QUICK DETAILS:
OMEZOL 40 Contents:
•Each vial of this medicine contains Omeprazole (as sodium) 40mg as the active ingredient.
•The other ingredients are disodium edetate, sodium hydroxide.
OMEZOL 40 Character:
OMEZOL 40 is a white or almost white lyophilized powder which comes in a clear glass vial fitted with a rubber cap and metal seal.
OMEZOL 40 Pack:
1 vial plus 1 ampoule.
1. What OMEZOL 40 is and what it is used for
This medicine contains the active substance omeprazole. It belongs to a group of medicines called ‘proton pump inhibitors’. They work by reducing the amount of acid that your stomach produces.
OMEZOL 40 is used to treat duodenal ulcers, gastric ulcers, reflux oesophagitis and oesophageal reflux disease and the prevention of acid aspiration.
2. What you need to know before you take OMEZOL 40
•If you are allergic (hypersensitive) to omeprazole or any of the other ingredients of this medication.
•If you are allergic to other proton pump inhibitor medicines (e.g. pantoprazole, lansoprazole, rabeprazole, esomeprazole).
•If you are taking a medicine containing nelfinavir (used for HIV infection).
Take special care with OMEZOL 40
OMEZOL 40 may hide the symptoms of other diseases. Therefore, if any of the following happen to you before you are given OMEZOL 40 or after you are given it, talk to your doctor straight away:
•You have severe liver problems.
Taking a proton pump inhibitor like Omeprazole, especially over a period of more than one year, may slightly increase your risk of fracture in the hip, wrist or spine. Tell your doctor if you have osteoporosis or if you are taking corticosteroids (which can increase the risk of osteoporosis).
Using other medicines
You must not be given Omeprazole if you are taking a medicine containing
Tell your doctor or pharmacist if you are taking any of the following medicines:
•Digoxin (used to treat heart problems)
•Medicines that are used to thin your blood, such as warfarin or other vitamin K blockers.
•Rifampicin (used to treat tuberculosis)
If your doctor has prescribed the antibiotics amoxicillin and clarithromycin as well as Omeprazole to treat ulcers caused by Helicobacter pylori infection, it is very important that you tell your doctor about any other medicines you are taking.
Pregnancy and breast-feeding
Before you are given Omeprazole, tell your doctor if you are pregnant or trying to get pregnant. Your doctor will decide whether you can be given Omeprazole during this time.
Omeprazole is excreted in breast milk but is not likely to influence the child when therapeutic doses are used. Your doctor will decide whether you can take Omeprazole if you are breastfeeding.
Driving and using machines
Omeprazole is not likely to affect your ability to drive or use any tools or machines. Side effects such as dizziness and visual disturbances may occur (see section 4). If affected, you should not drive or operate machinery.
It can be used as an alternative to oral therapy.
You must not be given OMEZOL 40
•If you are not sure, talk to your doctor, nurse or pharmacist before you are given this medicine.
•You lose a lot of weight for no reason and have problems swallowing.
•You get stomach pain or indigestion.
•You begin to vomit food or blood.
•You pass black stools (blood-stained faeces).
•You experience severe or persistent diarrhoea, as omeprazole has been associated with a small increase in infectious diarrhoea.
Please tell your doctor, nurse or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. This is because Omeprazole can affect the way some medicines work and some medicines can have an effect on Omeprazole.
nelfinavir (used to treat HIV infection).
•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 taking Omeprazole
•Atazanavir (used to treat HIV infection)
•Tacrolimus (in cases of organ transplantation)
•St John,s wort (Hypericum perforatum) (used to treat mild depression)
•Cilostazol (used to treat intermittent claudication)
•Saquinavir (used to treat HIV infection)
•Clopidogrel (used to prevent blood clots (thrombi)).
1.How to take OMEZOL 40
Being given OMEZOL 40
• It will be given to you by a doctor or nurse who will decide how much you need. •The medicine will be given to you as an injection or infusion into one of your veins.
Dosage
In patients with duodenal ulcer, gastric ulcer or reflux oesophagitis where oral medication is inappropriate, 40 mg once daily is recommended. In patients with Zollinger-Ellison syndrome the recommended initial dose given intravenously is 60 mg daily. Higher daily doses may be required and the dose should be adjusted individually. When doses exceed 60 mg daily, the dose should be divided and given twice daily.
Special populations
Paediatric patients
Method of Administration
OMEZOL 40 can be given as a slow intravenous injection. The solution for IV injection is obtained by adding to the vial of the solvent provided. Discoloration may occur if incorrect reconstitution technique is used. After reconstitution the injection should be given slowly over a period of at least 3 minutes. The solution should be used within 4 hours of reconstitution.
