What is a Patient Information Leaflet and why is it useful?

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

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 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.

IE:

HPRA Pharmacovigilance
Earlsfort Terrace
IRL - Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.hpra.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. 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

Alliance Pharmaceuticals Limited
Avonbridge House
Bath Road
Chippenham
Wiltshire
SN15 2BB
UK

Manufacturer:

Kleva S A
189 Parnithos Avenue
136 71 Acharnai
Athens
Greece

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