Package leaflet: Information for the patient

Bloctil, 100 mg, hard capsules
Racecadotril
Please read this leaflet carefully before taking this medicine, as it contains
important information for the patient.
This medicine should always be taken exactly as described in this patient leaflet or as directed by
the doctor or pharmacist.

Keep this leaflet so that you can read it again if necessary.
If you need advice or further information, please consult your pharmacist.
If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement after 2 days or if you feel worse, contact your doctor.

Table of contents of the leaflet

What Bloctil is and what it is used for
Important information before taking Bloctil
How to take Bloctil
Possible side effects
How to store Bloctil
Contents of the pack and other information

1. What is Bloctil and what is it used for
Bloctil is a medicine used in the treatment of diarrhoea.
Bloctil is indicated in adults for the symptomatic treatment of acute diarrhoea when causal therapy is not possible.
Racecadotril may be used as an adjunctive treatment when causal therapy is possible.

2. Important information before taking Bloctil

WHEN NOT TO TAKE Bloctil

if you are allergic to racecadotril or any of the other ingredients of this medicine (listed in section 6);
if you have previously experienced severe skin rash or skin peeling, blisters and (or) mouth ulcers after taking racecadotril.

Warnings and precautions – Special caution with racecadotril is required
Serious skin reactions, including drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported during treatment with racecadotril. If you notice any of the symptoms related to serious skin reactions described in section 4, you should stop taking racecadotril immediately and seek medical advice without delay.
Before starting treatment with Bloctil, consult your doctor or pharmacist if:

There is blood or pus in the stool and fever is present. Diarrhoea may be due to a bacterial infection which should be treated by a doctor;
Chronic diarrhoea or antibiotic-associated diarrhoea is present;
There are impaired kidney or liver function;
Persistent or uncontrolled vomiting occurs;
Lactose intolerance is present (see "Bloctil contains lactose").

Skin reactions have been reported during treatment with this medicine. In most cases, these were mild or moderate reactions. If severe skin reactions occur, treatment must be stopped immediately.
Bloctil with other medicines
Tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
In particular, inform your doctor if you are taking any of the
following medicines:

angiotensin-converting enzyme (ACE) inhibitors (e.g. captopril, enalapril, lisinopril, perindopril, ramipril) used to lower blood pressure or to help heart function.

Pregnancy and breastfeeding
Bloctil is not recommended during pregnancy, suspected pregnancy, or while breastfeeding.
Consult your doctor or pharmacist before taking this medicine.
Driving and operating machinery
Bloctil has negligible or no effect on the ability to drive and operate machinery.
Bloctil contains lactose
Bloctil contains lactose (a type of sugar). If you have been previously diagnosed with intolerance to certain sugars, consult your doctor before taking this medicine.
3. How to take Bloctil
This medicine should always be taken exactly as described in this patient leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
The recommended dose for adults is one capsule three times daily.
Bloctil should preferably be taken before main meals; however, at the start of treatment, one capsule may be taken at any time of day.
The capsule should be swallowed whole with a glass of water.
Dose adjustment is not necessary in elderly patients.
Treatment should be continued until two normal stools have been passed.
If there is no improvement after 2 days of treatment with Bloctil or if you feel worse, consult your doctor. Treatment should not last longer than 7 days.
To replace fluids lost due to diarrhoea, this medicine should be used together with an adequate intake of fluids and salts (electrolytes). The best way to replenish fluids and electrolytes is by drinking oral rehydration solutions (if in doubt, consult your doctor or pharmacist).
Use in children and adolescents
Bloctil is not appropriate for use in children and adolescents.
Other formulations of racecadotril are available for use in children and adolescents.
Taking more Bloctil than recommended
Contact your doctor or pharmacist immediately.
Missed dose of Bloctil
Do not take a double dose to make up for a missed dose. Take the next dose at the usual time.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody gets them.
You should stop taking Bloctil and seek immediate medical help if any of the following symptoms occur:

Angioedema, such as:
swelling of the face, tongue or throat
difficulty swallowing
urticaria and breathing difficulties
Widespread rash, high fever and enlarged lymph nodes (DRESS syndrome);
Breathing difficulties, swelling, dizziness, rapid heartbeat, sweating and feeling faint, which are symptoms of a sudden, severe allergic reaction.

The following adverse reactions have been reported:
Common (may affect up to 1 in 10 people): headache.
Uncommon (may affect up to 1 in 100 people): rash and erythema (reddening of the skin).
Frequency unknown (frequency cannot be estimated from the available data):
erythema multiforme (pinkish skin lesions on limbs and inside the mouth), tongue swelling,
facial swelling, lip swelling, eyelid swelling, urticaria, nodular erythema (subcutaneous inflammatory nodules),
papular rash (skin lesions with small, firm, nodular changes), prurigo (itchy skin lesions), pruritus (generalized itching), toxic skin eruption.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301, Fax: +48 22 49 21 309, E-mail: [email protected]
Adverse reactions can also be reported to the Marketing Authorisation Holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Bloctil
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the sachet and carton after: Expiry date (EXP). The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.
No special storage conditions apply.

6. Contents of the pack and other information

What Bloctil contains
The active substance is racecadotril. One capsule contains 100 mg of racecadotril.
The other ingredients are: monohydrate lactose, pregelatinized corn starch, magnesium
stearate, anhydrous colloidal silicon dioxide.
The capsule shell contains gelatin, iron oxide yellow (E 172), and titanium dioxide (E 171).

What Bloctil looks like and contents of the pack
Bloctil is available as yellow, hard gelatin capsules containing white or almost white powder.
The package (cardboard box) contains 6 or 10 hard capsules in blisters.

Marketing Authorisation Holder
Rivopharm Limited
5th Floor, Block A, The Atrium Blackthorn Road
Sandyford, Dublin 18
Ireland

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

This medicinal product is authorised in the European Economic Area member states under the following names:
Bulgaria BLOCTIL 100 mg hard capsules
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