Patient Information Leaflet

Flusemide 20 mg Tablets

Nicardipine Hydrochloride

Read this leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What is Flusemide and what it is used for

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

3. How to take Flusemide

4. Possible side effects

5. Storage of Flusemide

6. Contents of the pack and additional informational

The nicardipine hydrochloride, active ingredient of Flusemide, is a drug belonging to the group of calcium antagonists that acts at the level of blood vessels by relaxing smooth muscle. It also increases blood flow at the cerebral level.

This medication is indicated for:

• Treatment of essential, moderate, or mild essential hypertension (high blood pressure).
• Prevention and treatment of ischemia (decreased blood flow) due to cerebral infarction.
• Prevention of neuronal deterioration due to cerebral blood vessel contraction caused by hemorrhage.

Do not take Flusemide:

- if you are allergic to nicardipine or any of the other components of this medication (listed in section 6).

- if you have recently experienced cerebral hemorrhages.

- if you have hypertensive intracranial disease (increased pressure inside the skull).

- if you are pregnant or breastfeeding.

- if you have advanced aortic stenosis (abnormal narrowing of one of the heart valves).

- if you are under 18 years old.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Flusemide.

If you experience pain within 30 minutes of starting treatment or after increasing the dose, stop taking this medication.

Immediate relief of chest pain in an acute or sudden angina attack should be treated with a different type of medication.

This medication should be used with caution (e.g., closely monitor at the start of treatment) in:

• patients with heart problems,
• patients with liver and/or kidney problems,
• elderly patients,
• patients after suffering a stroke (infarction or cerebral hemorrhage).

Inform your doctor if you are to undergo any diagnostic tests (including blood and urine tests, etc...) as this medication may affect the results.

Children and adolescents.

This medication is contraindicated in patients under 18 years old.

Flusemide use with other medications

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

Some medications may interact with this medication, requiring a dose change or discontinuation of one of them.

Cimetidine (used for gastric ulcers) increases nicardipine plasma levels.

Care should be taken when administering carbamazepine (used for epilepsy) and nicardipine together.

This medication may be used in combination with other medications for the treatment of high blood pressure (beta-blockers, diuretics), but consider the possibility of a potential additive effect resulting in postural hypotension (a drop in blood pressure when standing after sitting or lying down.).

Elevated levels of ciclosporin (used as an immunosuppressant) have been reported in combination with nicardipine.

The simultaneous administration of nicardipine and digoxin (used for the treatment of certain heart diseases) may increase the effects of digoxin.

Rifampicin (used for the treatment of certain infectious diseases) may significantly reduce its plasma levels, so the combined use of rifampicin and nicardipine should be done with caution.

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

Flusemide use with food, drinks, and alcohol

Nicardipine can be taken regardless of meals, except as indicated in section 3.

Use in pregnant women or breastfeeding women

This medication should 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 medication should not be used during breastfeeding.

Driving and operating machinery

This medication should be used with caution in patients whose activity requires attention and who have observed dizziness during treatment with this medication. Therefore, especially at the beginning of treatment, it is recommended to exercise caution when driving vehicles or operating machinery, or not to perform these tasks until the response to the medication is satisfactory.

Flusemide contains lactose

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

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

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

Essential Hypertension Treatment

The recommended dose for the treatment of essential hypertension is 1 tablet of 20 mg three times a day, which can be increased to a dose of 30 mg three times a day. Before increasing the dose, three days must have passed with the initial dose to achieve stable plasma concentrations.

This medication cannot be administered at a dose of 30 mg.

Prevention and Treatment of Cerebral Ischemia

The recommended dose for the prevention and treatment of cerebral ischemia is 20 to 30 mg three times a day.

This medication cannot be administered at a dose of 30 mg.

Prevention of Neuronal Deterioration due to Cerebral Vessel Contraction caused by Hemorrhage

The prevention of neurological deterioration caused by cerebral vasospasm after subarachnoid hemorrhage is 120 mg per day (2 tablets of 20 mg three times a day), which can be subsequently reduced to 1 tablet of 20 mg three times a day.

The groove serves only to break the tablet and facilitate its intake, but not to divide into equal doses.

The tablets of this medication must be swallowed without chewing, with a sufficient amount of liquid but not with orange juice. They can be taken during or between meals, but it is not recommended to administer them with fatty foods.

If you take more Flusemide than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Flusemide

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

If you interrupt treatment with Flusemide

When treatment with nicardipine is abandoned prematurely, your original discomforts may return. Therefore, take this medication for the entire time your doctor prescribes it, even if your discomforts have disappeared. Always consult your doctor if you decide to discontinue treatment.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

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

Infrequent Adverse Effects(may affect up to 1 in 100 patients):

Palpitations, hypotension, peripheral edema, dizziness, headache (cephalalgia), drowsiness, insomnia, nausea, gastrointestinal discomfort, constipation, diarrhea, frequent salivation, feeling of weakness (asthenia), shortness of breath, frequent urination.

Rare Adverse Effects(may affect up to 1 in 1,000 patients):

Increased hepatic enzymes.

Adverse Effects of Unknown Frequency(cannot be estimated from available data):

Acute pulmonary edema, abnormally low platelet count (thrombocytopenia); redness and anaphylactic reaction.

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 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 box after CAD.

The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or 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 packaging and unused medications. By doing so, you will help protect the environment.

Composition of Flusemide

• The active ingredient is nicardipine hydrochloride.
• The other components are lactose, cornstarch, microcrystalline cellulose, colloidal silica, povidone, and magnesium stearate.

Appearance of the product and contents of the packaging

Yellowish clear, round, and scored tablets.

They are presented in packaging of30 or 60 tablets.

Only some sizes of packaging may be commercially marketed.

Holder of the marketing authorization and Responsible for manufacturing

Laboratorios Q Pharma S.L.

C/ Portugal 27, Entlo C

Alicante 03003 Spain

Last review date of this leaflet: April 2020

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