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ZANTAC TABLETS 150MG

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

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Reason for update: Type IB Batch Release Site UpdateType 1B (C.I.3.a) – to align SmPC with CSP following PSUR
WS with consequential updates to PIL. Includes QRD 9 (SmPC, PIL, Labelling)
MHRA Approval Date: 13 October 2015
Text Date: 11 August 20165 February 2015
Text Issue and Draft No.: Issue 86 Draft 1
SPC Issue and Draft No.: Issue 11 Draft 1
CO Number: CO-0114638

LOGO GSK
Package leaflet: Information for the user
®

Zantac Tablets 150 mg and 300 mg
ranitidine hydrochloride
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, pharmacist or nurse.
 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, pharmacist or nurse. This includes
any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1 What Zantac is and what it is used for
2 What you need to know before you take Zantac
3 How to take Zantac Tablets
4 Possible side effects
5 How to store Zantac
6 Contents of the pack and other information

1

What Zantac is and what it is used for

Zantac contains a medicine called ranitidine. This belongs to a group of medicines
called H2-receptor antagonists. It lowers the amount of acid in your stomach.
For adults (including the elderly) Zantac is used to:
 heal and stop ulcers in the stomach, or the part of the gut it empties into (the
duodenum)
 help clear up infection in your stomach, when taken with antibiotic medicines
(medicines taken to treat germs)
 stop stomach ulcers when they are a side effect of some medicines
 stop ulcers from bleeding
 improve problems caused by acid in the food pipe (oesophagus) or too much acid
in the stomach. Both of these can cause pain or discomfort sometimes known as
‘indigestion’, ‘dyspepsia’ or ‘heartburn’
 stop acid coming up from the stomach while under anaesthetic during an
operation.
For children (3 to 18 years) Zantac is used to:
 heal ulcers in the stomach, or the part of the gut it empties into (the duodenum)
 heal and stop problems caused by acid in the food pipe (oesophagus) or too
much acid in the stomach. Both of these can cause pain or discomfort sometimes
known as ’indigestion’, ’dyspepsia’ or ’heartburn’.

2

What you need to know before you take Zantac

Reason for update: Type IB Batch Release Site UpdateType 1B (C.I.3.a) – to align SmPC with CSP following PSUR
WS with consequential updates to PIL. Includes QRD 9 (SmPC, PIL, Labelling)
MHRA Approval Date: 13 October 2015
Text Date: 11 August 20165 February 2015
Text Issue and Draft No.: Issue 86 Draft 1
SPC Issue and Draft No.: Issue 11 Draft 1
CO Number: CO-0114638

Do not take Zantac if:
 you are allergic to ranitidine or any of the other ingredients of this medicine (listed
in section 6).
If you are not sure, talk to your doctor or pharmacist before taking Zantac.
Warnings and precautions
Check with your doctor or pharmacist before taking your medicine if:
 you have stomach cancer
 you have kidney problems. You will need to take a different amount of Zantac
 you have had stomach ulcers before and you are taking Non-Steroidal AntiInflammatory (NSAID) medicines
 you have a rare condition called acute porphyria
 you are over 65 years old
 you have lung disease
 you are diabetic
 you have any problems with your immune system.
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist
before using this medicine.
Other medicines and Zantac
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines. This includes medicines that you buy without a prescription and
herbal medicines. This is because Zantac can affect the way some other medicines
work. Also some other medicines can affect the way Zantac works.
In particular tell your doctor or pharmacist if you are taking any of the following
medicines:
 Non-Steroidal Anti-Inflammatory (NSAID) medicines, for pain and inflammation
 lidocaine, a local anaesthetic
 propranolol, procainamide or n-acetylprocainamide, for heart problems
 diazepam, for worry or anxiety problems
 phenytoin, for epilepsy
 theophylline, for breathing problems (asthma)
 warfarin, for thinning your blood.
 glipizide, for lowering blood glucose
 atazanavir or delaviridine, for treating HIV infection
 triazolam, for insomnia
 gefitnib, for lung cancer
 ketoconazole, an anti fungal medicine, sometimes used for treating thrush
 sucralfate, for treating stomach ulcers.
Midazolam is a medicine that may be given to you just before you have an operation.
Tell the doctor you are taking Zantac before your operation in case he or she wants
to give you midazolam.
If you are not sure if any of the above apply to you, talk to your doctor, pharmacist or
nurse before taking Zantac.
Pregnancy, breast-feeding and fertility

Reason for update: Type IB Batch Release Site UpdateType 1B (C.I.3.a) – to align SmPC with CSP following PSUR
WS with consequential updates to PIL. Includes QRD 9 (SmPC, PIL, Labelling)
MHRA Approval Date: 13 October 2015
Text Date: 11 August 20165 February 2015
Text Issue and Draft No.: Issue 86 Draft 1
SPC Issue and Draft No.: Issue 11 Draft 1
CO Number: CO-0114638

If you are pregnant or breast-feeding, think you may be pregnant or are planning to
have a baby, ask your doctor, pharmacist or nurse for advice before taking this
medicine. You should not take this medicine unless your doctor advises it is
essential.

