Edemox 250 mg tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Edemox 250 mg tablets

Acetazolamide

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 you should not give it to other people even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Edemox is and what it is used for
2. What you need to know before taking Edemox
3. How to take Edemox
4. Possible side effects
5. How to store Edemox
6. Contents of the pack and other information

1. What Edemox is and what it is used for

Edemox is a medicine that contains acetazolamide as the active substance. Acetazolamide is a diuretic medicine (a medicine that increases urine elimination) belonging to the group of sulfonamides. Acetazolamide helps reduce edema (fluid accumulation) by assisting in the reduction of pressure.

This medicine is used for:

• Treating fluid accumulation due to heart problems, medication use, or other causes, usually in combination with other diuretics.
• Treating, together with other medicines, open-angle glaucoma and secondary glaucoma (eye diseases characterized by increased intraocular pressure).
• Preoperative treatment of acute closed-angle glaucoma.
• Treating, together with other medicines, petit mal epilepsy (epilepsy with mild seizures).

2. What you need to know before taking Edemox

Do not take Edemox

• If you are allergic to acetazolamide or to any of the other ingredients of this medicine (listed in section 6).
• If you are allergic to sulfonamides.
• If you have:
  • severe renal insufficiency (serious kidney problems)
  • severe hepatic insufficiency (serious liver problems)
  • hepatic cirrhosis (a disease characterized by liver degeneration)
  • sodium or potassium depletion (decreased levels of sodium or potassium)
  • hyperchloremic acidosis (increased acidity in body fluids and tissues)
  • adrenal insufficiency (a hormonal deficiency)
  • a special type of glaucoma known as chronic non-congestive angle-closure glaucoma, when used long-term.
• If you are in the first trimester of pregnancy.

Warnings and precautions

Talk to your doctor before starting to take this medicine.

• If you have previously experienced lung or breathing problems (fluid in the lungs) after taking acetazolamide.

Take special care if:

• you are elderly
• you have renal insufficiency (kidneys not functioning properly)
• you have hepatic insufficiency (liver not functioning properly)
• you are taking antiepileptic drugs, as suicidal tendencies have been reported. Patients and caregivers should seek medical advice if signs of suicidal behavior occur
• you have pulmonary obstruction or emphysema (excessive air in the lungs)
• you have cardiac insufficiency (heart not functioning properly)
• you develop a skin rash without a known cause
• you experience temporary hearing loss
• your blood test results show a sudden drop in blood components (white blood cells, red blood cells, and platelets)
• you have diabetes, as it may increase or decrease blood and urine glucose levels; this should be considered in patients with glucose intolerance or diabetes mellitus
• you have a history of kidney stones; the benefit should be weighed against the risk of forming new stones
• you will be exposed to sunlight. You should avoid prolonged sun exposure
• if you experience shortness of breath or difficulty breathing after taking Edemox, seek immediate medical attention (see also section 4).

Decreased vision or eye pain may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion or choroidal detachment). This may occur within hours after taking Edemox. Contact your doctor as soon as possible if you experience these symptoms.

Use of Edemox with other medicines

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

The following medicines may interact with Edemox when used at the same time:

