ISOCOLAN 34,8 G Oral solution powder

Зміст інструкції

1. ISOCOLAN 29.5 g + 2.843 g + 0.843 g + 0.733 g + 0.371 g powder for oral solution, 14.75 g + 1.422 g + 0.422 g + 0.366 g + 0.186 g powder for oral solution, 7.375 g + 0.711 g + 0.211 g + 0.183 g + 0.093 g powder for oral solution
   1. WHAT ISOCOLAN IS AND WHAT IT IS USED FOR
   2. WHAT YOU NEED TO KNOW BEFORE TAKING ISOCOLAN
   3. HOW TO TAKE ISOCOLAN
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE ISOCOLAN
   6. CONTENT OF THE PACK AND OTHER INFORMATION

ISOCOLAN 29.5 g + 2.843 g + 0.843 g + 0.733 g + 0.371 g powder for oral solution, 14.75 g + 1.422 g + 0.422 g + 0.366 g + 0.186 g powder for oral solution, 7.375 g + 0.711 g + 0.211 g + 0.183 g + 0.093 g powder for oral solution

macrogol 4000 + sodium sulfate + sodium bicarbonate + sodium chloride + potassium chloride

Read this leaflet carefully before using this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it may be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. WHAT ISOCOLAN IS AND WHAT IT IS USED FOR

ISOCOLAN contains as active ingredients macrogol (polyethylene glycol) and sodium and potassium salts and is an
laxative (purgative) with osmotic action (it works by retaining water in the colon). This medicine is indicated
in adults and children over 8 years of age and weighing more than 20 kg for the treatment of
constipation and clinical conditions that require complete emptying of the last part of the intestine,
the large intestine (for example, preoperative preparation, diagnostic investigations). Consult your doctor if
you do not feel better or if you feel worse after a short period of time.

2. WHAT YOU NEED TO KNOW BEFORE TAKING ISOCOLAN

Do not take ISOCOLAN

• If you are allergic to the active ingredients or any of the other ingredients of this medicine (listed in section 6).
• If you have a perforation of the stomach or intestine or are at risk of developing one.
• If you suspect you have an obstruction of the intestine.
• If you have a severe inflammatory disease of the intestine (such as ulcerative colitis and Crohn's disease) or toxic megacolon (large dilation of the colon), associated with symptomatic stenosis (narrowing).
• If you have syndromes of abdominal pain of unknown origin.
• If you have colitis (inflammation of the colon) acute, nausea, vomiting, marked increase or decrease in peristalsis (wave-like movements of the intestine that propagate from top to bottom and push food and digestion products through the intestine) or rectal bleeding (the terminal part of the intestine). The presence of one or more of these signs and symptoms requires adequate investigation by the doctor in order to exclude the presence of pathological conditions in which laxatives cannot be used (see previous points).
• If you are in a severe state of dehydration. The use of ISOCOLAN is not recommended during pregnancy and breastfeeding (see “Pregnancy and breastfeeding”).

The use of ISOCOLAN is not recommended in children under 8 years of age and weighing less than 20
Kg (see “Children and adolescents”).

Warnings and precautions
Consult your doctor or pharmacist before taking ISOCOLAN.
Do not use the medicine if you suspect you have lesions that block the intestinal cavity and/or if you have abdominal pain, nausea and/or vomiting.
If you develop side effects such as swelling, shortness of breath, fatigue, dehydration (symptoms include thirst, dry mouth and weakness) or heart problems, stop using ISOCOLAN and contact your doctor immediately.
Take ISOCOLAN with particular caution:

• If you suffer from heart disorders.
• If you suffer from kidney disorders.
• If you have a compromised swallowing reflex and mental state, due to the risk of aspiration from regurgitation (reflux of stomach contents upwards, even into the mouth).
• In case of diarrhea, if you are predisposed to electrolyte imbalances (for example if you suffer from severe liver or kidney dysfunction, if you are taking diuretics or if you are elderly); in this case, undergo frequent electrolyte checks. Very rare cases of allergic reaction such as rash, urticaria and edema (fluid accumulation) have been reported following the use of medicines containing macrogol (polyethylene glycol) and exceptional cases of anaphylactic shock (severe, rapidly developing allergic reaction that can be fatal) have been reported (see section 4 “Possible side effects”). If you experience sudden abdominal pain or rectal bleeding while taking ISOCOLAN for bowel preparation, consult a doctor immediately. Repeated use of laxatives, especially stimulant laxatives, can lead to dependence (and therefore the need to gradually increase the dosage), chronic constipation and intestinal atony (loss of normal intestinal function). Therefore, do not take a laxative for the treatment of constipation for a prolonged period of time.

The treatment of chronic (long-lasting) or recurrent constipation always requires the intervention of a doctor for diagnosis, prescription of drugs and monitoring during therapy. A diet rich in fluids
favors the action of the medicine.
The absorption of other medicines may be temporarily reduced due to the increased
gastrointestinal transit rate induced by Isocolan. Consult your doctor if you are taking other medicines and/or
need to thicken liquids in order to ingest them safely (see section “Other medicines and
ISOCOLAN”).
Consult your doctor when the need for a laxative derives from a sudden change in previous
bowel habits (frequency and characteristics of bowel movements) that lasts for more than 2 weeks or when
the use of the laxative fails to produce effects. The treatment of constipation with any medicine is
only an adjunct (a help) to a healthy lifestyle and a diet that includes:

• Increased intake of fluids and fiber.
• Appropriate physical activity and retraining of intestinal motility. You can take ISOCOLAN if you have diabetes or if you follow a galactose-free diet because the medicine does not contain sugar or polyols.

Children and adolescents
Do not administer ISOCOLAN to children under 8 years of age and weighing less than 20 Kg (see
“Do not take ISOCOLAN”). In children over 8 years of age and weighing more than 20 Kg the
medicine can only be used after consulting a doctor and the treatment should not exceed 3
months (due to lack of clinical data in case of treatments exceeding 3 months).

Other medicines and ISOCOLAN
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicine.
.
Some medicines may not work effectively during the use of ISOCOLAN which may delay
absorption, making them less effective or ineffective (e.g. antiepileptics, digoxin and immunosuppressant agents).
If you need to thicken liquids in order to ingest them safely, ISOCOLAN may counteract
the effect of the thickener.
In severe cases of laxative abuse, dehydration or hypokalaemia (decreased potassium in the blood) may occur, which may determine cardiac or neuromuscular dysfunction, especially in the event of concomitant treatment with cardiac glycosides (drugs that stimulate heart function), diuretics (drugs that increase urine production) or corticosteroids (anti-inflammatory drugs).

ISOCOLAN with food
Taking licorice increases the risk of hypokalaemia, therefore do not take licorice during
treatment with ISOCOLAN.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
In case of pregnancy or breastfeeding, take the medicine only if necessary, under the direct control
of the doctor, who will assess the expected benefit for you in relation to the possible risk to the fetus or infant.

Driving and using machines
ISOCOLAN does not impair the ability to drive vehicles or operate machinery.

ISOCOLAN contains sodium
This medicine contains 15.76 mmol of sodiumper 8.7 g sachet; 31.53 mmol of sodiumper 17.4 g sachet
and 63.06 mmol of sodiumper 34.8 g sachet, the main component of table salt.
This corresponds, respectively for each dose, to 18%, 36% and 72% of the maximum
recommended daily intake with the diet of an adult.
Talk to your doctor or pharmacist if you need 2 or more sachets of ISOCOLAN a day for a
prolonged period, especially if you have been advised to follow a low-sodium diet.

ISOCOLAN contains potassium
This medicine contains 1.34 mmol of potassiumper 8.7 g sachet; 2.68 mmol of potassiumper
17.4 g sachet and 5.36 mmol of potassiumper 34.8 g sachet.
To be taken into consideration in patients with reduced kidney function or in patients following a
low-potassium diet.

3. HOW TO TAKE ISOCOLAN

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
doubts, consult your doctor or pharmacist.
The effect of ISOCOLAN manifests 24 to 48 hours after administration.
The restoration of intestinal motility induced by treatment must be maintained by a healthy lifestyle and
an appropriate diet (see “Warnings and precautions”). The daily dose should be adjusted to
clinical effects and may vary from one sachet every other day, one day on and one day off,
(especially in children) up to 2 sachets per day.

Preparation method
For the extemporaneous preparation of the solution, pour the contents of one sachet into a container,
filling it with the amount of water indicated on the sachet itself (500 ml, 250 ml or 125 ml respectively
for the sachets of 34.8 g, 17.4 g and 8.7 g), stir well to obtain a homogeneous solution and drink slowly
within 15-30 minutes. If it is not ingested immediately, the solution should be stored in the refrigerator and,
in any case, used within 48 hours of its preparation. Do not add other ingredients to the reconstituted solution.
In the 17.4 g pack, it is possible to use half a sachet diluted in half the volume (125
ml of water).
Intestinal cleansing

Adults
The recommended dose is 4 liters of the solution obtained by dissolving each of the 8
sachets of 34.8 g in 500 ml of water. Take this amount in a single dose, the afternoon before the examination, or divided into
two doses, 2 liters the evening before the examination and 2 liters on the morning of the examination. Take 250 ml every 15
minutes, until the 4 liters are finished. It is preferable that each single dose is ingested quickly. The
first evacuation occurs, as a rule, about 90 minutes after the start of administration. After
taking the entire recommended dose, the rectal effluent will be clear. The preparation should be taken after
a fast of 3-4 hours. In any case, no solid foods should be ingested from 2 hours before taking it until
the examination is performed. Water intake is free. The solution is more palatable if
cooled.
Treatment of constipation

Adults
The recommended dose is 1 sachet of 34.8 g dissolved in 500 ml of water. Depending on the situation and only
under medical control and advice, you may take a second dose 6-12 hours apart (1 sachet of
17.4 g to be dissolved in 250 ml of water or 1 sachet of 8.7 g to be dissolved in 125 ml of water), depending on
individual response and the desired effect. Take the appropriate amount of reconstituted solution in 15-30
minutes, away from meals.
Maintenance therapy
To maintain and consolidate the laxative effect and the regularization of the bowel (the intestinal tract as a
whole), you can take the 8.7g sachets (to be dissolved in 125 ml of water) or the 17.4g sachets (to be dissolved in 250 ml of water) 1-2 times a day for a few days, according to schemes to be established
according to individual response and the desired effect. Better efficacy of the product is obtained
by taking it in the evening before bedtime.

Use in children (over 8 years of age and weighing over 20 Kg) and adolescents
In children, treatment should not exceed 3 months, due to the lack of clinical data for treatments exceeding 3
months. The recommended doses must be proportionally reduced, using the 8.7 g sachets dissolved
in 125 ml of water or 17.4 g sachets dissolved in 250 ml of water. Depending on the situation and only under
medical control, you can administer a second dose 12 hours apart, or according to schemes established by
the doctor in relation to the desired effect and individual sensitivity.

If you take more ISOCOLAN than you should
The abuse of laxatives can lead to serious problems (see “Warnings and precautions”). In case of
accidental intake of an excessive dose of ISOCOLAN, immediately inform your doctor or go to
the nearest hospital.
Excessive doses can cause diarrhea, abdominal pain and vomiting that disappear when treatment
is temporarily interrupted or the dosage is reduced (see paragraph 4 “Possible side
effects”).
Excessive fluid loss due to diarrhea or vomiting may require correction of electrolyte imbalances (see “Warnings and precautions”). Generally, conservative measures are sufficient;
plenty of fluids, especially fruit juices, should be administered.
Cases of aspiration have been reported when large volumes of macrogol (polyethylene glycol) and electrolytes are
administered via nasogastric tubes (medical devices used to provide artificial nutrition to
patients who are unable or refuse to eat normally).
Children with neurological damage who present oromotor dysfunction (difficulty in motor control and
coordination of lips, tongue, cheeks and pharynx) are particularly at risk of aspiration.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

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

Adults
Generally, the reported side effects have been minor and transient and have mainly affected
the gastrointestinal tract.

Common side effects (may affect less than 1 in 10 people)

• Abdominal pain and/or abdominal distension.
• Diarrhea.
• Nausea.

