Pantoprazole 40 Mg Gastro-Resistant Tablets
30 mm
8 mm
30 mm
8 mm
What is in this leaflet:
1. What Pantoprazole 40 mg tablets are and what they are used for
2. What you need to know before you take Pantoprazole 40 mg tablets
3. Howto take Pantoprazole 40 mg tablets
4. Possible side effects
5. Howto store Pantoprazole 40 mg tablets
6. Contents of the pack and other information
1. What Pantoprazole 40 mg tablets are and what they are used for
2. What you need to know before you take Pantoprazole 40 mg tablets
Package leaflet: Information for the user
Pantoprazole 40 mg gastro-resistant tablets
Pantoprazole sodium sesquihydrate
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 further questions, please 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. This includes any possible side effects not listed in this leaflet. See section 4.
Pantoprazole 40 mg tablets are a preparation for treating acid-related diseases of the stomach and intestine. They are a “selective proton pump inhibitor”, something which reduces the amount of acid produced in yourstomach.
Pantoprazole 40 mg 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.
Do not take this medicine:
- if you are allergic to Pantoprazole or to any of the other ingredients of this medicine (See section 6).
- if you are allergic to medicines containing other proton pump inhibitors
- in combination with antibiotics, if you have moderate to severe liver or kidney problems.
Warnings and precautions
Talkto your doctor or pharmacist before taking Pantoprazole:
- if you have severe liver problems. Please tell your doctor if you have ever had problems with your liver. Your doctor may check your liver enzymes more frequently. The dose may be reduced or the treatment may be stopped.
- if you have an increased secretory condition (e.g. Zollinger - Ellison syndrome), or reduced body stores or risk factors for reduced vitamin B12and receive pantoprazole longterm 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 (forthe treatment of HIV-infection) at the same time as pantoprazole 40 mg, ask your doctor for specific advice.
- if you have ever had a skin reaction after treatment with a medicine similar to any drug that reduces stomach acid. If you get a rash on your skin, especially in areas exposed to the sun tell your doctor as soon as you can, as you may need to stop your treatment. Rememberto also mention any other ill effects like pain in your joints.
- if you are due to have a specific blood test (Chromogranin A).
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 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 tablets on long-term basis (longer that 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.
Other medicines and Pantoprazole
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
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• Medicines such as ketoconazole, itraconazole and
posaconazole (used for treatment of 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, orthinning of the blood. You may need further checks.
• Atazanavlr (used to treat HIV-infection). Atazanavir must not be used together with Pantoprazole 40mg.
Pregnancy, breast-feeding and fertility
There are no adequate data from the use of Pantoprazole 40 mg tablet in pregnant women. Excretion into human milk has been reported.
If you are pregnant, or think you may be pregnant or are planning to have a baby, 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
These tablets have no known effect on the ability to drive and to use machinery. Possible side effects (see section 4) like dizziness and disturbances in vision such as blurred vision may decrease the ability to react.
Pantoprazole tablets contain sodium
To be taken into consideration by patients on a controlled sodium diet.
3. How to take Pantoprazole 40 mg 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 40 mg tablets?
Take one hour before breakfast without chewing or breaking and swallow them whole with some water.
Unless told otherwise by your doctor, the recommended dose is:
Adults and adolescents 12 years of age and above:
For reflux oesophagitis:
One tablet daily.
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
4. Possible Side Effects
8 weeks. The treatment period for duodenal ulcers is usually between 2 and 4 weeks.
For stomach and duodenal ulcers:
One tablet daily.
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:
Two tablets a day (the recommended starting dose)
Take the two tablets before breakfast. Your doctor may later adjust the dosage, depending on the amount of stomach acid you produce. If prescribed more than two tablets a day, take the tablets in two equal doses. If your doctor prescribes a daily dosage 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 (forthis 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 40 mg tablets than you should
Consult your doctor or pharmacist. There are no known symptoms of overdose.
If you forget to take Pantoprazole 40 mg tablets
Do nottake a double dose to make upforthe forgotten dose. Take your next normal dose atthe usual time.
If you stop taking Pantoprazole 40 mg 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.
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 casually 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 disease/angioedema), severe dizziness with vary fast heartbeat and heavy sweating.
Serious skin conditions (frequency not known): with blistering ofthe skin and rapid deterioration of yourgeneral condition, erosion (including slight bleeding) of eyes, nose, mouth/lips or genitals (Stevens-Johnson-Syndrome, Lyell-Syndrome, Erythema mulitforme) and sensitivity to light.
Other serious conditions (frequency not known):
yellowing ofthe skin or whites ofthe eyes (severe damage to liver cells, jaundice) or fever, rash and enlarged kidneys sometimes with painful urination and lower back pain (serious inflammation ofthe kidneys).
Other known side effects are:
• Uncommon (may affect up to 1 in 100 people) headache; dizziness; diarrhoea; feeling sick, vomiting; abdominal distension and flatulence (wind); dry mouth; constipation; abdominal pain and discomfort; skin rash, exanthema, eruption; itching; feeling weak, exhausted or generally unwell; sleep disorders, fracture ofthe hip, wrist or spine.
• Rare (may affect up to 1 in 1,000 people) disturbances in vision such as blurred vision; hives; pain in the joints; muscle pains; weight changes; raised body temperature; swelling ofthe extremities (peripheral oedema); allergic reactions; breast enlargement in males; depression; agranulocytosis (severe reduction in number of white blood cells, which makes infections more likely) and taste disorders.
• Very Rare (may affect up to 1 in 10,000 people) 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, rash, possibly with pain in the joints. 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 (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 fats in the blood
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• 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.
Reporting of side effects
If you get any side effects, talk to you doctor, pharmacist or nurse. This includes any possible side effects in this leaflet. You can also report side effects directly via the Yellow Card Scheme 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 Pantoprazole 40 mg Tablets
• Keep this medicine out of the sight and reach of children.
• Do not store above 25°C.
• Do not use this medicine 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.
• Do not throw away any medicine via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measure will help protect the environment.
6. Contents of the pack and other information
What Pantoprazole 40 mg tablets contain
The active substance is pantoprazole. One tablet contains 40 mg pantoprazole as sodium sesquihydraie.
The other ingredients are:
Core: Mannitol, Crospovidone type A, Sodium carbonate, Calcium stearate.
Coating: Hydroxy propyl methyl cellulose 5cP, Povidone K-25, Propylene glycol, Titanium dioxide (E171), Iron oxide yellow (E172), Methacrylicacid and ethyl acralate copolymer dispersion, Triethyl citrate.
What Pantoprazole 40 mg tablets look like and contents of the pack
• The tablets are yellow, oval, biconvex, enteric coated, plain on both sides.
• This medicine is available in blister packs containing 28 tablets.
Marketing Authorization Holder and Manufacturer:
Bristol Laboratories Ltd.,
Unit 3, Canalside, Northbridge Road,
Berkhamsted, Hertfordshire, HP4 1 EG, United Kingdom Telephone: 0044 (0) 1442200922
Fax: 0044(0)1442873717
Email: info@bristol-labs.co.uk
Pantoprazole 40 mg gastro-resistant tablets;
PL 17907/0485
This is leaflet was revised in August 2016
To requests copy of this leaflet in Braille, large print oraudio format, please contact the licence holder at the address (or telephone, fax, email) above. 5
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