pregnancy: Do not take manidipine if you are pregnant or think you might be. Calcium channel blockers may harm the unborn baby. If you become pregnant while taking this medicine, contact your doctor immediately.
  • Breastfeeding: It is not known whether manidipine passes into breast milk. You should not breastfeed while taking this medicine unless explicitly advised by your doctor.

• Driving and using machines: Manidipine may cause dizziness or fatigue in some people. If you experience these symptoms, do not drive or operate machinery.

• Other medicines: Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, especially:

  • Other antihypertensives (to lower blood pressure)
  • CYP3A4 inhibitors (such as ketoconazole, itraconazole, erythromycin, clarithromycin, ritonavir), as they may increase the effects of manidipine
  • CYP3A4 inducers (such as rifampicin, phenytoin, carbamazepine, phenobarbital), as they may reduce the effectiveness of manidipine

Talk to your doctor before taking this medicine if any of the above apply to you.

Do not take manidipino cinfa

• If you are allergic to manidipino, to other calcium channel blockers, or to 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 myocardial infarction within the last 4 weeks, or if you suffer from unstable angina (chest pain due to inadequate oxygen supply to the heart), or if you have heart failure and are not receiving specific treatment;
• If you have moderate or severe liver disease.

Manidipino 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 manidipino cinfa

• If you have certain heart conditions (e.g., left ventricular dysfunction, obstruction of the left ventricular outflow tract, right-sided heart failure in patients with untreated sick sinus syndrome without a pacemaker).
• If you have heart rhythm disorders.
• If you are elderly or have mild liver impairment (see section 3 “How to take manidipino cinfa”).
• If you are undergoing peritoneal dialysis.

You should also inform your doctor:

• If you are pregnant, think you may be pregnant, are trying to become pregnant, or are breastfeeding (see section “Pregnancy and Breast-feeding”).

Taking manidipino cinfa with other medicines

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

It is especially important to 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 may increase the blood pressure-lowering effect of manidipino;
• Medicines that may affect the metabolism of the active substance in manidipino, such as antiprotease drugs, cimetidine (used to treat gastric ulcers), 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 for heart rhythm disorders (such as amiodarone and quinidine);
• Medicines containing digoxin, used in the treatment of heart disorders.

If you are taking any of the medicines listed above, your doctor may prescribe an alternative medicine or adjust the dose of manidipino or of the other medicine.

Taking manidipino cinfa with food, drinks, and alcohol

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

Pregnancy and breast-feeding

If you are pregnant or breastfeeding, 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 trying to become pregnant.

Since manidipino 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 appropriate alternative treatment.

Breast-feeding

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

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

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

manidipino cinfa contains lactose.

If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.

3. How to take manidipine cinfa

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

Dosage

Initially, the recommended dose of manidipine is 10 mg once daily. After 2–4 weeks, if the reduction in blood pressure is considered insufficient, your doctor may increase this dose to 20 mg once daily (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 suffer from any kidney or liver disease, your doctor may prescribe you a reduced dose.

Administration

Manidipine should be taken in the morning after breakfast. The tablet should be swallowed whole, 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 first speaking to your doctor.

If you take more manidipine cinfa than you should

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 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 about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

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

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

Fluid accumulation in tissues causing swelling (edema), hot flushes, dizziness, faintness, headache, palpitations.

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

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

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

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

Very rare adverse effects (may affect up to 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 care but usually resolve upon discontinuation of treatment.

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

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of manidipino cinfa

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

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of manidipino cinfa

• The active substance is manidipine hydrochloride, 10 mg.
• The other components are lactose monohydrate, corn starch, low-substituted hydroxypropylcellulose, hydroxypropylcellulose, magnesium stearate and riboflavin (E-101).

Appearance of the product and contents of the pack

manidipino cinfa 10 mg tablets are presented as yellow, round, scored tablets.

Each pack contains 28 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization 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 the most recent revision of this leaflet: September 2024

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

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/73231/P_73231.html

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