Pantoprazole 40 Mg Gastro-Resistant Tablets
£
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 or nurse.
- 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.
What is in this leaflet:
1. What Pantoprazole 40 mg gastro-resistant tablets are and what they are used for
2. What you need to know before you take Pantoprazole 40 mg gastro-resistant tablets
3. How to take Pantoprazole 40 mg gastro-resistant tablets
4. Possible side effects
5. How to store Pantoprazole 40 mg gastro-resistant tablets
6. Contents of the pack and other information
1. What Pantoprazole 40 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 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:
- An infection with a bacterium called Helicobacter pylori in patients with duodenal ulcers and stomach ulcers in combination with two antibiotics (Eradication therapy). The aim is to get rid of the bacteria and so reduce the likelihood of these ulcers returning.
- Stomach and duodenal ulcers.
- Zollinger-Ellison-Syndrome and other conditions producing too much acid in the stomach.
2. What you need to know before you take Pantoprazole 40 mg gastro-resistant tablets
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 40 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 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 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 40 mg gastro-resistant tablets
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 40 mg for eradication of Helicobacterpylori.
- If you suffer from severe liver problems, you should not take more than one tablet 20 mg pantoprazole a day (for this purpose tablets containing 20 mg pantoprazole are available).
Children below12years
These tablets are not recommended for use in children below 12 years.
If you take more Pantoprazole 40 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 40 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 40 mg gastro-resistant 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 medicine, ask your doctor, pharmacist or nurse.
4. Possible side effects
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 40 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
Do not take Pantoprazole 40 mg gastro-resistant tablets
- ifyouareallergictopantoprazoleor anyofthe 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 40 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 yourdoctorifyou 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 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 ad vice.
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)
- 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 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,
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are notsure.
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 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 an infection with a bacterium called Helicobacter pylori in patients with duodenal ulcers and stomach ulcers in combination with two antibiotics (Eradication therapy) One tablet 40 mg, two times a day plus two antibiotic tablets of either amoxicillin, clarithromycin and metronidazole (or tinidazole), each to be taken two times a day with your pantoprazole tablet. Take the first pantoprazole 40 mg tablet 1 hour before breakfast and the second pantoprazole 40mg tablet 1 hour before your evening meal. Follow your doctor’s instructions and make sure you read the package leaflets for these antibiotics. The usual treatment period is one to two weeks.
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. Yourdoctor 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
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 (may affect up to 1 in 100 people)
an increase in liver enzymes.
- Rare (may affect up to 1 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 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
What Pantoprazole 40 mg gastro-resistant tablets contain
The active substance is pantoprazole. Each gastro-resistant tablet contains 40 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: methacrvlic acid-ethylacrylate copolymer (1:1), triethyl citrate, sodium laurilsulfate, titanium dioxide (E171), 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 40 mg gastro-resistant tablets look like and contents of the pack
Pantoprazole 40 mg gastro-resistant tablets are yellow enteric coated oval shaped, biconvex tablets imprinted with 'IV on one side and plain on other side.
Pantoprazole 40 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 the following names
Austria Pantoprazol Ranbaxy 40 mg
Filmtabletten
Belgium
Denmark
Germany
Italy
Netherlands
Poland
Spain
Sweden United Kingdom
YOEVID 40mg maagsapresistente tabletten Pantoprazol Ranbaxy enterotabletter 40mg PANTOPRAZOL BASICS 40 mg magensaftresistente Tabletten
PANTOPRAZOLO RANBAXY Pantoprazol 40 Ranbaxy, maagsapresistente tabletten Ranloc
PANTOPRAZOL Ranbaxygen 40mg Comprimidos gastrorresistentes EFG Pantoprazol Ranbaxy 40 mg enterotabletter Pantoprazole 40 mg Gastro-resistant Tablets
This leaflet was last revised in March 2014.
