PACKAGE LEAFLET: INFORMATION FOR THE USER    saraoooLrooo

Pantoprazole 40 mg Powder for Solution for Injection

Pantoprazole    A SANDOZ

Read all of this leaflet carefully before you start using 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 pharmacist.

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

•    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).

ill-effects like pain in your joints.

Tell your doctor immediately if you

notice any of the following symptoms:

•    an unintentional loss of weight

•    repeated vomiting

•    difficulty in swallowing

•    vomiting blood

•    you look pale and feel weak (anaemia)

•    you notice blood in your stools

•    severe and/or persistent diarrhoea, as Pantoprazole 40 mg Powder for Solution for Injection has been associated with a small increase in infectious diarrhoea.

What is in this leaflet

1.    What Pantoprazole 40 mg Powder for Solution for Injection is and what it is used for

2.    What you need to know before you use Pantoprazole 40 mg Powder for Solution for Injection

3.    How to use Pantoprazole 40 mg Powder for Solution for Injection

4.    Possible side effects

5.    How to store Pantoprazole 40 mg Powder for Solution for Injection

6.    Contents of the pack and other information

What Pantoprazole 40 mg 1 Powder for Solution for ' Injection is and what it is used for

Pantoprazole 40 mg Powder for Solution for Injection is a selective “proton pump inhibitor”, a medicine which reduces the amount of acid produced in your stomach. It is used for treating acid-related diseases of the stomach and intestine.

This preparation is injected into a vein and will only be given to you if your doctor thinks pantoprazole injections are more suitable for you at the moment than pantoprazole tablets. Tablets will replace your injections as soon as your doctor sees fit.

Pantoprazole 40 mg Powder for Solution for Injection is used for treating:

•    Reflux oesophagitis. An inflammation of your oesophagus (the tube which connects your throat to your stomach) accompanied by the regurgitation of stomach acid.

•    Stomach and duodenal ulcers.

•    Zollinger-Ellison-Syndrome and other conditions producing too much acid in the stomach.

Your doctor may decide that you need some tests to rule out malignant disease because pantoprazole also alleviates the symptoms of cancer and could cause delay in diagnosing it. If your symptoms continue in spite of your treatment, further investigations will be considered.

Other medicines and Pantoprazole 40 mg Powder for Solution for Injection

Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.

Pantoprazole 40 mg Powder for Solution for Injection injections may influence the effectiveness of other medicines, so tell your doctor if you are taking:

•    Medicines such as ketoconazole, itraconazole and posaconazole (used to treat fungal infections) or erlotinib (used for certain types of cancer) because Pantoprazole 40 mg Powder for Solution for Injection may stop these and other medicines from working properly.

•    Warfarin and phenprocoumon, which affect the thickening, or thinning of the blood. You may need further checks.

•    Atazanavir (used to treat HIV-infection).

•    Methotrexate (used to treat rheumatoid arthritis, psoriasis, and cancer) - if you are taking methotrexate your doctor may temporarily stop your Pantoprazole 40 mg powder for solution for injection treatment.

Pregnancy and breast-feeding

There is no adequate data from the use of pantoprazole in pregnant women. Excretion into human milk has been reported. If you are pregnant, or think you may be pregnant, or if you are breast-feeding, you should use this medicine only if your doctor considers the benefit for you greater than the potential risk to your unborn child or baby.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or nurse for advice before taking any medicine.

Driving and using machines

If you experience side effects like dizziness or disturbed vision, you should not drive or operate machines.

What you need to know 2 before you use Pantoprazole ' 40 mg Powder for Solution for Injection

How to use Pantoprazole 3. 40 mg Powder for Solution for Injection

Do not use Pantoprazole 40 mg

powder for solution for injection:

•    If you are allergic to pantoprazole or any of the other ingredients of this medicine (see section 6).

•    If you are allergic to medicines containing other proton pump inhibitors.

Warnings and precautions

•    If you have severe liver problems. Please tell your doctor if you ever had problems with your liver in the past. He will check your liver enzymes more frequently. In the case of a rise of liver enzymes the treatment should be stopped.

•    If you are taking a medicine containing atazanavir (for the treatment of HIV-infection) at the same time as pantoprazole, ask your doctor for specific advice.

•    If you have ever had a skin reaction after treatment with a medicine similar to Pantoprazole 40 mg powder for solution for injection 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 Pantoprazole 40 mg powder for solution for injection. Remember to also mention any other

Your nurse or your doctor will administer the daily dose to you as an injection into a vein over a period of 2 - 15 minutes.

The usual dose is:

For gastric ulcers, duodenal ulcers and reflux oesophagitis.

One vial (40 mg pantoprazole) a day.

For the long-term treatment of Zollinger-Ellison syndrome and other conditions in which too much stomach acid is produced.

Two vials (80 mg pantoprazole) a day.

Your doctor may later adjust the dose, depending on the amount of stomach acid you produce. If you are prescribed more than two vials (80 mg) a day, the injections will be given in two equal doses. Your doctor may prescribe a temporary dose of more than four vials (160 mg) a day.

If your stomach acid level needs to be controlled rapidly, a starting dose of 160 mg (four vials) should be enough to lower the amount of stomach acid sufficiently.

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

A ready-to-use solution is prepared by injecting 10 ml of physiological sodium chloride 9 mg/ml (0.9%) solution for injection into the vial containing the dry powder. The reconstituted solution should be colourless to faintly yellow. This solution may be administered directly or after mixing it with 100 ml

physiological sodium chloride 9 mg/ml (0.9%) solution for injection, or glucose monohydrate 55 mg/ml (5%) solution for injection. Glass or plastic containers should be used for dilution.

Pantoprazole 40 mg Powder for Solution for Injection should not be prepared or mixed with solvents other than those stated.

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Special patient groups:

•    If you suffer from severe liver problems, the daily injection should be only

20 mg (half a vial).

•    Children (under 18 years). These injections are not recommended for use in children.

If you use more Pantoprazole 40 mg Powder for Solution for Injection than you should

These doses are carefully checked by your nurse or your doctor so an overdose is extremely unlikely.There are no known symptoms of overdose.

If you have any further questions about the use of this medicine, ask your doctor or nurse.

4. Possible side effects

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

If you get any of the following side effects, tell your doctor immediately, or contact the casualty department at your nearest hospital:

•    Serious allergic reactions (may affect up to 1 in 1,000 people): swelling of the tongue and/or throat, difficulty in swallowing, hives (nettle rash), difficulties in breathing, allergic facial swelling (Quincke’s oedema/ angioedema), severe dizziness with very fast heartbeat and heavy sweating.

•    Serious skin conditions (frequency cannot be estimated from the available data): blistering of the skin and rapid deterioration of your general condition, erosion (including slight bleeding) of eyes, nose, mouth/lips or genitals (Stevens-Johnson-Syndrome, Lyell-Syndrome, Erythema multiforme) and sensitivity to light.

•    Other serious conditions (frequency cannot be estimated from the available data): yellowing of the skin or whites of the eyes (severe damage to liver cells, jaundice) or fever, rash, and enlarged kidneys sometimes with painful urination and lower back pain (serious inflammation of the kidneys).

Other possible side effects are:

•    Common (may affect up to 1 in 10 people)

inflammation of the wall of the vein and blood clotting (thrombophlebitis) where the medicine is injected.

•    Uncommon (may affect up to 1 in 100 people)

headache; dizziness; diarrhoea; feeling sick, vomiting; bloating and flatulence (wind); constipation; dry mouth; abdominal pain and discomfort; skin rash, exanthema, eruption; itching; feeling weak, exhausted or generally unwell; sleep disorders. Taking a proton pump inhibitor like Pantoprazole, 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).

•    Rare (may affect up to 1 in 1,000 people)

distortion or complete lack of the sense of taste; disturbances in vision such as blurred vision; hives; pain in the joints; muscle pains; weight changes; raised body temperature; swelling of the extremities (peripheral oedema); allergic reactions; depression; breast enlargement in males.

•    Very Rare (may affect up to 1 in 10,000 people) disorientation.

•    Not known (frequency cannot be estimated from the available data) Hallucination, confusion (especially in patients with a history of these symptoms); “pins and needles” (paraesthesia); muscle spasm; decreased sodium level in blood; rash, possibly with pain in the joints. If you are on Pantoprazole 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 doctor 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.

After preparation the solution must be used within 12 hours. 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 longer than 12 hours at not more than 25°C.

The medicine should be administered intravenously over 2-15 minutes.

Side effects identified through blood tests:

•    Uncommon (may affect up to 1 in 100 people)

an increase in liver enzymes.

•    Rare (may affect up to 1 in 1,000 people)

an increase in bilirubin; increased fats in the blood; sharp drop in circulating granular white blood cells, associated with high fever.

•    Very Rare (may affect up to 1 in 10,000 people)

a reduction in the number of blood platelets, which may cause you to bleed or bruise more than normal; a reduction in the number of white blood cells, which may lead to more frequent infections; coexisting abnormal reduction in the number of white and red blood cells, as well as platelets.

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 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.

How to store Pantoprazole 5. 40 mg Powder for Solution for Injection

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the label after EXP. The expiry date refers to the last day of that month.

Do not store above 25°C.

Keep container in outer carton in order to protect it from light.

Use the reconstituted solution within 12 hours.

Use the reconstituted and diluted solution within 12 hours.

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 longer than 12 hours at not more than 25°C.

Do not use Pantoprazole 40 mg powder for solution for injection if you notice that the visual appearance has changed (e.g. if cloudiness or precipitation is observed).

The content of the vial is meant for single use; any product that has remained in the vial has to be discarded.

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 Contents of the pack and . other information

What Pantoprazole 40 mg Powder for Solution for Injection contains:

Active substance: One vial of Pantoprazole 40 mg Powder for Solution for Injection contains 45.11 mg pantoprazole sodium sesquihydrate, equivalent to 40 mg pantoprazole.

Other ingredients: the medicinal product contains no other ingredients than the active substance.

What Pantoprazole 40 mg Powder for Solution for Injection looks like and contents of the pack:

Pantoprazole 40 mg Powder for Solution for Injection is a glass vial closed with a red rubber stopper and sealed by an aluminium cap, containing a white to yellowish powder, i.e. the powder for solution for injection.

The vials are packed in carton boxes. Each box contains 1, 5, 10 or 20 glass 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 last revised in

10/2015.    SZ00000LT000

The content of the vial is for single intravenous use only. Any product that has remained in the container or whose visual appearance has changed (e.g. if cloudiness or precipitation is observed) must be discarded.

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