MANIDIPINA 20 mg Tabletka Powlekana

Treść ulotki

1. Manidipina Zentiva 20 mg tablets
   1. What is Manidipina Zentiva and what is it used for?
   2. What you need to know before you take Manidipina Zentiva
   3. HOW TO TAKE MANIDIPINA ZENTIVA
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE MANIDIPINA ZENTIVA
   6. PACKAGE CONTENTS AND OTHER INFORMATION

Manidipina Zentiva 20 mg tablets

Generic medicine
contains important information for you .

• If you have any doubts, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not give it to other people, even if their symptoms are the same as yours, as it could be dangerous. If you experience any side effects, including those not listed in this leaflet, tell 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 you take 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 is Manidipina Zentiva and what is it used for?

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

2. What you need to know before you take Manidipina Zentiva

Do not take Manidipina Zentiva if:

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

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

• you suffer from mild liver damage, as the effects of manidipina may increase (see section 3 “How to take Manidipina Zentiva”)
• you are elderly, a dose reduction is required (see section 3 “How to take Manidipina Zentiva”)
• you suffer from heart disorders (such as left ventricular dysfunction, an obstacle to left ventricular ejection in right heart failure, in patients with sinus node disease without a pacemaker or coronary artery disease).

Other medicines and Manidipina Zentiva
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
In particular, tell your doctor if you are taking:

• medicines, such as ketoconazole, itraconazole (used to treat fungal infections); phenytoin, carbamazepine, phenobarbital (used to treat epilepsy); rifampicin (antibiotic); These can change the rate at which manidipina is distributed throughout the body.
• other medicines used to treat high blood pressure such as diuretics (water pills), beta-blockers and/or other antihypertensives (these medicines can increase the effect of lowering blood pressure of Manidipina Zentiva).
• digoxin (used in the treatment of heart disorders).
• amifostine (used as protection 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 prostate enlargement).

Manidipina Zentiva with food and drink
Patients should not consume alcohol or grapefruit juice during treatment with
manidipina.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are
breastfeeding, ask your doctor or pharmacist for advice before taking this
medicine.

Pregnancy
Manidipina Zentiva should not be used during pregnancy.

Breastfeeding
The use of Manidipina Zentiva should be avoided during breastfeeding. If the use of Manidipina
Zentiva is necessary, breastfeeding should be stopped.

Fertility
Changes in sperm head morphology that may impair fertilization have been
reported in some patients treated with calcium antagonists.

Driving and using machines
Be careful while driving or using machines as dizziness may occur.

Manidipina Zentiva contains lactoseIf you have been told by your doctor that you have an intolerance to
some sugars, contact your doctor before taking this medicine.

3. HOW TO TAKE MANIDIPINA ZENTIVA

Always take this medicine exactly as your doctor or pharmacist has instructed. If you have any doubts, consult your doctor.
The recommended initial dose is 10 mg once a day.
If after 2 - 4 weeks of treatment the antihypertensive effect of Manidipina Zentiva is
insufficient, your doctor may increase the dosage to 20 mg once a day.
If you are elderly or if you suffer from renal or hepatic dysfunction, your doctor may prescribe a lower dose (10 mg once a day).
If you feel that the action of Manidipina Zentiva is too strong or too weak, talk to your
doctor or pharmacist.
The tablets should be taken in the morning after breakfast, with some liquid and without chewing.

Use in children
Children should not take Manidipina Zentiva.

If you take more Manidipina ZentIVA than you should
If you (or someone else) have swallowed more tablets at the same time, or if you think a
child has swallowed any tablets, contact the Emergency Room of the nearest hospital or your doctor immediately. As with other calcium antagonists, it is assumed that an
overdose may cause a lowering of blood pressure and an increase in
heart rate.

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

If you stop taking Manidipina Zentiva
Your doctor will tell you how long the treatment will last. Do not stop treatment until your
doctor tells you to.
If you have further questions about the use of this medicine, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Adverse reactions are generally mild and temporary. However, some effects may be
serious and require medical attention.
The following side effects may occur during the intake of manidipine (the active
ingredient of Manidipina Zentiva). Adverse effects are commonly dose-dependent and usually
disappear later and during the course of treatment.

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

• Headache, dizziness, vertigo.
• Strong heartbeat (palpitations), swelling caused by fluid retention.
• Hot flashes.

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

• Sensations of tingling on the skin (paresthesia).
• Fast heartbeat.
• Low blood pressure.
• Shortness of breath.
• Feeling unwell (nausea), vomiting, constipation, dry mouth, digestive disorders.
• Skin rash, eczema.
• Weakness or lack of energy.
• Increased liver enzymes and/or increased kidney 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 pain, abdominal pain, diarrhea.
• Skin redness, itching.
• Irritability.

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

• Heart attack; in isolated cases in patients with pre-existing angina, an increase in frequency, duration and severity of these incidents may occur.
• Inflammation of the gums and excessive growth of the gums, which generally disappear with discontinuation of treatment.

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

• Movement disorders, called extrapyramidal syndrome, have been reported with some calcium channel blockers.
• Muscle pain.
• Breast enlargement with or without breast tenderness in men (gynecomastia).

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

5. HOW TO STORE MANIDIPINA ZENTIVA

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

6. PACKAGE CONTENTS AND OTHER INFORMATION

What Manidipina Zentiva contains
The active ingredient is manidipine hydrochloride. Each tablet contains 20 mg of manidipine
hydrochloride.
The other ingredients are lactose monohydrate, corn starch, low substituted hydroxypropylcellulose, hydroxypropylcellulose, magnesium stearate, riboflavin.

Description of the appearance of ManidipinaZentivaand package contents
Manidipina Zentiva is available in a dosage of 20 mg
The 20 mg tablets are oval, convex, yellow in color, with a median fracture line.
The incision line on the tablet is to facilitate breaking it to make it easier to swallow and not to divide it into equal doses.
Manidipina Zentiva is available in the following package size:
28 tablets.
.

Marketing Authorisation Holder:
Zentiva Italia S.r.l.
Viale L.Bodio 37/b
20158 Milano

Manufacturer:
Abiogen Pharma SpA
Via Meucci 36,
56121 Ospedaletto
Pisa – Italy
Doppel Farmaceutici S.r.l.
Via Volturno, 48
20089 Quinto de’ Stampi, Rozzano
Milano - Italy

This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations:
France: Manidipine Zentiva 10 /20 mg comprimé
Italy: Manidipina Zentiva 20 mg tablets