BARNIDIPINE SWANPOND INVESTMENTS 20 mg PROLONGED-RELEASE HARD CAPSULES

2. What you need to know before you take Barnidipine Swanpond Investments

Do not take Barnidipine Swanpond Investments

• if you are allergic to barnidipine or any of the other ingredients of this medicine (listed in section 6).
• if you are allergic to other dihydropyridines (used for the treatment of high blood pressure).
• if you have liver disease.
• if you have severe kidney disease.
• if you have certain heart conditions: untreated heart failure, certain types of chest pain (unstable angina) or acute heart attack.

• if you are taking any of the following medicines: protease inhibitors (medicines used for the treatment of AIDS), ketoconazole or itraconazole (medicines used for the treatment of fungal infections), erythromycin or clarithromycin (antibiotics).

Warnings and precautions

Consult your doctor or pharmacist before taking barnidipine

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

Children and adolescents

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

Other medicines and Barnidipine Swanpond Investments

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

It is especially important if you are using any of the following medicines, as they SHOULD NOT be used with barnidipine:

• Protease inhibitors (medicines used for the treatment of AIDS).
• Ketoconazole or itraconazole (medicines used 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 reduction in blood pressure.
• Cimetidine (a medicine used for the treatment of stomach problems) as it may increase the effects 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 your dose of barnidipine.

Taking Barnidipine Swanpond Investments with drinks and alcohol

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

Pregnancy and breastfeeding

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

You should not take barnidipine during pregnancy unless clearly necessary.

You should not take barnidipine during breastfeeding. Barnidipine may pass into breast milk.

Driving and using machines

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

Excipients:

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

3. How to take Barnidipine Swanpond Investments

Dosage

Follow exactly the administration instructions of this medicine given by your doctor. If you are unsure, ask your doctor or pharmacist.

The recommended initial dose is 1 capsule of barnidipine 10 mg once a day. During treatment, your doctor may recommend increasing the dose to 1 capsule of barnidipine 20 mg once a day or 2 capsules of barnidipine 10 mg once a day.

If you are elderly, you can take the normal dose. Your doctor will probably monitor you closely at the beginning of treatment.

Instructions for proper use

• Take the capsule once a day, in the morning. It is recommended to associate the intake of the capsule with something you do daily, such as brushing your teeth or having breakfast.
• Swallow the capsule whole, preferably with a glass of water. Barnidipine can be taken before, during, and after meals as you prefer.
• Even if you do not feel the signs or symptoms of high blood pressure, it is important to continue taking barnidipine every day to get all the benefits of blood pressure reduction.

If you take more Barnidipine Swanpond Investments than you should

If you have accidentally taken a large number of capsules at once, you should immediately consult 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 Swanpond Investments

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 not take a double dose to make up for the missed doses and continue with the usual schedule once a day.

If you have any further questions on 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 that causes difficulty breathing or dizziness, you should inform your doctor or nurse immediately.

Barnidipine may cause:

Very common: may affect more than 1 in 10 people

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

Common: may affect up to 1 in 10 people

• dizziness
• palpitations

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

• rapid heart rate
• 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).

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, 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: http://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Barnidipine Swanpond Investments

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 carton and blister 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 further information

Composition of Barnidipine Swanpond Investments

• The active substance is 20 mg of barnidipine hydrochloride.
• The other ingredients (excipients) are:

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

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

Printing ink:shellac glazes, propylene glycol (E1520), black iron oxide (E172), and potassium hydroxide.

Appearance and pack contents

Hard gelatin capsules filled with yellow to pale yellow granules. The cap is yellow, marked with "1000" in black ink. Body yellow marked with "0020" in black ink.

Barnidipine Swanpond Investments prolonged-release hard capsules EFG are available in packs containing 28 and 56 capsules in OPA/Al/PVC-Aluminum blisters.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Swan Pond Investments Ltd

Landscape House

Baldonnell Business Park

Baldonnell,

Dublin,

D22 P3K7,

Ireland

Manufacturer

Balkanpharma-Dupnitsa AD

3, Samokovsko Shosse Str.

Dupnitza 2600

Bulgaria

Date of last revision of this leaflet:April 2023

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