Manidipine Mylan Generics

PACKAGE LEAFLET: INFORMATION FOR THE USER

Manidipine Mylan Generics 10 mg tablets, 20 mg tablets

Generic Medicine
Please read all of this leaflet carefully before you start taking this medicine.

• 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. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If any of the side effects worsens, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Contents of this leaflet:

1. What Manidipine Mylan Generics is and what it is used for
2. Before you take Manidipine Mylan Generics
3. How to take Manidipine Mylan Generics
4. Possible side effects
5. How to store Manidipine Mylan Generics
6. Further information

1. WHAT MANIDIPINE MYLAN GENERICS IS AND WHAT IT IS USED FOR

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

2. BEFORE TAKING MANIDIPINE MYLAN GENERICS

Do not take Manidipine Mylan Generics:

• if you are allergic (hypersensitive) to manidipine or to other calcium antagonists, or to any of the excipients of manidipine tablets (see section 6 for the complete list of excipients)
• 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 within the previous 4 weeks
• if you suffer from untreated congestive heart failure
• if you have severe renal impairment (creatinine clearance < 10 ml/min)
• if you suffer from moderate to severe hepatic impairment
• if you are a child

Take special care with Manidipine Mylan Generics:

• if you have mild liver damage, as the effects of manidipine may be increased (see section 3 “How to take Manidipine Mylan Generics”)
• if you are elderly, a dose reduction is required (see section 3 “How to take Manidipine Mylan Generics”)
• if you suffer from heart disease
• if you are taking other medicines (see section “Taking Manidipine Mylan Generics with other medicines”).

Taking Manidipine Mylan Generics with other medicines
Inform your doctor or pharmacist if you are taking, or have recently taken, any other
medicines, including those without a prescription or medicines for any of the following
conditions:

• Hypertension, 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)

Taking Manidipine Mylan Generics with food and drinks
Patients must not consume alcohol or grapefruit juice during treatment with
manidipine.
Pregnancy and breastfeeding
Manidipine Mylan Generics must not be used during pregnancy. Manidipine should be avoided during breastfeeding. If treatment with manidipine is necessary, breastfeeding must be discontinued.
Fertility
In some patients treated with calcium antagonists, alterations in sperm head morphology have been reported, which may impair fertilization.
Ask your doctor for advice before taking any medicine.
Driving and using machines
Be careful when driving or operating machinery, as dizziness may occur.
Important information about some excipients of Manidipine Mylan Generics
Manidipine Mylan Generics contains lactose, a type of sugar. If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

3. HOW TO TAKE MANIDIPINE MYLAN GENERICS

Always take Manidipine Mylan Generics exactly as directed by your doctor.
If you have any doubts, consult your doctor.
If you feel that the effect of Manidipine Mylan Generics is too strong or too weak, discuss it with your doctor or pharmacist.
Children must not take manidipine.
Your doctor will determine the duration of treatment. Do not stop treatment unless instructed by your doctor.
The tablets should be taken in the morning after breakfast, with some liquid, and without chewing.
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 a reduced dose (10 mg once daily).
If you take more Manidipine Mylan Generics than you should
If you (or someone else) have ingested a large number of tablets 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 increased heart rate.
If you forget to take Manidipine Mylan Generics
If you have forgotten to take a dose, take it as soon as possible and then return to your regular dosing schedule.
Never take a double dose to make up for a forgotten dose.
If you stop taking Manidipine Mylan Generics
Contact your doctor before stopping treatment with Manidipine Mylan Generics.
If you have any doubts about using Manidipine Mylan Generics, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, manidipine may cause adverse reactions, although not everybody experiences them.
The following adverse reactions may occur with the use of Manidipina Mylan Generics.
Common (≥1/100, <1/10): headache, dizziness, vertigo, swelling due to fluid retention, palpitations, hot flushes.
Uncommon (≥1/1,000, <1/100): skin tingling sensation, weakness or lack of energy, increased heart rate, low blood pressure, difficulty breathing, nausea, vomiting, constipation, dry mouth, digestive disorders, skin rash, eczema, increased liver enzymes and/or increased renal parameters (your doctor is aware of this).
Rare (≥1/10,000, <1/1,000): somnolence, numbness, chest pain, angina, high blood pressure, stomach pain, abdominal pain, skin redness, itching, and irritability.
Very rare (<1/10,000): myocardial infarction, inflammation and swelling of the gums, which usually disappear after discontinuation of treatment. In isolated cases, in patients with pre-existing angina, an increase in the frequency, duration, and intensity of these attacks may occur.
Frequency not known: extrapyramidal syndrome has been reported with some calcium antagonists.
If any of the adverse reactions worsens, or if you notice any adverse reaction not listed in this leaflet, inform your doctor.

5. HOW TO STORE MANIDIPINE MYLAN GENERICS

Keep out of the reach and sight of children.
Do not use the medicine after the expiry date stated on the packaging after the word
“Exp.”. The expiry date refers to the last day of the month.
This medicine does not require any special storage conditions.
Medicines must not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines you no longer use. This will help protect
the environment.

6. OTHER INFORMATION

What Manidipine Mylan Generics 10 mg contains
The active substance is manidipine hydrochloride 10 mg.
The excipients are: monohydrate lactose, maize starch, low-substituted hydroxypropylcellulose, hydroxypropylcellulose, magnesium stearate, riboflavin.

What Manidipine Mylan Generics 20 mg contains
The active substance is manidipine hydrochloride 20 mg.
The excipients are: monohydrate lactose, maize starch, low-substituted hydroxypropylcellulose, hydroxypropylcellulose, magnesium stearate, riboflavin.

Description of the appearance of Manidipine Mylan Generics and contents of the pack
Manidipine 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 Mylan Generics is available in the following pack sizes:
10 mg: 28, 30, 84, 90 tablets
20 mg: 28, 30, 84, 90 tablets

Not all pack sizes may be marketed.

Marketing Authorization Holder:
Mylan S.p.A
Via Vittor Pisani, 20
20124 Milan - Italy

Responsible manufacturer for batch release:
Abiogen Pharma S.p.A
Via Meucci 36,
56014 Ospedaletto
Pisa - Italy

This Patient Information Leaflet was last approved in October 2010