Forlax Junior contains the active substance macrogol 4000

1. WHAT FORLAX JUNIOR IS AND WHAT IT IS USED FOR

Forlax Junior contains the active substance macrogol 4000 and belongs to a group of medicines called osmotic laxatives. They work by increasing the fluid volume of the stool, which helps against problems caused by very slow bowel movements. Forlax Junior is not absorbed into the bloodstream and is not broken down in the body.

Forlax Junior is used to treating constipation in children from 6 months to 8 years of age.

This medicine is a powder that should be dissolved in a glass of water and that your child should drink. It usually takes 1 to 2 days before it takes effect.

Treatment of constipation with medication should only be done in addition to a healthy lifestyle and healthy diet.

2. BEFORE YOU USE FORLAX JUNIOR

Do not use Forlax Junior

Do not give Forlax Junior

  • if your child is allergic (hypersensitive) to macrogol (polyethylene glycol) or any of the other ingredients of this medicine (listed in section 6).
  • if your child has a disease, such as severe intestinal disease
    • inflammatory bowel disease ( ulcerative colitis, Crohn’s disease, abnormal enlargement of the intestine)
    • perforation (hole) in the gastrointestinal tract, or risk of perforation (hole) in the gastrointestinal tract
    • obstruction (stop) in the intestine or suspicion of obstruction in the intestine
    • abdominal pain for no known reason.

Do not give this medicine if any of the above apply to your child. If you are not sure, talk to your doctor or pharmacist before giving this medicine.

Take special care with Forlax Junior

Cases of allergic reactions with skin rash and swelling of the face or throat ( angioedema ) have been reported in adults who have taken medicines containing macrogol (polyethylene glycol). Occasional severe cases of severe allergic reactions have been reported to cause lethargy, collapse or difficulty breathing, and general malaise. If your child experiences any of these symptoms seek medical attention immediately.

Before starting treatment, the organic disease should be ruled out, talk to a doctor before giving the medicine to your child.

As this medicine can sometimes cause diarrhea, talk to your doctor or pharmacist before giving this medicine to your child:

• has impaired liver or kidney function

• take diuretics ( diuretics ) because the child is at risk of getting low levels of sodium (salt) or potassium in the blood.

Use of other medicines

The uptake of other drugs may be temporarily reduced during use with Forlax, especially drugs with a narrow dose range or short half-life, such as:

Digoxin (a medicine used to treat heart diseases such as heart failure, heart fibrillation, and irregular heartbeat),

antiepileptics (medicines for epilepsy ),

coumarins (blood thinners) and

Immunosuppressive agents (medicines used after transplantation or against autoimmune diseases such as rheumatoid osteoarthritis and multiple sclerosis ).

This can lead to reduced efficacy of these drugs.

Tell your doctor or pharmacist if your child is taking or has recently taken any other medicines, including medicines obtained without a prescription.

Pregnancy and breastfeeding

Forlax Junior can be used during pregnancy and lactation.

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Not relevant

Important information about some of the ingredients of Forlax Junior

If you have been told by your doctor that your child has an intolerance to some sugars (sorbitol), you should consult a doctor before giving this medicine to your child. Forlax Junior contains a small amount of sugar called sorbitol, which is converted to fructose.

The content of sulfur dioxide can in rare cases cause severe hypersensitivity reactions and difficulty breathing

Forlax Junior can be given to children who are diabetic or on a galactose-free diet.

3. HOW TO USE FORLAX JUNIOR

Always take Forlax Junior exactly as described in this leaflet or as directed by your doctor or pharmacist. Ask your doctor or pharmacist if you are unsure.

The recommended dose is based on your child’s age:

• From 6 months to 1 year: 1 sachet per day.

• From 1 to 4 years: 1-2 sachets per day.

• From 4 to 8 years: 2-4 sachets per day.

Dissolve the contents of the bag in a glass of water (at least ½ dl) immediately before use and drink the liquid. Give Forlax Junior to your child in the morning if dose one is 1 sachet per day. If the dose is more than 1 sachet per day, give half in the morning and a half in the evening.

For children over one year of age, the daily dose can be adjusted based on the effect achieved.

Note the following:

• It usually takes 1 to 2 days before Forlax Junior takes effect.

• Children should not be treated with Forlax Junior for longer than 3 months.

• Improving the frequency of bowel movements can be maintained after treatment with Forlax by sticking to a healthy lifestyle and diet.

Talk to your doctor or pharmacist if symptoms worsen or do not improve.

If you use more Forlax Junior then you should 

Too much Forlax Junior can cause diarrhea, stomach pain, or vomiting. Diarrhea usually disappears when treatment is stopped or if the dose is reduced.

If your child has severe diarrhea or vomiting, consult a doctor as soon as possible as your child may need treatment to prevent salt deficiency caused by fluid loss.

If you forget to take Forlax Junior

Give your child the next dose as soon as you remember, but do not give a double dose to make up for a forgotten dose.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Forlax Junior can cause side effects, although not everybody gets them.

Side effects that are usually mild and transient are:

In children:

Common (may affect 1 in 10 users)

  • Stomach pain
  • Diarrhea that can cause soreness around the rectum (anus)

Uncommon (may affect 1 in 100 users)

  • Nausea or vomiting
  • Inflated stomach

No known frequency (cannot be calculated from the available data)

  • Allergic reactions (skin rash, hives ( urticaria ), swelling of the face or throat, difficulty breathing, dizziness or collapse)

Additional side effects that have been seen in adults:

Uncommon (may affect 1 in 100 people):

  • Abdominal pain and abdominal swelling
  • Nausea
  • Diarrhea

Uncommon (affects 1 to 10 users in 1000):

Urgent need to go to the toilet

• Stool incontinence

No known frequency (cannot be calculated from the available data)

• Low levels of potassium in the blood which can cause muscle weakness, twitching, or abnormal heart rhythm

• Low levels of sodium in the blood which can cause fatigue and confusion, muscle twitching, seizures, and coma

• Dehydration due to severe diarrhea, especially in the elderly

• Reddening of the skin

5. HOW TO STORE FORLAX JUNIOR

Keep this medicine out of the sight and reach of children.

Do not give Forlax Junior after the expiry date which is stated on the bottom of the carton. The expiration date is the last day of the specified month.

Forlax Junior does not require any special storage instructions.

The medicine should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. FURTHER INFORMATION

Content declaration

The active substance is 4 g macrogol 4000 per sachet .

The other ingredients are: saccharin sodium (E954), flavoring (orange-grapefruit) containing orange and grapefruit oils, concentrated orange juice, citral, acetaldehyde, linalool, ethyl butyrate, alpha terpineol, octanal, beta-gamma hexanol, maltdexoline (sorbitol), BHA (E320) and sulfur dioxide (E220).

What the medicine looks like and the contents of the pack

Forlax Junior is an almost white powder that smells and tastes like orange-grapefruit, which is to be dissolved into a drink.

Forlax Junior is available in pack sizes of 10, 20, 30, or 50 sachets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Institute of Synthesis Products (IPSEN) AB

Kista Science Tower

Färögatan 33

164 51 Kista

Tel: 08-451 60 00

info.se@ipsen.com

Manufacturer

Beaufour Ipsen Industry

Rue Ethe Virton

28100 Dreux

France

Muhammad Nadeem

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