Pantoprazole 40 Mg Gastro-Resistant Tablets
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Package Leaflet: Information for the user
Pantoprazole 40 mg Gastro-resistant Tablets
Pantoprazole
Read this entire leaflet carefully before you start taking this medicine.
- 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 any of the side effects get 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 40 mg tablets are and what they are used for
2. Before you take Pantoprazole 40 mg tablets (Some of the information for your safety)
3. How to take Pantoprazole 40 mg tablets
4. Possible side effects
5. How to store this medicines
6. Further information
1. WHAT PANTOPRAZOLE 40 MG TABLETS ARE AND WHAT THEY ARE USED FOR
Pantoprazole 40 mg 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 40 mg 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. BEFORE YOU TAKE PANTOPRAZOLE 40 MG TABLETS Do not take Pantoprazole 40 mg 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 a medicine containing atazanavir (for the treatment of HIV- infection) at the same time.
Take special care with Pantoprazole 40 mg tablets:
• 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 long-term treatment. As with all acid reducing agents, pantoprazole may lead to a 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 diarrhoeia as Pantoprazole has been associated with a small increase in infectious diarrhoia
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.
Taking other medicines
Pantoprazole 40 mg 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.
3. HOW TO TAKE PANTOPRAZOLE 40 MG TABLETS
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 40 mg 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 patter, 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:
T reatment 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 40 mg tablets than you should
Consult your doctor or pharmacist. There are no known symptoms of overdose.
If you forget to take Pantoprazole 40 mg 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 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 40 mg 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:
Approximately 5 % of patients can be expected to experience adverse drug reactions (ADRs). The most commonly reported ADRs are diarrhoea and headache, both occurring in approximately 1 % of patients.
The following undesirable effects have been observed in clinical studies with pantoprazole.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
|
Frequency |
Very common (>1/10) |
Common (>1/100 to <1/10) |
Uncommon (>1/1,000 to <1/100) |
Rare (>1/1 0,000 to <1/1,000) |
Very rare (<1/10,000) |
|
System Organ Class | |||||
|
Blood and lymphatic system |
Thrombocytopenia; Leukopenia | ||||
|
Nervous system disorders |
Headache; Dizziness | ||||
|
Eye disorders |
Disturbances in vision / blurred vision | ||||
|
Gastrointestinal Disorders |
Diarrhoea; Nausea / vomiting; Abdominal distension and bloating; Constipation; Dry mouth; Abdominal pain and discomfort | ||||
|
Skin and subcutaneous tissue disorders |
Rash / exanthema / eruption; Pruritus |
Urticaria; Angioedema | |||
|
Musculoskeleta l, connective tissue disorders |
Arthralgia; Myalgia | ||||
|
Metabolism and nutrition disorders |
Hyperlipidae mias and lipid increases; Weight changes | ||||
|
General disorders and administration site conditions |
Asthenia, fatigue and malaise |
Body temperature increased; Oedema peripheral | |||
|
Immune system disorders |
Hypersensitivity (incl. anaphylactic reactions and anaphylactic shock) | ||||
|
Hepatobiliary disorders |
Liver enzymes increased (transaminases, Y-GT) |
Bilirubin increased | |||
|
Psychiatric disorders |
Sleep disorders |
Depression (and all aggravations) |
Disorientation (and all aggravations) |
Frequency not known: 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.
The following additional undesirable effects have been reported postmarketing:
Hepatobiliary disorders: Hepatocellular injury, Jaundice, Hepatocellular failure
Psychiatric disorders: Hallucination, Confusion (especially in pre-disposed patients, as well as the aggravation of these symptoms in case of preexistence)
Renal and urinary disorders: Interstitial nephritis
Skin and subcutaneous tissue disorders: Stevens-Johnson syndrome, Lyell syndrome; Erythema multiforme, Photosensitivity
Please remember:
• The expected benefits of your medicine will usually be greater than the risks of suffering any harmful side effects.
• 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 40 MG 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 250 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. FURTHER 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), Opacode Black [Shellac (E904), Iron oxide black (E172), Propylene glycol (E1520), Ammonium hydroxide 28% (E527)]
What Pantoprazole 40 mg tablets look like and contents of the pack
Yellow oval, biconvex, enteric coated tablets imprinted with 'CL25' on one side and plain on other side.
Pantoprazole 40mg tablets are available in the following pack sizes: Blister-strip pack having 28 gastro-resistant tablets.
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Marketing Authorisation Holder
Macleods Pharma UK Limited,
Wynyard Park House, Wynyard Avenue, Wynyard,
Billingham, TS22 5TB, United Kingdom
Manufacturer
Mawdsleys Brooks and Co Ltd Unit 22, Quest Park, Wheatley Hall Road,
Doncaster, DN2 4LT, United Kingdom
This leaflet was last revised in 08/2014
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