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DIAMOX SR Capsule (2018)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Diamox SR 250mg Prolonged-release Capsules.

Qualitative and quantitative composition

Each capsule contains 250 mg acetazolamide. Excipient(s): For a full list of excipients, see section 6.1.

Pharmaceutical form

Prolonged-release capsule. Orange spherical pellets contained in a size 1 capsule with clear body and opaque orange cap. GS 250 is printed on the orange cap in black text.

Therapeutic indications

Glaucoma.

Posology and method of administration

Capsules should be swallowed whole. Do not chew or crush. <u>Adults:</u> One or two 250mg capsules a day. <u>Children:</u> This product is not intended for administration to children. There is no relevant ...

Contraindications

Acetazolamide should not be used in patients hypersensitive to sulphonamides or other sulphonamide derivatives including acetazolamide or any excipients in the formulation Acetazolamide is contra-indicated ...

Special warnings and precautions for use

Increasing the dose does not increase the diuresis and may increase the incidence of drowsiness and/or paraesthesia. Suicidal ideation and behaviour have been reported in patients treated with anti-epileptic ...

Interaction with other medicinal products and other forms of interaction

Acetazolamide is a sulphonamide derivative. Sulphonamides may potentiate the effects of folic acid antagonists. Possible potentiation of the effects of folic acid antagonists, hypoglycaemics and oral anti-coagulants ...

Pregnancy and lactation

Use in pregnancy Acetazolamide should not be used in pregnancy, especially during the first trimester. (See section 5.3) Use in lactation Acetazolamide has been detected in low levels in the milk of lactating ...

Effects on ability to drive and use machines

Acetazolamide has minor or moderate influence on the ability to drive and use machines. Some adverse reactions to acetazolamide, such as drowsiness, fatigue and myopia, may impair the ability to drive ...

Undesirable effects

Adverse reactions during short-term therapy are usually non-serious. Those effects which have been noted include: Blood and Lymphatic system disorder Uncommon: Thrombocytopenia, Leukopenia, Aplastic anaemia, ...

Overdose

Electrolyte imbalance, development of an acidotic state and central nervous effect might be expected to occur. Serum electrolyte levels, (particularly potassium) and blood pH should be monitored. Supportive ...

Pharmacodynamic properties

Pharmacotherapeutic Group: Carbonic anhydrase inhibitors ATC Code: S01EC01 Acetazolamide is a potent inhibitor of the enzyme carbonic anhydrase; the enzyme that catalyses the reversible reaction involving ...

Pharmacokinetic properties

DIAMOX SR is a sustained release formulation designed to obtain a smooth and continuous clinical response. Acetazolamide is readily absorbed after oral administration and binds tightly to plasma proteins ...

Preclinical safety data

Adverse reactions not observed in clinical studies, but seen in animals at exposure levels to clinical exposure levels and with possible relevance to clinical use were as follows: Acetazolamide has been ...

List of excipients

<u>Film coated Pellets:</u> Microcrystalline Cellulose, sodium Lauryl sulphate, purified water, ethylcellulose, Hydroxypropylmethyl cellulose (E464), mineral oil light and Pigment Blend PB-230005 Orange ...

Incompatibilities

None.

Shelf life

<u>Blister packs:</u> 36 months. <u>Polypropylene bottles:</u> 24 months.

Special precautions for storage

Store below 30°C. Store in the original package in order to protect from light and moisture.

Nature and contents of container

Blister Packs: 28 and 30 Capsules/ Pack Opaque UPVC/PVDC blister Pack heat sealed with aluminium foil backing in an outer carton Not all pack sizes may be marketed.

Special precautions for disposal and other handling

Not applicable.

Marketing authorization holder

Mercury Pharmaceuticals Ltd., Capital House, 85 King William Street, London EC4N 7BL, UK

Marketing authorization number(s)

PL 12762/0145

Date of first authorization / renewal of the authorization

22 June 2004

Date of revision of the text

05/01/2018

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