MANIDIPINO STADA 10 MG TABLETS EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Manidipino Stada 10 mg tablets EFG

Manidipino Stada 20 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 must not be given to other people, 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 these adverse effects are not listed in this leaflet. See section 4.

Leaflet contents

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

2. What you need to know before taking Manidipino Stada

3. How to take Manidipino Stada

4. Possible adverse effects

5. How to store Manidipino Stada

6. Contents of the pack and other information

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

Manidipino Stada tablets contain an active substance belonging to calcium channel blockers, which block the influx of calcium into smooth muscle cells of blood vessels, resulting in vasodilation and a consequent reduction in blood pressure.

Manidipino is indicated for the treatment of mild to moderate essential hypertension in adults.

2. What you need to know before taking Manidipino Stada

Do not take Manidipino Stada

• If you are allergic (hypersensitive) to manidipine or to any of the other ingredients of this medicine (listed in section 6).
• 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 severe kidney disease.
• If you have moderate to severe liver disease.

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

Warnings and precautions

Talk to your doctor or pharmacist before you start taking Manidipino Stada.

Take special care with Manidipino Stada

• 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 impairment (see section 3).

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”).
• if you are undergoing peritoneal dialysis.

Other medicines and Manidipino Stada

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

It is especially important to inform 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 manidipine;
• medicines that may affect the metabolism of the active substance manidipine, such as protease inhibitors, cimetidine (used for the treatment of gastric ulcers), or certain antibiotics (used to treat bacterial infections, such as clarithromycin, erythromycin, and rifampicin), or antifungal agents (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 rhythm 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 another medicine.

Taking Manidipino Stada 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.

Fertility, 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 or pharmacist 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 pregnancy is confirmed, and will recommend appropriate alternative treatment.

Breast-feeding

Consult your doctor if you are breast-feeding or planning to breast-feed.

Manidipine should be avoided in women who are breast-feeding. If treatment with manidipine cannot be discontinued, your doctor will advise you to stop breast-feeding.

Driving and using machines

Occasionally, in some patients being treated 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 Stada contains lactose

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

3. How to take Manidipino Stada

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

Initially, the usual dose of manidipine is 10 mg once daily.

After 2–4 weeks, if the blood pressure reduction is considered insufficient, your doctor may increase the dose to 20 mg once daily.

Children and adolescents must not take manidipine (see section 2).

Dose adjustment:

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

If you feel that the effect of manidipine is too strong or too weak, inform your doctor or pharmacist.

Administration

Manidipino should be taken in the morning or 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 manidipine than you should

If you have accidentally taken more tablets than you should, contact your doctor immediately, as your blood pressure may become abnormally low.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, stating the medicine and the amount ingested. It is recommended to bring the medicine packaging and leaflet to the healthcare professional.

If you forget to take Manidipino Stada

If you forget to take a dose, take the next dose as scheduled.

Do not take a double dose to make up for forgotten doses.

If you stop taking Manidipino Stada

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.

Common adverse effects (may affect up to 1 in 10 people): headache, dizziness, vertigo, swelling due to fluid retention, palpitations, hot flushes.

Uncommon (may affect up to 1 in 100 people): sensation of tingling or painful numbness (paresthesia), lack of energy, increased heart rate (tachycardia), low blood pressure (hypotension), difficulty breathing (dyspnea), weakness, nausea, vomiting, constipation, dry mouth, gastric 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 (may affect up to 1 in 1,000 people): drowsiness, numbness, chest pain due to inadequate blood supply to the heart (angina pectoris), high blood pressure, stomach pain (gastralgia), abdominal pain, skin redness, itching and irritability, decreased appetite (anorexia), abnormal blood test results (increased blood bilirubin), jaundice.

Very rare (may affect up to 1 in 10,000 people): myocardial infarction, in patients with pre-existing angina pectoris may experience an increase in frequency, duration or severity of these attacks, inflammation and overgrowth of the gums, which require careful dental care but usually resolve upon discontinuation of treatment.

Adverse effects with unknown frequency (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 Stada

Keep out of the reach and sight 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 drains or household waste. Return unused medicines and their packaging to the SIGRE point at your pharmacy. If you are unsure, please ask your pharmacist how to dispose of medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

The active substance is manidipine dihydrochloride.

The other components are monohydrate lactose, corn starch, low-substituted hydroxypropylcellulose, hydroxypropylcellulose, magnesium stearate, riboflavin.

Appearance of the product and contents of the pack

Manidipine is available in two strengths: 10 and 20 mg.

The 10 mg tablets are round, convex, yellow in colour and scored.

The 20 mg tablets are oval, convex, yellow in colour and scored.

Manidipino Stada is available in pack sizes of 28, 30 and 90 tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

Abiogen Pharma SpA

Via Meucci 36, Ospedaletto

56121 Pisa

Italy

or

Doppel Farmaceutici S.r.l.

Via Volturno, 48

20089 Quinto de Stampi, Rozzano (Milan)

Italy

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

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