Pantoprazole 40 Mg Gastro-Resistant Tablets
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Pantoprazole 40 mg
Gastro-resistant Tablets
Pantoprazole
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.
In this leaflet:
1. What Pantoprazole is and what it is used for
2. Before you take Pantoprazole
3. How to take Pantoprazole
4. Possible side effects
5. How to store Pantoprazole
6. Further information
1. what pantoprazole is and what it is
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 regurgitating 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. before you take pantoprazole
Do not take Pantoprazole
- If you are allergic (hypersensitive) to pantoprazole or to any of the other ingredients of Pantoprazole (see section 6).
- If you are allergic to medicines containing other proton pump inhibitors.
Take special care with Pantoprazole:
- 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 as a longterm 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 BI2 and receive pantoprazole long-term treatment. As with all acid reducing agents, pantoprazole may lead to a reduced absorption of vitamin BI2.
- 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 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 I 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 may influence the effectiveness of other medicines, so tell your doctor if you are taking
- Medicines such as ketoconazole, itraconazole and posaconazole (used to treat fungal infections) or erlotnib (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).
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.
3. how to take pantoprazole
Always take Pantoprazole 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?
Take the tablets I 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 I hour before breakfast and the second pantoprazole tablet I 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 I 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, take the tablets in twice daily.
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 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 20 mg pantoprazole are available).
- Children below I2 years. These tablets are not recommended for use in children below I2 years.
If you take more Pantoprazole than you should
Tell your doctor or pharmacist. There are no known symptoms of overdose.
If you forget to take your Pantoprazole
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
Do not stop taking the 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.
4. possible side effects
Like all medicines, Pantoprazole 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 1 user in 10)
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 disease / 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 known 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. 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).
- Rare (affects 1 to 10 users in 10,000) 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 (affects less than 1 user in 10,000) disorientation.
- Not known (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 Protium 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 l,000)an increase in liver enzymes
- Rare (affects 1 to 10 users in 10,000)
an increase in bilirubin; increased fats in the blood; sharp drop in circulating granular white blood cells, associated with high fever.
- 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; coexisting abnormal reduction in the number of red and white blood cells, as well as platelets.
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.
5. how to store pantoprazole
Keep out of the reach and sight of children.
Do not use Pantoprazole 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.
For HD PE bottles: do not use tablets beyond 2 months after first opening of the bottle.
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 contains
The active substance is pantoprazole. Each gastro-resistant tablet contains 40 mg of pantoprazole (as sodium sesquihydrate).
The other ingredients are:
Core: sodium carbonate (anhydrous), mannitol, crospovidone, povidone K90, calcium stearate.
Coating: hypromellose, povidone K25, titanium dioxide (El7l), yellow iron oxide (El72), propylene glycol, methacrylic acid-ethyl acrylate copolymer (l:l), polysorbate 80, sodium laurilsulfate, triethyl citrate, Printing ink: shellac, red, black and yellow iron oxide (El72) and ammonia solution, concentrate.
What Pantoprazole looks like and contents of the pack
A yellow, oval, biconvex film-coated tablet imprinted with “P40” on one side.
Packs: high density polyethylene bottle with low density polyethylene screw cap, aluminium/aluminium blisters with cardboard reinforcement, aluminium/ aluminium blisters without cardboard reinforcement.
Pantoprazole 40 mg is available in the following pack sizes:
Packs with 7, l0, l4, l5, 24, 28, 30, 48, 56, 60, 84, 90, 98, 100, ll2, l 68 gastro-resistant tablets Hospital packs with 50, 90, 100, l40, 140 (l0xl4), 700 (5xl40) gastro-resistant tablets
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Takeda GmbH Byk-Gulden-StraBe 2 D-78467 Konstanz Germany
Manufacturer
Takeda GmbH Production site Oranienburg LehnitzstraBe 70 - 98 D-l65l5 Oranienburg Germany
This leaflet was last approved in 11/2012.
Detailed information on this medicinal product is available on the website of the Heads of Medicines Agenies (HMA) http://www.hma.eu
GBR F.l/lll2/6xxxxxx