If you are given more OMEZOL 40 than you should
If you think you have been given too much Omeprazole, talk to your doctor straight away.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you notice any of the following rate but serious side effects, stop using and contact a doctor immediately:
•Sudden wheezing, swelling of your lips, tongue and throat or body, rash, fainting or difficulties to swallow (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'.
•Yellow skin, dark urine and tiredness which can be symptoms of liver problems.
Side effects may occur with certain frequencies, which are defined as follows: Very common: affects more than 1 user in 10
Other side effects include:
•Feeling sick (nausea) or being sick (vomiting).
•Blood problems such as a reduced number of white cells or platelets. This can cause weakness, bruising or make infections more likely.
•Allergic reactions, sometimes very severe, including swelling of the lips, tongue and throat, fever, wheezing.
•Feeling agitated, confused or depressed.
•Liver problems, including jaundice which can cause yellow skin, dark urine, and tiredness.
•Hair loss (alopecia).
•Joint pains (arthralgia) or muscle pains (myalgia). •Severe kidney problems (interstitial nephritis).
•Changes in blood count including agranulocytosis (lack of white blood cells).
•Muscle weakness.
•Omeprazole can be given to adults including the elderly.
•There is limited experience with Omeprazole for intravenous use in children.
Alternative to oral therapy
Impaired Renal Function
Dose adjustment is not needed in patients with impaired renal function.
Impaired Hepatic Function
As plasma half-life of omeprazole is increased in patients with impaired hepatic function a daily dose of 10 - 20 mg may be sufficient.
Elderly (> 65 years old)
Dose adjustment is not needed in the elderly.
There is limited experience with Omeprazole for intravenous use in children.
Intravenous Injection
Intravenous Infusion
OMEZOL 40 can be given as an intravenous infusion (over a period of 20-30 minutes or more). The contents of one vial must be dissolved in 100 mL saline for infusion or 100 mL 5％ dextrose for infusion. The solution should be used within 12 hours when omeprazole is dissolved in saline and within 6 hours when dissolved in 5％ dextrose. After reconstitution, start the infusion immediately. The constituted solution should not be mixed or co-administered in the same infusion set with any other drug.
Common: affects 1 to 10 users in 100
Uncommon: affects 1 to 10 users in 1,000
Rare: affects 1 to 10 users in 10,000
Very rare: affects less than 1 user in 10,000
Not known: frequency cannot be estimated from the available data.
Common side effects
•Headache.
•Effects on your stomach or gut: diarrhoea, stomach pain, constipation, wind (flatulence).
Uncommon side effects
•Swelling of the feet and ankles.
•Disturbed sleep (insomnia).
•Dizziness, tingling feelings such as “pins and needles”, feeling sleepy.
•Spinning feeling (vertigo).
•Changes in blood tests that check how the liver is working.
•Skin rash, lumpy rash (hives) and itchy skin.
•Generally feeling unwell and lacking energy.
Rare side effects
•Low levels of sodium in the blood. This may cause weakness, being sick (vomiting) and cramps.
•Taste changes.
•Eyesight problems such as blurred vision.
•Suddenly feeling wheezy or short of breath (bronchospasm).
•Dry mouth.
•An inflammation of the inside of the mouth.
•An infection called “thrush” which can affect the gut and is caused by a fungus.
•Skin rash on exposure to sunshine.
•Increased sweating. Very rare side effects
•Aggression.
•Seeing, feeling or hearing things that are not there (hallucinations).
•Severe liver problems leading to liver failure and inflammation of the brain.
•Sudden onset of a severe rash or blistering or peeling skin. This may be associated with a high fever and joint pains (Erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).
•Enlarged breasts in men.Go to top of the page
Contents of the pack and other information
•Each vial of this medicine contains Omeprazole (as sodium) 40mg as the active ingredient.
•The other ingredients are disodium edetate, sodium hydroxide.
What OMEZOL 40 looks like and contents of the pack
OMEZOL 40 is a white or almost white lyophilized powder which comes in a clear glass vial fitted with a rubber cap and metal seal.
The pack contains a vial containing 40 mg omeprazole, also contains an ampoule containing 10 ml 0.9％ sodium chloride injections.
What OMEZOL 40 contains
How to store OMEZOL 40
Do not use after the expiry date ‘EXP’ shown on the container. The expiry date refers to the last day of that month.
Keep out of the reach and sight of children.
Store below 25°C. Protect from light and moisture.
Once the medicine has been mixed with provided solvent, the solution should be used straight away. Any unused liquid should be disposed of safely.
QUICK DETAILS:
OMEZOL 40 Contents:
•Each vial of this medicine contains Omeprazole (as sodium) 40mg as the active ingredient.
•The other ingredients are disodium edetate, sodium hydroxide.
OMEZOL 40 Character:
OMEZOL 40 is a white or almost white lyophilized powder which comes in a clear glass vial fitted with a rubber cap and metal seal.
OMEZOL 40 Pack:
1 vial plus 1 ampoule.
1. What OMEZOL 40 is and what it is used for
This medicine contains the active substance omeprazole. It belongs to a group of medicines called ‘proton pump inhibitors’. They work by reducing the amount of acid that your stomach produces.
OMEZOL 40 is used to treat duodenal ulcers, gastric ulcers, reflux oesophagitis and oesophageal reflux disease and the prevention of acid aspiration.
2. What you need to know before you take OMEZOL 40
•If you are allergic (hypersensitive) to omeprazole or any of the other ingredients of this medication.
•If you are allergic to other proton pump inhibitor medicines (e.g. pantoprazole, lansoprazole, rabeprazole, esomeprazole).
•If you are taking a medicine containing nelfinavir (used for HIV infection).
Take special care with OMEZOL 40
OMEZOL 40 may hide the symptoms of other diseases. Therefore, if any of the following happen to you before you are given OMEZOL 40 or after you are given it, talk to your doctor straight away:
•You have severe liver problems.
Taking a proton pump inhibitor like Omeprazole, especially over a period of more than one year, may slightly increase your risk of fracture in the hip, wrist or spine. Tell your doctor if you have osteoporosis or if you are taking corticosteroids (which can increase the risk of osteoporosis).
Using other medicines
You must not be given Omeprazole if you are taking a medicine containing
Tell your doctor or pharmacist if you are taking any of the following medicines:
•Digoxin (used to treat heart problems)
•Medicines that are used to thin your blood, such as warfarin or other vitamin K blockers.
•Rifampicin (used to treat tuberculosis)
If your doctor has prescribed the antibiotics amoxicillin and clarithromycin as well as Omeprazole to treat ulcers caused by Helicobacter pylori infection, it is very important that you tell your doctor about any other medicines you are taking.
Pregnancy and breast-feeding
Before you are given Omeprazole, tell your doctor if you are pregnant or trying to get pregnant. Your doctor will decide whether you can be given Omeprazole during this time.
Omeprazole is excreted in breast milk but is not likely to influence the child when therapeutic doses are used. Your doctor will decide whether you can take Omeprazole if you are breastfeeding.
Driving and using machines
Omeprazole is not likely to affect your ability to drive or use any tools or machines. Side effects such as dizziness and visual disturbances may occur (see section 4). If affected, you should not drive or operate machinery.
It can be used as an alternative to oral therapy.
You must not be given OMEZOL 40
•If you are not sure, talk to your doctor, nurse or pharmacist before you are given this medicine.
•You lose a lot of weight for no reason and have problems swallowing.
•You get stomach pain or indigestion.
•You begin to vomit food or blood.
•You pass black stools (blood-stained faeces).
•You experience severe or persistent diarrhoea, as omeprazole has been associated with a small increase in infectious diarrhoea.
Please tell your doctor, nurse or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. This is because Omeprazole can affect the way some medicines work and some medicines can have an effect on Omeprazole.
nelfinavir (used to treat HIV infection).
•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 taking Omeprazole
•Atazanavir (used to treat HIV infection)
•Tacrolimus (in cases of organ transplantation)
•St John,s wort (Hypericum perforatum) (used to treat mild depression)
•Cilostazol (used to treat intermittent claudication)
•Saquinavir (used to treat HIV infection)
•Clopidogrel (used to prevent blood clots (thrombi)).
1.How to take OMEZOL 40
Being given OMEZOL 40
• It will be given to you by a doctor or nurse who will decide how much you need. •The medicine will be given to you as an injection or infusion into one of your veins.
Dosage
In patients with duodenal ulcer, gastric ulcer or reflux oesophagitis where oral medication is inappropriate, 40 mg once daily is recommended. In patients with Zollinger-Ellison syndrome the recommended initial dose given intravenously is 60 mg daily. Higher daily doses may be required and the dose should be adjusted individually. When doses exceed 60 mg daily, the dose should be divided and given twice daily.
Special populations
Paediatric patients
Method of Administration
OMEZOL 40 can be given as a slow intravenous injection. The solution for IV injection is obtained by adding to the vial of the solvent provided. Discoloration may occur if incorrect reconstitution technique is used. After reconstitution the injection should be given slowly over a period of at least 3 minutes. The solution should be used within 4 hours of reconstitution.
