Pantoprazole 20 mg
Gastro-resistant Tablets
Pantoprazole (as sodium sesquihydrate)
Read all of this leaflet carefully before you start taking this medicine.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you. Do 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 gets 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 20 mg tablets are and what they are used for
- 2. Before you take Pantoprazole 20 mg tablets (some of the information for your safety).
- 3. How to take Pantoprazole 20 mg tablets
- 4. Possible side effects
- 5. How to store this medicine
- 6. Further information
What Pantoprazole 20 Mg Tablets Are And What They Are Used For
Pantoprazole 20 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 20 mg tablets are used for:
- treating mild forms of oesophageal disease caused by reflux of acid from the stomach (with or without mild inflammation of the oesophagus) and the associated symptoms (e.g. heartburn, acid regurgitation, pain on swallowing).
- long-term management of reflux oesophagitis (inflammation of the oesophagus accompanied by the regurgitation of stomach acid) and preventing its return.
- preventing duodenal and stomach ulcers caused by non-steroidal anti-inflammatory drugs (NSAIDs, for example, ibuprofen) in patients at risk who need to take NSAIDs continuously.
Before You Take Pantoprazole 20 Mg Tablets
Do not take Pantoprazole 20 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).
- if you are taking a medicine containing atazanavir (for the treatment of HIV-infection) at the same time.
Take special care with Pantoprazole 20 mg tablets
- 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 20 mg tablets as a long-term treatment, and treatment may then be stopped.
- if you need to take medicines called NSAIDs continuously and receive Pantoprazole 20 mg tablets 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 and 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 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 20 mg tablets 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 20 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.
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
Clinical experience in pregnant women is limited. There is no information as to whether the active substance passes into human breast milk.
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 greater than the potential risk for your 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.
Important information about some of the ingredients of Pantoprazole 20 mg tablets
Pantoprazole 20 mg tablets contain soya lecithin. If you are allergic to peanut or soya, do not use this medicinal product.
How To Take Pantoprazole 20 Mg Tablets
Always take Pantoprazole 20 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 20 mg tablets?
Take before a meal 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 treating mild forms of oesophageal disease caused by reflux of acid from the stomach (with or without mild inflammation of the oesophagus) and the associated symptoms (e.g. heartburn, acid regurgitation, pain on swallowing):
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, as needed.
For long-term management and for preventing the return of reflux oesophagitis
one tablet a day.
If the illness returns, the dose may be doubled, 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:
For preventing duodenal ulcers in patients who need to take NSAIDs continuously
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 tablets than you should
Tell your doctor or pharmacist. There are no known symptoms of overdose.
If you forget to take Pantoprazole 20 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 20 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.
Possible Side Effects
Like all medicines, Pantoprazole 20 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 (incl. slight bleeding) of eyes, nose, mouth/lips or genitals (Stevens-Johnson-Syndrome, Lyell-Syndrome, Erythema multiforme) and sensitivity to light.
These are very rare side effects (fewer than 1 in every 10,000 patients gets them).
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 (fewer than 1 in every 100 patients treated)
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 (fewer than 1 in every 1,000 patients treated)
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 (fewer than 1 in every 10,000 patients treated)
disorientation.
Other side effects reported in general use:
Hallucination, confusion.
Side effects identified through blood tests:
Uncommon (fewer than 1 in every 100 patients treated)
an increase in liver enzymes
Rare (fewer than 1 in every 1,000 patients treated)
an increase in bilirubin; increased fats in the blood
Very Rare (fewer than 1 in every 10,000 patients treated)
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 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.
How To Store Pantoprazole 20 Mg Tablets
Keep out of the reach and sight of children.
Do not use Pantoprazole 20 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.
For HDPE bottles: do not use tablets beyond 2 months after first opening of the bottle.
This medicine does not require any special storage conditions.
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.
Further Information
What Pantoprazole 20 mg Tablets contain
The active substance is pantoprazole. One tablet contains 20 mg of pantoprazole (as sodium sesquihydrate).
The other ingredients are: sodium carbonate, mannitol, crospovidone, povidone K90, calcium stearate, hypromellose, povidone K25, titanium dioxide (E171), yellow Iron oxide (E172), propylene glycol, methacrylic acid‑ethyl acrylate copolymer (1:1), polysorbate 80, sodium lauryl sulfate, triethyl citrate, printing ink brown [shellac, red, black and yellow
ferric oxide, soya lecithin, titanium dioxide (E171) and dimeticone emulsion].
What Pantoprazole 20 mg Tablets look like and contents of the pack
A yellow, oval, biconvex film-coated tablet imprinted with “P20” on one side.
Packs: high density polyethylene bottles with low density polyethylene screw cap, aluminium/aluminium blisters with cardboard reinforcement and aluminium/ aluminium blisters without cardboard reinforcement
Pantoprazole 20 mg tablets are available in the following pack sizes:
Packs with 7, 10, 14, 15, 24, 28, 30, 48, 56, 60, 84, 90, 98, 100, 112, 168 gastro-resistant tablets.
Hospital packs with 50, 56, 84, 90, 112, 140, 140 (10x14 or 5x28), 500, 700 (5x140), 280 (20x14 or 10x28) gastro-resistant tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Manufacturer
This leaflet was last approved in 05/2009
GRBR F.1/0609/6XXXXXX
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