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PANTOPRAZOLE 20 MG GASTRO-RESISTANT TABLETS
Active substance(s): PANTOPRAZOLE SODIUM SESQUIHYDRATE / PANTOPRAZOLE SODIUM SESQUIHYDRATE / PANTOPRAZOLE SODIUM SESQUIHYDRATE
Pantoprazole 40 mg
Package leaflet: Information for the patient
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
• This medicine has been prescribed for you only. Do not
pass it on to others. It may harm them, even if their signs
of illness are the same as yours.
• If you get any side effects talk to your doctor or
pharmacist. This includes any possible side effects not
listed in this leaflet. See section 4.
What is in this leaflet
1. What Pantoprazole is and what it is used for
2. What you need to know before you take Pantoprazole
3. How to take Pantoprazole
4. Possible side effects
5. How to store Pantoprazole
6. Contents of the pack and other information
What Pantoprazol is and what it is used for
Pantoprazole contains the active substance pantoprazole.
Pantoprazole is a selective “proton pump inhibitor”, a
medicine which reduces the amount of acid produced in
your stomach. It is used for treating acid-related diseases
of the stomach and intestine.
Pantoprazole is used to treat adults and adolescents 12
years of age and above for
• Reflux oesophagitis. An inflammation of your oesophagus
(the tube which connects your throat to your stomach)
accompanied by the regurgitation of stomach acid.
Pantoprazole is used to treat adults for
• An infection with a bacterium called Helicobacter pylori
in patients with duodenal ulcers and stomach ulcers in
combination with two antibiotics (eradication therapy).
The aim is to get rid of the bacteria and so reduce the
likelihood of these ulcers returning.
• Stomach and duodenal ulcers
• Zollinger-Ellison-Syndrome and other conditions
producing too much acid in the stomach.
What you need to know before you take
Do not take Pantoprazole
• If you are allergic to pantoprazole or to any of the other
ingredients of this medicine (listed in section 6).
• If you are allergic to medicines containing other proton
Warnings and precautions
Talk to your doctor or pharmacist before taking Pantoprazole
• If you have severe liver problems. Please tell your doctor
if you have ever had problems with your liver. He will
check your liver enzymes more frequently, especially
when you are taking Pantoprazole as a long-term
treatment. In the case of a rise of liver enzymes the
treatment should be stopped.
• If you have reduced body stores or risk factors for
reduced vitamin B12 and receive long-term treatment
with pantoprazole. As with all acid reducing agents,
pantoprazole may lead to a reduced absorption of
• If you are taking HIV protease inhibitors such as
atazanavir (for the treatment of HIV-infection) at the same
time as pantoprazole, ask your doctor for specific advice.
• Taking a proton pump inhibitor like Pantoprazole,
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
• If you are due to have a specific blood test
• If you have ever had a skin reaction after treatment with
a medicine similar to Pantoprazole that reduces stomach
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. Remember
to also mention any other ill-effects like pain in your joints.
Tell your doctor immediately, before or after taking this
medicine, if you notice any of the following symptoms,
which could be a sign of another, more serious, disease:
• an unintentional loss of weight
• vomiting, particularly if repeated
• vomiting blood; this may appear as dark coffee grounds
in your vomit
• you notice blood in your stools; which may be black or
13 June 2017
PANTONE® GREEN C
Pantoprazole (as pantoprazole sodium sesquihydrate)
EAS1058b LEA PANTOPRAZOLE 40mg TAB TUK
tarry in appearance
difficulty in swallowing or pain when swallowing
you look pale and feel weak (anaemia)
severe and/or persistent diarrhoea, because
Pantoprazole has been associated with a small increase
in infectious diarrhoea.
Your doctor may decide that you need some tests to rule out
malignant disease because pantoprazole also alleviates the
symptoms of cancer and could cause delay in diagnosing it.
If your symptoms continue in spite of your treatment, further
investigations will be considered.
If you are on Pantoprazole 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.
If you take Pantoprazole 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.
Children and adolescents
Pantoprazole is not recommended for use in children as it
has not been proven to work in children below 12 years of
Other medicines and Pantoprazole
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.
This is because Pantoprazole may influence the
effectiveness of other medicines, so tell you doctor if you
• Medicines such as ketoconazole, itraconazole and
posaconazole (used to treat fungal infections) or erlotinib
(used for certain types of cancer) because Pantoprazole
may stop these and other medicines from working
• Warfarin and phenprocoumon, which affect the
thickening, or thinning of the blood. You may need further
• Medicines used to treat HIV infection, such as atazanavir.
Methotrexate (used to treat rheumatoid arthritis,
psoriasis, and cancer) - if you are taking methotrexate
your doctor may temporarily stop your pantoprazole
treatment because pantoprazole can increase levels
of methotrexate in the blood.
Fluvoxamine (used to treat depression and other
psychiatric diseases) – if you are taking fluvoxamine
your doctor may reduce the dose.
Rifampicin (used to treat infections).
St. John’s wort (Hypericum perforatum) (used to treat
Pregnancy and breast-feeding
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 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.
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
Pantoprazole has no or negligible influence 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.
How to take Pantoprazole
Always take this medicine exactly as your doctor or
pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.
Method of administration
Take the tablets 1 hour before a meal without chewing or
breaking them and swallow them whole with some water.
The recommended dose is:
Adults and adolescents 12 years of age and above
To treat reflux oesophagitis
The recommended dose is one tablet a day. Your doctor may
tell you to increase to 2 tablets daily. The treatment period
for reflux oesophagitis is usually between 4 and 8 weeks.
Your doctor will tell you how long to take your medicine.
