Package leaflet: Information for the user. Pantoprazole Bluefish 40 mg gastro-resistant tablets pantoprazole

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1 Package leaflet: Information for the user Pantoprazole Bluefish 40 mg gastro-resistant tablets pantoprazole Read all of this leaflet carefully before you start taking 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 or nurse. This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signsof the illness are the same as yours. If you get any of the side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet, See section 4. Whjat is in this leaflet: 1. What Pantoprazole Bluefish is and what it is used for 2. What you need to know before you take Pantoprazole Bluefish 3. How to take Pantoprazole Bluefish 4. Possible side effects 5. How to store Pantoprazole Bluefish 6. Contents of the pack and other information 1. What Pantoprazole Bluefish is and what it is used for Pantoprazole belongs to a group of medicines called proton pump inhibitors. Proton pump inhibitors reduce the amount of acid that your stomach makes. You have been given Pantoprazole Bluefish, because you have a condition caused by stomach acid. Pantoprazole Bluefish 40 mg gastro-resistant tablets are used in the short-term treatment and to relieve the symptoms of: duodenal ulcer gastric ulcer esophagitis (inflammation of esophagus) caused be acid secretion. Additionally, the preparation is used: in combination with antibiotics in patients whose ulceration is related to Helicobacter pylori bacteria. in the long-term treatment of conditions where gastric acid is constantly being secreted too much (e.g. Zollinger Ellison syndrome). 2. What you need to know before you take Pantoprazole Bluefish Do not take Pantoprazole Bluefish if you are allergic to pantoprazole or any of the other ingredients of this medicine (listed in section 6). If you are allergic to other proton pump inhibitors if you are taking atazanavir (which is used for the treatment of HIV infection). If you have any relevant impairment of liver or kidney function and product has been prescribed for you for the eradication of Helicobacter pylori. Page 1 of 6

2 Warnings and precautions Talk to your doctor or pharmacist or nurse before taking Pantoprazole Bluefish if you have severe liver impairment. In case of severe hepatic disorder your doctor should monitor your liver function while you use Pantoprazole Bluefish if you have been diagnosed with vitamin B12 malabsorption if your doctor has given you Pantoprazole Bluefish in addition to other medicines intended for the treatment of Helicobacter pylori infection (antibiotics): please also read the package leaflets of these medicinal products carefully. if you have ever had a skin reaction after treatment with a medicine similar to Pantoprazole Bluefish that reduces stomach acid. Tell your doctor immediately if you notice any of the following symptoms: an unintentional weight loss repeated vomiting or vomiting blood dark stool severe or persistent diarrhoea difficulty in swallowing you look and feel pale (anaemia) Your doctor may perform or have performed an additional investigation called an endoscopy in order to diagnose your condition and/or exclude malignant disease. Taking a proton pump inhibitor like Pantoprazole Bluefish, 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) 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 Bluefish. Remember to also mention any other ill-effects like pain in your joints. Children Pantoprazole Bluefish are not recommended for children. Other medicines and Pantoprazole Bluefish Other concomitant medication may affect the efficacy and safety of this medicine. Pantoprazole Bluefish may also affect the efficacy and safety of other medications. Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Remember to tell your doctor about your treatment with Pantoprazole Bluefish if you are prescribed another medicine while the treatment is still ongoing. It is especially important to tell your doctor: if you are using atazanavir which is used for the treatment of HIV infection if you are using ketoconazole or itraconazole which are used for the treatment of fungal infections, since pantoprazole may affect their concentrations in your body. if you are using anticoagulant medicines, e.g. warfarin, since it may be necessary to monitor your blood coagulation tests more often. if you are taking methotrexate (used to treat arthritis, psoriasis and cancer). Pantoprazole Bluefish with food and drink Take Pantoprazole Bluefish with water one hour before a meal. Page 2 of 6

3 Pregnancy and breast-feeding If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. There are 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 for your unborn child or baby. Driving and using machines There are no known effects on the ability to drive and use machines. If you experience side effects like dizziness or disturbed vision, you should not drive or operate machines. 3. How to take Pantoprazole Bluefish Always take this medicine exactly as your doctor or pharmacist has told you. You should check with your doctor or pharmacist if you are not sure. Method of administration: Do not chew or crush Pantoprazole Bluefish but swallow them whole with liquid one hour before a meal. Dosage: Always take Pantoprazole Bluefish exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure about the dosage. Duodenal ulcer: The recommended dose is 1 tablet (40 mg) daily. Gastric ulcer and esophagitis (inflammation of esophagus) caused by acid secretion: The recommended dose is 1 tablet (40 mg) daily. In combination with antibiotics in patients whose ulceration is related to Helicobacter pylori bacteria: The recommended dose is 1 tablet (40 mg) two times daily in combination with antibiotics. The second Pantoprazole Bluefish should be taken one hour before the evening meal. Long-term treatment of conditions where gastric acid is constantly being secreted too much (e.g. Zollinger-Ellison syndrome): Initial dose is 2 tablets (2 x 40 mg) daily. With doses above 80 mg daily, the dose should be divided and given twice daily. Elderly and patients with renal impairment: Daily dose of 40 mg should not be exceeded, except in elderly whose ulceration is related to Helicobacter pylori bacteria. Patients with hepatic impairment: Dose of 1 tablet (40 mg) should be given every second day. Use in children: Pantoprazole Bluefish should not be used in children. Page 3 of 6

4 If you take more Pantoprazole Bluefish than you should If you or someone you know accidentally takes a lot more than the stated dose (an overdose) you should contact a doctor immediately. If you forget to take Pantoprazole Bluefish Do not take a double dose to make up for a forgotten tablet. If you forget to take a dose, take it as soon as you remember, unless it is almost time for your next dose. If you stop taking Pantoprazole Bluefish Do not change the dosage or stop the medication without discussing it with your doctor first, especially if you are taking Pantoprazole Bluefish together with antibiotics in order to eradicate Helicobacter pylori, as this may increase the resistance of the germ to certain antibiotics. If you have any further questions on the use of this medicine, ask you doctor or pharmacist 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, stop taking these tablets and tell your doctor immediately or contact the casualty department at your nearest hospital. Serious allergic reactions (frequency rare: 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, facial swelling (Quincke s oedema / angioedema), severe dizziness with very fast heartbeat and heavy sweating. Serious skin conditions (frequency not known: frequency cannot be estimated from the available data): blistering of the skin and rapid deterioration of your general health, blistering (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 not known: 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 side effects are: Uncommon (affects 1 to 10 users in 1,000): 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; fracture of the hip, wrist or spine. Rare (affects 1 to 10 users in 10,000): 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; agranulocytosis (severe reduction in number of white blood cells, which makes infections more likely), taste disorders. Page 4 of 6

5 Very Rare (affects less than 1 user in 10,000): disorientation, thrombocytopenia (reduction in blood platelets, which increases risk of bleeding or bruising), leukopenia (decrease in the number of white blood cells (leukocytes)), pancytopenia (severe reduction in blood cells which can cause weakness, bruising or make infections more likely). Not known: (frequency cannot be estimated from the available data): Pins and needles / tingling, hallucination, confusion (especially in patients with a history of these symptoms); decreased sodium level, decreased calcium level, decreased potassium level in blood. Rash, possibly with pain in the joints. If you are on Pantoprazole Bluefish 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. Side effects identified through blood tests: Uncommon (affects 1 to 10 users in 1,000); an increase in liver enzymes. Rare (affects 1 to 10 users in 10,000); an increase in bilirubin; increased fats in the blood. Very Rare (affects less than 1 user in 10,000); 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. 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. Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine. 5. How to store Pantoprazole Bluefish Keep this medicine out of the sight and reach of children. Store below 30ºC. Do not use this medicine after the expiry date which is stated on the pack after EXP. The expiry date refers to the last day of that month. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longeruse. These measures will help to protect the environment. Page 5 of 6

6 6. Contents of the pack and other information What Pantoprazole Bluefish contains The active substance is pantoprazole. Each gastro-resistant tablet contains 40 mg pantoprazole (as pantoprazole sodium sesquihydrate) The other ingredients are disodium phosphate anhydrous, mannitol, microcrystalline cellulose, croscarmellose sodium, magnesium stearate, hypromellose, triethyl citrate, sodium starch glycolate (Type A), methacrylic acid-ethyl acrylate copolymer (1:1) and yellow iron oxide (E 172). What Pantoprazole Bluefish look like and contents of the pack Pantoprazole Bluefish 40 mg gastro-resistant tablets are yellow, oval, biconvex and smooth tablets with a dimension of 11.6mm x 6mm. Pack sizes: Boxes of 7, 14, 28, 56 and 100 gastro-resistant tablets in blister packs. Not all pack sizes may be marketed Marketing Authorisation Holder and Manufacturer Bluefish Pharmaceuticals AB Torsgatan Stockholm Sweden This medicinal product is authorized in the Member States of the EEA under the following names: Name of the Member State Austria Denmark Finland Ireland Italy Netherland Poland Portugal Spain Sweden (RMS) Name of the medicinal product Pantoprazole Bluefish 40 mg magensaftresistente tabletten Pantoprazole Bluefish 40mg Pantoprazole Bluefish 40 mg enterotabletia/enterotabletter Pantoprazole Bluefish 40 mg gastro resistant tablet Pantoprazole Bluefish 40 mg gastroresistenti Pantoprazol Bluefish 40 mg maagsapresistente tabletten Pantoprazole Bluefish 40mg enterotabletter Pantoprazole Bluefish Pantoprazole Bluefish 40 mg comprimidos gastroresistentes Pantoprazole Bluefish 40 mg enterotabletter This leaflet was last approved in 26 November 2015 Page 6 of 6