Alliance Pharmaceuticals Ireland
Ranitidine 50mg/2ml Solution for Injection and Infusion
Package leaflet: Information for the user
Ranitidine 50mg/2ml Solution for Injection and Infusion
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 nurse.
- If you get any side effects talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
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:
- Heal and stop ulcers of the stomach or duodenum (the stomach empties into this part of the intestine)
- 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 ulcers from bleeding
- Stop acid coming up from the stomach while under anaesthetic during an operation.
It is used in children (6 months to 18 years) to:
- Heal ulcers in the stomach, or part of the gut that 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 HAVE RANITIDINE INJECTION
Do not have Ranitidine Injection:
- if you are allergic to ranitidine or to any of the other ingredients in this medicine (listed in Section 6).
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 have stomach cancer
- If you have kidney problems. You will need to have a different amount of Ranitidine Injection.
- If you have a heart problem or a history of heart trouble
- If you have a rare condition called acute porphyria
- If you have had stomach ulcers before
- If you are over 65 years old
- If you have lung disease
- If you are diabetic
- If you have problems with your immune system
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:
- lidocaine, a local anaesthetic
- anticoagulants (such as warfarin), used to thin the blood
- propranolol, procainamide or n-acetylprocainamide, for heart problems
- diazepam, for worry or anxiety problems
- phenytoin, for epilepsy
- theophylline, for breathing problems (asthma)
- glipizide, for lowering blood glucose
- atazanavir or delaviridine, for treating HIV infection
- gefitnib for lung cancer
- ketoconazole for fungal infections or thrush
- triazolam for insomnia.
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 taking erlotinib, a drug used for the treatment of certain types of cancer, talk to your doctor before you take Ranitidine Injection. Ranitidine contained in Ranitidine Injection may decrease the amount of erlotinib in your blood and your doctor may need to adjust your treatment if it is used while you are receiving erlotinib.
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:
- As a single injection into a muscle
- As a slow infusion into a vein. This is where the drug is slowly given to you over a few minutes
- As a continuous infusion into a vein. This is where the drug is slowly given to you over a few hours.
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:
- Allergic reactions, the signs may include:
- Severe itching of the skin, rash or hives on the skin
- Swelling of the hands, feet, ankles, face, lips, tongue, mouth or throat, which may cause difficulties in swallowing or breathing.
- Swelling on other parts of the body
- Chest pain, shortness of breath, wheezing or having trouble breathing
- Unexpected 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 pains, this may be a sign of something called ‘pancreatitis’
- An irregular heartbeat either slower or faster than normal
- Collapse
Other side effects
Tell 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 side effects that may show up in blood tests:
- Increase of serum creatinine in 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
- Depression
- Confusion, hallucinations (seeing or hearing unexplained things)
- Blood changes that may result in unusual tiredness, shortness of breath, being more likely to get infections bruising more easily
- Uncontrolled movements
- Your small blood vessels can become swollen (known as vasculitis). Signs of this can include: a rash, swollen joints or kidney problems
- Headaches (sometimes severe)
- Diarrhoea
- Feeling dizzy or having blurred vision
- 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
- Red blotches or lumps on the skin that may look like targets, unexplained hair loss
- Your joints or muscles are painful and swollen
- If you are a man, sexual impotence (this is normally reversible), tenderness of the breast, breast discharge and/or breast enlargement.
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:
UK:
The Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow CArd in the Google Play or Apple App Store.
IE:
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. CONTENTS OF THE PACK AND OTHER 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.