Package Insert: Information for the Patient

Barnix20 mg Modified-Release Hard Capsules

Barnidipine Hydrochloride

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

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, 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 any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert.

1. What is Barnix and how is it used

2. What you need to know before starting to take Barnix

3. How to take Barnix

4. Possible adverse effects

5. Storage of Barnix

6. Contents of the package and additional information

The active ingredient of Barnix belongs to a group of medications called calcium antagonists.Barnix causes a dilation of blood vessels, which leads to a reduction in blood pressure. Barnix capsules are a prolonged-release form. This means that the active ingredient is absorbed by the body gradually and has a longer-lasting effect. This is why taking a daily dose is sufficient.

Barnixis used for the treatment of high blood pressure.

Do not take Barnix

• if you are allergic to barnidipine or any of the other ingredients in 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, unstable angina or acute heart attack.

• if you are taking any of the following medications: protease inhibitors (used to treat HIV), ketoconazole or itraconazole (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 cannot be used in children or adolescents under 18 years old.

Use of Barnix with other medications

Inform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medication.

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

• Protease inhibitors (used to treat HIV).
• Ketoconazole or itraconazole (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 (used to treat stomach problems) as it may increase the effects of Barnix.

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

Taking Barnix with beverages 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, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

You should not use Barnix during pregnancy unless it is clearly necessary.

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

Driving and operating machinery

There is no information to suggest that Barnix affects the ability to drive or operate machinery. However, as Barnix may cause dizziness/dizziness, you should know how this medication may affect you before driving or operating machinery.

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

Dosage

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

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

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 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. Barnix can be taken before, during, or after meals as you prefer.
• Even if you do not feel the signs or symptoms of high blood pressure, it is essential 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 amount of capsules at once, you should immediately consult with your doctor or someone should take you to the emergency room. Possible symptoms of overdose include weakness, slowness, or increased heart rate, drowsiness, confusion, nausea, vomiting, and seizures.

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

If You Forget to Take Barnix

If you forget to take your dose of Barnix, take it as soon as you remember at your usual time. If more than 24 hours have passed, do not take a double dose to compensate 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.

Like all medications, this medication may produce adverse effects, although not everyone will experience them.

If you experience a severe allergic reaction that causes difficulty breathing or dizziness, you must inform your doctor or nurse immediately.

Barnix may cause the following:

Very frequent: affects more than 1 in 10 people

• Headache
• Flushing of the face
• Fluid accumulation (edema) in arms and legs,

Frequent: may affect up to 1 in 10 people

• Dizziness
• Palpitations

Unknown: the frequency cannot be estimated from available data

• Accelerated heart rate
• Blood tests showing changes in liver function
• Rash

These adverse 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 Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:http://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

Do not store at a temperature above 25?°C.

Do not use Barnix after the expiration date that appears on the packaging after CAD.The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Barnix

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

• The other components (excipients) are:

Contents of the capsule: carboxymethylcellulose, polisorbate 80, sucrose, ethylcellulose, and talc,

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

Ink for printing: shellac, propylene glycol (E1520), black iron oxide (E172), and ammonia.

Appearance of the product and contents of the packaging

The capsules are yellow.

Barnix 20 carries the code 155 20.

Barnix capsules are presented in packaging containing 10, 14, 20, 28, 30, 50, 56, 98, or 100 capsules in aluminum-aluminum blister (with a PVC and polyamide coating). Some packaging sizes may only be commercially available.

Marketing Authorization Holder

Laboratorios BIAL, S.A .

C/ Alcalá 265, Edificio 2, Planta 2ª

28027 Madrid

SPAIN

Responsible for manufacturing

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 with the following names:

Spain: Barnix

Netherlands: Cyress

Last review date of this leaflet: October 2019

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