Pantoprazole 40 Mg Gastro-Resistant Tablets
LULU 92
155 mm_,
141 mm_J 14 mm
IIIIIJNIIIII
PACKAGE LEAFLET: INFORMATION FOR THE USER
Pantoprazole 40 mg Gastro-resistant Tablets
Pantoprazole
Read this entire leaflet carefully before you start taking this medicine because it contains important information for you.
• Keep this leaflet. You may need to read it again.
• If you have further questions, please ask your doctor or your pharmacist.
• This medicine has been prescribed for you personally and you should not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Pantoprazole gastro-resistant tablets are and what it is used for
2. What you need to know before you take Pantoprazole gastro-resistant tablets
3. How to take Pantoprazole gastro-resistant tablets
4. Possible side effects
5. How to store this medicines
6. Contents of the pack and other information
1. WHAT PANTOPRAZOLE GASTRO-RESISTANT TABLETS ARE AND WHAT THEY ARE USED FOR
Pantoprazole gastro-resistant tablets are a preparation for treating acid-related diseases of the stomach and intestine. They are a "selective proton pump inhibitor", something which reduces the amount of acid produced in your stomach.
Pantoprazole gastro-resistant tablets are used for treating:
Adults and adolescents 12 years of age and above
• Reflux oesophagitis.
Adults
• Eradication of Helicobacter pylori (H. pylori) in combination with appropriate antibiotic therapy in patients with H. pylori associated ulcers.
• Gastric and duodenal ulcer.
• Zollinger-Ellison-Syndrome and other pathological hypersecretory conditions.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PANTOPRAZOLE GASTRO-RESISTANT TABLETS
Do not take Pantoprazole gastro-resistant tablets:
• If you are allergic (hypersensitive) to Pantoprazole or to any of the other Ingredients of this medicine (see section 6 for a list of these).
• In combination with antibiotics, if you have moderate to severe liver or kidney problems.
• If you are taking medicine containing atazanavir (for the treatment of HIV- infection) at the same time.
Warnings and Precautions
Talk to your doctor before taking Pantoprazole:
• If you have ever had a skin reaction after treatment with a medicine similar to Pantoprazole that reduces stomach acid.
If you get a rash on your skin, especially in areas exposed to the sun tell your doctor as soon as you can, as you may need to stop your treatment with Pantoprazole. Remember to also mention any other ill- effects like pain in your joints.
• If you have severe liver problems. Please tell your doctor if you have ever had problems with your liver. Your doctor may check your liver enzymes more frequently. The dose may be reduced or the treatment may be stopped.
• If you need to take medicines called NSAIDs continuously and are prescribed pantoprazole 40 mg 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 are taking a medicine containing atazanavir (for the treatment of HIV-infection) at the same time as pantoprazole, ask your doctor for specific advice.
• If you have reduced body stores or risk factors for reduced vitamin B12 and receive pantoprazole longterm treatment. As with all acid reducing agents, pantoprazole may lead to reduced absorption of vitamin B12.
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 40 mg 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.
Other medicines and Pantoprazole gastro-resistant Tablets
Pantoprazole gastro-resistant Tablets may influence the effectiveness of other medicines, so:
• Tell your doctor if you are taking any other medicines (e.g. ketoconazole) because Pantoprazole may stop certain other medicines from working properly.
• Tell your doctor if you are taking any other medicines especially medicines such as warfarin and phenprocoumon, which affect the thickening, or thinning of the blood. You may need further checks.
• Tell your doctor if you are taking a medicine containing atazanavir (used to treat HIV-infection). Atazanavir must not be used together with Pantoprazole 40mg.
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 to be greater than the potential risk for your unborn child.
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 machinery.
Always take Pantoprazole 40 mg tablets 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 gastro-resistant tablets
Tablets should not be chewed or crushed, and should be swallowed whole one hour before a meal with some water.
Recommended dose:
Adults and adolescents 12 years of age and above:
Reflux oesophagitis
One pantoprazole 40 mg gastro-resistant tablet per day. In individual cases the dose may be doubled (increase to two tablets daily) especially when there has been no response to other treatment. A four week period is usually required for the treatment of reflux oesophagitis. If this is not sufficient, healing will usually be achieved within a further four weeks.
Adults:
Eradication of H. pylori in combination with two appropriate antibiotic:
In H. pylori positive patients with gastric and duodenal ulcers, eradication of the germ by a combination therapy should be achieved. Considerations should be given to official local guidance (e.g. national recommendations) regarding bacterial resistance and the appropriate use and prescription of antibacterial agents. Depending upon the resistance pattern, the following combinations can be recommended for the eradication of H. pylori:
a) twice daily one Pantoprazole 40 mg gastro-resistant tablet + twice daily 1000 mg amoxycillin
+ twice daily 500 mg clarithromycin
b) twice daily one Pantoprazole 40 mg gastro-resistant tablet
+ twice daily 400 - 500 mg metronidazole (or 500 mg tinidazole)
+ twice daily 250 - 500 mg clarithromycin
c) twice daily one Pantoprazole 40 mg gastro-resistant tablet + twice daily 1000 mg amoxicillin
+ twice daily 400 - 500 mg metronidazole (or 500 mg tinidazole)
In combination therapy for eradication of H. pylori infection, the second pantoprazole 40 mg gastro-resistant tablet should be taken one hour before the evening meal. The combination therapy is implemented for seven days in general and can be prolonged for a further seven days to a total duration of up to two weeks.
