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Omeprazole 40 Mg Powder For Solution For Infusion

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Pharma Code 26    Pharma Code 26



TFTVil

HOSPITALS

PACKAGE LEAFLET: INFORMATION FOR THE USER

OMEPRAZOLE 40 mg POWDER FOR SOLUTION FOR INFUSION

omeprazole

Read all of this leaflet carefully before you start using this

medicine.

•    Keep this leaflet. You may need to read it again.

•    If you have any further questions, ask your doctor, nurse or pharmacist.

•    This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

•    If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell yourdoctor, nurse or pharmacist.

IN THIS LEAFLET:

1.    What Omeprazole is and what it is used for

2.    Before Omeprazole is given to you

3.    How Omeprazole is given to you

4.    Possible side effects

5.    How to store Omeprazole

6.    Further information

(1 WHAT OMEPRAZOLE IS AND WHAT IT IS USED FOR

Omeprazole contains the active substance omeprazole. It belongs to agroup of medicines called a "proton pump inhibitor". They work by reducing the amount of acid that your stomach produces.

Omeprazole 40 mg powder for solution for infusion can be used as an alternative to oral therapy.

Q before omeprazole is given to you

You must not be given Omeprazole

•    if you are allergic (hypersensitive) to omeprazole or any of the other ingredients of Omeprazole

•    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).

If you are not sure, talk to your doctor, nurse or pharmacist before you are given this medicine.

Take special care with Omeprazole

Omeprazole may hide the symptoms of other diseases. Therefore, if any of the following happen to you before you are given Omeprazole or after you are given it, talk to your doctor straight away:

•    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

•    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 yourdoctor if you have osteoporosis or if you are taking corticosteroids (which can increase the risk of osteoporosis).

Using other medicines

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.

You must not be given Omeprazole if you are taking a medicine containing nelfinavir (used to treat HIV infection).

Tell your doctor or pharmacist if you are taking any of the following medicines:

•    Ketoconazole, itraconazole orvoriconazole (used to treat infections caused by a fungus)

•    Digoxin (used to treat heart probelms)

•    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

•    Medicines that are used to thin your blood, such as warfarin or othervitamin K blockers. Yourdoctormay need to monitoryou when you start orstop taking Omeprazole

•    Rifampicin (used to treat tuberculosis)

•    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)).

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.

Yourdoctorwill decide whetheryou can take Omeprazole ifyou are breast-feeding.

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.

Important information about some of the ingredients of Omeprazole 40 mg powder for solution for infusion:

This medicinal productcontains less than 1 mmol sodium (23 mg) per dose, i.e. essentially "sodium free".

HOW OMEPRAZOLE IS GIVEN TO YOU

•    Omeprazole can be given to adults including the elderly

•    There is limited experience with Omeprazole for intravenous use in children.

Being given Omeprazole

•    Omeprazole will be given to you by a doctor who will decide how much you need

•    The medicine will be given to you as an infusion into one of your veins.

If you are given more Omeprazole than you should:

If you think that you have been given too much medicine, you may experience some of the possible side effects listed below, please inform yourdoctor.

(4 ) POSSIBLE SIDE EFFECTS

Like all medicines, Omeprazole can cause side effects although not everybody gets them.

If you notice any of the following rare but serious side effects, stop using Omeprazole 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 occurwith certain frequencies which are defined as follows:

Very common: affects more than 1 user in10

Common:    affects 1to10 users in 100

Uncommon: affects 1to10 users in 1,000

Rare:    affects 1to10 users in 10,000

Very rare:    affects 1 in 10 users in 100,000

Not known: frequency cannot be estimated from the available data

Other side effects include:

Common side effects

•    Headache

•    Effects on your stomach or gut: diarrhoea, stomach pain, constipation, wind (flatulence)

•    Feeling sick (nausea) or being sick (vomiting).

Uncommon side effects

•    Swelling of the feet and ankles

•    Disturbed sleep (insomnia)

•    Dizziness, tingling feelings such as "pins and needles", feeling sleepy

•    Spinningfeeling(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

•    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

•    Low levels of sodium in the blood. This may cause weakness, being sick (vomiting) and cramps

•    Feeling agitated, confused or depressed

•    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

•    Liver problems, including jaundice which can cause yellow skin, dark urine, and tiredness

•    Hairloss(alopecia)

•    Skin rash on exposure to sunshine

•    Joint pains (arthralgia) or muscle pains (myalgia)

•    Severe kidney problems (interstitial nephritis)

•    Increased sweating.

Very rare side effects

•    Changes in blood count including agranulocytosis (lack of white blood cells)

•    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)

•    Muscle weakness

•    Enlarged breasts in men

•    Hypomagnesaemia.

If you are on omeprazole for more than three months it is possible that the levels of magnesium in your blood may fall. Low levels of magnesium can be seen as fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, increased heart rate. Ifyou get any of these symptoms, please tell yourdoctor promptly. Low levels


of magnesium can also lead to a reduction in potassium orcalcium levels in the blood. Yourdoctor may decide to perform regular blood tests to monitor your levels of magnesium.

Irreversible visual impairment has been reported in isolated cases of critically ill patients who have received omeprazole intravenous injection, especially at high doses, but no causal relationship has been established.

Omeprazole may in very rare cases affect the white blood cells leading to immune deficiency. If you have an infection with symptoms such as feverwith a severely reduced general condition or fever with symptoms of a local infection such as pain in the neck, throat or mouth or difficulties in urinating, you must consult your doctor as soon as possible so that a lack of white blood cells (agranulocytosis) can be ruled out by a blood test. It is important for you to give information about your medicine at this time.

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 or pharmacist.


HOW TO STORE OMEPRAZOLE

•    Keep out of the reach and sight of children.

•    Do not use Omeprazole after the expiry date which is stated on the vial and carton after EXP. The expiry date refers to the last day of that month.

•    Store in the original package in order to protect from light.

•    Shelf life after reconstitution:

Solution forinfusion reconstituted with sodium chloride 9 mg/ml (0.9%) should be used within 12 hours after preparation.

Solution forinfusion reconstituted with glucose 50 mg/ml (5%) should be used within 6 hours after preparation.

From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longerthan 24 hours at 2 to 8°C, unless reconstitution has taken place in controlled and validated aseptic conditions.

•    Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

(6 FURTHER information
What Omeprazole contains

•    The active substance is omeprazole. Each vial of powder for solution for infusion contains 42.6 mg omeprazole sodium equivalent to 40 mg omeprazole.

•    The other ingredients are sodium hydroxide and disodium edetate.

What Omeprazole looks like and contents of the pack

Omeprazole 40 mg powder for solution for infusion is a white powder and comes in a vial.

The dry powder in the vial is made into a solution before it is given to you. The reconstituted product is clear and free from visible particles.

This medicine is available in two pack-sizes: 1or 5 glass vials. The vials are supplied in cartons.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

TEVA UK Limited, Eastbourne, BN22 9AG.

Manufacturer

SIRTON PHARMACEUTICALS sPa., PiazzaXXSettembre, 2, 22079 Villa Guardia (CO), Italy.

This leaflet was last revised in May 2012

PL 00289/1032


5004459

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