Nerdipina Retard 40 mg prolonged-release hard capsules
SpainTable of Contents
Package Leaflet: Information for the User
Introduction
PACKAGE LEAFLET: INFORMATION FOR THE USER
Nerdipina Retard 40 mg prolonged-release hard capsules
Nicardipine Hydrochloride
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
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Package leaflet:
- What Nerdipina Retard is and what it is used for
- What you need to know before taking Nerdipina Retard
- How to take Nerdipina Retard
- Possible side effects
- How to store Nerdipina Retard
- Contents of the pack and other information
1. What Nicardipine Retard is and what it is used for
Nicardipine 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.
Nicardipine Retard is indicated for:
- The treatment of mild to moderate essential arterial hypertension
- The prevention and treatment of ischemia due to cerebral infarction or its sequelae
- The prevention of neurological deterioration caused by cerebral vasospasm secondary to subarachnoid hemorrhage
2. What you need to know before taking Nerdipina Retard
Do not take Nerdipina Retard:
- If you are allergic (hypersensitive) to nicardipine or to any of the other ingredients of this medicine (listed in section 6)
- If you have recently suffered cerebral hemorrhage
- If you have intracranial hypertension
- If you have advanced aortic stenosis
Warnings and precautions:
Consult your doctor, pharmacist, or nurse before starting to take Nerdipina Retard:
- If you have liver and/or kidney impairment. It is advisable to discontinue treatment if abnormalities in liver or kidney function parameters occur during therapy.
- If ischemic pain (angina pectoris) occurs within 30 minutes after taking the medicine, treatment must be interrupted.
- When nicardipine is used to replace treatment with β-blockers (another group of medicines used to treat hypertension), these should not be stopped abruptly.
Children and adolescents
Nerdipina Retard must not be taken by children and adolescents under 18 years of age.
Use of Nerdipina Retard with other medicines
Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Nicardipine must not be administered together with other vasodilators to avoid additive effects. Caution should be exercised when administering it concomitantly with other antihypertensive medicines.
Certain medicines, such as cimetidine, may increase plasma levels of nicardipine; therefore, patients receiving both drugs simultaneously should be carefully monitored.
The concomitant administration of nicardipine and digoxin is not recommended, as it may lead to increased effects of digoxin.
In particular, inform your doctor if you are taking other medicines that affect the body's immune system, such as cyclosporine, tacrolimus, or sirolimus.
Nicardipine increases plasma concentrations of cyclosporine; therefore, plasma levels of cyclosporine should be monitored and its dose adjusted accordingly.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.
If you are pregnant, consult your doctor before taking nicardipine. Studies in pregnant women have not been conducted; therefore, it should only be used if, in the doctor’s judgment, it is necessary.
This medicine is not recommended during breastfeeding, as it has been shown to pass into breast milk.
Driving and using machines
Nerdipina Retard is a hypotensive medicine and may therefore impair reaction ability, which should be taken into account if you need to drive or operate machinery.
The effect is intensified if alcohol is consumed simultaneously.
Nerdipina Retard contains sucrose.
This medicine contains sucrose. If your doctor has informed you of an intolerance to certain sugars, consult him before taking this medicine.
3. How to take Nerdipina Retard
Follow exactly the administration instructions for this medicine provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
The capsules must be swallowed whole, without chewing.
The dose will be individually adjusted for each patient according to the therapeutic response obtained.
Hypertension
The initial dose is 1 capsule of 40 mg twice daily, which may be increased to 1 capsule of 40 mg three times daily.
At least three days should elapse at the initial dose before increasing it, in order to achieve stable plasma concentrations.
If considered necessary, nicardipine may be administered concomitantly with diuretics or β-blockers.
Cerebral ischemia due to stroke
The recommended dose is 1 capsule of 40 mg twice daily.
Prevention of neurological deterioration due to cerebral vasospasm following subarachnoid hemorrhage
An initial dose of 120 mg daily (1 capsule of 40 mg three times daily) is recommended. Subsequently, the dose may be reduced to 80 mg daily (1 capsule of 40 mg twice daily).
Use in the Elderly
It should be administered with caution. Treatment should be initiated with 1 capsule of 40 mg once daily. According to the response, the dosage may be adjusted, maintaining adequate monitoring.
Renal Impairment
It is recommended to initiate treatment with a dose of 1 capsule of 40 mg twice daily, subsequently adjusting the dosage according to the response obtained.
Hepatic Impairment
It is recommended to initiate treatment with a dose of 1 capsule of 40 mg once daily. According to the response, the dose may be modified, but with adequate monitoring. It should be administered carefully in patients with impaired liver function.
If you take more Nerdipina Retard than you should
If you have taken more than you should, consult your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number (91) 562 04 20, indicating the medicine and the amount taken.
In case of overdose, hypotension, bradycardia, palpitations, flushing, dizziness, confusion, and slurred speech may occur.
In case of overdosage, cardiac and respiratory functions should be monitored, and you should seek immediate medical attention.
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 discontinue treatment before consulting your doctor. Your doctor will advise you on the duration of your treatment with Nerdipina Retard.
If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
The possible adverse effects are listed below according to their frequency.
Frequent adverse effect (May affect up to 1 in 10 patients): redness
Uncommon adverse effects (May affect up to 1 in 100 patients):
Dizziness, headache, somnolence, insomnia, palpitations, hypotension, edema of the lower limbs, nausea, epigastric pain, constipation, diarrhea, increased salivation, frequent urination, asthenia, suffocation, weakness.
Rare adverse effects (May affect up to 1 in 1000 patients):
Transient elevations in renal function (BUN, creatinine) and increased 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 the number of platelets), and allergic reaction.
Reporting of 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 leaflet. You may also report them directly through the Spanish System for Pharmacovigilance of Human Medicines (https://www.notificaram.es ). By reporting adverse 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 stated on the packaging after EXP. The expiry date is the last day of the month indicated.
Store below 30°C.
Keep in the original packaging to protect from light and moisture.
Medicines must not be disposed of via wastewater or household waste. Unused medicines and their containers should be taken to the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This helps protect the environment.
6. Package contents and other information
Composition of Nerdipina Retard
- The active substance is nicardipine hydrochloride*. Each capsule contains 40 mg of nicardipine hydrochloride.
- The other components are: Sucrose, polymethacrylic acid copolymer and acrylic acid esters, polysorbate 80 (E433), polyethylene glycol 400 (E1521), polyethylene glycol 6000 (E1521), talc (E553b), hydroxypropylmethylcellulose (E464), and acrylic-methacrylic acid copolymer with quaternary ammonium groups.
- The capsule shell contains: gelatin, titanium dioxide (E171), and edible black ink (containing shellac (E904), dehydrated 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 contents of the container
Nerdipina Retard capsules are opaque white and marked with “ 40” and “LT 545” in black ink. They are supplied 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 the most recent revision of this leaflet: July 2017
Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/