Pantoprazole 40 Mg Gastro-Resistant Tablets
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Pantoprazole 40 mg gastro-resistant tablets
Pantoprazole
The name of your medicine is Pantoprazole 40 mg gastro-resistant tablets, which will be referred to as Pantoprazole tablets throughout the rest of this document.
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 onto 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.
In this leaflet:
1. What Pantoprazole tablets are and what they are used for
2. Before you take Pantoprazole tablets
3. How to take Pantoprazole tablets
4. Possible side effects
5. How to store Pantoprazole tablets
6. Further information
1. WHAT PANTOPRAZOLE TABLETSAREANDWHAT THEYARE USED FOR
Pantoprazole tablets are selective “proton pump inhibitors”, 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:
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 ofthese ulcers returning.
- Stomach and duodenal ulcers.
- Zollinger-Ellison-Syndrome and other conditions producing too much acid in the stomach.
2. BEFORE YOU TAKE PANTOPRAZOLE TABLETS
Do not take Pantoprazole tablets if you
• are allergic (hypersensitive) to pantoprazole or any of the other ingredients of
Pantoprazole tablets (see Section 6 for a full list).
• 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.
- If 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.
- 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 advise.
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 tablets have 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
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Remember to tell your doctor about your treatment with Pantoprazole tablets if you are prescribed another medicine while the treatment is still ongoing.
• It is especially important to tell your doctor if you're 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.
• Atazanavir (used for the treatment of HIV infection)
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
Pantoprazole tablets may cause dizziness and visual disturbances.
Know how this medicine affects youbefore driving or using machines.
Important information about some of the ingredients of Pantoprazole tablets
This medicine contains sucrose. If you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
3. HOWTOTAKEPANTOPRAZOLETABLETS
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 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, 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 tablet 1 hour before breakfast and the second pantoprazole 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.
Manufacturer
PSI supply nv
Axxes Business Park
Guldensporenpark 22 - Block C
9820 Merelbeke
Belgium
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 stoptakingthemedicine.
Special patient groups:
- If you have kidney problems, moderate or severe liver problems, you should not take Pantoprazole tablets for eradication ofHelicobacter pylori.
- 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 tablets than you should
If you or someone you know accidentally takes a lot more than the stated dose (an overdose) you should contact a doctor immediately. There are no known symptoms of overdose.
If you forget to take Pantoprazole tablets
If you forget to take a dose, take it as soon as you remember, unless it is almost time for your next dose. Do not take a double dose to make up for a forgotten tablet.
If you stop taking Pantoprazole tablets
Do not change the dosage or stop the medication without discussing it with your doctor first.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLESIDEEFFECTS
Like all medicines, Pantoprazole tablets can cause side effects, although not everybody gets them.
The frequency of possible side effects listed below is defined using the following convention:
very common (affects more than 1userin10)
common (affects 1 to 10 users in 100)
uncommon (affects 1 to 10 users in 1,000)
rare (affects 1 to 10 users in 10,000)
very rare (affects less than 1 user in 10,000)
not known (frequency cannot be estimated from the available data)
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; feelingweak, exhausted or generally unwell; sleep disorders.
Taking a proton pump inhibitor like Pantoprazole tablets, especially over a period of more than one year, may slightly increase your risk of fracture in the hip, wrist or spine. Tell your doctor if you have osteoporosis or if you are taking corticosteroids (which can increase the risk of osteoporosis).
- 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.
- Very Rare (affects less than 1 user in 10,000) disorientation.
- Notknown (frequency cannot be estimated from the available data)
Hallucination, confusion (especially in patients with a history of these symptoms); decreased sodium level in blood.
If you are on Pantoprazole tablets 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, of if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE PANTOPRAZOLE TABLETS
Keep out of the reach and sight of children.
This medicinal product does not require any special storage conditions.
Expirydate
Do not use Pantoprazole tablets after the expiry date which is stated on the packaging. The expiry date refers to the last day of that month.
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
• Each gastro-resistant tablet contains 40 mg Pantoprazole (as pantoprazole sodium sesquihydrate 45,2 mg).
• The other ingredients are The core tablet:
Sodium carbonate, anhydrous - Mannitol - Sucrose - Talc - Calcium stearate -Silicon dioxide The coating:
Hypromellose - Talc - Macrogol - Methacrylic acid-ethyl acetate co-polymer -Titanium dioxide (E171) - Triethyl citrate - Iron oxide red (E172) - Iron oxide black (E172)
The printing ink:
Shellac - Iron oxide black (E172) - Propylene glycol - Ammonium hydroxide.
What Pantoprazole tablets look like and contents of the pack
The 40 mg gastro-resistant tablets are reddish-black coloured, biconvex, oval shaped, coated tablets imprinted with 'P40' on one side and plain on the other side.
Pack sizes
Boxes of7,14,15,28,30,56,60,98 and 100 gastro-resistant tablets in blister packs.
Not all pack sizes may be marketed.
Marketing authorisation holder and manufacturer
Marketing authorisation holder Jubilant Pharmaceuticals nv Axxes Business Park Guldensporenpark 22 - Block C 9820 Merelbeke Belgium
This leaflet was last approved in 05/2012.