Pantoprazole 40 Mg Gastro-Resistant Tablets
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Read all of this leaflet carefully before you start taking this medicine.
♦ Keep this leaflet. You may need to read it again.
♦ Ifyou have any furtherquestions, askyour doctor or pharmacist.
♦ 'This medicine has been prescribed foryou. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
♦ Ifany ofthe side effects gets serious, or ifyou notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
♦ The full name of this medicine is Pantoprazole 40mg Gastro-resistantTablets butwithin the leaflet it will be referred to as Pantoprazole tablets.
In this leaflet:
D What Pantoprazole tablets are and what they are used for 2 Before you take S How to take Q Possible side effects 5 How to store B Further information
D What Pantoprazole tablets are and what they are used for
Pantoprazole isa selective "proton pump inhibitor", a medicinewhich reducestheamountofacid produced in your stomach. It is used for treating acid-related diseases of the stomach and intestine.
Pantoprazole tablets are used for treating:
Adultsand adolescents 12yearsofage and above:
♦ Refluxoesophagitis.An inflammation ofyouroesophagus (thetube which connectsyour throat to your stomach) accompanied bythe regurgitation of stomach acid.
Adults:
♦ Stomach and duodenal ulcers.
♦ Zollinger-Ellison-Syndromeand other conditions producing too much acid in the stomach.
2 Before you take
Do not take Pantoprazole tablets if you
♦ are allergic (hypersensitive) to pantoprazole or any of theother ingredients of Pantoprazole tablets.
♦ are allergic to medicinescontaining other proton pump inhibitors.
Take special care with Pantoprazole tablets if you
♦ have severe liver problems. Please tell your doctor if you ever had problems with your liver in the past. He will checkyour liver enzymes more frequently,especially when you aretaking Pantoprazole tablets as a longterm treatment. In the case ofa rise of liver enzymes the treatment should be stopped.
♦ havean increased secretorycondition (e.g.Zollinger-Ellison syndrome),oryou have reduced body stores or risk factorsfor reduced vitamin B12 and receive pantoprazole long-term treatment.As with all acid reducing agents, pantoprazole maylead to a reduced absorption of vitamin B12.
♦ are taking a medicine containing atazanavir (for thetreatment of HIV-infection) at the same time as pantoprazole, ask your doctor for specific advice.
Taking a proton pump inhibitor like Pantoprazole, especially over a period of more than oneyear, may slightly increaseyour risk of fracture in the hip, wrist or spine.Tell your doctor ifyou have osteoporosis or ifyou aretaking corticosteroids (which can increasethe risk of osteoporosis)
continued top of next column
AAAG8707
Tell your doctor immediately if you notice any of the following symptoms:
♦ an unintentional lossofweight
♦ repeated vomiting
♦ difficulty swallowing
♦ vomiting blood
♦ you look pale and feel weak (anaemia)
♦ you notice blood in your stools
♦ 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 symptomsofcancer and could cause delay in diagnosing it. Ifyour symptoms continue in spite ofyour treatment,further investigations will be considered.
Ifyou take Pantoprazoletablets on a long-term basis (longerthan 1 year)yourdoctorwill probably keepyou under regular surveillance. You should report any newand exceptional symptoms and circumstances wheneveryou seeyourdoctor.
Taking other medicines
Pantoprazole tablets may influence the effectiveness of other medicines, so tell your doctor ifyou are taking
♦ Medicines such as ketoconazole, itraconazole and posaconazole (used to treatfungal infections) or erlotinib (used for certain typesofcancer) 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.
♦ Methotrexate (used in treatment ofcancerand autoimmune diseases)
♦ Atazanavir (used to treat HIV-infection).
Please tell your doctor or pharmacist ifyou are taking or have recentlytaken any other medicines, including medicines obtained without a prescription.
Pregnancy and breast-feeding
Thereare no adequatedata from the use of pantoprazole in pregnant women. Excretion into human milk has been reported. Ifyou are pregnant, or thinkyou maybe pregnant,or ifyou are breast-feeding,you should usethis medicine only ifyour doctor considersthe benefitforyou greater than the potential riskforyour unborn child or baby.
