Gastrolit

Package Leaflet: Information for the User

GASTROLIT, Powder for Oral Solution

• This leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a doctor or pharmacist should be consulted.
• If the patient experiences any side effects, including those not listed in this leaflet, the doctor or pharmacist should be informed. See section 4.
• If there is no improvement after 2 days of therapy, a doctor should be consulted.

Table of Contents of the Leaflet:

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

1. WHAT IS GASTROLIT AND WHAT IS IT USED FOR

Gastrolit is a powder for oral solution, containing a set of electrolytes and glucose, which are deficient in dehydration states, especially during diarrhea.

Indications:

The solution, after dissolution, is used to prevent and treat mild dehydration in the course of diarrhea. It should be used from the onset of diarrhea or vomiting to prevent dehydration and associated electrolyte loss (see Clinical Dehydration Scale, section 2). Dehydration is particularly dangerous in children, as fluid loss in the body occurs much faster than in adults, which is why children under 3 years of age should be under medical supervision as soon as possible. Oral rehydration solutions like Gastrolit can be used before consulting a doctor. Dehydration can also occur due to excessive sweating caused by fever, heat, intense exercise, reduced fluid intake, weakened thirst, or lack of thirst (especially in the elderly). Gastrolit replaces water and salts (electrolytes) lost due to diarrhea and other dehydration states mentioned above. The sugar (glucose) in the product supports the absorption of water and sodium from the intestines, and bicarbonate corrects acid-base balance disorders in the body. Chamomile extract soothes inflammatory conditions of the digestive tract and has a spasmolytic effect.

2. IMPORTANT INFORMATION BEFORE TAKING GASTROLIT

When not to take Gastrolit

• If the patient is allergic to glucose, sodium chloride, potassium chloride, sodium bicarbonate, chamomile extract (or other plants of the Asteraceae family), or any other component of this medicine listed in section 6,
• If the patient has increased potassium levels in the blood,
• If the patient has acute or chronic renal failure with electrolyte balance disorders,
• If the patient has anuria,
• If the patient is severely dehydrated (see Clinical Dehydration Scale),
• If the patient is unconscious (risk of choking),
• If the patient is in hemodynamic shock (risk of choking),
• If the patient has intestinal obstruction,
• If the patient is vomiting profusely.

Warnings and precautions

Before starting to take Gastrolit, the patient should discuss it with a doctor or pharmacist:

• in patients with heart failure and high blood pressure due to the sodium content in the medicine,
• in patients with renal function disorders leading to reduced or completely blocked urine excretion,
• in patients with other chronic diseases,
• in patients with liver diseases,
• in case of blood in the stool,
• in case of diarrhea lasting more than 24-48 hours, even if it is mild,
• in case of severe abdominal pain,
• in case of changes in mental state (e.g., irritability, apathy, or lethargy),
• in case of fever above 39°C,
• due to the glucose content, it is not recommended to use the medicine in diabetic patients,
• during therapy, a diet with limited sodium or potassium content should be used,
• children under 3 years of age should be under medical supervision as soon as possible. Oral rehydration therapy is insufficient in case of severe dehydration; medical consultation and intravenous rehydration therapy may be necessary. Symptoms of severe dehydration include rapid pulse, breathing difficulties, fever, extreme fatigue, muscle cramps, headache, nausea, tingling of limbs, vomiting, confusion, seizures, and loss of consciousness. In infants, acute diarrhea can cause dehydration, leading to rapid deterioration of the clinical condition, requiring immediate medical consultation. Clinical Dehydration Scale (Clinical Dehydration Scale, CDS)

Gastrolit and other medicines

Due to the risk of increased potassium levels in the blood, the medicine should not be used with medicines that increase potassium levels in the body (e.g., potassium-sparing diuretics, such as spironolactone, angiotensin-converting enzyme inhibitors used in the treatment of hypertension). It should be remembered that diarrhea can affect the absorption of many medicinal products.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks she may be pregnant, or plans to have a child, she should consult a doctor or pharmacist before taking this medicine. Gastrolit can be used in pregnant and breastfeeding women in recommended doses.

Driving and using machines

Gastrolit does not affect psychomotor performance and does not limit the ability to drive vehicles and operate machines.

Important information about some ingredients of the medicine

Gastrolit contains glucose; if the patient has previously been diagnosed with intolerance to some sugars, the patient should contact a doctor before taking the medicine. The medicine contains 12 mmol of sodium in the prepared oral solution, which should be taken into account in patients with renal function disorders and in patients controlling sodium intake in their diet. Gastrolit contains potassium, which should be taken into account in patients with reduced renal function and in patients controlling potassium intake in their diet.

3. HOW TO TAKE GASTROLIT

Gastrolit should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist. In case of doubts, the doctor or pharmacist should be consulted again.

Children under 3 years of age should be under medical supervision as soon as possible.

Method of preparing the solution: The medicine should be given to the patient to drink after dissolving it in hot, boiled water (the contents of 1 sachet in 200 ml of water) and cooling it. To prepare a larger volume of the solution, e.g., 500 ml, 3 sachets of Gastrolit should be dissolved in 600 ml of water. The prepared solution should not be sweetened. A sediment may precipitate from the solution, which does not affect the medicinal value of the medicine. It should be ensured that the contents of the sachet are mixed with the appropriate amount of water (200 ml), which will ensure the optimal effectiveness of the medicine. Mixing the powder with an insufficient amount of water may cause excessive salt intake. The contents of the sachet should not be mixed with fluids other than water. Rapid administration of the solution is safe but may cause vomiting. Better tolerance of the medicine is achieved by cooling it and administering it in small portions in repeated doses, using, for example, a teaspoon. If the medicine is well tolerated, the dose can be gradually increased.

