Leaflet: information for the user

Manidipino Aurovitas 20 mg tablets EFG

manidipine dihydrochloride

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, pharmacist or nurse.
• 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, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

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

2.What you need to know before you start taking Manidipino Aurovitas

3.How to take Manidipino Aurovitas

4.Possible side effects

5.Storage of Manidipino Aurovitas

6.Contents of the pack and additional information

Manidipino Aurovitas contains an active ingredient called manidipino dihydrochloride. Manidipino hydrochloride belongs to a group of medications 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.

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

Do not takeManidipino Aurovitas

• if you are allergic to manidipino, other calcium channel blockers, or 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.

Warnings and precautions

Consult your doctor before starting to take Manidipino Aurovitas

• If you have some heart problems (for example, left ventricular dysfunction, left ventricular outflow tract obstruction, right heart failure in patients with untreated sick sinus syndrome not treated with a pacemaker).
• If you have heart rhythm disturbances.
• If you are an elderly patient or have any mild liver problems (see section “How to take Manidipino Aurovitas”).
• If you are undergoing peritoneal dialysis.

You must 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”).

Children and adolescents

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

Other medications andManidipino Aurovitas

Inform your doctor if you are taking, have taken recently, or may need 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 for the treatment of gastric ulcers), or certain antibiotics (used for the treatment of bacterial diseases, such as clarithromycin, erythromycin, and rifampicin), or some antifungals (used for the treatment of 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).
• Medications that contain digoxin, used in the treatment of heart rhythm disturbances.

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.

Manidipino Aurovitas intake 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 lactation

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

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 Aurovitas contains lactose

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

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 usual dose of manidipino is 10 mg per day. 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 a day (usual maintenance dose).

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

Reduction of dose

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

Method of 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.

Duration of treatment

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 Aurovitas than you should

If you have accidentally taken more tablets than you should, consult your doctor immediately as your blood pressure level may be abnormally low, or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount taken.

If you forgot to take Manidipino Aurovitas

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 Aurovitas

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

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

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 more than 1 in 100 people but less than 1 in 10 people):

Fluid accumulation in tissues causing inflammation (edema), hot flashes, dizziness, vertigo, headaches, palpitations.

Less frequent side effects (may affect more than 1 in 1,000 people but less than 1 in 100 people):

Prickling or painful numbness (paresthesia), increased heart rate (tachycardia), reduced blood pressure (hypotension), difficulty breathing (dyspnea), weakness, dry mouth, nausea, vomiting, constipation, gastrointestinal discomfort, skin rash, skin inflammation with redness and itching (eczema), transient alterations in laboratory tests for some enzymes (ALT, AST, LDH, GammaGT, ALP, blood urea nitrogen, and blood creatinine).

Rare side 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, 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 the blood), jaundice.

Very rare side 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 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 possible side effects that do not appear in this leaflet. 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.

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

Store in the original packaging to protect it from light.

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

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE point of your pharmacy. Ask your pharmacist how to dispose of packaging and medications you no longer need. This will help protect the environment.

Composition of ManidipinoAurovitas

• The active ingredient is manidipino dihydrochloride.Cada comprimido contiene 20 mg de manidipino dihidrocloruro.
• The other components are lactose monohydrate, cornstarch, low-substitution hydroxypropylcellulose, low-viscosity hydroxypropylcellulose, magnesium stearate, purified water.

Appearance of the product and contents of the package

Manidipino Aurovitas20 mg tablets EFG:[Size: approximately 11.65 x 6.5 mm]

White to off-white or pale yellow tablets, oval-shaped, uncoated, engraved with “MA 20” on one face and a groove on the other face. The tablet can be divided into equal doses.

Manidipino Aurovitas20 mg tablets EFG are available in PVC/PVdC white opaque-Aluminum blisters.

Blister pack: 28, 30 or 90 tablets.

Only some sizes of packaging may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Responsible 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 medicine is authorized in the Member States of the European Economic Area with the following names:

France:MANIDIPINE ARROW 20 mg, comprimé sécable

Italy:Manidipina Aurobindo

Spain:Manidipino Aurovitas 20 mg tablets EFG

Portugal:Manidipina Generis

Last review date of this leaflet:August 2024

Further detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)