MANIDIPINA 10 mg Таблетки

Содержание инструкции

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

Manidipina Teva 10 mg tablets

Manidipina Teva 20 mg tablets
Generic medicine
Read this leaflet carefully before taking this medicine as it contains
important information for you.

• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Manidipina Teva tablets contain 10 mg of the active ingredient manidipine, which belongs to
a group of medicines called dihydropyridine calcium antagonists.
Manidipina Teva tablets contain 20 mg of the active ingredient 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 blood vessels to reduce pressure.

2. What you need to know before taking Manidipina Teva

Do not take Manidipina 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 suffer from untreated congestive heart failure.
• If you suffer from severe renal insufficiency (creatinine clearance < 10 ml/min).
• If you suffer from moderate to severe hepatic insufficiency.
• If you are a child.

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

• If you suffer from mild liver damage, as the effects of manidipine may increase (see section 3 “How to take Manidipina Teva”).
• If you are an elderly patient, a dose reduction is required (see section 3 “How to take Manidipina Teva”).
• If you suffer from heart disease.
• If you are taking other medicines (see “Other medicines and Manidipina Teva”).

Other medicines and Manidipina Teva
Tell 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).

Manidipina Teva with food, drinks and alcohol
Patients should not consume alcohol or grapefruit juice during treatment with
manidipine.

Pregnancy, breastfeeding and fertility
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.
Pregnancy
Manidipina Teva should not be used during pregnancy.
Breastfeeding
The use of manidipine should be avoided during breastfeeding. If the use of manidipine is
necessary, breastfeeding should be stopped.
Fertility
In some patients treated with calcium antagonists, alterations in sperm head morphology have been reported, which may impair fertilization.

Driving and using machines
Be careful while driving or using machines, as dizziness may occur.

Manidipina Teva contains lactose
If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking
this medicine.

3. How to take Manidipina Teva

Take this medicine following exactly the instructions of your doctor.
If you have any doubts, consult your doctor or pharmacist.
If you feel that the effect of Manidipina Teva is too strong or too weak, talk to your doctor or
pharmacist.

Use in children and adolescents
Children should not take Manidipina Teva.
Your doctor will tell you how long to continue the treatment. Do not stop the treatment until your
doctor tells you to discontinue it.
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 Teva 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, it is possible that an overdose may cause
excessive peripheral vasodilation leading to a decrease in blood pressure and an
increase in heart rate.

If you forget to take Manidipina Teva
If you have forgotten to take a dose, take it as soon as possible and then return to your regular
schedule.
Do not take a double dose to make up for a missed dose.

If you stop taking Manidipina Teva
Contact your doctor before stopping taking Manidipina Teva.
If you have any further questions on 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.
With the use of Manidipina Teva, the following side effects may occur.

Common (may affect up to 1 in 10 people):headache, dizziness, vertigo, swelling caused by
fluid retention, palpitations, hot flushes.

Uncommon (may affect up to 1 in 100 people): feeling of tingling on the skin, weakness
or lack of energy, fast heartbeat, low blood pressure, difficulty breathing,
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 (may affect up to 1 in 1,000): drowsiness, lethargy, chest pain, angina,
increased blood pressure, stomach pain, abdominal pain, skin redness,
pruritus and irritability.

Very rare (may affect up to 1 in 10,000): myocardial infarction, inflammation and
swelling of the gums which usually disappear after stopping 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 available data): with some calcium-
antagonists, extrapyramidal syndrome has been reported; muscle pain; breast enlargement with or without
breast tenderness in men (gynecomastia).
.

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/it/responsabili .
By reporting side effects you can help provide more information on the safety
of this medicine.

5. How to store Manidipina Teva

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 package and on the blister after
“Exp.”. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in wastewater 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 Teva contains:

• The active ingredient is manidipine hydrochloride. Each 10 mg tablet of Manidipina Teva contains 10 mg of manidipine hydrochloride. Each 20 mg tablet of Manidipina Teva contains 20 mg of manidipine hydrochloride.
• The other ingredients are lactose monohydrate, corn starch, low substituted hydroxypropylcellulose, hydroxypropylcellulose, magnesium stearate, riboflavin.

Description of the appearance of Manidipina Teva and contents of the pack
Manidipina Teva tablets are available in 2 dosages: 10 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 Teva is available in the following pack sizes:
28, 30 and 90 tablets
Not all pack sizes may be marketed.

Marketing Authorisation Holder:
Teva Italia S.r.l.
Piazzale Luigi Cadorna, 4
20123 Milan

Manufacturer responsible 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
Milan - Italy