• Oral anticoagulants (medicines to treat and prevent blood clots, such as aspirin): may cause severe acidosis and increase central nervous system toxicity.
• Hypertensive agents (medicines to raise blood pressure): dosage adjustment of acetazolamide may be necessary.
• Cardiac glycosides (medicines used to treat heart conditions): dosage adjustment of acetazolamide may be necessary.
• Other carbonic anhydrase inhibitors (medicines to reduce edema): simultaneous use is not recommended due to possible additive effects.
• Topiramate (used to treat certain types of seizures in epileptic patients): may increase the risk of kidney stone formation associated with topiramate use.
• Antidiabetics (medicines for diabetes): may enhance the effect of these medicines.
• Amphetamines (central nervous system stimulants): may enhance amphetamine action and/or toxicity.
• Antiepileptics (medicines for epilepsy): may increase or decrease blood levels of these medicines.
• Benzodiazepines (such as triazolam, used to treat insomnia or difficulty sleeping): respiratory difficulty may occur.
• Cyclosporine (an immunosuppressant used in transplant patients): may increase cyclosporine blood levels, enhancing its action and/or toxicity.
• Ciprofloxacin (for treating infections): may cause kidney stones and nephrotoxicity.
• Corticosteroids (substances with anti-inflammatory, immunosuppressive, and metabolic effects): acetazolamide may cause low blood potassium levels.
• Digoxin (to treat certain heart problems): risk of digitalis toxicity if low blood potassium levels occur during treatment.
• Ephedrine and pseudoephedrine (potent central nervous system stimulants): may enhance ephedrine toxicity.
• Erythromycin (for treating infections): may enhance the antibiotic effect.
• Memantine (to treat symptoms of Alzheimer's disease): may reduce memantine elimination.
• Methenamine (for treating urinary tract infections): may reduce the urinary antiseptic effect of methenamine.
• Other diuretics (thiazides): may increase their hypokalemic and hyperuricemic effects.
• Procaine (a short-acting local anesthetic): may enhance anesthetic toxicity.
• Quinidine (to treat abnormal heart rate): may enhance quinidine toxicity.
• Lithium salts (antidepressant): acetazolamide causes loss of antidepressant efficacy.
• Salicylates (medicines with anti-inflammatory, analgesic, and antipyretic properties): during concomitant treatment with high doses of salicylates, the risk of salicylate intoxication may increase, leading to metabolic acidosis and increased tissue penetration of salicylates.
• Timolol (to reduce intraocular pressure): may enhance beta-blocker toxicity, worsening pre-existing respiratory insufficiency.

Interference with laboratory tests and other diagnostic procedures

If you are scheduled for any diagnostic tests (including blood and urine tests), inform your doctor that you are taking this medicine, as it may alter test results.

• Acetazolamide decreases potassium and increases uric acid levels in blood, serum, or plasma, and may interfere with urine protein testing.
• Acetazolamide interferes with the HPLC analytical method used to measure theophylline levels in blood.

Use of Edemox with alcohol

Avoid alcohol consumption while taking this medicine.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

This medicine must not be taken during the first trimester of pregnancy; it is contraindicated. During the remainder of pregnancy, it should only be used if no safer therapeutic alternatives are available.

Its use is not recommended in breastfeeding mothers.

Driving and using machines

Some adverse reactions, such as drowsiness, fatigue, and transient myopia, may affect your ability to drive or operate machinery. If you experience these effects, you should avoid driving and operating machinery.

Use in athletes

Athletes should be informed that acetazolamide is a prohibited substance in competitive sports and may lead to a positive doping test result.

3. How to take Edemox

Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist.

The recommended doses are:

Adults:

• Diuretic:

The initial dose is usually 250 mg/day (1 tablet daily) in the morning. If the response is unsatisfactory, switch to 250 mg (1 tablet) on alternate days or 250 mg/day (1 tablet daily) for two consecutive days followed by one day off.

• Glaucoma:

This medicine is usually required as an adjunct to other treatment.

For the treatment of open-angle glaucoma, administer one to four daily doses of 250 mg (1 to 4 tablets daily). Doses exceeding 1 g (4 tablets) daily usually do not increase the response.

Secondary glaucoma and preoperative treatment of acute angle-closure glaucoma: 250–1,000 mg/day (1 to 4 tablets daily), divided into several doses (250 mg (1 tablet) every four hours).

• Epilepsy:

250–1,000 mg/day (1 to 4 tablets daily), in several divided doses depending on the severity of the condition. Doses exceeding 1 g (4 tablets) daily may not increase the response.

It is recommended to start with 250 mg (1 tablet) once daily, maintaining the usual dose of the other antiepileptic drug.

Elderly patients:

Although no specific geriatric problems have been described in this age group, dosage in elderly patients should be established cautiously, starting treatment with the lowest effective dose.

Renal impairment:

Acetazolamide is excreted via the kidneys, so dose reduction may be necessary, particularly in patients whose laboratory tests show creatinine clearance values < 60 ml/min. In patients with moderate to severe renal disorders, the dose should be reduced by half or the dosing interval increased, changing from doses every six or eight hours to administration every twelve hours.

Use in children and adolescents

The safety and efficacy of acetazolamide have not been established in patients aged 12 years and younger.

• Diuretic:

Adolescents over 12 years: 5 mg/kg once daily in the morning.

