CASENLAX

Package leaflet: Information for the patient

Casenlax 10 g oral solution in sachet

Macrogol 4000
Please read this leaflet carefully before taking this medicine because it contains
important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or
pharmacist has instructed you.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Contact your doctor if you do not notice any improvement or if you experience worsening of symptoms.

For RR packages, subject to medical prescription, the box below must be included as
required by the QRD templates
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Casenlax is and what it is used for
2. What you need to know before taking Casenlax
3. How to take Casenlax
4. Possible side effects
5. How to store Casenlax
6. Contents of the pack and other information

1. What Casenlax is and what it is used for

The name of this medicine is Casenlax 10 g oral solution.
Casenlax is considered an osmotic laxative.
Casenlax is indicated for the symptomatic treatment of constipation in adults and children aged 8 years and older. It should be used in conjunction with appropriate lifestyle modifications and dietary measures (see section 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 cases of constipation, the maximum treatment duration in children is 3 months.

2. What you need to know before taking Casenlax

Occasional constipation:
Occasional constipation may be related to a recent change in lifestyle. There are medications that can be used for short-term treatment. Consult your doctor if you experience recent-onset constipation that cannot be explained by changes in your lifestyle, or if constipation is accompanied by abdominal pain, fever, or bloating.

Chronic constipation (long-lasting constipation):
Chronic constipation may be caused by:

• An intestinal disease requiring medical advice.
• Intestinal dysfunction (imbalance) caused by dietary habits and lifestyle.

Treatment includes, among other measures:

• Increasing dietary fiber intake (vegetables, wholemeal bread, and fruit);
• Increasing fluid and fruit juice intake;
• Increasing physical activity (sports, walking, etc.);
• Re-establishing the defecation reflex.

Do not take Casenlax
If you are allergic to Macrogol (P.E.G. = polyethylene glycol) or to any of the other
components of this medicine (listed in section 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 gastrointestinal perforation.
If you have or suspect intestinal obstruction.

Warnings and precautions
Talk to 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). This risk is higher if you are elderly, have liver or kidney problems, or are taking diuretics (medicines that increase urine production). If you belong to any of these groups and develop diarrhoea, you should see a doctor to have your electrolyte levels checked via a blood test.

Children
Consult your doctor before giving this treatment to your child in order to rule out any organic cause of constipation. After 3 months of treatment, your doctor should reassess your child's clinical condition.

Other medicines and Casenlax
Casenlax may delay the absorption of other medicines, making them less effective or ineffective, particularly those with a narrow therapeutic index (e.g. antiepileptics, digoxin, and immunosuppressive agents). Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
Casenlax can be used during pregnancy.

Breastfeeding
Casenlax can be used during breastfeeding.

Driving and using machines
Casenlax does not affect the ability to drive or operate machinery.

Casenlax contains a negligible amount of sugars or polyols and can therefore be prescribed to diabetic patients or patients on a galactose-free diet.

Casenlax contains sodium benzoate
This medicine contains 4 mg of sodium benzoate E211 per sachet.

Casenlax contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per sachet, i.e. essentially “sodium-free”.

3. How to take Casenlax

Take this medicine exactly as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.
For oral use.
The recommended dose is: 1 or 2 sachets per day, preferably taken as a single dose in the morning.
It is recommended to drink 125 ml of liquid (for example, water) after each dose.
1 sachet contains 20 ml of oral solution and 10 g of macrogol 4000.
The daily dose should be adjusted according to the clinical response and may range from 1 sachet every other day (especially in children) up to a maximum of 2 sachets per day.
The effect of Casenlax occurs within 24–48 hours after administration.
Improved bowel movement frequency after taking Casenlax can be maintained through a healthy lifestyle and dietary measures.

Use in children and adolescents
In children, treatment should not exceed 3 months due to lack of clinical data for treatment periods longer than 3 months.
Treatment should be discontinued gradually and resumed if constipation recurs.

If you take more Casenlax than you should
You may develop diarrhoea, abdominal pain, and vomiting, which resolve when treatment is temporarily stopped or the dose is reduced.
In case of severe diarrhoea or vomiting, you must contact a doctor as soon as possible, as you may require treatment to prevent loss of salts (electrolytes) due to fluid loss.

If you forget to take Casenlax
Do not take a double dose to make up for the missed dose.

4. 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
(pruritic rash), skin rash, facial oedema (swelling of the face), Quincke's oedema (rapid swelling
of the deep layers of the skin), urticaria (hives) 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 contact a
doctor urgently.

Adults:
In general, adverse reactions have been mild and transient and mainly involved 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
• Urgency of defecation
• Faecal incontinence

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

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

Children/adolescents:
As in the adult population, adverse reactions have generally been mild and transient and mainly
involved 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 may cause diarrhoea, abdominal pain and vomiting, which usually resolve when
the dose is reduced or treatment is discontinued.

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

5. How to store Casenlax

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the sachet/box after
Exp.
The expiry date refers to the last day of that month.
Do not use this medicine if you notice any visible signs of deterioration.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Casenlax contains
The active substance is: Macrogol 4000.
Each sachet contains 10 g of macrogol 4000.
The other components (excipients) are: Sodium benzoate (E 211), potassium sorbate, citric acid,
sodium citrate, sucralose and purified water.

Description of the appearance of Casenlax and contents of the pack
Casenlax is a clear, colourless, odourless and tasteless solution.
It is available in packs containing 10, 20, 30, 50 and 100 sachets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Casen Recordati S.L.
Autovía de Logroño, Km 13,300
50180 UTEBO. Zaragoza (Spain)

Marketing Authorisation Holder in Italy
RECORDATI Industria Chimica e Farmaceutica S.p.A.
Via M. Civitali, 1 – 20148 Milano

This medicinal product is authorised in the European Economic Area countries under the following names:
France: Casenlax 10g solution buvable en sachet
Germany: Casenlax 10g Lösung zum Einnhmen in Beuteln
Italy: Casenlax 10g soluzione orale in bustina
Portugal: Casenlax 10g solução oral em saquetas
Spain: Casenlax 10g solución oral en sobre

Further information
More detailed information on this medicinal product is available on the website of AIFA (Italian Medicines Agency):
"http://www.agenziafarmaco.gov.it"