Manidipine Teva

Patient Information Leaflet: Information for the User

Manidipine Teva 10 mg tablets, 20 mg tablets

Generic 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 their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Manidipine Teva is and what it is used for

Manidipine Teva tablets contain 10 mg of the active substance manidipine, which belongs to a group of medicines called dihydropyridine calcium antagonists.
Manidipine Teva 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 (high blood pressure).
Manidipine works by relaxing the blood vessels, thereby reducing blood pressure.

2. What you need to know before taking Manidipine Teva

Do not take Manidipine Teva:

• If you are allergic to manidipine, to other calcium antagonists, or to any of the other ingredients of this medicine (listed in section 6).
• If 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.
• 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.

Warnings and precautions
Talk to your doctor or pharmacist before taking Manidipine Teva:

• If you have mild liver impairment, as the effects of manidipine may be increased (see section 3 “How to take Manidipine Teva”).
• If you are an elderly patient, a dose reduction is required (see section 3 “How to take Manidipine Teva”).
• If you have heart diseases.
• If you are taking other medicines (see “Other medicines and Manidipine Teva”).

Other medicines and Manidipine Teva
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
Tell your doctor or pharmacist if you are taking medicines for any of the following conditions:

• High blood pressure (such as diuretics and/or beta-blockers).
• Viral and bacterial infections.
• Mental disorders.
• Irregular heartbeat (such as amiodarone, quinidine, digoxin).
• Allergies (such as terfenadine, astemizole).

Manidipine Teva 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 might be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Manidipine Teva must not be used during pregnancy.
Breastfeeding
The use of manidipine should be avoided during breastfeeding. If the use of manidipine is necessary, breastfeeding must be discontinued.
Fertility
In some patients treated with calcium antagonists, abnormalities of sperm heads have been reported, which may impair fertilization.
Driving and using machines
Be cautious when driving or operating machinery, as dizziness may occur.
Manidipine Teva 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 Teva

Take this medicine exactly as your doctor has instructed.
If you have any doubts, consult your doctor or pharmacist.
If you feel that the effect of Manidipine Teva is too strong or too weak, discuss this with your doctor or pharmacist.

Use in children and adolescents
Children must not take Manidipine Teva.

Your doctor will advise you on how long to take the medicine. Do not stop treatment until your doctor tells you to do so.

Take the tablets in the morning after breakfast, with a little liquid, without chewing them.

The usual starting 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 have renal or hepatic impairment, your doctor may prescribe you a reduced dose (10 mg once daily).

If you take more Manidipine Teva than you should
If you (or someone else) have taken several tablets at the same time, or if you think a child has taken 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 low blood pressure and increased heart rate.

If you forget to take Manidipine Teva
If you forget to take a dose, take it as soon as possible, then go back to your regular dosing schedule.
Do not take a double dose to make up for the missed dose.

If you stop taking Manidipine Teva
Contact your doctor before stopping treatment with Manidipine Teva.

If you have any 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 everybody gets them.
The following side effects may occur with the use of Manidipine Teva:
Common (may affect up to 1 in 10 people): headache, dizziness, vertigo, swelling due to fluid retention, palpitations, hot flushes.
Uncommon (may affect up to 1 in 100 people): tingling sensation on the skin, weakness or lack of energy, rapid heartbeat, low blood pressure, difficulty breathing, nausea, vomiting, constipation, dry mouth, digestive disturbances, skin rash, eczema, increased liver enzymes and/or increased renal parameters (your doctor is aware of this).
Rare (may affect up to 1 in 1,000 people): drowsiness, numbness, chest pain, angina, increased blood pressure, stomach pain, abdominal pain, skin redness, itching, and irritability.
Very rare (may affect up to 1 in 10,000 people): myocardial infarction, 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 the frequency, duration, and intensity of these attacks may occur.
Not known (frequency cannot be estimated from the available data): extrapyramidal syndrome has been reported with some calcium antagonists; muscle pain; breast enlargement with or without breast tenderness in men (gynecomastia).

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 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 Teva

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister 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 medicines 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 Manidipine Teva contains:

• The active substance is manidipine hydrochloride. Each 10 mg tablet of Manidipine Teva contains 10 mg of manidipine hydrochloride. Each 20 mg tablet of Manidipine Teva contains 20 mg of manidipine hydrochloride.
• The other components are monohydrate lactose, maize starch, low-substituted hydroxypropylcellulose, hydroxypropylcellulose, magnesium stearate, riboflavin.

Description of the appearance of Manidipine Teva and contents of the pack
Manidipine Teva tablets are 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 Teva is available in the following pack sizes:
28, 30 and 90 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder:
Teva Italia S.r.l.
Piazzale Luigi Cadorna, 4
20123 Milano
Italy

Responsible person for batch release:
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