Package Leaflet: Information for the User

Manidipino ratiopharm 10 mg tablets EFG

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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

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

3.How to take Manidipino ratiopharm

4.Possible side effects

5.Storage of Manidipino ratiopharm

6.Contents of the pack and additional information

Manidipino ratiopharm contains 10 mg of the active ingredient manidipino, which belongs to a group of medications called dihydropyridines calcium channel blockers.

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

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

Do not takeManidipino ratiopharm

-if you are allergic to manidipino 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 uncontrolled congestive heart failure

-if you have severe kidney insufficiency (creatinine clearance <10)

-if you have moderate to severe liver insufficiency

-if you are a child or an adolescent under 18 years of age

Warnings and precautions

Consult your doctor or pharmacist before starting to take Manidipino ratiopharm.

• If you have any mild liver problems since the effects of manidipino may be increased (see section 3 “How to take Manidipino ratiopharm”)
• If you are an elderly patient, a dose reduction may be necessary (see section 3 “How to take Manidipino ratiopharm”)

• If you have heart rhythm disturbances
• If you are taking other medications simultaneously (see “Taking Manidipino ratiopharm with other medications”).
• If you are undergoing peritoneal dialysis.

Other medications and Manidipino ratiopharm

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 reduce blood pressure, such as beta-blockers or other antihypertensive drugs. These medications, in fact, may increase the blood pressure-lowering effect of manidipino;
• Medications that may influence the metabolism of the active substance contained in Manidipino ratiopharm, such as protease inhibitors, cimetidine (used to treat gastric ulcers), or certain antibiotics (used to treat bacterial diseases, 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 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 ratiopharm or another medication.

TakingManidipino ratiopharm with food, drinks, and alcohol

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

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 ratiopharm should not be taken during pregnancy.

Breastfeeding

The use of manidipino should be avoided during breastfeeding. If treatment with manidipino is necessary, breastfeeding should be discontinued.

Driving and operating machinery

Be careful while driving or operating machinery as it may cause dizziness.

Manidipino ratiopharm contains lactose

If your doctor has told you 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. If in doubt, consult your doctor or pharmacist again.

If you believe the action of Manidipino ratiopharm is too strong or weak, inform 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, liver and kidney insufficiency

If you are an elderly patient or suffer from kidney or liver 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 Manidipino ratiopharm (see section 2 “Do not take Manidipino ratiopharm”).

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, swallowing them without chewing, with a little liquid.

If you take more Manidipino ratiopharm than you should

If you (or someone else) have taken too many tablets at once, or if you believe a child has taken a tablet, consult the nearest hospital emergency service or your doctor immediately. Like 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 Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Manidipino tablets

If you forget a dose, take the next dose as usual.

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

If you interrupt treatment with Manidipino ratiopharm

Before interrupting treatment with Manidipino ratiopharm, consult your doctor.

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

Like all medications,this medicationmay 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 severe and require medical attention.

The following side effects may occur when taking Manidipino ratiopharm.

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

Infrequent (may affect up to 1 in 100 people):tingling sensation in the skin, weakness or lack of energy, rapid heart rate, hypotension, difficulty breathing, nausea, vomiting, constipation, dry mouth, gastrointestinal disturbances, rash, eczema, increased liver enzymes and/or increased renal parameters (your doctor knows that this may occur).

Rare (may affect up to 1 in 1,000 people):drowsiness, chest pain, angina pectoris, hypertension, stomach pain (gastralgia), abdominal pain, diarrhea, decreased appetite, jaundice, skin redness, itching, irritability, abnormal blood test results (e.g., increased bilirubin in the blood).

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

Unknown frequency (the 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 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 prospectus. 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 medication.

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

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

This medication does not require special conditions for conservation.

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

Composition of Manidipino ratiopharm

The active ingredient is manidipino dihydrochloride.

Each tablet contains 10 mg of manidipino dihydrochloride.

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

Appearance of the product and contents of the packaging

Manidipino ratiopharm 10 mg tablets: round, convex, yellow-colored, and scored tablets.

Manidipino is available in the following packaging sizes:

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

Not all packaging sizes may be marketed.

Holder of the marketing authorization and responsible manufacturer

Holder

Teva Pharma, S.L.U.

C/ Anabel Segura 11, Edificio Albatros B 1st Floor

Alcobendas 28108 Madrid

Responsible manufacturer

Merckle GmbH

Ludwig-Merckle-Strasse 3

89143 Blaubeuren

Germany

or

Doppel Farmaceutici S.r.l.

Via Volturno, 48

20089 Quinto de Stampi, Rozzano, MILANO

Italy

or

Abiogen Pharma S.p.A.

Via Antonio Meucci, 36 Ospedaletto

56121 Pisa,

Italy

or

Vamfarma S.r.l

Via Kennedy 5, 26833 Comazzo (LO),

Italy

Last review date of this leaflet: July 2024

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