Package Insert: Information for the User

Edemox 250 mg Tablets

Acetazolamide

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

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

Edemox is a medication that contains acetazolamide as its active ingredient. Acetazolamide is a diuretic medication (a medication that increases urine elimination) that belongs to the sulfonamide group. Acetazolamide helps to reduce edemas (fluid concentration) by reducing pressure.

This medication is used for:

• Treating fluid accumulation due to heart problems, medication use, or other reasons, usually in combination with other diuretics.
• Treating, in combination with other medications, open-angle glaucoma and secondary glaucoma.
• Preoperative treatment of acute angle-closure glaucoma.
• Treating, in combination with other medications, petit mal epilepsy (epilepsy with mild seizures).

Do not take Edemox

• If you are allergic to acetazolamide or any of the other components of this medication (listed in section 6).
• If you are allergic to sulfonamides.
• If you have:
• • Severe kidney problems (renal insufficiency)
  • Severe liver problems (liver insufficiency)
  • Cirrhosis (a disease characterized by liver degeneration)
  • Depletion of sodium or potassium (decrease in sodium or potassium levels)
  • Hyperchloremic acidosis (increase in acidity in liquids and tissues)
  • Adrenal insufficiency (a hormonal deficiency)
  • A type of glaucoma known as chronic closed-angle glaucoma, in long-term therapy.
• If you are in the first trimester of your pregnancy.

Warnings and precautions

Consult your doctor before starting to take this medication.

• If you have experienced respiratory or pulmonary problems (fluid in the lungs) after taking acetazolamide in the past.

Be especially careful if:

• You are an elderly patient
• You have kidney problems (kidney not functioning correctly)
• You have liver problems (liver not functioning correctly)
• You are using medications to treat epilepsy, as there have been cases of suicidal tendencies. Patients and caregivers should seek medical advice if signs of suicidal behavior appear
• You have obstructive pulmonary disease or emphysema (excessive air in the lungs)
• You have heart failure (heart not functioning correctly)
• You develop any skin rash without known cause
• You temporarily lose your hearing
• Your blood test results (white blood cells, red blood cells, and platelets) drop suddenly
• You have diabetes, as it may increase or decrease blood glucose and urine glucose levels, so it should be taken into account in patients with glucose intolerance or diabetes mellitus.
• You have a history of kidney stones, the benefit should be weighed against the risk of new stone formation.
• You will be exposed to the sun. You should avoid prolonged sun exposure.
• If you experience shortness of breath or difficulty breathing after taking Edemox, seek medical attention immediately (see also section 4).

Decreased vision or eye pain may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal detachment or choroidal detachment). This can occur in the hours following Edemox intake. Consult your doctor as soon as possible if you experience these symptoms.

Use of Edemox with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

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

• Oral anticoagulants (medications for the treatment and prevention of thrombi, such as aspirin): may cause severe acidosis and increase the toxicity on the central nervous system.
• Antihypertensive agents (medications to raise blood pressure): may require adjustment of the acetazolamide dose.
• Cardiac glycosides (medications used to treat heart problems): may require adjustment of the acetazolamide dose.
• Other carbonic anhydrase inhibitors (medication to reduce edema): Not recommended for simultaneous use due to possible additive effects.
• Topiramate (for the treatment of certain types of seizures in people with epilepsy): may increase the risk of kidney stone formation associated with the use of topiramate.
• Antidiabetic agents (medications for diabetes): may potentiate the effect of these medications.
• Amphetamines (central nervous system stimulants): may potentiate the action and/or toxicity of amphetamines.
• Antiepileptic agents (medications for epilepsy): may increase or decrease blood levels of these medications.
• Benzodiazepines (such as triazolam, used for the treatment of insomnia or difficulty sleeping): may cause respiratory difficulty.
• Ciclosporin (immunosuppressive medication used in transplant patients): may increase blood levels of ciclosporin, potentiating its action and/or toxicity.
• Ciprofloxacin (for the treatment of infections): may cause kidney stones and nephrotoxicity.
• Corticosteroids (substances with anti-inflammatory, immunosuppressive, and metabolic effects): acetazolamide may cause low potassium levels in the blood.
• Digoxin (for the treatment of certain heart problems): risk of digitalis toxicity if low potassium levels in the blood occur during treatment.
• Ephedrine and pseudoephedrine (potent central nervous system stimulants): may potentiate the toxicity of ephedrine.
• Erythromycin (for the treatment of infections): may potentiate the effect of the antibiotic.
• Memantine (for the treatment of Alzheimer's disease symptoms): may reduce the elimination of memantine.
• Methenamine (for the treatment of urinary tract infections): may reduce the antimicrobial effect of methenamine in the urine.
• Other diuretics (thiazides): may increase their hypokalemic and hyperuricemic effects.
• Procaine (short-acting local anesthetic): may potentiate the toxicity of the anesthetic.
• Quinidine (for the treatment of abnormal heart rate): may potentiate the toxicity of quinidine.
• Lithium salts (antidepressant): acetazolamide may cause a loss of efficacy as an antidepressant
• Salicylates (medications with anti-inflammatory, analgesic, and antipyretic properties): during simultaneous treatment with high doses of salicylates, the risk of salicylate poisoning may increase, causing metabolic acidosis and increasing tissue penetration of salicylates.
• Timolol (for reducing eye pressure): may potentiate the toxicity of the beta-blocker, causing worsening of pre-existing respiratory insufficiency.

Interference with laboratory tests and other diagnostic tests

If you are to undergo any diagnostic test (including blood, urine, etc) inform your doctor that you are using this medication, as it may alter the results.

