BARNIDIPINE TEVA 10 mg PROLONGED-RELEASE HARD CAPSULES

Introduction

Package Leaflet: Information for the Patient

Barnidipine Teva 10 mg Hard Capsules, Modified Release EFG

barnidipine hydrochloride

Read all of 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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

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

The active substance of Barnidipine Teva belongs to a group of medicines called calcium channel blockers. Barnidipine causes a dilation of the blood vessels which leads to a reduction of blood pressure. Barnidipine Teva capsules are manufactured in a "prolonged release" form. This means that the active substance is absorbed gradually into the body and has a longer-lasting effect. This is why taking one dose per day is sufficient.

Barnidipine is used for the treatment of high blood pressure.

2. What you need to know before you take Barnidipine Teva

Do not takeBarnidipine Teva

• 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 (used for the treatment of high blood pressure)
• if you have liver disease
• if you have severe kidney disease
• if you have these specific heart diseases: untreated heart failure, certain forms of chest pain (unstable angina) or acute heart attack
• if you are taking one of the following medicines: protease inhibitors (medicines used for the treatment of AIDS), ketoconazole or itraconazole (medicines for the treatment of fungal infections), erythromycin or clarithromycin (antibiotics, see "Other medicines and Barnidipine Teva").

Warnings and precautions

Consult your doctor or pharmacist before taking Barnidipine Teva

• if you have kidney disease
• if you have heart disease

Children and adolescents

Barnidipine must not be used in children or adolescents under 18 years.

Other medicines and Barnidipine Teva

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

This is especially important if you are using any of the following medicines as they MUST NOTbe used with barnidipine (see "Do not take Barnidipine Teva"):

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

Also, inform your doctor if you are taking:

• Other medicines used for the treatment of high blood pressure, as they may cause additional blood pressure reduction.
• Cimetidine (a medicine used for the treatment of stomach problems) as it may increase the effect of barnidipine.
• Phenytoin or carbamazepine (medicines used for the treatment of epilepsy) or rifampicin (an antibiotic) as higher doses of barnidipine may be needed. If you stop treatment with these medicines, your doctor may reduce the dose of barnidipine.

Taking Barnidipine Tevawith drinks and alcohol

Be particularly careful when drinking alcohol or grapefruit juice, as they may increase the effect of barnidipine.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Do not use this medicine during pregnancy unless clearly necessary.

Do not use this medicine while breast-feeding. Barnidipine may pass into breast milk.

Driving and using machines

There is no information to suggest that this medicine affects the ability to drive or use machines. However, as this medicine may cause dizziness, you should know how it affects you before driving or using machines.

Barnidipine Teva contains sucrose

If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

3. How to take Barnidipine Teva

Take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

The recommended initial dose is 10 mg once a day. Your doctor may increase this dose to 1 capsule of 20 mg once a day or 2 capsules of 10 mg once a day.

If you are an elderly person, you can take the normal dose. It is likely that your doctor will monitor you closely at the beginning of treatment.

Instructions for use

• Take the capsule once a day, in the morning. It is recommended to associate taking the capsule with something you do every day, such as brushing your teeth or having breakfast.
• Swallow the capsule whole, preferably with a glass of water. You can take this medicine before, during, or after meals, as you prefer.
• Even when you do not feel any signs or symptoms of high blood pressure, it is important that you continue taking this medicine every day to get all the benefits of blood pressure reduction.

If you take more Barnidipine Tevathan you should

If you have accidentally taken a large number of capsules at once, you should immediatelyconsult your doctor or someone should take you to the emergency department. The possible symptoms of overdose include weakness, slowing or increased heart rate, drowsiness, confusion, nausea, vomiting, and convulsions.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Barnidipine Teva

If you forget to take your dose of barnidipine at the usual time, take it as soon as possible on the same day.

If more than 24 hours have passed, DO NOTtake a double dose to make up for the missed doses and continue with the usual schedule once a day.

If you have any other questions about the use of this medicine or want to stop treatment, 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 that causes difficulty breathing or dizziness, you should inform your doctor or nurse immediately.

Barnidipine may cause the following:

Frequent: may affect up to 1 in 10 people

• headache
• flushing
• fluid accumulation (edema) in arms and legs
• dizziness
• palpitations

Frequency not known: frequency cannot be estimated from the available data

• rapid heartbeats
• blood tests showing changes in liver function
• rash

These side effects tend to decrease or disappear during treatment (within a month for fluid accumulation and within two weeks for flushing, headache, and palpitations).

The following side effects have been observed in some of the other medicines belonging to the same group of medicines as barnidipine:

• gum overgrowth (gingival hyperplasia),
• rarely, chest pain (precordial pain) or chest tightness (angina pectoris) (may affect up to 1 in 1,000 people),
• very rarely, an increase in the frequency or severity of angina attacks in patients with pre-existing angina (may affect up to 1 in 10,000 people)
• heart attack (myocardial infarction) has been observed in isolated cases.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Barnidipine Teva

Keep this medicine out of the sight and reach of children.

Do not store above 25°C.

Do not use this medicine after the expiry date which is stated on the blister and on the carton after EXP. The expiry date is the last day of the month shown.

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

Composition of Barnidipine Teva

• The active substance is barnidipine. Each capsule contains 10 mg of barnidipine hydrochloride, equivalent to 9.3 mg of barnidipine.
• The other ingredients (excipients) are:

Contents of the capsule: sugar spheres (with sugar syrup, corn starch, and sucrose), carboxymethylcellulose, polysorbate 80, ethylcellulose, talc.

Body of the capsule: titanium dioxide (E171), yellow iron oxide (E172), gelatin.

Printing ink: Shellac, propylene glycol, black iron oxide (E172), potassium hydroxide.

Appearance ofBarnidipine Tevaand contents of the pack

Barnidipine Teva 10 mg hard capsules, modified release EFG are hard gelatin capsules filled with granules, yellow to yellowish in color. The cap of the capsule is yellow with black printing "1000" and the body is yellow with black printing "0010".

Available in 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

Netherlands

Manufacturer

Teva Nederland BV

Swensweg 5

Haarlem 2031 GA

Netherlands

or

Teva Operations Poland Sp. z.o.o

ul. Mogilska 80

Krakow, 31-546

Poland

or

Balkanpharma-Dupnitsa AD

3 Samokovsko Shosse Str.

Dupnitsa, 2600

Bulgaria

You can request more information about this medicine from the local representative of the marketing authorisation holder:

Teva Pharma, S.L.U

C/ Anabel Segura, 11, Edificio Albatros B, 1ª planta,

Alcobendas 28108, Madrid (Spain)

Date of last revision of this leaflet:February 2022

You can access detailed and updated information about this medicine by scanning the QR code included in the packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/info/87089

Detailed and updated information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/