COLCHIMAX Tablet

For

- the treatment and prevention of gout attacks

- familial Mediterranean fever

- Behcet’s disease

- other acute microcrystalline attacks.

Dosage

Acute gout:

COLCHIMAX should be taken in tablet and half-tablet doses spread out over the course of the day.

No single dose should exceed 1mg colchicine.

In case of early therapy, a low dose of 1-2mg colchicine may be used on the 1st day of treatment.

Do not exceed:

- 3mg colchicine on the 1st day of treatment,

- 2mg colchicine on the 2nd and 3rd days of treatment,

- 1mg colchicine on the 4th and subsequent days of treatment.

If diarrhoea occurs, reduce the dosage.

Prophylaxis of acute gout / other microcrystalline events / Behcet’s disease:

1mg colchicine daily. If diarrhoea occurs, reduce the dosage to 0.5mg colchicine.

Periodic disease:

Adults: 1-2mg colchicine daily. Your doctor may increase the dosage in 0.5mg steps up to a maximum of 2mg colchicine daily, depending on the clinical and biological response.

Children: Because of the presence of tiemonium sulfate and opium powder, use of COLCHIMAX in children is not recommended.

Mode and route of administration: Oral route.

Administration frequency: This medicine should preferably be taken at meal times.

- Several renal disease

- Severe hepatic disease

- Glaucoma (acute ocular pain with visual disorders)

- Micturition disorders (prostate or bladder disorders)

- Breastfeeding

- Treatment with antibiotics such as pristinamycin or those of the macrolides family except spiramycin

- Digestive disorders (diarrhoea, nausea, vomiting), urticaria, skin rashes, dry mouth, thickening of bronchial secretions, dry eyes, vision disorders, heart rhythm disorders (palpitation), constipation, urinary disorders, irritability, mental confusion in elderly people.

- Exceptionally: blood disorders.

- Azoospermia (absence of spermatozoids in the sperm) and neuro-muscular disorders which are reversible after cessation of treatment.

Consult your doctor.

Lactation: Contraindicated.

The use of this medication is not recommended in patients with galactose intolerance, a Lapp lactase deficiency or a glucose or galactose malabsorption syndrome (rare hereditary diseases). Concomitant use of Colchicine with certain antibiotics.

Use this medicine with caution in case of:

- Prostate disorders

- Severe renal disease

- Severe hepatic disease

- Cardiac disorders

- Thyroid disorders

- Chronic bronchitis

- Certain digestive diseases

- In bed-ridden patients or those with reduced physical activity.

In the case of long term treatment, check the haemogram regularly.

Sports players: See the package insert about the details.

Dicycloverine

Dicycloverine relieves smooth muscle spasm of the intestinal tract. This action is achieved via a dual mechanism:

1) a specific anticholinergic effect (anti-muscarinic) at the Acetylcholine receptor sites and

2) a direct effect upon smooth muscles.

It is therefore useful for abdominal colics.

Dicycloverine is rapidly absorbed after oral administration reaching peak values within 60-90minutes. The principal route of elimination is via the urine.

Paracetamol

Paracetamol has antipyretic and mild analgesic actions. It is rapidly and completely absorbed after oral administration. Peak plasma concentrations occur within 0.5-2 hours. It is extensively metabolised and excreted in the urine.