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PRAZAFILE 20 MG GASTRO-RESISTANT TABLETS

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Pharmafile Limited
Initial approval

PL 16002/0087 –

PACKAGE LEAFLET: INFORMATION FOR THE USER

Prazafile 20 mg Gastro-resistant Tablets
Pantoprazole (as pantoprazole sodium sesquihydrate)
Read all of this leaflet carefully because it contains important information for you.
This medicine is available without prescription. However, you still need to use Prazafile carefully to
get the best results from it.






Keep this leaflet. You may need to read it again.
Ask your pharmacist if you need more information or advice.
You must contact a doctor if your symptoms worsen or do not improve after 2 weeks.
You should not take Prazafile for more than 4 weeks without consulting a doctor.
If any of the side effects become serious, or if you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.

In this leaflet:
1. What Prazafile 20 mg Gastro-resistant Tablets are and what they are used for
2. Before you take Prazafile 20 mg Gastro-resistant Tablets
3. How to take Prazafile 20 mg Gastro-resistant Tablets
4. Possible side effects
5. How to store Prazafile 20 mg Gastro-resistant Tablets
6. Further information
1. WHAT PRAZAFILE 20 MG GASTRO-RESISTANT TABLETS ARE AND WHAT THEY ARE
USED FOR
Prazafile belongs to a group of medicines called proton pump inhibitors. It contains the active
substance pantoprazole, which blocks the ‘pump’ that produces stomach acid. Hence it reduces
the amount of acid in your stomach.
Prazafile is used for the short-term treatment of reflux symptoms (e.g. 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 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 symptoms after just one day of treatment with Prazafile, 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.

2. BEFORE YOU TAKE PRAZAFILE 20 MG GASTRO-RESISTANT TABLETS
Do not take Prazafile:
• if you are allergic (hypersensitive) to pantoprazole or to any of the other ingredients of Prazafile
(see Section 6 ‘Further Information’)
• if you are taking a medicine containing atazanavir (for the treatment of HIV-infection)
• if you are taking other medicines which limit the amount of acid produced in your stomach,
such as another proton pump inhibitor (omeprazole, lansoprazole or rabeprazole) or a H2
antagonist (e.g. ranitidine, famotidine). See ‘Taking other medicines’
• if you are under 18 years of age
• if you are pregnant or breast-feeding.

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If you do experience any of these symptoms your doctor may decide that you need some tests.
Take special care with Prazafile
It is important that you talk to your doctor before taking Prazafile if any of the following applies to
you as your doctor may need to advise alternative treatments or tests:
• 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
and/or if you experience any 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 a blood test, endoscopy or a breath test called a C-urea test.
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:
• 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
• you experience severe and/or persistent diarrhoea. Pantoprazole has been associated with a
small increase in infectious diarrhoea.
If you have been suffering from repetitive heartburn or indigestion symptoms for some time,
remember to see your doctor regularly.
If you are due to have a blood test, tell your doctor that you are taking this medication.
You may experience relief from our symptoms after just one day of treatment with Pantoprazole
Tablets, but this medication is not meant to bring immediate relief. You should not take it as a
preventive measure.
Taking other medicines
Prazafile may stop certain other medicines from working properly.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines,
including medicines obtained without a prescription. In particular please tell your doctor if you are
taking any of the following:
• atazanavir (used to treat HIV-infection). Do not use Pantoprazole if you are taking atazanavir
• medicines used to limit the amount of acid produced in your stomach, such as proton pump
inhibitors (e.g. omeprazole, lansoprazole, rabeprazole) or H2 antagonists (e.g. ranitidine,
famotidine). Do not use Pantoprazole if you are taking any of these medicines
• ketoconazole (used for fungal infections)
• warfarin and phenprocoumon (used to thin blood and prevent clots)as you may need further
blood tests.
If needed, Prazafile can be taken with antacids (e.g. magaldrate, alginic acid, sodium bicarbonate,
aluminium hydroxide, magnesium carbonate, or combinations thereof).

Taking Prazafile with food and drink

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Initial approval

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The tablet should be swallowed whole with water before a meal.
Pregnancy and breast-feeding
Do not take Prazafile if you are pregnant or think you may be pregnant.
Do not take Prazafile if you are breast-feeding.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
If you experience side effects such as dizziness or disturbed vision, you should not drive or operate
machines.
Important information about some of the ingredients of Prazafile
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 PRAZAFILE 20 MG GASTRO-RESISTANT TABLETS
Always take Prazafile exactly as described in this leaflet. You should check with your doctor or
pharmacist if you are not sure.
Take one 20 mg Prazafile a day. Do not exceed this recommended dose.
Take the tablet before a meal, at the same time every day. You should swallow the tablet whole
with some water. Do not chew, crush or break the tablet.
You should take this medicine for at least 2-3 consecutive days. Stop taking Prazafile when you
are completely symptom-free. You may experience relief from your acid reflux and heartburn
symptoms after just one day of treatment with Prazafile, but this medicine is not meant to bring
immediate relief and it might be necessary to take it for 7 days to achieve complete relief of
symptoms.
If you have no symptom relief after taking this medicine for 2 weeks continuously, consult your
doctor.
Do not take Prazafile for more than 4 weeks without consulting your doctor.
Children
Prazafile should not be used by children and young people under 18 years of age.
If you take more Prazafile than you should
If you or someone else takes too many Prazafile 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 Prazafile
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 product, ask your doctor or pharmacist.

