- ranitidine hydrochloride
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet are: PL18157/0019, PL16853/0130.
Ranitidine 50mg/2ml Solution for Injection and Infusion
Package leaflet: Information for the user
Ranitidine 50mg/2ml Solution for Injection and Infusion
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
The name of this medicine is Ranitidine 50mg/2ml Solution for Injection and Infusion (referred to as Ranitidine Injection throughout this leaflet).
What is in this leaflet:
1. What Ranitidine Injection is and what it is used for
2. What you need to know before you have Ranitidine Injection
3. How to have Ranitidine Injection
4. Possible side effects
5. How to store Ranitidine Injection
6. Contents of the pack and other information
1. WHAT RANITIDINE INJECTION IS AND WHAT IT IS USED FOR
Ranitidine Injection is a solution for injection or infusion into a vein, or injection into a muscle. It contains ranitidine as the active substance.
Ranitidine is one of a group of medicines called H2-antagonists that lowers the amount of acid in your stomach.
It is used in adults (including the elderly) to:
It is used in children (6 months to 18 years) to:
2. WHAT YOU NEED TO KNOW BEFORE YOU HAVE RANITIDINE INJECTION
Do not have Ranitidine Injection:
If you are not sure talk to your doctor or pharmacist before having Ranitidine Injection.
Warnings and precautions
Talk to your doctor or pharmacist before having Ranitidine Injection:
If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before having this medicine.
Other medicines and Ranitidine Injection
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines that you buy 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 tell your doctor or pharmacist if you are taking any of the following medicines:
Midazolam may also be given before an operation. Tell your doctor you are taking ranitidine before you have an operation in case he or she wants to give you midazolam.
If you are not sure if any of the above applies to you, talk to your doctor, pharmacist or nurse before having Ranitidine Injection.
Pregnancy and breast-feeding
If you are pregnant, might become pregnant or breast-feeding you should not be given this medicine unless your doctor advises it is essential.
Ask your doctor, pharmacist or nurse for advice before taking any medicine, if you are pregnant or breast-feeding.
Driving and using machines
Ranitidine Injection is unlikely to affect your ability to drive or operate machinery
Ranitidine Injection contains Sodium and Potassium
Ranitidine Injection contains less than 1 mmol sodium (23 mg) per 50 mg, i.e. essentially sodium-free.
Ranitidine Injection contains less than 1mmol potassium (39mg) per 50mg, i.e. essentially potassium-free
3. HOW TO HAVE RANITIDINE INJECTION
You will never be expected to give yourself this medicine. It will always be given to you by someone who is trained to do so.
Your doctor will decide the correct dose of Ranitidine Injection for you.
Adults (including the elderly) and adolescents (12 years and older): This can be given by the doctor or nurse in one of three ways:
The recommended dose for an adult (including the elderly) and adolescents (12 years and older) is 50 mg every 6 to 8 hours, as a single injection into a muscle.
Different doses may also be given to you as a slow infusion or continuous infusion, depending on what condition you are being treated for.
Children and infants (6 months to 11 years): The dose will be given by a slow injection into a vein. The maximum dose is 50mg every 6 or 8 hours. It is usually only given if your child is unable to take ranitidine by mouth.
Kidney disease: If your kidneys are not working properly your doctor may give you a lower dose.
Your doctor or nurse will give you Ranitidine Injection so it is unlikely that you will receive too much. If you think that the effect of Ranitidine Injection is too strong or too weak or you have missed a dose, talk to your doctor or nurse. If you have any further questions on the use of this product, ask your doctor or nurse.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Ranitidine Injection can cause side effects, although not everybody gets them.
Serious side effects
If any of the following happen, tell your doctor or nurse immediately as you may need urgent medical attention:
Other side effects
Tell your doctor at your next visit if you notice any of the following:
Rare side effects that may show up in blood tests:
Check with your doctor as soon as possible if you notice any of the following:
Reporting of side effects
If you get any side effects talk to your doctor 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 INJECTION
Do not store above 25°C.
Keep ampoules in the carton to protect them from light.
Keep this medicine out of the sight and reach of children.
Ranitidine Injection should not be used after the expiry date which is stated on the ampoule and carton. 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.
6. FURTHER INFORMATION
What Ranitidine Injection contains
The active substance is ranitidine. One 2ml ampoule contains 50mg of ranitidine as ranitidine hydrochloride.
Other ingredients are sodium chloride, potassium dihydrogen phosphate, disodium hydrogen phosphate dihydrate and water for injections.
What Ranitidine Injection looks like and contents of the pack
Ranitidine Injection is a clear, colourless liquid in amber glass ampoules.
Each carton of Ranitidine Injection contains 5 ampoules.
Marketing Authorisation Holder
This leaflet was last revised in May 2016
Alliance and associated devices are registered trademarks of Alliance Pharmaceuticals Limited
© Alliance Pharmaceuticals Limited 2016
Ranitidine PIL UK ROI 006