French pharmacy
0
French pharmacy
Forlax 4g 20 bags on sale in our pharmacy bio, is indicated for the treatment of constipation in children aged 6 months to 8 years.
For warnings, precautions for use and contraindications, please consult the instructions for use.
It may be helpful to distinguish constipation in infants from constipation in older children. Indeed, constipation in infants is quite rare and most often results from insufficient hydration, whether in water or milk.
In children, on the other hand, if hydration also plays a role, constipation generally has a dietary origin. With them we find a low consumption of fiber but rather rich in food promoting constipation (rice, potato, bananas, chestnuts, starchy foods in general, hard-boiled eggs, chocolate, boiled carrots…).
Constipation in children can also have an emotional origin. In fact, constipation can appear:
Forlax 4g 20 Sachets contains an osmotic laxative . It increases the amount of water in the feces, which helps to solve the problems due to a slowed intestinal transit. Forlax 4g is not absorbed into the bloodstream and is not changed in the body. It is used for the treatment of constipation in children aged 6 months to 8 years.
The treatment of constipation with a drug should be combined with rules of healthy living and a healthy diet.
The contents of the sachet should be diluted in approximately 50 ml of water.
The laxative effect occurs 24 to 48 hours after taking the medication.
Usual dosage :
The active substance is Macrogol 4000, each sachet containing 4.00g.
The other ingredients are: sodium saccharin (E954) and orange-grapefruit flavor (containing essential oils of orange and grapefruit, orange juice concentrate, citral, acetic aldehyde, linalool, ethyl butyrate, alpha terpineol, octanal, beta gamma hexenol, maltodextrin, gum arabic, sorbitol (E420), BHA (E 320) and sulfur dioxide (E 220).
Do not give Forlax 4g 20 Sachets if :
- your child is allergic (hypersensitive) to Macrogol (polyethylene glycol) or to any of the other ingredients of the medicine, which are listed in section 6 "Additional information" of the package leaflet.
- your child has a disease such as severe bowel disease:
Very rare cases of allergic manifestations manifesting as a rash on the skin and swelling of the face have been reported in adults after taking medicines containing Macrogol (polyethylene Glycol). Isolated cases of severe allergic manifestations leading to unconsciousness or malaise and feelings of general malaise have been reported.
If your child has any of these symptoms, contact your doctor immediately. An organic cause must have been ruled out before initiating treatment; contact your pharmacist or doctor before administering this medicine.
Since this medication can sometimes cause diarrhea, contact your doctor or pharmacist before giving this medication if your child:
Use of other drugs
If your child is taking or has recently taken other medicines, including medicines obtained without a prescription, talk to your doctor or pharmacist.
Box of 20 sachets.
Attention, the drug is not a product like the others. Read the package leaflet carefully before ordering. Keep medicines out of the reach of children. If symptoms persist, seek the advice of your doctor or pharmacist. Beware of incompatibilities on your current products.
Pharmacovigilance Report an adverse drug reaction(s)
ANSM - Last updated: 11/03/2015
FORLAX 4 g, powder for oral solution in sachet
Macrogol 4000
· Keep this leaflet, you may need to read it again.
· If you have any further questions, ask your doctor or pharmacist.
· This medication has been prescribed to your child. Do not give this to anyone else. It could be harmful to them, even if the signs of their illness are identical to those of your child.
· If your child's symptoms worsen or persist, consult a doctor.
· If your child has any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet.
What is in this leaflet?
1. What is FORLAX 4 g, powder for oral solution in sachets and in which cases it is used?
2. What should I know before taking FORLAX 4 g powder for oral solution in sachet ?
3. How to take FORLAX 4 g, powder for oral solution in sachet ?
4. What are the possible side effects?
5. How to store FORLAX 4 g powder for oral solution in sachet ?
6. Additional Information.
1. WHAT FORLAX 4g, powder for oral solution in sachets AND WHAT CASES IS IT USED FOR?
FORLAX is indicated for the treatment of constipation in children aged 6 months to 8 years.
This medicine is in the form of a powder that must be dissolved in a glass of water and drink. Its effects generally manifest in 24h to 48 hours.
The treatment of constipation with a medication must be associated with healthy lifestyle and healthy eating.
2. BEFORE YOU TAKE FORLAX 4 g powder for oral solution in sachet?
List of information needed before taking the medication
Not applicable
Never give Forlax:
· If your child has a disease such as severe bowel disease:
- inflammation of the intestine (such as ulcerative colitis, Crohn's disease, abnormal dilatation of the intestine),
- perforation of the intestine or risk of perforation of the intestine,
- Ileus or suspicion of obstruction of the intestine,
- Abdominal pain of uncertain cause.
· Do not give this medicine to your child if you are suffering from any of the conditions listed above. In case of doubt, tell your doctor or pharmacist before giving this medicine.
Precautions for use; special warnings
Warnings and Precautions
If your child presents any of these symptoms contact your doctor immediately.
An organic cause must have been discarded before initiating treatment; contact your pharmacist or doctor before taking this medication.
To the extent that this medication can sometimes cause diarrhea, contact your doctor or pharmacist before giving this medication if your child:
· has impaired renal or hepatic function,
· takes diuretics (medicines increasing urinary excretion) as your child is likely to have a decrease in blood levels of sodium (salt) and potassium.
Use is not recommended in patients with fructose intolerance (rare hereditary disease).
Interaction with other medicines
Other medicines and FORLAX
Interactions with food and beverages
Not applicable.
Interactions with Herbal Medicines or Alternative Therapies
Not applicable.
Use during pregnancy and lactation
Pregnancy and breast feeding
Forlax can be taken during pregnancy and lactation.
If you are pregnant or breastfeeding, think you may be pregnant or plan a pregnancy, ask your doctor or pharmacist for advice before taking this medicine.
