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Active substance(s): RANITIDINE

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Ranitidine 150mg Film-coated 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 or 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 is and what it is used for
2. What you need to know before you take Ranitidine
3. How to take Ranitidine
4. Possible side effects
5. How to store Ranitidine
6. Contents of the pack and other information

1. What Ranitidine is and what it is used for
The name of your medicine is Ranitidine 150mg Tablets (called Ranitidine in this leaflet). This belongs
to a group of medicines called “H2 antagonists”.
Ranitidine works by lowering the amount of acid in your stomach. It can be used for the following:
Adults and the elderly (65 years and over)

To treat or prevent ulcers in your stomach and duodenum (the part of the gut the stomach empties into)

To treat or prevent ulcers caused by medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs).
This includes medicines such as aspirin, ibuprofen, ketoprofen and piroxicam

To treat ulcers that can happen after an operation

To help prevent ulcers from bleeding in seriously ill people or people who are known to have ulcers that

For an inflamed food pipe (oesophagitis) where stomach acid has travelled up into your food pipe

For other problems due to too much acid in your stomach such as chronic indigestion or heartburn

The management of Zollinger-Ellison Syndrome. This is a problem with your pancreas where too much
acid in the stomach can cause ulcers in your stomach, duodenum, gut and food pipe

For people at risk of breathing in acid from their stomach (aspiration). This might happen during an
operation with a general anaesthetic or in women during labour

To help clear up infection in your stomach when taken with antibiotic medicines.
Children (3 to 18 years)

To treat ulcers in the stomach or the part of the gut it empties into (the duodenum) over a short period
of time

To treat and stop problems caused by acid in the food pipe or too much acid in the stomach with
symptoms of indigestion, excessive burping or heartburn
Safety and efficacy in new-born patients has not been established.
Ranitidine is the common (generic) name. Your doctor may have given you this medicine before from
another company and it may have looked slightly different. Either brand will have the same effect.

2. What you need to know before you take Ranitidine
Do not take Ranitidine if:

You are allergic (hypersensitive) to Ranitidine or any of the other ingredients of this medicine (listed
in Section 6).
Do not take Ranitidine if the above applies to you. If you are not sure, talk to your doctor or pharmacist or
nurse before taking Ranitidine.
Warnings and precautions
Check with your doctor or pharmacist or nurse before taking your medicine if:

You have stomach cancer

You have kidney problems. Your doctor may reduce your dose if your kidneys do not work properly

You have had stomach ulcers before and you are taking Non-Steroidal Anti-Inflammatory
medicines (NSAIDs)

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 taking
Other medicines and Ranitidine
Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines. This includes medicines obtained without a prescription and herbal medicines. This is
because Ranitidine can affect the way some other medicines work. Also some other medicines can affect
the way Ranitidine works.
In particular, please tell your doctor or pharmacist if you are taking any of the following:

Medicines such as ibuprofen or aspirin, known as NSAIDs (non-steroidal anti-inflammatory drugs)

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 antifungal medicine, sometimes used for treating thrush

Sucralfate, for treating stomach ulcers.
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.
Driving and using machines
You may feel dizzy or see things that are not there while taking this medicine. If this happens, do not drive or
use any tools or 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 if you are not
Taking this medicine

Swallow the tablets whole with a full glass of water

Your treatment may last between 4 and 12 weeks

Keep taking your tablets until your doctor tells you to stop. Do not stop taking them because you feel
How much to take - adults and the elderly
Depending on what you are taking Ranitidine for, there are different doses. The usual doses are: To heal or
prevent ulcers caused by NSAID medicines or an operation

150mg twice a day.

To prevent ulcers bleeding

150mg twice a day
Inflamed food pipe
 Either 150mg twice a day.

