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GALPHARM DIARRHOEA RELIEF PLUS 2 MG / 125 MG TABLETS

Active substance(s): LOPERAMIDE HYDROCHLORIDE / SIMETICONE

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Galpharm Diarrhoea Relief Plus
2mg / 125mg Tablets

(Loperamide Hydrochloride / Simeticone)
PACKAGE LEAFLET:
INFORMATION FOR THE USER
Read all of this leaflet carefully before you
start taking this medicine because it
contains important information for you.
Always take this medicine exactly as described
in this leaflet or as your doctor or pharmacist
have told you.
• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more
information or advice.
• If you get any side effects, talk to your doctor
or pharmacist. This includes any possible side
effects not listed in this leaflet.
• You must talk to a doctor if you do not feel
better or if you feel worse after two days.
WHAT IS IN THIS LEAFLET:
1. What Galpharm Diarrhoea Relief Plus 2mg
/ 125mg Tablets is and what it is used for
2. What you need to know before you take
Galpharm Diarrhoea Relief Plus 2mg /
125mg Tablets
3. How to take Galpharm Diarrhoea Relief Plus
2mg / 125mg Tablets
4. Possible side effects
5. How to store Galpharm Diarrhoea Relief Plus
2mg / 125mg Tablets
6. Contents of the pack and other information

What Galpharm Diarrhoea Relief
Plus 2mg / 125mg Tablets is and
what it is used for
The tablets are used to treat a short-lived attack
of diarrhoea when it occurs with stomach cramps,
bloating and wind.
The tablets contain loperamide hydrochloride,
which helps reduce diarrhoea by slowing down
an overactive bowel. It also helps the body to
absorb more water and salts from the bowel.
The tablets also contain simeticone, which
breaks up the trapped wind in the bowel that
causes cramps and bloating.

What you need to know before
you take Galpharm Diarrhoea
Relief Plus 2 mg / 125 mg Tablets
Do not take Galpharm Diarrhoea Relief Plus
2mg / 125mg Tablets
• In children less than 12 years old.
• If you are allergic (hypersensitive) to
loperamide hydrochloride, simeticone or any
of the other ingredients of the tablets (see
section 6).
• If you have a high temperature (e.g. above
38°C) or blood in your stools.
• If you are having a flare up of an inflammatory
bowel condition like ulcerative colitis.
• If you have severe diarrhoea after taking
antibiotics.
• If you are constipated or your stomach
appears swollen.

Warnings and precautions
Talk to your doctor or pharmacist:
• Galpharm Diarrhoea Relief Plus 2mg / 125mg
Tablets only treat the symptoms of diarrhoea.
In some cases, the cause of your diarrhoea
may require treatment. If symptoms persist or
worsen, please contact your doctor.
• If you have severe diarrhoea your body loses
more fluid, sugars and salts than normal.
You will need to replace the fluid by drinking
more liquid than usual. Ask your pharmacist
about special powders which replace the
sugars and salts.
• If you have AIDS and your stomach becomes
swollen, stop taking the tablets immediately
and contact your doctor.
• If you have liver disease, check with your
doctor before using the tablets. Some of the
side-effects might be more troublesome.
Other medicines and Galpharm Diarrhoea
Relief Plus 2mg / 125mg Tablets
Tell your doctor or pharmacist if you are taking or
have recently taken any other medicines, including
medicines obtained without a prescription,
because Galpharm Diarrhoea Relief Plus 2mg /
125mg Tablets may interact with them.
In particular tell your doctor or pharmacist if you
are taking, have recently taken or might take any
of the following medicines:
• Quinidine (used to treat abnormal heart
rhythms or malaria)
• Itraconazole or Ketoconazole (an antifungal
medicine)
• Gemfibrozil (used to treat high cholesterol)
• Ritonavir (used to treat HIV infection and AIDS)
• Desmopressin (used in the treatment of
diabetes insipidus and bedwetting)
Pregnancy, breast-feeding and fertility
• Ask your doctor or pharmacist for advice
before taking this medicine if you are
pregnant, think you are pregnant or planning
to become pregnant.
• Do not take this medicine if you are breastfeeding as small amounts of the medicine may
get into your milk. Talk to your doctor about a
suitable treatment.
Driving and using machines
This medicine may make you feel dizzy, tired or
sleepy. If affected do not drive or operate machinery.

