PATIENT INFORMATION LEAFLET

Nerdipina Retard 40 mg prolonged-release hard capsules

Nicardipine Hydrochloride

Nicardipina Retard contains the active ingredient nicardipine (as hydrochloride) which belongs to a group of medications known as dihydropyridine derivatives. Nicardipine is a potent vasodilator that decreases peripheral total resistance and reduces blood pressure.

Nicardipina Retard is indicated for:

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

.

Do not take Nerdipina Retard:

• If you are allergic (hypersensitive) to nicardipine or any of the other components of this medication (listed in section 6)
• If you have recently suffered from cerebral hemorrhages
• If you have endocranial hypertension
• If you have advanced aortic stenosis

Warnings and precautions:

Consult with your doctor, pharmacist, or nurse before starting to take Nerdipina Retard:

• If you have liver and/or kidney impairment. It is advisable to suspend treatment if, during the same, alterations in liver or kidney function parameters appear,
• If angina pectoris (ischemic pain) appears within 30 minutes of taking the medication, treatment should be interrupted,
• When nicardipine is used to substitute treatment with β-blockers (another group of medications used to treat hypertension), these should not be abruptly discontinued.

Children and adolescents:

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

Use of Nerdipina Retard with other medications:

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

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

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

The simultaneous administration of nicardipine and digoxin is not indicated, as it may cause an increase in digoxin effects.

Especially, inform your doctor if you are using other medications to control the body's immune system, such as ciclosporin, tacrolimus, or sirolimus.

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

Pregnancy and lactation:

If you are pregnant, or in a lactation period, or think you may be pregnant, or intend to become pregnant, consult your doctor, or pharmacist before using this medication.

If you are pregnant, consult your doctor before taking nicardipine. No studies have been conducted in pregnant women, so its use will only be carried out if, in the doctor's opinion, it is necessary.

This medication is not recommended during lactation, as it has been observed to pass into breast milk.

Driving and operating machinery:

Nerdipina Retard is a hypotensive medication, which may alter reaction time, and this should be taken into account if you need to drive or operate machinery.

The effect is intensified if taken simultaneously with alcohol.

Nerdipina Retard contains saccharose.

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

Follow exactly the administration instructions of this medication 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.

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 be able to achieve stable plasma concentrations.

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

Cerebral ischemia after stroke

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

Prevention of neurological deterioration caused by cerebral vasospasm after subarachnoid hemorrhage

A recommended initial dose of 120 mg per day (1 capsule of 40 mg three times a day) is suggested. The dose can then 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 following this dosage regimen, maintaining adequate monitoring.

Renal insufficiency

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

Liver insufficiency

It is recommended to start treatment with doses of 1 capsule of 40 mg once a day. According to the response, it 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 Toxicological Information Service immediately. Telephone (91) 562 04 20 indicating the medication 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 you should see your doctor quickly.

If you forgot to take Nerdipina Retard

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with 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 other doubts about the use of this medication, ask your doctor, pharmacist, or nurse.

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

The possible adverse effects are listed below in accordance with their frequency.

Adverse effect frequent (may affect up to 1 in 10 patients): flushing

Adverse effects infrequent (may affect up to 1 in 100 patients):

Dizziness, headache, drowsiness, insomnia, palpitations, hypotension, lower limb edema, nausea, epigastric pain, constipation, diarrhea, frequent salivation, frequent urination, asthenia, dyspnea, weakness.

Adverse effects rare (may affect up to 1 in 1000 patients):

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

Unknown frequency (frequency cannot be estimated from available data):

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

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist or nurse, 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 Medicinal Products for Human Use (https://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 use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Store below 30°C

Store in the original packaging to protect it from light and humidity

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE Point of the pharmacy.In case of doubt, ask your pharmacist how to dispose of unused packaging and medications. This will help protect the environment.

Composition of Nerdipina Retard

• The active ingredient is nicardipine hydrochloride*. Each capsule contains 40 mg of nicardipine hydrochloride.
• The other components 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 coating 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 iron oxide red (E172)).

*Nicardipine chloride. Astellas Pharma Inc-Japan.

Appearance of the product and contents of the packaging

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

Holder of the marketing authorization.

FERRER INTERNACIONAL, S.A.

Gran Vía Carlos III, 94

08028 Barcelona (Spain)

Responsible for manufacturing

:

FERRER INTERNACIONAL, S.A.

Joan Buscalla, 1-9.

08173 Sant Cugat del Vallés (Barcelona).

Date of the last review of this leaflet:July 2017

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