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RANITIDINE TABLETS 150MG

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

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Package leaflet: Information for the patient
Ranitidine 150mg and 300mg Tablets
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 Ranitidine Tablets are and what they are used for
2.
What you need to know before you take Ranitidine Tablets
3.
How to take Ranitidine Tablets
4.
Possible side effects
5.
How to store Ranitidine Tablets
6.
Contents of the pack and other information

1.

What Ranitidine Tablets are and what they are used for

The full name of your medicine is Ranitidine 150mg and 300mg Tablets but within the leaflet it will
be referred to as Ranitidine Tablets.
Ranitidine Tablets contain 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) Ranitidine Tablets are 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) Ranitidine Tablets are 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 Ranitidine Tablets

Do not take Ranitidine Tablets:

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 Ranitidine Tablets.

Warnings and precautions
Talk to 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 Ranitidine Tablets

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 Ranitidine Tablets
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 Ranitidine Tablets can affect the way some other medicines work. Also some other medicines
can affect the way Ranitidine Tablets 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 Ranitidine Tablets 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 Ranitidine Tablets.
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.

3.

How to take Ranitidine 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:

150mg in the morning and 150mg in the evening, or

300mg 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 2mg for each kg of body weight, twice a day for four weeks. This dose may be
increased to 4mg 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 2.5mg for each kg of body weight, twice a day for two weeks. This dose may be
increased to 5mg for each kg, twice a day. Take each dose about 12 hours apart.
If you take more Ranitidine Tablets than you should
Ranitidine Tablets are 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 Ranitidine Tablets

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 Ranitidine Tablets
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 Ranitidine Tablets 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

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.

How to store Ranitidine Tablets

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 outer carton.
These tablets should be stored in a dry place, at or store below 25˚C, in order to protect from light in
the package or container supplied. DO NOT transfer them to another container.
Unless your doctor tells you to, DO NOT keep these tablets for longer than you need. Ask your
pharmacist how to throw away medicines you no longer use. These measures will help protect the
environment.

6.

Contents of the pack and other information

What Ranitidine Tablets contain

The active substance is ranitidine (as the hydrochloride) 150mg or 300mg

The other ingredients are microcrystalline cellulose, croscarmellose sodium, magnesium
stearate and colloidal silicon dioxide.
The tablet coating contains macrogol, hypromellose, polydextrose, vanillin and titanium oxide
(E171). The tablets are also polished with carnauba wax.
What Ranitidine Tablets look like and contents of the pack
Ranitidine 150mg Tablets are round, white film-coated biconvex tablets engraved ”C” over “321”
Ranitidine 300mg Tablets are round, white film-coated biconvex tablets engraved ”C322”
The product is available in:
Blister strips in packs of 28, 30, 56, 60, 84, 112, 120 tablets.
HDPE tablet containers in pack sizes of 100, 250, 500 and 1000 tablets.
See outer packaging or the pharmacy label for contains i.e. the number of tablets.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Crescent Pharma Limited,
Units 3 & 4 Quidhampton Business Units,
Polhampton Lane, Overton,
Hampshire, RG25 3ED,
UK
Manufacturer
Apotex Inc.
Ontario, Canada
on behalf of Marketing Authorisation Holder Crescent Pharma Limited,
Units 3 & 4 Quidhampton Business Units,
Polhampton Lane, Overton,
Hampshire, RG25 3ED,
UK

This leaflet was last revised in 04/2017

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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