Package leaflet: Information for the patient

Pantoprazole 20 mg gastro-resistant tablets

(Pantoprazole)

What is in this leaflet

1. What Pantoprazole 20 mg gastro-resistant tablets are and what they are used for

2.    What you need to know before you take Pantoprazole 20 mg gastro-resistant tablets

3.    How to take Pantoprazole 20 mg gastro-resistant tablets

4.    Possible side effects

5.    How to store Pantoprazole 20 mg gastro-resistant tablets

6.    Contents of the pack and other information

1. What Pantoprazole 20 mg gastro-resistant tablets are and what they are 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 disease of the stomach and intestine.

Pantoprazole is used for:

Adults and adolescents 12 years of age and above:

-    treating symptoms (e.g. heartburn, acid regurgitation and 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. What you need to know before you take Pantoprazole 20 mg gastro-resistant tablets

Do not take Pantoprazole 20 mg gastro-resistant tablets

-    if you are allergic to pantoprazole or any of the other ingredients of this medicine (listed in section 6).

-    if you are allergic to medicines containing other proton pump inhibitors.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking Pantoprazole 20 mg gastro-resistant tablets

-    if you are pregnant, planning to become pregnant or breastfeeding (see below in this section “Pregnancy, breast-feeding and fertility”)

-    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 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 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.

-    ifyou have reduced body stores or risk factors for reduced vitamin B 12 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.

Tell your doctor immediately ifyou 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 yourstools

-    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 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 riskof osteoporosis).

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. Ifyou 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.

Other medicines and Pantoprazole 20 mg gastro-resistant tablets

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

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

-    Methotrexate (a chemotherapy medicine used in high doses to treat cancer and psoriasis). If you are taking a high dose of methotrexate, your doctor may temporarily stop your Pantoprazole treatment

-    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)

Pregnancy, breast-feeding and fertility

There are no adequate data from the use of pantoprazole in pregnant women. Excretion into human breast milk has been reported. Ifyou are pregnant, or think you may be pregnant, or ifyou 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.

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.

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 20 mg gastro-resistant tablets

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist ifyou 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 aae and above:

To treat symptoms (e.g. heartburn, acid regurgitation, pain on swallowing) associated to gastrooesophageal 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 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.

Read all of this leaflet carefully before you start using 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, pharmacist ornurse.

-    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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

This medicinal Member States names

Austria

Belgium

Denmark

France

Germany

Italy

Netherlands

Poland

Spain

Sweden United Kingdom

2441

Package leaflet: Information for the patient

Pantoprazole 20 mg gastro-resistant tablets

(Pantoprazole)

Read all of this leaflet carefully before you start using this medicine because it contains important information foryou.

-    Keep this leaflet. You may need to read it again.

-    If you have any further questions, ask your doctor, pharmacist or nurse.

-    This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even iftheirsigns of illness are the same asyours.

-    If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1. What Pantoprazole 20 mg gastro-resistant tablets are and what they are used for

2.    What you need to know before you take Pantoprazole 20 mg gastro-resistant tablets

3.    How to take Pantoprazole 20 mg gastro-resistant tablets

4.    Possible side effects

5.    How to store Pantoprazole 20 mg gastro-resistant tablets

6.    Contents of the pack and other information

1.    What Pantoprazole 20 mg gastro-resistant tablets are and what they are 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 disease of the stomach and intestine.

Pantoprazole is used for:

Adultsandadolescerrts12yearsofageandabove:

-    treating symptoms (e.g. heartburn, acid regurgitation and 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.    What you need to know before you take Pantoprazole 20 mg gastro-resistant tablets

Do not take Pantoprazole 20 mg gastro-resistant tablets

-    if you are allergic to pantoprazole or any of the other ingredients of this medicine (listed in section 6).

-    if you are allergic to medicines containing other proton pump inhibitors.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking Pantoprazole 20 mg gastro-resistant tablets

-    if you are pregnant, planning to become pregnant or breastfeeding (see below in this section “Pregnancy, breast-feeding and fertility”)

-    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 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 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 B 12 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 doctorfor specific advice.

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)

-    younoticebloodinyourstools

-    severe and/ or persistent diarrhoea, as Pantoprazole has been associated with a small increase in infectious diarrhoea.

Yourdoctor 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 yourdoctor.

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 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.

Other medicines and Pantoprazole 20 mg gastro-resistant tablets

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Pantoprazole may influence the effectiveness of other medicines, so tell yourdoctor if you are taking:

-    Methotrexate (a chemotherapy medicine used in high doses to treat cancer and psoriasis). If you are taking a high dose of methotrexate, your doctor may temporarily stop your Pantoprazole treatment

-    Medicines such as ketoconazole, itraconazole and posaconazole (used to treat fungal infections) or eriotinib (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 H IV-infection)

Pregnancy, breast-feeding and fertility

There are no adequate data from the use of pantoprazole in pregnant women. Excretion into human breast 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 yourunbom child or baby.

