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Pantoprazole Bluefish

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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.


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:


What you need to know before you take Pantoprazole Bluefish


Do not take Pantoprazole Bluefish


Warnings and precautions

Talk to your doctor or pharmacist or nurse before taking Pantoprazole Bluefish


Tell your doctor immediately if you notice any of the following symptoms:


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:


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.


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.


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.

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.


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):

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


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:


Name of the Member State

Name of the medicinal product

Austria

Pantoprazole Bluefish 20 mg magensaftresistente tabletten

Denmark

Pantoprazole Bluefish 20mg

Ireland

Pantoprazole Bluefish 20 mg gastroresistant tablet

Italy

TECNOZOL 20 mg gastroresistenti

Netherland

Pantoprazol Bluefish 20 mg maagsapresistente tabletten

Poland

Pantoprazole Bluefish 20mg enterotabletter

Portugal

Pantoprazole Bluefish

Spain

Pantoprazole Bluefish 20 mg comprimidos gastroresistentes

Sweden (RMS)

Pantoprazole Bluefish 20 mg enterotabletter


This leaflet was last approved in 2016-11-04

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