Manidipino Teva 20 mg tablets EFG
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Manidipino Teva 20 mg tablets EFG
manidipino 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 or pharmacist.
- 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 could harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
Leaflet contents:
- What Manidipino Teva is and what it is used for
- What you need to know before taking Manidipino Teva
- How to take Manidipino Teva
- Possible side effects
5 Storage of Manidipino Teva
- Contents of the pack and other information
1. What Manidipino Teva is and what it is used for
Manidipino Teva tablets contain 20 mg of the active substance manidipine (as manidipine 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.
2. What you need to know before taking Manidipino Teva
Do not take Manidipino Teva
- If you are allergic to manidipine or to other calcium channel blockers or to any of the other ingredients of this medicine (listed in section 6).
- If you suffer from unstable angina (chest pain not caused by stress or exercise, or occurring at night) or during the first 4 weeks following a myocardial infarction.
- If you suffer from untreated congestive heart failure.
- If you have severe renal impairment (creatinine clearance <10 ml/min).
- If you have moderate to severe hepatic impairment.
- 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, as the effects of manidipine may be increased (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 medicines (see “Taking Manidipino Teva with other medicines”).
- If you are undergoing peritoneal dialysis.
Other medicines and Manidipino Teva
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicine.
It is especially important that you 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 in fact increase the blood pressure-lowering effect of manidipine;
- Medicines that may influence the metabolism of the active substance contained in Manidipino Teva, such as antiprotease drugs, cimetidine (used for the treatment of 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 for heart rate disorders (such as amiodarone);
- Medicines containing digoxin, used in the treatment of heart disorders.
If you are taking any of the medicines listed above, your doctor may prescribe another medicine or adjust the dose of Manidipino Teva or of the other medicine.
Taking Manidipino Teva with food, drinks, and alcohol
Patients must not drink alcohol or grapefruit juice during treatment with manidipine.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.
Pregnancy
Manidipino Teva must not be used during pregnancy.
Breastfeeding
The use of manidipine should be avoided during breastfeeding. If treatment with manidipine is necessary, breastfeeding must be discontinued.
Driving and using machines
Be cautious when driving or operating machinery, as you may experience dizziness.
Manidipino Teva contains lactose
This medicine 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 Teva
Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.
If you think that the effect of Manidipino Teva is too strong or too weak, consult your doctor or pharmacist.
The recommended starting dose is 10 mg once daily.
If after 2-4 weeks of treatment the antihypertensive effect of manidipino is insufficient, your doctor may increase the dose to 20 mg once daily.
Elderly patients, hepatic and renal impairment
If you are elderly or have renal or hepatic impairment, your doctor may prescribe you a lower dose (10 mg once daily).
Use in children and adolescents
Children and adolescents under 18 years of age must not take this medicine (see section 2 “Do not take Manidipino Teva”).
Your doctor will advise you on how long to take the medicine. Do not stop treatment until your doctor tells you to do so.
The tablets should be taken in the morning after breakfast with some liquid, without chewing.
If you take more Manidipino Teva than you should
If you (or someone else) swallow a large number of tablets at the same time, or if you think your child has swallowed any tablets, contact your nearest hospital or your doctor immediately. As with other calcium channel blockers, overdose may cause excessive peripheral vasodilation leading to low blood pressure and increased heart rate.
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, indicating the medicine and the amount ingested.
If you forget to take Manidipino Teva
If you forget a dose, take the next dose at your usual time.
Do not take a double dose to make up for forgotten doses.
If you stop taking Manidipino Teva
Before stopping treatment with Manidipino Teva, consult your doctor.
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. The following adverse effects may occur while you are taking Manidipino Teva.
If adverse effects occur, they will mainly be mild and temporary. However, some adverse effects may be serious and require medical attention.
Common (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): skin tingling sensation, weakness or lack of energy, rapid heartbeat, low blood pressure, difficulty breathing, nausea, vomiting, constipation, dry mouth, gastrointestinal disorders, skin rash, eczema, increase in liver enzymes and/or increase in renal parameters (your doctor is aware of these).
Rare (may affect up to 1 in 1,000 people): somnolence, dizziness, chest pain, angina pectoris, high blood pressure, stomach pain (gastralgia), abdominal pain, diarrhoea, decreased appetite, jaundice, skin redness, itching, irritability, abnormal blood test results (e.g., increased blood bilirubin).
Very rare (may affect up to 1 in 10,000 people): myocardial infarction, inflammation of the gums and excessive gum growth, which usually resolves upon discontinuation of treatment. In isolated cases, patients with pre-existing angina pectoris may experience an increase in the frequency, duration, and severity of these episodes.
Frequency not known (frequency cannot be estimated from the 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 (gynaecomastia), cloudy fluid (when undergoing dialysis through a tube in the abdomen).
Reporting of adverse effects:
If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if they are possible adverse effects not listed in this leaflet. You can 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 Teva
Keep out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and packaging following 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 or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If you are unsure how to dispose of unused medicines or their containers, ask your pharmacist. This will help protect the environment.
6. Contents of the pack and other information
Composition of Manidipino Teva
- The active substance is manidipino dihydrochloride.
Each tablet contains 20 mg of manidipino 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
The 20 mg tablets are convex oval-shaped, yellow in colour, with a central groove.
Manidipino Teva is available in the following pack sizes:
14, 28, 30, 56, 84, 90, 98, 112 tablets
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Teva Pharma S.L.U.
C/ Anabel Segura nº11, Edificio Albatros B, 1st floor
Alcobendas 28108 Madrid, Spain
Manufacturer
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
Date of the most recent revision of this leaflet: July 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/)