Losec IV Injection 40 mg
Powder for solution for injection
omeprazole
Please read all of this leaflet carefully before you are given this medicine.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor, nurse or pharmacist.
- If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, nurse or pharmacist.
In this leaflet:
- 1. What Losec IV Injection is and what it is used for
- 2. Before Losec IV Injection is given to you
- 3. How Losec IV Injection is given to you
- 4. Possible side effects
- 5. How to store Losec IV Injection
- 6. Further information
What Losec IV Injection is and what it is used for
Losec IV Injection contains a medicine called omeprazole. This belongs to a group of medicines called ‘proton pump inhibitors’.
They work by reducing the amount of acid that your stomach produces.
Losec IV Injection is used when you are unable to have treatment by mouth. It is used to treat:
- ‘Gastro-oesophageal reflux disease’ (GORD).
- Ulcers in the upper part of the intestine (duodenal ulcer) or stomach (gastric ulcer). If you have had an ulcer in the past and need to keep taking a medicine called an NSAID (Non-Steroidal Anti-Inflammatory Drug), Losec IV Injection can stop ulcers from forming or heal one that is already there.
- Prevention of damage to the lungs caused by breathing in fluids from the stomach. This may occur during an operation.
- Too much acid in the stomach, caused by a growth in the pancreas (Zollinger-Ellison syndrome).
Further information about ulcers and GORD
If you have ulcers or gastro-oesophageal reflux disease (GORD), this section contains information about your condition.
What is an ulcer?
An ulcer is a break or hole in the lining of the stomach or the gut.
What causes an ulcer?
- Usually, there is a balance between the protection of the stomach or gut lining and the attack from stomach acid. Ulcers form when there is too much acid or not enough protection.
- Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) may occasionally cause ulcers. If you have had an ulcer in the past, but need to keep taking an NSAID, your doctor may prescribe Losec IV Injection to protect your stomach or gut.
What is gastro-oesophageal reflux disease (GORD)?
This is where acid from the stomach escapes into the food pipe (oesophagus). The food pipe does not have a protective lining.
When acid gets into the food pipe, it can cause pain, inflammation and heartburn.
What should you do if you do not feel relief from your symptoms?
Talk to your doctor who will be able to review you and your treatment.
How can I help myself?
If you have gastro-oesophageal reflux disease or an ulcer, as well as being given Losec IV Injection, the following may help:
- Do not eat just before going to bed. Also, try raising the head of your bed by 20 cm.
- Lose weight if needed and do not wear tight clothing.
- Stop smoking.
- Eat less fat and more protein.
- Do not have caffeine, alcohol, tomatoes or hot spicy food - these can make your symptoms worse.
Before Losec IV Injection is given to you
You must not be given Losec IV Injection if:
- You are allergic (hypersensitive) to omeprazole or any of the other ingredients of this medicine (listed in Section 6: Further information).
- You are taking a medicine called atazanavir (used to treat HIV).
You must not be given Losec IV Injection if any of the above apply to you. If you are not sure, talk to your doctor or nurse before you are given this medicine.
Take special care with Losec IV Injection
Check with your doctor or nurse before you are given Losec IV Injection if:
- You have any liver problems. Your doctor may reduce your dose.
Taking other medicines
Please tell your doctor or nurse if you are taking, or have recently taken, any other medicines. This includes medicines that you buy without a prescription. This is because Losec IV Injection can affect the way some medicines work and some medicines can have an effect on Losec IV Injection.
You must not be given Losec IV Injection if you are taking the following medicine:
- Atazanavir (used to treat HIV).
Tell your doctor or nurse if you are taking any of the following medicines:
- Ketoconazole, itraconazole or voriconazole (used to treat infections caused by a fungus).
- Diazepam (used to treat anxiety, relax muscles or in epilepsy).
- Phenytoin (used in epilepsy). If you are taking phenytoin, your doctor will need to monitor you when you start or stop having Losec IV Injection.
- Medicines that are used to thin your blood, such as warfarin or other vitamin K blockers. Your doctor may need to monitor you when you start or stop having Losec IV Injection.
- Digoxin (used for heart problems).
- Tacrolimus (used in organ transplants).
Pregnancy and breast-feeding
Before you are given Losec IV Injection, tell your doctor if you are pregnant, trying to get pregnant or breast-feeding. Your doctor will decide whether you can be given Losec IV Injection during this time.
Driving and using machines
Losec IV Injection is not likely to affect you being able to drive or use any tools or machines.
How Losec IV Injection is given to you
- Losec IV Injection can be given to adults including the elderly.
- It should not be given to children or young people under the age of 18.
- The solution for injection should not be used if there are small bits in it.
- The solution for injection should be used for one patient during one treatment.
Being given Losec IV Injection
- Losec IV Injection will be given to you by a doctor who will decide how much you need.
- The usual starting dose is 10 ml. It will be given to you slowly over 5 minutes.
- The medicine will be given to you as an injection into one of your veins. This will last for 5 minutes.
- If you are going to have an operation in hospital where you will have a general anaesthetic, Losec IV Injection will be given one hour before the operation.
If you are given too much Losec IV Injection
If you think you have been given too much Losec IV Injection, talk to your doctor straight away.
Possible side effects
Like all medicines, Losec IV Injection can cause side effects, although not everybody gets them. The side effects are usually mild and go away after a short time.
If you notice any of the following serious side effects, stop having Losec IV Injection and tell a doctor or contact the casualty department at your nearest hospital straight away:
- Swelling of the lips, tongue and throat, fever or wheezing (severe allergic reaction).
- Reddening of the skin with blisters or peeling. There may also be severe blisters and bleeding in the lips, eyes, mouth, nose and genitals. This could be ‘Stevens-Johnson syndrome’ or ‘toxic epidermal necrolysis’.
These effects are rare, affecting less than 1 in 1,000 people.
Other side effects include:
Common (affects less than 1 in 10 people)
- Headache.
- Effects on your stomach or gut: stomach pain, constipation, diarrhoea, wind (flatulence).
- Feeling sick (nausea) or being sick (vomiting).
Uncommon (affects less than 1 in 100 people)
- Disturbed sleep (insomnia).
- Dizziness.
- Tingling feelings such as ‘pins and needles’.
- Feeling sleepy.
- Spinning feeling (vertigo).
- Feeling light-headed or faint.
- Skin rash, lumpy rash (hives), itchy skin and dermatitis.
- Changes in blood tests that show how well your liver is working.
- Generally feeling unwell.
Rare (affects less than 1 in 1,000 people)
- Dry or sore mouth.
- An infection called ‘thrush’ which can affect the mouth or gullet and is caused by a fungus.
- Taste changes.
- Feeling anxious, confused or depressed.
- Aggression.
- Seeing, feeling or hearing things that are not there (hallucinations).
- Skin rash on exposure to sunshine.
- Blurred vision.
- Hair loss (alopecia).
- Painful swollen joints.
- Aching muscles or muscle weakness.
- Increased sweating.
- Kidney problems.
- Liver problems, including jaundice which can cause yellow skin, dark urine, and tiredness.
- Severe liver problems leading to liver failure and inflammation of the brain.
- Enlarged breasts in men.
- Being unable to get an erection (impotence).
- Low levels of sodium in the blood. This may cause weakness, being sick (vomiting) and cramps.
- Blood problems such as reduced numbers of white cells or platelets. This can cause weakness, bruising or make infections more likely.
Eye sight (visual) problems that do not get better have been seen in a small number of very ill patients who have been given this medicine (omeprazole) by injection, particularly at high doses. However, it is not known if these problems are caused by omeprazole.
Do not be concerned by this list of possible side effects. You may not get any of them. If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, nurse or pharmacist.
How to store Losec IV Injection
- The doctor and hospital pharmacist are responsible for storing, using and disposing of Losec IV Injection correctly.
- Keep out of the reach and sight of children.
- Do not use this medicine after the expiry date shown on the carton. The expiry date refers to the last day of that month.
- If the injection is made outside of validated aseptic conditions, it should be used within 4 hours.
- Any unused contents should be discarded.
- Do not store above 25°C.
- Keep the vial in the outer carton in order to protect it from light.
Further information
What Losec IV Injection 40 mg contains
The active substance is omeprazole sodium. Each vial of powder for solution for injection contains 42.6 mg of omeprazole sodium, equivalent to 40 mg of omeprazole. Each vial also contains sodium hydroxide.
Each vial is for one injection when mixed with one ampoule containing the solvent for injection. The solvent for injection contains macrogol 400 (polyethylene glycol), citric acid monohydrate and water for injections.
What Losec IV Injection 40 mg looks like and contents of the pack
Losec IV Injection comes in a glass vial and glass ampoule. The vial contains a powder for solution for injection. The ampoule contains a solvent for solution for injection.
Marketing Authorisation Holder and Manufacturer
The Marketing Authorisations for Losec IV Injection 40 mg and Solvent are held by
Losec IV Injection 40 mg and Solvent are manufactured by
To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge:
0800 198 5000 (UK only)
Please be ready to give the following information:
Product name Losec IV Injection 40 mg
Reference number 17901/0135
This is a service provided by the Royal National Institute of Blind People.
Leaflet prepared: September 2009
© AstraZeneca 2009
Losec is a trade mark of the AstraZeneca group of companies.
GI 09 0049
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