Racedril Go

Package Leaflet: Information for the Patient

Racedryl Go, 30 mg, Granules for Oral Suspension

Racecadotril

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

This Medication Should Always be Taken Exactly as Described in this Package Leaflet for the Patient or as Advised by a Doctor or Pharmacist.

• This Package Leaflet Should be Kept in Case it Needs to be Read Again.
• If Advice or Additional Information is Needed, a Pharmacist Should be Consulted.
• If a Child Experiences any Undesirable Effects, Including any Undesirable Effects not Listed in this Package Leaflet, the Doctor or Pharmacist Should be Informed (see Section 4).
• If There is no Improvement or the Patient Feels Worse after 2 Days, a Doctor Should be Consulted.

Table of Contents of the Package Leaflet

• 1. What is Racedryl Go and What is it Used for
• 2. Important Information Before Taking Racedryl Go
• 3. How to Take Racedryl Go
• 4. Possible Undesirable Effects
• 5. How to Store Racedryl Go
• 6. Contents of the Package and Other Information

1. What is Racedryl Go and What is it Used for

Racedryl Go is a Medication Used as a Supplementary Symptomatic Treatment of Acute Diarrhea in Children Over 6 Years of Age, with Concurrent Use of Oral Rehydration and Standard Supportive Care, if Such Treatment Alone Does not Allow for Control of Clinical Symptoms, and Causal Treatment is not Possible. When Causal Treatment is Possible, Racedryl Go may be Used as a Supplementary Treatment. The Medication is Intended for Children Over 6 Years of Age. If There is no Improvement or the Patient Feels Worse after 2 Days, a Doctor Should be Consulted.

2. Important Information Before Taking Racedryl Go

When Not to Take Racedryl Go

• If the Child is Allergic to Racecadotril or any of the Other Ingredients of this Medication (listed in Section 6);
• If the Patient has Ever Experienced a Severe Skin Rash or Exfoliation, Blisters, and (or) Ulcers of the Mouth After Taking Racecadotril;
• If the Child has Chronic Diarrhea or Diarrhea Caused by Antibiotics;
• In Children with Renal or Hepatic Impairment, Regardless of the Severity of the Disease;
• If the Child has Prolonged, Uncontrolled Vomiting;
• If the Child has an Intolerance to Some Sugars, a Doctor Should be Consulted Before Administering Racedryl Go to the Child;
• If the Child is Under 6 Years of Age.

Warnings and Precautions

Before Starting Racedryl Go, a Doctor or Pharmacist Should be Consulted if:

• The Child has Blood or Pus in the Stool and has a Fever. The Cause may be a Bacterial Infection or the Presence of Other Severe Diseases;
• The Child has Prolonged or Uncontrolled Vomiting;
• The Child has Diabetes (see "Racedryl Go Contains Sucrose");
• The Child's Diarrhea has a Very Large Volume, Vomiting Persists, Signs of Dehydration Appear (pallor, Dryness of Mucous Membranes, Lethargy) or there is a Lack of Appetite - in Such Cases, Intravenous Rehydration may be Necessary and the Child may Require Hospital Treatment;
• The Child has a History of Angioedema Unrelated to Racecadotril Treatment, as it may be at Increased Risk of Angioedema.

Particular Caution Should be Exercised when Using Racecadotril. Severe Skin Reactions, Including Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), have been Reported with Racecadotril. If the Patient Notices any of the Symptoms Associated with Severe Skin Reactions Described in Section 4, they Should Stop Taking Racecadotril and Seek Medical Attention Immediately. Taking the Medication does not Change the Standard Rehydration Method. It is Very Important to Rehydrate Children During Treatment for Acute Diarrhea.

Racedryl Go and Other Medications

The Doctor Should be Informed of all Medications Currently or Recently Taken by the Child, as well as any Medications Planned to be Administered to the Child. In Particular, the Doctor Should be Informed of Medications such as:

• Angiotensin-Converting Enzyme Inhibitors (e.g., Captopril, Enalapril, Lisinopril, Perindopril, Ramipril) Used to Lower Blood Pressure or Facilitate Heart Function.

Pregnancy and Breastfeeding

This Medication is Intended for Children. If the Patient is Pregnant or Breastfeeding, Thinks they may be Pregnant, or is Planning to have a Child, they Should Consult a Doctor or Pharmacist Before Using this Medication. Before Using any Medication, a Doctor or Pharmacist Should be Consulted. Racedryl Go Should not be Used During Pregnancy or Breastfeeding.

Driving and Operating Machinery

Racedryl Go has no Influence or a Negligible Influence on the Ability to Drive and Operate Machinery.

Racedryl Go Contains Sucrose

If the Child has an Intolerance to Some Sugars, a Doctor Should be Consulted Before Administering Racedryl Go to the Child. Racedryl Go Contains 2.9 g of Sucrose in Each Sachet. In Children with Diabetes, the Amount of Sucrose Taken with Racedryl Go Should be Included in the Daily Sugar Intake of the Child.

