Pantoprazole 20 Mg Gastro-Resistant Tablets
Out of date information, search anotherRead all of this leaflet carefully before you start using this medicine because it contains important information for you.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 this leaflet
1. What Pantoprazole 20 mg gastro-resistant tablets is and what it is used for
2. What you need to know before you take Pantoprazole 20 mg gastro-resistant tablets
3. How to take Pantoprazole 20 mg gastro-resistant tablets
4. Possible side effects
5. How to store Pantoprazole 20 mg gastro-resistant tablets
6. Contents of the pack and other information
1. WHAT PANTOPRAZOLE 20 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 20 mg gastro-resistant tables are used for:
Adults and adolescents 12 years of age and above:
• treating symptoms (e.g. heartburn, acidic regurgitation and 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
Adults:
• preventing duodenal and stomach ulcers caused by anti-inflammatory drugs (NSAIDs, for example, ibuprofen) in patients at risk who need to take NSAIDs continuously.
2. BEFORE YOU TAKE PANTOPRAZOLE 20 MG GASTRO-RESISTANT TABLETS
Do not take Pantoprazole 20 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 20 mg gastro-resistant tablets
• if you are pregnant, planning to become pregnant or breastfeeding (see “pregnancy and breast-feeding”)
• If you have severe liver problems. Please tell your doctor if you have ever had problems with your liver. 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 need to take medicines called NSAIDs continuously and receive Pantoprazole because you have an increased risk of developing stomach and intestinal complications. Any increased risk will be assessed according to your own personal risk factors such as your age (65 years old or more), a history of stomach or duodenal ulcers or of stomach or intestinal bleeding.
• 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 B 12.
• 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 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 your symptoms 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 2.18mg, mannitol 18.1mg, propylene glycol 1.36mg
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 20 mg gastro-resistant tablets
Pantoprazole may influence the effectiveness of other medicines, so tell your doctor if your 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-infection)
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 or pharmacist 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 20 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 age and above:
To treat symptoms (e.g. heartburn, acid regurgitation, pain on swallowing) associated to gastrooesophageal 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. Your doctor will tell you 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 in the return of reflux oesophagitis
The usual dose is one tablet a day. If the illness returns, your doctor can double the dose, in which case you can use Pantoprazole 40 mg tablets instead, one a day. After healing, you can reduce the dose back again to one tablet 20 mg a day.
Adults:
To prevent duodenal and stomach ulcers in patients who need to take NSAIDs continuously
The usual dose is one tablet a day.
Special patient groups:
• If you suffer from severe liver problems, you should not take more than one 20 mg tablet a day.
• Children below 12 years. These tablets are not recommended for use in children below 12 years.
If you take more Pantoprazole 20 mg gastro-resistant tablets than you should
Tell your doctor or pharmacist. There are no known symptoms of overdose.
If you forget to take Pantoprazole 20 mg gastro-resistant tablets
Do not take a double dose to make up for a forgotten dose. Take your next normal dose at the usual time.
If you stop taking Pantoprazole 20 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
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 includes any side effects not listed in this leaflet.
5. HOW TO STORE PANTOPRAZOLE 20 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 medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines 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 1 to 10 users in 10000):
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 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”)
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,
What Pantoprazole 20mg gastro-resitant tablets contains
The active substance is pantoprazole. Each gastro-resistant tablet contains 20 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: methacrvlic 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 (E172), N-butyl alcohol, propylene glycol, ammonium hydroxide (28%)
What Pantoprazole 20 mg gastro-resistant tablets look like and contents of the pack
Pantoprazole 20 mg gastro-resistant tablets are yellow enteric coated oval shaped, biconvex tablets imprinted with ‘II’ on one side and plain on other side.
Pantoprazole 20 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 following names
Austria Pantoprazol Ranbaxy 20 mg
Filmtabletten
Belgium YOEVID 20mg
maagsapresistente tabletten
Denmark Pantoprazol Ranbaxy
enterotabletter 20mg
France Pantoprazole Ranbaxy
20 mg, comprime gastro-resistant
Germany PANTOPRAZOL BASICS
20 mg magensaftresistente Tabletten
Italy PANTOPRAZOLO
RANBAXY 20 mg compresse gastroresistenti
Netherlands Pantoprazol 20 Ranbaxy,
maagsapresistente tabletten
Poland Ranloc
Portugal Pantoprazol Ranbaxy
20 mg Comprimidos gastroresistentes
Spain PANTOPRAZOL Ranbaxygen
20mg Comprimidos gastroresistentes EFG
Sweden Pantoprazol Ranbaxy 20 mg
United Kingdom Pantoprazole 20 mg gastro-resistant tablets
This leaflet was last revised in May 2012.
LPUK055/20/A