Leaflet: information for the user

Manidipino Teva 20 mg tablets EFG

manidipine dihydrochloride

Read this leaflet carefully before you start taking the 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 or pharmacist.
• This medicine has been prescribed for you only. Do 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 or pharmacist, even if they are not listed in this leaflet. See section 4.

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

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

3.How to take Manidipino Teva

4.Possible side effects

5Storage of Manidipino Teva

6. Contents of the pack and additional information

Manidipino Teva tablets contain 20 mg of the active ingredient manidipino (as manidipino dihydrochloride), which belongs to a group of medicines called dihydropyridine calcium channel blockers.

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

Manidipino Teva works by relaxing blood vessels, thereby reducing blood pressure.

Do not take Manidipino Teva

• If you are allergic to manidipine or to other calcium channel blockers or to any of the other components of this medication (listed in section 6).
• If you have unstable angina (chest pain not caused by stress or exercise or at night) or during the first 4 weeks after a myocardial infarction.
• If you have untreated congestive heart failure.
• If you have severe kidney failure (creatinine clearance <10ml)
• If you have moderate to severe liver failure.
• If you are a child or adolescent under 18 years of age.

Warnings and precautions

Consult your doctor or pharmacist before starting to take manidipino Teva.

• If you have mild liver problems because they may increase the effects of manidipine (see section 3 “How to take Manidipino Teva”)
• If you are an elderly patient, a dose reduction is required (see section 3 “How to take Manidipino Teva”)
• If you have heart diseases
• If you are taking other medications (see “Taking Manidipino Teva with other medications”).
• If you are undergoing peritoneal dialysis.

Other medications and Manidipino Teva

Inform your doctor or pharmacist 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 lower blood pressure, such as beta-blockers or other antihypertensive drugs. These medications, in fact, may increase the blood pressure-lowering effect of manidipine;
• Medications that may influence the metabolism of the active substance contained in Manidipino Teva, 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 some antifungals (used to treat fungal infections, such as ketoconazole and itraconazole), or phenytoin, carbamazepine, phenobarbital (used to treat epilepsy), terfenadine, astemizole (used to treat allergies), quinidine, and class III antiarrhythmics used in heart rhythm problems (such as amiodarone);
• Medications that contain digoxin, used in the treatment of cardiac arrhythmias.

If you are taking any of the medications mentioned above, your doctor may prescribe another medication or adjust the dose of Manidipino Teva or another medication.

Taking Manidipino Teva with food, drinks, and alcohol

Patients should not take alcohol or grapefruit juice during treatment with manidipine.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

Manidipino Teva should not be used during pregnancy.

Breastfeeding

The use of manidipine should be avoided during breastfeeding. If necessary, treatment with manidipine should be interrupted.

Driving and operating machinery

Be careful while driving or operating machinery as you may experience dizziness.

Manidipino Teva contains lactose

This medication contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult with him before taking this medication.

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

If you think the effect of Manidipino Teva is too strong or too weak, consult your doctor or pharmacist.

The recommended initial dose is 10 mg once a day.

If after 2-4 weeks of treatment the antihypertensive effect of manidipino is insufficient, your doctor may increase the dose to 20 mg once a day.

Patients with advanced age, hepatic and renal insufficiency

If you are an elderly patient or suffer from renal or hepatic insufficiency, your doctor may prescribe a lower dose (10 mg once a day).

Use in children and adolescents

Children and adolescents under 18 years of age should not take this medication (see section 2 “Do not take Manidipino Teva”).

Your doctor will indicate the duration of your treatment. Do not interrupt treatment until your doctor tells you to.

The tablets should be taken in the morning after breakfast with a little liquid and without chewing.

If you take more Manidipino Teva than you should

If you (or someone else), swallow a lot of tablets at the same time, or if you think your child has swallowed a tablet, contact your nearest hospital or doctor immediately.As with other calcium channel blockers, in case of overdose, excessive peripheral vasodilation may occur, leading to a drop in blood pressure and an increase in heart rate.

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.

If you forget to take Manidipino Teva

If you forget a dose, take the next dose in the usual manner.

Do not take a double dose to compensate for missed doses.

If you interrupt treatment with Manidipino Teva

Before interrupting the intake of Manidipino Teva, consult your doctor.

If you have any other questions 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. The following side effects may occur while taking Manidipino Teva.

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

Frequent (may affect up to 1 in 10 people):headache, dizziness, vertigo, swelling caused by fluid retention, palpitations, hot flushes.

Uncommon (may affect up to 1 in 100 people): feeling of pins and needles in the skin, weakness or lack of energy, rapid heart rate, low blood pressure, difficulty breathing, nausea, vomiting, constipation, dry mouth, gastrointestinal disturbances, skin rash, eczema, increased liver enzymes and/or increased renal parameters (your doctor is aware of them).

Rare (may affect up to 1 in 1,000 people):drowsiness, dizziness, chest pain, angina pectoris, high blood pressure, stomach pain (gastralgia), abdominal pain,diarrhea, loss of appetite, jaundice,skin redness, itching, irritability,abnormal blood test results (for example, increased bilirubin in the blood).

Very rare (may affect up to 1 in 10,000 people):myocardial infarction, inflammation of the gums and excessive growth of the gums that usually disappears with the removal of treatment. In isolated cases, patients with pre-existing angina pectoris may experience an increase in frequency, duration, and severity of these incidents.

Frequency not known (the frequency cannot be estimated from the 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 performing dialysis through a tube in the abdomen).

Reporting of side effects:

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is possible side effects that do not appear in this leaflet. You can also report them directly through theSpanish 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 out of sight and reach of children.

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

This medication does not require special storage conditions.

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

Composition of Manidipino Teva

• The active ingredient is manidipino dihydrochloride.

Each tabletcontains 20 mg of manidipinodihydrochloride.

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

Appearance of the product and content of the container

The 20 mg tablets are oval, convex, yellow in color, with a groove in the middle.

Manidipino Teva is available in the following container sizes:

14, 28, 30, 56, 84, 90, 98, 112 tablets

Not all container sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Teva Pharma S.L.U.

C/ Anabel Segura nº11, Edificio Albatros B 1ª planta

Alcobendas 28108 Madrid

Responsible for manufacturing

Abiogen Pharma SpA

Via Antonio Meucci 36, Ospedaletto

56121 Pisa – Italy

or

Doppel Farmaceutici S.r.l.

Via Volturno, 48

20089 Quinto de Stampi, Rozzano, MILANO

Italy

or

Vamfarma S.r.l

Via Kennedy 5, 26833 Comazzo (LO),

Italy

Last review date of this leaflet: July 2024

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