&
Package leaflet: Information for the patient
Pantoprazole 40 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 foryou only. Do not pass it on to others. It may harm them, even iftheirsignsofillnessarethe 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 40 mg gastro-resistant tablets are and what they are used for
2. What you need to know before you take Pantoprazole 40 mg gastro-resistant tablets
3. How to take Pantoprazole 40 mg gastro-resistant tablets
4. Possible side effects
5. How to store Pantoprazole 40 mg gastro-resistant tablets
6. Contents of the pack and other information
1. What Pantoprazole 40 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 treating:
Adults and adolescents 12yearsofageandabove:
- Reflux oesophagitis.An inflammation of your oesophagus (the tube which connects your throat to your stomach) accompanied by the regurgitation of stomach acid.
Adults:
- An infection with a bacterium called Helicobacter pylori in patients with duodenal ulcers and stomach ulcers in combination with two antibiotics (Eradication therapy). The aim is to get rid of the bacteria and so reduce the likelihood of these ulcers returning.
- Stomach and duodenal ulcers.
- Zollinger-Ellison-Syndrome and otherconditions producing too much acid in the stomach.
2. What you need to know before you take Pantoprazole 40 mg gastro-resistant tablets
Do not take Pantoprazole 40 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 40 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 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 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)
- you notice blood in yourstools
- 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 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. 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 40 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 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 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, orthinkyou 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 riskforyour 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 40 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 howshould 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 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 an infection with a bacterium called Helicobacter pylori in patients with duodenal ulcers and stomach ulcers in combination with two antibiotics (Eradication therapy)
One tablet 40 mg, two times a day plus two antibiotic tablets of either amoxicillin, clarithromycin and metronidazole (or tinidazole), each to be taken two times a day with your pantoprazole tablet. Take the first pantoprazole 40 mg tablet 1 hour before breakfast and the second pantoprazole 40mg tablet 1 hour before your evening meal. Follow your doctor's instructions and make sure you read the package leaflets for these antibiotics. The usual treatment period is one to two weeks.
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 40 mg for eradication of Helicobacterpylori.
- If you suffer from severe liver problems, you should not take more than one tablet 20 mg pantoprazole a day (for this purpose tablets containing 20 mg pantoprazole are available).
Children below 12 years
These tablets are not recommended for use in children below 12 years.
If you take more Pantoprazole 40 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 40 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 40 mg gastro-resistant tablets
Do not stop taking these tablets without first talking toyourdoctoror pharmacist.
If you have any further questions about the use of this medicine, askyourdoctor, 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 atyour 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 upto 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 up to 1 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 40 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 40 mg gastro-resistant tablets contain
The active substance is pantoprazole. Each gastro-resistant tablet contains 40 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 40 mg gastro-resistant tablets look like and contents of the pack
Pantoprazole 40 mg gastro-resistant tablets are yellow enteric coated oval shaped, biconvex tablets imprinted with TV on one side and plain on other side.
Pantoprazole 40 mg gastro-resistant tablets come in packs of7,14,15,28,30,50,56,60,90, 98,100 and 500 gastro-resistant tablets. Not all packsizes 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 the following names
Austria Pantoprazol Ranbaxy 40 mg
Filmtabletten
Belgium YOEVID 40mg maagsapresistente
tabletten
Denmark Pantoprazol Ranbaxy entero-
tabletter 40mg
Germany PANTOPRAZOL BASICS 40 mg
magensaftresistente Tabletten Italy PANTOPRAZOLO RANBAXY
Netherlands Pantoprazol 40 Ranbaxy,
maagsapresistente tabletten Poland Ranloc
Spain PANTOPRAZOL Ranbaxygen
40mg Comprimidos gastro-resistentes EFG
Sweden Pantoprazol Ranbaxy 40 mg
enterotabletter
United
Kingdom Pantoprazole 40 mg Gastro-
resistant Tablets
This leaflet was last revised in March 2014.
LPUK055/40/C RANBAXY