NERDIPINA RETARD 40 mg PROLONGED-RELEASE HARD CAPSULES

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Nerdipina Retard 40 mg prolonged-release hard capsules

Nicardipine Hydrochloride

Contents of the pack:

1. What is Nerdipina Retard and what is it used for
2. What you need to know before you take Nerdipina Retard
3. How to take Nerdipina Retard
4. Possible side effects.
5. Storage of Nerdipina Retard
6. Contents of the pack and further information

1. What is Nicardipina Retard and what is it used for

Nerdipina Retard contains the active substance nicardipine (as hydrochloride) which belongs to a group of medicines called dihydropyridine derivatives. Nicardipine is a potent vasodilator that decreases total peripheral resistance and reduces blood pressure.

Nerdipina Retard is indicated for:

• Treatment of essential, moderate or mild arterial hypertension
• Prevention and treatment of ischemia due to cerebral infarction or its sequelae
• Prevention of neurological deterioration caused by cerebral vasospasm secondary to subarachnoid hemorrhage

2. What you need to know before you take Nerdipina Retard

Do not take Nerdipina Retard:

• If you are allergic (hypersensitive) to nicardipine or any of the other ingredients of this medicine (listed in section 6)
• If you have recently suffered from cerebral hemorrhage
• If you have intracranial hypertension
• If you have advanced aortic stenosis

Warnings and precautions:

Consult your doctor, pharmacist, or nurse before taking Nerdipina Retard:

• If you have liver and/or kidney problems. It is advisable to discontinue treatment if liver or kidney function parameters are altered during treatment.
• If ischemic pain (angina pectoris) appears within 30 minutes after taking the medicine, treatment should be discontinued.
• When nicardipine is used to replace treatment with β-blockers (another group of medicines used to treat hypertension), they should not be discontinued abruptly.

Children and adolescents

Children and adolescents under 18 years of age should not take Nerdipina Retard.

Use of Nerdipina Retard with other medicines

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

Nicardipine should not be administered with other vasodilators to avoid additive effects. Caution should be exercised when administering with other antihypertensive medicines.

Certain medicines, such as cimetidine, may increase nicardipine plasma levels, so patients receiving these two drugs simultaneously should be carefully monitored.

Concomitant administration of nicardipine and digoxin is not recommended, as it may increase the effects of digoxin.

In particular, inform your doctor if you are using other medicines to control the body's immune system, such as cyclosporin, tacrolimus, or sirolimus.

Nicardipine increases cyclosporin plasma concentrations, so cyclosporin plasma concentrations should be monitored and the dose of cyclosporin reduced accordingly.

Pregnancy and breastfeeding

If you are pregnant, breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

If you are pregnant, consult your doctor before taking nicardipine. No studies have been conducted in pregnant women, so its use will only be done if the doctor considers it necessary.

It is not recommended to take this medicine during breastfeeding, as it has been observed to pass into breast milk.

Driving and using machines

Nerdipina Retard is a hypotensive agent, so it may alter reaction capacity, which should be taken into account when driving or operating machinery.

The effect is increased if taken simultaneously with alcohol.

Nerdipina Retard contains sucrose.

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

3. How to take Nerdipina Retard

Follow exactly the administration instructions of this medicine indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The capsules should be swallowed whole, without chewing.

The dose will be adjusted individually for each patient according to the therapeutic response obtained.

Arterial hypertension

The initial dose is 1 capsule of 40 mg twice a day, which can be increased to 1 capsule of 40 mg three times a day.

Before increasing the dose, at least three days should pass with the initial dose to achieve stable plasma concentrations.

If necessary, nicardipine can be administered with diuretics or β-blockers.

Ischemia due to cerebral infarction

The recommended dose is 1 capsule of 40 mg twice a day.

Prevention of neurological deterioration caused by cerebral vasospasm after subarachnoid hemorrhage

An initial dose of 120 mg per day (1 capsule of 40 mg three times a day) is recommended. Subsequently, the dose can be reduced to 80 mg per day (1 capsule of 40 mg twice a day).

Use in the elderly

It should be administered with caution. It is recommended to start treatment with 1 capsule of 40 mg once a day. According to the response, the dose can be modified, maintaining adequate monitoring.

Renal insufficiency

It is recommended to start treatment with a dose of 1 capsule of 40 mg twice a day, adjusting the dosage subsequently according to the response obtained.

Hepatic insufficiency

It is recommended to start treatment with a dose of 1 capsule of 40 mg once a day. According to the response, the dose can be modified, but maintaining adequate monitoring. It should be administered carefully in patients with altered liver function.

If you take more Nerdipina Retard than you should

If you have taken more than you should, consult your doctor, pharmacist, or call the Toxicology Information Service. Telephone (91) 562 04 20 indicating the medicine and the amount taken.

In case of overdose, hypotension, bradycardia, palpitations, flushing, dizziness, confusion, and stuttering speech may appear.

In case of overdose, cardiac and respiratory functions should be monitored, and medical attention should be sought immediately.

If you forget to take Nerdipina Retard

Do not take a double dose to make up for forgotten doses.

If you stop taking Nerdipina Retard

Do not stop treatment before consulting your doctor. Your doctor will indicate the duration of your treatment with Nerdipina Retard.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Possible side effects are listed below by frequency:

Common side effect (may affect up to 1 in 10 people): flushing

Uncommon side effects (may affect up to 1 in 100 people):

Dizziness, headache, somnolence, insomnia, palpitations, hypotension, edema of lower limbs, nausea, epigastric pain, constipation, diarrhea, frequent salivation, frequent urination, asthenia, shortness of breath, weakness.

Rare side effects (may affect up to 1 in 1,000 people):

Transient elevations of renal function (BUN, creatinine) and elevation of liver enzymes.

Frequency not known (frequency cannot be estimated from the available data):

Acute pulmonary edema (abnormal accumulation of fluid in the lungs), thrombocytopenia (decrease in platelet count), and allergic reaction.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines (https://www.notificaram.es). By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Nerdipina Retard

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

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date is the last day of the month stated.

Store below 30°C

Store in the original package to protect from light and moisture

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 Nerdipina Retard

• The active substance is nicardipine hydrochloride*. Each capsule contains 40 mg of nicardipine hydrochloride.
• The other ingredients are: sucrose, copolymer of polymethacrylic acid and acrylic acid esters, polysorbate 80 (E433), polyethylene glycol 400 (E1521), polyethylene glycol 6000 (E1521), talc (E553b), hydroxypropylmethylcellulose (E464), and copolymer of acrylic acid and methacrylic acid with quaternary ammonium groups.
• The capsule shell contains: gelatin, titanium dioxide (E171), and edible black ink (contains shellac (E904), anhydrous alcohol (E1510), isopropyl alcohol, butyl alcohol, propylene glycol (E1520), strong ammonia solution, and red iron oxide (E172)).

*Nicardipine hydrochloride. Astellas Pharma Inc-Japan.

Appearance of the product and pack contents

Nerdipina Retard capsules are white opaque and marked with "40" and "LT 545" in black ink. They are available in packs of 60 capsules.

Marketing authorization holder

FERRER INTERNACIONAL, S.A.

Gran Vía Carlos III, 94

08028 Barcelona (Spain)

Manufacturer

FERRER INTERNACIONAL, S.A.

Joan Buscalla, 1-9.

08173 Sant Cugat del Vallés (Barcelona).

Date of last revision of this leaflet:July 2017

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/