10 g powder for oral solution, sachet
macrogol 4000

1. WHAT FORLAX IS AND WHAT IT IS USED FOR

Forlax contains the active substance Makrogol 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 is not absorbed into the bloodstream and is not broken down in the body.

Forlax is used to treat temporary constipation in adults and children over 8 years of age. This medicine is a powder that should be dissolved in a glass of water (at least ½ dl) just before ingestion. 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.

Self-care treatment of temporary constipation should not last longer than 14 days. You must talk to a doctor if you do not feel better or if you feel worse after 14 days.

2. BEFORE YOU USE FORLAX

Do not use Forlax

  • if you are allergic to macrogol (polyethylene glycol) or any of the other ingredients of this medicine (listed in section 6).
  • if you have a serious intestinal disease such as:
    • inflammatory bowel disease (eg ulcerative colitisCrohn’s disease, abnormal enlargement of the intestine)
    • perforation (hole) in the gastrointestinal tract, or risk of this
    • if you have a bowel obstruction or a suspected bowel obstruction
    • if you have abdominal pain for no known reason

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

Take special care with Forlax

Cases of allergic reactions with rash and swelling of the face and throat ( angioedema ) have been reported during treatment with drugs 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 you experience any of these symptoms, stop taking Forlax and seek medical attention immediately.

Before starting treatment, the organic disease should be ruled out.

Because Forlax can sometimes cause diarrhea, talk to your doctor or pharmacist before taking this medicine if you:

  • have impaired liver or kidney function
  • take diuretics ( diuretics ) or are older, as you may be at low levels of sodium (salt) or potassium in your 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 used to treat epilepsy ),

coumarins (blood thinners) and

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

This can lead to reduced efficacy of these drugs.

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Intake of Forlax with food and drink

Forlax can be used by diabetics and people on a galactose-free diet.

Pregnancy and breastfeeding

Forlax 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

Forlax has no known effect on the ability to drive or use machines.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Important information about some of the ingredients (s) of Forlax

If you have been told by your doctor that you have an intolerance to some sugars (sorbitol), you should contact your doctor before taking this medicine. Forlax 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.

3. HOW TO USE FORLAX

Always take Forlax exactly as described in this leaflet or as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

Adults and children over 8 years

The recommended dose is 1-2 sachets per day that are taken as a single dose in the morning.

The daily dose can be adjusted based on the result of the treatment, from 1 sachet every other day (especially in children) up to a maximum of 2 sachets per day.

Dissolve the contents of the bag in a glass of water (at least ½ dl) immediately before use and then drink.

Note the following:

  • Forlax usually works within 24-48 hours.
  • Treatment with Forlax should not last longer than 14 days without a doctor’s prescription.
  • If Forlax is prescribed by a doctor, the treatment time with Forlaxho’s children should not exceed 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 you do not feel better or if you feel worse after 14 days. This is especially true if you bought Forlax without a prescription.

If you use more Forlax then you should 

If you have ingested too much medicine or if e.g. a child ingested the medicine by mistake, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.

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

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

If you forget to take Forlax

Take the next dose as soon as you remember, but do not take a double dose to make up for a forgotten dose .

4. POSSIBLE SIDE EFFECTS

Like all medicines, Forlax 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)

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

In adults

Common (may affect 1 in 10 users)

  • Stomach pain
  • Inflated stomach
  • Nausea
  • Diarrhea

Uncommon (may affect 1 to 100 users)

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

  • Decreased sodium levels in the blood that can cause fatigue and confusion, muscle twitching, seizures and coma
  • Decreased potassium levels in the blood which can cause muscle weakness, twitching or abnormal heart rhythm
  • Dehydration due to severe diarrhea especially in the elderly
  • Symptoms of an allergic reaction such as redness of the skin, rash, hives ( urticaria ), swelling of the face or throat ( angioedema ), difficulty breathing, lethargy or collapse.

5. HOW TO STORE FORLAX

Keep this out of the reach and sight of children.

Do not use Forlax after the expiry date which is stated on the carton.

The expiration date is the last day of the specified month.

Forlax does not require any special storage instructions.

Medicines 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 10 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, linalol, ethyl butyrate, alpha-terpineol, octanal, beta-gamma-hexenol, acacitol , BHA (E320) and sulfur dioxide (E220).

What the medicine looks like and contents of the pack

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

Forlax is available in pack sizes: 10, 50 or 100 sachets (prescription), and 20 sachets (over-the-counter). Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Institute of Synthesis Products (IPSEN) AB

Kista Science Tower

Färögatan 33

164 51 Kista

Tel: 08- 451 60 00

info.se@ipsen.com

Beaufour Ipsen Industry

Rue Ethe Virton

28100 Dreux

France

Muhammad Nadeem

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