If, to ensure healing of the ulcers, further treatment with pantoprazole is indicated, the dose recommendations for duodenal and gastric ulcers should be considered.
If combination therapy is not an option, e.g. if the patient has tested negative for H. pylori, the following dose guidelines apply for pantoprazole monotherapy:
Treatment of gastric ulcer
One pantoprazole 40 mg gastro-resistant tablet per day. In individual cases the dose may be doubled (increase to two tablets daily) especially when there has been no response to other treatment. A four week period is usually required for the treatment of gastric ulcers. If this is not sufficient, healing will usually be achieved within a further four weeks.
Treatment of duodenal ulcer
One pantoprazole 40 mg gastro-resistant tablet per day. In individual cases the dose may be doubled (increase to two tablets daily) especially when there has been no response to other treatment. A duodenal ulcer generally heals within two weeks. If a two week period of treatment is not sufficient, healing will be achieved in almost all cases within a further two weeks.
Zollinger-Ellison-Syndrome and other pathological hypersecretory conditions:
For the long-term management of Zollinger-Ellison-Syndrome and other pathological hypersecretory conditions patients should start their treatment with a daily dose of 80 mg (two tablets of pantoprazole 40 mg). Thereafter, the dose can be titrated up or down as needed using measurements of gastric acid secretion to guide. With doses above 80 mg daily, the dose should be divided and given twice daily. A temporary increase of the dose above 160 mg pantoprazole is possible but should not be applied longer than required for adequate acid control.
Treatment duration in Zollinger-Ellison-Syndrome and other pathological hypersecretory conditions is not limited and should be adapted according to clinical needs.
Special populations:
Children below 12 years of age:
Pantoprazole 40 mg gastro-resistant tablets are not recommended for use in children below 12 years of age due to limited data on safety and efficacy in this age group.
Renal Impairment:
No dose adjustment is necessary in patients with impaired renal function.
Pantoprazole gastro-resistant tablets must not be used in combination treatment for eradication of H. pylori in patients with impaired renal function since currently no data are available on the efficacy and safety of pantoprazole gastro-resistant tablets in combination treatment for these patients.
Elderly:
No dose adjustment is necessary in the elderly.
If you take more Pantoprazole gastro-resistant tablets than you should
Consult your doctor or pharmacist. There are no known symptoms of overdose.
If you forget to take Pantoprazole 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 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 product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Pantoprazole gastro-resistant Tablets can cause side effects, although not everybody gets them.
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) rash, possibly with pain in the joints 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.
• 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 you are on Pantoprazole gastro-resistant Tablets, 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.
Taking a proton pump inhibitor like Pantoprazole gastro-resistant Tablets, 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).
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.
Reporting of side effects:
If you get any side effects, talk to your doctor. This includes any possible side effects in this leaflet. You can also report side effects directly via Yellow Card Scheme at www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE PANTOPRAZOLE GASTRO-RESISTANT TABLETS
Keep out of the reach and sight of children.
Do not use Pantoprazole 40 mg tablets after the expiry date, which is stated on the carton and the container. The expiry date refers to the last day of that month.
Do not store above 25° C.
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. CONTENTS OF THE PACK AND OTHER INFORMATION What Pantoprazole 40 mg tablets contain
The active substance is pantoprazole. One tablet contains 40 mg of pantoprazole (as sodium sesquihydrate). The other ingredients are:
Core: Mannitol (E421), Crospovidone type A (E1202), Sodium carbonate anhydrous, Calcium stearate. Coating: Hydroxy propyl methyl cellulose 5 cP (E464), Povidone k-25 (E1201), Propylene glycol(E1520), Titanium dioxide (E171), Iron oxide yellow (E172), Methacrylic acid copolymer dispersion, Triethyl citrate (E1505).
What Pantoprazole 40 mg tablets look like and contents of the pack
Yellow oval, biconvex, enteric coated tablets, plain on both sides.
Pantoprazole 40 mg gastro-resistant tablets are available in blister-strip pack having 28 tablets.
Marketing Authorisation Holder and Manufacturer
Wilcare Pharma Limited,
Building 6 Unit 14, Croxley Green Business Park,
Watford, England WD18 8YH
If you would like this leaflet in a different format or register a complaint please contact the Marketing Authorisation holder listed above or send an email to complaints@wilcarepharma.co.uk
This leaflet was last revised in November 2015
141 mm 155 mm
Center fold 290 mm
◄-►