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RANITIDINE 75MG TABLETS BP

Active substance(s): RANITIDINE HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

If you are elderly, have chronic lung disease, diabetes
or a weak immune system, you may be at greater risk
of pneumonia.

Children
Ranitidine is not recommended for children under
16 years of age.

(Ranitidine Hydrochloride)

Taking other medicines - Please tell your doctor or
pharmacist if you are taking or have recently taken
any other medicines, including medicines obtained
without a prescription, or the following:
• Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)
e.g. aspirin, ibuprofen, naproxen (for any condition)
• the antibiotics cefuroxime, amoxicillin and
metronidazole
• sucralfate (for duodenal ulcers), warfarin (to prevent
blood clots), procainamide, N-acetylprocainamide
(for heart problems), triazolam, midazolam (to help
you sleep), glipizide (for diabetes), ketoconazole (for
fungal infections), atazanavir, delavirdine (to treat
HIV), gefitinib (for the treatment of cancer).

If you take more Ranitidine than you should
Contact your doctor or nearest hospital emergency
department immediately. Take the container and any
remaining tablets with you.

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Mylan Design Department,
Albany Gate, Darkes Lane,
Potters Bar, Herts, EN6 1AG

ARTWORK FOR SUBMISSION
Proof Revision Reason: Correcting spelling.

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Re.g. Officer: Catherine Mountford

Change/Creation Reason: Update to match brand leader.

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Packed @: Gerard
PL: 04569/0431

TBC

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Proof # & Date: 4 24.01.11

Supersedes: 10001566

(if applicable)

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AWCC: TBC
Dimensions: 170 x 240 mm

Pharma: TBC
Code: 10002884

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Assurance
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PRO
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Product: Ranitadine Tablets 75 mg x 24 P

Marketing
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1. WHAT RANITIDINE IS AND WHAT IT IS USED FOR
Ranitidine belongs to a group of medicines called
histamine H2 antagonists. It reduces the amount of
acid in the stomach to relieve symptoms of stomach
upsets such as:
• heartburn
• indigestion
• acid indigestion
• excess acid.
It can also be taken to prevent these symptoms
before consuming certain types of food or drink.
2. BEFORE YOU TAKE RANITIDINE
Do not take Ranitidine if:
• you are allergic (hypersensitive) to ranitidine
hydrochloride or any of the other ingredients of
this medicine.
Take special care with Ranitidine - You should tell
your doctor before taking this medicine if:
• you have a liver or kidney problem
• you have a rare inherited disease of the blood
called porphyria
• you have experienced unintended weight loss and
have the symptoms of excess acid at the same time
• you are middle aged or elderly and have
experienced new or recently changed symptoms of
excess acid.
Ranitidine may hide the symptoms of other diseases.
Before initiation of ranitidine treatment your doctor
may carry out an endoscopy to diagnose your
condition and/or exclude other diseases.

If you stop taking Ranitidine
Speak to your doctor first before you stop taking this
medicine.
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.

Pregnancy and breast-feeding
Ranitidine can enter your baby's blood if taken when
you are pregnant and is found in human breast milk if
taken when you are breast-feeding. Ranitidine should
only be taken when you are pregnant or
breast-feeding if it is absolutely necessary. If you are
pregnant or breast-feeding ask your doctor or
pharmacist for advice before taking Ranitidine.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Ranitidine can cause side effects,
although not everybody gets them. The following
side effects may happen with this medicine.

Driving and using machines
Ranitidine should not affect your ability to drive or
use machines.
Important information about some of the
ingredients of Ranitidine
These tablets contain the colourant sunset yellow
(E110) which may cause allergic reactions.
3. HOW TO TAKE RANITIDINE
Always take Ranitidine exactly as your doctor has told
you. You should check with your doctor or pharmacist
if you are not sure. Swallow the tablets whole with a
glass of water.
The usual dose is:
Adults including the elderly
Treatment of heartburn, indigestion, acid
indigestion and excess acid
One tablet as soon as you have the symptoms. If
symptoms persist for more than one hour or return,
take another tablet.
Prevention of acid indigestion, indigestion, excess
acid and heartburn
One tablet, half to one hour before eating or drinking.
The maximum dose is four tablets in any 24 hour period
in divided doses. Do not take Ranitidine for more than 2
weeks continuously unless advised by your doctor.
If you have kidney problems your doctor may change
your dosage.
LT1421AB

