BARNIDIPINE SWANPOND INVESTMENTS 10 mg PROLONGED-RELEASE HARD CAPSULES

Introduction

Leaflet: Information for the Patient

Barnidipine Swanpond Investments 10 mg Hard Capsules of Modified Release EFG

barnidipine hydrochloride

Read this leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the Leaflet

1. What is Barnidipine Swanpond Investments and what is it used for
2. What you need to know before taking Barnidipine Swanpond Investments
3. How to take Barnidipine Swanpond Investments
4. Possible side effects
5. Storage of Barnidipine Swanpond Investments
6. Package contents and additional information

1. What is Barnidipine Swanpond Investments and what is it used for

The active ingredient of barnidipine belongs to a group of medications called calcium antagonists. Barnidipine causes a dilation of blood vessels, which leads to a reduction in blood pressure. Barnidipine capsules are a prolonged-release form. This means that the active ingredient 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 taking Barnidipine Swanpond Investments

Do not take Barnidipine Swanpond Investments

• if you are allergic to barnidipine or any of the other components of this medication (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 forms of chest pain (unstable angina) or acute heart attack.

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take 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 of age.

Other medications and Barnidipine Swanpond Investments

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

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

• Protease inhibitors (medications used for the treatment of AIDS).
• Ketoconazole or itraconazole (medications used for the treatment of fungal infections).
• Erythromycin or clarithromycin (antibiotics).

Also, inform your doctor if you are taking:

• Other medications used for the treatment of high blood pressure, as they may cause additional blood pressure reduction.
• Cimetidine (medication used for the treatment of stomach problems) as it may increase the effects of barnidipine.

• Phenytoin or carbamazepine (medications used for the treatment of epilepsy) or rifampicin (an antibiotic) as higher doses of barnidipine may be needed. If you stop treatment with these medications, your doctor may reduce your dose of barnidipine.

Taking Barnidipine Swanpond Investments with beverages 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 plan to become pregnant, consult your doctor or pharmacist before using this medication.

You should not use barnidipine during pregnancy unless clearly necessary.

You should not use 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, since barnidipine may cause dizziness, you should know how this medication affects you before driving or using machines.

Excipients:

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

3. How to take Barnidipine Swanpond Investments

Dosage

Follow exactly the administration instructions of this medication indicated by your doctor. In case of doubt, consult 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. It is likely that your doctor will 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 obtain 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 room. 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 Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Barnidipine Swanpond Investments

If you forgot 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 other questions about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone experiences 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:

Very common: affects more than 1 in 10 people

• headache
• flushing of the face
• 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 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 of the face, headache, and palpitations).

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: http://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Barnidipine Swanpond Investments

Keep this medication out of sight and reach of children.

Do not store above 25°C.

Do not use this medication after the expiration date shown on the box and blister after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Barnidipine Swanpond Investments

• The active ingredient is 10 mg of barnidipine hydrochloride.
• The other components (excipients) are:

Contents of the capsule:sugar spheres (contains sugar syrup, cornstarch, 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 of the product and package contents

Hard gelatin capsules filled with yellow to yellowish granules. The cap is yellow, marked with "1000" in black ink. Body yellow marked with "0010" in black ink.

Barnidipine Swanpond Investments hard capsules of modified release EFG are presented in packages containing 28 and 56 capsules in OPA/Al/PVC - Aluminum blisters.

Marketing authorization holder and manufacturer

Marketing authorization 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 the last revision of this leaflet:April 2023

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