Omeprazole 20 Mg Capsules
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Omiprazole 20mg leaflet | |||||
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e-mail : artworkcd@yahoo.com Ph : +91-09845609386 |
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28-08-12 | |||||
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Omeprazole 20mg Capsules RclOH " 1£?m
(Omeprazole)
PACKAGE LEAFLET: INFORMATION FOR THE USER
Read all of this leaflet carefully before you start taking
these capsules
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• Your doctor has prescribed these capsules foryou. Do not pass them on to others. They may harm them even if their symptoms are the same as yours.
• If any of the side effects get serious, or if you notice any side effects not listed in the leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Omeprazole Capsules are and what they are used for
2. Before you take Omeprazole Capsules
3. Howto take Omeprazole Capsules
4. Possible side effects
5. Howto store Omeprazole Capsules
6. Further information
I. What Omeprazole Capsules are and what they are used for
What are Omeprazole Capsules for?
The active ingredient, omeprazole, belongs to a group of
medicines called “proton pump inhibitors”. It works by
reducing the production of acid in your stomach.
Omeprazole is used to treat the following conditions:
• Reflux oesophagitis and Oesophageal disease, where acid from the stomach escapes into the food pipe causing pain, inflammation and heartburn.
• Acid indigestion (dyspepsia) which can cause stomach pain and/or discomfort.
• Ulcers in the upper part of the intestine (duodenal ulcer) or stomach (gastric ulcer). For patients who have had previous trouble with an ulcer and need to continue therapy with a non-steroidal anti-inflammatory drug (NSAID), omeprazole can heal ulcers or prevent an ulcer developing. In such patients, omeprazole protects the stomach or duodenum whilst they are taking NSAIDs.
• Ulcers which are infected with bacteria called Helicobacter pylori.
• Prevention of damage to the lungs caused by breathing in stomach fluids (acid aspiration), e.g. before an operation.
• Zollinger-Ellison syndrome, when excess stomach acids are produced dueto agrowth in the pancreas.
• treatment of reflux oesophagitis and oesophageal reflux disease in the children Over I year old and weigh >IOkg
2. Before you take Omeprazole Capsules
• Ketoconazole, itraconazole or Voriconazole (for fungal infections)
• Clarithromycin (for bacterial infections)
• Tacrolimus (for immune suppression)
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without prescription.
Pregnancy and Breastfeeding:
Tell your doctor if you are, you think you might be or are planning to become pregnant. You should not take Omeprazole Capsules if you are pregnant or breast feeding without discussion with your doctor.
Driving and using machines:
These capsules on rare occasions make you hallucinate, confused and feel light-headed. Other possible side effects are sleepiness and visual impairment. Make sure you are not ^ affected before you drive or operate machinery.
Important information about some of the ingredients of Omeprazole Capsules
The product contains sucrose. If you have been told by your doctor that you have an intolerance to some sugars contact your doctor before taking this medicine.
3. How to take Omeprazole Capsules
Always take Omeprazole Capsules exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
You can take your capsules with food or on an empty stomach at any time of the day. The capsules should not be chewed or crushed. They should be swallowed whole with a drink of water. If you have trouble swallowing the capsules, open the capsule and mix the granules with some fruit juice or yoghurt and then take immediately.
The length of your course of treatment will depend on what condition you are suffering from:-
Treatment for heartburn (Reflux oesophagitis and oesophageal reflux disease)
The usual dose for adults is 20 mg omeprazole taken once a day for 4 weeks. Your doctor may ask you to continue taking the capsules or increase the dose depending on how you respond to treatment. To stop your symptoms returning your doctor may tell you to continue to take 20 mg omeprazole or reduce thedoseto I0mg.
Do not take Omeprazole Capsules:
• If you are (hypersensitive) allergic to omeprazole or any of the other ingredients in Omeprazole capsules. An allergic reaction may include a rash, itching, difficulty breathing or swelling in the face lips throat or tongue.
• If you are taking a medicine called atazanavir.
