PACKAGE LEAFLET: INFORMATION FOR THE USER Omeprazol XXX 40 mg powder for solution for infusion omeprazole

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1 PACKAGE LEAFLET: INFORMATION FOR THE USER Omeprazol XXX 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 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 your doctor or pharmacist. In this leaflet: 1. What Omeprazol XXX 40 mg powder for solution for infusion is and what it is used for 2. Before you are given Omeprazol XXX 40 mg powder for solution for infusion 3. How Omeprazol XXX 40 mg powder for solution for infusion will be given 4. Possible side effects 5. How to store Omeprazol XXX 40 mg powder for solution for infusion 6. Further information 1. WHAT OMEPRAZOL XXX 40 MG POWDER FOR SOLUTION FOR INFUSION IS AND WHAT IT IS USED FOR Omeprazol XXX 40 mg powder for solution for infusion is a type of drug called a proton pump inhibitor. Omeprazole works by reducing the production of acid in your stomach. Each vial is for one infusion. Omeprazol XXX 40 mg powder for solution for infusion is used to treat the following conditions when you are unable to take the medicine by mouth: - Acid from the stomach escaping into the gullet (oesophagus) causing pain, inflammation and heartburn (reflux oesophagitis). - Ulcers in the upper part of the intestine (duodenal ulcer) - Mild and benign (non-cancerous) ulcers in the stomach.. - Excessive acid production in the stomach caused by a condition called Zollinger-Ellison syndrome. 2. BEFORE YOU ARE GIVEN OMEPRAZOL XXX 40 MG POWDER FOR SOLUTION FOR INFUSION Do not use Omeprazol XXX 40 mg powder for solution for infusion if: - you are allergic (hypersensitive) to omeprazole or to any of the other ingredients of omeprazole - you are taking atazanavir (drug used for the treatment of HIV) Omeprazol XXX 40 mg powder for solution for infusion is given to you with special care in case of one of the following conditions: - Tell your doctor if you suffer or have recently suffered from any of the following symptoms: unintentional weight loss, recurrent vomiting or vomiting of blood, or dark stools. He/she may then perform an additional investigation called endoscopy in order to diagnose your condition and/or exclude other more serious conditions. - Treatment with gastric acid inhibitors leads to a slightly increased risk of gastrointestinal infections. Inform your doctor if you suffer from gastrointestinal symptoms like diarrhoea and abdominal pain. 1

2 - Omeprazole should not be given to children under the age of one. - If you have or have had problems with your liver or kidneys you should tell your doctor. He/she may check how they are working with blood tests especially if you have to take this medicine for a long time. - Blindness and deafness have been reported with the use of Omeprazole, therefore the monitoring of visual and auditory senses may be necessary. - If you suffer from peptic ulcer, the possibility of a bacterial infection caused by Helicobacter pylori should be determined and existing infection should be eliminated prior to omeprazole therapy Ask your doctor for advice if any of the above situations applies to you. Taking other medicines Medicines that are taken concomitantly may influence each other in terms of effect(s) and/or side effect(s). This is called interaction. Interactions may also occur if you have taken medicines recently or will use them in the near future. It is especially important that you tell your doctor if you are taking or have recently taken any medicine which contains: - Atazanavir (drug used for treatment of HIV) - Ketoconazole and itraconazole (medicine used for the treatment of fungal infections) and other medicines whose absorption is influenced by the degree of acidity in the stomach - Digoxin (medicine for heart conditions). - Drugs that are also metabolised by the liver, such as warfarin (a drug to avoid blood coagulation) and phenytoin (a drug for the treatment of epilepsy, for instance) - Disulfiram (medicine to treat alcoholism) - Ciclosporin and tacrolimus (medicines that inhibit the defence mechanism and thus prevents rejection) - Clarithromycin (drug to avoid/fight certain infections) - St. John s Wort (extract from a medicinal plant, which is often used as a natural antidepressant). - Vitamin B12. - benzodiazepines (drugs with sedative, sleep-inducing and/or muscle-relaxing properties), such as diazepam, triazolam, flurazepam - some drugs used to treat depression, such as citalopram, imipramine and clomipramine - Voriconazole (medicine used for the treatment of fungal infections) If you are taking these types of medicines, you should bear these observations in mind and ask your doctor or pharmacist for advice. Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Pregnancy and breast-feeding Tell your doctor if you are pregnant, think you might be pregnant or plan to become pregnant and also if you are breast-feeding. Your doctor will need to consider any possible risks of you or your child, taking Omeprazol XXX 40 mg powder for solution for infusion. At present, there is insufficient information available to evaluate whether the active substance, omeprazole, has such kind of adverse effects. To date there is no evidence. Driving and using machines There is no evidence of effects on the ability to drive or use machines. It should be remembered that side effects such as drowsiness and visual disturbances may occur and may possibly affect the ability to drive or use machines. Important information about some of the ingredients of Omeprazol XXX 40 mg powder for solution for infusion: 2

3 This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially sodium free. 3. HOW OMEPRAZOL XXX 40 MG POWDER FOR SOLUTION FOR INFUSION WILL BE GIVEN Omeprazol XXX 40 mg powder for solution for infusion is only for adults and should not be given to children under the age of one. Your medicine will be given to you by a health care specialist who will decide how much you need. To start with, this will usually be 100 ml infusion given to you slowly over 20 minutes to half an hour. The reconstituted solution should not be used if particles are present and should be used on one patient during one treatment. If you are given more medicine than you should have received: Omeprazole infusion is well tolerated even in high doses. There is no information available on the effects of overdosing. If you suspect that you have been given too much medicine, you may experience some of the possible side effects listed below, please inform your doctor. 4. POSSIBLE SIDE EFFECTS Like all medicines, Omeprazole may sometimes cause side effects. These are usually mild and diminish rapidly. The following side effects have been reported at the approximate frequencies shown: Very common (affecting more than one person in 10) Common (affecting fewer than one person in ten but more than one person in 100) Uncommon (affecting fewer than one person in 100 but more than one person in 1,000) Rare (affecting fewer than one person in 1,000 but more than one person in 10,000) Very rare (affecting fewer than one person in 10,000 but more than one person in 100,000) Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness Gastrointestinal disorders: - Common: Diarrhoea, constipation, stomach ache, feeling sick, vomiting, wind. - Rare: Dry mouth, thrush in the mouth or gullet, brownish-black discoloration of the tongue, inflammation of the mouth, inflammation of the pancreas Nervous system disorders: - Common: Headaches, dizziness, light headedness, feeling faint, sleepiness, trouble sleeping - Uncommon: Pins and needles, - Rare: Reversible mental confusion, depression and hallucinations in case of severely ill patients, generally feeling unwell Endocrine disorders: - Rare: Development of breasts in men 3

4 Blood and lymphatic system disorders: - Rare: Blood disorders (decrease in the number of circulating white blood cells, platelets, or red blood cells in blood) which may lead to frequent infections with symptoms of fever, severe chills, sore throat, mouth ulcers, bleeding or bruising more easily than normal or tiredness Hepatobiliary disorders: - Uncommon: Increase in hepatic enzymes - Rare: Liver disease which may colour your skin and eyes yellow, Liver failure which can lead to brain damage, Musculoskeletal and connective tissues disorders: - Rare: Painful swollen joints, aching muscles or muscle weakness Skin and subcutaneous tissue disorders: - Uncommon. Rash, itching, - Rare: Skin sensitivity to light, severe skin blisters, severe blisters and bleeding in the lips, eyes, mouth, nose and genitals, unusual hair loss or thinning; Other: - Uncommon: Feeling unwell - Rare: Allergic reactions, sometimes very severe, including swelling of the lips, tongue and throat, kidney disease, increased sweating, blurred vision, low blood sodium. If you are very unwell, you may feel confused, nervous, aggressive, depressed and see, feel or hear things that are not there. It is not known whether these side effects are caused directly by Omeprazole. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or your pharmacist. 5. HOW TO STORE OMEPRAZOL XXX 40 MG POWDER FOR SOLUTION FOR INFUSION Store Omeprazol XXX 40 mg powder for solution for infusion in the original package, in order to protect from light, below 25 C. When your infusion is made it should be used immediately. Keep out of the reach and sight of children. Do not use this product after the expiry date which is stated on the label after EXP (The expiry date refers to the last day of that month.) 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 Omeprazol XXX 40 mg powder for solution for infusion contains - The active ingredient 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 Omeprazol XXX 40 mg powder for solution for infusion looks like and contents of the pack 4

5 Omeprazol XXX 40 mg powder for solution for infusion is a white to almost white powder. In its dissolved form it is a clear liquid. One package contains 1 or 5 injection vial (s). One injection vial contains 40 mg omeprazole. Marketing Authorisation Holder To be completed nationally Manufacturer To be completed nationally This leaflet was last approved in 5

6 The following information is intended for medical or healthcare professionals only: Indications Gastric antisecretory treatment in severely ill patients where oral therapy is inappropriate with: - Reflux oesophagitis, - Duodenal or benign gastric ulcer - Zollinger-Ellison-Syndrome Posology and method of administration Dosage (adults only) Treatment in patients where oral therapy is inappropriate e.g. in severely ill patients with either reflux oesophagitis, duodenal ulcer or gastric ulcer: Omeprazol XXX 40 mg powder for solution for infusion given as an intravenous infusion once daily is recommended for up to 5 days. The i.v. infusion produces an immediate decrease in intragastric acidity and a mean decrease over 24 hours of approximately 90%. Zollinger-Ellison syndrome: An initial dose of 60 mg of Omeprazol XXX 40 mg powder for solution for infusion in an intravenous infusion is recommended. A higher daily dose may be needed and must be determined individually. If this is more than 60 mg/day the daily dose must be distributed over two administrations. Administration Omeprazol XXX 40 mg powder for solution for infusion is for intravenous administration only and must not be given by any other route. Omeprazol XXX 40 mg powder for solution for infusion should only be dissolved in 100 ml 5% glucose solution for infusion. No other solutions for i.v. infusion should be used (see section 6.6). After reconstitution from a microbiological point of view, use immediately (i.e. within 6 hours) and any unused portion should be discarded. The duration of administration should be minutes. For a 20 mg doses half of the reconstituted solution should be used and any unused solution should be discarded. Use in the Elderly: Dosage adjustment is not necessary. Use in Children: There is limited experience of use in children. Omeprazole should not be used in children under 1 year of age since no data are available. The dosage recommendations are as follows: Age Weight Dosage 1 year of age kg 10 mg once daily. The dosage can be increased to 20 mg once daily if needed. 2 years of age > 20 kg 20 mg once daily. The dosage can be increased to 40 mg once daily if needed. Impaired renal function: Dose adjustment is not required in patients with impaired renal function. Impaired hepatic function: As half-life is increased in patients with impaired hepatic function, the dose requires adjustment and a daily dose of 10mg - 20mg may be sufficient. 6

7 Contraindications - Known hypersensitivity to omeprazole or to any of the other constituents of the formulation. - Omeprazole should not be administered with atazanavir due to an important reduction in atazanavir exposure (see section 4.5) Special warnings and precautions for use In patients with peptic ulcer disease Helicobacter pylori-status should be determined if relevant. In patients who are shown to be Helicobacter pylori-positive, the elimination of the bacterium by eradication therapy should be aimed wherever possible. When gastric ulcer is suspected the possibility of malignancy should be excluded before treatment with Omeprazol XXX 40 mg powder for solution for infusion is instituted, as treatment may alleviate symptoms and delay diagnosis. The diagnosis of reflux oesophagitis should be confirmed endoscopically. Decreased gastric acidity due to any means including proton-pump inhibitors, increases gastric counts of bacteria normally present in the gastrointestinal tract. Treatment with acid-reducing drugs may lead to a slightly increased risk of gastrointestinal infections, such as Salmonella and Campylobacter. In patients with severe impaired hepatic function, liver enzyme values should be checked periodically during treatment with omeprazole. During combination treatment caution should be exercised in patients with renal or hepatic dysfunction (for dose restriction see section 4.2). Omeprazole should not be used in infants and children under the age of 1 year (see section 4.2). Blindness and deafness have been reported in the use of the injection form of omeprazole; therefore, in severely ill patients the monitoring of visual and auditory senses is recommended. This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially sodium free Special precautions for disposal and other handling The entire contents of each vial should be dissolved in 100 ml 5% glucose solution for infusion. Omeprazol XXX 40 mg powder for solution for infusion should initially be dissolved in a few ml of fluid. No other solutions for i.v. infusion should be used. Use on one patient during one treatment only. 7

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