MANIDIPINA 10 mg Tablets

Зміст інструкції

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

Manidipina Pharmacare 10 mg tablets, Phamacare 20 mg tablets

Generic medicine

Important information for you.

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

Contents of this leaflet:

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

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

Pharmacotherapeutic category – ATC code: C08CA11
Manidipina Pharmacare tablets contain 1 active ingredient called manidipine hydrochloride,
which belongs to a group of medicines called calcium antagonists, which prevent calcium from entering the
cells of smooth muscle, causing an expansion of blood vessels and thus reducing blood pressure.
Manidipina Pharmacare is used to treat mild to moderate hypertension in adults.

2. What you need to know before taking Manidipina Pharmacare

Warnings and precautions
If you are intolerant to certain types of sugar, talk to your doctor before taking Manidipina Pharmacare

Do not take Manidipina Pharmacare

• If you are allergic to the active ingredient or to any other active ingredient belonging to the dihydropyridine group or to any of the other ingredients of this medicine (listed in section 6).
• If you have heart problems, for example if you have had a heart attack in the last 4 weeks or if you suffer from unstable angina (chest pain caused by a lack of oxygen to the heart) or untreated heart failure.
• If you suffer from moderate to severe liver disease.
• If you suffer from severe kidney disease.

Manidipina Pharmacare should not be administered to children and adolescents under 18 years of age.

Warnings and precautions
Consult your doctor or pharmacist before taking Manidipina Pharmacare.
Pay particular attention with Manidipina Pharmacare:
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• If you suffer from certain heart problems (including left ventricular dysfunction, where an obstruction blocks blood being pumped from the left ventricle, right heart failure, and in patients with sick sinus syndrome who have not had a pacemaker implanted).
• If you suffer from coronary artery disease.
• If you are elderly or have mild liver disease (see section 3).
• If you are undergoing peritoneal dialysis.

You should also consult your doctor:

• If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding (see section “Pregnancy and breastfeeding”).

Other medicines and Manidipina Pharmacare
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
It is particularly important that you tell your doctor if you have taken any of the following medicines:

• A diuretic (used to remove water from the body by increasing the amount of urine produced) and other medicines that lower blood pressure, such as beta-blockers and any other antihypertensive medicine, as these medicines can increase the blood pressure lowering effect of Manidipina Pharmacare.
• Medicines that affect the metabolism of the active ingredient of Manidipina Pharmacare, such as protease inhibitors, cimetidine (used to treat stomach ulcers), or certain antibiotics (medicines used to treat bacterial infections, such as clarithromycin, erythromycin and rifampicin), antifungals (medicines used to treat infections caused by a fungus, such as ketoconazole and itraconazole), and phenytoin, carbamazepine, phenobarbital, terfenadine, astemizole and Class III antiarrhythmics used to treat heart rate problems (medicines such as amiodarone and quinidine).
• Medicines that contain digoxin, which are used to treat heart problems.

If you have taken any of the medicines listed above, your doctor may prescribe you a different medicine or
adjust the dose of Manidipina Pharmacare or the other medicine.

Manidipina Pharmacare with food, beverages and alcohol
Manidipina Pharmacare should not be taken with grapefruit juice as there is a risk that blood
pressure may be reduced too much.
Drinking alcohol can increase the drop in blood pressure achieved with Manidipina Pharmacare.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy or if you are breastfeeding
ask your doctor or pharmacist for advice before taking this medicine.
Since Manidipina Pharmacare should not be used during pregnancy, your doctor will recommend that you
stop taking this medicine before becoming pregnant or as soon as you discover you are
pregnant, and will prescribe suitable treatment for you.

Breastfeeding
Tell your doctor if you are breastfeeding or are about to start breastfeeding.
Because the use of Manidipina Pharmacare is not recommended for breastfeeding women, and therapy with
Manidipina Pharmacare cannot be interrupted, your doctor will recommend that you stop breastfeeding.
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Driving and operating machinery
Occasionally, some people taking medicine for high blood pressure may experience
a feeling of dizziness. If this happens to you, contact your doctor before driving or operating machinery.

Manidipina Pharmacare 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 Pharmacare

Take this medicine following the instructions of your doctor exactly. If you have any doubts, ask your
doctor or pharmacist.

