DIURAMID 250 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Diuramid, 250 mg, Tablets
   1. Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.
   2. Package Leaflet Contents
3. What is Diuramid and what is it used for
4. Important information before taking Diuramid
   1. When not to take Diuramid:
   2. Warnings and precautions
   3. If the patient experiences suicidal thoughts or behaviors, they should contact their doctor immediately
   4. Diuramid and other medications
   5. Diuramid with food and drink
   6. Pregnancy and breastfeeding
   7. Driving and using machines
   8. Diuramid contains sodium
5. How to take Diuramid
   1. Glaucoma
   2. Epilepsy
   3. Edema in circulatory failure and induced by medications
   4. Acute mountain sickness
   5. Overdose of Diuramid
   6. Missed dose of Diuramid
6. Possible side effects
   1. In case of shortness of breath, skin changes, or other severe side effects, the patient should stop taking the medication and seek medical help immediately.
   2. Reporting side effects
7. How to store Diuramid
8. Package contents and other information
   1. What Diuramid contains
   2. What Diuramid looks like and what the package contains
   3. Marketing authorization holder and manufacturer
   4. Marketing authorization holder
   5. Manufacturer

Package Leaflet: Information for the Patient

Diuramid, 250 mg, Tablets

Acetazolamide

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this package leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medication has been prescribed specifically for you. Do not pass it on to others. The medication may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including those not listed in this package leaflet, they should inform their doctor or pharmacist. See section 4.

Package Leaflet Contents

• 1. What is Diuramid and what is it used for
• 2. Important information before taking Diuramid
• 3. How to take Diuramid
• 4. Possible side effects
• 5. How to store Diuramid
• 6. Package contents and other information

1. What is Diuramid and what is it used for

Diuramid is a medication from the group of carbonic anhydrase inhibitors with a diuretic effect, used in the treatment of glaucoma, epilepsy (in combination with other medications), and edema caused by circulatory failure or induced by medications. It is also used in the prevention and treatment of acute mountain sickness.

2. Important information before taking Diuramid

When not to take Diuramid:

• if the patient is allergic to acetazolamide, other sulfonamides, or any of the other ingredients of this medication (listed in section 6)
• if the patient has liver or kidney function disorders, liver cirrhosis, adrenal insufficiency, decreased sodium or potassium levels in the blood, or hypochloremic acidosis (associated with decreased chloride levels in the blood)
• in cases of long-term treatment of chronic uncontrolled glaucoma with a closed angle.

Warnings and precautions

Before starting Diuramid, the patient should discuss it with their doctor or pharmacist if:

• the patient has kidney problems, such as kidney stones
• the patient has lung problems, such as chronic bronchitis and emphysema, which can cause breathing difficulties
• the patient has experienced respiratory or breathing problems after taking acetazolamide in the past (fluid in the lungs)
• the patient has diabetes or glucose intolerance (see "Diuramid and other medications").

If the patient experiences shortness of breath or difficulty breathing after taking Diuramid, they should seek medical help immediately (also see section 4).
Worsening vision or eye pain may be symptoms of fluid accumulation in the eye (excessive fluid between the choroid and sclera or detachment of the choroid).
This can occur within a few hours of taking Diuramid. If these symptoms occur, the patient should contact their doctor immediately.
There have been reports of suicidal thoughts or behaviors in a small number of patients taking antiepileptic medications, including acetazolamide.

If the patient experiences suicidal thoughts or behaviors, they should contact their doctor immediately

and consult with them.
Diuramid may affect the results of some laboratory tests.
During treatment with acetazolamide, skin reactions such as Stevens-Johnson syndrome or toxic epidermal necrolysis may occasionally occur (see section 4). If symptoms such as flu-like symptoms, progressive rash (often with blisters or
changes in mucous membranes) occur, the patient should stop the treatment and consult their doctor.

