Patient leaflet - Pantoprazole 40 mg gastro-resistant tablets
1. What Pantoprazole is and what it is used for
Pantoprazole contains the active substance pantoprazole.
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, 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 (reduced bone density) or if you are taking corticosteroids (which can increase the risk of osteoporosis). Pantoprazole is used to treat adults and adolescents 12 years of age and above for:
Symptoms (for example heartburn, acid
regurgitation, pain when swallowing) associated with gastroesophageal reflux disease caused by the reflux of acid from the stomach.
Pantoprazole is used to treat adults for:
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 ulcer.
Zollinger-Ellison-Syndrome
and other conditions producing too much acid in the stomach.
2. What you need to know before you take Pantoprazole
Do not take Pantoprazole
If you are allergic to Pantoprazole or to any of
the other ingredients of this medicine (See section 6).
If you are allergic to medicines containing
other proton pump inhibitors. (e.g. omeprazole, lansoprazole, rabeprazole, esomeprazole).
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Pantoprazole
If you have severe liver problems. Please tell
your doctor if you have 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 long-term treatment with pantoprazole. As with all acid reducing agents, pantoprazole may lead to a reduced absorption of vitamin B12.
If you are taking HIV protease inhibitors such
as atazanavir (for the treatment of HIV-infection) at the same time as pantoprazole, ask your doctor for specific advice.
- Taking a proton pump inhibitor like
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.
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.
You are due to have a specific blood test
(Chromogranin A).
Te l l y o u r d o c t o r immediately before or a f t e r t a k i n g t h i s medicine, if you notice any of the following
- you look pale and feel weak (anaemia) symptoms, which could be a sign of another, more serious, disease:
- an unintentional loss of weight (not related to a diet or an exercise programme)
- vomiting, particularly if repeated
- vomiting blood; this may appear as dark coffee grounds in your vomit
- you notice blood in your stools; which may be black or tarry in appearance
- difficulty in swallowing or pain when swallowing
- chest pain
- stomach pain
- Severe and/or persistent diarrhoea, because this medicine has been associated with a small increase in infectious diarrhoea
Serious skin reactions have been reported in connection with treatment with pantoprazole, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction, conneosinophilia and systemic symptoms (DRESS), and erythema multiforme. Stop taking pantoprazole and call your doctor immediately if you report any of the symptoms related to the serious skin reactions described in section 4.
¡ Extreme tiredness or lack of energy 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.
This medicine may affect the way that your body absorbs vitamin B , particularly if you need to
12 take it for a long time. Please contact your doctor if you notice any of the following symptoms, which could indicate low levels of Vitamin B : 12
¡ Pins and needles
¡ Sore or red tongue, mouth ulcers
¡ Muscle weakness
¡ Disturbed vision
¡ Problems with memory, confusion, depression
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.
Children and adolescents
Pantoprazole is not recommended for use in children as the efficacy has not been studied in children below 12 years of age.
Other medicines and Pantoprazole
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines,
including medicines obtained
without a prescription.
This is because
Pantoprazole may influence
the effectiveness of other medicines, so tell your doctor if you are taking:
- Medicines such as ketoconazole, itraconazole and posaconazole (used to treat fungal infections) or erlotinib (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.
- Medicines used to treat HIV-infection, such as atazanavir.
- Methotrexate (used to treat rheumatoid arthritis, psoriasis, and cancer) – if you are taking methotrexate your doctor may temporarily stop your Pantoprazole treatment because pantoprazole can increase levels of methotrexate in the blood.
- Fluvoxamine (used to treat depression and other psychiatric diseases) – if you are taking fluvoxamine your doctor may reduce the dose.
- Rifampicin (used to treat infections).
- St John's wort (Hypericum perforatum) (used to treat mild depression).
Talk to your doctor before taking pantoprazole if a specific urine test (for THC, tetrahydro cannabinol) should be performed.
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 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. 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.
Driving and using machines
Pantoprazole has no or negligible influence on the ability to drive and use machines.
If you experience side effects like dizziness or disturbed vision, you should not drive or operate machines.
Pantoprazole contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per tablet, that is to say essentially 'sodium-free'.
3. How to take Pantoprazole
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose is:
Adults and adolescents 12 years of age and above:
To treat reflux oesophagitis
The recommended 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 recommended treatment period is one to two weeks.
For the treatment of stomach and duodenal ulcers.
The recommended dose is 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 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.
Patients with kidney problems
If you have kidney problems, you should not take Pantoprazole for eradication of Helicobacter pylori.
Patients with liver problems
If you suffer from severe liver problems, you should not take more than one 20 mg pantoprazole tablet per day (20 mg pantoprazole tablets are available in this case).
If you suffer from moderate or severe liver problems, you should not take pantoprazole for eradication of Helicobacter pylori.
Use in children and adolescents
These tablets are not recommended for use in children below 12 years.
Method of administration
Take the tablets 1 hour before a meal without chewing or breaking them and swallow them whole with some water.
If you take more Pantoprazole than you should
Consult your doctor or pharmacist. There are no known symptoms of overdose.
If you forget to take Pantoprazole
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
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, pharmacist or nurse.
4. Possible side effects
Like all medicines, this medicine 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:
may affect up to 1 in 1,000 people): 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: frequency cannot be estimated from the available data): You may notice one or more of the following reactions: blistering of the skin and rapid deterioration of your general condition, erosion (including slight bleeding) of eyes, nose, mouth/lips or genitals or skin sensitivity / rash, especially in sun-exposed areas of the skin. Pain in the joints or flu-like symptoms, fever, swollen glands (e.g. armpit) may also occur and blood tests may show changes in certain white blood cells or liver enzymes (Stevens-Johnson-Syndrome, Lyell-Syndrome, and Erythema multiforme, subacute cutaneous lupus erythematosus, drug rash with eosinophilia and systemic symptoms (DRESS), and sensitivity to light).
Slightly reddish circular or bull's-eye spots on
the trunk, often with blisters in the center, scaling, ulcers in the mouth, throat, nose, genitals and eyes. These severe rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis). Generalized rash, elevated body temperature and adenopathy (DRESS or drug hypersensitivity)
Other serious conditions
(frequency not known: f r e q u e n c y c a n n o t b e estimated from the available
data): 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:
- Common (may affect up to 1 in 10 people) Benign polyps in the stomach
Uncommon (may affect up to 1 in 100 people)
Headache; dizziness; diarrhoea; feeling sick, vomiting; bloating and flatulence (wind); constipation; dry mouth; abdominal pain and discomfort; tingling, skin rash, exanthema, eruption; itching; feeling weak, exhaustion or generally unwell; sleep disorders; fracture in the hip, wrist or spine.
Rare (may affect up to 1 in 1,000 people)
Distortion or complete lack of the sense of taste; disturbances in vision such as blurred vision; hives; pain in the joints; muscle pains; weight changes; raised body temperature; high fever; swelling of the extremities (peripheral oedema); allergic reactions; depression; breast enlargement in males.
Very Rare (may affect up to 1 in 10,000 people)
Disorientation
Not known (frequency cannot be estimated from the available data)
Hallucination, confusion (especially in patients with a history of these symptoms); feeling of tingling, prickling, pins and needles, burning sensation or numbness, rash, possibly with pain in the joints, inflammation in the large bowel, that causes persistent watery diarrhoea.
- Rare (may affect up to 1 in 1,000 people) Side effects identified through blood tests:
Uncommon (may affect up to 1 in 100 people)
An increase in liver enzymes
An increase in bilirubin; increased fat levels in blood; sharp drop in circulating granular white blood cells, associated with high fever.
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; coexisting abnormal reduction in the number of red and white blood cells, as well as platelets.
Not known (frequency cannot be estimated from the available data)
Low levels of sodium,
magnesium, calcium or
potassium in blood (see
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.gov.uk/ yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Pantoprazole
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 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 (e.g. via toilet or sink). 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 contains
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: Hypromellose 5 cP (E464), Povidone K
- 25 (E1201), Propylene glycol (E1520), Titanium dioxide (E171), Iron oxide yellow (E172), Methacrylic acid – ethyl acrylate copolymer (1:1) dispersion 30%, Triethyl citrate (E1505).
What Pantoprazole 40 mg tablets looks like and contents of the pack
Yellow, oval, biconvex, enteric-coated tablets, plain on both the sides.
Pantoprazole 40mg tablets are available in the following pack sizes:
Blister-strip pack having 14, 28, 30, 56, 60, 90, 98 or 100 gastro-resistant tablets.
Marketing Authorization Holder
Macleods Pharma UK Limited
Wynyard Park House, Wynyard Avenue,
Wynyard, Billingham, TS22 5TB,
United Kingdom.
Manufacturer
IDIFARMA DESARROLLO FARMACÉUTICO, S.L.
Poligono Mocholi, C/Noain,
1, 31110 NOAIN (NAVARRA)
SPAIN