Barnix 10 mg modified-release hard capsules
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
Barnix 10 mg modified-release hard capsules
Barnidipine hydrochloride
Read the entire leaflet carefully before you start taking this medicine, because 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 medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet.
Leaflet contents
- What Barnix is and what it is used for
- What you need to know before taking Barnix
- How to take Barnix
- Possible side effects
- How to store Barnix
- Contents of the pack and other information
1. What Barnix is and what it is used for
The active substance in Barnix belongs to a group of medicines called calcium antagonists. Barnix causes dilation of blood vessels, resulting in a reduction of blood pressure. Barnix capsules are an extended-release formulation. This means that the active substance is gradually absorbed into the body and has a prolonged effect. For this reason, once-daily dosing is sufficient.
Barnix is used for the treatment of high blood pressure.
2. What you need to know before taking Barnix
Do not take Barnix
-
if you are allergic to barnidipine or to any of the other components 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 forms 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 starting Barnix
- if you have kidney disease.
- if you have heart disease.
Children and adolescents
Barnix must not be used in children or adolescents under 18 years of age.
Taking Barnix with other medicines
Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
It is especially important to inform your doctor if you are taking any of the following medicines, as they must not be used together 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 food and alcohol
Take special care 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 are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
You should not use Barnix during pregnancy unless clearly necessary.
You must not use Barnix while breastfeeding. Barnidipine may pass into breast milk.
Driving and using machines
There is no information suggesting that Barnix affects the ability to drive or use machines. However, since Barnix may cause dizziness/vertigo, you should know how this medicine affects you before driving or operating machinery.
Barnix contains sucrose. If your doctor has informed you of an intolerance to certain sugars, consult with him before taking this medicine.
3. How to take Barnix
Dosage
Follow exactly the instructions given by your doctor for taking this medicine. If you are unsure, consult your doctor or pharmacist.
The recommended starting dose is 1 capsule of Barnix 10 mg once daily. During treatment, your doctor may recommend increasing the dose to one capsule of Barnix 20 mg once daily or two capsules of Barnix 10 mg once daily.
If you are elderly, you may 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 advisable to associate taking the capsule with a daily routine activity, such as brushing your teeth or having breakfast.
- Swallow the capsule whole, preferably with a glass of water. Barnix may be taken before, during, or after meals, according to your preference.
- Even if you do not feel signs or symptoms of high blood pressure, it is important to continue taking Barnix every day to obtain the full 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 contact your doctor or go to the emergency room. Possible symptoms of overdose include weakness, slowed or increased heartbeat, drowsiness, confusion, nausea, vomiting, and seizures.
In case of overdose or accidental ingestion, contact the Toxicology Information Service at telephone (91) 562 04 20.
If you forget to take Barnix
If you forget to take your dose of Barnix at your 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; continue with your usual once-daily schedule.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
If you experience a severe allergic reaction causing difficulty breathing or dizziness, you must inform your doctor or nurse immediately.
Barnix may cause the following:
Very common: affects more than 1 in 10 people
- headache
- facial flushing
- fluid accumulation (edema) in arms and legs
Common: may affect up to 1 in 10 people
- dizziness
- palpitations
Not known: frequency cannot be estimated from available data
- rapid heartbeat
- blood tests showing changes in liver function
- rash
These adverse effects tend to decrease or disappear during treatment (within one month for fluid accumulation and within two weeks for facial flushing, headache, and palpitations).
Reporting of adverse effects
If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: http://www.notificaram.es. By reporting adverse 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 packaging after EXP. The expiry date refers to the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of unused medicines and their containers. This will help protect the environment.
6. Contents of the pack and other information
Composition of Barnix
-
The active substance is 10 mg of barnidipine hydrochloride, equivalent to 9.3 mg of barnidipine per capsule.
-
The other components (excipients) are:
Capsule contents: 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), ammonia.
Appearance of the product and contents of the pack
The capsules are yellow.
Barnix 10 bears 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). Only certain 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 medicinal product is authorized in the European Economic Area member states under the following names:
Spain: Barnix
Netherlands: Cyress
Date of the most recent review of this leaflet: June 2025
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/