Diuramid and other medications

The patient should inform their doctor or pharmacist about all medications they are currently taking or have recently taken, as well as any medications they plan to take.
It is especially importantto inform the doctor about the use of:

• folic acid
• oral anticoagulants (e.g., warfarin)
• acetylsalicylic acid
• digitalis glycosides (e.g., digoxin)
• blood pressure-lowering medications
• antiepileptic medications (especially phenytoin, primidone, and carbamazepine)
• other carbonic anhydrase inhibitors (e.g., dorzolamide or brinzolamide, also used in the treatment of glaucoma)
• amphetamines
• methenamine (a medication used to prevent and treat chronic or recurrent urinary tract infections)
• quinidine (a medication used to treat heart conditions and certain types of malaria)
• lithium (a medication used to treat manic-depressive disorders)
• medications that lower blood glucose levels. Acetazolamide may increase or decrease blood glucose levels. The doctor may recommend adjusting the dose of insulin or oral antidiabetic medications in patients with diabetes.
• cyclosporine (a medication used to protect against transplant rejection)
• sodium bicarbonate (a medication used to neutralize excess stomach acid).

Diuramid with food and drink

See section 3.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medication.
Acetazolamide passes into breast milk in small amounts. Due to the risk of side effects in the breastfed child, the patient should decide with their doctor whether to stop taking the medication or stop breastfeeding during treatment.

Driving and using machines

The medication may cause side effects that affect the ability to drive or operate machines. The patient should not drive or operate machines during treatment with Diuramid.

Diuramid contains sodium

The medication contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered "sodium-free".

3. How to take Diuramid

This medication should always be taken as directed by the doctor or pharmacist. If the patient has any doubts, they should consult their doctor or pharmacist.
The doctor will determine the appropriate dose for each patient individually.

Glaucoma

Typically, the following dosing is recommended for adults:
In open-angle glaucoma
250 mg (1 tablet) 1 to 4 times a day.
Doses greater than 1000 mg (4 tablets) do not increase the effectiveness of treatment.
In secondary glaucoma
250 mg (1 tablet) every 4 hours.
In some patients, the medication is effective at a dose of 250 mg (1 tablet) 2 times a day (in short-term treatment).
In acute glaucoma attacks
250 mg (1 tablet) 4 times a day.

Epilepsy

Adults and children:
Typically 8 to 30 mg/kg body weight per day, in 1 to 4 divided doses.
The optimal dose is 375 mg to 1000 mg (1 to 4 tablets) per day.
When taking acetazolamide with other antiepileptic medications, the initial dose is 250 mg (1 tablet) once a day. Then, if necessary, the doctor will gradually increase the dose. In children, the dose should not exceed 750 mg per day.

Edema in circulatory failure and induced by medications

Initially 250 mg to 375 mg (1 to 1.5 tablets) once a day, in the morning.
Optimal diuretic effect occurs when the medication is taken every other day or for 2 consecutive days with a 1-day break.
During treatment with acetazolamide, the patient should continue the treatment recommended for circulatory failure, such as taking digitalis glycosides, restricting salt in the diet, and supplementing potassium.
The doctor may recommend adjusting the dose of acetazolamide if it is taken with digitalis glycosides or blood pressure-lowering medications.

Acute mountain sickness

The recommended dose is 500 mg to 1000 mg (2 to 4 tablets) per day, in divided doses.
In cases of rapid ascent to high altitude (over 500 meters per day): 1000 mg (4 tablets) per day in divided doses.
The medication should be taken 24 to 48 hours before the planned ascent to significant altitude, and if symptoms occur, treatment should be continued for the next 48 hours or longer if necessary.
Method of administration
The medication can be taken independently of meals.

Overdose of Diuramid

In case of overdose, the patient should seek medical help immediately.
Symptoms of overdose may be similar to side effects that occur during treatment with acetazolamide.

