MANIDIPINA 10 mg Tablets

Зміст інструкції

1. MANIDIPINA DOC Generici 10 mg tablets, 20 mg tablets
   1. What is MANIDIPINA DOC GENERICI and what it is used for
   2. What you need to know before taking MANIDIPINA DOC GENERICI
   3. How to Take MANIDIPINA DOC Generici
   4. Possible side effects
   5. How to store MANIDIPINA DOC GENERICI
   6. Contents of the pack and other information

MANIDIPINA DOC Generici 10 mg tablets, 20 mg tablets

Generic medicine

Important information for you.

• If you have any doubts, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it could be dangerous.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What MANIDIPINA DOC Generici is and what it is used for
• 2. What you need to know before you take MANIDIPINA DOC Generici
• 3. How to take MANIDIPINA DOC Generici
• 4. Possible side effects
• 5. How to store MANIDIPINA DOC Generici 6 Contents of the pack and other information.

1. What is MANIDIPINA DOC GENERICI and what it is used for

MANIDIPINA DOC Generici 10 mg tablets contain 10 mg of the active ingredient manidipine, which
belongs to a group of medicines called dihydropyridine calcium antagonists.
MANIDIPINA DOC Generici 20 mg tablets contain 20 mg of the active ingredient manidipine, which
belongs to a group of medicines called dihydropyridine calcium antagonists.
Manidipine is indicated for the treatment of essential mild to moderate hypertension (high blood
pressure).
Manidipine works by relaxing blood vessels to reduce pressure.

2. What you need to know before taking MANIDIPINA DOC GENERICI

Do not take MANIDIPINA DOC Generici:

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

Warnings and precautions
Talk to your doctor or pharmacist before taking MANIDIPINA DOC Generici.

• If you suffer from mild liver damage, as the effects of manidipine may increase (see section 3 “How to take MANIDIPINA DOC Generici”).
• If you are elderly, a dose reduction is required (see section 3 “How to take MANIDIPINA DOC Generici”).
• If you suffer from heart disease.
• If you are taking other medicines (see “Taking MANIDIPINA DOC Generici with other medicines”).

Other medicines and MANIDIPINA DOC Generici
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicine.
It is important to tell your doctor if you are taking any of the following medicines:

• diuretics (used to eliminate water from the body by increasing urine production) and other medicines that lower blood pressure, such as β-blockers and any other antihypertensive medicine. In fact, these medicines can intensify the antihypertensive effect of MANIDIPINA DOC Generici.
• Medicines that affect the metabolism of the active ingredient contained in MANIDIPINA DOC Generici, such as protease inhibitor drugs, cimetidine (used to treat stomach ulcers), or certain antibiotics (used to treat bacterial infections, such as clarithromycin, erythromycin and rifampicin), or some antifungal drugs (used to treat fungal infections, such as ketoconazole and itraconazole), or phenytoin, carbamazepine, phenobarbital, terfenadine and astemizole or class III antiarrhythmics used for heart rate problems (such as amiodarone and quinidine).
• Medicines containing digoxin, used to treat heart disorders.

MANIDIPINA DOC Generici with food and drink and alcohol
Patients should not consume alcohol or grapefruit juice during treatment with manidipine.

Pregnancy and breastfeeding and fertility
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, or if you are breastfeeding
ask your doctor or pharmacist for advice before taking this medicine.
MANIDIPINA DOC Generici should not be used during pregnancy. The use of manidipine should
be avoided during breastfeeding. If the use of manidipine is necessary, breastfeeding should be
stopped.

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

Driving and using machines
Be careful while driving vehicles or using machines as dizziness may occur.
MANIDIPINA DOC Generici contains lactose.
If your doctor has diagnosed you with intolerance to certain sugars, contact him/her before taking this
medicine.

