FLUSEMIDE 20 mg TABLETS

Introduction

Package Leaflet: Information for the Patient

Flusemide 20 mg Tablets

Nicardipine Hydrochloride

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

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

Contents of the Package Leaflet

1. What is Flusemide and what is it used for
2. What you need to know before taking Flusemide
3. How to take Flusemide
4. Possible side effects
5. Storage of Flusemide
6. Package Contents and Additional Information

1. What is Flusemide and what is it used for

Nicardipine hydrochloride, the active ingredient of Flusemide, is a medication belonging to the group of calcium antagonists that acts on blood vessels by relaxing smooth muscle. It also increases blood flow to the brain.

This medication is indicated for:

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

2. What you need to know before taking Flusemide

Do not take Flusemide:

• if you are allergic to nicardipine or any other component of this medication (listed in section 6).
• if you have recently experienced cerebral hemorrhage.
• if you have endocranial hypertension (increased pressure inside the skull).
• if you are pregnant or breastfeeding.
• if you have advanced aortic stenosis (abnormal narrowing of the heart valve opening).
• 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 after starting therapy or after increasing the dose, stop treatment with 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., close monitoring at the start of treatment) in:

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

If you are going to undergo any diagnostic tests (including blood or urine tests), inform your doctor that you are taking this medication, as it may alter the results.

Children and Adolescents.

This medication is contraindicated in children under 18 years old.

Taking Flusemide with Other Medications

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

Some medications may interact with this medication, and it may be necessary to change the dose or discontinue treatment with one of them.

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

Caution should be exercised 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 the possibility of an additive effect resulting in postural hypotension (drop in blood pressure when standing up from sitting or lying down) should be considered.

Increased levels of cyclosporine (used as an immunosuppressant) have been reported when used in combination with nicardipine.

Concomitant administration of nicardipine and digoxin (used for the treatment of certain heart conditions) may increase the effects of digoxin.

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

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

Taking Flusemide with Food, Drinks, and Alcohol

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

Use in Pregnant or Breastfeeding Women

This medication should not be used during pregnancy.

There have been reports of acute pulmonary edema (abnormal accumulation of fluid in the lungs) when nicardipine is used during pregnancy.

This medication should not be used during breastfeeding.

Driving and Using Machines

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

Flusemide contains Lactose

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

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3. How to Take Flusemide

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

The dose should be adjusted in each patient according to the therapeutic response obtained.

Treatment of Essential Hypertension

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 should pass with the initial dose to achieve stable plasma concentrations.

A dose of 30 mg cannot be administered with this medication.

Prevention and Treatment of Ischemia due to Cerebral Infarction

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

A dose of 30 mg cannot be administered with this medication.

Prevention of Neuronal Deterioration due to Contraction of Cerebral Blood Vessels caused by Hemorrhage

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

The score line is only for breaking the tablet and facilitating its intake, but not for dividing it into equal doses.

The tablets of this medication should be swallowed without chewing, with a sufficient amount of liquid, but not with grapefruit juice. They can 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, 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 make up for forgotten doses.

If you stop taking Flusemide

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

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

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

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

Palpitations, hypotension, peripheral edema (fluid accumulation in arms and legs), dizziness, headache, somnolence, insomnia, nausea, gastrointestinal disorders, constipation, diarrhea, frequent salivation, feeling of weakness, shortness of breath, frequent urination.

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

Increased liver enzymes.

Side effects of unknown frequency(cannot be estimated from available data):

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

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Flusemide

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

Do not use this medication after the expiration date shown on the box after CAD.

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

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and unused medications in the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Flusemide

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

Appearance of the Product and Package Contents

Light yellow, round, and scored tablets.

Available in packs of 30 or 60 tablets.

Not all 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 last revision of this package leaflet: April 2020

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