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PANTOPRAZOLE 20 MG GASTRO-RESISTANT TABLETS

Active substance(s): PANTOPRAZOLE SODIUM SESQUIHYDRATE

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TEVA UK Ref:

Version:

231-30-88146-H LEA PANTOPRAZOLE 20mg TAB TUK
1

6 November 2015

Pantoprazole 20 mg
Gastro-resistant Tablets

Tell your doctor immediately if you notice any of the
following symptoms:
Pantoprazole (as pantoprazole sodium sesquihydrate) • an unintentional loss of weight
• repeated vomiting
PACKAGE LEAFLET: INFORMATION FOR THE USER • difficulty in swallowing
Read all of this leaflet carefully before you start taking • vomiting blood
• you look pale and feel weak (anaemia)
this medicine.
• you notice blood in your stools
• Keep this leaflet. You may need to read it again.
• severe and/or persistent diarrhoea, as Pantoprazole
• If you have any further questions, ask your doctor or
Tablets have been associated with a small increase
pharmacist.
in infectious diarrhoea.
• This medicine has been prescribed for you. Do not
pass it on to others. It may harm them, even if their Your doctor may decide that you need some tests to
rule out malignant disease because pantoprazole also
symptoms are the same as yours.
alleviates the symptoms of cancer and could cause
• If any of the side effects become serious, or if you
delay in diagnosing it. If your symptoms continue in
notice any side effects not listed in this leaflet,
spite of your treatment, further investigations will be
please tell your doctor or pharmacist.
considered.
In this leaflet:
If you get a rash on your skin, especially in areas
1. What Pantoprazole Tablets are and what they are
exposed to the sun tell your doctor as soon as you
used for
can, as you may need to stop your treatment with
2. Before you take Pantoprazole Tablets
Pantoprazole tablets. Remember to also mention any
3. How to take Pantoprazole Tablets
other ill-effects like pain in your joints.
4. Possible side effects
If you take Pantoprazole Tablets on a long-term basis
5. How to store Pantoprazole Tablets
(longer than 1 year) your doctor will probably keep
6. Further information
you under regular surveillance. You should report any
WHAT PANTOPRAZOLE TABLETS ARE AND new and exceptional symptoms and circumstances
whenever you see your doctor.
WHAT THEY ARE USED FOR

1

Pantoprazole Tablets are 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.

Taking other medicines

Pantoprazole Tablets are used for:

• Medicines such as ketokonazole, itraconazole and
posaconazole (used to treat fungal infections) or
erlotinib (used for certain types of cancer) because
Pantoprazole Tablets 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).

Adults and adolescents 12 years of age and above:
• Treating symptoms (e.g. heartburn, acid
regurgitation, pain on swallowing) associated to
gastro-oesophageal reflux disease caused by reflux
of acid from the stomach.
• Long-term management of reflux oesophagitis
(inflammation of the oesophagus accompanied by
the regurgitation of stomach acid) and preventing
its return.
Adults:
• Preventing duodenal and stomach ulcers caused by
non-steroidal anti-inflammatory drugs (NSAIDs, for
example, ibuprofen) in patients at risk who need to
take NSAIDs continuously.

2

BEFORE YOU TAKE PANTOPRAZOLE
TABLETS

Do not take Pantoprazole Tablets
• If you are allergic (hypersensitive) to pantoprazole
or to any of the other ingredients of Pantoprazole
Tablets (see section 6).
• If you are allergic to medicines containing other
proton pump inhibitors.
Take special care with Pantoprazole Tablets
• 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 Tablets as a long-term treatment. In
the case of a rise of liver enzymes the treatment
should be stopped.
• if you have ever had a skin reaction after treatment
with a medicine similar to Pantoprazole tablets that
reduces stomach acid.
• If you need to take medicines called NSAIDs
continuously and receive Pantoprazole Tablets
because you have an increased risk of developing
stomach and intestinal complications. Any
increased risk will be assessed according to your
own personal risk factors such as your age (65 years
old or more), a history of stomach or duodenal
ulcers or of stomach or intestinal bleeding.
• 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.
• 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 advice.
Taking a proton pump inhibitor like Pantoprazole
Tablets, 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).

Pantoprazole Tablets may influence the effectiveness
of other medicines, so tell your doctor if you are
taking

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 are 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 Tablets
This product contains 2.93 mg of sodium per tablet.
You should take this into account if you are on a
controlled sodium diet.

