RANITIDINE 300MG TABLETS BP

Active substance: RANITIDINE

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Ranitidine 150mg and Ranitidine 300mg Tablets
Ranitidine hydrochloride Ph. Eur
Read all of this leaflet carefully before you start taking this medicine.
 Keep this leaflet. You may need to read it again
 If you have any further questions, ask your doctor or pharmacist
 This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their
symptoms are the same as yours
 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
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

1. What Ranitidine is and what it is used for
The name of your medicine is Ranitidine 150mg and 300mg 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
bleed
 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
Children (3 to 18 years)
 To treat ulcers in the stomach 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
Neonates
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. 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)
 You have a blood problem called acute porphyria
Do not take Ranitidine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist
before taking Ranitidine.
Take special care with Ranitidine
Check with your doctor or pharmacist before taking your medicine if:
 You are pregnant, might become pregnant or are breast-feeding
 You are elderly
 You have kidney, liver or heart problems. Your doctor may reduce your dose if your kidneys do not work
properly
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Ranitidine.
Stomach cancer
Ranitidine may hide the signs of stomach cancer. This is more likely to happen if you are middle-aged or
elderly or when the cancer is very new. Your doctor will check to make sure you do not have stomach cancer
before you start taking your tablets.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken 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)
Operations or tests
If you see another doctor or go into hospital, tell them you are taking Ranitidine and any other medicines you
may be taking.
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.

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
sure.
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
better
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. For serious ulcers you may be given 300mg twice a day
To prevent ulcers bleeding
 150mg twice a day

How much to take - adults and the elderly (continued)
Inflamed food pipe
 Either 150mg twice a day or just 300mg at night
 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
Chronic indigestion
 150mg twice a day
Heart burn
 150mg twice a day or just 300mg at night
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), or 300mg at night
How much to take - children from3 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 or 300mg 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 have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, Ranitidine 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,
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
The following side effects may happen for the first few days but will then usually go away. Please tell
your doctor if you get any of the following and they get troublesome or last for longer than a few
days:
 You feel dizzy, confused, depressed, see or hear things than are not there (hallucinations)
 You have muscle and joint pain or a headache
 Men getting swollen or tender breasts
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.

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.

6. Further information
What Ranitidine contains
 The active substance is ranitidine hydrochloride. The tablets come in two strengths, containing
equivalent to 150mg or 300mg ranitidine Ph. Eur
 The other ingredients are croscarmellose sodium, magnesium stearate, microcrystalline cellulose (E460),
polymethacrylate, hydroxypropylmethylcellulose, polyethylene glycol 6000, purified talc, titanium dioxide
(E171)
What Ranitidine looks like and contents of the pack
The tablets are white to yellowish in colour.
 The 150 mg tablets are circular in shape, and are marked with a triangle on one side and a straight line
on the other
 The 300 mg tablets are oblong in shape, and are marked with a triangle on one side and a straight line
on the other
Ranitidine is only available from your pharmacist on prescription in pack sizes of 30s (300mg) and 60s
(150mg).
MA holder: Zanza Laboratories (Holdings) Limited, Unit 2A, Olympic Way, Sefton Business Park, Liverpool,
L30 IRD, UK
Date of last revision: October 2013 165/04

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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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