Barnidipine teva

Package leaflet: Information for the user

Barnidipine Teva, 10 mg modified-release capsules, hard
Barnidipine Teva, 20 mg modified-release capsules, hard
barnidipine hydrochloride
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet

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

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

The active substance in Barnidipine Teva belongs to a group of medicines called calcium antagonists.
Barnidipine Teva lowers blood pressure by relaxing and widening blood vessels. Barnidipine Teva is formulated as modified-release capsules. This means that the active substance is gradually absorbed into the body and has a prolonged effect. Therefore, one dose per day is sufficient.
Barnidipine Teva is used to treat high blood pressure.

2. Important information before using Barnidipine Teva

When not to use Barnidipine Teva:

• if the patient is allergic to barnidipine or to any of the other ingredients of this medicine (listed in section 6)
• if the patient has hypersensitivity to dihydropyridines (present in medicines used to treat high blood pressure)
• if the patient has liver disease
• if the patient has severe kidney disease
• if the patient has any of the following specific heart conditions: untreated heart failure, certain forms of chest pain (unstable angina), or sudden cardiac arrest
• if the patient is taking any of the following medicines: protease inhibitors (medicines used in the treatment of AIDS), ketoconazole or itraconazole (medicines used to treat fungal infections), erythromycin or clarithromycin (antibiotics; see "Taking Barnidipine Teva with other medicines").

Warnings and precautions
Before starting Barnidipine Teva, inform your doctor or pharmacist if:

• the patient has kidney disease
• the patient has heart disease.

Children and adolescents
Barnidipine Teva must not be used in children and adolescents under 18 years of age.
Barnidipine Teva and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines they plan to take.
This is particularly important when using any of the following medicines, because DO NOT
TAKE them together with Barnidipine Teva (see section "When not to use Barnidipine Teva"):

• protease inhibitors (medicines used in the treatment of AIDS)
• ketoconazole or itraconazole (medicines used in the treatment of fungal infections)
• erythromycin or clarithromycin (antibiotics).

Also inform your doctor if the patient is taking:

• other medicines used to treat high blood pressure, due to the risk of further lowering of blood pressure
• cimetidine (a medicine used to treat stomach disorders), as it may enhance the effect of Barnidipine Teva
• phenytoin or carbamazepine (medicines used for epilepsy), or rifampicin (an antibiotic), as higher doses of Barnidipine Teva may be required. After stopping these medicines, your doctor may reduce the dose of Barnidipine Teva.

Taking Barnidipine Teva with drinks and alcohol
Exercise particular caution when consuming alcohol or grapefruit juice, as they may increase the effect of Barnidipine Teva.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.
Do not use Barnidipine Teva during pregnancy unless absolutely necessary.
Do not use Barnidipine Teva during breastfeeding. Barnidipine may pass into breast milk.
Driving and using machines
There is no information suggesting that barnidipine affects the ability to drive or operate machinery. However, Barnidipine Teva may cause dizziness; therefore, before driving or operating machinery, ensure that the patient knows how this medicine affects them.
Barnidipine Teva contains sucrose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult their doctor before taking this medicine.

3. How to use Barnidipine Teva

Barnidipine Teva must always be used exactly as directed by your doctor or pharmacist.
If you are unsure, consult your doctor or pharmacist.
The usual starting dose is 10 mg once daily. Your doctor may increase this dose to
1 capsule of 20 mg once daily or 2 capsules of 10 mg once daily.
In elderly patients, the normal dose of the medicine may be used. At the beginning of treatment, your doctor
will likely monitor treatment very closely in this patient group.
Instructions for use

• Take the capsule once daily in the morning. It is recommended to associate taking the capsule with a daily routine activity, such as brushing your teeth or eating breakfast.
• Swallow the capsule whole, preferably with a glass of water. Barnidipine Teva may be taken before, during, or after a meal, depending on personal preference.
• To achieve the full benefit of blood pressure reduction, continue taking Barnidipine Teva every day, even if you do not experience any symptoms of high blood pressure.

