Vasexten

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

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

Barnidipine hydrochloride
Please read this leaflet carefully before 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 give it to other people, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact 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 taking 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 Vasexten is and what it is used for

The active substance of Vasexten belongs to a group of medicines called calcium antagonists. Vasexten® causes dilation of blood vessels, resulting in a lowering of blood pressure. Vasexten capsules are "extended-release". This means that the active substance is gradually absorbed by the body and its effect is prolonged over time. For this reason, once-daily administration 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 to 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 hypertension)
• if you have liver disease
• if you have severe kidney disease
• if you have any of the following heart conditions: untreated heart failure, certain types of chest pain (due to unstable angina pectoris), or acute heart attack
• if you are taking 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 have kidney disease
• if you have heart disease

Children and adolescents
Vasexten must not be given to children or adolescents under 18 years of age.
Other medicines and Vasexten
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
This is particularly important if you are taking 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)

Also inform your doctor if you are taking:

• other medicines for the treatment of hypertension, as they may cause a further drop in blood pressure
• cimetidine (a medicine used to treat stomach disorders), as it may 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 required. If you stop treatment with any of these medicines, your doctor may reduce your dose of Vasexten.

Vasexten with food, drinks and alcohol
Be especially cautious when consuming alcohol or grapefruit juice, as these beverages may increase the effect of Vasexten.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
You must not use Vasexten during pregnancy unless strictly necessary.
Do not use Vasexten if you are breastfeeding. It may be excreted in breast milk.
Driving and using machines
There are no data suggesting that Vasexten may impair the ability to drive or operate machinery. However, Vasexten may cause dizziness; therefore, you must be certain how this medicine affects you before driving or operating machinery.
Vasexten capsules contain sucrose. If you have been diagnosed with an intolerance to certain sugars by your doctor, consult him before taking this medicine.

3. How to take Vasexten

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

Instructions for correct use

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

If you take more Vasexten than you should
If you accidentally take a large number of capsules at once, you must contact your doctor immediately or go to a hospital emergency department. Symptoms that may occur following an overdose include weakness, decreased or increased heart rate, drowsiness, confusion, nausea, vomiting, and seizures.

If you forget to take Vasexten
If you forget to take Vasexten at the usual time, 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 missed capsule, but continue regularly with your daily dose.
If you have any questions about the use of this medicine, consult 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 in breathing or dizziness, you must inform your doctor or nurse immediately.

Vasexten may cause:

Very common: affects more than 1 in 10 people

• headache
• facial flushing
• fluid accumulation (edema) in the arms and legs

Common: affects up to 1 in 10 people

• dizziness
• palpitations

Not known: frequency cannot be estimated from the available data

• increased heart rate
• blood tests showing changes in liver function
• skin rash

These side effects usually decrease or disappear during treatment (within one month for fluid accumulation, and within two weeks for facial flushing, headache, and palpitations).
If you experience any side effect, including those not listed in this leaflet, consult 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 stated on the carton after "EXP.". The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Pack contents 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 components are: Capsule contents: 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 pack contents
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 packed in aluminium/aluminium blisters (with PVC and polyamide coating) contained in cardboard cartons containing 10, 14, 20, 28, 30, 50, 56, 98 or 100 capsules. Not all pack sizes may be marketed.

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

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

This medicinal product is authorized in the European Economic Area countries under the following names:
Belgium Vasexten
Greece Vasexten
Italy Vasexten
Netherlands Vasexten
Luxembourg Vasexten
Spain Vasexten

This patient information leaflet was last approved on: July 2013