• Epilepsy and Glaucoma:

The daily dose for children depends on the child's weight. It is generally 8 to 30 mg per kg in divided doses, up to a maximum daily dose of 750 mg (3 tablets), given in several doses.

Method of administration

The tablets should be taken orally.

Acetazolamide should preferably be administered on an empty stomach, although if nausea or vomiting occurs, it may be taken with milk or food to reduce gastrointestinal intolerance. Food does not delay the rate of absorption or reduce the extent of absorption.

Due to its diuretic effect, if administered as a single daily dose, it should be taken in the morning. If administered in more than one dose per day, the last dose should be taken before 6–8 p.m. to prevent the diuretic effect from interfering with the patient's nighttime rest.

If you take more Edemox than you should

Do not take more than 1.5 g/day (6 tablets daily).

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

In case of overdose, treatment should be discontinued and symptomatic and supportive treatment initiated, with special attention to maintaining fluid and electrolyte balance and adequate fluid intake. Serum electrolytes (especially potassium) and blood pH should be monitored. Acetazolamide may be dialyzable, particularly in cases of overdose and renal failure.

There is no specific antidote.

If you forget to take Edemox

Do not take a double dose to make up for missed doses.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

In short-term therapies, adverse effects consist of tingling sensations in the face, hands, and feet; tinnitus and hearing disturbances; loss of appetite and weight; taste disturbances; gastrointestinal disorders (nausea, vomiting, and diarrhoea); increased frequency of urination; flushing; thirst; headache; dizziness; fatigue; irritability; agitation; lack of coordination; general malaise; depression; decreased libido; and occasionally, drowsiness or transient confusion and blurred vision, which always resolve upon discontinuation of treatment. Photosensitivity has also been reported.

In long-term therapies, metabolic acidosis (excessive acidity in the blood) and disturbances in electrolyte balance may occur, including hypokalaemia (low blood potassium levels) and hyponatraemia (low blood sodium levels). Other possible effects include dizziness, transient myopia, dark stools containing blood, presence of sugar, blood, and crystals in the urine, gastrointestinal bleeding, pain and increased frequency of urination, yellowish discoloration of the skin and eyes, growth retardation (in children), hepatic function disturbances, muscle weakness or seizures, gastrointestinal disorders (nausea, vomiting, and diarrhoea), fever, low blood levels of red blood cells, white blood cells, and platelets, skin allergic reactions, and acute inflammatory diseases (such as erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis), or kidney damage. Acetazolamide may induce osteomalacia (softening of the bones) in patients simultaneously treated with carbamazepine, primidone, or phenytoin. Rarely, fulminant hepatic necrosis (severe liver disorder) has been reported. Long-term acetazolamide therapy increases the risk of nephrolithiasis (kidney stones). All these manifestations resolve upon dose reduction or discontinuation of treatment.

Contact a doctor immediately if you experience any of the following symptoms:

• If you experience a severe skin reaction: a red, scaly rash with lumps under the skin and blisters (exanthematous pustulosis). The frequency of this adverse effect is considered unknown (cannot be estimated from available data).
• If you have difficulty breathing or shortness of breath. These may be symptoms of fluid accumulation in the lungs (pulmonary edema). The frequency of this adverse effect cannot be estimated from available data (frequency unknown).

Frequency "unknown": Decreased vision or eye pain due to fluid accumulation in the vascular layer of the eye (choroidal effusion or detachment).

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 Medicinal Products: www.notificaRAM.es.

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Edemox

No special storage conditions are required.

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.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If you are in doubt, ask your pharmacist how to 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 Edemox

• The active substance is acetazolamide. Each tablet contains 250 mg of acetazolamide.
• The other components are calcium sulfate dihydrate, sodium carboxymethylstarch (type A) (derived from potato starch), talc and povidone.

Appearance of the product and contents of the pack

White, cylindrical, bevel-edged tablets with the letter "W" as an emblem.

Pack contents: 20 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

CHIESI ESPAÑA, S.A.U.

Plaça d’Europa, 41-43, planta 10
08908 L’Hospitalet de Llobregat (Barcelona)

Manufacturer

LABORATORIOS ALCALA FARMA S.L.

Avenida de Madrid, 82
28802 - Alcalá de Henares (Madrid)

Date of the most recent review of this leaflet: August 2024.

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