Flusenide 20 mg tablets
SpainTable of Contents
Patient Information Leaflet
Introduction
Patient Information Leaflet
Flusemide 20 mg tablets
Nicardipine 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, ask your doctor or pharmacist.
- This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
Leaflet Contents
- What Flusemide is and what it is used for
- What you need to know before taking Flusemide
- How to take Flusemide
- Possible adverse effects
- How to store Flusemide
- Contents of the pack and other information
1. What Flusemide is and what it is used for
Nicardipine hydrochloride, the active substance in Flusemide, is a drug belonging to the group of calcium antagonists that acts on blood vessels by relaxing smooth muscle. It also increases blood flow at the cerebral level.
This medicine is indicated for:
- Treatment of essential, mild to moderate arterial hypertension (high blood pressure).
- Prevention and treatment of cerebral ischemia (reduced blood supply) due to cerebral infarction.
- Prevention of neuronal damage caused by constriction of cerebral blood vessels following hemorrhage.
2. What you need to know before taking Flusemide
Do not take Flusemide:
- if you are allergic to nicardipine or to any of the other components of this medicine (listed in section 6).
- if you have recently had cerebral hemorrhage.
- if you have intracranial hypertension (increased pressure inside the skull).
- if you are pregnant or breastfeeding.
- if you have advanced aortic stenosis (abnormal narrowing of the opening of one of the heart valves).
- if you are under 18 years of age.
Warnings and precautions
Consult your doctor or pharmacist before starting to take Flusemide.
If you experience pain within 30 minutes after starting treatment or after increasing the dose, stop taking this medicine.
Immediate relief of chest pain during an acute or sudden angina attack should be treated with a different type of medication.
This medicine should be used with caution (e.g., close monitoring at the start of treatment) in:
- patients with heart problems,
- patients with liver and/or kidney problems,
- elderly patients,
- patients who have had a stroke (cerebral infarction or hemorrhage).
If you are scheduled to undergo any diagnostic tests (including blood or urine tests, etc.), inform your doctor that you are taking/using this medicine, as it may alter test results.
Children and adolescents
This medicine is contraindicated in individuals under 18 years of age.
Taking Flusemide with other medicines
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Some medicines may interact with this medicine, requiring a dose adjustment or discontinuation of one of the treatments.
Cimetidine (used for gastric ulcers) increases plasma levels of nicardipine.
Caution should be exercised when carbamazepine (used for epilepsy) and nicardipine are administered together.
This medicine may be used in combination with other drugs for the treatment of high blood pressure (beta-blockers, diuretics), but the possibility of an additive effect leading to postural hypotension (a drop in blood pressure when sitting up after lying down or standing up after sitting) should be considered.
Elevated levels of cyclosporine (used as an immunosuppressant) have been reported when used concomitantly with nicardipine.
Concomitant administration of nicardipine and digoxin (used to treat certain heart conditions) may increase the effects of digoxin.
Rifampicin (used to treat certain infectious diseases) may substantially reduce plasma levels of nicardipine; therefore, the combined use of rifampicin and nicardipine should be done with caution.
In particular, inform your doctor if you are taking other medicines to control the body's immune system, such as cyclosporine, tacrolimus, or sirolimus.
Taking Flusemide with food, drinks, and alcohol
Nicardipine may be taken independently of meals, except as indicated in section 3.
Use in pregnant or breastfeeding women
This medicine must not be used during pregnancy.
Cases of acute pulmonary edema (abnormal accumulation of fluid in the lungs) have been reported when nicardipine is used during pregnancy.
This medicine must not be used during breastfeeding.
Driving and using machines
This medicine should be used with caution in patients whose activities require alertness and who have experienced dizziness during treatment with this drug. For this reason, especially at the beginning of treatment, caution is advised when driving vehicles or operating machinery, or such activities should be avoided until the response to the medicine is satisfactory.
Flusemide contains lactose
This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him/her before taking this medicine.
3. How to take Flusemide
Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
The dose must be adjusted individually according to the therapeutic response achieved in each patient.
Treatment of essential arterial hypertension
The recommended dose for the treatment of essential hypertension is 1 tablet of 20 mg three times daily, which may be increased to a dose of 30 mg three times daily. Before increasing the dose, three days should elapse at the initial dose to achieve stable plasma concentrations.
A dose of 30 mg cannot be administered with this medicine.
Prevention and treatment of ischemia due to cerebral infarction
The recommended dose for the prevention and treatment of ischemia following cerebral infarction is 20 to 30 mg three times daily.
A dose of 30 mg cannot be administered with this medicine.
Prevention of neuronal damage due to constriction of cerebral blood vessels following hemorrhage
The prevention of neurological deterioration caused by cerebral vasospasm after subarachnoid hemorrhage is 120 mg daily (2 tablets of 20 mg three times daily), which may subsequently be reduced to 1 tablet of 20 mg three times daily.
The tablet score is intended solely for ease of breaking the tablet and facilitating swallowing, but not for dividing it into equal doses.
The tablets of this medicine must be swallowed whole, without chewing, with sufficient liquid, but not with grapefruit juice. They may be taken during or between meals, but administration with fatty foods is not recommended.
If you take more Flusemide than you should
In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.
If you forget to take Flusemide
Do not take a double dose to make up for missed doses.
If you stop taking Flusemide
When treatment with nicardipine is discontinued prematurely, your original symptoms may return. Therefore, take this medicine for as long as your doctor prescribes, even if your symptoms have disappeared. Always consult your doctor if you decide to stop treatment.
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.
Uncommon adverse effects (may affect up to 1 in 100 patients):
Palpitations, hypotension, fluid accumulation in arms and legs (peripheral edema), dizziness, headache (cephalalgia), somnolence, insomnia, nausea, gastric discomfort, constipation, diarrhea, increased salivation, feeling of weakness (asthenia), suffocation, frequent urination.
Rare adverse effects (may affect up to 1 in 1,000 patients):
Increased liver enzymes.
Adverse effects of unknown frequency (cannot be estimated from available data):
Abnormal fluid accumulation in the lungs (acute pulmonary edema), abnormally low platelet count (thrombocytopenia); flushing and anaphylactic reaction.
Reporting of 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 leaflet. You may also report them directly via the Spanish Pharmacovigilance System for 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 Flusemide
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton 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 unused medicines and their containers at the SIGRE Point located at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of medicines and containers you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Flusemide
- The active substance is nicardipine hydrochloride.
- The other components are lactose, corn starch, microcrystalline cellulose, colloidal silicon dioxide, povidone, and magnesium stearate.
Appearance of the product and contents of the pack
Light yellow, round, scored tablets.
Available in packs of 30 or 60 tablets.
Only certain pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Laboratorios Q Pharma S.L.
C/ Portugal 27, Entlo C
Alicante 03003 Spain
Date of the most recent review of this leaflet: April 2020
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/