FORLAX Uses, Dosage, Side Effects, Precautions & Warnings

what is forlax used for
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forlax Generic drug of the Therapeutic class: Gastro-EnteroHepatology
active ingredients: Macrogol 4000

Important to know about FORLAX ?

  • FORLAX is indicated for the treatment of constipation in adults and children over 8 years of age.
  • This medicine is in the form of a powder that must be dissolved in a glass of water (at least 50 ml) and drink. Its effect usually occurs in 24 hours to 48 hours.
  • The treatment of constipation with a drug must be associated with rules of lifestyle and a healthy diet.

what is forlax used for  and indication?

  • Symptomatic treatment of constipation in adults and children from 8 years.
  • An organic cause should be discarded before initiating treatment. FORLAX 10 g should remain a temporary treatment of constipation, lasting no more than 3 months in children, in combination with appropriate dietary measures.
  • The persistence of the disorders in spite of the combined hygienic and dietary measures will have to seek out and treat an underlying pathology.

FORLAX Dosage

Oral way.

  1. The dosage is 1 to 2 sachets per day, preferably in a single dose in the morning.
  2. The contents of each sachet should be dissolved in a glass of water just before administration.
  3. The effect of FORLAX occurs within 24 to 48 hours of administration.
  4. In children, in the absence of clinical data beyond 3 months, the duration of treatment should not exceed 3 months.
  5. Improvement of the intestinal transit induced by the treatment will be maintained by hygienic and dietary measures.
  6. The daily dose should be adapted according to the clinical effects obtained and can range from 1 sachet every other day (especially in children) to 2 sachets per day.

Contraindications

Severe inflammatory bowel disease (ulcerative colitis, Crohn’s disease) or toxic megacolon, associated with symptomatic stenosis,

Digestive perforation or risk of digestive perforation,

Ileus or suspected intestinal obstruction,

Painful abdominal syndromes of unknown cause

Hypersensitivity to macrogol (polyethylene glycol) or to any of the excipients.

How it works?

Pharmacokinetic data confirm the absence of digestive resorption and biotransformation of macrogol 4000 after oral ingestion.

FORLAX Side Effects

The frequency of adverse reactions can be classified as follows:

  • Very common ( > 1/10), common (≥ 1/100 to <1/10), uncommon (≥ 1/1000 to <1/100), rare (≥ 1/10 000 to <1/1000) ), very rare (<1 / 10,000), not known (can not be estimated from the available data).

In adults:

The side effects listed in the table below have been reported in clinical studies (including approximately 600 patients) and in product marketing. In general, these side effects have always been minor and transient, and mainly concerned the digestive system:

Organ system

Side effects

Gastrointestinal disorders

Frequent

Abdominal pain

Abdominal distention

Diarrhea

nausea

Rare

vomiting

Defecation imperious

Fecal incontinence

Metabolism and nutrition disorders 

Not known frequency

Electrolyte disturbances (hyponatremia, hypokalemia) and / or dehydration especially in the elderly

Immune system disorders

Not known frequency

Hypersensitivity: anaphylactic shock, angioedema, urticaria, rash, pruritus, erythema.

In children:

The undesirable effects listed in the table below have been reported in clinical trials involving 147 children aged 6 months to 15 years of age and when marketing the product. As with adults, these side effects have generally been minor and transient and mainly involved the digestive system:

Organ system

Side effects

Gastrointestinal disorders

Frequent

Abdominal pain

Diarrhea*

Rare

vomiting

Abdominal distension, Nausea

Immune system disorders

Not known frequency

Hypersensitivity (anaphylactic shock, angioedema, urticaria, rash, pruritus).

* Diarrhea can cause perianal pain.

FORLAX Interactions

Not applicable.

FORLAX Warnings and Precautions :

Special warnings

Medication treatment of constipation is only an adjunct to the hygienic and dietary treatment such as:

  • · Enrichment of the vegetable fiber and beverage feed,
  • · Adapted physical activity and re-education of the exemption.
  • An organic cause must be discarded before initiating treatment.

This medicine contains macrogol (polyethylene glycol). Hypersensitivity reactions (anaphylactic shock, angioedema, urticaria, rash, pruritus, erythema) have been reported with specialties containing macrogol, .

This medicine contains sulfur dioxide and in rare cases can cause severe allergic reactions and bronchospasm.

This drug contains sorbitol. Its use is not recommended in patients with fructose intolerance (rare hereditary disease).

In case of diarrhea, patients at risk of fluid and electrolyte imbalance (eg, subject, patient with hepatic impairment or renal failure or diuretic therapy) should be monitored and electrolyte control should be considered.

Cases of inhalation have been reported during nasogastric tube administration of large volumes of polyethylene glycol and electrolytes. Children with neurological involvement with oromotor disorders are particularly exposed to this risk of inhalation.

Special precautions for use

Because FORLAX does not contain a significant amount of sugar or polyol, it can be prescribed to diabetic patients or to patients on a galactose-free diet.

Drive and use machines

Not applicable.

FORLAX and PREGNANCY / BREAST FEEDING / FERTILITY:

Pregnancy

  • Studies in animals have not shown any direct or indirect harmful effects on reproduction.
  • There is limited data (less than 300 pregnancies) on the use of Forlax in pregnant women.
  • No effects during pregnancy are expected as systemic exposure to Forlax is negligible.
  • Forlax can be used during pregnancy.

Breastfeeding

  • There are no data on the excretion of Forlax in breast milk.
  • No effects in breastfed newborns / infants are expected as the systemic exposure of the woman who is breastfeeding at Forlax is negligible. Forlax can be used while breastfeeding.

Fertility

  • No fertility studies have been performed with Forlax. However, since macrogol 4000 is not absorbed significantly, no effect on fertility is expected.

What should I do if I miss a dose?

Take the dose but do not double it to make up for the dose you forgot to take.

What happens if I overdose from?

  • Taking too much FORLAX can cause diarrhea, which usually disappears when treatment is stopped or the dose is reduced.
  • If you have severe diarrhea or vomiting you should contact a doctor as soon as possible because you may need treatment to prevent loss of salts (electrolytes) due to fluid loss.

What is  Forms and Composition?

FORMS 
  • Powder for oral solution (with a smell and taste of orange and grapefruit, white to whitish):   Sachets, box of 20.
COMPOSITION
  p bag
Macrogol (DCI) 4000 * 10 g
  • Excipients: saccharin sodium (E 954), orange grapefruit flavor (including sorbitol [E 420] and sulfur dioxide [E 220]).

*  PEG 4000 or polyethylene glycol 4000

NOT’s

Edrug-online contains comprehensive and detailed information about drugs available in the medical field, and is divided into four sections:

general information:

  • Includes a general description of the drug, its use, brand names, FAQs, and relevant news and articles

Additional information:

  • General explanation about dealing with the medicine: how to take the medicine, the doses and times of it, the start and duration of its effectiveness, the recommended diet during the period of taking the medicine, the method of storage and storage, recommendations in cases for forgetting the dose and instructions to stop taking the drug and take additional doses.

Special warnings:

  • For pregnant and breastfeeding women, the elderly, boys and drivers, and use before surgery.

Side effects:

  • It treats possible side effects and drug interactions that require attention and its effect on continuous use.
  • The information contained in this medicine is based on medical literature, but it is not a substitute for consulting a doctor.

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