500 mg of powder for injection, solution 
acetazolamide

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

  • Save this information, you may need to read it again.
  • If you have any further questions, ask your doctor or nurse.
  • If you get any side effects, talk to your doctor or nurse. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet you will find information about: 
1. What Diamox is and what it is used for 
2. What you need to know before you are given Diamox  
3. How to give Diamox 
4. Possible side effects 
5. How to store Diamox 6. Contents of the pack 
and other ingredients information 

1. What Diamox is and what it is used for

Diamox contains acetazolamide as the active ingredient, which lowers the pressure inside the eye by reducing the production of aqueous humor (fluid inside the eyeball).

Diamox is used as a short-term treatment in eye surgery as there is reason to fear that the pressure in the eye will rise. Diamox is also used before eye surgery to treat acute narrow-angle glaucoma. It is also used as adjunctive therapy in the treatment of epilepsy ( petit mal ).

2. What you need to know before you are given Diamox 

You should not be given Diamox

  • if you are allergic to acetazolamide or any of the other ingredients of this medicine (listed in section 6).
  • if you have renal hyperchloraemic acidosis (disturbance in the body’s salt balance due to disturbance in kidney function)
  • if you have Addison’s disease (decreased production of corticoid hormones in the adrenal glands above the kidneys)
  • if you have or have had a severe liver or kidney function
  • if you have low levels of sodium and/or potassium in your blood
  • if you are allergic to sulfonamides
  • if you are being treated for chronic non-congestive narrow-angle glaucoma (a type of glaucoma in which the normal drainage channels in the eye have narrowed, leading to increased pressure in the eye and impaired vision). Your doctor will talk to you about this.

Warnings and cautions

Talk to your doctor or pharmacist before giving Diamox:

  • if you suffer from a lung or respiratory problems such as emphysema
  • if you have or have previously had kidney problems such as kidney stones
  • if you have diabetes or problems with your blood sugar

If skin effects or severe changes in the blood count occur, your doctor may stop the treatment and start other appropriate treatment.

Diamox can in rare cases affect the white blood cells so that the defense against infection deteriorates.

If you get an infection with symptoms such as fever with severe general deterioration or fever with local infection symptoms such as sore throat/pharynx/mouth or urination problems, you should see a doctor as soon as possible so that blood tests can rule out a lack of white blood cells ( agranulocytosis ). It is important that you then information about your medication.

A small number of people who have been treated with anti-epileptic drugs such as Diamox have had thoughts of harming themselves or committing suicide. If you ever get these thoughts, contact your doctor immediately.

Other medicines and Diamox

Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines.

The effects of any of these medicines may change, especially if you take or use any of the following:

  • medicines for epilepsy or seizures (especially phenytoin, topiramate, carbamazepine, or primidone)
  • drugs for diabetes to lower blood sugar (e.g., metformin )
  • other medicines in a group called carbohydrase inhibitors (used to treat high pressure inside the eye/eyes)
  • drugs that affect folic acids such as methotrexate, pyrimethamine, or trimethoprim
  • blood thinners such as warfarin
  • aspirin and closely related drugs such as acetylsalicylic acid
  • cardiac drugs such as cardiac glycosides (eg digoxin )
  • medicines for high blood pressure
  • drugs for urinary tract infections (methenamine)
  • medicines containing amphetamine (a stimulant), quinidine (treats irregular heartbeats), memantine (treats Alzheimer’s disease ), or lithium (treats serious mental problems)
  • ciclosporin (used after transplants to suppress the immune system)
  • treatment with sodium bicarbonate (used in conditions where there is too much acid in your body)

Diamox may affect some medical examinations. If you are visiting a hospital or clinic for a medical examination, tell your doctor that you are taking Diamox. Contact your doctor. It may be necessary to change dose one.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Diamox can affect the fetus. Diamox should therefore not be used if you are pregnant, think you may be pregnant, or are planning to have a baby. Ask your doctor or pharmacist for advice before taking any medicine.

Breast-feeding

Acetazolamide passes into breast milk. There is a risk that children who are breastfed will be affected. Do not use Diamox during lactation except on certain prescriptions from the doctor.

Ask your doctor or pharmacist for advice before taking any medicine.

Fertility

There is a risk that potency and sexual desire in men are affected.

Driving and using machines

If Diamox makes you feel dizzy, drowsy, or confused, do not drive or use machines. It can temporarily cause myopia; if this happens and you feel that you can no longer drive safely, stop driving and consult a doctor.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Diamox contains sodium

Diamox contains less than 1 mmol sodium (23 mg) per dose, ie essentially ‘sodium-free’.