3

How to take Zantac Tablets

Always take this medicine exactly as your doctor or pharmacist has told you. You
should check with your doctor or pharmacist if you are not sure.
Taking this medicine
 Take this medicine by mouth.
 Swallow each tablet whole with a glass of water.
The usual dose for an adult (including the elderly) is either:
 150 mg in the morning and 150 mg in the evening, or
 300 mg at bedtime.
Your exact dose will depend on your particular stomach condition, your doctor will tell
you the dose you should take.
Use in children 12 years and over:
The adult dose is given.
Use in children over 30 kg of weight and from 3 to 11 years:
Your doctor will work out the right dose for you based on your child’s weight.
Treatment of stomach or duodenal (small intestine) ulcers:
The usual dose is 2 mg for each kg of body weight, twice a day for four weeks. This
dose may be increased to 4 mg for each kg, twice a day. Take each dose about 12
hours apart. The duration of treatment may be increased to 8 weeks.
Treatment of heartburn due to too much acid:
The usual dose is 2.5 mg for each kg of body weight, twice a day for two weeks. This
dose may be increased to 5 mg for each kg, twice a day. Take each dose about 12
hours apart.
If you take more Zantac than you should
Zantac is not normally harmful if you take more than you should, unless you take
many tablets at once. If this applies to you (or someone else taking this medicine),
you should go to your nearest hospital casualty department straight away.
Take the medicine pack or any remaining medicine with you so that the doctor knows
what you have taken.
If you forget to take Zantac
 If you forget a dose, take it as soon as you remember it, unless it is nearly time
for your next dose.
 Do not take a double dose to make up for a forgotten dose.
If you stop taking Zantac

Reason for update: Type IB Batch Release Site UpdateType 1B (C.I.3.a) – to align SmPC with CSP following PSUR
WS with consequential updates to PIL. Includes QRD 9 (SmPC, PIL, Labelling)
MHRA Approval Date: 13 October 2015
Text Date: 11 August 20165 February 2015
Text Issue and Draft No.: Issue 86 Draft 1
SPC Issue and Draft No.: Issue 11 Draft 1
CO Number: CO-0114638

After a few days of taking the tablets you should start to feel much better. Do not stop
taking the tablets without talking to your doctor or pharmacist first, otherwise the
original pain and discomfort may come back.
If you have any further questions on the use of this product, ask your doctor or
pharmacist.

4

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets
them.
The following side effects may happen with this medicine.
Stop taking Zantac 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 (may affect up to 1 in 100 people)
 stomach pain
 constipation
 feeling sick (nausea)
Rare (may affect up to 1 in 1,000 people)
 skin rash
Rare side effects that may show up in blood tests:
 increase of serum creatinine in the blood (kidney function test)
 changes to liver function
Check with your doctor as soon as possible if you notice any of the following:
Very rare (may affect up to 1 in 10,000 people)
 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 depressed, confused, seeing or hearing unexplained things
(hallucinations)
 headache (sometimes severe)
 feeling dizzy or having blurred vision
 your joints or muscles are painful or swollen or you cannot control their
movement

Reason for update: Type IB Batch Release Site UpdateType 1B (C.I.3.a) – to align SmPC with CSP following PSUR
WS with consequential updates to PIL. Includes QRD 9 (SmPC, PIL, Labelling)
MHRA Approval Date: 13 October 2015
Text Date: 11 August 20165 February 2015
Text Issue and Draft No.: Issue 86 Draft 1
SPC Issue and Draft No.: Issue 11 Draft 1
CO Number: CO-0114638











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
flushing or marks on your skin that look like targets
unexplained hair loss
diarrhoea
impotence
breast tenderness and/or breast enlargement
breast discharge
awareness of the heart beat and/or increased heart rate

Not known (frequency cannot be estimated from the available data)
 shortness of breath
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.

5




6

How to store Zantac
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 label. The
expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your
pharmacist how to throw away medicines you no longer use. These measures
will help to protect the environment.

Contents of the pack and other information

What Zantac contains:
 The active substance is ranitidine (as the hydrochloride) 150 mg or 300 mg
 The other ingredients are microcrystalline cellulose, magnesium stearate ,
methylhydroxypropyl cellulose (E464), titanium dioxide (E171) and triacetin. 300
mg tablets also contain croscarmellose sodium.
What Zantac looks like and contents of the pack
Zantac Tablets 150 mg are round, white tablets.
Zantac Tablets 300 mg are white, capsule-shaped tablets.
Cartons contain aluminium foil strips or push through double foil blisters. 150 mg
strength cartons contain 60 tablets in strips of 10 and 300 mg strength cartons
contain 30 tablets in strips of 5.
Marketing Authorisation Holder and Manufacturer

Reason for update: Type IB Batch Release Site UpdateType 1B (C.I.3.a) – to align SmPC with CSP following PSUR
WS with consequential updates to PIL. Includes QRD 9 (SmPC, PIL, Labelling)
MHRA Approval Date: 13 October 2015
Text Date: 11 August 20165 February 2015
Text Issue and Draft No.: Issue 86 Draft 1
SPC Issue and Draft No.: Issue 11 Draft 1
CO Number: CO-0114638

Product licence held by Glaxo Wellcome UK Ltd, Stockley Park West, Uxbridge,
Middlesex UB11 1BT
Manufactured by Aspen Bad Oldesloe GmBH, Industriestrasse 32-36, 23843 Bad
Oldesloe, GermanyGlaxo Wellcome S.A., Avenida de Extremadura 3, 09400 Aranda
de Duero, Burgos, Spain
The information provided applies only to Zantac Tablets 150 mg and 300 mg
Other sources of information
To listen to or request a copy of this leaflet in Braille, large print or audio please call,
free of charge:

0800 198 5000 (UK Only)
Please be ready to give the following information:
Product name

Zantac Tablets 150 mg
Zantac Tablets 300 mg

Reference number

10949/0042

This is a service provided by the Royal National Institute of Blind People.
This leaflet was last revised in August 2016February 2015.
Zantac is a registered trade mark of the GSK group of companies.
 20165 GSK group of companies. All rights reserved.
LOGO GSK

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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