Manidipine Zentiva

PACKAGE LEAFLET: INFORMATION FOR THE USER

Manidipina Zentiva 20 mg tablets

Generic medicine
Please read this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful. If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4. Contents of this leaflet:
  1. What Manidipina Zentiva is and what it is used for
  2. What you need to know before taking Manidipina Zentiva
  3. How to take Manidipina Zentiva
  4. Possible side effects
  5. How to store Manidipina Zentiva
  6. Contents of the pack and other information

1. What Manidipina Zentiva is and what it is used for

Manidipina Zentiva tablets contain 20 mg of the active substance called manidipine,
which belongs to a group of medicines known as dihydropyridine calcium antagonists.
Manidipina Zentiva is indicated for the treatment of mild to moderate essential hypertension
(arterial hypertension).
Manidipina Zentiva works by relaxing the blood vessels, thereby reducing blood pressure.

2. What you need to know before taking Manidipine Zentiva

Do not take Manidipine Zentiva if:

• you are allergic to manidipine or to other calcium antagonists or to any of the other ingredients of this medicine (listed in section 6).
• you are a child or adolescent under 18 years of age.
• you suffer from unstable angina (chest pain not caused by stress or exercise, or nocturnal pain) or if you have had a myocardial infarction less than 4 weeks ago.
• you have untreated congestive heart failure.
• you have severe renal impairment (creatinine clearance < 10 ml/min).
• you have moderate to severe hepatic impairment.

Warnings and precautions
Talk to your doctor or pharmacist before taking Manidipine Zentiva if:

• you have mild liver damage, as the effects of manidipine may be increased (see section 3 “How to take Manidipine Zentiva”).
• you are elderly, as a lower dose may be required (see section 3 “How to take Manidipine Zentiva”).
• you suffer from heart disorders (such as left ventricular dysfunction, left ventricular outflow obstruction in right heart failure, patients with sinus disease without a pacemaker, or coronary artery disease).

Other medicines and Manidipine Zentiva
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, inform your doctor if you are taking:

• medicines such as ketoconazole, itraconazole (used to treat fungal infections); phenytoin, carbamazepine, phenobarbital (used to treat epilepsy); rifampicin (an antibiotic); these may alter the rate at which manidipine is distributed in the body.
• other medicines used to treat high blood pressure such as diuretics ("water pills"), beta-blockers and/or other antihypertensives (these may enhance the blood pressure-lowering effect of Manidipine Zentiva).
• digoxin (used in the treatment of heart disorders).
• amifostine (used as a protective agent in chemotherapy and radiotherapy).
• medicines called tricyclic antidepressants / antipsychotics (used to treat mental disorders).
• baclofen (used as a muscle relaxant).
• corticosteroids (hormones).
• alpha-blockers (used to treat high blood pressure or benign prostatic hyperplasia).

Manidipine Zentiva with food and drinks
Patients must not consume alcohol or grapefruit juice during treatment with manidipine.

Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Manidipine Zentiva must not be used during pregnancy.
Breastfeeding
Manidipine Zentiva should be avoided during breastfeeding. If treatment with Manidipine Zentiva is necessary, breastfeeding must be discontinued.
Fertility
Sperm head abnormalities that may impair fertilization have been reported in some patients treated with calcium antagonists.

Driving and using machines
Be careful when driving or operating machinery, as dizziness may occur.

Manidipine Zentiva contains lactose
If your doctor has informed you that you have an intolerance to certain sugars, consult your doctor before taking this medicine.

3. HOW TO TAKE MANIDIPINE ZENTIVA

Always take this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor.
The recommended starting dose is 10 mg once daily.
If after 2–4 weeks of treatment the antihypertensive effect of Manidipine Zentiva is insufficient, your doctor may increase the dose to 20 mg once daily.
If you are elderly or have renal or hepatic impairment, your doctor may prescribe a lower dose (10 mg once daily).
If you feel that the effect of Manidipine Zentiva is too strong or too weak, discuss it with your doctor or pharmacist.
The tablets should be taken in the morning after breakfast, with some liquid, and must not be chewed.

