BARNIX 20 mg PROLONGED-RELEASE HARD CAPSULES

2. What you need to know before taking Barnix

Do not take Barnix

• 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 to treat 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 medications: protease inhibitors (medications used to treat AIDS), ketoconazole or itraconazole (medications used to treat fungal infections), erythromycin or clarithromycin (antibiotics).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Barnix

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

Children and adolescents

Barnix should not be used in children or adolescents under 18 years of age.

Using Barnix with other medications

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

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

• Protease inhibitors (medications used to treat AIDS).
• Ketoconazole or itraconazole (medications used to treat fungal infections).
• Erythromycin or clarithromycin (antibiotics).

Also, inform your doctor if you are taking:

• Other medications used to treat high blood pressure, as they may cause additional blood pressure reduction.
• Cimetidine (a medication used to treat stomach problems) as it may increase the effects of Barnix.

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

Taking Barnix with drinks and alcohol

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

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 Barnix during pregnancy unless clearly necessary.

You should not use Barnix during breastfeeding. Barnidipine may pass into breast milk.

Driving and using machines

There is no information to suggest that Barnix affects your ability to drive or use machines. However, since Barnix may cause dizziness, you should know how this medication affects you before driving or using machines.

Barnix 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 Barnix

Dosage

Follow the instructions for administration of this medication exactly as indicated by your doctor. If in doubt, consult your doctor or pharmacist.

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

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

Instructions for proper use

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

If you take more Barnix 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. Possible symptoms of overdose include weakness, slowing or increased heart rate, drowsiness, confusion, nausea, vomiting, and convulsions.

In case of overdose or accidental ingestion, contact the Toxicology Information Service, phone (91) 562 04 20.

If you forget to take Barnix

If you forgot to take your dose of Barnix 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 daily.

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.

Barnix 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

Unknown: 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 package 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 help provide more information on the safety of this medication.

5. Storage of Barnix

Keep this medication out of sight and reach of children.

Do not store above 25°C.

Do not use Barnix after the expiration date stated on the packaging 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 any unused medications at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Barnix

• The active substance is 20 mg of barnidipine hydrochloride, equivalent to 18.6 mg of barnidipine per capsule.

• The other components (excipients) are:

Capsule content: carboxymethyl ethyl cellulose, polysorbate 80, sucrose, ethyl cellulose, and talc

Capsule components: titanium dioxide (E171), yellow iron oxide (E172), and gelatin

Printing ink: shellac, propylene glycol (E1520), black iron oxide (E172), and ammonia

Appearance and package contents

The capsules are yellow.

Barnix 20 bears the code 20 LT155.

Barnix capsules are available in packs containing 10, 14, 20, 28, 30, 50, 56, 98, or 100 capsules in aluminum-aluminum blisters (with a PVC and polyamide coating). Not all pack sizes may be marketed.

Marketing authorization holder

Laboratorios BIAL, S.A.

C/ Alcalá 265, Edificio 2, Planta 2ª

28027 Madrid

SPAIN

Manufacturer

Delpharm Novara s.r.l.

Via Crosa 86

28065 Cerano (NO), Italy

This medication is authorized in the Member States of the European Economic Area under the following names:

Spain: Barnix

Netherlands: Cyress

Date of the last revision of this package leaflet: June 2025

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