4.

POSSIBLE SIDE EFFECTS

Like all medicines Prazafile can cause side effects, although not everybody will experience them.

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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 experience any of the following serious side effects stop taking this medicine straight
away and tell your doctor immediately or contact the emergency department at your nearest
hospital. Take this leaflet and/or the tablets with you.





Serious allergic reactions (rare): 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): 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, rash when exposed to the sun.
Other serious reactions (frequency not known): Yellowing of the skin and whites of the
eyes (jaundice) caused by severe liver damage or blood problems, or kidney problems such as
painful urination and lower back pain with fever.

Other side effects include:
• Uncommon side effects: Headache, dizziness, diarrhoea, feeling sick, vomiting, bloating
(feeling of fullness or tightness in the stomach), flatulence (wind), constipation, dry mouth,
stomach pain and discomfort, a skin rash or hives, itching, feeling weak, feeling exhausted or
generally unwell, sleep disorders, liver problems, increase in liver enzymes (seen in blood
tests).


Rare side effects: Disturbances in vision such as blurred vision, swelling of limbs
(extremities), pain in the joints (arthralgia), muscle pain (myalgia), depression, weight changes,
increase in body temperature, increased bilirubin (a bile pigment) and levels of fat in the blood
(seen in blood tests).



Very rare side effects: Disorientation, reduction in the number of blood platelets which may
cause you to bleed or bruise more than normal (thrombocytopenia), reduction in the number of
white blood cells which may lead to more frequent infections (leukopenia).



Frequency not known: Hallucination, confusion (especially in patients with a history of these
symptoms), decreased level of sodium in blood.

If any of the side effects become serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
5.

HOW TO STORE PRAZAFILE 20 MG GASTRO-RESISTANT TABLETS

Keep out of the reach and sight of children.
Aluminium blister packs – Store below 30ºC.

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Pharmafile Limited
Initial approval

PL 16002/0087 –

HDPE container –After first opening the HDPE container the shelf life of the contents is 28 days.
Do not use Prazafile after the expiry date which is stated on the bottle label, blister and outer
carton. The expiry date refers to the last day of that month.
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 Prazafile contains
• The active substance is Pantoprazole, each gastro-resistant Tablet contains 20 mg
Pantoprazole (as pantoprazole sodium sesquihydrate 22.6 mg).
• The other ingredients are Disodium Phosphate Anhydrous, Mannitol, Cellulose
Microcrystalline, Croscarmellose Sodium, Magnesium Stearate, Hypromellose (Type 6cP),
Triethyl Citrate, Sodium Starch Glycolate (Type A), Methacrylic acid-Ethyl acrylate
copolymer, Yellow Iron Oxide (E 172) and Purified Water.
What Prazafile look like and contents of the pack
Prazafile are oval, yellow tablets available in aluminium blister packs containing 7 and 14 tablets*
or HDPE containers with child resistant closure containing 28 tablets*.
*Not all packs may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder: Pharmafile Ltd, Medici House, Unit 2 Ashbourne Manufacturing
Park, Ashbourne, Co. Meath, Ireland.
Manufacturers:
Teva Pharma S.L.U. Poligono Industrial Malpica, calle C, Numero 4, 50016, ZARAGOZA, Spain.
TEVA Pharmaceutical Works Private Limited Company
Pallagi út 13, 4042 Debrecen Hungary
TEVA Pharmaceutical Works Private Limited Company
H-2100 Gödöllő, Táncsics Mihály út 82 Hungary (Headquarters: 4042 Debrecen, Pallagi út 13)
TEVA UK Ltd
Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG, United Kingdom
Pharmachemie B.V.
Swensweg 5, 2031 GA Haarlem, Netherlands
This medicinal product is authorised in the Member States of the EEA under the following names:
Poland - Prazafile
This leaflet was last updated in August 2011.
The following recommendations for lifestyle and dietary changes may also help to relieve heartburn
or acid related symptoms:




reduce weight (if overweight), avoid large meals, eat slowly and avoid eating less than three
hours before bedtime
stop smoking and reduce alcohol and caffeine consumption
avoid tight-fitting clothing or belts

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elevate bed head (if you suffer from nocturnal symptoms)
reduce intake of food that can cause heartburn e.g. chocolate, peppermint, spearmint, fatty and
fried food, acidic food, spicy food, citrus fruits, fruit juices and 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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