Use in children
Children must not take Manidipine Zentiva.

If you take more Manidipine Zentiva than you should
If you (or someone else) have taken more tablets at the same time, or if you think a child has ingested any tablets, contact immediately the Emergency Department of the nearest hospital or your doctor. As with other calcium antagonists, overdose is expected to cause lowering of blood pressure and an increase in heart rate.

If you forget to take Manidipine Zentiva
If you have forgotten to take a dose, take it as soon as possible and then return to your regular dosing schedule.
Never take a double dose to make up for a forgotten dose.

If you stop taking Manidipine Zentiva
Your doctor will advise you on how long to take the medicine. Do not stop treatment unless instructed by your doctor.

If you have further doubts 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 experiences them.
Adverse reactions are generally mild and temporary. However, some effects may be serious and require medical treatment.
The following adverse effects may occur during treatment with manidipine (the active substance in Manidipina Zentiva). Common adverse effects are dose-dependent and usually diminish over time during treatment.

Common (may affect up to 1 in 10 people):

• Headache, dizziness, vertigo.
• Strong or forceful heartbeat (palpitations), swelling due to fluid retention.
• Flushing (hot flushes).

Uncommon (may affect up to 1 in 100 people):

• Tingling sensations on the skin (paresthesia).
• Fast heartbeat.
• Low blood pressure.
• Shortness of breath.
• Feeling unwell (nausea), vomiting, constipation, dry mouth, digestive disturbances.
• Skin rash, eczema.
• Weakness or lack of energy.
• Increase in liver enzymes and/or increase in renal parameters (your doctor is aware of this).

Rare (may affect up to 1 in 1,000 people):

• Drowsiness, lethargy.
• Chest pain, angina.
• High blood pressure.
• Stomach ache, abdominal pain, diarrhea.
• Skin redness, itching.
• Irritability.

Very rare (may affect up to 1 in 10,000 people):

• Heart attack; in isolated cases, patients with pre-existing angina may experience an increase in frequency, duration, and severity of such episodes.
• Inflammation of the gums and excessive gum growth, which generally resolve upon discontinuation of treatment.

Frequency not known (frequency cannot be estimated from the available data):

• Movement disorders, known as extrapyramidal syndrome, have been reported with some calcium inhibitors.
• Muscle pain.
• Breast swelling with or without breast tenderness in men (gynecomastia).

Reporting of adverse effects
If you experience any adverse effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report adverse effects directly via the national reporting system at the website:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE MANIDIPINE ZENTIVA

Keep this medicine out of sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the container after "Exp.". The expiry date refers to the last day of that month.
Do not use this medicine if you notice any signs of deterioration.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. PACK CONTENTS AND OTHER INFORMATION

What Manidipine Zentiva contains
The active substance is manidipine hydrochloride. Each tablet contains 20 mg of manidipine
hydrochloride.
The other ingredients are monohydrate lactose, maize starch, low-substituted hydroxypropylcellulose,
hydroxypropylcellulose, magnesium stearate, riboflavin.
Description of the appearance of Manidipine Zentiva and contents of the pack
Manidipine Zentiva is available in the 20 mg strength.
The 20 mg tablets are yellow, oval-shaped, convex, with a central break line.
The score line on the tablet is intended to facilitate swallowing by allowing the tablet to be broken into pieces and does not indicate that the tablet should be split into equal doses.
Manidipine Zentiva is available in the following pack size:
28 tablets.
.
Marketing Authorization Holder:
Zentiva Italia S.r.l.
Viale L. Bodio 37/b
20158 Milan, Italy
Manufacturer:
Abiogen Pharma SpA
Via Meucci 36,
56121 Ospedaletto
Pisa – Italy
Doppel Farmaceutici S.r.l.
Via Volturno, 48
20089 Quinto de’ Stampi, Rozzano
Milan - Italy
This medicinal product is authorized in the European Economic Area countries under the
following names:
France: Manidipine Zentiva 10/20 mg comprimè
Italy: Manidipina Zentiva 20 mg tablets
This leaflet was last approved on: