Forlax 10 g

Package Leaflet: Information for the User

FORLAX 10 g, powder for oral solution preparation
Macrogol 4000

Read the package leaflet carefully before using the medicine, as it contains

important information for the patient.

• This leaflet should be kept in case it needs to be read again.
• In case of any doubts, the doctor or pharmacist should be consulted.
• This medicine has been prescribed specifically for one person. It should not be given to others. The medicine may harm another person, even if their disease symptoms are the same.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Forlax 10 g and what is it used for
• 2. Important information before taking Forlax 10 g
• 3. How to take Forlax 10 g
• 4. Possible side effects
• 5. How to store Forlax 10 g
• 6. Package contents and other information

1. What is Forlax 10 g and what is it used for

Forlax 10 g contains macrogol 4000 as the active substance and belongs to a group of medicines called osmotic laxatives. It works by increasing the amount of water in the stool, which helps to overcome problems related to slow bowel movements. Forlax 10 g is not absorbed into the bloodstream and is not broken down in the body.
Forlax 10 g is used for the symptomatic treatment of constipation in adults and children from 8 years of age.
The medicine is in the form of a powder, which should be dissolved in a glass of water (at least 50 ml) and drunk. The medicine usually takes 24 to 48 hours to work.
Treatment of constipation with medicines should only supplement a healthy lifestyle and diet.

2. Important information before taking Forlax 10 g

When not to take Forlax 10 g

• if the patient is allergic (hypersensitive) to macrogol (polyethylene glycol) or any of the other ingredients (listed in section 6).
• if the patient has a disease such as severe intestinal disease:
• inflammatory bowel disease (such as ulcerative colitis, Crohn's disease, intestinal stricture)
• intestinal perforation or risk of intestinal perforation
• intestinal obstruction or suspected intestinal obstruction
• abdominal pain of unknown cause

Do not take this medicineif any of the above symptoms occur. In case of doubts, before taking the medicine, consult a doctor or pharmacist.

Warnings and precautions

There have been reports of allergic reactions, including rash and swelling of the face or throat (anaphylaxis) after taking products containing macrogol (polyethylene glycol) in adults. Single severe allergic reactions have been reported, which led to fainting, collapse, or difficulty breathing and caused general malaise. If such symptoms occur, stop taking Forlax 10 g and consult a doctor immediately.
Since this medicine may sometimes cause diarrhea, before taking it, consult a doctor or pharmacist if:

• there is impaired liver or kidney function,
• diuretics (diuretic medicines) are being taken or in the case of elderly people, as they may be at increased risk of low sodium (salt) or potassium levels in the blood.

Before taking Forlax, consult a doctor or pharmacist if the patient has swallowing disorders.
In patients with swallowing difficulties, avoid mixing Forlax 10 g - a laxative containing macrogol (polyethylene glycol) - with food thickeners based on starch. This may cause the formation of a watery liquid that can enter the lungs and cause pneumonia.

Forlax 10 g and other medicines

When using Forlax, there may be a temporary decrease in the absorption of other medicines, leading to a decrease in their effectiveness, particularly for medicines with a narrow therapeutic index or short half-life, such as digoxin, antiepileptic drugs, coumarins, and immunosuppressants.
Tell the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Forlax 10 g may reduce the effectiveness of thickeners used in cases where fluids need to be thickened for safe swallowing.

Pregnancy and breastfeeding

Forlax can be used during pregnancy and breastfeeding.
If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult a doctor or pharmacist before taking this medicine.

Driving and using machines

No studies have been conducted on the effects on the ability to drive and/or use machines.

Important information about some ingredients of Forlax 10 g

Due to the presence of sulfur dioxide, Forlax 10 g may rarely cause severe hypersensitivity reactions and breathing difficulties.
This medicine contains 1.7 mg of sorbitol in each sachet. However, Forlax 10 g can be used in patients with diabetes or those on a galactose-free diet.
This medicine contains less than 1 mmol (23 mg) of sodium per sachet, which means the medicine is considered "sodium-free".

3. How to take Forlax 10 g

Forlax 10 g should always be taken according to this leaflet or the doctor's or pharmacist's instructions.
In case of doubts, consult a doctor or pharmacist.

Use in children over 8 years and adults

The recommended dose is one to two sachets per day, best taken as a single dose in the morning.
The daily dose depends on the effect achieved and ranges from one sachet every other day (especially in children) to a maximum of two sachets per day.
The contents of the sachet should be dissolved in a glass of water (at least 50 ml) immediately before consumption, then drink the prepared solution.

Note:

• The effect of Forlax 10 g appears within 24-48 hours of administration.
• In children, the treatment period with Forlax 10 g should not exceed 3 months.
• The improved bowel movements achieved with Forlax 10 g can be maintained provided a healthy lifestyle and dietary recommendations are followed.
• The doctor or pharmacist should be informed if symptoms worsen or if there is no improvement.

Taking more than the recommended dose of Forlax 10 g

Taking too much of Forlax 10 g may cause diarrhea, abdominal pain, or vomiting.
Diarrhea usually resolves after stopping the medicine or reducing the dose.
In case of severe diarrhea or vomiting, consult a doctor as soon as possible, as treatment to prevent loss of electrolytes (salts) accompanying fluid loss may be necessary.

Missing a dose of Forlax 10 g

The next dose should be taken as soon as possible, but a double dose should not be taken to make up for the missed dose.

4. Possible side effects

Like all medicines, Forlax 10 g can cause side effects, although not everybody gets them.
Side effects that are usually mild and do not last long include:

In children

Common (may affect up to 1 in 10 people)

• Abdominal pain
• Diarrhea, which can also cause anal discomfort

Uncommon (may affect up to 1 in 100 people)

• Nausea (nausea) or vomiting
• Abdominal bloating

Frequency not known (frequency cannot be estimated from the available data)

• Allergic reactions (hypersensitivity) (rash, hives, swelling of the face or throat, difficulty breathing, fainting, or collapse)

In adults:

Common (may affect up to 1 in 10 people)

• Abdominal pain
• Abdominal bloating
• Nausea (nausea)
• Diarrhea

Uncommon (may affect up to 1 in 100 people)

• Vomiting
• Sudden need to go to the toilet
• Fecal incontinence

Frequency not known (frequency cannot be estimated from the available data)

• Low potassium levels in the blood, which can cause muscle weakness, muscle tremors, or irregular heartbeat
• Low sodium levels in the blood, which can cause fatigue and confusion, muscle tremors, seizures
• Dehydration due to severe diarrhea, especially in elderly people.
• Symptoms of an allergic reaction, such as skin redness, rash, hives, swelling of the face or throat, difficulty breathing, fainting, or collapse

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the doctor or pharmacist should be informed. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder or its representative.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Forlax 10 g

The medicine should be stored out of sight and reach of children.
Do not use Forlax 10 g after the expiry date stated on the carton. The expiry date refers to the last day of the month.
There are no special precautions for storing Forlax 10 g.
Medicines should not be disposed of via wastewater or household waste. Ask the pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Forlax 10 g contains

The active substance of the medicine is macrogol 4000 - 10.00 g in each sachet.
The medicine also contains:
sodium saccharin (E954), orange-grapefruit flavor [essential oils: orange and grapefruit, concentrated orange juice, citral, acetic aldehyde, linalol, ethyl acetate, alpha-terpineol, octanal, beta-gamma-hexenol, maltodextrin, arabic gum, sorbitol, butylated hydroxyanisole (E320), and sulfur dioxide (E220)].

What Forlax 10 g looks like and what the package contains

Forlax 10 g is an almost white powder with an orange-grapefruit smell and taste, from which an oral solution is prepared.
Forlax 10 g is available in packages containing 10, 20, 50, or 100 sachets of powder.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

MAYOLY PHARMA FRANCE
3 Place Renault
92500 Rueil-Malmaison
France

Manufacturer

MAYOLY Industrie
Rue Ethe Virton
28100 Dreux, France

For more information, contact the representative of the marketing authorization holder:

MAYOLY POLSKA Sp. z o.o.
ul. Domaniewska 39B
02-672 Warsaw
tel.: 22 166 26 26
Date of last revision of the leaflet:March 2025