PACKAGE LEAFLET: INFORMATION FOR THE USER    sz^ltoba

Omeprazole 40 mg

Powder for Solution for Infusion

Omeprazole sodium    A SANDOZ

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.

•    If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, nurse or pharmacist. See section 4.

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

IWhat Omeprazole is and what it is used for

Omeprazole 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.

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

2 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

•    You have ever had a skin reaction after treatment with a medicine similar to Omeprazole that reduces stomach acid.

If you get a rash on your skin, especially in areas exposed to the sun tell your doctor as soon as you can, as you may need to stop your treatment with Omeprazole. Remember to also mention any other ill-effects like pain in your joints.

This medicine contains less than 1 mmol sodium (23 mg) per 40 mg dose. This means it is essentially “sodium-free”.

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 or voriconazole (used to treat infections caused by a fungus)

•    Digoxin (used to treat heart problems)

•    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 other vitamin K blockers. Your doctor may need to monitor you when you start or stop 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.

Your doctor will decide whether you can take Omeprazole if you 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.

3 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 you have been given too much Omeprazole, talk to your doctor straight away.

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.

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The following information is intended for medical or healthcare professionals only:

The entire contents of each vial is to be dissolved in approximately 5 ml and then immediately diluted to 100 ml. Sodium chloride 9 mg/ml (0.9%) solution for infusion or glucose 50 mg/ml (5%) solution for infusion must be used. The stability of omeprazole is influenced by the pH of the solution for infusion, which is why no other solvent or quantities should be used for dilution.

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Preparation

1.    With a syringe draw 5 ml of infusion solution from the 100 ml infusion bottle or bag

2.    Add this volume to the vial with the freeze-dried omeprazole, mix thoroughly making sure all omeprazole is dissolved

3.    Draw the omeprazole solution back into the syringe

4.    Transfer the solution into the infusion bag or bottle

5.    Repeat steps 1-4 to make sure all omeprazole is transferred from the vial into the infusion bag or bottle.

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Side effects may occur with certain frequencies, which are defined as follows:

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

•    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

•    Fracture in the hip, wrist or spine.¹ 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

•    Hair loss (alopecia)

•    Skin rash on exposure to sunshine

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

•    Severe kidney problems (interstitial nephritis)

•    Increased sweating.

•    Inflammation in the gut (leading to diarrhoea).

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

•    Low levels of magnesium in the blood.²

¹Taking 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).

²If 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. If you get any of these symptoms, please tell your 7doctor promptly. Low levels of magnesium can also lead to a reduction in potassium or calcium levels in the blood. Your doctor may decide to perform regular blood tests to monitor your levels of magnesium.

Not known (frequency cannot be estimated from the available data)

• Rash, possibly with pain in the joints.

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 fever with 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.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly the Yellow Card Scheme (www.mhra.gov.uk/yellowcard). By reporting side effects you can help provide more information on the safety of this medicine.

5 How to store Omeprazole

Keep out of the reach and sight of children.

Do not store above 25°C. Store in the original package in order to protect from light.

Do not use Omeprazole 40 mg Powder for Solution for Infusion after the expiry date which is stated on the label after EXP. The expiry date refers to the last day of that month.

After preparation of the solution by your doctor or nurse, it must be stored below 25°C and used within 12 hours of reconstitution in the physiological saline solution or within 6 hours of reconstitution, if a glucose solution has been used.

From a microbiological point of view, the product should be used immediately unless it has been reconstituted under controlled and validated aseptic conditions.

The reconstituted solution should not be used if particles are present. The content of the vial is meant for single use; any product that has remained in the vial has to be discarded.

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 40 mg Powder for Solution for Infusion contains

Each vial of powder for solution for infusion contains the active ingredient omeprazole sodium, equivalent to 40 mg omeprazole.

Each vial also contains sodium hydroxide and disodium edetate.

Each vial is for one infusion.

What Omeprazole 40 mg Powder for Solution for Infusion looks like and contents of the pack

The powder for solution for infusion is a white to almost white powder.

Omeprazole powder for solution for infusion is available in pack sizes of 1,

5, 10 or 20 vials.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing authorisation holder:

Sandoz Ltd, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, UK.

Manufacturer:

Lek Pharmaceuticals d.d., Verovskova 57, 1526 Ljubljana, Slovenia.

This leaflet was revised

in 04/2016.    SZ90712LT05A

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Alternative preparation for infusions in

flexible containers

1.    Use a double-ended transfer needle and attach to the injection membrane of the infusion bag. Connect the other needle-end from the vial with freeze-dried omeprazole

2.    Dissolve the omeprazole substance by pumping the infusion solution back and forward between the infusion bag and the vial

3.    Make sure all omeprazole is dissolved.

The solution for infusion is to be administered in an intravenous infusion for 20-30 minutes.

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