Pantoprazole 20 Mg Gastro-Resistant Tablets
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PACKAGE LEAFLET: INFORMATION FOR THE USER
Pantoprazole 20 mg gastro-resistant Tablets
Read all of this 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.
- Ifyou 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 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 Pantoprazole gastro-resistant Tablets is and what it is used for What you need to know before you take Pantoprazole gastro-resistant Tablets How to take Pantoprazole gastro-resistant Tablets Possible side effects
How to store Pantoprazole gastro-resistant Tablets Contents of the pack and other information
1. WHAT PANTOPRAZOLE GASTRO-RESISTANT TABLETS IS AND
WHAT IT IS USED FOR
Pantoprazole gastro-resistant Tablets 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 gastro-resistant Tablets is used for:
Adults and adolescents 12 years of age and above:
- Treating symptoms (e.g. heartburn, acid regurgitation, pain on swallowing) associated to gastro-oesophageal reflux disease caused by reflux of acid from the stomach.
- Long-term management of reflux oesophagitis (inflammation of the oesophagus accompanied by the regurgitation of stomach acid) and preventing its return.
Adults:
- Preventing duodenal and stomach ulcers caused by non-steroidal antiinflammatory drugs (NSAIDs, for example, ibuprofen) in patients at risk who need to take NSAIDs continuously.
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 Pantoprazole gastro-resistant Tablets (see section 6).
- If you are allergic to medicines containing other proton pump inhibitors.
Warnings and precautions
- 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 gastro-resistant Tablets as a longterm treatment. In the case of a rise of liver enzymes the treatment should be stopped.
- If you need to take medicines called NSAIDs continuously and receive Pantoprazole gastro-resistant 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 or 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.
- 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 advise.
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 gastro-resistant Tablets 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 gastro-resistant 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.
Other medicines
Pantoprazole gastro-resistant Tablets may influence the effectiveness of other medicines, so tell your doctor if your are taking
- Medicines such as ketoconazole, itraconazole and posaconazole (used to treat fungal infections) or erlotinib (used for certain types of cancer) because Pantoprazole gastro-resistant Tablets 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.
- Atazanavir (used to treat HIV-infection).
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
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 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
If you experience side effects like dizziness or disturbed vision, you should not drive or operate machines.
3. HOW TO TAKE PANTOPRAZOLE GASTRO-RESISTANT TABLETS
Always take Pantoprazole gastro-resistant 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?
Take the tablets 1 hour before a meal without chewing or breaking them and swallow them whole with some water.
Unless told otherwise by your doctor, the usual dose is:
Adults and adolescents 12years of age and above:
To treat symptoms (e.g. heartburn, acid regurgitation, pain on swallowing) associated to gastro-oesophageal reflux disease
The usual dose is 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, when required.
For long-term management and for preventing the return of reflux oesophagitis
The usual dose is one tablet a day. If the illness returns, your doctor can double the dose, in which case you can use Pantoprazole gastro-resistant Tablets 40 mg tablets instead, one a day. After healing, you can reduce the dose back again to one tablet 20 mg a day.
Adults:
To prevent duodenal and stomach ulcers in patients who need to take NSAIDs continuously
The usual dose is 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 gastro-resistant Tablets than you should
Tell your doctor or pharmacist. There are no known symptoms of overdose.
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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.
The frequency of possible side effects listed below is defined using the following convention:
very common (affects more than 1 user in 10) common (affects 1 to 10 users in 100) uncommon (affects 1 to 10 users in 1,000) rare (affects 1 to 10 users in 10,000) very rare (affects less than 1 user in 10,000)
not known (frequency cannot be estimated from the available data)
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) 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 or pharmacist. 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 GASTRO-RESISTANT TABLETS
Keep this medicine out of the sight and reach of children.
Do not use Pantoprazole 20 mg gastro-resistant tablets after the expiry date, which is stated on the carton after EXP. The expiry date refers to the last day of that month.
Do not store above 30° 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 PACKAND OTHER INFORMATION
What Pantoprazole 20 mg gastro-resistant tablets contains
The active substance is pantoprazole. Each gastro-resistant tablet contains 20 mg of
pantoprazole (as sodium sesquihydrate).
The other ingredients are:
Core: Mannitol (E421), Crospovidone (Type-A), 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 and ethyl acralate copolymer dispersion (1:1) [Polysorbate 80, Sodium Lauryl sulphate], Triethyl citrate (E1505), Opacode Black [Shellac (E904), Iron oxide black (E172), Propylene glycol (E1520), Ammonium hydroxide 28% (E527)]
What Pantoprazole 20 mg gastro-resistant tablets look like and contents of the pack
Yellow oval, biconvex enteric coated tablets imprinted 'CL24' on one side and plain on other side. (Approximately 8.45 mm x 4.2 mm)
Pantoprazole 20mg tablets are available in the following pack size:
Blister-strip pack having 28 gastro-resistant tablets.
Marketing Authorisation Holder and Manufacturer
Marketing Authorization Holder
Wilcare Pharma Limited,
Building 6 Unit 14,
Croxley Green Business Park,
Watford, England WD18 8YH
Manufacturer
Mawdsleys Brooks and Co Ltd.,
Unit 22, Quest Park,
Wheatley Hall Road, Doncaster,
DN2 4LT, United Kingdom
If you would like this leaflet in a different format please contact the licence holder at the following address:
Wilcare Pharma Limited, Building 6 Unit 14, Croxley Green business Park, Watford, England WD 18 8YH
This leaflet was last revised in March 2015