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KIRKLAND SIGNATURE INDIGESTION RELIEF 75MG TABLETS

Active substance(s): 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 nonsteroidal 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.
Further information overleaf ➥

If you are unsure about how many tablets to take or
when to take them, ask your doctor or pharmacist.
Do not give these tablets to children under 16
years of age.
Do not take any other medicine (including nonprescription 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). The printing ink contains
Opacode S-1-17823 Black (containing shellac,
Isopropyl alcohol, Iron oxide black, N-Butyl alcohol,
Propylene glycol and Ammonium Hydroxide 28%).
What this medicine looks like and contents of
the pack
Kirkland Signature Indigestion Relief 75mg Tablets
are light pink, round, biconvex, film coated tablets
printed with “75” in black edible ink 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: Ranbaxy Ireland Limited, Spafield,
Cork Road, Cashel, Co. Tipperary, Ireland.
Leaflet revision date: March 2014.

4005079

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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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