Taking more Barnidipine Teva than prescribed
If you accidentally take more capsules than prescribed at one time, contact your doctor immediately or have someone take you to the nearest hospital emergency department.
Possible symptoms of overdose include weakness, slowed or rapid heartbeat, drowsiness, disorientation, nausea, vomiting, and seizures.
If you forget to take Barnidipine Teva
If you miss a dose of Barnidipine Teva at your usual time, take the capsule as soon as possible on the same day.
If you only remember the missed dose the next day, DO NOT take a double dose to make up for the missed dose.
Simply continue taking the medicine at your usual daily dose.
If you have any doubts about how to use the medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Barnidipine Teva may cause adverse effects, although not everyone experiences them.
If you experience a severe allergic reaction causing difficulty breathing or dizziness, you must immediately inform your doctor or nurse.
Barnidipine Teva may cause the following adverse effects:

Barnidipine Teva 20 mg:
Very common: may occur in more than 1 in 10 people

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

Common: may occur in no more than 1 in 10 people

• dizziness
• palpitations

Barnidipine Teva 10 mg:
Common: may occur in no more than 1 in 10 people

• headache
• facial flushing
• fluid accumulation (oedema) in arms or legs
• dizziness
• palpitations

Barnidipine Teva 10 mg, 20 mg:
Frequency unknown: cannot be estimated from available data

• increased heart rate
• blood tests showing liver function abnormalities
• rash

These adverse effects usually diminish or disappear during treatment (within one month for fluid accumulation and within two weeks for facial flushing, headache, and palpitations).
For some other medicines belonging to the same class as Barnidipine Teva, the following adverse effects have been observed:

• gingival hyperplasia
• chest pain on the left side of the chest (precordial pain) or chest pain (angina pectoris) – rarely observed (may occur in no more than 1 in 1,000 people)
• very rarely observed increase in frequency or severity of angina attacks in patients with pre-existing angina pectoris (may occur in no more than 1 in 10,000 people)
• myocardial infarction (heart attack) – observed in single cases

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Barnidipine Teva

Keep this medicine out of sight and reach of children.
Do not store above 25°C.
Do not use this medicine after the expiry date stated on the carton and blister pack after Exp.
The expiry date refers to the last day of the stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Barnidipine Teva contains

• The active substance is barnidipine. Each capsule contains 10 mg or 20 mg of barnidipine hydrochloride, equivalent to 9.3 mg or 18.6 mg of barnidipine, respectively.
• Other ingredients are:
  Capsule contents: sucrose, pellets (sucrose, corn starch, starch hydrolysate), carboxymethylcellulose (CMC), polysorbate 80, ethylcellulose (10 cP) and talc.

Capsule shell: titanium dioxide (E171), yellow iron oxide (E172), purified water, gelatin.
Printing ink: shellac, propylene glycol, black iron oxide (E172), potassium hydroxide.

What Barnidipine Teva looks like and contents of the pack

Barnidipine Teva 10 mg modified-release hard capsules contain yellow or pale yellow granules. The capsule cap is yellow with black print "1000", and the body is yellow with black print "0010".

Barnidipine Teva 20 mg modified-release hard capsules contain yellow or pale yellow granules. The capsule cap is yellow with black print "1000", and the body is yellow with black print "0020".

Barnidipine Teva is available in packs containing perforated and non-perforated blisters of 28, 30, 56 or 60 capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Teva B.V.
Swensweg 5
2031 GA Haarlem
The Netherlands

Manufacturers
Balkanpharma-Dupnitsa AD
3 Samokovsko Shosse Str.
2600 Dupnitsa
Bulgaria

Teva Operations Poland Sp. z o.o.
ul. Mogilska 80
31-546 Kraków
Poland

Teva Nederland B.V.
Swensweg 5
2031 GA Haarlem
The Netherlands

For further information, contact the local representative of the Marketing Authorisation Holder:
Teva Pharmaceuticals Polska Sp. z o.o., ul. Emilii Plater 53, 00-113 Warsaw, tel. (22) 345 93 00.

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

| Member State | Name of the medicinal product | |------------------|-----------------------------------| | Bulgaria | Барнитенс 10 mg твърди капсули с изменено освобождаване
Barnitens 10 mg hard modified-release capsules
Барнитенс 20 mg твърди капсули с изменено освобождаване
Barnitens 20 mg hard modified-release capsules | | Estonia | Barnidipino Teva 10 mg cápsulas duras de liberación prolongada EFG
Barnidipino Teva 20 mg cápsulas duras de liberación prolongada EFG | | The Netherlands | Barnidipine HCl Teva Retard 10 mg, harde capsules met gereguleerde afgifte
Barnidipine HCl Teva Retard 20 mg, harde capsules met gereguleerde afgifte | | Poland | Barnidipine Teva | | Italy | Barnidipina cloridrato Teva |