Each enteric coated tablet contains 20 mg or 40 mg of pantoprazole (as sodium sesquihydrate).
Excipients/Inactive Ingredients: Tablet core: Mannitol, anhydrous sodium carbonate, sodium starch glycolate (type A), methacrylic acid copolymer (Eudragit E PO or equivalent), calcium stearate.
Sub coating: Opadry white OY-D-7233 (hypromellose, titanium dioxide E171, talc, macrogol 400, sodium laurilsulphate).
Enteric coating: Kollicoat MAE 30 DP, yellow (methacrylic acid-ethyl acrylate copolymer dispersion, propylene glycol, yellow iron oxide (E172), titanium dioxide (E171), talc).
Panrazol (Pantoprazole) is a selective "proton pump inhibitor", a medicine which reduces the amount of acid produced in the stomach. It is used for treating acid-related diseases of the stomach and intestine.
Panrazol is used for treating: Adults and adolescents 12 years of age and above: EC tab 20 mg: Treating symptoms (e.g. heartburn, acid regurgitation, pain on swallowing) associated to gastro-oesophageal reflux disease caused by reflux of acid from the stomach.
Long-term management of reflux oesophagitis (inflammation of the oesophagus accompanied by the regurgitation of stomach acid) and preventing its return.
EC tab 40 mg: Reflux oesophagitis: An inflammation of the oesophagus (the tube which connects the throat to the stomach) accompanied by the regurgitation of stomach acid.
Adults: EC tab 20 mg: Preventing duodenal and stomach ulcers caused by non-steroidal anti-inflammatory drugs (NSAIDs, for example, ibuprofen) in patients at risk who need to take NSAIDs continuously.
EC tab 40 mg: 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.
Always take Panrazol exactly as the doctor has told. Check with the doctor or pharmacist if not sure.
When and how to take Panrazol: Take the tablets 1 hour before a meal without chewing or breaking them and swallow them whole with some water.
Unless told otherwise by the doctor, the usual dose is: Adults and adolescents 12 years of age and above: EC tab 20 mg: To treat symptoms (e.g. heartburn, acid regurgitation, pain on swallowing) associated to gastro-oesophageal reflux disease: The usual dose is one tablet a day. This dose usually brings relief within 2‑4 weeks - at most after another 4 weeks. The doctor will tell how long to continue taking the medicine. After this any recurring symptoms can be controlled by taking one tablet daily, when required.
For long-term management and for preventing the return of reflux oesophagitis: The usual dose is one tablet a day. If the illness returns, the doctor can double the dose, in which case the patient can use Panrazol 40 mg tablets instead, one a day. After healing, the patient can reduce the dose back again to one tablet 20 mg a day.
EC tab 40 mg: To treat reflux oesophagitis: The usual dose is one tablet a day. The doctor may tell the patient to increase to 2 tablets daily. The treatment period for reflux oesophagitis is usually between 4 and 8 weeks. The doctor will tell the patient how long to take the medicine.
Adults: EC tab 20 mg: To prevent duodenal and stomach ulcers in patients who need to take NSAIDs continuously: The usual dose is one tablet a day.
EC tab 40 mg: 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 pantoprazole tablet. Take the first pantoprazole tablet 1 hour before breakfast and the second pantoprazole tablet 1 hour before evening meal. Follow the doctor's instructions and make sure to 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 the doctor, the dose may be doubled.
The doctor will tell the patient how long to take the 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. The doctor may later adjust the dose, depending on the amount of stomach acid the patient produce. If prescribed more than two tablets a day, the tablets should be taken twice daily.
If the doctor prescribes a daily dose of more than four tablets a day, the patient will be told exactly when to stop taking the medicine.
Special patient groups: If the patient suffers from severe liver problems, he/she 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.
EC tab 40 mg: If the patient has kidney problems, moderate or severe liver problems, he/she should not take Panrazol for eradication of Helicobacter pylori.
If the patient forgets to take Panrazol: Do not take a double dose to make up for the forgotten dose. Take the next, normal dose at the usual time.
If the patient stops taking Panrazol: Do not stop taking these tablets without first talking to the doctor or pharmacist.
If the patient has any further questions about the use of the product, ask the doctor or pharmacist.
Consult the doctor or pharmacist. There are no known symptoms of overdose.
Do not take Panrazol: If the patient is allergic (hypersensitive) to pantoprazole or to any of the other ingredients of Panrazol (see Description).
If the patient is allergic to medicines containing other proton pump inhibitors.
Subacute cutaneous lupus erythematosus (SCLE) Proton pump inhibitors are associated with very infrequent cases of SCLE. If lesions occur, especially in sun-exposed areas of the skin, and if accompanied by arthralgia, the patient should seek medical help promptly and the health care professional should consider stopping Panrazol. SCLE after previous treatment with a proton pump inhibitor may increase the risk of SCLE with other proton pump inhibitors.
If the patient has severe liver problems. Tell the doctor if the patient ever had liver problems in the past. He will check the liver enzymes more frequently, especially when the patient is taking Panrazol as a long-term treatment. In the case of a rise of liver enzymes the treatment should be stopped.
If the patient has 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 the patient is taking a medicine containing atazanavir (for the treatment of HIV-infection) at the same time as pantoprazole, ask the doctor for specific advise.
