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KIRKLAND SIGNATURE INDIGESTION RELIEF 75MG TABLETS

Active substance(s): RANITIDINE HYDROCHLORIDE / RANITIDINE HYDROCHLORIDE / RANITIDINE HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION LEAFLET FOR THE USER

Kirkland Signature Indigestion Relief 75mg Tablets
TM

(Ranitidine Hydrochloride)
Read all of this leaflet carefully
because it contains important
information for you.
This medicine is available without
prescription. However, you still need to
take this medicine carefully to get the
best results from it.
• Keep this leaflet. You may need to
read it again.
• Ask your pharmacist if you need
more information or advice.
• You must contact a doctor if your
symptoms worsen or do not
improve after 6 days.
• If any of the side effects gets serious,
or if you notice any side effects not
listed in this leaflet, please tell your
doctor or pharmacist.
In this leaflet:
1. What this medicine is and what it
is used for
2. Before you take this medicine
3. How to take this medicine
4. Possible side effects
5. How to store this medicine
6. Further information
WHAT THIS MEDICINE IS
AND WHAT IT IS USED FOR
Ranitidine belongs to a group of medicines
called H2 antagonists which works by
reducing the amount of acid in your
stomach which helps in the short term relief
of acid related indigestion and heartburn.
BEFORE YOU TAKE
THIS MEDICINE
Do not take this medicine
• If you are, or have ever been told you
are allergic to Ranitidine or to any of
the other ingredients in these tablets
(an allergic reaction may include rash,
itching, swollen face or lips, or
breathing difficulties). See section 6 for
a list of ingredients.
• If you are under 16 years of age.
Take special care with this medicine:
• If you have been diagnosed with or
told you are at risk from a duodenal
(part of the small intestine) ulcer.
• If you have unexplained weight loss or
have associated indigestion.
• If you are receiving medical attention
for any reason.
• If you have kidney problems.
• If you suffer from porphyria (excess
protein in your urine).
• If you have difficulty with swallowing.
• If you have persistent stomach pain.
If any of the above applies to you, please
talk to your doctor or pharmacist for
advice, if you have not already done so
before taking this medicine.
Taking other medicines:
Please tell your doctor or pharmacist if
you are taking or have recently taken any
other medicines obtained without a
prescription.
This particularly applies to the following:
- If you are taking medicines known as
non- steroidal anti-inflammatory drugs
(NSAIDs) such as aspirin or Ibuprofen
(a pain relieving medicine)
- Warfarin (an anti-coagulant)
- Ketoconazole (an antifungal agent)

- Triazolam and Midazolam (drugs used
for sedation e.g. to treat insomnia)
- Glipizide (a drug used to treat diabetes)
- Atazanavir and Delavirdine (drugs used
to treat HIV)
- Gefitinib (a drug used to treat some
cancers)
- Theophylline (used in the treatment of
asthma)
- Sucralfate (an ulcer healing drug)
- Antacids (for your stomach)
- Procainamide (used to treat an irregular
heart beat).
If you are taking antacids or Sucralfate
(having discussed this with your doctor)
ensure that this medicine is taken at least
two hours before you take them.
Taking this medicine with food and
drink:
This medicine should be swallowed whole
with a glass of water. You should not
drink alcohol when taking this medicine.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice
before taking any medicine.
This medicine should not be taken
during pregnancy. If you become
pregnant while taking this medicine you
should talk to your doctor immediately.
It is also not advised to take this
medicine while breast-feeding as this
medicine passes into breast milk.
Driving or using machines:
There have been no reported effects on
the ability to drive or operate machinery.
Important information about some of
the ingredients of this medicine
This medicinal product contains 0.31mg
of sodium (salt) per dose. This should be
taken into consideration by patients on a
controlled sodium (salt) diet. The tablets
also contain castor oil. This may cause
stomach upset and diarrhoea.
HOW TO TAKE THIS MEDICINE
Check the label to see how many tablets
to take and how often to take them. The
tablets should be swallowed whole with
a glass of water.
The usual doses of this medicine are:
Adults, the elderly and children over
the age of 16 years:
Take one tablet whenever the symptoms
of acid-related indigestion and heartburn
appear, day or night.
Do not take more than two tablets in
24 hours.
You should not take the tablets for more
than 6 days continuously. If the symptoms
worsen or persist after 6 days, consult
your doctor or pharmacist.
You should not purchase a second pack
of tablets without the advice of a
pharmacist or doctor.
If you are unsure about how many
tablets to take or when to take them, ask
your doctor or pharmacist.