Not applicable.
Effects on ability to drive or use machines
Not applicable
List of excipients with known effect
Important information about some of the components of FORLAX
If your doctor has told you that your child is intolerant to some sugars (sorbitol), contact your doctor before giving this medicine. This medicine contains a small amount of sugar called sorbitol which is transformed into the body into fructose.
This medicinal product contains sulfur dioxide and may cause allergic reactions and respiratory discomfort.
Forlax may nevertheless be given to your child if he is diabetic or if he must follow a diet free of galactose.
3. HOW TO TAKE FORLAX 4 g powder for oral solution in sachet?
Dosage
The usual recommended dosage depends on the age of your child.
· From 6 months to 1 year: 1 sachet per day.
· From 1 to 4 years: 1 or 2 sachets per day.
· From 4 to 8 years: 2 to 4 sachets per day.
Dissolve the contents of the sachet in a glass of water (minimum 50 ml) immediately before giving it to your child. If only 1 sachet is sufficient, give your child the medicine in the morning. If more than 1 sachet is required, give the medication to your child in the morning and evening.
In children over 1 year of age, the daily dose must be adjusted to the effect achieved.
Note that :
· Forlax usually works within 24h to 48 hours.
· The duration of treatment with Forlax should not exceed 3 months in children.
· Improving the intestinal transit of your child after taking Forlax can be maintained by adopting rules of hygiene and feeding.
· Contact your pharmacist or doctor if symptoms worsen or persist.
Symptoms and Instructions for Overdose
If your child took more FORLAX than it should:
Taking too much Forlax can cause diarrhea, abdominal pain or vomiting. Diarrhea usually disappears when treatment is discontinued or the dose decreased.
If your child is suffering from severe diarrhea or vomiting, you should contact a doctor as soon as possible as your child may need treatment to prevent loss of salts (electrolytes) due to fluid loss.
Instructions for omission of one or more doses
If you forget to give FORLAX to your child:
Give the next dose but do not double it to compensate for the dose you have forgotten to give.
Not applicable.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Description of adverse reactions
Like all medicines, FORLAX may cause side effects, although not everybody gets them.
Usually moderate and short-term adverse events include:
In children:
Common (can affect up to 1 in 10 patients)
· Abdominal pain
· Diarrhea that can cause pain in the anus.
Uncommon (can affect up to 1 in 100 patients)
· Nausea or vomiting
· Abdominal bloating
Frequency not known (frequency can not be estimated from available data)
· Allergic reaction (hypersensitivity) to type of rash, hives, swelling of the face or throat, difficulty breathing, loss of consciousness or collapse.
Other effects observed in adults:
Uncommon (can affect up to 1 in 100 patients)
· Need to go to the saddle
· Fecal incontinence.
Frequency not known (frequency can not be estimated from available data)
· Low potassium in the blood, which can cause muscle weakness, muscle contractions or abnormal heart rhythm
· Low levels of sodium in the blood can cause fatigue and confusion, muscle contractions, convulsions and coma.
· Dehydration caused by severe diarrhea, especially in the elderly.
· Redness of the skin
Declaration of side effects
If you experience any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. You can also report adverse reactions directly through the national reporting system: National Agency for the Safety of Medicines and Health Products (Ansm) and network of Regional Centers of Pharmacovigilance. Website: www.ansm.sante.fr .
By reporting adverse reactions, you are helping to provide more information about the safety of the drug.
5. HOW TO STORE FORLAX 4 g powder for oral solution in sachet?
Keep this medicine out of the reach and sight of children.
This medicine does not require special precautions for storage.
If necessary, warnings against visible signs of deterioration
Do not dispose of medicines in sewage or household waste. Ask your pharmacist how to discard any medications you are no longer using. These measures will help protect the environment.
Full list of active substances and excipients
What Forlax contains
The active substance is macrogol 4000, each sachet containing 4.00 g.
The other ingredients are : saccharin sodium (E954) and orange-grapefruit flavoring (containing orange and grapefruit essential oils, orange juice concentrate, citral, aldehyde acetic, linalool, ethyl butyrate, alpha terpineol, octanal, beta gamma hexenol, maltodextrin, gum arabic, sorbitol (E420), butylhydroxyanisole (E320) and sulfur dioxide (E220) .
Pharmaceutical form and content
Aspect of Forlax and contents of the pack
Forlax comes in boxes of 10, 20, 30 and 50 sachets.
Not all pack sizes may be marketed.
65, QUAI GEORGES GORSE
92100 BOULOGNE-BILLANCOURT
65, QUAI GEORGES GORSE
92100 BOULOGNE-BILLANCOURT
BEAUFOUR IPSEN INDUSTRIE
STREET VIRTON
28100 DREUX
Names of the medicinal product in the Member States of the European Economic Area
In accordance with the regulations.
Date of approval of the notice
The last date on which this leaflet was approved is {date}.
AMM under exceptional circumstances
Detailed information on this medicine is available on the ANSM website (France).
Information for health professionals only
Not applicable.
Osmotic laxative
macrogol
. Presentations . Composition . Indications . Contraindications . Warning . Pregnancy and breastfeeding . Directions for use and dosage . Advice . Undesirable effects . Lexicon
FORLAX 4 g: powder for oral solution (flavors: orange, grapefruit); box of 20 bags.
Refunded at 30%. - price: 2,37 euro (s).
FORLAX 10 g: powder for oral solution (flavors: orange, grapefruit); box of 20 bags.
Refunded at 30%. - price: 2,76 euro (s).
Laboratory Ipsen Pharma
| p sachet | p sachet | |
| Macrogol (polyethylene glycol) 4000 | 4 g | 10 g |
Usual dosage:
