OLOPEG SOLUTION CONCENTRATE 200 ml.

What is Olopeg and what it is used
Olopeg is an osmotic laxative.

Olopeg be used for:
rapid relief of constipation;
gut cleansing prior to diagnostic examination (eg. colonoscopy) and surgery.

2. What you need to know before taking Olopeg
Do not take Olopeg in case of:
known allergy to macrogol (polyethylene glycol) or any of the other ingredients of this medicine (listed in section 6);
abdominal pain of unknown origin;
bowel obstruction or suspected bowel obstruction (ileus);
abnormal narrowing (stenosis), perforation or risk of perforation of the stomach or intestines;
disorders in gastric emptying;
acute gastrointestinal ulcers;
severe inflammatory bowel disease (Crohn's disease, ulcerative colitis, toxic megacolon, toxic or rapidly progressive colitis);
loss of consciousness.
Warnings and Precautions
If your health is poor or you have a serious medical problem, you need to carefully read the possible side effects listed in section 4. Contact your doctor or pharmacist if you have any concerns.

Before taking Olopeg tell your doctor if you suffer from:
cardiac insufficiency, circulatory insufficiency or functional disorders of the kidneys (renal failure), and liver disease;
consciousness disorders;
binge inhalation of fluid in the lungs or vomiting and impaired swallowing reflex and reflex vomiting;
Severe dehydration.
If you have symptoms such as edema, shortness of breath, worsening fatigue, dehydration or heart failure, showing poor balance between water and electrolytes in the body, intake Olopeg should be immediately terminated, electrolytes should be measured and need to be taken adequate measures.
If you have diabetes, carbohydrate exchange units should not be taken into account when taking this medicine.
If you are prone to violation of water-electrolyte balance (eg patients taking diuretics), you must use Olopeg only upon consultation with your doctor and with caution. In case of diarrhea, should you be appointed to follow up the water and electrolyte balance.
Elderly patients should use Olopeg with caution, since elderly patients are more susceptible to any adverse reactions caused by medicines. It should be borne in mind especially in the case of diarrhea, and a possible infringement of water and electrolyte balance.
If you suffer from gastric reflux or heart rhythm disturbances, you must use Olopeg only under medical supervision.
You should contact your doctor, even if the above remarks relating to past situations.

Children
Constipation - the available data do not support the use of Olopeg in children under 2 years of age.
For bowel cleansing prior to diagnostic examination - not enough data for use in children under 18 years. Therefore, Olopeg should not be used to cleanse the bowel in children and adolescents under 18 years.

Other medicines and Olopeg
Tell your doctor or pharmacist if you are taking, you have recently taken or might take any other medicines.
When performing diagnostic testing of the fluid carried by lavage of the intestine, enzymes that can be used in these tests (eg. ELISA) may be affected by the polyethylene glycol, which is contained in Olopeg.

Interactions between Olopeg and other drugs during treatment of constipation:
No clinical reports of interactions between Olopeg and other drugs. However, the effect of certain drugs may be weakened while taking Olopeg since their absorption by the body, can be temporarily reduced. Therefore, it is recommended that you take other medicines at least two hours before or after taking Olopeg.

Interactions between Olopeg and other medicines taken during bowel cleansing:
Medicinal products may be flushed from the gastrointestinal tract, or to reduce or stop their absorption by the body if they are taken several hours before the Olopeg or during treatment with Olopeg. This particularly applies to medicinal products with delayed release. Often, when vital evidence necessary to give another product immediately before or while taking Olopeg. In these cases, the oral form of another medicinal product should be replaced with intravenous or intramuscular form.

Olopeg with food and drink
When taking Olopeg for bowel cleansing prior to diagnostic examination or bowel surgery should stop taking solid food 2 to 3 hours before the first Olopeg the end of the study.

Pregnancy and lactation
If you are pregnant or breast-feeding, you think you may be pregnant or planning to become pregnant, ask your doctor or pharmacist before taking this medicine.
There is not enough information about the application of Olopeg during pregnancy and lactation. Therefore Olopeg medicinal product should be administered to pregnant or lactating women only when absolutely necessary.

Driving and using machines
There is no evidence that Olopeg affect your ability to drive or operate machinery.

Olopeg contains potassium and sodium
Potassium diet or reduced kidney function:
If you suffer from reduced kidney function or are on a diet low in potassium, please note the amount of potassium from 1,26 mmol (49 mg), which is contained in a dose Olopeg (125 ml of a ready to use solution).

Sodium diet:
If you're on a diet with low sodium content, please note the amount of sodium by 8,09 mmol (186 mg), which is contained in a dose Olopeg (125 ml of a ready to use solution).

3. How to take Olopeg
Always take this medicine exactly as you have been told by your doctor or pharmacist. If you are unsure, ask your doctor or pharmacist.
As with all laxatives, use of Olopeg not recommended for extended periods. During treatment with Olopeg should not exceed two weeks. If necessary, Olopeg can be used repeatedly.

For fast relief of constipation
For additional treatment with maintaining a proper lifestyle and diet.
The daily dose should be adjusted in accordance with the results.
Before starting treatment, your doctor must rule out the possibility of organic disease.

