Drug FORLAX have composition Macrogol, Flavour, Saccharin sodium, FORLAX Symptomatic treatment of constipation in adults and children aged 8 years and above

Phosphalugel is an antacid. It reduces the acidity of the stomach

Duphalac indications Constipation, Where soft stool is considered of medical benefit

QUALITATIVE AND QUANTITATIVE COMPOSITION

Each sachet contains 10g of macrogol 4000.

Macrogol 4000   10.00g

Flavour (orange – grapefruit)  0.15g

Saccharin sodium    0.017g

Per sachet of 10.17g

+ Composition of the orange-grapefruit flavour

Orange and grapefruit oils, concentrated orange juice, citral. acetaldehyde, linalol, ethyl butyrate, alpha terpincol, octanal,beta gamma hexenol. maltodextrine. gum arabic, sorbitol, BHA (E320) and sulphur dioxide (E220).

PHARMACEUTICAI FORM

Powder for oral solution in sachet.

Single dose sachet containing an almost white powder with an odour and taste of orange grapefruit

INDICATIONS

Symptomatic treatment of constipation in adults and children aged 8 years and above. An organic disorder should have been niled out before initiation of treatment. FORLAX l0g should remain a temporary treatment of constipation adjuvant to appropriate hygienic and dietary measures, with a maximum 3-month treatment course in children. If symptoms pasist despite hygienic and dietary measures, an underlying cause should be suspected and treated

METHOD OF ADMINISTRATION

l to 2 sachets per day, preferably utken asti single dose in the morning. Each sachet should be dissolved in a glass of water just before use.

The effect of FORLAX becomes apparent within 24 to 48 hours after its administration.

In children, treatment should not exceed 3 months in the lack of clinical data more than 3 months.Treatment-induced restoration of bowel movements will be maintained by hygienic and dietary measures.

The daily dose should be adapted according to the clinical effects and may range from one sachet every other day (especially in children) up to 2 sachets a day.

CONTRAINDICATIONS

– severe inflammatory bowel disease (such as ulcerative colitis, Crohn’s disease) or toxicitiegicolon, associated with symptomatic stenosis,

– digestive perforation or risk of digestive perforation,

– ileus or suspicion of intestinal obstruction,

– painful abdominal syndromes of indeterminate cause.

– hypersensitivity to macmgol (polyethylene glycol) or to any of the excipients.

SPELTAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE

Warning

The treatment of constipation with any medicinal product is only an adjuvant to a healthy lifestyle and diet, for example: increased intake at liquids and dietary fibre

– appropriate physical activity and rehabilitation of the bowel reflex.

Patients with hereditary problems of fructose intolerance should not take this medicinal product.

Due to the presence of sulphur dioxide, it may rarely cause severe hypersensitivity reactions and bronchospasm.

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

Precaution for you

Very rare cases of hypersensitivity reactions (rash, urticaria, oedema) have been reported with drags containing macmgol (polyetliylene glycol). Exceptional tees of anaphy lactic shock have been reported.

FORI AX dose not contain a significant quantity of sugar or polyol and can he prescribed to diabetic patients or patients on a galactose-free

INTERRACTION WITH OTHER  MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION

Not applicable

PREGNANCY AND LACTATION

Pregnancy

Macrogol 4000 was not teratogenic in rats or rabbits

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

Lactation

No effects on the breast feeding newborn/infant are anticcipated since the sys temic exposure of the breast-feeding woman to macrogol 4000 is negligible. FORLAX can be used during breast feeding.

EFFECTS ON ABILITY TO DRIVE AND USE MACHINES

Not applicable

UNDESIRANLE EFFECTS

Adverse Drug Reactions are listed under headings of frequency using the folloing categories:

Very common (>=1/10): common (>=1/100 to < 1/10), incommon( (>=1/1000 to < 1/100); rare (>=1/10,000 to < 1/1000); very rare (<1/10 to < 1/10,000); unknown (cannot be estimated from the availanle data)

Adult population:

The undesirable effects listed in the table below has been reoirted during  clinical trials (including 600 adult atients) and post – marketing use

Generally, adverse reactions have been minor and transitory and have mainly concerned the gastrointestinal system:

System Organ Class	Adverse reactions
Gastrointestinal disorders
Common	Abdominal pain and/ or distension Diarrhoea Nausea
Uncommon	Vomiting Urgency to defecate Fecal incontinence
Metabolism and Nutrition Disorders
Unknown	Electrolytes disorders (Hyponatremia, Hypokalaemia) and or dehydration, especially in elderly paiterns
Immune system disorders
Very rare	Hypersensitivity reactions (Pruritus. Rash. Face oedema, Quincke oedema. Urticaria. Anaphylactic shock)

Paediatric population

The undesirabk effects Usted in the table below have been repotted 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 minor and transitory and have mainly concerned the gastrointestinal system:

System Organ Class	Adverse reactions
Gastrointestinal disorders
Common	Abdummal pain Diarrhoea
Uncommon	Vomiting Bloating Nausea
Immune system disorders
Unknown |	Hypersensitivity reactions

* Diarrhoea may cause perianal soreness

OVERDOSE

Overdose leads to diarrhoea which disappears when treatment is temporarily interrupted or the dosage is reduced.

Excessive fluid loss by diarrhoea or vomiting may require correction of electrolyte disturbances.

Cases of aspiration have been reported when extensive volumes of polyethylene glycol and electrolytes were administered with nasogastric tube. Ncurologically impaired children who have ormotor dysfunction are particularly at risk of aspiration.

PHARMACODYNAMIC PROPERTIES

OSMOTIC LAXATIVE, ATC code: A06AD15

A: gastrointestinal tract and metabolism

High molecular weight (4000) macrogols (PEG) are long linear polymers which retain water molecules by means of hydrogen bunds. When

administered by the oral route, they lead to an increase in volume of intestinal fluids

The volume of unabsorbed intestinal fluid accounts tor the laxative properties of the solution.

PRECLINICAL SAFETY DATA

Toxicological studies in different species of animals did not reveal any sign of systemic or local gastrointestinal toxicity of macrogol 4000.

Macrogol 4000 had no teratogenic, mutagenic, nor carcinogenic effect, Potential drug interactions studies performed in rats on some.

NSAIDs, anticoagulants, gastric antisecretory agents, or on a hypoglycaemic sulfamide showrd the FORLAX did not interfere with gastrointestinal absorption of these compounds

PHARMACOKINETIC PROPERTIES

The pharmacokinetic data confirm that macrogol 4000 undergoes niether gastrointestinal resorption nor biotranformation following oral ingestion

SHELF LIFE: 3 years

STORAGE: stored below 30⁰ C

NATURE AND CONTENTS OF CONTAINER

10,167 g of powder in signle dose sachet ( Paper/Aluminium/PE)

Box of 10,20, or 50 cachet.

Read the pack insert carefully before use. Ask Doctor or Pharmacist if need more information.