Diamox

Italy
Brand name Diamox
Form tablets
Active substance / Dosage
ACETAZOLAMIDE
Prescription type Prescription only
ATC code
S01EC01
Registration number 009277
Manufacturer TEOFARMA S.R.L.
Diamox tablets

Table of Contents

Package leaflet: Information for the patient

Diamox 250 mg tablets

acetazolamide
Please read this leaflet carefully before taking this medicine because it contains important information for you.

  • Keep this leaflet. 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. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
  • If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Diamox is and what it is used for

Diamox contains the active substance acetazolamide, a diuretic that belongs to the class of sulfonamides and works by increasing urine excretion.
Diamox is used for:

  • the treatment of fluid accumulation in the body (oedema) caused by heart failure;
  • the treatment of elevated pressure in the eye (glaucoma);
  • the treatment of eye swelling caused by fluid accumulation;
  • the treatment of epilepsy, in combination with other medicines;
  • prevention of acute mountain sickness.

2. What you need to know before taking Diamox

DO NOT take Diamox

  • if you are allergic to acetazolamide or to any of the other ingredients of this medicine (listed in section 6);
  • if you suffer from excessive acid production with nausea and vomiting (hyperchloremic acidosis);
  • if you have low levels of potassium in the blood;
  • if you have low levels of sodium in the blood;
  • if you have kidney failure;
  • if you have liver failure, including cirrhosis (chronic inflammation of the liver);
  • if you have adrenal gland failure;
  • if you suffer from chronic non-congestive angle-closure glaucoma (a type of eye disorder caused by increased pressure in the eyes);
  • during pregnancy and while breastfeeding (see section "Pregnancy and breastfeeding").

Warnings and precautions
Talk to your doctor or pharmacist before taking Diamox.
Your doctor will carry out regular checks to monitor possible effects of acetazolamide on your body's metabolism and blood cells (such as sodium, potassium, white blood cells, red blood cells, platelets, glucose).
Additionally, inform your doctor if you experience suicidal thoughts or behaviors during treatment. Your doctor will closely monitor you and assess whether you need appropriate treatment.
Be especially careful with Diamox and consult your doctor:

  • if you have kidney damage and suffer from heart disease;
  • if you suffer from chronic obstructive bronchopulmonary disease and emphysema (respiratory diseases affecting the lungs and bronchi, causing breathing difficulties);
  • if you suffer from reduced alveolar ventilation (a respiratory disorder reducing air exchange in the lungs);
  • if you are taking high doses of aspirin;
  • if your kidney function is reduced;
  • if you suffer or have suffered from kidney stones;
  • if you have diabetes mellitus or impaired sugar tolerance;
  • if you are an elderly patient with reduced kidney function.

If severe forms of altitude sickness occur, for example, high-altitude pulmonary edema or high-altitude cerebral edema, when ascending rapidly while using acetazolamide, this does not eliminate the need for immediate descent.
If severe allergic reactions occur, stop treatment and consult your doctor immediately.
Children and adolescents
To date, adequate studies on the safety and efficacy of acetazolamide in children and adolescents are not available.
Your doctor will carefully monitor the growth and development of children and adolescents undergoing prolonged treatment.
Other medicines and Diamox
Inform your doctor or pharmacist if you are currently using, have recently used, or might use any other medicines.
In particular, inform your doctor if you are taking or are about to take:

  • medicines containing mercury (to increase urine production);
  • miotics (to constrict the pupil and lower eye pressure);
  • carbamazepine, phenytoin, primidone (for the treatment of epilepsy);
  • antihypertensives (for the treatment of high blood pressure);
  • quinidine and cardiac glycosides (for the treatment of heart disorders);
  • other medicines to increase urine production;
  • amphetamines (to stimulate the nervous system);
  • tricyclic antidepressants (for the treatment of depression);
  • other sulfonamides and sulfonamide derivatives;
  • folic acid antagonists (a vitamin);
  • medicines for the treatment of diabetes;
  • methenamine (for the treatment and prevention of urinary tract infections);
  • sodium bicarbonate;
  • cyclosporine (to reduce immune system reactions);
  • aspirin;
  • lithium (for the treatment of certain mental disorders).

Diamox may also interfere with laboratory tests and other diagnostic tests: inform your doctor before undergoing any examination.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
To date, adequate studies in pregnant women are not available.
If you are pregnant, your doctor will assess whether the benefits to you clearly outweigh the risks to the fetus/child before prescribing Diamox.
Breastfeeding
If you are breastfeeding, your doctor will assess whether the benefits to you clearly outweigh the risks to the fetus/child before prescribing Diamox, due to the possibility of developing serious adverse reactions.
Driving and using machines
Diamox may cause drowsiness and confusion.
If you experience these effects, do not drive or operate machinery until they have disappeared.
For those engaged in sports
Using this medicine without therapeutic need constitutes doping and may lead to a positive anti-doping test.