Daily Dose:
Use in children and adolescents:
From 2 to 4 years: 7,5 ml to 15 ml concentrate Olopeg *.
From 4 to 8 years: 15 ml to 30 ml of concentrate Olopeg *.
From 8 to 18 years: 20 ml to 35 ml of concentrate Olopeg *. * The required amount Olopeg concentrate must be diluted in fourfold volume of water before ingestion (eg. 7,5 ml Olopeg concentrate + 30 ml water).

Adults:
2-3 times a day, before taking Olopeg mix 25 ml of concentrate with 100 ml of water (125 ml in all).

Elderly:
Initially, once a day, before administration dilute 25 ml Olopeg concentrate (13,125 g Macrogol 4000) in 100 ml of water (total 125 ml).

Bowel cleansing prior to diagnostic examination
Administration of the solution for gut cleansing should be initiated for a period of about 4 hours, usually on the day of the study. It has all the necessary quantity of the medicinal product to be taken in the evening before the study, or part of it to be taken in the evening before the study, and the rest of the morning on the day of the survey.
You should not eat solid food 2 to 3 hours before the first Olopeg the end of the study.
To prepare 1 liter ready to use solution, mix 200 ml of Olopeg concentrate with 800 ml of drinking water.
For a complete emptying of the bowel should take 3 to 4 liters of ready to use solution.
You should take a ready to use solution portions of 200-300 ml every 10 minutes until the rectal mucus becomes transparent or while taking a peak of 4 liters.
In practice, you will get diarrhea, as part of the process of cleansing the intestines. Therefore, you must have permanent access to a toilet.
If you have gastrointestinal problems should temporarily reduce your intake of Olopeg or stop it until the symptoms subside.

Use in children:
For bowel cleansing - there is not enough information about the application of Olopeg in children under 18 years. Therefore, Olopeg should not be used to cleanse the bowel in children and adolescents under 18 years.

If you take more dose Olopeg
If you take more dose Olopeg can get acute pain, flatulence (gas) or acute diarrhea. If you develop any of these symptoms, please immediately contact your doctor!

If you forget to take Olopeg
If you take significantly less than the recommended dose of Olopeg, cleansing the intestines may not be enough and planned research can not be done. Strictly follow your doctor's instructions or those mentioned in the leaflet.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following adverse reactions may occur during treatment with macrogol 3350 and 4000.

Possible side effects during treatment of constipation
Common side effects occurring in 1 to 10 in every 100 patients treated:
abdominal pain, bloating, stomach rumble and nausea as a result of increasing the volume of intestinal contents.
Rare side effects which occur in less than 1 in 10,000 patients treated:
allergic reactions such as skin reaction, runny nose (rhinitis), swelling of the dermis (edema edema) and anaphylaxis.
Possible side effects during bowel cleansing
Common side effects occurring in 1 to 10 in every 100 patients treated:
Nausea, bloating, abdominal cramps and gas. These reactions are caused by the adoption of relatively large quantities of liquid over a short period of time. Also reported discomfort and trouble sleeping.
Rare side effects occurring in 1 to 10 in every 1000 patients treated:
Vomiting and irritation in the anal area.
Rare side effects which occur in less than 1 in 10,000 patients treated:
After administration of solutions containing polyethylene glycol, are observed arrhythmia, tachycardia and fluid accumulation in body tissues (edema). Therefore, in high-risk patients require close monitoring of fluid and electrolyte balance. In some cases they observed decreased levels of calcium in serum.
Rash (hives), runny nose (rhinorrhea) or eczema (dermatitis) and anaphylactic shock have been reported. It is assumed that these symptoms are symptoms of allergy. Stop taking Olopeg and immediately contact your doctor.
Side effects that occur with unknown frequency (can not be established from the available data):
There have been several cases of the syndrome Mallory - Weiss / Mallory-Weiss / (breaks in the lining of the stomach, near the place where the stomach connects with the esophagus) caused by vomiting after administration of a solution for bowel cleansing, comprising polyethylene glycol .
If you get any side effects, contact your doctor or pharmacist. This includes any possible effects not listed in this leaflet, side effects.

5. How to store Olopeg
Keep out of reach of children.
This medicinal product does not require any special storage conditions.
Shelf life after first opening: 3 weeks.
Shelf life of ready-to-use solution: 48 hours.

Do not use this medicine after the expiry date stated on the bottle label and carton after "EXP.". The expiry date refers to the last day of that month.
Do not dispose of medications in wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.

6. Contents of the pack and further information
What Olopeg
The active substances are macrogol 4000, sodium citrate, citric acid anhydrous, sodium chloride and potassium chloride.
1 ml of concentrate (5 ml of a ready to use solution) contains:
macrogol 4000: 525,0 mg;
Sodium citrate: 19,5 mg;
citric acid, anhydrous: 16,5 mg;
sodium chloride: 7,3 mg;
potassium chloride: 1,9 mg.
The other ingredients are: raspberry flavor, acesulfame potassium and purified water.
The concentration of electrolyte ions diluted in 1 liter of ready-to-use solution, is as follows:
Sodium: 64,8 mmol / 1;
Potassium: 10,1 mmol / 1;
Chloride: 30,1 mmol / 1;
Citrate: 30,5 mmol / 1.
Olopeg looks like and contents of the pack
Olopeg a clear colorless liquid.
The ready to use solution is a clear colorless liquid with the aroma and taste of raspberry.