BARNIX 10 mg PROLONGED-RELEASE HARD CAPSULES

2. What you need to know before you take Barnix

Do not take Barnix

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

Warnings and precautions

Talk to your doctor or pharmacist before taking 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 medicines

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 Barnix:

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

Also, inform your doctor if you are taking:

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

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

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 the ability to drive or use machines. However, since Barnix may cause dizziness, you should know how this medicine affects you before driving or using machines.

Barnix 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 Barnix

Dosage

Follow exactly the administration instructions of this medicine given by your doctor. In case of 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 start 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 increase of 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 forgotten doses, and continue with the usual schedule once daily.

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, inform your doctor or nurse immediately.

Barnix may cause:

Very common: affects 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

Unknown: 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).

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are 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 Barnix

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

Do not store above 25°C.

Do not use Barnix after the expiry date stated on the pack after EXP. The expiry date is the last day of the month indicated.

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 Barnix

• The active substance is 10 mg of barnidipine hydrochloride, equivalent to 9.3 mg of barnidipine per capsule.

• The other ingredients (excipients) are:

Capsule content: carboxymethyl ethylcellulose, polysorbate 80, sucrose, ethylcellulose, 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 packaging

The capsules are yellow.

Barnix 10 is marked with the code 10 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 medicine is authorized in the Member States of the European Economic Area under the following names:

Spain: Barnix

Netherlands: Cyress

Date of last revision of this leaflet: June 2025

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