How to take Galpharm Diarrhoea
Relief Plus 2mg / 125mg Tablets
• Always take this medicine exactly as described
in this leaflet or as your doctor or pharmacist
has told you. Check with your doctor or
pharmacist if you are not sure.
• For oral administration
• Swallow whole with a drink
• The score line is only there to help you break the
tablet if you have difficulty swallowing it whole.
Further information overleaf ➥

Use in adults over 18 years old
Swallow two tablets initially, followed by one
tablet after every loose stool (bowel movement).
Do not take more than 4 tablets in a day. If you
are no better after two days, stop taking the
tablets and contact your doctor.
Use in adolescents from 12 to 18 years old
Swallow one tablet initially, followed by one
tablet after every loose stool (bowel movement).
Do not take more than 4 tablets in a day. If you
are no better after two days, stop taking the
tablets and contact your doctor.

Other effects:
• Vomiting, indigestion, constipation, wind,
dizziness, loss of consciousness or decreased
consciousness.
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side
effects not listed in this leaflet.

How to store Galpharm Diarrhoea
Relief Plus 2mg / 125mg Tablets
Keep this medicine out of the sight and
reach of children.

Use in children
Do not give the tablets to children less than 12
years old.

Do not use this medicine after the expiry date
which is stated on the blister and box. The
expiry date refers to the last day of that month.

If you take more Galpharm Diarrhoea Relief
Plus 2mg / 125mg Tablets than you should
Too many tablets may make you feel drowsy, or
make it difficult to think clearly or carry out
normal activities. Your muscles may feel stiff or
you may experience breathing difficulties. You
may have a dry mouth or the pupils of your eyes
may become small. You may have stomach
pain, feel sick or vomit, be constipated or have
difficulty passing water.

This medicinal product does not require any
special storage conditions.

If you have taken too many Galpharm Diarrhoea
Relief Plus 2mg / 125mg Tablets, contact a
doctor or hospital.
If you forget to take Galpharm Diarrhoea
Relief Plus 2mg / 125mg Tablets
Take one tablet after the next loose stool (bowel
movement).
Do not take a double dose to make up for a
forgotten dose.
If you have any further questions on the use of
this product, ask your doctor or pharmacist.

Possible side effects
Like all medicines, this medicine can cause side
effects, although not everybody gets them.
If you experience any of the following stop
using the medicine and seek immediate
medical help:
• Allergic reactions including swelling of the face,
tongue or throat, difficulty swallowing,
unexplained wheezing, shortness of breath which
may be accompanied by skin rash or hives.
If you experience any of the following, stop
using the medicine and talk to your doctor:
• Difficulties passing water
• Stomach pain or swollen stomach
• Severe constipation.
Other effects which may occur include
Common side-effects (less than 1 in 10 but more
than 1 in 100 people get these):
• Feeling sick, or a change in the way some
things taste.
Uncommon side-effects (less than 1 in 100, but
more than 1 in 1000 people get these):
• Drowsiness, constipation, rash

Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines no
longer required. These measures will help
protect the environment.

Contents of the pack and
other information
What Galpharm Diarrhoea Relief Plus 2mg /
125mg Tablets contain
The active ingredients are: Loperamide
hydrochloride (2 mg per tablet) and Simeticone
(measured as 125 mg dimeticone per tablet).
The other ingredients are: microcrystalline
cellulose (E460), Sodium starch glycolate,
Hypromellose (E464), Povidone (E2101),
Calcium phosphate (E341), Mannitol (E421) and
Magnesium Stearate (E572).
What Galpharm Diarrhoea Relief Plus 2mg /
125mg Tablets look like and contents of the
pack
The tablets are white to off white caplets with
“LO-SI” debossed on one side and ‘2’ & ‘125’
debossed on the opposite side at either side of
a scoreline.
Each pack contains 6 or 12 tablets in blister
strips. Not all pack sizes may be marketed.
Marketing Authorisation Holder
Wrafton Laboratories Limited, Wrafton,
Braunton, Devon, EX33 2DL United Kingdom
Manufacturer
Alcala Farma, Avenida de Madrid 82,
28802 Alcala de Henares (Madrid), Spanje
This medicinal product is authorised in the
Member States of the EEA under the
following names:
NL: Losinoba 2 mg/125mg, tabletten
UK: Galpharm Diarrhoea Relief Plus 2mg /
125mg Tablets
Text revised: January 2016.

4006349

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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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