Decreased gastric acidity due to any means, including proton pump inhibitors, increases gastric counts of bacteria normally present in the gastrointestinal tract. Treatment with proton pump inhibitors may lead to slightly increased risk of gastrointestinal infections such as Salmonella and Campylobacter and possibly Clostridium difficile.
Taking a proton pump inhibitor like Pantoprazole, especially over a period of more than one year, may slightly increase the patient's risk of fracture in the hip, wrist or spine. Tell the doctor if the patient has osteoporosis or if he/she is taking corticosteroids (which can increase the risk of osteoporosis).
Long-term (a year or longer) and multiple daily dose PPI therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist or spine. Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated.
Tell the doctor immediately if the patient notices any of the following symptoms: an unintentional loss of weight; repeated vomiting; difficulty in swallowing; vomiting blood; looks pale and feel weak (anaemia); blood in the stools; severe and/or persistent diarrhoea, as Panrazol has been associated with a small increase in infectious diarrhoea.
The doctor may decide that the patient needs some tests to rule out malignant disease because pantoprazole also alleviates the symptoms of cancer and could cause delay in diagnosing it. If the symptoms continue in spite of the treatment, further investigations will be considered.
If the patient takes Panrazol on a long-term basis (longer than 1 year) the doctor will probably keep the patient under regular surveillance. The patient should report any new and exceptional symptoms and circumstances whenever he/she sees the doctor.
Driving and using machines: If the patient experiences side effects like dizziness or disturbed vision, he/she should not drive or operate machines.
EC tab 20 mg: If the patient needs to take medicines called NSAIDs continuously and receive Panrazol because of an increased risk of developing stomach and intestinal complications. Any increased risk will be assessed according to the patient's own personal risk factors such as age (65 years old or more), a history of stomach or duodenal ulcers or of stomach or intestinal bleeding.
There are no adequate data from the use of pantoprazole in pregnant women. Excretion into human milk has been reported. If the patient is pregnant, or thinks may be pregnant, or breast-feeding, she should use this medicine only if the doctor considers the benefit for the patient greater than the potential risk for her unborn child or baby.
Ask the doctor or pharmacist for advice before taking any medicine.
Like all medicines, Panrazol can cause side effects, although not everybody gets them.
The frequency of possible side effects listed as follows 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 the patient gets any of the following side effects, stop taking these tablets and tell the doctor immediately, or contact the casualty department at the 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 the patient's 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; feeling weak, exhausted or generally unwell; sleep disorders; fracture of the hip, wrist or spine.
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.
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 the patient is on Pantoprazole for more than three months it is possible that the levels of magnesium in the blood may fall. Low levels of magnesium can be seen as fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, increased heart rate. If the patient gets any of these symptoms, tell the doctor promptly.
Low levels of magnesium can also lead to a reduction in potassium or calcium levels in the blood. The doctor may decide to perform regular blood tests to monitor the levels of magnesium.
Warning: Hypomagnesemia, symptomatic and asymptomatic, has been reported rarely in patients treated with PPIs for at least three months, in most cases after a year of therapy. Serious adverse events include tetany, arrhythmias, and seizures.
In most patients, treatment of hypomagnesemia required magnesium replacement and discontinuation of the PPI.
For patients expected to be on prolonged treatment or who take PPIs with medications such as digoxin or drugs that may cause hypomagnesemia (e.g., diuretics), health care professionals may consider monitoring magnesium levels prior to initiation of PPI treatment and periodically.
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 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 the patient notices any side effects not listed, tell the doctor or pharmacist.
Panrazol may influence the effectiveness of other medicines, so tell the doctor if the patient is taking: Medicines such as ketoconazole, itraconazole and posaconazole (used to treat fungal infections) or erlotinib (used for certain types of cancer) because Panrazol may stop these and other medicines from working properly.
Warfarin and phenprocoumon, which affect the thickening, or thinning of the blood. The patient may need further checks.
Atazanavir (used to treat HIV-infection).
Concomitant use of Proton Pump Inhibitors (PPIs) with Methotrexate: Literature suggests that concomitant use of PPIs with methotrexate (primarily at high dose) may elevate and prolong serum levels of methotrexate and/or its metabolite, possibly leading to methotrexate toxicities. A temporary withdrawal of the PPI may be considered in some patients receiving treatments with high dose methotrexate.
Case reports, published population pharmacokinetic studies, and retrospective analyses suggest that concomitant administration of PPIs and methotrexate (primarily at high dose) may elevate and prolong serum levels of methotrexate and/or its metabolite hydroxymethotrexate. However, no formal drug interaction studies of methotrexate with PPIs have been conducted.
Tell the doctor or pharmacist if the patient is taking or has recently taken any other medicines, including medicines obtained without a prescription.
Store below 25°C.
Medicines should not be disposed of via wastewater or household waste. Ask the pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Keep out of the reach and sight of children.
A02BC02 - pantoprazole ; Belongs to the class of proton pump inhibitors. Used in the treatment of peptic ulcer and gastro-oesophageal reflux disease (GERD).
EC tab 20 mg (elliptical, biconvex, light yellow) x 14's. 40 mg (elliptical, biconvex, dark yellow) x 14's.