ROMIDAB Film-coated tablet Ref.[115215] Active ingredients: Metformin

It is important that ROMIDAB tablets be taken in divided doses with meals.

Adults

Initially, one 500 mg tablet three times a day, or one 850 mg or 1000 mg tablet twice a day, with or after food. After 10 to 15 days the dose should be adjusted according to blood glucose measurements. A slow increase in dose may improve gastro-intestinal tolerability. Good diabetic control may be achieved within a few days, but it is not unusual for the full effect to be delayed for up to two weeks. If control is incomplete a cautious increase in dosage to a maximum of 2550 mg daily is justified. Once control has been obtained it may be possible to reduce the dosage of ROMIDAB.

Children and adolescents

ROMIDAB is not recommended for use in type 1 diabetes mellitus. ROMIDAB can be used in children from 12 years of age and adolescents. The usual starting dose is 500 mg or 850 mg once daily, given during meals or after meals. After 10 to 15 days the dose should be adjusted on the basis of blood glucose measurements. A slow increase in dose may improve gastro-intestinal tolerability. The maximum recommended dose of ROMIDAB is 2000 mg daily, taken as 2 or 3 divided doses.

Elderly

ROMIDAB dose in the elderly should be adjusted based on renal function (See “WARNINGS AND SPECIAL PRECAUTIONS ”).

Combination therapy

(See “ WARNINGS AND SPECIAL PRECAUTIONS”).

Hypoglycaemia can occur when ROMIDAB is given concomitantly with other oral antidiabetics, insulin or alcohol. In excessive doses, and particularly if there is a possibility of accumulation, lactic acidosis may develop. Lactic acidosis is a medical emergency and must be treated in hospital. Intense symptomatic and supportive therapy is recommended which should be particularly directed at correcting fluid loss and correcting blood glucose levels.

Treatment of Overdosage

There is no specific antidote for overdose with ROMIDAB. Treatment is supportive and symptomatic and should be directed at correcting fluid loss and metabolic disturbances. Haemodialysis is the most effective way to remove lactate and metformin (ROMIDAB).

Store at or below 25°C.

Keep container tightly closed. Keep blisters in outer carton until required for use.

KEEP OUT OF REACH OF CHILDREN.

1. Blister Pack:

Tablets are packed in clear PVC/PVdC aluminium blister packs:

ROMIDAB 500 mg TABLETS: 28’s (2 × 14’s), 56’s (4 × 14’s), 84’s (6 × 14’s), 100’s (10 × 10’s).

ROMIDAB 850 mg TABLETS: 28’s (2 × 14’s), 56’s (4 × 14’s), 60’s (6 × 10’s), 84’s (6 × 14’s).

ROMIDAB 1000 mg TABLETS: 28’s (2 × 14’s), 56’s (4 × 14’s), 60’s (6 × 10’s), 84’s (6 × 14’s).

The blister pack is packed in a cardboard carton.

2. HDPE Container:

Tablets are packed in a white opaque HDPE container with a white opaque stock ribbed closure and induction sealing wad. A 1 g active carbon sachet is included in each HDPE container. The exact amount of sachets per HDPE container is indicated in brackets in the following pack sizes:

ROMIDAB 500 mg TABLETS: 28’s (1), 56’s (1), 84’s (2), 300’s (3), 500’s (5)

ROMIDAB 850 mg TABLETS: 28’s (1), 56’s (1), 84’s (2), 300’s (4), 500’s (6)

ROMIDAB 1000 mg TABLETS: 28’s (1), 56’s (1), 84’s (2), 300’s (4), 500’s (6)

The HDPE container is packed in a cardboard carton.