Pantoprazole 40 Mg Gastro-Resistant Tablets
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Pantoprazole sodium sesquihydrate
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 foryoursafety)
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
PACKAGE LEAFLET: INFORMATION FORTHE USER
Read this entire leaflet carefully before you start taking
this medicine.
- Keep this leaflet. You may need to read it again.
- Ifyou have further questions, please ask yourdoctororyour pharmacist.
- This medicine has been prescribed for you personally and you should not pass it on to others. It may harm them, even if theirsymptoms are the same as yours.
- If any of the side effects get serious, or ifyou notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
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 inyourstomach.
Pantoprazole 40 mg tablets are used fortreating:
• moderate to severe forms of reflux oesophagitis (an inflammation of your oesophagus accompanied by the regurgitating of stomach acid).
• 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.
• deoudenal ulcers
• stomach Ulcers
• Zollinger-Ellison syndrome and other conditions producing too much acid in the stomach.
2. BEFORE YOU TAKE PANTOPRAZOLE 40 MG TABLETS
Do not take Pantoprazole 40 mg tablets:
- ifyou are allergic (hypersensitive) to Pantoprazole orto 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:
• ifyou 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 orthe treatment may 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.
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 yourstools
• 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.
Taking other medicines
Pantoprazole 40 mg tablets may influence the effectiveness of other medicines, so:
• Tell your doctor ifyou 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 ifyou are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Pregnancy and breast-feeding
Clinical experience in pregnant women is limited. There is no information as to whether the active substance passes into human breast milk?70 mm
If you are pregnant, orthinkyou may be pregnant, or if you are breast-feeding, you should use this medicine only if your doctor considers the benefit for you greater than the potential riskforyour unborn child or baby.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
These tablets have no known effect on the ability to drive and to use machinery. Possible side effects (see section 4) like dizziness and disturbances in vision such as blurred vision may decrease the ability to react.
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?
Take one hour before breakfast without chewing or breaking 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:
For reflux oesophagitis: one tablet a day.
After consultation with your doctor, the dose may be doubled.
Your doctor will tell you how long to take your medicine. The treatment period for reflux oesophagitis is usually between 4 and 8 weeks.
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:
amoxicillin, clarithromycin and metronidazole, each to be taken two times a day with your pantoprazole tablet. Take the first pantoprazole tablet one hour before breakfast and the second pantoprazole tablet before your evening meal. Follow your doctor's instructions and make sure you read the package leaflets for these antibiotics.
The usual combinations are the following:
- Pantoprazole 40 mg + 500 mg clarithromycin +1000 mg amoxicillin
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Artwork Same Size Size : 270 x 240 mm
- Pantoprazole 40 mg + 500 mg clarithromycin +500 mg metronidazole
- Pantoprazole 40 mg + 500 mg metronidazole +1000 mg amoxicillin
all taken two times daily. The usual treatment period is one to two weeks.
Forstomach and duodenal ulcers:
One tablet daily.
After consultation with your doctor, the dose may be doubled.
Your doctor will tell you how long to take your medicine. The treatment period forstomach 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:
Two tablets a day
(the recommended starting dose)
Take the two tablets before breakfast. Your doctor may later adjust the dosage, depending on the amount of stomach acid you produce. If prescribed more than two tablets a day, take the tablets in two equal doses. If your doctor prescribes a daily dosage of more than four tablets a day, you will be told exactly when to stop taking the medicine.
Special patient groups:
- If you have kidney problems, you should not take more than one tablet a day.
- If you suffer from severe liver problems, you should take one tablet every other day.
-Children below 12 years. These tablets are not recommended for use in children below 12 years.
- The elderly (65 years or more). The elderly should not take more than one tablet a day, except when treatment combines this medicine with the antibiotics mentioned above, in which the maximum number of tablets is two.
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:
Serious allergic reactions: swelling of the tongue and/or throat, difficulty in swallowing, hives (nettle rash), difficulties in breathing, allergic facial swelling (Quincke's disease / angioedema), severe dizziness with very fast heartbeat and heavy sweating.
Serious skin conditions: with 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) and sensitivity to light.
Other serious conditions: 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 known side effects are:
• Uncommon (may affect up to 1 in 100 people) headache; dizziness; diarrhoea; feeling sick, vomiting; abdominal distension and flatulence; constipation; dry mouth; abdominal pain and discomfort; skin rash, exanthema, eruption; itching; feeling weak, exhausted or generally unwell; sleep disorders.
• Rare (may affect up to 1 in 1,000 people) 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
• Very Rare (may affect up to 1 in 10,000 people) disorientation.
Other side effects reported in general use:
Hallucination, confusion.
Side effects identified through blood tests:
• Uncommon (may affect up to 1 in 100 people) an increase in liver enzymes
• Rare (may affect up to 1 in 1,000 people) an increase in bilirubin; increased fats in the blood
• Very Rare (may affect up to 1 in 10,000 people)
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.
Please remember:
• The expected benefits of your medicine will usually be greaterthan 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.
Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.aov.uk/vellowcard By reporting side effects you can help provide more information on the safety of this medicine.
Do not use Pantoprazole 40 mg tablets after the expiry date, which is stated on the carton and the container after EXP. The expiry date refers to the last day of the month.
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.
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.
Marketing Authorization Holder and Manufacturer:
Bristol Laboratories Ltd.,
Unit 3, Canalside, Northbridge Road,
Berkhamsted, Hertfordshire,
HP4 1EG, United Kingdom Telephone: 0044 (0) 1442200922 Fax: 0044(0)1442873717
Email: info@bristol-labs.co.uk
Pantoprazole 40 mg gastro-resistant tablets;
PL 17907/0485
This is leaflet was revised in March 2015
To request a copy of this leaflet in Braille, large print or audio format, please contact the licence holder at the address (or telephone, fax, email) above.
240 mm
5. HOW TO STORE PANTOPRAZOLE 40 MG TABLETS
Keep out of the reach and sight of children.
Do not store above 25° C.
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