• Acetazolamide decreases potassium and increases uric acid in blood tests, serum, or plasma and may alter the protein test in urine.
• Acetazolamide interferes with the analysis method (HPLC) for the evaluation of theophylline in blood.

Use of Edemox with alcohol

Avoid consuming alcohol while undergoing treatment with this medication.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

This medication should not be taken during the first trimester of pregnancy, it is contraindicated. During the rest of the pregnancy, it is only recommended to administer it if there are no safer therapeutic alternatives.

It is not recommended for use in lactating mothers.

Driving and operating machinery

Some adverse reactions, such as drowsiness, fatigue, and transient myopia, may affect the ability to drive or operate machinery. If these effects are noticed, driving and operating machinery should be avoided.

Use in athletes

It is reported to athletes that acetazolamide is a prohibited substance in competitive sports, susceptible to producing a positive result in a doping control.

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

The recommended doses are:

Adults:

• Diuretic:

The initial dose is usually 250 mg/day (1 tablet per day) in the morning. In case of unsatisfactory response, change to 250 mg (1 tablet) every other day or 250 mg/day (1 tablet per day) for two consecutive days and one day of rest.

• Glaucoma:

It is usually necessary to use this medication as an aid to another treatment.

In the treatment of open-angle glaucoma, this medication should be administered once to four times a day at a dose of 250 mg (1 to 4 tablets per day). Doses above 1 g (4 tablets) per day do not usually increase the response.

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

• Epilepsy:

250-1,000 mg/day (1 to 4 tablets per day), in several doses, according to the severity of the case. Doses above 1 g (4 tablets) per day may not increase the response.

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

Older patients:

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

Renal insufficiency:

Acetazolamide is excreted by the kidneys, so it may be necessary to reduce the dose, especially in patients whose creatinine clearance values are <60

Use in children and adolescents

The safety and efficacy of acetazolamide have not been established in patients under 12 years old.

• Diuretic:

Adolescents over 12 years: 5 mg/kg, once a day in the morning.

• Epilepsy and Glaucoma:

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

Form of use

The tablets should be taken orally.

Acetazolamide should be administered preferably in the morning, on an empty stomach, although if nausea or vomiting appears, it can be administered with milk or food to reduce gastrointestinal intolerance. Food does not delay or reduce the rate of absorption or the degree of absorption.

Due to its diuretic effect, if given in a single dose, it should be administered in the morning, and if administered in more than one dose, the last dose should be given before 18-20 hours in the evening to avoid 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 per day).

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

In case of overdose, treatment should be discontinued and symptomatic and supportive treatment should be initiated, especially maintaining the electrolyte balance and sufficient fluid intake. Blood electrolyte levels (especially potassium) and blood pH should be monitored. Acetazolamide may be dialyzable, especially in cases of overdose and renal insufficiency.

There is no specific antidote.

If you forgot to take Edemox

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

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Inshort-term therapiesconsist of a tingling sensation in the face, hands, and feet, ringing in the ears and hearing disturbances, loss of appetite and weight, taste alterations, and gastrointestinal disorders (nausea, vomiting, and diarrhea), increased urination frequency, flushing, thirst, headache, dizziness, fatigue, irritability, agitation, lack of coordination, general discomfort, depression, decreased libido, and occasionally, drowsiness or transient confusion, blurred vision that always reverses when treatment is stopped. Photosensitivity has also been reported.

Inlong-term therapiesmay cause metabolic acidosis (excessive acidity in the blood) and electrolyte imbalance, including hypokalemia (low potassium levels in the blood) andhyponatremia (low sodium levels in the blood). It may also present with dizziness, transient myopia, dark stools containing blood, presence of sugar, blood, and crystals in the urine, digestive hemorrhage, pain and increased frequency of urination, yellow discoloration of the skin and eyes, growth retardation (in children), liver function alteration, muscle weakness or seizures, gastrointestinal disorders (nausea, vomiting, and diarrhea), 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 (weak bones) in patients treated simultaneously with carbamazepine, primidone, or phenytoin. In rare cases, fulminant hepatic necrosis (severe liver disorder). Long-term acetazolamide therapy increases the risk of nephrolithiasis (kidney stones). All these manifestations subside when the dose is reduced or treatment is discontinued.

Seek medical attention immediately if you experience any of the following symptoms:

• If you experience a severe skin reaction: a red, scaly rash with bumps under the skin and blisters (pustular exanthema). The frequency of this side effect is considered unknown (cannot be estimated from available data).
• If you present difficulty breathing or difficulty breathing. These may be symptoms of fluid accumulation in the lungs (pulmonary edema). The frequency of this side effect cannot be estimated from available data (unknown frequency).

“Unknown frequency”: Decreased vision or eye pain due to fluid accumulation in the vascular layer of the eye (choroidal hemorrhage or detachment).

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es.

By reporting side effects, you can contribute to providing more information on the safety of this medicine.

This product does not require special storage conditions.

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

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medication at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and unused medication. By doing so, you will help protect the environment.

Composition of Edemox

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

Appearance of the product and contents of the packaging

White, cylindrical tablets with beveled edges, with the anagram W.

The contents of the packaging are 20 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

CHIESI ESPAÑA, S.A.U.

Plaça d’Europa, 41-43, 10th floor

08908 L’Hospitalet de Llobregat (Barcelona)

Responsible for manufacturing

LABORATORIOS ALCALA FARMA S.L.

Avenida de Madrid, 82

28802 - Alcalá de Henares (Madrid)

Last review date of this leaflet: August 2024.

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