Askyour doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Ifyou experience side effects like dizziness or disturbed vision,you should not drive or operate machines.
Pantoprazole tablets contain sodium
This medicinal product contains34.64mg of sodium per maximum dailydose of 160mg (3 tablets).To be taken into consideration by patients on a controlled sodium diet.
B How to take
Always take Pantoprazole tablets exactlyasyour doctor has told you. You should check with your doctor or pharmacist ifyou 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 swallowthem whole with somewater.
Unlesstold otherwise byyour doctor, the usual dose is:
Adults and adolescents 12 years of age and above:
To treat reflux oesophagitis
The usual dose is onetablet a day. Your doctor may tell you to increase to 2 tablets daily.Thetreatment period for reflux oesophagitis is usually between 4 and 8 weeks.
Your doctor will tell you how long to takeyour medicine.
continued over page
Adults:
For the treatment of stomach and duodenal ulcers.
The usual dose is one tablet a day.After consultation with your doctor, the dose may be doubled.
Your doctor will tell you how long to takeyour medicine. Thetreatment period for stomach ulcers is usually between 4and8 weeks.Thetreatment period for duodenal ulcers is usually between 2 and 4 weeks.
For the long-term treatment of Zollinger-Ellison-Syndrome and of other conditions in which too much stomach acid is produced.
The recommended starting dose is usuallytwo tabletsa day.
Take the two tablets 1 hour before a meal. Your doctor may later adjust the dose, depending on the amount of stomach acid you produce. If prescribed more than two tablets a day,thetablets should betaken twicedaily. Ifyourdoctor prescribes a dailydose of morethan four tablets a day,you will be told exactlywhen to stop taking the medicine.
Special patient groups:
• Ifyou have kidney problems, moderateor severe liver problems, you should not take Pantoprazole tablets for eradication of Helicobacter pylori.
• If you suffer from severe liver problems, you should not take more than one tablet 20mg pantoprazole a day (for this purpose tablets containing 20mg pantoprazole are available).
• Children below 12 years. These tablets are not recommended for use in children below 12years.
If you take more Pantoprazole tablets than you should
Contact 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 theforgotten dose.Take your next, normal dose at the usual time.
If you stop taking Pantoprazole tablets
Do not stop taking these tablets withoutfirst talking to your doctor or pharmacist.
Ifyou haveanyfurtherquestionson the use ofthis product,askyour doctor or pharmacist.
□ Possible side effects
Like all medicines, Pantoprazole tablets 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 ofthetongue and/or throat, difficulty in swallowing, hives (nettle rash), difficulties in breathing, allergicfacial swelling (Quincke's oedema/angioedema), severe dizziness with veryfast heartbeat and heavy sweating.
• Serious skin conditions (frequency not known):
blistering ofthe skin and rapid deterioration ofyour general condition,erosion (including slight bleeding) ofeyes, nose, mouth/lips or genitals (Stevens-Johnson-Syndrome, Lyell-Syndrome, Erythema multiforme) and sensitivity to light.
• Other serious conditions (frequency not known):
yellowing ofthe skin or whites ofthe eyes (severe damage to liver cells, jaundice) orfever, rash,and enlarged kidneys sometimes with painful urination and lower back pain (serious inflammation ofthe kidneys).
Other side effects are:
Uncommon (affects ItolO 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 ofthe hip, wrist or spine. Rare (affects 1 to lOusers in 10,000): disturbances in vision such as blurred vision; hives; pain in the joints; muscle pains; weightchanges; raised bodytemperature; swelling ofthe extremities (peripheral oedema); allergic reactions; depression; breast enlargement in males;agranulocytosis (severe reduction in number of white blood cells, which makes infections more likely), taste disorders.
continued top of next column AAAG8707
Very Rare (affects less than 1 user in 10,000): disorientation, thrombocytopenia (reduction in blood platelets, which increases risk of bleeding or bruising), leukopenia (decrease in the number ofwhite blood cells (leukocytes)), pancytopenia (severe reduction in blood cells which can cause weakness, bruising or make infections more likely).
