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Co-Amilozide Tablets 2.5/25

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Document: spc-doc_PL 34109-0005 change

SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Co-amilozide tablets 2.5/25

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Co-amilozide tablets 2.5/25

1 tablet contains 2.84mg amiloride hydrochloride (2.5mg anhydrous amiloride hydrochloride)

and 25mg hydrochlorothiazide.

3    PHARMACEUTICAL FORM

Tablets

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

Potassium-conserving diuretic and antihypertensive.

For the treatment of conditions requiring diuretic therapy with the maintenance of a safe serum potassium level, e.g. congestive heart failure, in particular when treated with digitalis, and other diuretic-treated cardiac conditions. Hypertension, when diuretic-induced hypokalaemia persists despite appropriate measures. Hepatic cirrhosis with ascites and oedema.

Co-amilozide can be given together with other antihypertensive drugs such as beta-adrenergic blocking agents.

4.2 Posology and method of administration

Adults:

Hypertension: initially 1 tablet daily, increasing if necessary to a maximum of 2 tablets daily.

Congestive heart failure: initially 1 tablet daily, increasing if necessary to a maximum of 4 tablets daily.

Oedema and ascites in cirrhosis of the liver: initially 2 tablets daily, increasing if necessary to a maximum of 4 tablets daily; dose should be reduced for maintenance if possible.

Elderly:

In elderly patients in initial dose of 1 Co-Amilozide 2.5/25 tablet is recommended. Children:

Co-Amilozide is not recommended for the treatment of children, as safety and effectiveness in children have not been established.

The tablets are intended for oral administration.

4.3 Contraindications

Known hypersensitivity to thiazides, related sulphonamides, or amiloride hydrochloride. Anuria. Acute renal insufficiency or rapidly advancing renal impairment (BUN> 10 mmol/1, serum creatinine> 130 micromol/1).

Diabetic nephropathy. Elevated serum potassium levels (>5.5mmol/1). Concomitant treatment with other potassium sparing agents. Potassium supplementation, unless serum potassium is carefully monitored. Seriously reduced hepatic function. Manifest gout.

4.4 Special warnings and precautions for use

Should not be given to patients with renal impairment, as the use of potassium conserving agents may result in the rapid development of hyperkalaemia, which may also be caused in diabetic patients. Hyperkalaemia in aged patients with normal renal function has been reported. Thiazide-induced hypokalaemia, hyponatraemia and raised blood urea nitrogen may occur. Regular monitoring of serum creatinine, serum electrolytes (particularly potassium and sodium), and blood urea nitrogen is important, especially in elderly and diabetic patients. Co-amilozide should be given with great care to patients at risk of developing metabolic or respiratory acidosis, such as those with cardiopulmonary disease or poorly controlled diabetes. Treatment should be discontinued prior to glucose tolerance testing. In cirrhotic patients the risk of hepatic encephalopathy should be kept in mind.

4.5 Interaction with other medicinal products and other forms of interaction

Increased risk of hyperkalaemia if ACE-inhibitors are administered concomitantly.

4.6 Pregnancy and lactation

Not recommended during pregnancy. Hydrochlorothiazide crosses the placental barrier and may cause foetal or neonatal hyperglycaemia, thrombocytopenia or electrolyte disturbances. Hydrochlorothiazide is also excreted in breast milk, and lactation should be discontinued if the use of co-amilozide is considered of importance to the mother.

4.7 Effects on ability to drive and use machines

None stated.

4.8 Undesirable effects

Nausea, vomiting, cramps in calf muscles, exanthem, hypotension and electrolyte disturbances.

4.9 Overdose

Nausea, vomiting, cramps in calf muscles, exanthem, hypotension and electrolyte disturbances. Symptomatic treatment.

5    PHARMACOLOGICAL PROPERTIES

5.1    Pharmacodynamic properties

Co-amilozide is a diuretic and antihypertensive combining the natriuretic action of hydrochlorothiazide with the potassium-conserving effect of amiloride hydrochloride.

5.2 Pharmacokinetic properties

Absorption:

Gastrointestinal absorption of hydrochlorothiazides ranges between 60-80%, and for amiloride it is about 50%. Both drugs are rapidly absorbed upon oral administration, and maximum plasma levels are reached 3-4 hours after administration.

Distribution:

Hydrochlorothiazide and amiloride are rapidly distributed, and observable diuresis occurs within 1-2 hours.

Biotransformation:

Amiloride is not bound to plasma proteins and has a plasma half life of 6-10 hours. Hydrochlorothiazide has a plasma half life of about 10 hours. Its biological half-life is up to 15 hours.

Excretion:

Amiloride and hydrochlorothiazide are excreted unchanged, mainly in the urine.

5.3 Preclinical safety data

As Co-Amilozide has been proven essentially similar to Moduretic, no preclinical testing has been performed.

6    PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Rice starch, cellulose microcrystalline, lactose, magnesium stearate, povidone (K-valve 29-32) and talc. Alcohol (96 percent) and purified water are used during the manufacturing of Co-Amilozide tablets 2.5/2 5, but are not detectable in the finished product.

6.2 Incompatibilities

None relevant.

6.3 Shelf life

2 years.

6.4 Special precautions for storage

None stated.

6.5 Nature and contents of container

Securitainers: Opaque polypropylene containers having snap on polyethylene lids with integral tear-off security seals, e.g. J & J “Securitainer” or Wrangby “Snap-Secure” container.

Pack size: 30 or 100 white or almost white tablets.

6.6 Special precautions for disposal

None.

7    MARKETING AUTHORISATION HOLDER

Genethics (UK) Limited

Boumpoulinas 11, 1st Floor

Nicosia

PC. 1060

Cyprus

8    MARKETING AUTHORISATION NUMBER(S)

PL 34109/0005

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

17/03/2009

10    DATE OF REVISION OF THE TEXT

17/03/2009