Take special care with Omeprazole Capsules:
Tell your doctor before you start taking these Capsules:
• If you have liver problems.
This is because your doctor may reduce the dose.
• If you are going to have an operation and anaesthetic (including at the dentist).
• If your doctor has told you that you have problems with an inherited sugar intolerance disease
• Taking a proton pump inhibitor like Omeprazole, 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).
Taking other medicines:
Please tell your doctor if you are taking any of the following
medicines:
• Diazepam (foranxiety)
• Phenytoin (for epilepsy)
• Warfarin (for thinning of the blood)
• Digoxin (forthe heart)
For children (I year and older): the usual dose is based on age and weight. The usual dose is I0mg or 20mg. The dose will be taken once a day. The treatment for heartburn and acid reflux disease is 2-4 weeks but your doctor may treat for up to 8 weeks.
Relief of Acid Indigestion (Dyspepsia)
The usual dose is 10 mg or 20 mg once a day for a period of 2 - 4 weeks. Your doctor will tell you how long to take your capsules for. If you do not experience any improvement in your symptoms you should return to your doctor.
Treatment of ulcers in the upper part of the intestine (duodenal ulcer) and stomach (gastric ulcer)
The usual dose is 20 mg omeprazole once a day for a period of 4-8 weeks depending on your symptoms. Your doctor may increase the dose depending on how you respond to treatment. To stop your ulcer coming back, the usual dose is omeprazole 10 mg once daily unless your symptoms return. If your symptoms return, your doctor may increase the dose.
Treatment and prevention of stomach ulcers, duodenal ulcers and associated symptoms caused by NSAIDs
If you have previously had trouble with an ulcer and need to continue taking a NSAID the recommended dose is omeprazole 20 mg once daily. Your doctor will advise how long you need to take the capsules for.
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Artw#rl< • • Creative Desians |
Artwork No. |
031007/1 |
Colours Used | |||
|
Customer |
Accord |
■ |
Balck | |||
|
Description |
Omiprazole 20mg leaflet | |||||
|
Market |
UK | |||||
|
Language |
English | |||||
|
Size |
160 x 280 mm | |||||
|
Min. Font Size |
8 pt | |||||
|
Page No. |
2 of 2 | |||||
|
e-mail : artworkcd@yahoo.com Ph : +91-09845609386 |
Version No. |
7 | ||||
|
Date |
28-08-12 | |||||
|
Softwa re |
Illustrator 1 0 | |||||
|
Packaging Development |
Quality Assurance (QA) |
Quality Control (QC) |
Production | |||
Treatment of Ulcers caused by infection with the bacteria called Helicobacter Pylori
The usual dose is omeprazole 40 mg once a day or 20 mg taken twiceadayforaperiodof I -2weeks. Yourdoctorwill also tell you to take one or two of the following antibiotics; amoxicillin, clarithromycin, metronidazole ortinidazole. For children over 4 years the dosage is based on weight and the usual dose is I0mg or 20mg twice a day for I week. Your child will also be given the following antibiotics to take at the same time as Omeprazole Capsules: amoxicillin and clarithromycin.
Follow the directions for taking your medicine very carefully and if you are unsure about anything, ask your doctor or pharmacist.
Before a hospital operation when you are to be given a general anaesthetic
The usual dose is omeprazole 40 mg taken the evening before surgery, and another 40mg dose two to six hours before surgery.
Zollinger - Ellison Syndrome
The usual starting dose is omeprazole 60 mg once a day. If the dose is more than 80 mg a day, half the dose should be taken in the morning and half at night. Your doctor will tell you how many capsules to take and when to take them.
If you take more Omeprazole capsules than you should:
If you swallow too many tablets or someone else accidentally takes your medicine, contact your doctor, pharmacist or nearest hospital straight away.
If forget to take Omeprazole capsules:
Try to take a dose, take it as soon as you remember. If it is nearly time for your next dose just take the next dose and forget about the one you missed. Do not take a double dose to make up for forgotten individual doses.
If you stop taking Omeprazole capsules:
Do not stop taking Omeprazole capsules without first discussing it with your doctor.
