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PANTOPRAZOLE KRKA 20 MG GASTRO-RESISTANT TABLETS

Active substance(s): PANTOPRAZOLE SODIUM SESQUIHYDRATE / PANTOPRAZOLE SODIUM SESQUIHYDRATE / PANTOPRAZOLE SODIUM SESQUIHYDRATE

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1.3.1
SPC, Labeling and Package Leaflet

Pantoprazole sodium sesquihydrate
GB

Package leaflet: Information for the user
Pantoprazole Krka 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.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told
you.
Keep this leaflet. You may need to read it again.
Ask your pharmacist if you need more information or advice.
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.
You must talk to a doctor if you do not feel better or if you feel worse after 2 weeks.
What is in this leaflet
1.
2.
3.
4.
5.
6.

What Pantoprazole Krka is and what it is used for
What you need to know before you take Pantoprazole Krka
How to take Pantoprazole Krka
Possible side effects
How to store Pantoprazole Krka
Contents of the pack and other information

1.

What Pantoprazole Krka is and what it is used for

Pantoprazole Krka contains the active substance pantoprazole, which blocks the ‘pump’ that produces
stomach acid. Hence it reduces the amount of acid in your stomach.
Pantoprazole Krka is used for the short-term treatment of reflux symptoms (for example heartburn,
acid regurgitation) in adults.
Reflux is the backflow of acid from the stomach into the gullet (“foodpipe”), which may become
inflamed and painful. This may cause you symptoms such as a painful burning sensation in the chest
rising up to the throat (heartburn) and a sour taste in the mouth (acid regurgitation).
You may experience relief from your acid reflux and heartburn symptoms after just one day of
treatment with Pantoprazole Krka, but this medicine is not meant to bring immediate relief. It may be
necessary to take the tablets for 2–3 consecutive days to relieve the symptoms.
You must talk to a doctor if you do not feel better or if you feel worse after 2 weeks.

2.

What you need to know before you take Pantoprazole Krka

Do not take Pantoprazole Krka:
if you are allergic to pantoprazole or any of the other ingredients of this medicine (listed in
section 6),
if you are taking a medicine containing atazanavir (for the treatment of HIV-infection).
Warnings and precautions
Talk to your doctor or pharmacist before taking Pantoprazole Krka.
Talk to your doctor first if:

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1.3.1
SPC, Labeling and Package Leaflet
-

Pantoprazole sodium sesquihydrate
GB

you have been treated for heartburn or indigestion continuously for 4 or more weeks
you are over 55 years old and taking non-prescription indigestion treatment on a daily basis
you are over 55 years old with new or recently changed symptoms
you have previously had a gastric ulcer or stomach surgery
you have liver problems or jaundice (yellowing of skin or eyes)
you regularly see your doctor for serious complaints or conditions
you are due to have an endoscopy or a breath test called a C-urea test
you have ever had a skin reaction after treatment with a medicine similar to Pantoprazole Krka
that reduces stomach acid.
you are due to have a specific blood test (Chromogranin A).

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 Krka. 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 (not related to a diet or an exercise programme)
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 tarry in appearance
difficulty in swallowing or pain when swallowing
you look pale and feel weak (anaemia)
chest pain
stomach pain
severe and/or persistent diarrhoea, because Pantoprazole Krka has been associated with a small
increase in infectious diarrhoea.
Your doctor may decide that you need some tests.
If you are due to have a blood test, tell your doctor that you are taking this medicine.
You may experience relief from your acid reflux and heartburn symptoms after just one day of
treatment with Pantoprazole Krka, but this medicine is not meant to bring immediate relief. You
should not take it as a preventive measure.
If you have been suffering from repetitive heartburn or indigestion symptoms for some time,
remember to see your doctor regularly.
Children and adolescents
Pantoprazole Krka should not be used by children and young people under 18 years of age due to a
lack of safety information in this younger age group.
Other medicines and Pantoprazole Krka
Pantoprazole Krka may stop certain other medicines from working properly. Tell your doctor or
pharmacist if you are using any medicines containing one of the following active substances:
ketoconazole (used for fungal infections).
warfarin and phenprocoumon (used to thin blood and prevent clots). You may need further
blood tests.
atazanavir (used to treat HIV-infection). You must not use Pantoprazole Krka if you are taking
atazanavir.
methotrexate (used to treat rheumatoid arthritis, psoriasis, and cancer) – if you are taking
methotrexate your doctor may temporarily stop your Pantoprazole Krka treatment.

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1.3.1
SPC, Labeling and Package Leaflet

Pantoprazole sodium sesquihydrate
GB

Do not take Pantoprazole Krka with other medicines which limit the amount of acid produced in your
stomach, such as another proton pump inhibitor (omeprazole, lansoprazole or rabeprazole) or an H2
antagonist (e.g. ranitidine, famotidine).
However, you may take Pantoprazole Krka with antacids (e.g.magaldrate, alginic acid, sodium
bicarbonate, aluminium hydroxide, magnesium carbonate, or combinations thereof), if needed.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines
including medicines obtained without a prescription. This also includes herbal or homeopathic
remedies.
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.
You should not take this medicine if you are pregnant or while-breastfeeding.
Driving and using machines
If you experience side effects like dizziness or disturbed vision, you should not drive or use machines.
Pantoprazole Krka contains sorbitol (E420). If you have been told by your doctor that you have an
intolerance to some sugars, contact your doctor before taking this medicinal product.

3.

How to take Pantoprazole Krka

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told
you. Check with your doctor or pharmacist if you are not sure.
Take one tablet a day. Do not exceed this recommended dose of 20 mg pantoprazole daily.
You should take this medicine for at least 2–3 consecutive days. Stop taking Pantoprazole Krka when
you are completely symptom-free. You may experience relief from your acid reflux and heartburn
symptoms after just one day of treatment with Pantoprazole Krka, but this medicine is not meant to
bring immediate relief.
If you have no symptom-relief after taking this medicine for 2 weeks continuously, consult your
doctor.
Do not take Pantoprazole Krka tablets for more than 4 weeks without consulting your doctor.
Take the tablet before a meal, at the same time every day. You should swallow the tablet whole with
some water. Do not chew or break the tablet.
If you take more Pantoprazole Krka than you should
Tell your doctor or pharmacist straight away. If possible take your medicine and this leaflet with you.
There are no known symptoms of overdose.
If you forget to take Pantoprazole Krka
Do not take a double dose to make up for a forgotten dose. Take your next, normal dose, the next day,
at your usual time.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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1.3.1
SPC, Labeling and Package Leaflet

Pantoprazole sodium sesquihydrate
GB

Tell your doctor immediately or contact the casualty department at your nearest hospital, if you get
any of the following serious side effects. Stop taking this medicine straight away, but take this leaflet
and/or the tablets with you.
Serious allergic reactions (rare: may affect up to 1 in 1,000 people): Hypersensitivity
reactions, so-called anaphylactic reactions, anaphylactic shock and angioedema. Typical
symptoms are: swelling of the face, lips, mouth, tongue and/or throat, which may cause
difficulty in swallowing or breathing, hives (nettle rash), severe dizziness with very fast
heartbeat and heavy sweating.
Serious skin reactions (frequency not known: frequency cannot be estimated from the
available data): rash with swelling, blistering or peeling of the skin, losing skin and bleeding
around eyes, nose, mouth or genitals and rapid deterioration of your general health, or rash
when exposed to the sun.
Other serious reactions (frequency not known): yellowing of the skin and eyes (due to severe
liver damage), or kidney problems such as painful urination and lower back pain with fever.
Other side effects include:
Common side effects (may affect up to 1 in 10 people):
benign polyps in the stomach
Uncommon side effects (may affect up to 1 in 100 people):
headache; dizziness; diarrhoea; feeling sick, vomiting; bloating and flatulence (wind);
constipation; dry mouth; bellyache and discomfort; skin rash or hives; itching; feeling weak,
exhausted or generally unwell; sleep disorders; increase in liver enzymes in a blood test.
Rare side effects (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;
pain in the joints; muscle pains; weight changes; raised body temperature; swelling of the
extremities; allergic reactions; depression; increased bilirubin and fat levels in blood (seen in
blood tests); breast enlargement in males; high fever and a sharp drop in circulating granular
white blood cells (seen in blood tests).Very rare side effects (may affect up to 1 in 10,000
people):
disorientation; reduction in the number of blood platelets, which may cause you to bleed or
bruise more than normal; 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 (seen in blood tests).
Frequency not known:
hallucination, confusion (especially in patients with a history of these symptoms); decreased
level of sodium in blood; decreased level of magnesium in blood; rash, possibly with pain in the
joints.
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 Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the safety of this medicine.

5.

How to store Pantoprazole Krka

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 packaging after EXP. The expiry
date refers to the last day of that month.

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1.3.1
SPC, Labeling and Package Leaflet

Pantoprazole sodium sesquihydrate
GB

Store in the original package in order to protect from moisture.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to
throw away medicines you no longer use. These measures will help protect the environment.

6.

Contents of the pack and other information

What Pantoprazole Krka contains
The active substance is pantoprazole. Each gastro-resistant tablet contains 20 mg pantoprazole
as pantoprazole sodium sesquihydrate.
The other ingredients are mannitol, crospovidone (type B), anhydrous sodium carbonate,
sorbitol (E420) and calcium stearate in the tablet core, and hypromellose, povidone, titanium
dioxide (E171), yellow iron oxide (E172), propylene glycol, methacrylic acid - ethyl acrylate
copolymer (1:1) dispersion 30 per cent, sodium laurilsulfate, polysorbate 80, macrogol 6000 and
talc in the film-coating.
What Pantoprazole Krka looks like and contents of the pack
The 20 mg gastro-resistant tablets are light yellowish brown, oval (3 mm x 9 mm), slightly biconvex
film-coated tablets.
Pantoprazole Krka is available in boxes of 7 and 14 gastro-resistant tablets in blister packs of 7 or 14
tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
This leaflet was last revised in 03/2017

--------------------------------------------------------------------------------------------------------------------------The following recommendations for lifestyle and dietary changes may also help to relieve heartburn or
acid related symptoms.
Avoid large meals
Eat slowly
Stop smoking
Reduce alcohol and caffeine consumption
Reduce weight (if overweight)
Avoid tight-fitting clothing or belts
Avoid eating less than three hours before bedtime
Elevate bedhead (if you suffer from nocturnal symptoms)
Reduce intake of food that can cause heartburn. These might include: Chocolate, peppermint,
spearmint, fatty and fried food, acidic food, spicy food, citrus fruits and fruit juices, tomatoes.

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Expand Transcript

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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