Pantoprazole 20 Mg Gastro-Resistant Tablets
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Pantoprazole 20 mg gastro-resistant Tablets
Pantoprazole
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 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.
Pantoprazole 20 mg gastro-resistant Tablets will be referred to as Pantoprazole Tablets in this leaflet.
In this leaflet:
1. What Pantoprazole T ablets are and what they are used for
2. Before you take Pantoprazole Tablets
3. How to take Pantoprazole T ablets
4. Possible side effects
5. How to store Pantoprazole Tablets
6. Further information
1. WHAT PANTOPRAZOLE TABLETS ARE AND WHAT THEY ARE USED FOR
Pantoprazole belongs to a group of medicines called proton pump inhibitors. Proton pump inhibitors reduce the amount of acid that your stomach makes.
You have been given Pantoprazole because you have a condition caused by stomach acid.
Pantoprazole Tablets are used:
- in the treatment of mild gastro-oesophageal reflux disease (a condition in which gastric content may rise up to the oesophagus and which can be associated with oesophagitis) caused by acid secretion, and the associated symptoms, such as heartburn, acidic belches and pains on swallowing
- in the long-term treatment and in the prevention of relapse in reflux oesophagitis (a condition in which backwash of gastric content in oesophagus lead to inflammation and pain)
- in the prevention of gastric and duodenal ulcers caused by anti-inflammatory drugs in high-risk patients needing continuous treatment with anti-inflammatory drugs.
2. BEFORE YOU TAKE PANTOPRAZOLE TABLETS
Do not take Pantoprazole Tablets
- if you are allergic (hypersensitive) to pantoprazole or any of the other ingredients of Pantoprazole Tablets
- if you are taking atazanavir (which is used for the treatment of HIV infection).
Take special care with Pantoprazole Tablets
Please tell the doctor who prescribed this medicine:
- if you have severe liver impairment. In case of severe liver disorder your doctor should monitor your liver function while you use Pantoprazole Tablets
- if you have been diagnosed with vitamin B12 malabsorption
- if your doctor has given you Pantoprazole Tablets together with anti-inflammatory medicines to treat your pain or rheumatic disease: please also read the package leaflets of these medicines carefully
- if you take Pantoprazole 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.
If you are on Pantoprazole 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, 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).
Please tell your doctor if you suffer or have recently suffered from any of the following symptoms: unintentional weight loss, recurrent vomiting or vomiting of blood, or dark stool. Your doctor may perform or have performed an additional investigation called an endoscopy in order to diagnose your condition and/or exclude malignant disease.
Taking other medicines
Other concomitant medication may affect the efficacy and safety of this medicine. Pantoprazole Tablets may also affect the efficacy and safety of other medications. Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Remember to tell your doctor about your treatment with Pantoprazole Tablets if you are prescribed another medicine while the treatment is still ongoing.
It is especially important to tell your doctor:
- if you are using atazanavir, which is used for the treatment of HIV infection
- if you are using ketoconazole or itraconazole, which are used for the treatment of fungal infections, since pantoprazole may affect their concentrations in your body
- if you are using anticoagulant medicines, e.g. warfarin, since it may be necessary to monitor your blood coagulation tests more often.
Taking Pantoprazole Tablets with food and drink
The gastro-resistant tablets should be taken 1 hour before food with water.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.
Experience with use of pantoprazole in pregnant women is limited. There is no information on the excretion of pantoprazole into human breast milk. If you are pregnant or if you are breast-feeding, you should use this medicine only if your treating physician considers the benefit for you greater than the potential risk for your unborn child or baby.
Driving and using machines
There are no known effects on the ability to drive and use machines.
Adverse drug reactions such as dizziness and visual disturbances may occur and which may decrease the ability to react.
Important information about some of the ingredients of Pantoprazole Tablets
This medicinal product contains phenylalanine. May be harmful for the people with phenylketonuria.
3. HOW TO TAKE PANTOPRAZOLE TABLETS
Always take Pantoprazole Tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Method of administration
The tablets should be swallowed whole, with sufficient fluid (e.g. one glass of water) and should not be chewed or crushed.
Dosage
Always take Pantoprazole Tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure about the dosage.
Adults and adolescents 12 years of age and above:
Treatment of mild reflux disease and the associated symptoms (e.g. heartburn, acidic belches and pain in swallowing):
The recommended dose is 1 tablet (20 mg) daily.
In case successful treatment has been performed (2-4 weeks), the reoccurring symptoms may be treated with 1 tablet a day (as maximum daily dose) whenever the symptoms reoccur. Please ask your doctor for further advice.
Long-term treatment and the prevention of relapse in reflux oesophagitis:
For long-term treatment the recommended dose is 1 tablet (20 mg) daily, if relapse occurs, the dosage is increased to 40 mg daily (2 x 20 mg tablets or 1 x 40 mg tablet).
Adults:
Prevention of gastric and duodenal ulcers caused by antiinflammatory drugs:
The recommended dose is 1 tablet (20 mg) daily.
Elderly and patients with kidney problems:
Daily dose of 2 tablets (40 mg) should not be exceeded. Patients with liver problems:
Daily dose 1 tablet (20 mg) should not be exceeded. Children:
Pantoprazole Tablets is not recommended for use in children below 12 years.
If you take more Pantoprazole Tablets than you should
If you or someone you know accidentally takes a lot more than the stated dose (an overdose) you should contact a doctor immediately.
If you forget to take Pantoprazole Tablets
If you forget to take a dose, take it as soon as you remember, unless it is almost time for your next dose. Do not take a double dose to make up for a forgotten tablet.
If you stop taking Pantoprazole Tablets
Do not change the dosage or stop the medication without discussing it with your doctor first.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Pantoprazole Tablets can cause side effects, although not everybody gets them.
Tell your doctor immediately or contact the casualty department at your nearest hospital, if you get any of the following serious side effects. Stop taking this medicine straight away, but take this leaflet and/or the tablets with you.
- Serious allergic reactions (rare): hypersensitivity reactions, so-called anaphylactic reactions, anaphylactic shock and angioedema. Typical symptoms are: swelling of the face, lips, mouth, tongue and/or throat, which may cause difficulty in swallowing or breathing, hives (nettle rash), severe dizziness with very fast heartbeat and heavy sweating.
- Serious skin reactions (frequency not known): rash with swelling, blistering or peeling of the skin, losing skin and bleeding around eyes, nose, mouth or genitals and rapid deterioration of your general health, or rash when exposed to the sun.
- Other serious reactions (frequency not known):
yellowing of the skin and eyes (due to severe liver damage), or kidney problems such as painful urination and lower back pain with fever.
Other known side effects include:
- Uncommon side effects: (affects 1 to 10 users in 1,000)
headache; dizziness; diarrhoea; feeling sick, vomiting; bloating and flatulence (wind); constipation; dry mouth; stomach ache and discomfort; skin rash or hives; itching; feeling weak, exhausted or generally unwell; sleep disorders; increase in liver enzymes in a blood test, fracture of the hip, wrist or spine (see section 2 “Take special care with Pantoprazole Tablets”).
- Rare side effects: (affects 1 to 10 users in 10,000)
disturbances in vision such as blurred vision; pain in the joints; muscle pains; weight changes; raised body temperature; swelling of the extremities; allergic reactions; depression; increased bilirubin and fat levels in blood (seen in blood tests).
- Very rare side effects (affects less than 1 user in 10,000)
disorientation; reduction in the number of blood platelets, which may cause you to bleed or bruise more than normal; reduction in the number of white blood cells, which may lead to more frequent infections.
- Frequency not known (cannot currently be estimated) hallucination, confusion (especially in patients with a history of these symptoms); decreased level of sodium in blood, decreased levels of magnesium in blood (hypomagnesaemia) (see Section 2 “Take special care with Pantoprazole Tablets”.
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 TABLETS!
Keep out of the reach and sight of children.
Do not use Pantoprazole Tablets after the expiry date which is stated on the packaging. 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. FURTHER INFORMATION
What Pantoprazole Tablets contain
The active substance is pantoprazole.
Each gastro-resistant tablet contains 20 mg pantoprazole (as pantoprazole sodium sesquihydrate).
The other ingredients are Mannitol (E 421), Sodium carbonate, anhydrous (E 500), Crospovidone, Hydroxypropylcellulose, Talc (E 553b), Calcium stearate, Zein F4000 (containing phenylalanine), Methacrylic acid-ethyl acrylate copolymer (1:1), Triethyl citrate (E 1505), Titanium dioxide (E 171), Hypromellose, Macrogol 400, Iron oxides, yellow and black (E 172), Shellac (E 904), N-butyl alcohol, Water, Propylene glycol (E 1520), Methylated Spirit, Isopropyl alcohol.
What Pantroprazole Tablets look like and contents of the pack
Yellow, round, biconvex coated tablets printed with “P20” on one side with black ink and plain on the other side.
Tablets are presented in blisters (aluminium base and lid) and packed in cartons of 7, 14, 15, 28, 30, 50, 56, 60, 84, 100, 112 tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Dr. Reddy’s Laboratories (UK) Ltd, 6 Riverview Road, Beverley. HU17 0LD, UK
This medicinal product is also authorised in the Member States of the EEA under the following names:
DE: Pantobeta 20 mg magensaftresistente Tabletten ES: Pantoprazol Aphar 20 mg Comprimidos Gastrorresistentes EFG
IT: Pantoprazolo Dr. Reddy’s 20 mg compresse gastroresistenti
This leaflet was last updated in 09/2012. PL 08553/0270