If you have any further questions on the use of Omeprazole capsules askyour doctor or pharmacist.
4. Possible Side Effects
Like all medicines, Omeprazole capsules can cause side effects, although not everyone gets them. These side effects are usually mild and go away when you stop taking this medicine.
If you notice any of following serious side effects, stop taking Omeprazole Capsules and tell a doctor or contact the casualty department at your nearest hospital straight away:
An allergic reaction (angioedema): swelling of the face, lips, tongue, throat or difficulty breathing or swallowing. Reddening of skin with blisters or peeling. There may also be severe blisters and bleeding in lips,eyes,mouth,nose and genitals, this could be 'Stevens Jhonson- syndrome' or ' toxic epidermal necrolysis'.
These effects are rare, affecting less than I in 1000 people.
I Common: (affects less than I in 10 people)
; • Headache.
• Diarrhoea or constipation.
! • Feeling or being sick.
• Stomach ache or wind (sometimes with stomach pain).
These may occur at the beginning of the treatment. If these signs do not get better after a few days then contact the doctor.
Uncommon: (affects less than I in 100 people)
• Disturbed sleep (Insomnia)
• Dizziness
• Tingling feelings such as'pins and needles'
• Feeling sleepy
• Spinning feeling (Vertigo)
• Feeling light headed orfaint
• Skin rash, lumpy rash (hives), itchy skin and dermatitis.
• Changes in blood tests that show how well your liver is working.
• Generally feeling unwell
• Fracture ofthe hip, wrist or spine
Rare: (affects less than I in 1000 people)
• Dry or sore mouth
• An infection called 'thrush' which can affect the mouth or gullet and is caused byafungus.
• Taste changes
• Feelinganxious, confused ordepressed.
• Aggression
• Seeing, feeling or hearing things that are not there (hallucinations)
• Skin rash on exposure to sunshine
• Blurred vision
• Hair loss (alopecia)
• Painful swollen joints
• Aching muscles or muscle weakness.
• Increased sweating
• Kidney problems.
• Liver problems, including jaundice which can cause yellow skin, dark urine, and tiredness.
• Severe liver problems leading to liver failure and inflammation of brain.
• Enlarged breasts in men.
• Being unable to get an erection (impotence).
• Low levels of sodium in blood, this may cause weakness, being sick (vomiting) and cramps.
• Blood problems such as reduced number white cells or platelets. This can cause weakness, bruising or make infections more likely.
Frequency not known
If you are on Omeprazole 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 monitoryour levels of magnesium.
In these cases consult with your doctor or pharmacist.
Do not be concerned by this list of possible side effects. You may not get any of them.
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. Howto store Omeprazole Capsules
Keep out of the reach and sight of children.
Do not store above 30°C. Store in the original package.
Do not use Omeprazole Capsules after the expiry date which is stated on the label. The expiry date refers to the last day of that month.
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 Omeprazole Capsules contain
The active substance is omeprazole and each capsule contains 20mgof omeprazole as gastro resistant granules.
The other ingredients are sugar spheres, sodium starch glycollate, sodium lauryl sulfate, povidone, potassium oleate, oleic acid, hypromellose, methacrylic acid and ethyl acrylate copolymer, triethyl citrate, titanium dioxide and talc.
The capsule coating also contains gelatine, titanium dioxide (EI7I), quinoleine yellow (EI04), indigo carmine (EI32) and erythrosine (EI27).
The printing ink contains shellac, anhydrous ethyl alcohol, isopropyl alcohol, propylene glycol, N-butyl alcohol, polyvinylpyrrolidone, sodium hydroxide and titanium dioxide
(EI7I).
What Omeprazole 20mg Capsules look like and contents of the pack
The capsules have an orange body and blue cap and are marked with 020.
The capsules are supplied in bottles of 14 and 28 capsules.
Marketing Authorisation Holder and Manufacturer
Relonchem Limited, 27, Old Gloucester Street, London, WCI 3XX.
PL 20395/0017
Date Leaflet approved: August 2012
I POM I