MANIDIPINE AUROVITAS 20 mg TABLETS

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

Do not takeManidipine Aurovitas

• 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 have 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

Talk to your doctor before taking Manidipine Aurovitas

• If you have certain heart problems (e.g., 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 an elderly patient or have mild liver or kidney problems (see section "How to take Manidipine Aurovitas").
• 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 if you are breast-feeding (see section "Pregnancy and Breast-feeding").

Children and adolescents

Manidipine should not be given to children and adolescents under 18 years of age.

Other medicines and Manidipine Aurovitas

Tell your doctor 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 a different medicine or adjust the dose of manidipine or the other medicine.

Taking Manidipine Aurovitas with food, drinks, and alcohol

Do not take manidipine with grapefruit juice, as blood pressure may drop too low. Alcohol consumption 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 before taking 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.

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 this with your doctor before performing activities such as driving or operating machinery.

Manidipine Aurovitas contains lactose

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

3. How to take Manidipine Aurovitas

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

Dose

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 should not be given to children and adolescents (see section "Do not take Manidipine Aurovitas").

Dose reduction

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

Method of administration:

Manidipine should be taken in the morning after breakfast. The tablet should be swallowed without chewing, with a sufficient 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 dose prescribed and do not modify it without talking to your doctor first.

If you take more Manidipine Aurovitas than you should

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

If you forget to take Manidipine 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 Manidipine Aurovitas

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 may be serious and require medical attention.

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

Fluid accumulation in tissues causing swelling (edema), flushing, dizziness, headache, palpitations.

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

Painful tingling or numbness (paresthesia), increased heart rate (tachycardia), low blood pressure (hypotension), difficulty breathing (dyspnea), weakness, dry mouth, nausea, vomiting, constipation, gastrointestinal disorders, 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 people):

Irritability, skin redness, itching, stomach pain (gastralgia), abdominal pain, high blood pressure, drowsiness, 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 bilirubin in blood), jaundice.

Very rare side effects (may affect less than 1 in 1,000 people):

Heart attack, in patients with pre-existing angina, they may experience an increase in frequency 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 (when performing dialysis through a tube in the abdomen).

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any 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. Storing Manidipine Aurovitas

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

Store in the original package to protect from light.

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

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 Aurovitas

• The active substance is manidipine dihydrochloride. Each tablet contains 20 mg of manidipine dihydrochloride.
• The other ingredients are lactose monohydrate, cornstarch, low-substituted hydroxypropylcellulose, low-viscosity hydroxypropylcellulose, magnesium stearate, purified water.

Appearance and packaging

Manidipine Aurovitas 20 mg Tablets EFG: [Size: approximately 11.65 x 6.5 mm]

White to off-white or pale yellow oval-shaped tablets, without coating, engraved with "MA 20" on one side and a score line on the other side. The tablet can be divided into equal doses.

Manidipine Aurovitas 20 mg Tablets EFG are available in white opaque PVC/PVdC-Aluminum blister packs.

Blister pack: 28, 30, or 90 tablets.

Not all 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 medicine is authorized in the Member States of the European Economic Area under the following names:

France: MANIDIPINE ARROW 20 mg, sécable tablet

Italy: Manidipina Aurobindo

Spain: Manidipino Aurovitas 20 mg comprimidos EFG

Portugal: Manidipina Generis

Date of last revision of this leaflet:August 2024

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