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PANTOPRAZOLE 40MG GASTRO-RESISTANT TABLETS

Active substance(s): PANTOPRAZOLE SODIUM SESQUIHYDRATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Pantoprazole 40 mg gastro-resistant tablets
Pantoprazole
Read all of this leaflet carefully before you start taking this medicine.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you. Do not pass it on to others. It may harm them,
even if their symptoms are the same as yours.
If any side effect gets serious, or if you notice any side effects not listed in this leaflet, please
tell your doctor or pharmacist.
In this leaflet:
1.
What Pantoprazole is and what it is used for
2.
Before you take Pantoprazole
3.
How to take Pantoprazole
4.
Possible side effects
5.
How to store Pantoprazole
6.
Further information.
1.

WHAT PANTOPRAZOLE IS AND WHAT IT IS USED FOR

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 for treating:
Adults and adolescents 12 years of age and above:
-

Reflux oesophagitis. An inflammation of your oesophagus (the tube which connects your
throat to your stomach) accompanied by the regurgitation of stomach acid.

Adults:
-

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.

2.

BEFORE YOU TAKE PANTOPRAZOLE

Do not take Pantoprazole
if you are allergic (hypersensitive) to pantoprazole or any of the other ingredients of
Pantoprazole (see section 6).
If you are allergic to medicines containing other proton pump inhibitors.
Take special care with Pantoprazole
If you have severe liver problems. Please tell your doctor if you ever had problems with your
liver in the past. 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
pantoprazole long-term treatment. As with all acid reducing agents, pantoprazole may lead to a
reduced absorption of vitamin B12.
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
osteoporosis).
If you are taking a medicine containing atazanavir (for the treatment of HIV-infection) at the
same time as pantoprazole, ask your doctor for specific advise.

Tell your doctor immediately if you notice any of the following symptoms:
an unintentional loss of weight,
repeated vomiting
difficulty in swallowing
vomiting blood
you look pale and feel weak (anaemia)
you notice blood in your stools
Severe and/or persistent diarrhoea, as 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 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.
Taking other medicines
Pantoprazole may influence the effectiveness of other medicines, so tell your doctor if you are taking
-

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 properly.
Warfarin and phenprocoumon, which affect the thickening, or thinning of the blood. You may
need further checks.
Atazanavir (used to treat HIV-infection).

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines,
including medicines obtained without a prescription.
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 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.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
If you experience side effects like dizziness or disturbed vision, you should not drive or operate
machines.
Important information about some of the ingredients of Pantoprazole
Pantoprazole contains lactose. If you have been told by your doctor that you have an intolerance to
some sugars, contact your doctor before taking this medicinal product.
Pantoprazole contains Tartrazine (E102), this may cause allergic reactions.

3.

HOW TO TAKE PANTOPRAZOLE

Always take Pantoprazole exactly as your doctor has told you. You should check with your doctor or
pharmacist if you are not sure.
When and how should you take Pantoprazole?
Take the tablets 1 hour before a meal without chewing or breaking them and swallow them whole with
some water.
Unless told otherwise by your doctor, the usual dose is:
Adults and adolescents 12 years of age and above:
To treat reflux oesophagitis
The usual 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.
Adults:
For the treatment of an infection with a bacterium called Helicobater pylori in patients with
duodenal ulcers and stomach ulcers in combination with two antibiotics (Eradication therapy).
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 usual 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 produced.
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 the medicine.
Special patient groups:
If you have kidney problems, moderate or severe liver problems, you should not take
Pantoprazole for eradication of Helicobacter pylori
-

If you suffer from severe liver problems, you should not take more than one tablet 20mg
pantoprazole a day (for this purpose tablets containing 20mg pantoprazole are available).

-

Children below 12 years. 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 product, ask your doctor or pharmacist.
4.

POSSIBLE SIDE EFFECTS

Like all medicines, Pantoprazole can cause side effects, although not everybody gets them.
The frequency of possible side effects listed below is defined using the following convention:
Very common (affects more than 1 user in 10)
Common (affects 1 to 10 users in 100)
Uncommon (affects 1 to 10 users in 1,000)
Rare (affects 1 to 10 users in 10,000)
Very rare (affects less than 1 user in 10,000)
Not known (frequency cannot be estimated from the available data)
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): 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 know): 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): 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 disorder.
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.
Very rare (affects less than 1 user in 10,000)
disorientation.
Not known (frequency cannot be estimated from the available data)
Hallucination, confusion (especially in patients with a history of these symptoms); decreased sodium
level in blood.
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.

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 side effect gets serious, or if you notice any side effects not mentioned in the leaflet, please tell
your pharmacist or doctor.
5.

HOW TO STORE PANTOPRAZOLE

Keep out of the reach and sight of children.
Do not use Pantoprazole after the expiry date which is stated on the carton and the container after
EXP. The expiry date refers to the last day of that month.
When stored in blister packs do not store this medicine above 30C.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. These measures will help to protect the environment.
6.

FURTHER INFORMATION

What Pantoprazole contains
-

The active substance is pantoprazole. Each gastro-resitant tablet contains 40 mg of pantoprazole
(as sodium sesquihydrate).
The other ingredients are:
Cellulose, microcrystalline, lactose monohydrate, croscarmellose sodium, silica colloidal
anhydrous and magnesium stearate. The coating contains sodium lauryl sulphate, polysorbate
80, methacrylic acid-ethyl acrylate copolymer, triethylcitrate, polyvinyl alcohol, macrogol 3350,
titanium dioxide (E171), talc, iron oxide yellow (E172) and tartrazine aluminium lake (E102).

What Pantoprazole looks like and contents of the pack
The tablets are pale yellow and oblong.
Packs: plastic bottles and blister packs.
Pantoprazole is available in the following pack sizes
Packs with 7,14,15,28,30,50,56,60,100 and 250 gastro-resistant tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Generics [UK] Limited t/a Mylan,
Station Close,
Potters Bar,

Hertfordshire,
EN6 1TL,
United Kingdom.
Manufacturer
McDermott Laboratories t/a Gerard Laboratories
35/36 Baldoyle Industrial Estate, Grange Road,
Dublin 13,
Ireland
This medicinal product is authorised in the Member States of the EEA under the following
names:
Austria
Belgium
Czech Republic
Germany
Greece
Ireland
Italy
Netherland
Poland
Portugal
Slovakia
Slovenia
United Kingdom

Pantoprazol Mylan 40 mg - magensaftresistente Tabletten
Pantoprazole Mylan 40mg
Pantoprazol Mylan 40 mg
Pantoprazol Mylan40 mg magensaftresistente Tabletten
Pantoprazole/Generics 40mg
Protizole 40mg
Pantoprazolo Mylan Generics 40mg
Pantoprazol Mylan 40 mg, maagsapresistente tabletten
PantoGen 40mg
Zamotil Comprimidos 40mg
Pantoprazol Mylan 40 mg
Panpreza 40 mg gastrorezistentene tablete
Pantoprazole 40mg gastro-resistant tablets

This leaflet was last approved in 10/2012.

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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.

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