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.

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 20 mg gastro-resistant tablets

Always take this medicine exactly as your doctor or pharmacist has told you. 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 aae and above:

To treat symptoms (e.g. heartburn, acid regurgitation, pain on swallowing) associated to gastrooesophageal 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 returns, yourdoctor 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:

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:

-    If you sufferfrom severe liverproblems, you should nottakemorethanone20mgtabletaday.

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

If you take more Pantoprazole 20 mg gastro-resistant tablets than you should

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

If you forget to take Pantoprazole 20 mg gastro-resistant tablets

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 20 mg gastro-resistant tablets

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

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

4. Possible side effects

Like all medicines, this medicine 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 (may affect up to 1 in 1,000 people)]: 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 (frequency cannot be estimated from the available data)]: 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 (frequency cannot be estimated from the available data)]: 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 with possible progression to kidney failure)

Other known side effects are:

Uncommon (may affect up to 1 in 100 people):

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 (if Pantoprazole is used in high doses and over long duration; see section 2.2 “Warnings and precautions”)

Rare (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, hives, pain in the joints, muscle pains, weight changes, raised body temperature, high fever swelling of the extremities (peripheral oedema), allergic reactions, depression, breast enlargement in males

Very rare (may affect up to 1 in 10,000 people):

-    Disorientation

Not known (frequency cannot be estimated from the available data):

Tingling or numbness of the hands or feet, hallucination, confusion (especially in patients with a history of these symptoms), muscle spasms, decreased sodium level in blood, low levels of magnesium in your blood (hypomagnesaemia) (see section 2.2“Warnings and precautions”); low levels of calcium in your blood in association with reduction in magnesium levels, reduction in potassium levels.

Side effects identified through blood tests:

-    Uncommon(mayaffectupto1in100people):

an increase in liver enzymes

-    Rare (may affect uptol in 1,000 people):

an increase in bilirubin; increased fat level in the blood, sharp drop in circulating granular white blood cells, associated with high fever

- Very Rare ( may affect up to 1 in 10,000 people):

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

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 at: www.mhra.aov.uk/vellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

5.    How to store Pantoprazole 20 mg gastro-resistant 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 carton and blister after “EXP”. The expiry date refers to the last day of that month.

•    This medicine does not require any special storage conditions.

•    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 20mg gastro-resitant tablets contain

The active substance is pantoprazole. Each gastro-resistant tablet contains 20 mg pantoprazole (as sodium sesquihydrate).

The other ingredients are:

Core: sodium carbonate; anhydrous mannitol, crospovidone type A, hyprolose, cellulose; microcrystalline, calcium stearate Sub-coat: hypromellose, propylene glycol, povidone K30, titanium dioxide (E 171), yellow iron oxide (E172)

Enteric coat: methacrylic acid-ethylacrylate copolymer (1:1), triethyl citrate, sodium laurilsulfate, titanium dioxide (E 171), talc, yellow iron oxide (E172)

Printing ink: shellac, ethanol, isopropyl alcohol, black iron oxide (E 172), N-butyl alcohol, propylene glycol, ammonium hydroxide (28%)

What Pantoprazole 20 mg gastro-resistant tablets look like and contents of the pack

Pantoprazole 20 mg gastro-resistant tablets are yellow enteric coated oval shaped, biconvex tablets imprinted with 'll' on one side and plain onotherside.

Pantoprazole 20 mg gastro-resistant-tablets come in packs of 7,14,15,28,30,50,56,60,90, 98,100 and 500 gastro-resistant tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder

Ranbaxy (UK) Limited Building 4, Chiswick Park,

566 Chiswick High Road,

London, W45YE United Kingdom

Manufacturer

Ranbaxy Ireland Limited Spafield, Cork Road,

Cashel, Co. Tipperary,

Ireland

This medicinal product is authorised in the Member States of the EEA under following names

Austria    Pantoprazol Ranbaxy 20 mg

Filmtabletten

Belgium    YOEVID 20mg maagsapresistente

tabletten

Denmark    Pantoprazol Ranbaxy entero-

tabletter20mg

France    Pantoprazole Ranbaxy 20 mg,

comprime gastro-resistant Germany    PANTOPRAZOL BASICS 20 mg

magensaftresistente Tabletten Italy    PANTOPRAZOLO RANBAXY

Netherlands    Pantoprazol 20 Ranbaxy,

maagsapresistente tabletten Poland    Ranloc

Spain    PANTOPRAZOL Ranbaxygen

20mg, Comprimidos gastro-resistentes EFG

Sweden    Pantoprazol Ranbaxy 20 mg

enterotabletter

United

Kingdom    Pantoprazole 20 mg gastro-

resistant tablets

This leaflet was last revised in March 2014.

LPUK055/20/C RANBAXY

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