3. How to Take MANIDIPINA DOC Generici

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
doubts, consult your doctor or pharmacist.
If you feel that the action of MANIDIPINA DOC Generici is too strong or too weak, talk to your doctor
or pharmacist.
Children should not take manidipine.
Your doctor will indicate the duration of treatment. Do not stop treatment until your doctor tells you to.
The tablets should be taken in the morning after breakfast, with some liquid and without chewing.
The usual initial dose is 10 mg once a day.
If after 2 - 4 weeks of treatment the antihypertensive effect of manidipine is insufficient, your doctor
may increase the dose to 20 mg once a day.
If you are elderly or suffer from kidney or liver dysfunction, your doctor may prescribe you a reduced dose (10 mg
once a day).

If you take more MANIDIPINA DOC Generici 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, an overdose may cause excessive
peripheral vasodilation leading to a decrease in blood pressure and an increase in
heart rate.

If you forget to take MANIDIPINA DOC Generici
Do not take a double dose to make up for a missed dose.
If you have forgotten to take a dose, take it as soon as possible and then return to your regular schedule.

If you stop taking MANIDIPINA DOC Generici
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.
Contact your doctor before stopping to take Manidipina.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
With the use of MANIDIPINA DOC Generici, the following side effects may occur.

Common (≥1/100, <1/10):headache, dizziness, vertigo, swelling caused by fluid retention (edema),
palpitations, hot flushes.

Uncommon (≥1/1000, <1/100): sensation of tingling on the skin, weakness or lack of energy,
fast heartbeat, low blood pressure, difficulty breathing, nausea, vomiting, constipation,
dry mouth, digestive disorders, skin rash, eczema, increased liver enzymes and/or increased
kidney parameters (your doctor is aware of this).

Rare (≥1/10,000, <1/1000):drowsiness, lethargy, chest pain, chest pain due to inadequate
blood flow to the heart (angina pectoris), increased blood pressure, stomach pain, abdominal pain, skin
redness, itching and irritability, diarrhea, loss of appetite (anorexia), abnormal blood tests, jaundice.

Very rare (<1/10,000): heart attack, inflammation and swelling of the gums which usually disappear
after stopping treatment. In isolated cases, in patients with pre-existing angina pectoris, an
increase in the frequency, duration and intensity of these attacks may occur.

Frequency not known:the frequency cannot be estimated based on available data.
Abnormal skin redness (erythema multiforme), skin disorders with abnormal redness and scaling
(exfoliative dermatitis).
Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national reporting system at:
http://www.agenziafarmaco.gov.it/it/responsabili
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store MANIDIPINA DOC GENERICI

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

6. Contents of the pack and other information

What MANIDIPINA DOC Generici 10 mg contains
The active ingredient is manidipine hydrochloride 10 mg.
The other ingredients are: lactose monohydrate, corn starch, low substituted hydroxypropylcellulose,
hydroxypropylcellulose, magnesium stearate, riboflavin.

What MANIDIPINA DOC Generici 20 mg contains
The active ingredient is manidipine hydrochloride 20 mg.
The other ingredients are: lactose monohydrate, corn starch, low substituted hydroxypropylcellulose,
hydroxypropylcellulose, magnesium stearate, riboflavin.

Description of the appearance of MANIDIPINA DOC Generici and contents of the pack
Manidipina is available in 2 dosages: 10 and 20 mg.
The 10 mg tablets are round, convex, yellow in colour, with a median fracture line.
The 20 mg tablets are oval, convex, yellow in colour, with a median fracture line.
Manidipina is available in the following packs:
10 mg 28 tablets
20 mg 28 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and manufacturer
Marketing Authorisation Holder
DOC Generici S.r.l.
Via Turati 40
20121 Milano

Manufacturer:
Abiogen Pharma SpA
Via Meucci 36,
56014 Ospedaletto
Pisa - Italy
Doppel Farmaceutici S.r.l.
Via Volturno, 48

• 20089 – Quinto de Stampi – Rozzano (MI)