Manidipino Aurovitas 10 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Manidipino Aurovitas 10 mg tablets EFG

manidipine dihydrochloride

Read the entire 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, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

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

Manidipino is indicated for the treatment of high blood pressure (mild to moderate arterial hypertension).

2. What you need to know before taking Manidipino Aurovitas

Do not take Manidipino Aurovitas

• if you are allergic to manidipine, 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.

Warnings and precautions

Consult your doctor before starting to take Manidipino Aurovitas

• If you have certain heart problems (for example, left ventricular dysfunction, obstruction of the left ventricular outflow tract, right-sided heart failure in patients with sick sinus syndrome not treated with a pacemaker).
• If you have heart rhythm disorders.
• If you are elderly or have mild liver problems (see section “How to take Manidipino Aurovitas”).
• 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 if you are breastfeeding (see section “Pregnancy and Breast-feeding”).

Children and adolescents

Manidipino must not be given to children or adolescents under 18 years of age.

Other medicines and Manidipino Aurovitas

Inform your doctor if you are taking, have recently taken, or might need to 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 may in fact increase the blood pressure-lowering effect of manidipine.
• Medicines that may affect the metabolism of the active substance in manidipine, such as protease inhibitors, cimetidine (used to treat gastric ulcers), or certain antibiotics (used to treat bacterial infections, such as clarithromycin, erythromycin, and rifampicin), or 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 a different medicine or adjust the dose of manidipine or of the other medicine.

Taking Manidipino Aurovitas with food, drinks, and alcohol

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

Pregnancy and breast-feeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor 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 must 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 treatment.

Breast-feeding

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

Driving and use of machines

Occasionally, in some patients during 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 Aurovitas contains lactose

This medicine 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 Manidipino Aurovitas

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

Dosage

Initially, the usual dose of manidipine is 10 mg once daily. After 2–4 weeks of treatment, if the reduction in blood pressure is considered insufficient, your doctor may increase this dose to 20 mg once daily (usual maintenance dose).

Manidipine must not be administered to children or adolescents (see section “Do not take Manidipino Aurovitas”).

Dose reduction

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

Method of 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 change it without first talking to your doctor.

If you take more Manidipino Aurovitas than you should

If you have accidentally taken more tablets than you should, consult your doctor immediately, as your blood pressure level may become abnormally low, or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Manidipino Aurovitas

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 Manidipino Aurovitas

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 will experience them.

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

Frequent adverse effects (may affect more than 1 in 100 people but less than 1 in 10 people):

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

Uncommon adverse effects (may affect more than 1 in 1,000 people but less than 1 in 100 people):

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 more than 1 in 10,000 people but less than 1 in 1,000 people):

Irritability, skin redness, itching, stomach pain (gastralgia), abdominal pain, hypertension, 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 less than 1 in 10,000 people):

Myocardial infarction, in patients with pre-existing angina pectoris may experience an increase in frequency or severity of these attacks, inflammation or alteration of the gums, which requires careful dental care but usually resolves upon discontinuation of treatment.

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

Abnormal skin redness (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 Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Manidipino Aurovitas

Keep this medicine out of sight and reach of children.

Store in the original packaging to protect it from light.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point at your pharmacy. Ask your pharmacist how to properly dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Manidipino Aurovitas

• The active substance is manidipino dihydrochloride. Each tablet contains 10 mg of manidipino dihydrochloride.
• The other components are lactose monohydrate, corn starch, low-substituted hydroxypropylcellulose, hydroxypropylcellulose (low viscosity grade), magnesium stearate, purified water.

Appearance of the product and contents of the pack

Manidipino Aurovitas 10 mg tablets EFG: [Size: approximately 6 mm]

White to off-white or pale yellow, round, uncoated tablets, engraved with “MA 10” on one side and a score line on the other. The tablet can be divided into equal doses.

Manidipino Aurovitas 10 mg tablets EFG are available in opaque white PVC/PVdC-aluminum blister packs.

Blister pack: 28, 30 or 90 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer

APL Swift Services (Malta) Ltd.

HF26, Hal Far Industrial Estate, Hal Far,

Birzebbugia, BBG 3000

Malta

or

Generis Farmacêutica, S.A.

Rua João de Deus, nº19,

Venda Nova, 2700-487

Amadora

Portugal

or

Arrow Generiques – Lyon

26 avenue Tony Garnier,

Lyon, 69007

France

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

France: MANIDIPINE ARROW 10 mg, scored tablet

Italy: Manidipina Aurobindo

Spain: Manidipino Aurovitas 10 mg tablets EFG

Portugal: Manidipina Generis

Date of the most recent revision of this leaflet: August 2024

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