Missed dose of Diuramid

If a dose is missed, the patient should take it as soon as possible. However, if it is close to the time for the next dose, the patient should not take the missed dose but should return to the prescribed dosing schedule. The patient should not take a double dose to make up for the missed dose.
If the patient has any further doubts about taking this medication, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medications, Diuramid can cause side effects, although not everybody gets them.

In case of shortness of breath, skin changes, or other severe side effects, the patient should stop taking the medication and seek medical help immediately.

The patient should contact their doctor immediately if they experience:

• severe skin reaction: red, scaly rash with bumps under the skin and blisters (pustular psoriasis);
• shortness of breath or difficulty breathing. These may be symptoms of fluid accumulation in the lungs (pulmonary edema). The frequency of these side effects is unknown (it cannot be estimated from the available data).

The most common side effects that occur at the beginning of treatment are:

• numbness or tingling in the limbs (paresthesia), hearing disorders or tinnitus,
• loss of appetite, taste disorders, nausea, vomiting, diarrhea,
• frequent urination, blood in the urine, glucose in the urine,
• headaches, dizziness, hot flashes, depression,
• occasional drowsiness and disorientation,
• decreased libido,
• transient myopia,
• allergic reactions (e.g., facial, lip, tongue, or throat swelling, causing difficulty breathing or swallowing),
• hives,
• photosensitivity,
• liver failure (jaundice, dark urine, and pale stools), liver colic, and kidney colic,
• kidney stones,
• thirst,
• fatigue,
• irritability.

Acetazolamide, as a sulfonamide derivative, may cause side effects characteristic of sulfonamides, including:

• fever,
• rash,
• bone marrow suppression,
• crystalluria (excretion of crystals in the urine),
• kidney damage,
• fulminant liver necrosis,
• bullous skin reactions (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).

Diuramid may cause changes in blood test results, and the doctor may recommend regular blood tests. During treatment, the following may occur:

• decreased white blood cell count or anemia (low red blood cell count),
• decreased platelet count, which may affect blood clotting. If the patient experiences unexplained bruising, red or purple spots on the skin, they should inform their doctor.
• significant decrease in granulocyte count in peripheral blood,
• pancytopenia (a blood disorder characterized by a deficiency of all normal blood cell elements),
• acidosis (metabolic acidosis),
• electrolyte imbalance (including low sodium and/or potassium levels in the blood),
• high or low blood glucose levels,
• blood in the stool,
• kidney failure,
• flaccid muscle paralysis, seizures.

Additionally, the following have been observed:

• worsening vision or eye pain due to fluid accumulation in the eye (excessive fluid between the choroid and sclera or detachment of the choroid) - unknown frequency.

Reporting side effects

If the patient experiences any side effects, including those not listed in this package leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medication.

5. How to store Diuramid

There are no special storage instructions.
The medication should be stored out of sight and reach of children.
Do not use this medication after the expiration date stated on the packaging after EXP. The expiration date refers to the last day of the specified month.
The inscription on the packaging after the abbreviation EXP indicates the expiration date, and after the abbreviation Lot/LOT indicates the batch number.
Medications should not be disposed of in wastewater or household waste. The patient should ask their pharmacist how to dispose of unused medications. This will help protect the environment.

6. Package contents and other information

What Diuramid contains

• The active substance of the medication is acetazolamide. Each tablet contains 250 mg of acetazolamide.
• The other ingredients are: microcrystalline cellulose, povidone, sodium croscarmellose, colloidal silica, magnesium stearate.

What Diuramid looks like and what the package contains

Diuramid is a white, round, biconvex tablet.
The package contains 30 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
phone: +48 22 364 61 01

Manufacturer

Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
Zakłady Farmaceutyczne POLPHARMA S.A.
Medana Branch in Sieradz
ul. Władysława Łokietka 10, 98-200 Sieradz
Zakłady Farmaceutyczne POLPHARMA S.A.
Production Plant in Nowa Dęba
ul. Metalowca 2, 39-460 Nowa Dęba
Date of last revision of the package leaflet:December 2024