Dosage
The usual initial dose of Manidipina Pharmacare is 10 mg daily in a single dose.
After 2-4 weeks of treatment, if the reduction in blood pressure is considered insufficient, the
doctor may increase the dose to a maintenance dose of 20 mg daily in a single dose.
Manidipina Pharmacare should not be administered to children and adolescents (see section 2).

Dose adjustment:
If you are elderly or have kidney or liver disease, your doctor will prescribe a lower dose.
If you feel that the effect of Manidipina Pharmacare is too strong or too weak, talk to your doctor or
pharmacist.

Administration
Take Manidipina Pharmacare tablets in the morning after breakfast. The tablets should be
swallowed with a little water, without chewing.
You should try to take the daily dose every day at the same time.

Duration of treatment
It is important that you take Manidipina Pharmacare regularly for the entire time indicated by your doctor.
Take the dose prescribed by your doctor and do not change it without first discussing it with your doctor.

If you take more Manidipina Pharmacare than you should
If you accidentally take too many tablets, contact your doctor or pharmacist immediately as this
may cause an abnormal reduction in blood pressure.

If you forget to take Manidipina Pharmacare
If you accidentally forget to take a dose of Manidipina Pharmacare, resume treatment as
usual.
Do not take a double dose to make up for a missed dose.

If you stop taking Manidipina Pharmacare
It is important to take Manidipina Pharmacare regularly for the entire time indicated by your doctor.
If you have any doubts 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 everybody gets them.
Side effects are usually mild and temporary. However, some side effects can
become serious and require medical treatment.
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Common side effects (≥1/100, <1/10):accumulation of water in the tissues causing swelling (edema),
hot flushes, dizziness, giddiness, headache, palpitations.

Uncommon side effects (≥1/1000, <1/100): sensation of tingling and numbness (paresthesia),
fast heartbeat (tachycardia), low blood pressure (hypotension), difficulty breathing
(dyspnea), weakness, dry mouth, nausea, vomiting, constipation, stomach problems, skin rash,
skin inflammation with redness and itching (eczema), changes in the levels of enzymes that
can be detected in blood tests (ALT, AST, LDH, GGT, ALP, blood urea nitrogen, serum creatinine).

Rare side effects (≥1/10,000, <1/1000): hypertension, drowsiness, irritability, stomach pain
(gastralgia), abdominal pain, skin redness, itching, chest pain like angina due to an
insufficient blood supply to the heart, diarrhea, loss of appetite (anorexia), abnormal blood tests
(increased bilirubin levels), jaundice.

Very rare side effects (<1/10,000): heart attack, which is more common and more severe in patients who
already suffer from angina; inflammation and swelling of the gums which usually disappear after
stopping treatment and which require adequate dental treatment.

Side effects with unknown frequency(frequency cannot be estimated based on available
data): abnormal skin redness (erythema multiforme), skin disorders with abnormal redness and
scaling (exfoliative dermatitis), muscle pain, swelling of the breasts with or without breast tenderness
in men (gynecomastia), cloudy fluid (when performing dialysis through a catheter in the abdomen).

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly
through the national reporting system at: http://www.agenziafarmaco.gov.it/content/come-segnalare-una-
sospetta-reazione-avversa.
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Manidipina Pharmacare

Keep this medicine out of the sight and reach of children .
Do not use this medicine after the expiry date that 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 Pharmacare 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 Pharmacare 20 mg contains
The active ingredient is manidipine hydrochloride 20 mg.
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The other ingredients are: lactose monohydrate, corn starch, low substituted hydroxypropylcellulose,
hydroxypropylcellulose, magnesium stearate, riboflavin.

Description of the appearance of Manidipina Pharmacare and contents of the pack
Manidipina Pharmacare is available in 2 dosages: 10 and 20 mg
The 10 mg tablets are round, convex, yellow in color, with a median fracture line
The 20 mg tablets are oval, convex, yellow in color, with a median fracture line.
Manidipina Pharmacare is available in the following packs:
10 mg 28, 30, 90 tablets
20 mg 28, 30, 90 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:

Marketing Authorisation Holder:
PHARMACARE s.r.l.
Via Marghera, 29
20149 Milan - Italy

Manufacturer:
Abiogen Pharma S.p.A.
Via Meucci 36,
56014 Ospedaletto
Pisa – Italy

or
Doppel Farmaceutici S.r.l.
Via Volturno, 48
20089 Quinto de’ Stampi – Rozzano (Milan)
Italy
Vamfarma S.r.l.
Via Kennedy 5,
26833 Comazzo (LO)
Italy
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