NOTICE
ANSM - Last updated: 11/03/2015
Name of the medicinal product
FORLAX 10 g, powder for oral solution in sachet
Macrogol 4000
framed
Please read this leaflet carefully before you start taking this medicine because it contains important information for you.
· Keep this leaflet, you may need to read it again.
· If you have any further questions, ask your doctor or pharmacist.
· This medicine has been prescribed for you. Do not give this to anyone else. It could be harmful to them, even if the signs of their illness are the same as yours.
· If symptoms worsen or persist, consult a physician.
· If you experience any side effects, talk to your doctor or pharmacist. This also applies to any other side effects not mentioned in this leaflet.
Review summary
What is in this leaflet? :
1. What is Forlax and what is it used for?
2. What should be known before taking Forlax?
3. How to take Forlax?
4. What are the possible side effects?
5. How to store Forlax?
6. Additional information.
1. WHAT FORLAX 10 g, powder for oral solution in sachets AND WHAT CASES IS IT USED FOR?
Pharmacotherapeutic group
Forlax contains the active substance macrogol 4000 and belongs to a group of medications called osmotic laxatives. It helps to increase the amount of water in the faeces, which helps to solve problems related to a slowed intestinal transit. Forlax is not absorbed into the bloodstream and is not altered in the body.
Therapeutic indications
FORLAX is indicated for the treatment of constipation in adults and children over 8 years of age.
This medication is in the form of a powder that must be dissolved in a glass of water (minimum 50 ml) and drink. Its effect usually manifests itself 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 10 g, powder for oral solution in sachet?
List of information needed before taking the medication
Not applicable.
Cons-indications
Do not take Forlax:
· If you are allergic (hypersensitive) to macrogol (polyethylene glycol) or any of the other ingredients of this medication mentioned in section 6.
· If you have 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 take this medication if you are suffering from any of the conditions listed above. In case of doubt, tell your doctor or pharmacist before taking this medicine.
Precautions for use; special warnings
Warnings and Precautions
There have been reports of allergic reactions with rash on the skin and swelling of the face or throat (angioedema) in adults after taking macrogol (polyethylene glycol) medications.
Isolated cases of severe allergic manifestations leading to loss of consciousness, collapse, or difficulty breathing and general feeling of malaise have been reported.
If you experience any of these symptoms, stop taking Forlax and contact your doctor immediately.
To the extent that this medication can sometimes cause diarrhea, contact your doctor or pharmacist before
· you have impaired renal or hepatic function,
· you are taking diuretics (medicines increasing urinary excretion) or you are elderly, as you are likely to have a decrease in your blood sodium (salt) and potassium levels.
Use is not recommended in patients with fructose intolerance (rare hereditary disease).
Interaction with other medicines
Other medicines and FORLAX
If you are taking or have recently taken any other medicines, including medicines obtained without a prescription, talk to your doctor or pharmacist.
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.
Sport
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 you are intolerant to some sugars (sorbitol), contact your doctor before taking 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.
However, Forlax can be used if you are diabetic or if you have to go on a galactose-free diet.
3. HOW TO TAKE FORLAX 10 g powder for oral solution in sachet?
Instructions for proper use
When taking Forlax, always follow the directions in this leaflet or the advice of your doctor or pharmacist. In case of doubt, check with your doctor or pharmacist.
Dosage, Mode and / or route (s) of administration, Frequency of administration and Duration of treatment
Dosage
Adults and children over 8 years
The usual recommended dose is 1 to 2 sachets per day, preferably in single dose in the morning.
The daily dose can be adapted to the effect obtained and can vary from 1 sachet every 2 days (in children in particular) to 2 sachets per day at the most.
Dissolve the contents of the sachet in a glass of water (minimum 50 ml) immediately before taking Forlax.
Note that :
· Forlax usually works within 24h to 48 hours.
· In children, the duration of treatment with Forlax should not exceed 3 months.
· Improving your intestinal transit after taking Forlax can be maintained by adopting lifestyle rules and a diet.
· Contact your pharmacist or doctor if symptoms worsen or persist.
Symptoms and Instructions for Overdose
If you take more Forlax than you should:
Taking too much Forlax can cause diarrhea, abdominal pain or vomiting. Diarrhea usually disappears when treatment is discontinued or the dose decreased.
If you suffer from 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.
Instructions for omission of one or more doses
If you forget to take Forlax:
Take the dose but do not double it to compensate for the dose you have forgotten to take.
Risk of withdrawal syndrome
Not applicable
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Description of adverse reactions
Like all medicines, Forlax is likely to have side effects, although not everyone is.
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.
In adults:
Common (can affect up to 1 in 10 patients)
· Abdominal pain
· Abdominal bloating
· nausea
· Diarrhea
Uncommon (can affect up to 1 in 100 patients)
· vomiting
· Need to go to the saddle
· Fecal incontinence.
Unknown (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.
· Symptoms of an allergic reaction such as redness of the skin, rash, hives, swelling of the face or throat, difficulty breathing, loss of consciousness or collapse.
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 10 g powder for oral solution in sachet?
Keep this medicine out of the reach and sight of children.
Expiration date
Do not use this medicine after the expiry date which is stated on the bottom of the box after EXP. The expiry date refers to the last day of that month.
Storage conditions
This medicinal product does not require any special storage conditions.
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.
6. ADDITIONAL INFORMATION
Full list of active substances and excipients
What Forlax contains
The active substance is macrogol 4000, each sachet containing 10.00g.
The other ingredients are : saccharin sodium (E954) and orange-grapefruit flavoring (containing orange and grapefruit essential oils, concentrated orange juice, citral, aldehyde acetic, linalool, ethyl butyrate, alpha terpineol, octanal, beta gamma hexenol, maltodextrin, gum arabic, sorbitol (E420), butylhydroxyanisole (E 320) and sulfur dioxide (E 220 )).
Pharmaceutical form and content
Aspect of Forlax and contents of the pack
Forlax is in the form of a whitish powder which has an odor and taste of orange and grapefruit and is intended to be reconstituted as a drinkable solution.
Forlax comes in boxes of 10, 20, 50 and 100 sachets.
Not all pack sizes may be marketed.
Name and address of the marketing authorization holder and the holder of the manufacturing authorization responsible for the release of the lots, if different
Holder
IPSEN PHARMA
65, QUAI GEORGES GORSE
92100 BOULOGNE-BILLANCOURT
exploiting
IPSEN PHARMA
65, QUAI GEORGES GORSE
92100 BOULOGNE-BILLANCOURT
Maker
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
Not applicable.
Internet Information
Detailed information on this medicine is available on the ANSM website (France).
Information for health professionals only
Not applicable.
Other
Not applicable.