CASENLAX*ORAL POWDER 20SACHETS 10G

CASENLAX 10 g powder for oral solution in sachet
Macrogol 4000

What it is and what it is used for
The name of this medicine is Casenlax 10 g powder for oral solution in sachet.

Casenlax is considered an osmotic laxative.

Casenlax is indicated for the symptomatic treatment of constipation in adults and children aged 8 years and over. It should be used with appropriate lifestyle modifications and dietary measures (see paragraph 2).

Consult your doctor if you do not feel better or if you feel worse.

This medicine contains Macrogol (P.E.G. = polyethylene glycol).

In case of constipation, the maximum treatment period in children is 3 months.

What you need to know before taking the medicine
Occasional constipation:

Occasional constipation may be related to a recent change in lifestyle. There are medicines that can be used for short-term treatment. Ask your doctor for advice in case of recent constipation that cannot be explained by changes in your lifestyle, or in case of constipation associated with pain, fever or abdominal distension.

Chronic constipation (long-term constipation):

Chronic constipation can be caused by:

• An intestinal disease that requires medical advice.
• Intestinal dysfunction (imbalance) caused by eating habits and lifestyle.

Treatment includes, among other things:

• Increased proportion of fiber in the diet (vegetables, whole wheat bread and fruit);
• Increased intake of water and fruit juices;
• Increased physical activity (sports, walking...);
• Rehabilitation of the urge to defecate.

Do not take Casenlax

- If you are allergic to Macrogol (P.E.G. = polyethylene glycol) or any of the other ingredients of this medicine (listed in paragraph 6).
- If you have any intestinal or colon disease (such as ulcerative colitis, Crohn's disease).
- If you have abdominal pain of unknown cause.
- If you have or suspect you have gastrointestinal perforation.
- If you have or suspect intestinal obstruction.

Warnings and precautions
Consult your doctor or pharmacist before taking Casenlax.

If you develop diarrhoea during treatment with Casenlax, you may be at risk of developing electrolyte imbalances (a decrease in certain salts in the blood). You are more likely to be at risk if you are elderly or have liver or kidney problems or are taking diuretics (medicines to urinate). If you are one of these people and develop diarrhoea, you should be seen by a doctor for a check of electrolyte levels through a blood test.

Children

Ask your doctor for advice before giving this treatment to your child, in order to rule out any organic cause of constipation. After 3 months of treatment, your doctor will need to assess your child's clinical condition.

Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.

The most serious side effects are allergic reactions (hypersensitivity) which include itching (itchy rash), skin rash, facial oedema (swelling of the face), Quincke's oedema (rapid swelling of the deep layers of the skin), urticaria (hives-like rash) and anaphylactic shock. Their frequency has been reported as very rare (may affect up to 1 in 10,000 people) in the adult population and as not known (frequency cannot be estimated from the available data) in the paediatric population. If you notice any of the reactions listed above, stop taking the medicine immediately and consult a doctor urgently.

Adults:

In general, adverse reactions were mild and transient and mainly affected the gastrointestinal system. These side effects include:

Common (may affect up to 1 in 10 people)

• Abdominal pain
• Abdominal distension
• Diarrhoea
• Nausea

Uncommon (may affect up to 1 in 100 people)

• Vomiting
• Defecatory urgency
• Faecal incontinence

Not known (frequency cannot be estimated from the available data)

• Electrolyte disturbances (low blood levels of sodium and potassium: hyponatremia, hypokalaemia)
• Dehydration caused by severe diarrhoea, especially in elderly patients
• Erythema

Children/adolescents:

As in the adult population, adverse reactions were mild and transient and mainly affected the gastrointestinal system. These side effects include:

Common (may affect up to 1 in 10 people)

• Abdominal pain
• Diarrhoea (may cause perianal pain)

Uncommon (may affect up to 1 in 100 people)

• Vomiting
• Bloating
• Nausea

Excessive doses can cause diarrhoea, abdominal pain and vomiting which usually disappear when the dose is reduced or the treatment is temporarily suspended.

Reporting of side effects
If you get any side effects, including any not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazionireazioni-avverse.
By reporting side effects you can help provide more information on the safety of this medicine.