Further information overleaf ➥

Kirkland Signature Indigestion Relief 75mg Tablets

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Do not give these tablets to children
under 16 years of age.
Do not take any other medicine
(including non- prescription medicines)
without first checking with your doctor.
If you take more of this medicine
than you should:
If you have taken too much of this
medicine, or if someone else has taken
your medicine, you / they should contact
your doctor or your nearest hospital
casualty department immediately. Please
take any remaining medicine with you in
the carton in which it came so that staff
will know what has been taken.
If you forget to take this medicine
Take it as soon as you remember then
continue as before. If it is nearly time for
your next tablet, leave the missed dose
and continue as before. Do not take
more than two tablets in 24 hours.
Do not take a double dose to make up
for a missed dose.
If you have any further questions on the
use of this product, ask your doctor.
POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can
have side effects, although not
everybody gets them.
Stop taking the tablets and tell your
doctor immediately if you experience any
of the following rare effects:
• Sudden wheeziness or tightness in the
chest or throat, difficulty in breathing,
speaking and swallowing.
• Itchy skin rash (hives) or swelling of the
eyelids, face, neck or lips.
• Feeling faint.
These are all possible signs of a severe
allergic reaction.
If you notice any of the following side
effects, tell your doctor immediately.
• Severe stomach pain, being sick
(vomiting) or feeling sick (nausea), loss of
appetite, dry mouth, mouth ulceration,
flatulence, diarrhoea or constipation.
• Unusual tiredness, shortness of breath,
tendency to bruising, unexplained
fever or frequent infections.
• Fast, slow or irregular heart beat, high
blood pressure or flushing (redness of
the face, hands or body).
• Skin rash, itching, hair loss or
excessive sweating.
• Changes in liver function which may
cause, jaundice (yellowing of the skin
or the whites of the eyes).
• Inflammation of the kidneys.
• Depression, hallucinations, difficulty
sleeping (insomnia), nightmares,
confusion or feeling agitated.
• Headache, dizziness, migraine, tremor,
loss of co-ordination, loss of
consciousness, feeling lethargic or
sleepy.
• Blurred vision, double vision or
conjunctivitis.
• Pain in muscles and joints.
• In men swollen or tender breasts,
difficulty in achieving or maintaining
an erection.
There have been a few isolated reports
of blood abnormalities. This would only
usually be seen after you have had a
blood test. Your doctor may perform
blood tests to check for abnormalities
while you are taking this medicine.

Reporting of side effects
If you get any side effects, talk to your
doctor, pharmacist or nurse. This
includes any possible side effects not
listed in this leaflet. You can also report
side effects directly via the Yellow Card
Scheme at: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help
provide more information on the safety of
this medicine.
HOW TO STORE THIS MEDICINE
Do not store above 25ºC.
Store in the original container to protect
them from light.
Keep out of the sight and reach of children.
Do not use this medicine after the expiry
date which is stated on the blister and
outer carton after EXP. The expiry date
refers to the last day of that month.
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 to protect the environment.
FURTHER INFORMATION
What this medicine contains
The active ingredient is: Ranitidine
Hydrochloride
Each film-coated tablet contains
83.75mg of ranitidine hydrochloride,
equivalent to 75mg of ranitidine, as the
active ingredient.
The other ingredients are: The tablets
also contain some inactive ingredients:
microcrystalline cellulose, croscarmellose
sodium, colloidal anhydrous silica,
magnesium stearate and talc.
Film-coating on the tablets contains:
castor oil & Opadry OY-S-54902 Pink
which contains hypromellose, talc,
titanium dioxide (E171) and red ferric
oxide (E172).
What this medicine looks like and
contents of the pack
Kirkland Signature Indigestion Relief
75mg Tablets are light pink, round,
biconvex, film coated tablets with '75'
on one side.
Kirkland Signature Indigestion Relief
75mg Tablets are available in packs
containing 6, 10 or 12 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder:
Galpharm Healthcare Limited,
Wrafton, Braunton, Devon,
EX33 2DL, United Kingdom
Manufacturer:
Galpharm International Ltd.,
Elmhirst Park, Middle Field Road,
Barnsley, South Yorkshire,
S75 4LS, United Kingdom.
Text revised: April 2016.

HP/05/453

4005449

Expand Transcript

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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