PACKAGE LEAFLET: INFORMATION FOR THE USER

MANIDIPINA DOC Generici 10 mg tablets, 20 mg tablets

Equivalent 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 only. 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:

What MANIDIPINA DOC Generici is and what it is used for
What you need to know before taking MANIDIPINA DOC Generici
How to take MANIDIPINA DOC Generici
Possible side effects
How to store MANIDIPINA DOC Generici
Contents of the pack and other information

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

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

2. What you need to know before taking MANIDIPINE DOC GENERICS

Do not take MANIDIPINE DOC GENERICS:

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).
if you have 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.
if you have 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
Talk to your doctor or pharmacist before taking MANIDIPINE DOC GENERICS.

if you have mild hepatic impairment, as the effects of manidipine may be increased (see section 3 “How to take MANIDIPINE DOC GENERICS”).
if you are elderly, a dose reduction is required (see section 3 “How to take MANIDIPINE DOC GENERICS”).
if you have heart disease.
if you are taking other medicines (see “Taking MANIDIPINE DOC GENERICS with other medicines”).

Other medicines and MANIDIPINE DOC GENERICS
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicines.
It is important to inform 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 drugs. Indeed, these medicines may enhance the antihypertensive effect of MANIDIPINE DOC GENERICS.
medicines that affect the metabolism of the active ingredient in MANIDIPINE DOC GENERICS, such as antiprotease agents, cimetidine (used to treat gastric ulcers), or certain antibiotics (used to treat bacterial conditions, e.g. clarithromycin, erythromycin, and rifampicin), or certain antifungals (used to treat fungal infections, such as ketoconazole and itraconazole), or phenytoin, carbamazepine, phenobarbital, terfenadine and astemizole, or class III antiarrhythmics used for heart rhythm disorders (e.g. amiodarone and quinidine).
medicines containing digoxin, used to treat heart conditions.

MANIDIPINE DOC GENERICS with food, beverages and alcohol
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, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
MANIDIPINE DOC GENERICS must not be used during pregnancy. The use of manidipine should be avoided during breastfeeding. If the use of manidipine is necessary, breastfeeding must be discontinued.
Fertility
Alterations in sperm head morphology, which may impair fertilization, have been reported in some patients treated with calcium antagonists.
Driving and using machines
Exercise caution when driving or operating machinery, as dizziness may occur.
MANIDIPINE DOC GENERICS contains lactose.
If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.

3. How to Take MANIDIPINA DOC Generici

Take this medicine exactly as directed by your doctor or pharmacist. If you are
unsure, consult your doctor or pharmacist.
If you feel that the effect of MANIDIPINA DOC Generici is too strong or too weak, talk to your doctor
or pharmacist.
Children must not take manidipine.
Your doctor will determine the duration of treatment. Do not stop treatment before your doctor tells you to do so.
The tablets should be taken in the morning after breakfast, with some liquid, and must not be chewed.
The usual initial dose is 10 mg once daily.
If after 2–4 weeks of treatment the antihypertensive effect of manidipine is insufficient, your doctor
may increase the dose to 20 mg once daily.
If you are elderly or suffer from renal or hepatic impairment, your doctor may prescribe a reduced dose (10 mg
once daily).
If you take more MANIDIPINA DOC Generici than you should
If you (or someone else) have ingested more tablets than prescribed at once, or if you suspect that a child has
ingested any tablets, contact immediately the Emergency Department of the nearest hospital or your
doctor. As with other calcium antagonists, overdose may cause excessive
peripheral vasodilation leading to a drop 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 the missed dose.
If you forget to take a dose, take it as soon as possible and then return to your regular dosing schedule.
If you stop taking MANIDIPINA DOC Generici
If you have any doubts about using this medicine, consult your doctor or pharmacist.
Contact your doctor before stopping manidipine.

4. Possible side effects

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

Common (≥1/100, <1/10): headache, dizziness, vertigo, swelling due to fluid retention (oedema), palpitations, hot flushes.

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

Rare (≥1/10,000, <1/1000): drowsiness, numbness, chest pain, chest pain due to inadequate blood flow to the heart (angina pectoris), increase in blood pressure, stomach pain, abdominal pain, skin redness, itching and irritability, diarrhoea, loss of appetite (anorexia), abnormal blood test results, jaundice.

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

Frequency not known: frequency cannot be estimated from the available data.
Abnormal skin redness (erythema multiforme), skin disorders with abnormal redness and peeling (exfoliative dermatitis).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or pharmacist. You can also report side effects directly via 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 MANIDIPINE DOC GENERICS

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after Exp.
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
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. Package contents and other information

What MANIDIPINA DOC Generici 10 mg contains
The active substance is manidipine hydrochloride 10 mg.
The other ingredients are: monohydrate lactose, maize starch, low-substituted hydroxypropylcellulose,
hydroxypropylcellulose, magnesium stearate, riboflavin.
What MANIDIPINA DOC Generici 20 mg contains
The active substance is manidipine hydrochloride 20 mg.
The other ingredients are: monohydrate lactose, maize starch, low-substituted hydroxypropylcellulose,
hydroxypropylcellulose, magnesium stearate, riboflavin.
Description of the appearance of MANIDIPINA DOC Generici and contents of the pack
Manidipine is available in 2 strengths: 10 mg and 20 mg.
The 10 mg tablets are round, convex, yellow in colour, with a central break line.
The 20 mg tablets are oval, convex, yellow in colour, with a central break line.
Manidipine is available in the following pack sizes:
10 mg 28 tablets
20 mg 28 tablets.
It is possible that not all pack sizes are marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
DOC Generici S.r.l.
Via Turati 40
20121 Milan
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)