Pantoprazole 40 Mg Gastro-Resistant Tablets
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Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
• Keep this leaflet. You may need to read It again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you. 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet,._
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What is in n this leaflet:
1. What Pantoprazole 40 mg gastro-resistant tablets is and what it is used for
2. What you need to know before you take Pantoprazole 40 mg gastro-resistant tablets
3. How to take Pantoprazole 40 mg gastro-resistant tablets
4. Possible side effects
5. How to store Pantoprazole 40 mg gastro-resistant tablets
6. Contents of the pack and other information
1. WHAT PANTOPRAZOLE 40 MG GASTRO-
RESISTANT TABLETS 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 40 MG GASTRO-RESISTANT TABLETS
Do not take Pantoprazole 40 mg gastro-resistant tablets
• if you are allergic to pantoprazole or to any of the other ingredients of this medicine (listed in section 6).
• If you are allergic to medicines containing other proton pump inhibitors.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Pantoprazole 40 mg gastro-resistant 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 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 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 week (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 yoursymptoms continue in spite of your treatment, further investigations will be considered.
If you take Pantoprazole 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.
One gastro-resistant tablet contains sodium 4.36mg, mannitol 36.2mg, propylene glycol 2.72mg
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).
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.
Other medicines and Pantoprazole 40 mg gastro-resistant tablets
Pantoprazole may influence the effectiveness of other medicines, so tell you doctor if you are taking.
• Medicines such as ketoconazole, itraconazole and posaconazole (used to treat fungal infections) orerlotinib (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-infections)
Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Pregnancy, breast-feeding and fertility
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 breastfeeding, 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. If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this 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 40 MG GASTRO-RESISTANT 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?
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 aae 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 dayAfter 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 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.
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 you get any side effects, talk to your doctor, pharmacist or nurse. This includesany side effects not listed in this leaflet.
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 of age.
If you take more Pantoprazole 40 mg gastro-resistant tablets than you should
Consult your doctor or pharmacist. There are no known symptoms of overdose.
If you forget to take Pantoprazole 40 mg gastro-resistant tablets
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 40 mg gastro-resistant 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 medicine, ask your doctor, pharmacist or nurse.
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE PANTOPRAZOLE 40 MG
GASTRO-RESISTANT TABLETS_
• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date, which is stated on the carton and blister after “EXP”. The expiry date refers to the last day of that month.
• This medicine does not require any special storage conditions.
' Do not throw away any medicinesvia wastewater or household waste. Ask your pharmacist how to throw awaymedicines you no longer use. These measures will help protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
Like all medicines, this medicine 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).
Other side effects are:
Uncommon (affects 1 to 10 users in 1000):
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 (see section 2.2 “Warnings and precautions”)
Rare (affects 1to 10 users in 10000):
Disturbances in vision such as blurred vision, 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 10000)
• 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, low levels of magnesium in your blood (hypomagnesaemia) (see section 2.2 “Warnings and precautions”)
What Pantoprazole 40 mg gastro-resistant tablets contain
The active substance is pantoprazole. Each gastro-resistant tablet contains 40 mg pantoprazole (as sodium sesquihydrate).
The other ingredients are:
Core: sodium carbonate, anhydrous, mannitol, crospovidone type A, hyprolose, cellulose, microcrystalline, calcium stearate Sub-coat: hypromellose, propylene glycol, povidone K30, titanium dioxide (E 171), yellow iron oxide (E172)
Enteric coat: methacrylic acid-ethylacrylate copolymer (1:1), triethyl citrate, sodium laurilsulfate, titanium dioxide (E 171), talc, yellow iron oxide (E 172)
Printing ink: shellac, ethanol, isopropyl alcohol black iron oxide (E 172), N-butyl alcohol, propylene glycol, ammonium hydroxide (28%)
What Pantoprazole 40 mg gastro-resistant tablets look like and contents of the pack
Pantoprazole 40 mg gastro-resistant tablets are yellow enteric coated oval shaped, biconvex tablets imprinted with ‘IV on one side and plain on other side.
Pantoprazole 40 mg gastro-resistant tablets come in packs of 7,14,15,28,30,50,56,60,98,100 and 500 gastro-resistant tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder
Ranbaxy (UK) Limited Building 4, Chiswick Park,
566 Chiswick High Road,
London, W4 5YE United Kingdom
Manufacturer:
Ranbaxy Ireland Limited Spafield, Cork Road,
Cashel, Co. Tipperary,
Ireland
This medicinal product is authorised in the Member States of the EEA under the following names
Austria
Belgium Denmark Germany
Italy
Netherlands
Poland
Portugal
Spain
Sweden United Kingdom
Pantoprazol Ranbaxy 40 mg Filmtabletten YOEVID 40mg maagsapresistente tabletten Pantoprazol Ranbaxy enterotabletter40mg PANTOPRAZOL BASICS 40 mg magensaftresistente Tabletten PANTOPRAZOLO RANBAXY 40 mg compresse gastroresistenti Pantoprazol 40 Ranbaxy, maagsapresistente tabletten Ranloc
Pantoprazol Ranbaxy 40 mg Comprimidos gastroresistentes PANTOPRAZOL Ranbaxygen 40mg Comprimidos gastroresistentes EFG Pantoprazol Ranbaxy 40 mg enterotabletter Pantoprazole 40 mg Gastro-resistant Tablets
LPUK055/40/A