Skip to Content

UK Edition. Click here for US version.

ZANTAC SYRUP

Active substance(s): RANITIDINE HYDROCHLORIDE

View full screen / Print PDF » Download PDF ⇩
Transcript
1

12000000106513

12000000106513

Package leaflet: Information for the user

Zantac Syrup
®

GSK-ContractMfg-Eur-Deu-Germany-Aspen-Bad Oldesloe

ranitidine hydrochloride
United Kingdom-GBR
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 Syrup
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, of 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
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 Anti-Inflammatory (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.

Zantac
N/A
BE12_170X297

N/A
N/A
1
K

0

0

Pregnancy, breast-feeding and fertility
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.
Zantac Syrup contains ethanol (alcohol), propyl
hydroxybenzoate, butyl hydroxybenzoate and sorbitol
Zantac Syrup contains ethanol (alcohol), i.e. up to 800 mg per
dose. For this reason, it may be harmful for those suffering from
alcoholism. The ethanol content should also be taken into
account if Zantac Syrup is to be given to pregnant or
breast-feeding women, children and high risk groups such as
those suffering from:
· alcoholism
· liver disease
· epilepsy
· brain injury or disease.
Each 5 ml spoonful contains approximately 400mg of alcohol
which is equivalent to about two spoonfuls (10 ml) of beer or
one spoonful (5 ml) of wine. Talk to your doctor or pharmacist if
you are concerned. He/she may be able to suggest an alternative
formulation.
This medicine also contains propyl hydroxybenzoate and butyl
hydroxybenzoate which may cause allergic reactions (possibly
delayed) and sorbitol. If you have been told by your doctor that
you have an intolerance to some sugars, contact your doctor
before taking this medicine.

3 How to take Zantac Syrup
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.
· Use the spoon provided to carefully measure the dose
needed.
· Do not mix Zantac Syrup with anything (not even water)
before swallowing it.

8.0pt

9.0pt
8.0pt

100%
N

Aspen Bad Oldesloe
Additional Information Panel
Replacement: 12000000105272

Page 1 of 2

The usual dose for an adult (including the elderly) is either:
· two 5 ml spoonfuls in the morning and two 5 ml spoonfuls in
the evening, or
· four 5 ml spoonfuls 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 from 3 to 11 years:
Your doctor will work out the right dose in mls based on your
child’s weight. Make sure you follow the instructions on the label.
Treatment of stomach and duodenal 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 a lot of syrup 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.

· 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
· 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.

1
12000000106513
GSK-ContractMfg-Eur-Deu-Germany-Aspen-Bad Oldesloe

United Kingdom-GBR
Zantac
N/A
BE12_170X297

N/A
N/A
1
K

5 How to store Zantac

If you stop taking Zantac
After a few days of taking the syrup you should start to feel
much better. Do not stop taking the syrup 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 signs of something called
‘pancreatitis’
· a slow or irregular heartbeat.
Check with your doctor at your next visit if you notice any of
the following:

· 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 the month.
· Do not store above 25°C.
· Once opened, use within 28 days.
· 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.

0

0

6 Contents of the pack and other information
What Zantac contains:
· The active substance is ranitidine (as hydrochloride)
· The other ingredients are hydroxypropyl methylcellulose,
ethanol, propyl hydroxybenzoate, butyl hydroxybenzoate,
potassium dihydrogen orthophosphate, disodium hydrogen
orthophosphate, sodium chloride, saccharin sodium, sorbitol
solution, mint flavour, purified water.
· Each 10 ml dose contains 7.5% w/v ethanol (alcohol) i.e. up
to 800 mg per dose.
What Zantac looks like and contents of the pack
Zantac Syrup is a clear, pale yellow liquid that smells of mint.
Cartons contain one 300 ml amber glass bottle.
Marketing Authorisation Holder and Manufacturer
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, Germany

Uncommon (may affect up to 1 in 100 people)

The information provided applies only to Zantac Syrup.

· stomach pain
· constipation
· feeling sick (nausea)
Rare (may affect up to 1 in 1,000 people)

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:

· skin rash
Rare side effects that may show up in blood tests:

Please be ready to give the following information:

0800 198 5000 (UK Only)

· 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

Product name

Zantac Syrup

Reference number

10949/0108

This is a service provided by the Royal National Institute of Blind
People.
This leaflet was last revised in February 2015.
Zantac is a registered trade mark of the GSK group of
companies.
© 2015 GSK group of companies. All rights reserved.
12000000106513

8.0pt

9.0pt
8.0pt

100%
N

Aspen Bad Oldesloe
Additional Information Panel
Replacement: 12000000105272

Page 2 of 2

Expand view ⇕

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.

Hide