Forlax

Powder for oral solution in sachet. Almost white powder with an odour and taste of orange grapefruit.
4 g: Macrogol 4000 4.000 g per sachet.
10 g: Macrogol 4000 10.000 g per sachet.
Excipients with known effect: 4 g: Sorbitol (E420) 0.66 mg, Sulphur dioxide (E220) 4.8 x 10^-4 mg per sachet.
10 g: Sorbitol (E420) 1.7 mg, Sulphur dioxide (E220) 0.12 x 10^-2 mg per sachet**.
Excipients/Inactive Ingredients: Saccharin sodium (E954), orange-grapefruit flavour.
**Composition of the orange-grapefruit flavour: Orange and grapefruit essential oils, concentrated orange juice, citral, acetaldehyde, linalol, ethyl butyrate, alpha terpineol, octanal, beta gamma hexenol, maltodextrin, gum arabic, sorbitol, BHA (E320) and sulphur dioxide (E220).

Pharmacotherapeutic class: Osmotic laxative. ATC code: A06AD15 (A: digestive system and metabolism).
Pharmacology: Pharmacodynamics: High molecular weight (4000) macrogols are long linear polymers which retain water molecules by means of hydrogen bonds. When administered by the oral route, they lead to an increase in volume of intestinal fluids.
The volume of unabsorbed intestinal fluid accounts for the laxative properties of the solution.
Pharmacokinetics: The pharmacokinetic data confirm that macrogol 4000 undergoes neither gastrointestinal resorption nor biotransformation following oral ingestion.
Toxicology: Preclinical safety data: Toxicological studies in different species of animals did not reveal any signs of systemic or local gastrointestinal toxicity of macrogol 4000. Macrogol 4000 had no teratogenic or mutagenic effect. Potential drug interactions studies performed in rats on some NSAIDs, anticoagulants, gastric antisecretory agents, or on a hypoglycaemic sulfamide showed that FORLAX did not interfere with gastrointestinal absorption of these compounds. No carcinogenicity studies have been performed.

FORLAX should remain a temporary adjuvant treatment to appropriate lifestyle and dietary management of constipation, with a maximum 3-months treatment course in children. If symptoms persist despite associated dietary measures, an underlying cause should be suspected and treated.
4 g: Symptomatic treatment of constipation in children from 6 months to 8 years.
An organic disorder should have been ruled out by the doctor, especially in the age group under 2 years, before initiation of treatment.
10 g: FORLAX 10 g is indicated in symptomatic treatment of constipation in adults and children aged 8 years and above. An organic disorder should have been ruled out before initiation of treatment.

Oral route.
The effect of FORLAX becomes apparent within 24 to 48 hours after its administration.
Paediatric population: In children, treatment should not exceed 3 months due to a lack of clinical data more than 3 months.
Treatment-induced restoration of bowel movements will be maintained by hygienic (4 g)/lifestyle (10 g) and dietary measures.
Posology: 4 g: From 6 months to 1 year: 1 sachet (4 g) per day.
From 1 to 4 years: 1 to 2 sachets (4 to 8 g) per day.
From 4 to 8 years: 2 to 4 sachets (8 to 16 g) per day.
The daily dose should be adapted to the expected clinical effects.
10 g: The dosage is 1 to 2 sachets (10-20 g) per day, preferably taken as a single dose in the morning.
The daily dose should be adjusted according to the clinical response and may range from one sachet every other day (especially in children) up to 2 sachets a day.
Method of administration: The content of each sachet should be dissolved in about 50 ml of water just before use and taken in the morning. The resultant solution will be clear and transparent like water.
4 g: Taken in the morning in case of 1 sachet per day, or split among morning and evening in case of more than one sachet per day.

Diarrhoea, abdominal pain and vomiting have been reported. In cases of severe diarrhoea, weight loss and electrolytes imbalance may occur. Diarrhoea due to excessive dosing disappears when treatment is temporarily interrupted or the dosage is reduced.
Extensive fluid loss by diarrhoea or vomiting may require correction of electrolyte disturbances.