Stop taking Ranitidine and see a doctor straight
away, if you notice any of the following serious side
effects, you may need urgent medical treatment:
• allergic reactions, the signs may include:
* rash, itching or hives on the skin
* swelling of your face, lips, tongue or other parts of
the body
* chest pain, shortness of breath, wheezing or
having trouble breathing - unexplained fever and
feeling faint, especially when standing up.
• kidney problems, which can lead to back pain, fever,
pain when passing urine, blood in the urine and
changes in blood tests
• severe stomach pain, this may be a sign of
something called 'pancreatitis'
• a slow or irregular heartbeat.
Check with your doctor at your next visit if you notice
any of the following:
Uncommon (affect less than 1 in 100 people):
• diarrhoea, nausea, constipation, stomach pain.
Rare (affect less than 1 in 1,000 people):
• flushing or marks on your skin that look like targets
• unexplained hair loss
• false results in blood tests called 'liver function tests'
• a rash on its own.
Check with your doctor as soon as possible if you
notice any of the following:
Very rare (affect less than 1 in 10,000 people):
• breast discharge, breast tenderness and/or breast
enlargement in men
• headache (sometimes severe)
• feeling dizzy

If any side effect gets serious, or if you notice any
side effects not listed in this leaflet, please tell your
doctor or pharmacist.
5. HOW TO STORE RANITIDINE
Keep out of the reach and sight of children. Do not
use Ranitidine after the expiry date which is stated on
the carton after 'EXP'. The expiry date refers to the last
day of that month. Store in the original package, at a
temperature below 25°C. 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.
6. FURTHER INFORMATION
What Ranitidine contains
The active substance is ranitidine hydrochloride.
Each tablet contains 85 mg of ranitidine hydrochloride
(equivalent to 75 mg of ranitidine). The other ingredients
are microcrystalline cellulose, magnesium stearate,
hydroxypropylmethylcellulose, titanium dioxide (E171),
polydextrose, triethyl citrate, polyethylene glycol, sunset
yellow (E110) and iron oxide yellow (E172).
What Ranitidine looks like and contents of the pack
Tablets are peach, round, biconvex, film-coated, and
marked '75' on one side and 'G' on the reverse.
Ranitidine is available in blister packs of 6, 12, 24 or 48
tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder: Generics [UK] Ltd
t/a Mylan, Potters Bar, Hertfordshire, EN6 1TL, U.K.
Manufacturer: McDermott Laboratories Ltd (t/a
Gerard Laboratories), 35/36 Baldoyle Indsutrial Estate,
Grange Road, Dublin 13, Ireland.
This leaflet was last
approved in: 06/10/2011

LT1421AB 10002884

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Designer: Paul Whinnett

In this leaflet:
1. What Ranitidine is and what it is used for.
2. Before you take Ranitidine.
3. How to take Ranitidine.
4. Possible side effects.
5. How to store Ranitidine.
6. Further information.

If you forget to take Ranitidine
Take the next dose as soon as you remember unless it
is almost time for your next dose. Do not take a
double dose to make up for a forgotten dose.

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Customer: Mylan

Colours PMS:

Registration Officer
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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 Ranitidine 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 14 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.

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RANITIDINE INDIGESTION RELIEF
AND PREVENTION TABLETS

• having blurred vision which is reversible
• there can be changes in the level of certain
substances in your blood. This can lead to you
feeling unusually tired or short of breath and being
more likely to bruise or get an infection
• feeling confused, depression, seeing or hearing
unexplained things (hallucinations). This is
reversible and is more likely to happen in very ill or
elderly patients
• your joints or muscles are painful or swollen or you
cannot control their movement
• your small blood vessels can become swollen
(known as 'vasculitis'). Signs of this can include: a
rash, swollen joints or kidney problems
• your liver can become swollen. This can lead to:
nausea (feeling sick) or vomiting (being sick), loss of
appetite or generally feeling unwell, itching, fever,
yellowing of the skin and eyes or dark coloured urine
• impotence which is normally reversible and should
get better once you stop taking the medicine.

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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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