Uncommon side effects (may affect less than 1 in 100 people)

• Vomiting.
• Need to defecate (expulsion of feces).
• Fecal incontinence (involuntary and uncontrolled loss of feces and intestinal gas).

Very rare side effects (may affect less than 1 in 10,000 people)
Hypersensitivity reactions (allergy) such as itching, rash, facial edema, angioedema (rapid swelling,
edema, usually affecting eyelids, lips, face, neck, hands), urticaria, anaphylactic shock.

Side effects with unknown frequency (frequency cannot be estimated based on available data)
Electrolyte disturbances such as hyponatremia (decreased sodium in the blood) and hypokalemia
(decreased potassium in the blood) and/or dehydration, especially in elderly patients, redness of the
skin (erythema).
Cases of hypo-hyperkinetic cardiac arrhythmias (alterations in heart rhythm) have been reported,
probably secondary to alteration of vagal or sympathetic tone following distension of the intestinal
cavity, accelerated transit, frequent defecation,

Side effects in children and adolescents
As with the adult population, side effects have generally been minor and transient and have
mainly affected the gastrointestinal system.

Common side effects (may affect less than 1 in 10 people)

• Abdominal pain.
• Diarrhea (may cause perianal inflammation).

Uncommon side effects (may affect less than 1 in 100 people)

• Vomiting.
• Swelling.
• Nausea.

Side effects with unknown frequency (frequency cannot be estimated based on available data)

• Hypersensitivity reactions (anaphylactic shock, angioedema, urticaria, rash, itching). Reporting of side effects

If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national
reporting system at the website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. Reporting side
effects helps to provide more information on the safety of this medicine.

5. HOW TO STORE ISOCOLAN

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after Exp.
The expiry date refers to the last day of that month.
If not ingested immediately, the reconstituted solution must be stored at 2-8 °C (in
a refrigerator) and used within 48 hours of preparation. The remaining solution must be discarded.
Store the medicine in the original packaging to protect the product from humidity.
Do not use this medicine if you notice any visible signs of deterioration.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. CONTENT OF THE PACK AND OTHER INFORMATION

What ISOCOLAN contains
ISOCOLAN 29.5 + 2.843 + 0.843 + 0.733 + 0.371 powder for oral solution
Each 34.8 g sachet contains:

The active ingredients are: Macrogol 4000 29.5 g; Sodium sulfate 2.843 g; Sodium bicarbonate 0.843 g; Sodium chloride
0.733 g and Potassium chloride 0.371 g.

The other ingredients are: Sodium cyclamate, Acesulfame K, Saccharin, Natural flavour.

ISOCOLAN 14.75 + 1.422 + 0.422 + 0.366 + 0.186 powder for oral solution
Each 17.4 g sachet contains:

The active ingredients are: Macrogol 4000 14.75 g; Sodium sulfate 1.422 g; Sodium bicarbonate 0.422 g; Sodium
chloride 0.366 g and Potassium chloride 0.186 g.

The other ingredients are: Sodium cyclamate, Acesulfame K, Saccharin, Natural flavour.
ISOCOLAN 7.375 + 0.711 + 0.211 + 0.183 + 0.093 powder for oral solution
Each 8.7 g sachet contains:

The active ingredients are: Macrogol 4000 7.375 g; Sodium sulfate 0.711 g; Sodium bicarbonate 0.211 g; Sodium
chloride 0.183 g and Potassium chloride 0.093 g.

The other ingredients are: Sodium cyclamate, Acesulfame K, Saccharin, Natural flavour.

Description of the appearance of ISOCOLAN and content of the pack
Powder for oral solution.
Packs of:

• 2 or 4 or 8 sachets of 34.8 g with a 500 ml plastic container for the extemporaneous preparation of the solution
• 8 sachets of 34.8 g
• 8 sachets of 17.4 g
• 8 sachets of 8.7 g Not all pack sizes may be marketed.

Marketing Authorisation Holder
POLIFARMA S.p.A., Viale dell’Arte, 69 - 00144 Roma.

Manufacturer
SIGMAR ITALIA S.p.A.- via Sombreno, n. 11 - 24011 Almè (BG).