1 ml contains: Active substance:

Lactulose 667.0 mg (as lactulose, liquid)

Excipient: Benzyl alcohol (E1519) 2.0 mg

Syrup. Clear, viscous liquid, colourless or pale brownish-yellow.

Dogs and cats.

For the treatment of constipation (e.g. due to intestinal atony after surgery, hairballs, massive intestinal contents).

For the symptomatic treatment of disease conditions which require facilitated defecation (e.g. partial obstructions due to for example tumours and fractures, rectal diverticulum, proctitis and poisoning).

Do not use in animals with total gastro-intestinal obstruction, digestive perforation or risk of digestive perforation.

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

Lactulose solution contains some free lactose and galactose, and may alter the insulin requirements in diabetic patients. Use with caution in animals with pre-existing fluid and electrolyte imbalances, since lactulose may exacerbate these conditions, if diarrhoea occurs.

This veterinary medicinal product may cause flatulence and diarrhoea. Accidental ingestion should be avoided, especially by a child. To avoid accidental ingestion, the veterinary medicinal product must be used and kept out of reach of children. Always replace the cap after use.

This veterinary medicinal product contains benzyl alcohol. This preservative may cause hypersensitivity (allergic) reactions. People with known hypersensitivity to benzyl alcohol should avoid contact with the veterinary medicinal product. Wash hands after use. In case direct contact with skin or eyes should occur, rinse with clean water. If irritation persists, seek medical advice.

Signs of flatulence, gastric distention, cramping, etc. are common early in therapy, but generally abate with time. Diarrhoea and dehydration are signs of (relative) overdose; if this occurs, a veterinarian should be consulted.

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).

Can be used during pregnancy and lactation.

For oral administration.

Dogs and cats: 400 mg lactulose per kg body weight per day, corresponding to 0.6 ml veterinary medicinal product per kg body weight per day. This should preferably be divided into 2-3 doses over the day. The dosage may be adjusted as needed.

Approximately 2-3 days of treatment may be necessary before a treatment effect occurs.

Contact a veterinarian to adjust the treatment if abdominal discomfort or diarrhoea occur. The veterinary medicinal product can be mixed with feed or given directly into the mouth.

An overdose does not cause other adverse effects than those stated in Adverse reactions. Replace fluids and electrolytes if necessary.

Pharmacotherapeutic group: Osmotically acting laxative, lactulose.

ATCvet code: QA06AD11

Lactulose is a disaccharide (galactose/fructose) that is not hydrolysable by mammalian gut enzymes. Upon reaching the colon, lactulose is metabolized by the resident bacteria resulting in the formation of low molecular weight acids (lactic, formic and acetic acid) and CO2. These acids have a dual effect; they increase osmotic pressure drawing water into the bowel causing a laxative effect and also acidify colonic contents. The acidification causes NH3 (ammonia) to migrate from the blood into the colon where it is trapped as [NH4]+ (ammonium ion) and expelled with the faeces.

Lactulose is poorly absorbed after oral administration and it reaches the colon unchanged. In dogs and cats, less than 2% of an oral dose of lactulose is absorbed (in the small intestine). The absorbed drug is not metabolized and excreted unchanged in the urine within 24 hours.

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

Shelf life of the veterinary medicinal product as packaged for sale: 2 years

Shelf life after first opening of the bottle: 3 months

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

50 ml and 125 ml: HDPE bottle closed with a (LDPE) syringe inlay and a (HDPE) cap.

325 ml: HDPE bottle closed with a (LDPE) syringe inlay and a cap (PP).

Oral syringe (5 and 10 ml): Polypropylene (PP) barrel and plunger, graduated per 0.2 ml.

Cardboard box of 1 bottle of 50 ml with a 5ml oral syringe

Cardboard box of 1 bottle of 125 ml with a 5ml oral syringe

Cardboard box of 1 bottle of 325 ml with a 10ml oral syringe

Not all pack sizes may be marketed.

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

Dechra Regulatory BV, Handelsweg 25, 5531 AE Bladel, The Netherlands.

Vm 50406/4000

22 May 2019

May 2023

For animal treatment only. To be supplied only on veterinary prescription. Keep out of the sight and reach of children.