MANIDIPINA 10 mg Tablets

Зміст інструкції

1. Manidipina Mylan Generics 10 mg tablets, 20 mg tablets
   1. WHAT IS MANIDIPINA MYLAN GENERICS AND WHAT IT IS USED FOR
   2. BEFORE TAKING MANIDIPINA MYLAN GENERICS
   3. HOW TO TAKE MANIDIPINA MYLAN GENERICS
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE MANIDIPINA MYLAN GENERICS
   6. OTHER INFORMATION

Manidipina Mylan Generics 10 mg tablets, 20 mg tablets

Equivalent Medicinal Product

• If you have any doubts, 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 could be dangerous.
• If any of the side effects gets worse or if you notice any

pharmacist.

Contents of this leaflet:

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

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

Manidipina Mylan Generics tablets contain 10 mg of the active ingredient manidipina,
which belongs to a group of medicines called dihydropyridine calcium antagonists.
Manidipina Mylan Generics tablets contain 20 mg of the active ingredient manidipina,
which belongs to a group of medicines called dihydropyridine calcium antagonists.
Manidipina is indicated for the treatment of essential mild to moderate hypertension
(high blood pressure).
Manidipina works by relaxing the blood vessels in order to reduce pressure.

2. BEFORE TAKING MANIDIPINA MYLAN GENERICS

Do not take Manidipina Mylan Generics:

• if you are allergic (hypersensitive) to manidipine or 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 in the 4 weeks prior
• if you suffer from untreated congestive heart failure
• if you suffer from 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 Manidipina Mylan Generics:

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

Taking Manidipina Mylan Generics with other medicines
Tell 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 Manidipina Mylan Generics with food and drink
Patients should not consume alcohol or grapefruit juice during treatment with
manidipine.

Pregnancy and breastfeeding
Manidipina Mylan Generics should not be used during pregnancy. The use of manidipine
should be avoided during breastfeeding. If treatment with manidipine is necessary,
breastfeeding should 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 while driving or using machines as dizziness may occur.

Important information about some excipients of Manidipina Mylan Generics
Manidipina Mylan Generics contains lactose, which is a type of sugar. If your doctor has
diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3. HOW TO TAKE MANIDIPINA MYLAN GENERICS

Always take Manidipina Mylan Generics exactly as your doctor has instructed.
If you have any doubts, consult your doctor.
If you feel that the effect of Manidipina Mylan Generics is too strong or too weak, talk to your
doctor or pharmacist.
Children should not take manidipine.
Your doctor will indicate the duration of treatment. Do not stop treatment until your
doctor tells you to.
The tablets should be taken in the morning after breakfast, with some liquid and without chewing.
The usual initial dose is 10 mg once a day.
If after 2 - 4 weeks of treatment the antihypertensive effect of manidipine is
insufficient, your doctor may increase the dose to 20 mg once a day.
If you are elderly or suffer from kidney or liver dysfunction, your doctor may prescribe you a reduced dose
(10 mg once a day).

If you take more Manidipina Mylan Generics than you should
If you (or someone else) have swallowed many tablets at once, or if you think a
child has swallowed any tablets, contact the Emergency Room of the nearest
hospital or your doctor immediately. As with other calcium antagonists, an
overdose may cause excessive peripheral vasodilation leading to a
lowering of blood pressure and an increase in heart rate.

If you forget to take Manidipina Mylan Generics
If you have forgotten to take a dose, take it as soon as possible and then return to your
regular schedule.
Never take a double dose to make up for a missed dose.

If you stop taking Manidipina Mylan Generics
Contact your doctor before stopping treatment with Manidipina Mylan Generics.
If you have any further questions on the use of Manidipina Mylan Generics, ask your doctor or
pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, manidipina can cause side effects, although not everybody gets them.
With the use of Manidipina Mylan Generics, the following side effects may occur.

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

Uncommon (≥1/1000, <1/100): feeling of pins and needles on the skin, weakness or lack of
energy, fast heartbeat, low blood pressure, shortness of breath, nausea,
vomiting, constipation, dry mouth, digestive disorders, skin rash, eczema, increased
liver enzymes and/or increased kidney parameters (your doctor is aware of this).

Rare (≥1/10,000, <1/1000): drowsiness, lethargy, 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 in
general disappear after stopping 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 channel blockers.
If any of these side effects get worse, or if you notice any side effect

5. HOW TO STORE MANIDIPINA 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 wording
“Scad.”. The expiry date refers to the last day of the month.
This medicine does not require particular storage conditions.
Medicines should 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 Manidipina Mylan Generics 10 mg contains
The active ingredient is manidipine hydrochloride 10 mg.
The excipients are: lactose monohydrate, corn starch, low substituted hydroxypropylcellulose, hydroxypropylcellulose, magnesium stearate, riboflavin.

What Manidipina Mylan Generics 20 mg contains
The active ingredient is manidipine hydrochloride 20 mg.
The excipients are: lactose monohydrate, corn starch, low substituted hydroxypropylcellulose, hydroxypropylcellulose, magnesium stearate, riboflavin.

Description of the appearance ofManidipina Mylan Generics and contents of the pack
Manidipina is available in 2 dosages: 10 mg and 20 mg
The 10 mg tablets are round, convex, yellow in colour, with a median fracture line.
The 20 mg tablets are oval, convex, yellow in colour, with a median fracture line.
Manidipina Mylan Generics is available in the following packs:
10 mg: 28, 30, 84, 90 tablets
20 mg: 28, 30, 84, 90 tablets
Not all pack sizes may be marketed.

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

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