Not known (frequency cannot be estimated from the available data): pinsand needles/tingling, hallucination, confusion (especially in patients with a history of these symptoms); decreased sodium level,decreased calcium level, decreased potassium level in blood.
Ifyou areon Pantoprazolefor more than three months it is possible that the levels of magnesium in your blood mayfall. Low levelsof magnesium can be seen as fatigue, involuntary muscle contractions, disorientation, convulsions,dizziness, increased heart rate. Ifyou get any ofthese 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 decideto perform regular blood teststo monitoryour levelsofmagnesium.
Side effects identified through blood tests: Uncommon (affects ItolO users in 1,000): an increase in liver enzymes.
Rare (affects ItolO users in 10,000):
an increase in bilirubin; increased fats in the blood.
Very Rare (affects less than 1 user in 10,000): a reduction in the number of blood platelets, which may causeyou to bleed or bruise more than normal;a reduction in the number ofwhite blood cells, which may lead to morefrequent infections.
If any of the side effects gets serious, or ifyou notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Reporting of side effects
Ifyou get any sideeffects, talkto your doctor, pharmacist or nurse.This includes any possible side effects not listed in this leaflet. You can also report sideeffects directly via the internet at www.mhra.gov.uk/yellowcard
By reporting side effectsyou can help provide more information on the safety ofthis medicine.
B How to store
Keep out ofthe reach and sight of children.
Do not use Pantoprazole tablets after theexpirydate, which is stated on the carton and the container after EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Medicines should not be disposed ofvia wastewateror household waste.Askyour pharmacist how to dispose of medicines no longer required.These measures will help to protect the environment.
E Further information
What Pantoprazole tablets contain
♦ The active substance is pantoprazole. Each gastro-resistant tablet contains 40mg of pantoprazole (as sodium sesquihydrate).
♦ The other ingredients are:
Mannitol, Sodium carbonateanhydrous, Sodium starch glycolate, Methacrylic acid copolymer Calcium stearate, Opadry whiteOY-D-7233 (hypromellose, titanium dioxide, talc, macrogol, sodium lauryl sulphate), Kollicoat MAE 30 DP yellow (methacrylic acid-ethyl acrylate copolymer dispersion 30%, propylene glycol,yellow iron oxide,titanium dioxide, talc).
What Pantoprazole tablets look like and contents of the pack
Pantoprazole40mg Gastro-resistant Tablets are elliptical, biconvex,darkyellow gastro-resistant tablets.
Packsizes:28
Marketing Authorisation Holder:
Actavis Group PTC ehf Reykjavikurvegur 76-78 220 Hafnar^ordur Iceland
Manufacturer:
Balkanpharma - Dupnitsa AD 3 Samokovsko Schosse Str.,
Dupnitsa 2600 Bulgaria
This leaflet was last revised in May 2014
Ifyou would like a leaflet with larger text, please contact 01271 385257. vactavis
Actavis, Barnstaple, EX32 8NS, UK
Pantoprazole 40mg Gastro-resistant Tablets
Read all of this leaflet carefully before you start taking this medicine.
• 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
• The full name of this medicine is Pantoprazole 40mg Gastro-resistant Tablets but within the leaflet it will be referred to as Pantoprazole tablets.
In this leaflet:
1. What Pantoprazole tablets are and what they are used for
2. Before you take
3. How to take
4. Possible side effects
5. How to store
6. Further information
1. What Pantoprazole 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 diseases of the stomach and intestine.
Pantoprazole tablets are used for treating:
Adults and adolescents 12 years of age and above:
• Reflux oesophagitis. An inflammation of your oesophagus (the tube which connects your throat to your stomach) accompanied by the regurgitation of stomach acid.
Adults:
• Stomach and duodenal ulcers.
• Zollinger-Ellison-Syndrome and other conditions producing too much acid in the stomach.
2. Before you take
Do not take Pantoprazole tablets if you
• are allergic (hypersensitive) to pantoprazole or any of the other ingredients of Pantoprazole tablets.
• 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 ever had problems with your liver in
the past. 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.
• have an increased secretory condition (e.g. Zollinger -Ellison syndrome), or 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.
