Manidipine Pharmacare

Patient Information Leaflet: Information for the User

Manidipina Pharmacare 10 mg tablets

Manidipina Pharmacare 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 other people, even if they have the same symptoms as yours, because it may be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, contact 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 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

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

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

2. What you need to know before taking Manidipine Pharmacare

Warnings and precautions
If you are intolerant to certain types of sugars, speak with your doctor before taking Manidipine Pharmacare.

Do not take Manidipine Pharmacare

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

Manidipine Pharmacare must not be administered to children and adolescents under 18 years of age.
Warnings and precautions
Talk to your doctor or pharmacist before taking Manidipine Pharmacare.
Be especially careful with Manidipine Pharmacare:

• If you have certain heart conditions (including left ventricular dysfunction, in which an obstruction blocks blood being ejected from the left ventricle, right-sided heart failure, and in patients with sick sinus syndrome who do not have a pacemaker implanted).
• If you have 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 may be pregnant, planning a pregnancy, or breastfeeding (see section “Pregnancy and breastfeeding”).

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

• A diuretic (used to remove water from the body by increasing urine production) and other medicines that lower blood pressure, such as β-blockers and any other antihypertensive medicines, since these may increase the blood pressure-lowering effect of Manidipine Pharmacare.
• Medicines that affect the metabolism of the active substance in Manidipine 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 fungal infections, 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 containing digoxin, used to treat heart problems.

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

Manidipine Pharmacare with food, drinks and alcohol
Manidipine Pharmacare must not be taken with grapefruit juice, as there is a risk that blood pressure may drop excessively.
Drinking alcohol may increase the blood pressure-lowering effect of Manidipine Pharmacare.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Since Manidipine Pharmacare must not be used during pregnancy, your doctor will recommend that you stop taking this medicine before becoming pregnant or as soon as you find out you are pregnant, and will prescribe a suitable alternative treatment for you.

Breastfeeding
Inform your doctor if you are breastfeeding or planning to breastfeed.
Since taking Manidipine Pharmacare is not recommended for breastfeeding women, and treatment with Manidipine Pharmacare cannot be interrupted, your doctor will recommend that you stop breastfeeding.

Driving and using machines
Occasionally, some people taking medicines for high blood pressure may experience dizziness. If this happens to you, contact your doctor before driving or operating machinery.

Manidipine Pharmacare 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 Manidipine Pharmacare

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
Dosing
The usual initial dose of Manidipine Pharmacare is 10 mg once daily.
After 2-4 weeks of treatment, if the reduction in blood pressure is considered insufficient, your
doctor may increase the dose to a maintenance dose of 20 mg once daily.
Manidipine Pharmacare must 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 Manidipine Pharmacare is too strong or too weak, talk to your doctor or
pharmacist.
Administration
Take the Manidipine Pharmacare tablets in the morning after breakfast. The tablets should be
swallowed with some water, without chewing.
Try to take the daily dose at the same time every day.
Treatment duration
It is important that you take Manidipine Pharmacare regularly for the entire duration 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 Manidipine Pharmacare than you should
If you accidentally take too many tablets, contact your doctor or pharmacist immediately, as this
may cause abnormally low blood pressure.
If you forget to take Manidipine Pharmacare
If you accidentally forget to take a dose of Manidipine Pharmacare, resume treatment as usual.
Do not take a double dose to make up for the missed dose.
If you stop treatment with Manidipine Pharmacare
It is important to take Manidipine Pharmacare regularly for the entire duration indicated by your doctor.
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Side effects are usually mild and temporary. However, some side effects may become serious and require medical treatment.
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Common side effects (≥1/100, <1/10): fluid accumulation in tissues causing swelling (oedema), hot flushes, dizziness, vertigo, headache, palpitations.
Uncommon side effects (≥1/1000, <1/100): tingling and numbness sensation (paraesthesia), rapid heartbeat (tachycardia), low blood pressure (hypotension), difficulty breathing (dyspnoea), weakness, dry mouth, nausea, vomiting, constipation, stomach problems, rash, skin inflammation with redness and itching (eczema), changes in enzyme levels detectable in blood tests (ALT, AST, LDH, GGT, ALP, blood urea nitrogen, serum creatinine).
Rare side effects (≥1/10,000, <1/1,000): hypertension, drowsiness, irritability, stomach pain (gastralgia), abdominal pain, skin redness, itching, angina-like chest pain due to insufficient blood flow to the heart, diarrhoea, 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 resolve after discontinuation of treatment and require appropriate dental care.
Side effects with unknown frequency (frequency cannot be estimated from the available data): abnormal skin redness (erythema multiforme), skin disorders with abnormal redness and peeling (exfoliative dermatitis), muscle pain, breast swelling with or without breast tenderness in men (gynaecomastia), cloudy fluid (when performing dialysis through an abdominal catheter).
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the following website: 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 Manidipine Pharmacare

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 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 no longer in use. This will help protect the environment.

6. Package contents and other information

What Manidipine Pharmacare 10 mg contains
The active substance is manidipine hydrochloride 10 mg.
The other components are: lactose monohydrate, maize starch, low-substituted hydroxypropylcellulose,
hydroxypropylcellulose, magnesium stearate, riboflavin.
What Manidipine Pharmacare 20 mg contains
The active substance is manidipine hydrochloride 20 mg.
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The other components are: lactose monohydrate, maize starch, low-substituted hydroxypropylcellulose,
hydroxypropylcellulose, magnesium stearate, riboflavin.
Description of the appearance of Manidipine Pharmacare and package contents
Manidipine Pharmacare is available in two 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 Pharmacare is available in the following pack sizes:
10 mg: 28, 30, 90 tablets
20 mg: 28, 30, 90 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer:
Marketing Authorization 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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