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Package leaflet: Information for the user

Pantoprazole 20mg Gastro-resistant Tablets

BROWN & BURK

190 mm

r antoprazole ^as sodium sesqui hydrate)

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 pharmacist.

-    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. Th is includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1.    What P antoprazole Tablets are and what they are used for

2.    What you need to know before you take Pantoprazole Ta blets

3.    How to take Pantoprazole Ta blets

4.    Possible side effects

5.    How to store Pantoprazole Ta blets

6.    Contents of the pack and other information

1. What Pantoprazole Tablets are and what they are used for

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Pantoprazole Tablets are selective proton pump

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inhibitor ,    which    are    medicine that reduce the

amount of acid produced in your stomach. They are used for    treating    acid-related diseases of the

stomach and intestine.

Pantoprazole Tablets are used for:

Adults and adolescents 12 years of age and above:

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I resting symptoms ^e.g.

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JIIJJIJIIJ    heartburn, acid

regulation, 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 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 NSAID s continuously.

2. What you need to know before you take Pantoprazole Tablets

he 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

s e v e r e a n d /o r p e r s ist e n t d i a r r h o e a , a s 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 Tablets 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 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).

Other medicines and Pantoprazole tablets

Pantoprazole Tablets may influence the effectiveness of other medicines, so tell you 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 breastfeeding, 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.

instead, one a day. After healing, you can reduce the dose back again to one tablet 20mg a day.

Adults:

To prevent duodenal and stomach ulcers in patients who need to take NSAIDs continuously

The usual dose is one tablet a day.

Special patient groups

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. If you suffer from severe liver problems, you should not take more than one 20 mg tablet a day.

. Children below 12 years. These tablets are not recommended for use in children below 12 years

If you take more Pantoprazole Tablets than you should

Tell your doctor or pharmacist. There are no known symptoms of overdose.

If you forget to take Pantoprazole Tablets

Do not take a double dose to make up for the forgotten dose. Take your next, normal dose at the usual time.

If you stop taking Pantoprazole Tablets

Do not stop taking these tablets without first talking to your doctor or pharmacist.

If you have any further questions about the use of this product, ask your doctor or pharmacist.

4. Possible side effects

blood, sharp drop in circulating granular white blood cells, associated fever.

•    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; coexisting abnormal reduction in the number of red and white blood cells, as well as platelets

•    Frequency not known ( frequency cannot be

estimated from the available data) If you are on Pantoprazole Ta blets 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.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the 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.

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Do not take Pantoprazole Tablets

. If you a re a llergic (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.

Warning and precautions

. If you have severe liver problems. Please tell your doctor if you 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 need to take medicines called NSAIDs continuously and receive Pantoprazole Ta blets 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 Tablets as a 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.

Driving and using machines

If you experience side effects like dizziness or disturbed vision, you should not drive or operate machines.

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.

Un

ess told otherwise by your doctor, the usual dose

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Tell your doctor immediately if

you notice any of

Adults and adolescents 12 years of age and above:

To treat symptoms (e.g. heartburn, acid regulation, pain on swallowing) associated to gastro-oesophageal reflux disease

The usual dose is one tablet a day. This dose usually brings relief within 2 to 4 weeks-at most after another four weeks. Your doctor will tell you how long to continue taking the medicine. After this any reoccurring symptoms can be controlled by talking 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 returns, your doctor can double the dose, in which case you can use Pantoprazole 40 mg Ta blets

Like all medicines, Pantoprazole Ta blets 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):

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): 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. Taking a proton pump inhibitor like pantoprazole, especially over a period of more then one year, may slight 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).

•    Rare (affects 1 to 10 users in 10,000)

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; 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.

Side effects identified through blood tests:

•    Uncommon (affects 1 to 10 users in 1, 000) an

increase in liver enzymes.

5. How to store Pantoprazole Tablets

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 label, carton and container after EXP. The expiry date refers to the last day of that month.

Store in the original package in order to protect from light and moisture.

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. Contents of the pack and other information

What Pantoprazole Tablets contain

•    The active substance is pantoprazole. Each tablet contains 20 mg of pantoprazole (as sodium sesquihydrate).

•    The other ingredients are mannitol, crospovidone, anhydrous sodium carbonate, hydroxypropylcellulose,calcium stearate,

hypromellose, yellow iron oxide (E172), Ferric

oxide red, methacrylic acid-ethylacrylate -copolymer (1:1) and triethyl citrate.

What Pantoprazole Tablets look like and contents of the pack

Orange coloured, enteric coated oval biconvex tablets plain on both the sides.

Packs: Cartons containing aluminium blisters and HDPE container with polypropylene cap.

Pantoprazole 20 mg tablets are available in the following pack sizes:

Cartons of 7, 14, 15, 28, 30, 56, 60, 84, 90, 98, 100, 112, 140, 280, 500 & 700 tablets.

HDPE container of 1000 tablets.

Not all

pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Brown & Burk UK Ltd 5 Marryat Close Hounslow West Middlesex

TW4 5DQ UK.

This leaflet was last updated in January 2015

420mm

Rare (affects 1 to 10 users i 10,000)

An increase in bilirubin increased fats in the

BBUK CODE

Artwork code

6 mm

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