MANIDIPINA 10 mg Tablet

Зміст інструкції

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

Manidipina Sandoz 10 mg tablets, 20 mg tablets

Generic medicine
Read this leaflet carefully before using 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 because it could be dangerous.
• If any of the side effects gets worse, or if you notice any side effect not listed in this leaflet, tell your doctor or pharmacist.

Contents of this leaflet:

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

1. WHAT IS MANIDIPINA SANDOZ AND WHAT IT IS USED FOR

Manidipina Sandoz tablets contain 10 mg of the active ingredient manidipina, which
belongs to a group of drugs called dihydropyridine calcium antagonists.
Manidipina Sandoz tablets contain 20 mg of the active ingredient manidipina, which
belongs to a group of drugs called dihydropyridine calcium antagonists.
Manidipina is indicated for the treatment of essential hypertension from mild to
moderate (high blood pressure).
Manidipina works by relaxing blood vessels: in this way, blood pressure is
reduced.

2. BEFORE TAKING MANIDIPINA SANDOZ

Do not take Manidipina Sandoz

• if you are allergic (hypersensitive) to manidipine, to other calcium antagonists or to any of the excipients of Manidipina Sandoz tablets (for the list of excipients see paragraph 6).
• if you suffer from unstable angina (chest pain not caused by stress or exertion or night-time pain) or if you have had a myocardial infarction in the last 4 weeks
• 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 care with Manidipina Sandoz especially in the following cases

• if you suffer from mild liver damage, as the effects of manidipine may be increased (see paragraph 3 “How to take Manidipina Sandoz”)
• if you are an elderly patient, the dose needs to be reduced (see paragraph 3 “How to take Manidipina Sandoz”)
• if you suffer from heart disease
• if you are taking other medicines (see “Taking Manidipina Sandoz with other medicines”).

Taking Manidipina Sandoz with other medicines
Tell your doctor or pharmacist if you are taking or have recently taken other
medicines, including those available without a prescription, or 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).

Taking Manidipina Sandoz with food and drink
During treatment with Manidipina Sandoz, patients should not consume alcohol
and grapefruit juice.

Pregnancy and breastfeeding
Manidipina Sandoz should not be used during pregnancy. The use of manidipine
should be avoided during breastfeeding. If treatment with manidipine is
necessary, breastfeeding must be stopped.

Fertility
In some patients treated with calcium antagonists, alterations of the sperm head have been reported, which could impair fertilization.
Consult your doctor before taking any medicine.

Driving and using machines
Because dizziness may occur, be particularly careful while driving and using
machines.

Important information about some excipients of Manidipina Sandoz
Manidipina Sandoz contains lactose, which is a type of sugar. If your
doctor has diagnosed you with an intolerance to certain sugars, consult him/her before
taking manidipine.

3. HOW TO TAKE MANIDIPINA SANDOZ

Always take Manidipina Sandoz following strictly the instructions of your
doctor. If you have any doubts, consult your doctor.
If you think that the effect of Manidipina Sandoz is too strong or too weak, consult your
doctor or pharmacist.
Children should not take manidipine.
The doctor will establish the duration of treatment. Do not interrupt the treatment until
the doctor indicates it.
The tablets should be taken in the morning after breakfast, with some liquid and
without chewing them.
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 if you suffer from renal or hepatic dysfunction, your doctor may
prescribe you a lower dose (10 mg once a day).

If you take more Manidipina Sandoz than you should
If you (or someone else) have taken an excessive number of tablets
simultaneously, or if you think that a child has ingested one of the tablets, go
immediately to the emergency room of the nearest hospital or contact your doctor.
As with other calcium antagonists, it is possible that an overdose may cause
excessive peripheral vasodilation, which causes a reduction in blood
pressure and an increase in heart rate.

If you forget to take Manidipina Sandoz
If you forget a dose, take it as soon as possible, after which resume the normal
dosage.
Do not take a double dose to compensate for forgetting a single dose.

If you stop taking Manidipina Sandoz
Consult your attending physician before interrupting the intake of Manidipina Sandoz.
If you have any doubts about the use of this medicine, ask your doctor or
pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, manidipina can cause side effects, although not everybody gets them.
During treatment with Manidipina Sandoz, 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): sensations 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 rashes, 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 of the gums and excessive
growth of the gums, which usually disappear when treatment is stopped. In isolated cases patients with pre-existing angina may experience an
increase in the frequency, duration and intensity of these disorders.

Frequency not known: muscle pain, breast enlargement with or without breast tenderness
in men (gynecomastia), with some calcium antagonists, extrapyramidal syndrome has been reported.
If any of these side effects get worse, or if you notice any not listed in this leaflet, please tell your doctor or pharmacist.

5. HOW TO STORE MANIDIPINA SANDOZ

Keep Manidipina Sandoz out of the reach and sight of children.
Do not use Manidipina Sandoz after the expiry date, which is stated on the packaging.
The expiry date refers to the last day of the month.
This medicine does not require any special 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 to
protect the environment.

6. OTHER INFORMATION

What Manidipina Sandoz 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 Sandoz 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 of Manidipina Sandoz and contents of the pack
Manidipina Sandoz is available in two dosages: 10 and 20 mg.
The 10 mg tablets are round, convex, yellow in colour, with a central score line.
The 20 mg tablets are oval, convex, yellow in colour, with a central score line.
Manidipina Sandoz is available in the following pack sizes:
10 mg 14, 28, 30, 90 tablets
20 mg 14, 28, 30, 90 tablets
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Sandoz S.p.A. – Largo U. Boccioni, 1 – 21040 Origgio (VA)

Manufacturer responsible for batch release
Abiogen Pharma S.p.A.
Via Meucci 36,
56121 Ospedaletto
Pisa - Italy
Salutas Pharma GmbH
Otto-von -Guericke Allee 1
39179 Barleben
Germany
Lek Pharmaceuticals d.d.
Verovskova ulica 57
1526 Ljubljana
Slovenia