Each ml contains:

Active substance:

Hyoscine butylbromide 20 mg

(equivalent to 13.8 mg hyoscine)

Excipients:

Benzyl alcohol (E1519) 20 mg

Clear, colourless to slightly yellow solution

Treatment of acute spasms of the gastrointestinal tract (colic) and of the urinary tract.

As an aid in procedures for which reduced peristaltic activity of the gastrointestinal tract or reduced contractions in the urinary tract are required.

For intravenous or intramuscular use.

Horses, cattle and pigs: 0.2 - 0.4 mg of hyoscine butylbromide/kg body weight by intravenous injection (equivalent to 0.1 - 0.2 ml of the product/10 kg body weight).

Sheep: 0.7 mg of hyoscine butylbromide/kg body weight by intravenous injection (equivalent to 0.35 ml of the product/10 kg body weight).

To reduce contractions of the smooth muscle in the gastrointestinal or urinary tract (spasmolytic effect):

If necessary, treatment can be repeated once at 12 hours after initial administration according to the veterinarian criteria.

Only in cases where intravenous injection is not possible, the veterinary medicinal product may be administered intramuscularly at the higher dose specified for the respective target species.

For clinical procedures (see indications for use):

Administer immediately before inactivity in the gastrointestinal or urinary tract is required.

For clinical procedures use intravenous administration only.

A slow injection when using either the intravenous or the intramuscular route is recommended.

To ensure administration of a correct dosage, body weight should be determined as accurately as possible and dosing devices or syringes with suitable graduations are to be used.

The rubber stopper can be punctured a maximum of 25 times.

Do not use in case of paralytic ileus, mechanical obstruction, or cardiac disorders.

Do not use in cases of hypersensitivity to the active substance or to any of the excipients.

Do not use in horses with glaucoma.

Do not use in horses less than 6 weeks of age.

None.

Special precautions for use in animals

Horses should be monitored carefully following treatment.

The treatment is essentially symptomatic and an appropriate handling of the underlying disorder is necessary.

Special precautions to be taken by the person administering the veterinary medicinal product to animals

People with known hypersensitivity to hyoscine butylbromide or benzyl alcohol should avoid contact with the veterinary medicinal product.

Accidental self-injection may result in cardiac and circulatory effects. Avoid accidental self-injection. In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.

The product can cause skin and eye irritation. Avoid contact with skin and eyes. In the case of contact with skin, wash with soap and water. If irritation persists, seek medical advice. Wash hands after use.

If the product comes into contact with the eyes, rinse the eyes immediately with plenty of water and seek medical attention if irritation persists.

On very rare occasions, tachycardia may occur.

In horses, the veterinary medicinal product may cause colic due to inhibition of motility.

The frequency of adverse reactions is defined using the following convention:

- Very common (more than 1 in 10 animals treated displaying adverse

reaction(s))

- Common (more than 1 but less than 10 animals in 100 animals treated)

- Uncommon (more than 1 but less than 10 animals in 1,000 animals treated)

- Rare (more than 1 but less than 10 animals in 10,000 animals treated)

- Very rare (less than 1 animal in 10,000 animals treated, including isolated

reports

Laboratory studies in mice have not produced any evidence of a teratogenic effect. No information on use during pregnancy in the target species is available. An effect upon the smooth muscles of the birth canal can occur.

Hyoscine butylbromide, like all other anticholinergic agents, can inhibit the production of milk. Due to its low solubility in fat, excretion of hyoscine butylbromide in milk is very low.

Use only according to the benefit-risk assessment by the responsible veterinarian.

This medicinal product may enhance the tachycardic effects of beta-adrenergic drugs and may alter the effect of other drugs, such as digoxin.

The effects of hyoscine butylbromide may be potentiated by the concomitant use of other anticholinergic drugs. Co-administration with other anticholinergic or parasympatholytic drugs should be avoided.

Meat and offal:

Horse 3 days

Cattle 2 days

Sheep 18 days

Pig 9 day

Milk:

Horse, Cattle and Sheep 12 hours

In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal product.

This veterinary medicinal product does not require any special storage conditions before first opening.

After first opening do not store above 25 °C.

Cardboard box with colourless glass vial type II (Ph. Eur.). Bromobutyl rubber stopper, type I (Ph. Eur.) and pull off or flip off aluminium cap.

Pack size: Cardboard box with 1 vial of 50 ml.

Richter Pharma AG, Feldgasse 19, 4600 Wels, Austria

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.

Vm 22080/4014