Leaflet: information for the user

Manidipino Stada 10 mg tablets EFG

Manidipino Stada 20 mg tablets EFG

Manidipino dihidrocloruro

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 should not be given to other people, 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. Contents of the pack and additional information

Manidipino Stada tablets contain an active ingredient that belongs to the calcium channel blockers, which 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 mild to moderate essential hypertension in adults.

Do not take Manidipino Stada

• If you are allergic (hypersensitive) to manidipino, or to any of the other components of this medication (listed in section 6).
• 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 severe kidney disease.
• If you have moderate to severe liver disease.

Manidipino should 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 Stada

Be especially careful with Manidipino Stada

• If you have some heart problems (for example, left ventricular dysfunction, obstruction of the outflow tract of the left ventricle, right heart failure in patients with untreated sick sinus syndrome not treated with a pacemaker);
• If you have heart alterations;
• If you are elderly or have any mild liver problem (see section 3).

You should 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”).
• If you are undergoing peritoneal dialysis

Other medications and Manidipino Stada

Inform your doctor or pharmacist if you are taking or have taken recently or may have 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 the active substance manidipino, 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 alterations.

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 Stada with food, drinks, and alcohol

Do not take manidipino with grapefruit juice, as blood pressure may drop too low.

Consuming alcohol may enhance the blood pressure-lowering effect of manidipino.

Fertility, pregnancy, and breastfeeding

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

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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 performing activities such as driving or operating machinery.

Manidipino Stada contains lactose

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

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The usual initial dose of manidipino is 10 mg per day.

After 2-4 weeks, if the reduction in blood pressure is considered insufficient, your doctor may increase this dose to 20 mg once a day.

Children and adolescents should not take manidipino (see section 2).

Dose adjustment:

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

If you estimate that the action of manidipino is too strong or weak, inform your doctor or pharmacist.

Administration

Manidipino should be taken in the morning or 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.

Treatment duration

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 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.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

If you forget to take Manidipino Stada

If you forget to take a dose, 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 Stada

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 medications, this medication may produce adverse effects, although not all people may experience them.

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

Infrequent (may affect up to 1 in 100 people): prickling or painful numbness (paresthesia), lack of energy, increased heart rate (tachycardia), low blood pressure (hypotension), difficulty breathing (dyspnea), weakness, nausea, vomiting, constipation, dry mouth, stomach 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 (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 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 andovergrowth of the gums, which require careful dental attention but usually resolve with suspension of treatment.

Adverse effects of unknown frequency (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 fluid (when undergoing dialysis through a tube in the abdomen).

Reporting 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep out of the reach and sight of children.

Do not use this medicine after the expiration date that appears on the packaging, after CAD.

The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and medicines you no longer need at the SIGRE point of your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines you no longer need. By doing so, you will help protect the environment.

The active ingredient is manidipine dihydrochloride.

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

Appearance of the product and content of the packaging

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

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

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

Manidipine Stada is available in formats of 28, 30, and 90 tablets.

Only some packaging sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

STADA, S.L. Laboratory

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Responsible for manufacturing

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

Last review date of this prospectus:August 2024

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