3

HOW TO TAKE PANTOPRAZOLE TABLETS

Always take Pantoprazole Tablets 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 Tablets?
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 symptoms (e.g. heartburn, acid regurgitation,
pain on swallowing) associated to
gastro-oesophageal reflux disease
The usual dose is one tablet a day. This dose usually
brings relief within 2 - 4 weeks – at most after another
4 weeks. Your doctor will tell you how long to continue
taking the medicine. After this any recurring
symptoms can be controlled by taking one tablet
daily, when required.
For long-term management and for preventing the
return of reflux oesophagitis
The usual dose is one tablet a day. If the illness

TEVA UK Ref:

Version:

231-30-88146-H LEA PANTOPRAZOLE 20mg TAB TUK
returns, your doctor can double the dose, in which
case you can use Pantoprazole 40 mg Tablets instead,
one a day. After healing, you can reduce the dose back
again to one tablet 20 mg a day.
Adults:

1

6 November 2015

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
Special patient groups:
bilirubin; increased fats in the blood.
• If you suffer from severe liver problems, you should • Very Rare (affects less than 1 user in 10,000) a
not take more than one 20 mg tablet a day.
reduction in the number of blood platelets, which
may cause you to bleed or bruise more than
• Children below 12 years. These tablets are not
normal; a reduction in the number of white blood
recommended for use in children below 12 years.
cells, which may lead to more frequent infections.
If you take more Pantoprazole Tablets than you should
Tell your doctor or pharmacist. There are no known
If any of the side effects become serious, or if you
symptoms of overdose.
notice any side effects not listed in this leaflet, please
tell your doctor or pharmacist.
If you forget to take Pantoprazole Tablets
Do not take a double dose to make up for the
HOW TO STORE PANTOPRAZOLE TABLETS
forgotten dose. Take your next normal dose at the
usual time.
Keep out of the reach and sight of children.
If you stop taking Pantoprazole Tablets
Do not stop taking these tablets without first talking to Store below 30ºC.
your doctor or pharmacist.
Do not use Pantoprazole Tablets after the expiry date
If you have any further questions about the use of this which is stated on the pack after EXP. The expiry date
refers to the last day of that month.
product, ask your doctor or pharmacist.
To prevent duodenal and stomach ulcers in patients
who need to take NSAIDs continuously
The usual dose is one tablet a day.

5

Medicines should not be disposed of via wastewater
or household waste. Ask your pharmacist how to
dispose of medicines no longer required. These
Like all medicines, Pantoprazole Tablets can cause side measures will help to protect the environment.
effects, although not everybody gets them.

4

POSSIBLE SIDE EFFECTS

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).

6

FURTHER INFORMATION

What Pantoprazole Tablets contain
• The active substance is pantoprazole. Each
gastro-resistant tablet contains, 20mg of
pantoprazole (as pantoprazole sodium
sesquihydrate)
• The other ingredients are:
Core: Disodium Phosphate Anhydrous, Mannitol
(E421), Cellulose Microcrystalline, Croscarmellose
If you get any of the following side effects, stop taking
Sodium, Magnesium Stearate (vegetable)
these tablets and tell your doctor immediately, or
Coating: Hypromellose, Triethyl Citrate, Sodium
contact the casualty department at your nearest
Starch Glycolate (Type A), Methacrylic acid-Ethyl
hospital:
acrylate copolymer and Yellow Iron Oxide (E172).
• Serious allergic reactions (frequency rare): swelling
What Pantoprazole Tablets look like and contents of
of the tongue and/or throat, difficulty in swallowing,
the pack
hives (nettle rash), difficulties in breathing, allergic
Pantoprazole 20 mg gastro-resistant Tablets are oval,
facial swelling (Quincke’s oedema / angioedema),
yellow tablets.
severe dizziness with very fast heartbeat and heavy
Packs: bottles (HDPE containers with child resistant
sweating.
closure) and blister (aluminium/aluminium blister)
• Serious skin conditions (frequency not known):
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
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.
• 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, rash, possibly with pain in the joints..
If you are on Pantoprazole Tablets 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

Pantoprazole Tablets are available in the following
pack sizes:
Packs with 7, 14, 15, 28, 30, 56, 60,98 & 100
gastro-resistant tablets*.
*Not all pack sizes may be marketed
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
TEVA UK Limited
Brampton Road,
Hampden Park,
East Sussex,
BN22 9AG
United Kingdom
Manufacturer
Teva Pharma S.L.U.,
Poligono Industrial Malpica,
calle C, Numero 4,
50016, Zaragoza,
Spain
Tel: 00 34 976 57 17 84
This leaflet was last approved in October 2015
PL 00289/1496

88146-H

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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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