FORLAX Powder for solution Ref.[50353] Active ingredients: Macrogol

The treatment of constipation with any medicine is only an adjuvant to a healthy lifestyle and diet, for example:

• increase intake of liquids and dietary fibre,
• advice on appropriate physical activity and rehabilitation of the bowel reflex.

An organic disorder should have been excluded before initiation of treatment.

FORLAX contains macrogol (polyethylene glycol). Hypersensitivity (anaphylactic shock, angioedema, urticaria, rash, pruritus, erythema) to medicines containing macrogol (polyethylene glycol) have been reported, see section 4.8.

FORLAX contains sulphur dioxide, which may rarely cause severe hypersensitivity reactions and bronchospasm.

Patients with hereditary problems of fructose intolerance should not take FORLAX.

In case of diarrhoea, caution should be exercised in patients at risk of disturbances of water-electrolyte balance (e.g. the elderly or patients with impaired hepatic or renal function or patients taken diuretics) and electrolyte control considered.

Use with caution in patients with impaired gag reflex and patients prone to regurgitation or aspiration. Neurologically impaired children who have oralmotor dysfunction are particularly at risk of aspiration.

In patients with swallowing problems, who need the addition of a thickener to solutions to enhance an appropriate intake, interactions should be considered, (see section 4.5).

Precautions for use

FORLAX does not contain a significant quantity of sugar or polyol and can be prescribed to diabetic patients or patients on a galactose-free diet.

This medicine contains less than 1 mmol sodium (23 mg) per sachet that is to say essentially “sodium-free”.

There is a possibility that the absorption of other medicines could be transiently reduced during use with FORLAX, particularly medicines with a narrow therapeutic index or short half-life such as digoxin, anti-epileptics, coumarins and immunosuppressive medicines, leading to decreased efficacy.

FORLAX may result in a potential interactive effect when used with starchbased food thickeners. The polyethylene glycol (PEG) ingredient counteracts the thickening effect of starch, effectively liquefying preparations that need to remain thick for people with swallowing problems.

Pregnancy

Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).

There is a limited amount of data (less than 300 pregnancy outcomes) for the use of FORLAX in pregnant women.

No adverse effects during pregnancy are anticipated, since systemic exposure to FORLAX is negligible. FORLAX can be used during pregnancy.

Breastfeeding

There are no data on the excretion of macrogol 4000 in breast milk. As macrogol 4000 is not significantly absorbed, FORLAX may be administered during lactation.

Fertility

No fertility studies were conducted with FORLAX however since macrogol 4 000 is not significantly absorbed no effect on fertility is anticipated.

No studies on the effects on the ability to drive and use machines have been performed.

Adverse Drug Reactions are listed under headings of frequency using the following categories: Adverse Drug Reaction Classification Terminology (frequency): Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); unknown (postmarketing data).

Adults

The undesirable effects listed in the table below have been reported during clinical trials (including 600 adult patients) and post-marketing use. Generally, adverse reactions have been mostly mild and transitory and have mainly concerned the gastrointestinal system:

Children

The undesirable effects listed in the table below have been reported during clinical trials including 147 children aged from 6 months to 15 years and post-marketing use. The adverse reactions have generally been mostly mild and transitory and have mainly concerned the gastrointestinal system:

^* Diarrhoea may cause perianal soreness.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Health care providers are asked to report any suspected adverse reactions to SAHPRA via the “6.04 Adverse Drug Reactions Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8 or Acino Pharma (Pty) Ltd: E-mail: drugsafety_ZA@acino.swiss Tel: 060 998 7896

Not applicable.