VASEXTEN 20 mg Modified-Release Hard Capsule

Зміст інструкції

1. Vasexten  , 10 mg modified-release capsules,  , 20 mg modified-release capsules
   1. What is Vasexten and what is it used for
   2. What you need to know before taking Vasexten
   3. How to take Vasexten
   4. Possible side effects
   5. How to store Vasexten
   6. Contents of the pack and other information

Vasexten  , 10 mg modified-release capsules,  , 20 mg modified-release capsules

Barnidipine hydrochloride

Read this leaflet carefully before you start 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist.

Contents of this leaflet:

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

1. What is Vasexten and what is it used for

The active ingredient of Vasexten belongs to the group of drugs called calcium antagonists. Vasexten 
causes the dilation of blood vessels with a consequent lowering of arterial pressure. The
capsules of Vasexten are “extended release”. This means that the active ingredient is absorbed
by the body gradually and its effect is prolonged over time. For this reason, a single administration per day is sufficient.
Vasexten is used for the treatment of arterial hypertension.

2. What you need to know before taking Vasexten

Do not take Vasexten

• if you are allergic to barnidipine or any of the other ingredients of this medicine (listed in section 6)
• if you are allergic to dihydropyridines (substances present in medicines used to treat high blood pressure)
• if you suffer from liver diseases
• if you suffer from severe kidney diseases
• if you suffer from any of the following heart diseases: untreated heart failure, some forms of chest pain (due to unstable angina pectoris) or acute cardiac arrest
• if you are using any of the following medicines: protease inhibitors (medicines used to treat AIDS), ketoconazole or itraconazole (medicines used to treat fungal infections), erythromycin or clarithromycin (antibiotics).

Warnings and precautions
Talk to your doctor or pharmacist before taking Vasexten

• if you suffer from a kidney disease
• if you suffer from a heart disease

Children and adolescents
Vasexten should not be given to children or adolescents under the age of 18 years.

Other medicines and Vasexten
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
This is particularly important if you are using any of the following medicines, as they must not
be taken together with Vasexten:

• protease inhibitors (medicines used to treat AIDS)
• ketoconazole or itraconazole (medicines used to treat fungal infections)
• erythromycin or clarithromycin (antibiotics)

Tell your doctor also if you are taking:

• other medicines for the treatment of high blood pressure, which can cause a further lowering of blood pressure
• cimetidine (a medicine used to treat stomach diseases) as it can increase the effect of Vasexten
• phenytoin or carbamazepine (medicines used to treat epilepsy) or rifampicin (an antibiotic), as a higher dose of Vasexten may be needed. If you stop treatment with one of these medicines, your doctor may reduce your dose of Vasexten.

Vasexten with food, drinks and alcohol
Be particularly careful when drinking alcohol or grapefruit juice, as these drinks
can increase the effect of Vasexten.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, or if you are breastfeeding with breast
milk, ask your doctor or pharmacist for advice before taking this medicine.
You should not use Vasexten during pregnancy unless it is strictly necessary.
Do not use Vasexten if you are breastfeeding. It can be excreted in breast milk.

Driving and using machines
There is no data to suggest that Vasexten can impair the ability to drive and
use machines. However, Vasexten can cause dizziness, so you should be sure of the effect
the medicine has on you before driving or using machines.

Vasexten capsules contain sucrose. If your doctor has diagnosed you with an intolerance
to certain sugars, contact him before taking this medicine.

3. How to take Vasexten

Dosage
Take this medicine following exactly the instructions of your doctor. If you have any doubts, consult your
doctor or pharmacist.
The usual starting dose is 1 Vasexten 10 mg capsule once a day. Your doctor may
increase this dose to 1 Vasexten 20 mg capsule once a day, or two 10 mg capsules
once a day.
If you are elderly you can use the normal dosage. The doctor will likely monitor you more
closely at the beginning of treatment.

Instructions for correct use

• Take the capsule once a day, in the morning. It is preferable to associate taking the capsule with a daily activity, such as brushing your teeth or having breakfast.
• Swallow the capsules whole, preferably with a glass of water. You can take Vasexten before, during or after a meal, as you prefer.
• Even if you do not experience signs or symptoms of hypertension, it is important that you continue to take Vasexten every day, in order to obtain the full benefits related to the reduction of blood pressure.

If you take more Vasexten than you should
If you have accidentally taken a large quantity of capsules at once, you must contact
your doctor immediately or ask to be taken to a hospital emergency room. The
symptoms that may occur following an overdose are weakness, decrease or increase in
heart rate, drowsiness, confusion, nausea, vomiting and convulsions.

If you forget to take Vasexten
If you forget to take Vasexten at the usual time of day, take the capsule as soon as
possible, on the same day. If you only remember the next day, do not take a double dose to
make up for the forgotten capsule, but continue regularly with your daily dose.
If you have any doubts 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.
If you experience a severe allergic reaction causing difficulty breathing or dizziness, you should
inform your doctor or nurse immediately.
Vasexten may cause:
Very common: affects more than 1 in 10 patients

• headache
• facial redness
• fluid retention (edema) in the arms and legs

Common: affects up to 1 in 10 patients:

• dizziness
• palpitations

Not known: frequency cannot be estimated based on available data

• fast heartbeat
• blood tests showing changes in liver function
• skin rash

These side effects usually decrease or disappear during treatment (within one
month for fluid retention and within two weeks for facial redness, headache and
palpitations).
If you experience any side effects, including those not listed in this leaflet, please tell your
doctor or pharmacist.

5. How to store Vasexten

Keep this medicine out of the sight and reach of children.
Store Vasexten capsules at a temperature below 25°C.
Do not use Vasexten after the expiry date which is reported on the carton after ”EXP.”. The expiry
date refers to the last day of that month.
Do not dispose of any medicine in waste water 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 Vasexten contains

• Each Vasexten capsule contains 10 mg or 20 mg of barnidipine hydrochloride, equivalent to 9.3 mg and 18.6 mg of barnidipine per capsule, respectively.
• The other ingredients are: Capsule content: carboxymethyl ethylcellulose, polysorbate 80, sucrose, ethylcellulose and talc. Capsule shell: titanium dioxide (E 171), yellow iron oxide (E 172) and gelatin. Printing ink: shellac, propylene glycol (E 1520), black iron oxide (E 172), ammonia.

Description of the appearance of Vasexten and contents of the pack
Yellow capsules.
Vasexten 10 mg capsules are marked with the code 155 10
Vasexten 20 mg capsules are marked with the code 155 20
Vasexten capsules are packaged in aluminum/aluminum blisters (with a PVC and
polyamide coating) contained in cardboard boxes of 10, 14, 20, 28, 30, 50, 56, 98 or 100 capsules. Not all pack sizes may be marketed.

Marketing Authorisation Holder
Italfarmaco S.p.A
Viale F. Testi, 330
20126 Milan

Release Batch Responsible
Astellas Pharma Europe B.V.
Sylviusweg 62
2333 BE Leiden
Netherlands

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
Belgium Vasexten
Greece Vasexten
Italy Vasexten
Netherlands Vasexten
Luxembourg Vasexten
Spain Vasexten