For longer term treatment you may use 150mg twice a day
If the inflammation is severe, you may be given 150mg four times a day

How much to take - adults and the elderly (continued) Chronic indigestion
 150mg twice a day
Heart burn
 150mg twice a day
Zollinger-Ellison Syndrome
 150mg three times a day
 If you need more, your doctor may give you up to 6g a day. They will tell you how many times a
day you will need to take your medicine.
During an operation – to stop you breathing in acid from your stomach
 150mg the evening before your operation, then 150mg two hours before your general anaesthetic.
During labour – to stop you breathing in acid from your stomach

150mg when you start labour, then 150mg for every 6 hours that you are in labour.
How much to take - children from 12 to 18 years
Your doctor will decide the correct dose, the usual doses are:
To treat stomach ulcers, inflamed food pipe, heartburn or indigestion

150mg twice a day (morning and evening),

How much to take - children from 3 to 11 years and over 30 kilogram (kg) bodyweight Your
doctor will calculate the correct dose for your child based on your child’s weight.
To treat stomach ulcers

The usual dose is 4 to 8mg for each kilogram (kg) of bodyweight per day

150mg twice a day (morning and evening)

The most that can be taken in a day is 300mg

Treatment may last 4 to 8 weeks depending on the child’s response.
To treat an inflamed food pipe, heartburn or indigestion

The usual dose is 5 to 10mg for each kilogram (kg) of bodyweight per day

150mg twice a day (morning and evening)

The most that can be taken in a day is 600mg.
If you take more than you should
If you take more Ranitidine than you should, talk to a doctor or go to a hospital straight away. Take
the medicine pack with you.
If you forget to take Ranitidine

If you forget a dose, take it as soon as you remember it. However, if it is nearly time for the next
dose, skip the missed dose
 Do not take a double dose to make up for a forgotten dose.
If you stop taking Ranitidine
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 have side effects, although not everybody gets them. The
following side effects may happen with this medicine:
See a doctor straight away, if you notice any of the following serious side effects:

Allergic reactions – the signs include a skin rash, swollen or lumpy skin, you have difficulty breathing,
chest pain, shortness of breath, have a fever or feel faint

You have yellow skin or eyes. This could be a sign of inflammation of the liver (jaundice)

You have severe abdominal pains. This could be a sign of inflammation of the pancreas (pancreatitis)

You notice that you bruise more easily or have more nose bleeds than usual. You may also get more
infections than usual such as a sore throat. These could be signs of changes in your blood cells

You feel sick (nausea), more tired than usual, with a loss of appetite

You develop a slow or uneven heart beat

Inflammation of the liver (hepatitis) with flu-like symptoms or symptoms such as nausea

Kidney problems, which can lead to back pain, fever, pain when passing urine, blood in the urine and
changes in blood tests.
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)
 S k i n r a s h . 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
 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 or pharmacist. This includes any possible side
effects not listed in this leaflet. You can also report side effects via the Yellow Card Scheme
at :
By reporting side effects you can help provide information on the safety of this medicine.

5. How to store Ranitidine
Keep out of the sight and reach of children

Do not use the tablets after the expiry date which is stated on the carton and blister strip after EXP.
The expiry date refers to the last day of that month

Do not store above 25 °C. Store in the original packaging
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. pa a

6. Content of the pack and other Information other
What Ranitidine contains

The active substance is ranitidine hydrochloride. The tablets come in two strengths, containing
equivalent to 150mg or 300mg ranitidine

The other ingredients are croscarmellose sodium, magnesium stearate, microcrystalline cellulose (E460),
polymethacrylate, hypromellose, macrogol 6000 purified talc, titanium dioxide (E171), ferric oxide (E172),
sunset yellow (E110).

The 150 mg tablets are yellow circular in shape, marked with a triangle on one side and a straight line on
the other.
The Ranitidine tablets are available in blister packs of Pack sizes: 28, 30, 56, 60, 84, 90, 100, 112, 120,
168, and 180. Not all pack sizes may be marketed
Ranitidine is only available from your pharmacist on prescription in pack size of 60s (150mg).
MA holder: Medley Pharma Limited, Unit 2A, Olympic Way, Sefton Business Park, Liverpool, L30 IRD, UK
Date of last revision: September 2017


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Further information

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