How to give Diamox

Short-term treatment with eye surgery: The recommended dose is between 250-1000 mg daily.

Acute narrow-angle glaucoma: The recommended dose is 250-1000 mg daily divided into 2-4 doses. Diamox can be used with regular pupil astringents.

As an adjunctive treatment for epilepsy ( petit mal ): The recommended dose for adults is 375 – 1000 mg daily, divided into 2-4 doses.

When Diamox is given in combination with other antiepileptic drugs a starting dose of 250 mg daily is suggested in addition to the treatment already used. This dose is then increased to the above level.

Before taking Diamox and during treatment, your doctor will take blood samples to check if you still need to take Diamox.

If you are given too much Diamox

If you think you have been given too much of this medicine or if e.g. If a child has inadvertently ingested the medicine, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.

If you have any further questions on the use of this product, ask your doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

All medicines can cause allergic reactions, but severe allergic reactions are very rare.

Contact a doctor immediately if you get any of the following conditions

  • if you experience sudden wheezing, difficulty breathing, swelling of the eyelids, face, or lips, rash, or itching (especially if it affects the whole body). This side effect occurs in an unknown number of users (has been reported).
  • if you get an allergic reaction that causes joint pain, rash, and fever ( Stevens-Johnson syndrome ) severe disease with blisters on the skin and in a more serious condition ( toxic epidermal necrolysis ) with increased damage to the skin, or widespread rash with typical spots (erythema multi format ). This side effect is rare (may affect up to 1 in 1,000 people).
  • if you get an infection with symptoms such as fever with severe general deterioration or fever with local infection symptoms such as sore throat/pharynx/mouth or vomiting problems. Doctors should find out through blood tests if you have a severe lack of white blood cells ( agranulocytosis ). This side effect is rare (may affect up to 1 in 1,000 people). 
  • if you get a severe skin reaction: red, scaly rash with bumps under the skin and blisters (exanthematous pustulosis ). This side effect occurs in an unknown number of users (has been reported).
  • if you have severe liver (liver necrosis), inflammation of the liver ( hepatitis ), yellowing of the skin and eyes, dark urine and pale stools (jaundice), kidney failure. This side effect occurs in an unknown number of users (has been reported)
  • if you get increased acidity in your blood that can lead to symptoms such as nausea, vomiting, palpitations, or headaches. This side effect is common (may affect up to 1 in 10 people).

Other side effects that may occur:

Common (may affect up to 1 in 10 people) 

  • Taste disorder ( dysgeusia ) 
  • dizziness, fatigue

Uncommon (may affect up to 1 in 100 people ) 

  • tingling or numbness in fingers or toes
  • itching
  • vomiting or nausea
  • low back pain due to kidney stones
  • fever, weakness

Rare ( may affect up to 1 in 1,000 people) 

  • general fatigue, pallor of the skin, throat infection ( aplastic anemia )
  • muscle weakness
  • cramps (seizures)
  • temporary myopia that disappears when the dose is reduced or the treatment is stopped earrings or difficulty hearing
  • diarrhea
  • increased photosensitivity
  • increased hair in women

Has been reported (occurs in an unknown number of people):

  • headache, irritation, agitation
  • lack of muscle coordination
  • depression, drowsiness, confusion
  • impaired hearing
  • black or tar-like stools
  • hives
  • reddening of the skin
  • increased urine, cloudy urine, blood, or sugar in the urine
  • increased thirst,
  • decreased sexual desire
  • osteoporosis

The following can be seen in routine examinations:

  • altered liver function
  • blood or sugar may be present in the urine
  • altered uric acid levels in the blood
  • altered blood sugar levels
  • changes in the blood picture

Taking Diamox tablets for a long time can sometimes affect the amount of potassium or sodium in your blood. Your doctor will probably take blood samples to check that this is not happening. You may also experience bone thinning or risk of kidney stones with long-term treatment.

5. How to store Diamox

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

No special storage instructions.

Do not use this medicine after the expiry date which is stated on the carton. The expiration date is the last day of the specified month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substance is acetazolamide 500 mg per vial.
  • The other ingredients are sodium hydroxide, hydrochloric acid for pH adjustment 9.1- 9.2.

What the medicine looks like and the contents of the pack

Diamox 500 mg powder for solution for injection is a white compact in a type I glass vial with a rubber stopper and an aluminum seal.

Pack size: 1 vial.

Marketing Authorisation Holder

Amdipharm Limited

Temple Chambers

3 Burlington Road

Dublin 4

Ireland

Manufacturer

BAG Health Care GmbH

Amtsgerichtstrasse 1-5

D-35423, Lich

Germany

Muhammad Nadeem

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