Severe inflammatory bowel disease (ulcerative colitis, Crohn's disease) or toxic megacolon.
Digestive perforation or risk of digestive perforation.
Ileus or suspicion of intestinal obstruction, symptomatic stenosis.
Painful abdominal syndromes of indeterminate cause.
Hypersensitivity to the active substance or to any of the excipients.

Special Warning: The treatment of constipation with any medicinal product is only an adjuvant to a healthy lifestyle and diet, for example: increase intake of liquids and dietary vegetable fiber; advice on appropriate physical activity and rehabilitation of the bowel reflex.
An organic disorder should have been excluded before initiation of treatment.
This medicine contains macrogol (polyethylene glycol).
Hypersensitivity (anaphylactic shock, angioedema, urticaria, rash, pruritus, erythema) to drugs containing macrogol (polyethylene glycol) have been reported, see Adverse Reactions.
This medicine contains sulphur dioxide, which may rarely cause severe hypersensitivity reactions and bronchospasm.
This medicine contains less than 1 mmol sodium (23 mg) per sachet, that is to say essentially "sodium-free".
In case of diarrhoea, caution should be exercised in patients at risk of disturbances of water-electrolyte balance (e.g. the elderly, 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. Cases of aspiration have been reported when extensive volumes of polyethylene glycol and electrolytes were administered with nasogastric tube. Neurologically impaired children who have oral-motor 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 Interactions.
Precaution 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.
4 g: Data on a limited number of patients on efficacy in children under the age of 2 years are limited.
After a 3-months treatment course, a complete clinical supervision of constipation should be performed.
This medicine contains 0.66 mg of sorbitol in each sachet.
10 g: This medicine contains 1.7 mg of sorbitol in each sachet.
Effects on Ability to Drive and Use Machines: No studies on the effects on the ability to drive and/or use machines have been performed.

Pregnancy: Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity.
There are limited amount of data (less than 300 pregnancy outcomes) for the use of FORLAX in pregnant women.
No effects during pregnancy are anticipated since systemic exposure to FORLAX is negligible. FORLAX can be used during pregnancy.
Lactation: There are no data on the excretion of FORLAX in breast milk. No adverse effects on the breastfed newborn/infant are anticipated since the systemic exposure of the breast-feeding woman to FORLAX is negligible. FORLAX can be used during breast-feeding.
Fertility: No fertility studies were conducted with FORLAX. However, since macrogol 4000 is not significantly absorbed, no effect on fertility is anticipated.

4 g: The undesirable effects listed in the table as follows have been reported during clinical trials including 147 children aged from 6 months to 15 years and post-marketing use. Generally, adverse reactions have been mostly mild and transitory and have mainly concerned the gastrointestinal system.
Adverse Drug Reactions are listed under headings of frequency using the following categories: 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 (cannot be estimated from the available data). (See Table 1.)

Click on icon to see table/diagram/image

In adults, the following additional undesirable effects have been observed in clinical trials and post-marketing use: Gastro-intestinal disorders: Uncommon: Defaecation urgency, faecal incontinence.
Metabolism and nutrition disorders: Unknown: Electrolytes disorders (hyponatremia, hypokalaemia) and/or dehydration, especially in elderly patients.
Immune system disorders: Unknown: Erythema.
10 g: Adverse Drug Reactions are listed under headings of frequency using the following categories : 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); not known (cannot be estimated from the available data).
Adult population: The undesirable effects listed in the table as follows 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: (See Table 2.)

Click on icon to see table/diagram/image

Paediatric population: The undesirable effects listed in the table as follows have been reported during clinical trials including 147 children aged from 6 months to 15 years and post-marketing use. As in adult population, adverse reactions have generally been mostly mild and transitory and have mainly concerned the gastrointestinal system: (See Table 3.)

Click on icon to see table/diagram/image

There is a possibility that the absorption of other medicinal products could be transiently reduced during use with FORLAX, particularly medicinal products with a narrow therapeutic index or short half-life such as digoxin, anti-epileptics, coumarins and immunosuppressive agents, leading to decreased efficacy.
FORLAX may result in a potential interactive effect when used with starch-based 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.

Store below 30°C in the original package to protect from light.

Laxatives, Purgatives

A06AD15 - macrogol ; Belongs to the class of osmotically acting laxatives.

NP