3. How to Take Racedryl Go

This Medication Should Always be Taken Exactly as Described in this Package Leaflet for the Patient or as Advised by a Doctor or Pharmacist. In Case of Doubt, a Doctor or Pharmacist Should be Consulted. Racedryl Go is a Granule for Oral Suspension, which, After Dissolution in Water, Forms a White Suspension. The Medication can be Added to Food, Sprinkled into a Glass of Water or a Bottle of Formula, then Well Mixed and Immediately Administered to the Child. The Medication is Intended for Children Over 6 Years of Age.

Recommended Dose

Children with a Body Weight of 13 kg to 27 kg: 1 Sachet 3 Times a Day, at Equal Intervals. Children with a Body Weight Over 27 kg: 2 Sachets 3 Times a Day, at Equal Intervals. Treatment Should be Continued Until Two Normal Stools are Passed and Should not Last Longer than 7 Days. If There is no Improvement or the Patient Feels Worse after 2 Days, a Doctor Should be Consulted. To Supplement Lost Fluids Due to Diarrhea, this Medication Should be Used in Conjunction with an Appropriate Amount of Fluids and Electrolyte Solutions. The Best Way to Supplement Fluids and Electrolytes is to Drink Oral Rehydration Solutions (in Case of Doubt, a Doctor or Pharmacist Should be Consulted).

Overdose of Racedryl Go

In Case of Overdose, a Doctor or Pharmacist Should be Consulted Immediately.

Missed Dose of Racedryl Go

A Double Dose Should not be Taken to Make up for a Missed Dose. The Next Dose Should be Taken at the Usual Time.

4. Possible Undesirable Effects

Like all Medications, Racedryl Go can Cause Undesirable Effects, although not Everybody gets them.

Stop Taking Racedryl Go and Seek Medical Attention Immediately if any of the Following Symptoms Occur:

• Symptoms of Angioedema, such as: Swelling of the Face, Tongue, or Throat, Difficulty Swallowing, Hives, and Difficulty Breathing;
• Widespread Rash, High Fever, and Enlarged Lymph Nodes (DRESS Syndrome);
• Difficulty Breathing, Swelling, Dizziness, Rapid Heartbeat, Sweating, and a Feeling of Losing Consciousness, which are Symptoms of a Severe Allergic Reaction.

The Following Undesirable Effects have been Reported:

Frequent(may Occur in Less than 1 in 10 People):

• Headache.

Infrequent(may Occur in Less than 1 in 100 People):

• Tonsillitis;
• Rash;
• Redness (Redness of the Skin).

Frequency Unknown(Frequency cannot be Estimated from the Available Data):

• Multi-Form Erythema (Pink Spots on the Skin of the Extremities and Inside the Mouth);
• Tongue Swelling;
• Face Swelling;
• Lip Swelling;
• Eyelid Swelling;
• Hives;
• Nodular Erythema (Nodular Inflammatory Lesions of the Subcutaneous Tissue);
• Papular Rash (Rash with Small, Hard, and Nodular Lesions on the Skin);
• Pruritus (Itching);
• Urticaria (Itchy Skin Lesions);
• Toxic Epidermal Necrolysis.

Reporting Undesirable Effects

If any Undesirable Effects Occur, Including any Undesirable Effects not Listed in this Package Leaflet, the Doctor or Pharmacist Should be Informed. Undesirable Effects can be Reported Directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the 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. Undesirable Effects can also be Reported to the Marketing Authorization Holder. By Reporting Undesirable Effects, more Information can be Collected on the Safety of the Medication.

5. How to Store Racedryl Go

There are no Special Precautions for Storing the Medication. The Medication Should be Stored in a Place that is Inaccessible to Children. The Medication Should not be Used after the Expiration Date Stated on the Carton and Sachet after "EXP". The Expiration Date Refers to the Last Day of the Specified Month. Medications Should not be Disposed of in the Drain or Household Waste Containers. A Pharmacist Should be Asked how to Dispose of Unused Medications. This will Help Protect the Environment.

6. Contents of the Package and Other Information

What Racedryl Go Contains

• The Active Substance of the Medication is Racecadotril. Each Sachet of Racedryl Go Contains 30 mg of Racecadotril.
• The Other Ingredients are: Sucrose, Colloidal Anhydrous Silica, Povidone K-30.

What Racedryl Go Looks Like and What the Package Contains

Racedryl Go is a White or Almost White Granule for Oral Suspension, which, After Dissolution in Water, Forms a White Suspension. The Medication is Packaged in Paper/Polyester/Aluminum/Polyester Sachets in a Cardboard Box. Each Package Contains: 10, 16 Sachets.

Marketing Authorization Holder

Aflofarm Farmacja Polska Sp. z o.o., ul. Partyzancka 133/151, 95-200 Pabianice, Tel.: +48 42 22-53-100

Importer

Aflofarm Farmacja Polska Sp. z o.o., ul. Szkolna 31, 95-054 Ksawerów

Date of the Last Update of the Package Leaflet: