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VAPRINO 100 MG CAPSULES HARD

Active substance(s): RACECADOTRIL / RACECADOTRIL

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Package leaflet: Information for the user
Vaprino 100 mg capsules, hard
Racecadotril

Read all of this leaflet carefully before you start taking this medicine because it
contains important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may
harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any
possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
1.
What Vaprino is and what it is used for
1.
What you need to know before you take Vaprino Capsules
2.
How to take Vaprino Capsules
3.
Possible side effects
4.
How to store Vaprino Capsules
5.
Contents of the pack and other information
1.

What Vaprino Capsules is and what it is used for
- Vaprino Capsules is a medicine for the treatment of diarrhoea.
- Vaprino Capsules is indicated for the treatment of symptoms of acute diarrhoea
in adults over 18 years when specific treatment is not possible.
- If specific treatment is possible, Vaprino Capsules can be administered in
addition.

2.

What you need to know before you take Vaprino Capsules
Do not take Vaprino Capsules:
- if you are allergic to racecadotril or any of the other ingredients of this
medicine (listed in section 6).
- if you are suffering from diarrhoea and you have fever and/or there is blood or
pus in your stools. The cause of the diarrhoea may be an invasive bacterial
infection that should be treated by your doctor.
- if you are suffering from diarrhoea caused by antibiotics.
- if you have experienced swelling of the tongue, face, lips, eyelids and
subcutaneous tissue (angioedema) while you were under treatment with ACE
inhibitors (e.g. captopril, enalapril, lisinopril, perindopril, ramipril) (see also
Section 4 “Possible side effects”).

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Warnings and precautions
Talk to your doctor or pharmacist before taking .
You should tell your doctor if:
- you are suffering from an acute episode of ulcerative colitis
- you are suffering from kidney disease or impaired liver function
- you are suffering from persistent or uncontrolled vomiting
- you have intolerance to lactose.
In case of chronic diarrhoea, consult a medical doctor.
Occurrence of skin reactions has been reported with the use of the product. These
are in most cases mild and moderate. When experiencing severe skin reactions,
appearing initially as reddish target-like spots or circular patches often with central
blisters on the trunk, the treatment has to be stopped immediately and you should
contact your doctor and tell him that you are taking this medicine. Additional signs
to look for include ulcers in the mouth, throat, nose, genitals and conjunctivitis (red
and swollen eyes). Serious skin rashes are often accompanied by flu-like
symptoms. The rash may progress to widespread blistering or peeling of the skin.
Other medicines and Vaprino Capsules
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
ACE inhibitors (e.g. captopril, enalapril, lisinopril, perindopril, ramipril) are known
to cause angioedema. This risk may be elevated when used concomitantly with
Vaprino Capsules against acute diarrhoea.
Pregnancy, breast-feeding and fertility
Because of a lack of data, use of Vaprino Capsules is not recommended if you are
pregnant or breast-feeding, think you may be pregnant or are planning to have a
baby.
Ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
Vaprino has little or no effect on the ability to drive or use machines.
Vaprino Capsules contain lactose (a type of sugar)
If you have been told by your doctor that you have an intolerance to some sugars,
contact your doctor before taking this medicinal product.

3.

How to take Vaprino Capsules
Always take this medicine exactly as your doctor or pharmacist has told you. Check
with your doctor or pharmacist if you are not sure.
The recommended dose is:
1 capsule 3 times daily, preferably before main meals, to be swallowed whole with
a glass of water. On the first day of treatment, 1 additional capsule should be taken
initially, regardless of the time of day.
From the second day of treatment onwards, you can take 1 capsule 3 times daily.

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Treatment should be continued until 2 normal stools have been passed. However,
the duration of treatment should not exceed 3 days.
No dose adjustment is necessary in elderly patients.
Use in children and adolescents
For infants, children and adolescents, other formulations appropriate for the
relevant age group are available.
Duration of treatment
Do not take Vaprino for more than 3 days without medical advice.
Rehydration
To compensate for the loss of fluid due to your diarrhoea, this medicine should be
used together with an adequate replacement of fluid and salts (electrolytes). The
best replacement of fluid and salts is achieved with a so-called oral rehydration
solution (please ask your doctor or pharmacist if you are not sure).
If you take more Vaprino than you should
If you take more Vaprino than you should, please contact your doctor or pharmacist
immediately.
If you forget to take Vaprino Capsules
Do not take a double dose to make up for a forgotten dose. Just continue treatment
with the next dose at the usual time.
If you have any further questions on the use of this medicine, ask your doctor or
pharmacist.

4.

Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody
gets them.
The most common side effect is headache (may affect up to 1 in 10 people).
The following uncommon side effects have been reported (may affect up to 1 in
100 people):
Rash and erythema (skin redness).
Other side effects whose frequency cannot be estimated from the available data are:
Erythema multiforme (pink lesions on the arms and legs and inside the mouth),
angioedema (swelling of the tongue, face, lips, eyelids and cellular tissue beneath
the skin), urticaria (nettle rash), erythema nodosum (inflammation of the fatty tissue
beneath the skin with nodule formation), papular rash (a rash with small, hard,
nodular lesions), prurigo (itching skin lesions), generalised itching, toxic skin
eruption.

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You should stop taking Vaprino and seek immediate medical advice if you
experience symptoms of angioedema, such as:
- swelling of the face, tongue or larynx
- difficulty in swallowing
- urticaria (nettle rash) and difficulty in breathing.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any
possible side effects not listed in this leaflet. You can also report side effects
directly via the Yellow Card Scheme (website www.mhra.gov.uk/yellowcard). By
reporting side effects, you can help provide more information on the safety of this
medicine.

5.

How to store Vaprino Capsules
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and the
blister after . The expiry date refers to the last date of that month.
This medicine does not require any special storage conditions.
Do not throw away any medicines via wastewater. Ask your pharmacist how to
throw away medicines you no longer use. These measures will help protect the
environment.

6.

Contents of the pack and other information
What Vaprino contains
- The active substance is racecadotril. Each capsule, hard contains 100 mg
racecadotril.
- The other ingredients are lactose monohydrate, pregelatinised maize starch,
vegetable-derived magnesium stearate and colloidal anhydrous silica.
The capsule shell contains bovine-derived gelatine, yellow iron oxide (E 172) and
titanium dioxide (E 171).
What Vaprino looks like and contents of the pack
Vaprino Capsules are ivory-coloured capsules, hard, capsule size no. 2.
Each pack contains 6 or 10 capsules, hard.

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Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Sanofi
One Onslow Street
Guildford
Surrey
GU1 4YS
United Kingdom
Tel: 0845 372 7101
Email: uk-medicalinformation@sanofi.com

This medicinal product is authorised in the Member States of the EEA under
the following names:
Austria: Racecadotril Boehringer Ingelheim 100 mg hartkapseln
United Kingdom: Vaprino 100 mg Capsules, hard

This leaflet was last revised in August 2017.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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