Ranitidine 50mg/2ml Solution for Injection and Infusion

• 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).

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

• 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.

• 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”.

• 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.

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.

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.

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.

Ranitidine Injection is unlikely to affect your ability to drive or operate machinery

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

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

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

• 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.

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.

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.

Ranitidine Injection is a clear, colourless liquid in amber glass ampoules.

Each carton of Ranitidine Injection contains 5 ampoules.