If you are given more OMEZOL 40 than you should
If you think you have been given too much Omeprazole, talk to your doctor straight away.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you notice any of the following rate but serious side effects, stop using and contact a doctor immediately:
•Sudden wheezing, swelling of your lips, tongue and throat or body, rash, fainting or difficulties to swallow (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'.
•Yellow skin, dark urine and tiredness which can be symptoms of liver problems.
Side effects may occur with certain frequencies, which are defined as follows: Very common: affects more than 1 user in 10
Other side effects include:
•Feeling sick (nausea) or being sick (vomiting).
•Blood problems such as a reduced number of white cells or platelets. This can cause weakness, bruising or make infections more likely.
•Allergic reactions, sometimes very severe, including swelling of the lips, tongue and throat, fever, wheezing.
•Feeling agitated, confused or depressed.
•Liver problems, including jaundice which can cause yellow skin, dark urine, and tiredness.
•Hair loss (alopecia).
•Joint pains (arthralgia) or muscle pains (myalgia). •Severe kidney problems (interstitial nephritis).
•Changes in blood count including agranulocytosis (lack of white blood cells).
•Muscle weakness.
•Omeprazole can be given to adults including the elderly.
•There is limited experience with Omeprazole for intravenous use in children.
Alternative to oral therapy
Impaired Renal Function
Dose adjustment is not needed in patients with impaired renal function.
Impaired Hepatic Function
As plasma half-life of omeprazole is increased in patients with impaired hepatic function a daily dose of 10 - 20 mg may be sufficient.
Elderly (> 65 years old)
Dose adjustment is not needed in the elderly.
There is limited experience with Omeprazole for intravenous use in children.
Intravenous Injection
Intravenous Infusion
OMEZOL 40 can be given as an intravenous infusion (over a period of 20-30 minutes or more). The contents of one vial must be dissolved in 100 mL saline for infusion or 100 mL 5％ dextrose for infusion. The solution should be used within 12 hours when omeprazole is dissolved in saline and within 6 hours when dissolved in 5％ dextrose. After reconstitution, start the infusion immediately. The constituted solution should not be mixed or co-administered in the same infusion set with any other drug.
Common: affects 1 to 10 users in 100
Uncommon: affects 1 to 10 users in 1,000
Rare: affects 1 to 10 users in 10,000
Very rare: affects less than 1 user in 10,000
Not known: frequency cannot be estimated from the available data.
Common side effects
•Headache.
•Effects on your stomach or gut: diarrhoea, stomach pain, constipation, wind (flatulence).
Uncommon side effects
•Swelling of the feet and ankles.
•Disturbed sleep (insomnia).
•Dizziness, tingling feelings such as “pins and needles”, feeling sleepy.
•Spinning feeling (vertigo).
•Changes in blood tests that check how the liver is working.
•Skin rash, lumpy rash (hives) and itchy skin.
•Generally feeling unwell and lacking energy.
Rare side effects
•Low levels of sodium in the blood. This may cause weakness, being sick (vomiting) and cramps.
•Taste changes.
•Eyesight problems such as blurred vision.
•Suddenly feeling wheezy or short of breath (bronchospasm).
•Dry mouth.
•An inflammation of the inside of the mouth.
•An infection called “thrush” which can affect the gut and is caused by a fungus.
•Skin rash on exposure to sunshine.
•Increased sweating. Very rare side effects
•Aggression.
•Seeing, feeling or hearing things that are not there (hallucinations).
•Severe liver problems leading to liver failure and inflammation of the brain.
•Sudden onset of a severe rash or blistering or peeling skin. This may be associated with a high fever and joint pains (Erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).
•Enlarged breasts in men.Go to top of the page
Contents of the pack and other information
•Each vial of this medicine contains Omeprazole (as sodium) 40mg as the active ingredient.
•The other ingredients are disodium edetate, sodium hydroxide.
What OMEZOL 40 looks like and contents of the pack
OMEZOL 40 is a white or almost white lyophilized powder which comes in a clear glass vial fitted with a rubber cap and metal seal.
The pack contains a vial containing 40 mg omeprazole, also contains an ampoule containing 10 ml 0.9％ sodium chloride injections.
What OMEZOL 40 contains
How to store OMEZOL 40
Do not use after the expiry date ‘EXP’ shown on the container. The expiry date refers to the last day of that month.
Keep out of the reach and sight of children.
Store below 25°C. Protect from light and moisture.
Once the medicine has been mixed with provided solvent, the solution should be used straight away. Any unused liquid should be disposed of safely.