3. How to take Diamox

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Dosage
Your doctor will determine the most appropriate dose for you based on your weight and the condition being treated.

  • To increase urine production: one tablet to one and a half tablets once daily in the morning.
  • For the treatment of glaucoma: one tablet every 4–6 hours (4 to 6 tablets in 24 hours). In some cases, your doctor may reduce the dose to one tablet every 8–12 hours (2 to 3 tablets in 24 hours). In acute, particularly severe cases, your doctor may start treatment with 2 tablets, followed by one tablet every 4–6 hours.
  • For the treatment of epilepsy: one and a half to 4 tablets in 24 hours. If Diamox is replacing an ongoing epilepsy treatment, or is taken in addition to such treatment: your doctor will start you on one tablet per day and gradually increase the daily dose of Diamox to reach the recommended doses indicated above.
  • For the prevention of acute mountain sickness: one tablet per day.

If you take more Diamox than you should
If you accidentally ingest or use an excessive dose of Diamox, inform your doctor immediately
or go to the nearest hospital.
Your doctor will treat an overdose of Diamox according to your condition.
If you forget to take Diamox
Do not take a double dose to make up for a missed dose.
If you forget a dose, resume treatment according to the doses and timing advised by your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
The most commonly observed side effects at the beginning of treatment include:

  • altered sensation in the limbs or other parts of the body, particularly tingling, especially in hands and feet, numbness and itching of the extremities and face;
  • reduced or loss of appetite (anorexia);
  • hearing disturbances, such as ringing or buzzing in the ears;
  • taste disturbances;
  • stomach and intestinal disorders such as nausea, vomiting and diarrhoea;
  • increased urine production;
  • drowsiness;
  • confusion.

Other side effects:

  • severe reactions with destruction of the skin and mucous membranes (Stevens-Johnson syndrome and toxic epidermal necrolysis);

  • rapid death of liver tissue;

  • severe reduction in white blood cells, anaemia characterised by reduced production of blood cells (aplastic anaemia), and other changes in the number or quality of blood cells;

  • severe, rapidly occurring allergic reactions;

  • headache;

  • malaise;

  • fatigue;

  • fever;

  • hot flushes, skin redness;

  • growth delay in children;

  • paralysis characterised by reduced muscular tone;

  • thirst;

  • altered liver function, liver inflammation or yellowing of the skin, mucous membranes and eyes (jaundice);

  • changes in the number or quality of blood cells, for example: reduction in platelets, which may cause purple or reddish-brown spots on the skin; or reduction in all blood cells;

  • excessive production of acids at the metabolic level;

  • imbalance of substances in the blood, including: low levels of potassium in the blood, very rarely associated with intestinal obstruction due to paralysis of the intestinal muscles; high levels of uric acid in the blood;

  • altered ammonium metabolism;

  • low levels of sodium in the blood;

  • inadequate bone mineralisation if taken long-term with phenytoin;

  • increased or decreased blood sugar levels;

  • depression;

  • excitement;

  • loss of coordination of movements;

  • seizures;

  • dizziness;

  • skin allergic reactions, even severe, including itchy rashes, appearance of spots and/or raised lesions on the skin;

  • light sensitivity;

  • myopia;

  • visual disturbances, rarely after cataract surgery;

  • salt crystals in the urine;

  • increased risk of kidney stones (with prolonged treatment);

  • presence of blood in the urine;

  • abnormal liver function;

  • sugar in the urine;

  • kidney failure.

  • Contact your doctor immediately if you experience a severe skin reaction: red, scaly rash with pustules and blisters (exanthematous pustulosis). The frequency of this reaction is unknown (cannot be estimated from the available data).

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the following address
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Diamox

Keep this medicine out of the sight and reach of children.
Do not store above 25°C.
Do not use this medicine after the expiry date stated on the packaging after Exp. The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Diamox contains

  • The active substance is acetazolamide. Each tablet contains 250 mg of acetazolamide.
  • The other ingredients are sodium starch glycolate, povidone K29-32, calcium phosphate dibasic dihydrate, maize starch, magnesium stearate.

Description of the appearance of Diamox and contents of the pack
250 mg tablets.
Marketing Authorization Holder
TEOFARMA S.r.l. – Via F.lli Cervi, 8 – 27010 Valle Salimbene (PV)
Manufacturer
TEOFARMA S.r.l. – Viale Certosa, 8/A – 27100 PAVIA