Pantoprazole 40 Mg Gastro-Resistant Tablets
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PACKAGE LEAFLET: INFORMATION FOR THE USER
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 diseases 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. Before you take Pantoprazole
Do not take Pantoprazole
• If you are allergic (hypersensitive) to pantoprazole, sorbitol 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 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 corjtaining atazanavir (for the treatment of HIV-infection) at thp 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 (aqaemia)
• you notice blood in your stools
• severe and/or persistent diarrhbea, as Pantoprazole has been associated with a small increasp in infectious diarrhoea.
Your doctor may decide that you heed some tests to rule out malignant disease because pantqprazole also alleviates the symptoms of cancer and could cause delay in diagnosing it. If your symptoms continue in spite of yobr treatment, further investigations will be considered.
If you take Pantoprazole on a lonjj-term basis (longer than 1 year) your doctor will probably keep yop under regular surveillance. You should report any new and exceptional symptoms and circumstances whenever you see' your doctor.
Taking a proton pump inhibitor likp 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 qorticosteroids (which can increase the risk of osteoporosis):
Taking other medicines
Pantoprazole may influence the effectiveness of other medicines, so tell you doctor if you are takincj
• Medicines such as ketoconazolp, 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 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.
Important information about some of the ingredients of Pantoprazole
Pantoprazole contains sorbitol. If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicinal product.
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 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 (ortinidazole), 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.
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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 for eradication of Helicobacter 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 than you should
Consult your doctor or pharmacist. There are no known symptoms
of overdose.
If you forget to take 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 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.
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 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).
If you are on pantoprazole for njore 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 pny of these symptoms, please tell your doctor promptly. Low levels of magnesium can also lead to a reduction in potassium orcblcium levels in the blood. Your doctor may decide to perform regular blood tests to monitor your levels of magnesium.
Other side effects are:
• Uncommon (affects 1 to 10 users in 1,000)
Headache; dizziness; diarrhoea'; feeling sick, vomiting; bloating and flatulence (wind); constipatipn; dry mouth; abdominal pain and discomfort; skin rash, exanthema, eruption; itching; fracture of the hip, wrist or spine; feelincj weak, exhausted or generally unwell; sleep disorders.
• Rare (affects 1 to 10 users in 10,000)
Disturbances in vision such as blurred vision; hives; pain in the joints; muscle pains; weight chqnges; raised body temperature; swelling of the extremities (peripheral oedema); allergic reactions; depression; breast enlargement in males.
• Very Rare (affects less than 1 qser 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 sddium level in blood.
Side effects identified through blood tests:
• Uncommon (affects 1 to 10 usbrs in 1,000)
An increase in liver enzymes.
• Rare (affects 1 to 10 users in 10,000)
An increase in bilirubin; increasted 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.
5. How to store Pantoprazole
Keep out of the reach and sight of children.
Blister pack: Store in the original package in order to protect from moisture.
Container: Keep the container tightly closed in order to protect from moisture.
Expiry date
Do not use Pantoprazole after the expiry date which is stated on the packaging. The expiry date refers to the last day of that month.
HDPE tablet container:
Shelf life after the first opening is 3 months.
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
• Each gastro-resistant tablet contains 40 mg pantoprazole (as pantoprazole sodium sesquihydrate).
• The other ingredients are mannitol, crospovidone (type B), anhydrous sodium carbonate, sorbitol (E420), calcium stearate in the tablet core and hypromellose, povidone (K25), titanium dioxide (E171), yellow iron oxide (E172), propylene glycol, methacrylic acid - ethyl acrylate copolymer, sodium lauryl sulphate, polysorbate 80, macrogol 6000 and talc in the film-coating.
What Pantoprazole looks like and contents of the pack
The 40 mg gastro-resistant tablets are light brownish yellow, oval,
slightly biconvex tablets.
Pack sizes:
Boxes of 7,10,14,15, 28, 30, 56, 60, 84,100,100 x 1,112 and
140 gastro-resistant tablets in blister packs.
A plastic container of 250 gastro-resistant tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
KRKA, d.d., Novo mesto, Smarjeska cesta 6,8501 Novo mesto,
Slovenia
This leaflet was last approved in 12/2012