Prevention of dehydration (associated with mild diarrhea)

Treatment with Gastrolit solution should be started immediately after the onset of diarrhea. In case of diarrhea before dehydration occurs, preventive doses are used:

• Adults, adolescents, and children over 3 years of age:200 ml after each loose stool (corresponding to a solution from 1 sachet of powder)
• Children under 3 years of age and infants:Waiting for a medical consultation, 10 ml/kg body weight can be used after each loose stool

Dosing in dehydration

The instructions in section 2 should be read to determine when to consult a doctor. If the dehydration state does not require medical supervision or while waiting for a medical consultation, the following dosing is recommended: The dosing schedule is presented in the table.

1 sachet of Gastrolit should always be dissolved in 200 ml of hot, boiled water and cooled. To prepare a larger volume of the solution, e.g., 500 ml, 3 sachets of Gastrolit should be dissolved in 600 ml of water. The prepared solution should be measured and administered in the appropriate volume according to the dosing schedule.

The appropriate volume should be administered according to the table below.

Age group (body weight)

Adults

• first 4 hours 500 ml to 1000 ml to satisfy thirst
• then about 200 ml after each loose stool

Adolescents, older children, over 3 years of age

• first 4 hours 500 ml to satisfy thirst
• then about 100 ml to 200 ml after each loose stool

Children 1-3 years

(approximately 10-15 kg)

• first 4 hours usually 50 ml/kg body weight (500 ml to 750 ml)
• then about 10 ml/kg body weight after each loose stool (100 ml to 150 ml)

Infants ≥ 2-12 months

(approximately 5-10 kg)

• first 4-6 hours usually 50 to 100 ml/kg body weight (250 ml to 1000 ml)
• then about 10 ml/kg body weight after each loose stool (50 ml to 100 ml)

Taking the medicine with food and drink

• During treatment, other fluids (e.g., diluted juice) can also be administered. However, fluids with high sugar content should be avoided, as they may exacerbate diarrhea.
• The Gastrolit solution is not intended to quench thirst; doses larger than recommended should not be used without medical advice.
• During mild diarrhea, other fluids can be taken, and a normal diet suitable for the age can be continued.
• For the first 4 hours of rehydration, food should not be given, except for breastfed children, who can be fed normally.

Consult a doctor

The patient's weight and general condition should be monitored during treatment, and a doctor should be consulted in case of:

• children under 3 years of age,
• changes in mental state, e.g., irritability, apathy, or lethargy,
• fever above 39°C,
• blood in the stool,
• persistent vomiting,
• large volume of loose stools (>8 episodes/day), especially in children under 3 years of age,
• diarrhea lasting longer than 2 days,
• severe abdominal pain,
• no urination during the first 6 hours of treatment,
• symptoms of severe dehydration in the opinion of a family member,
• coexistence of severe chronic disease (e.g., diabetes, renal failure),
• other alarming symptoms.

Using more than the recommended dose of Gastrolit

If the patient has taken a larger dose of the medicine than they should or if someone else has taken it, they should immediately inform a doctor or pharmacist. Symptoms of overdose may include thirst, dryness in the mouth, difficulty swallowing, dehydration, low blood pressure, disorientation, drowsiness, stiffness of the neck, loss of consciousness, muscle tremors, and a feeling of weakness. Symptoms of overdose are more likely in patients with reduced renal function.

Missing a dose of Gastrolit

The missed dose should be taken as soon as remembered. If the patient feels that the effect of the medicine is too strong or too weak, they should consult a doctor. In case of doubts about the use of the medicine, a doctor or pharmacist should be consulted.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Gastrolit can cause side effects, although not everybody gets them. Too rapid administration of the solution may cause vomiting (see section 3 "How to take the product").Rarely, gastrointestinal disorders (nausea, vomiting) and increased potassium levels in the blood occur. If any of the side effects worsen or if any side effects not listed in the leaflet occur, a doctor or pharmacist should be informed. Reporting side effects: If any side effects occur, including those not listed in the leaflet, the doctor or pharmacist should be informed. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be collected on the safety of the medicine.

5. HOW TO STORE GASTROLIT

Store in a temperature below 25°C. Store in a place out of sight and reach of children. Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month. Medicines should not be disposed of via wastewater or household waste. A pharmacist should be asked how to dispose of medicines no longer required. This will help protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Gastrolit contains

Gastrolit is a complex preparation, and its active substances are: Sodium chloride 0.35 g, Potassium chloride 0.30 g, Sodium bicarbonate 0.50 g, Chamomile extract 0.02 g, Glucose 2.98 g. After dissolution, the solution contains: 60 mmol/l Na, 20 mmol/l K, 30 mmol/l HCO, 80 mmol/l glucose. The osmolality of the solution prepared by dissolving the contents of the sachet in 200 ml of water is 240 mOsm/kg.

What Gastrolit looks like and what the pack contains

Powder for oral solution. 14 or 15 sachets of 4.15 g of powder in a cardboard box.

Marketing authorization holder

Teva Pharmaceuticals Polska Sp. z o.o., ul. Emilii Plater 53, 00-113 Warsaw, Poland

Manufacturer

Teva Operations Poland Sp. z o.o., ul. Mogilska 80, 31-546 Kraków, Poland

Date of last revision of the leaflet: