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 highrisk patients needing continuous treatment with anti-inflammatory drugs.
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).
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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.
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.
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
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 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
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.
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.
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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.
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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.
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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
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
Austria
Denmark
Finland
Name of the medicinal product
Pantoprazole Bluefish 20 mg magensaftresistente tabletten
Pantoprazole Bluefish 20mg
Pantoprazole Bluefish 20 mg enterotabletia/enterotabletter
Ireland
Italy
Netherland
Poland
Portugal
Spain
Sweden (RMS)
Pantoprazole Bluefish 20 mg gastro‐resistant tablet
Pantoprazole Bluefish 20 mg gastroresistenti
Pantoprazol Bluefish 20 mg maagsapresistente tabletten
Pantoprazole Bluefish 20mg enterotabletter
Pantoprazole Bluefish
Pantoprazole Bluefish 20 mg comprimidos gastroresistentes
Pantoprazole Bluefish 20 mg enterotabletter
This leaflet was last approved in 26 November 2015
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