Bloctil

Package Leaflet: Information for the Patient

Bloctil, 100 mg, Hard Capsules

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 the Package Leaflet or as Advised by the Doctor or Pharmacist.

• This Package Leaflet Should be Kept in Case it Needs to be Read Again.
• If Advice or Additional Information is Needed, the Pharmacist Should be Consulted.
• If the Patient Experiences any Side Effects, Including those not Listed in the 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, the Doctor Should be Consulted.

Package Leaflet Contents

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

1. What is Bloctil and What is it Used For

Bloctil is a Medication Used to Treat Diarrhea.
Bloctil is Used in Adults to Treat Symptoms of Acute Diarrhea, if the Diarrhea Cannot be Treated Causally.
Racecadotril may be Used as a Supportive Treatment when Causal Treatment is Possible.

2. Important Information Before Taking Bloctil

When Not to Take Bloctil

• If the Patient 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 Skin Exfoliation, Blisters, and/or Oral Ulcers After Taking Racecadotril.

Warnings and Precautions - Special Caution Should be Exercised when Taking 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 Advice Immediately.
Before Taking Bloctil, the Patient Should Consult a Doctor or Pharmacist if:

• There is Blood or Pus in the Stool and Fever. The Cause of Diarrhea may be a Bacterial Infection that Should be Treated by a Doctor;
• There is Chronic Diarrhea or Diarrhea Caused by Taking Antibiotics;
• There are Kidney or Liver Function Disorders;
• There are Prolonged or Uncontrolled Vomiting;
• There is Lactose Intolerance (See "Bloctil Contains Lactose").

Severe Skin Reactions have been Reported with this Medication. In Most Cases, these were Mild or Moderate Reactions. If Severe Skin Reactions Occur, Treatment Should be Stopped Immediately.

Bloctil and Other Medications

The Doctor Should be Informed of all Medications Currently or Recently Taken by the Patient, as well as any Planned Medications.
Particularly, the Doctor Should be Informed if the Patient is Taking any of the Following Medications:

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

Pregnancy and Breastfeeding

Bloctil is not Recommended During Pregnancy, Suspected Pregnancy, and Breastfeeding.
Before Taking this Medication, the Doctor or Pharmacist Should be Consulted.

Driving and Operating Machinery

Bloctil has a Non-Significant or No Influence on the Ability to Drive and Operate Machinery.

Bloctil Contains Lactose

Bloctil Contains Lactose (a Type of Sugar). If the Patient has been Diagnosed with Intolerance to some Sugars, they Should Consult a Doctor Before Taking the Medication.

3. How to Take Bloctil

This Medication Should Always be Taken Exactly as Described in the Package Leaflet or as Advised by the Doctor or Pharmacist. In Case of Doubt, the Doctor or Pharmacist Should be Consulted.
The Recommended Dose for Adults is One Capsule Three Times a Day.
Bloctil Should be Taken Preferably Before Main Meals, but when Starting Treatment, One Capsule can be Taken at any Time of the Day.
The Capsule Should be Swallowed with a Glass of Water.
No Dose Adjustment is Necessary for Elderly Patients.
Treatment Should be Continued Until Two Normal Stools are Passed.
If there is no Improvement or the Patient Feels Worse After 2 Days of Taking Bloctil, the Doctor Should be Consulted. Treatment Should not Last Longer than 7 Days.
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 Oral Rehydration Solutions (in Case of Doubt, the Doctor or Pharmacist Should be Consulted).

Use in Children and Adolescents

Bloctil is not Suitable for Use in Children and Adolescents.
Other Forms of Racecadotril are Available for Use in Children and Adolescents.

Overdose of Bloctil

The Doctor or Pharmacist Should be Consulted Immediately.

Missed Dose of Bloctil

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 Side Effects

Like all Medications, Bloctil can Cause Side Effects, although not Everybody gets them.
Treatment with Bloctil Should be Stopped and Medical Help Sought Immediately if any of the Following Symptoms Occur:

• Angioedema, Such as:
• Facial, Tongue, or Throat Swelling
• Difficulty Swallowing
• Hives and Difficulty Breathing
• Widespread Rash, High Fever, 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:
Common (May Affect up to 1 in 10 People): Headache.
Uncommon (May Affect up to 1 in 100 People): Rash and Redness (Skin Redness).
Frequency Not Known (Frequency Cannot be Estimated from Available Data):
Multi-Form Erythema (Pink Spots on the Skin of the Extremities and Inside the Mouth), Tongue Swelling, Facial Swelling, Lip Swelling, Eyelid Swelling, Hives, Nodular Redness (Subcutaneous Inflammatory Conditions in the Form of Nodules), Papular Rash (Rash with Small, Hard, and Nodular Changes), Pruritus (Itchy Skin Changes), Itching (Generalized Itching), Toxic Epidermal Necrolysis.

Reporting Side Effects

If any Side Effects Occur, Including those not Listed in the Package Leaflet, the Doctor or Pharmacist Should be Informed. Side Effects can be Reported Directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products, Urzędowy Rejestr Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, Email: ndl@urpl.gov.pl.
Side Effects can also be Reported to the Marketing Authorization Holder.
Reporting Side Effects will Help to Gather More Information on the Safety of the Medication.

5. How to Store Bloctil

The Medication Should be Stored Out of Sight and Reach of Children.
This Medication Should not be Used After the Expiration Date Stated on the Sachet and Carton After: Expiration Date (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. The Pharmacist Should be Asked how to Dispose of Unused Medications. This will Help Protect the Environment.
No Special Precautions for Storage.

6. Package Contents and Other Information

What Bloctil Contains

The Active Substance of Bloctil is Racecadotril. One Capsule Contains 100 mg of Racecadotril.
The Other Ingredients are: Lactose Monohydrate, Corn Starch, Magnesium Stearate, Colloidal Silica.
The Capsule Shell Contains Gelatin, Yellow Iron Oxide (E 172), and Titanium Dioxide (E 171).

What Bloctil Looks Like and Contents of the Package

Bloctil is Available in the Form of Hard, Yellow Gelatin Capsules Containing a White or Almost White Powder.
The Package (Carton) Contains 6 or 10 Hard Capsules in Blister Packs.

Marketing Authorization Holder

Rivopharm Limited, 17 Corrig Road, Sandyford, Dublin 18, Ireland

Manufacturer

Holsten Pharma GmbH, Hahnstraße 31-35, 60528 Frankfurt am Main, Germany

This Medicinal Product is Authorized in the Member States of the European Economic Area Under the Following Names:

Bulgaria: BLOCTIL 100 mg твърди капсули
Lithuania: BLOCTIL 100 mg kietosios kapsulės
Latvia: BLOCTIL 100 mg kapsulas cietās
Poland: BLOCTIL
Czech Republic: RACIBUM
Romania: Racecadotril Rivopharm 100 mg capsule
Slovakia: BLOCTIL 100 mg tvrdé kapsuly
Hungary: RACIBUM 100 mg kemény kapszulák

Date of Last Revision of the Package Leaflet: 14.03.2024