• are taking a medicine containing atazanavir (for the treatment of HIV-infection) at the same time as pantoprazole, ask your doctor for specific advise.
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)
Tell your doctor immediately if you notice any of the following symptoms:
• an unintentional loss of weight
• repeated vomiting
• difficulty swallowing
• vomiting blood
• you look pale and feel weak (anaemia)
• you notice blood in your stools
• 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 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 other medicines
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 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.
• Methotrexate (used in treatment of cancer and autoimmune diseases)
• 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 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.
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.
Pantoprazole tablets contain sodium
This medicinal product contains 34.64mg of sodium per maximum daily dose of 160mg (3 tablets). To be taken into consideration by patients on a controlled sodium diet.
3. How to take
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 reflux oesophagitis
The usual dose is one tablet a day. Your doctor may tell you to increase to 2 tablets daily. The treatment period for reflux oesophagitis is usually between 4 and 8 weeks. Your doctor will tell you how long to take your medicine.
Adults:
For the treatment of stomach and duodenal ulcers.
The usual dose is one tablet a day. After consultation with your doctor, the dose may be doubled.
Your doctor will tell you how long to take your medicine. The treatment period for stomach ulcers is usually between 4 and 8 weeks. The treatment period for duodenal ulcers is usually between 2 and 4 weeks.
For the long-term treatment of Zollinger-Ellison-Syndrome and of other conditions in which too much stomach acid is produced.
The recommended starting dose is usually two tablets a day.
Take the two tablets 1 hour before a meal. Your doctor may later adjust the dose, depending on the amount of stomach acid you produce. If prescribed more than two tablets a day, the tablets should be taken twice daily.
If your doctor prescribes a daily dose of more than four tablets a day, you will be told exactly when to stop taking the medicine.
Special patient groups:
• If you have kidney problems, moderate or severe liver problems, you should not take Pantoprazole tablets for eradication of Helicobacter pylori.
• If you suffer from severe liver problems, you should not take more than one tablet 20mg pantoprazole a day (for this purpose tablets containing 20mg pantoprazole are available).
• 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
Contact 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 on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Pantoprazole tablets 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; 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; agranulocytosis (severe reduction in number of white blood cells, which makes infections more likely), taste disorders.
Very Rare (affects less than 1 user in 10,000): disorientation, thrombocytopenia (reduction in blood platelets, which increases risk of bleeding or bruising), leukopenia (decrease in the number of white blood cells (leukocytes)), pancytopenia (severe reduction in blood cells which can cause weakness, bruising or make infections more likely).
Not known (frequency cannot be estimated from the available data): pins and needles / tingling, hallucination, confusion (especially in patients with a history of these symptoms); decreased sodium level, decreased calcium level, decreased potassium level in blood.
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.
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 bilirubin; increased fats in the blood.
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.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
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 internet at 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
Keep out of the reach and sight of children.
Do not use Pantoprazole tablets after the expiry date, which is stated on the carton and the container after EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
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 Pantoprazole tablets contain
• The active substance is pantoprazole. Each gastro-resistant tablet contains 40mg of pantoprazole (as sodium sesquihydrate).
• The other ingredients are:
Mannitol, Sodium carbonate anhydrous, Sodium starch glycolate, Methacrylic acid copolymer
Calcium stearate, Opadry white OY-D-7233 (hypromellose, titanium dioxide, talc, macrogol, sodium lauryl sulphate), Kollicoat MAE 30 DP yellow (methacrylic acid-ethyl acrylate copolymer dispersion 30%, propylene glycol, yellow iron oxide, titanium dioxide, talc).
What Pantoprazole tablets look like and contents of the pack
Pantoprazole 40mg Gastro-resistant Tablets are elliptical, biconvex, dark yellow gastro-resistant tablets.
Pack sizes:28
Marketing Authorisation Holder:
Actavis Group PTC ehf Reykjavikurvegur 76-78 220 Hafnarfjordur Iceland
Manufacturer:
Actavis Ltd
BLB016 Bulebel Industrial Estate
Zejtun ZTN 3000
Malta
This leaflet was last revised in May 2014
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