Recenum Babi

Package Leaflet: Information for the Patient

Recenum Baby, 10 mg, Granules for Oral Suspension, in a Sachet

Racecadotril

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

• Keep this Package Leaflet, You May Need to Read it Again.
• If You Have Any Further Questions, Ask Your Doctor, Pharmacist, or Nurse.
• This Medication Has Been Prescribed for a Specific Person. Do Not Pass it on to Others. The Medication May Harm Them, Even if Their Symptoms are the Same.
• If the Child Experiences Any Side Effects, Including Those Not Listed in this Package Leaflet, Tell Your Doctor, Pharmacist, or Nurse (See Section 4).

Package Leaflet Contents

• 1. What is Recenum Baby and What is it Used For
• 2. Important Information Before Taking Recenum Baby
• 3. How to Take Recenum Baby
• 4. Possible Side Effects
• 5. How to Store Recenum Baby
• 6. Package Contents and Other Information

1. What is Recenum Baby and What is it Used For

Recenum Babyis a Medication Used to Treat Symptoms of Acute Diarrhea in Children Over

• 3 Months of Age. The Medication Should be Taken with a Large Amount of Fluids and a Supportive Diet, When These Alone are Not Enough to Control Diarrhea and When the Diarrhea Cannot be Treated Causally. Racecadotril May be Used as a Supportive Treatment When Causal Treatment is Possible.

2. Important Information Before Taking Recenum Baby

When Not to Take Recenum Baby

• 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 Oral Ulcers After Taking Racecadotril
• If the Child Has an Intolerance to Some Sugars, Consult a Doctor Before Giving the Child Recenum Baby
• The Child is Less Than 3 Months Old.

Warnings and Precautions

Before Taking Recenum Baby, Discuss it with Your Doctor or Pharmacist if:

• There is Blood or Pus in the Stool and the Child Has a Fever. The Cause May be a Bacterial Infection that Should be Treated by a Doctor
• The Child Has Chronic Diarrhea or Diarrhea Caused by Taking Antibiotics
• The Child Has Kidney or Liver Function Disorders

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• The Child Has Prolonged or Uncontrolled Vomiting
• The Child Has Diabetes (See "Recenum Baby Contains Sucrose").

Particular Caution Should be Exercised When Using Racecadotril. Skin Reactions Have Been Reported During Treatment with the Medication. In Most Cases, These Were Mild Reactions. Severe Skin Reactions, Including Drug Rash with Eosinophilia and Systemic Symptoms (DRESS), Have Also Been Reported with Racecadotril Treatment. 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.

Recenum Baby and Other Medications

Tell Your Doctor About All Medications the Child is Currently Taking or Has Recently Taken, as Well as Any Medications Planned to be Given to the Child. In Particular, Tell Your Doctor About Medications the Child is Taking:

• Angiotensin-Converting Enzyme Inhibitors (e.g., Captopril, Enalapril, Lisinopril, Perindopril, Ramipril) Used to Lower Blood Pressure or Make the Heart Work More Efficiently.

Pregnancy and Breastfeeding

This Medication is Intended for Children. If You are Pregnant or Breastfeeding, Think You May be Pregnant, or are Planning to Have a Child, Consult Your Doctor or Pharmacist Before Taking this Medication. Before Taking Any Medication, Consult Your Doctor or Pharmacist. Do Not Take Recenum Baby During Pregnancy or Breastfeeding.

Driving and Operating Machinery

Recenum Baby Has No Influence or a Negligible Influence on the Ability to Drive and Operate Machinery.

Recenum Baby Contains Sucrose

Recenum Baby Contains Approximately 0.98 g of Sucrose in One Sachet. If the Child Has Been Diagnosed with an Intolerance to Some Sugars, Consult a Doctor Before Giving the Child Recenum Baby. If the Doctor Prescribes More Than 5 Sachets of the Medication per Day for Diabetic Infants (Which Corresponds to More Than 5 g of Sucrose), This Should be Taken into Account in the Child's Daily Sugar Intake.

3. How to Take Recenum Baby

Recenum Baby Should Always be Given to the Child as Directed by the Doctor or Pharmacist. If in Doubt, Consult the Doctor or Pharmacist. Recenum Baby Comes in the Form of Granules Intended for Swallowing. The Granules Should be Added to Food or Mixed with Water in a Glass or Feeding Bottle, Well Mixed, and Given to the Child Immediately. After Dissolving in Water, it Forms a White Suspension. The Recommended Dose Depends on the Child's Body Weight: 1.5 mg/kg Body Weight per Dose (Which Corresponds to 1-2 Sachets), 3 Times a Day at Regular Intervals. For Children Weighing Up to 9 kg: One Sachet per Dose. For Children Weighing 9-13 kg: Two Sachets per Dose. The Doctor Will Decide on the Duration of Treatment with Recenum Baby. Treatment Should be Continued Until Two Normal Stools are Passed and Should Not Last Longer Than 7 Days. Page 2 4

Best Way to Replace Lost Fluids and Electrolytes

In Order to Replace Lost Fluids Due to Diarrhea, this Medication Should be Used in Conjunction with an Appropriate Amount of Fluids and Salts (Electrolytes). The Best Way to Replace Fluids and Electrolytes is to Drink So-Called Oral Rehydration Solutions (In Case of Doubt, Consult a Doctor or Pharmacist).

Taking More Than the Recommended Dose of Recenum Baby

In Case the Child Takes More Than the Recommended Dose of Recenum Baby, Seek Medical Attention Immediately.

Missing a Dose of Recenum Baby

Do Not Take a Double Dose to Make Up for a Missed Dose. Take the Next Dose at the Usual Time.

4. Possible Side Effects

Like All Medications, Recenum Baby Can Cause Side Effects, Although Not Everybody Gets Them. Stop Giving the Child Recenum Baby and Seek Medical Attention Immediately if the Following Symptoms of Angioedema Occur:

• Swelling of the Face, Tongue, or Throat
• Difficulty Swallowing
• Hives and Difficulty Breathing

Stop Taking Racecadotril and Seek Medical Help Immediately if Any of the Following Symptoms Occur:

• Widespread Rash, High Body Temperature, and Enlarged Lymph Nodes (DRESS Syndrome);
• Difficulty Breathing, Swelling, Dizziness, Rapid Heartbeat, Sweating, and Feeling of Losing Consciousness, Which are Symptoms of a Severe Allergic Reaction.

The Following Side Effects Have Been Reported: Not Very Common (Occurring in Less Than 1 in 100 Patients): Tonsillitis, Rash, and Erythema (Redness of the Skin). Frequency Not Known (Cannot be Estimated from the Available Data): Erythema Multiforme (Pink Spots on the Skin and Inside the Mouth), Tongue Swelling, Face Swelling, Lip Swelling, Eyelid Swelling, Hives, Erythema Nodosum (Subcutaneous Inflammatory Conditions in the Form of Nodules), Papular Rash (Rashes on the Skin with Small, Hard, and Nodular Changes), Pruritus (Itchy Skin Changes), Pruritus (Generalized Itching).

Reporting Side Effects

If You Experience Any Side Effects, Including Those Not Listed in this Package Leaflet, Tell Your Doctor or Pharmacist. Side Effects can be Reported Directly to: Department for 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, You can Help Provide More Information on the Safety of this Medication.

5. How to Store Recenum Baby

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Keep the Medication Out of Sight and Reach of Children. Do Not Use this Medication After the Expiration Date Stated on the Sachet and Carton. The Expiration Date Refers to the Last Day of the Specified Month. The Abbreviation "EXP" on the Packaging Indicates the Expiration Date, and "Lot" Indicates the Batch Number. Store Below 25°C. Medications Should Not be Disposed of via Wastewater or Household Waste. Ask Your Pharmacist How to Dispose of Medications No Longer Needed. This Will Help Protect the Environment.

6. Package Contents and Other Information

What Recenum Baby Contains

• The Active Substance is Racecadotril. Each Sachet Contains 10 mg of Racecadotril.
• The Other Ingredients are: Sucrose, Colloidal Anhydrous Silica, Povidone (K30).

What Recenum Baby Looks Like and What the Package Contains

Recenum Baby is a White or Almost White Granule for Oral Suspension. The Medication is Packaged in Paper/Polyester/Aluminum/Polyester Sachets in a Carton. The Package Contains: 10, 16, or 30 Sachets.

Marketing Authorization Holder and Importer:

US Pharmacia Sp. z o.o., ul. Ziębicka 40, 50-507 Wrocław

For More Detailed Information, Please Contact:

USP Zdrowie Sp. z o.o., ul. Poleczki 35, 02-822 Warszawa, Tel.: +48 (22) 543 60 00.

Date of the Last Update of the Package Leaflet:

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