For the treatment of an infection with a bacterium called
Helicobacter pylori in patients with duodenal ulcers and
stomach ulcers in combination with two antibiotics
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, allergic 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 condition, erosion (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),
possibly leading to kidney failure.
Other side effects are:
- Common (may affect up to 1 in 10 people)
benign polyps in the stomach.
- Uncommon (may affect up to 1 in 100 people)
- 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 in the hip, wrist or spine.
- Rare (may affect up to 1 in 1,000 people)
- distortion or complete lack of the sense of taste,
disturbances in vision such as blurred vision; hives;
pain in the joints; muscle pains; weight changes;
raised body temperature; high fever; swelling of the
extremities (peripheral oedema); allergic reactions;
depression; breast enlargement in males.
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PANTONE® GREEN C
One tablet, two times a day plus two antibiotic tablets of
either amoxicillin, clarithromycin and metronidazole (or
tinidazole), each to be taken two times a day with your
pantoprazole tablet. Take the first pantoprazole tablet 1 hour
before breakfast and the second pantoprazole tablet 1 hour
before your evening meal. Follow your doctor’s instructions
and make sure you read the package leaflets for these
antibiotics. The usual treatment period is one to two weeks.
For the treatment of stomach and duodenal ulcers:
The recommended dose is one tablet a day. After
consultation with your doctor, the dose may be doubled.
Your doctor will tell you how long to take your medicine. The
treatment period for stomach ulcers is usually between 4
and 8 weeks. The treatment period for duodenal ulcers is
usually between 2 and 4 weeks.
For the long-term treatment of Zollinger-Ellison-Syndrome
and of other conditions in which too much stomach acid is
The recommended starting dose is usually two tablets a day.
Take the two tablets 1 hour before a meal. Your doctor may
later adjust the dose, depending on the amount of stomach
acid you produce. If prescribed more than two tablets a
day, the tablets should be taken twice daily.
If your doctor prescribes a daily dose of more than four
tablets a day, you will be told exactly when to stop taking
Patients with kidney problems
If you have kidney problems, you should not take
Pantoprazole for eradication of Helicobacter pylori.
Patients with liver problems
If you suffer from severe liver problems, you should not take
more than one tablet 20 mg pantoprazole a day (for this
purpose tablets containing 20 mg pantoprazole are available).
If you suffer from moderate or severe liver problems, you
should not take Pantoprazole for eradication of
Use in children and adolescents
These tablets are not recommended for use in children
below 12 years.
If you take more Pantoprazole than you should
Consult your doctor or pharmacist. There are no known
symptoms of overdose.
If you forget to take Pantoprazole
Do not take a double dose to make up for a forgotten dose.
Take your next, normal dose at the usual time.
If you stop taking Pantoprazole
Do not stop taking these tablets without first talking to your
doctor or pharmacist.
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.
EAS1058b LEA PANTOPRAZOLE 40mg TAB TUK
- Very rare (may affect up to 1 in 10,000 people)
- Not known (frequency cannot be estimated from the
- hallucination, confusion (especially in patients with a
history of these symptoms); decreased sodium level in
blood; decreased magnesium level in blood (see
section 2); decreased calcium level in blood (in
association with decreased magnesium level);
decreased potassium level in blood; muscle spasm as
a consequence of electrolyte disturbances; feeling of
tingling, prickling, pins and needles, burning sensation
or numbness; rash, possibly with pain in the joints.
Side effects identified through blood tests:
• Uncommon (may affect up to 1 in 100 people)
an increase in liver enzymes.
• Rare (may affect up to 1 in 1,000 people)
an increase in bilirubin; increased fat levels in the blood,
sharp drop in circulating granular white blood cells,
associated with high fever
• Very rare (may affect up to 1 in 10,000 people)
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, coexisting abnormal
reduction in the number of red and white blood cells, as
well as platelets, which may lead to tiredness, being
short of breath and looking pale.
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
Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more
information on the safety of this medicine.
How to store Pantoprazole
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is
stated on the outer carton after EXP. The expiry date refers
to the last day of that month.
Store below 30 ºC.
Do not throw away any medicines via wastewater
medicines you no longer use. These measures will help
protect the environment.
Contents of the pack and other information
What Pantoprazole contains
• The active substance is pantoprazole. Each
gastro-resistant tablet contains, 40 mg pantoprazole (as
• The other ingredients are:
Tablet core: Disodium Phosphate Anhydrous, Mannitol
(E421), Cellulose Microcrystalline, Croscarmellose
Sodium, Magnesium Stearate (vegetable)
Film-coating: Hypromellose, Triethyl Citrate, Sodium
Starch Glycolate (Type A), Methacrylic acid-Ethyl
acrylate copolymer Yellow Iron Oxide (E172).
What Pantoprazole looks like and contents of the pack
Pantoprazole 40 mg gastro-resistant tablets are oval, yellow
Packs: bottles (HDPE containers with child resistant
closure) and blister (aluminium/aluminium blister).
Pantoprazole is available in the following pack sizes:
Aluminium/aluminium blister pack with 7, 14, 15, 28, 30, 56,
60, 98 or 100 gastro-resistant tablets.
HDPE containers with child resistant closure with 14, 15, 28,
30, 60 or 100 (2x50) gastro-resistant tablets.
Not all pack sizes may be marketed
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
TEVA UK Limited
Teva Pharma S.L.U.,
Poligono Industrial Malpica, calle C, Numero 4, 50016,
Tel: 00 34 976 57 17 84
This leaflet was last revised in March 2017
Source: Medicines and Healthcare Products Regulatory Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.