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Package leaflet: Information for the user

Pantoprazole Bluefish 20 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 signs of 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.

What 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 20 mg gastro-resistant tablets are used:

• in the treatment of mild gastroesophageal reflux disease (a condition in which gastric content may rise up to the esophagus and which can be associated with esophagitis) caused by acid secretion and the associated symptoms, such as heartburn, acidic belches and pains on swallowing

• in the long-term treatment and in the prevention of relapse in reflux esophagitis (a condition in which backwash of gastric content in esophagus lead to inflammation and pain)

• in the prevention of gastric and duodenal ulcers caused by anti-inflammatory drugs in high-risk patients needing continuous treatment with anti-inflammatory drugs.

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).

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 together with anti-inflammatory medicines to treat your pain or rheumatic disease: please also read the package leaflets of these medicines carefully

• if you take Pantoprazole Bluefish on a long-term basis (longer than 1 year): Your doctor will probably keep you under regular surveillance. You should report any new and exceptional symptoms and circumstances whenever you see your doctor.

• if you have ever had a skin reaction after treatment with a medicine similar to Pantoprazole Bluefish that reduces stomach acid.

• if you are due to have a specific blood test (Chromogranin A).

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.

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 areno adequate data fromthe useof pantoprazole in pregnant women. Excretion into human milkhas 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 doctorconsiders the benefit for you greater than the potential risk for your unborn child or baby.

Driving and using machines

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

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.

Treatment of mild reflux disease and the associated symptoms (e.g. heartburn, acidic belches and pain in swallowing):

The recommended dose is 1 tablet (20 mg) daily.

Long-term treatment and the prevention of relapse in reflux esophagitis:

For long-term treatment the recommended dose is 1 tablet (20 mg) daily, if relapse occurs, the dosage is increased to 40 mg daily (2 x 20 mg tablets or 1 x 40 mg tablets).

Prevention of gastric and duodenal ulcers caused by anti-inflammatory drugs:

The recommended dose is 1 tablet (20 mg) daily.

Elderly and patients with renal impairment:

Daily dose of 40 mg should not be exceeded.

Patients with hepatic impairment:

Daily dose of 20 mg should not be exceeded.

Use in children:

Pantoprazole Bluefish should not be used in children.

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.

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

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.

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.

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.

6. Contents of the pack and other information

What Pantoprazole Bluefish contains

• The active substance is pantoprazole. Each gastro-resistant tablet contains 20 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 20 mg gastro-resistant tablets are yellow, oval, biconvex and smooth tablets with a dimension of 8 mm x 5.5 mm.

Pack sizes:

Boxes of 14, 28, 56 and 100 gastro-resistant tablets in blister packs.

Not all pack sizes may be marketed

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Bluefish Pharmaceuticals AB

P.O. Box 49013

100 28 Stockholm

Sweden

Manufacturer

Bluefish Pharmaceuticals AB

Torsgatan 11

111 23 Stockholm

Sweden

This medicinal product is authorized in the Member States of the EEA under the following names:

This leaflet was last approved in 2016-11-04