Omeprazole 10 mg and 20 mg capsules
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.
Index
1 What Omeprazole capsules are and what they are used for
2 Before you take
3 How to take
4 Possible side effects
5 How to store
6 Further information
What Omeprazole capsules are and what they are used for
Omeprazole capsules are part of a group of drugs known as proton pump inhibitors. These medicines work by reducing the amount of acid produced in your stomach.They may be used to treat:
- Non-cancerous ulcers in the stomach (gastric) or upper part of the intestine (duodenal)
- Treating and preventing repeat cases of those ulcers caused by taking a non-steroidal anti-inflammatory drug (NSAID) such as aspirin, ibuprofen or diclofenac
- Relieving and preventing repeat cases of heartburn (reflux oesophagitis) where acid has escaped from the stomach into the gullet
- Excess acid produced in the stomach as a result of a growth in the pancreas (Zollinger-Ellison syndrome)
- Relief of pain and inflammation (gastro-oesophageal reflux disease or GORD) where acid has escaped from the stomach into the gullet
- Treating ulcers infected with bacteria called Helicobacter pylori in combination with antibiotics
Before you take
Do not take Omeprazole capsules and tell your doctor if you:
- are allergic (hypersensitive) to omeprazole or any of the other ingredients (see section 6).
- are taking clarithromycin and you have liver problems.
Check with your doctor or pharmacist before taking Omeprazole capsules if you:
- have kidney or liver problems.
- are elderly.
- are taking NSAIDs such as ibuprofen, diclofenac or aspirin.
- have been taking this medicine for over a year and have not had a check up.
- are seriously ill; your hearing and eyesight will need to be monitored.
test positive for Helicobacter pylori – this will affect your treatment.- have cancer – your doctor will make sure you do not.
There is a small risk that you will get an infection of your digestive tract.
Omeprazole capsules should not be used in infants and children under the age of 2 years
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Especially:
- triazolam, diazepam and flurazepam ( used for anxiety and insomnia)
- phenytoin (for the treatment of epilepsy)
- warfarin (to thin the blood)
- hexobarbital (used as a sedative)
- imipramine, clomipramine and citalopram (used for depression)
- disulfiram (used to treat alcoholism). If taken at the same time as omeprazole, muscular stiffness may occur
- ciclosporin (used to suppress the immune system)
- clarithromycin (an antibiotic)
- ketoconazole and itraconazole (used for the treatment of fungal infections)
- digoxin (used in certain heart problems)
- St. John’s wort (a herbal medicine)
- atazanavir (an antiviral product)
Pregnancy and breast-feeding
Do not take Omeprazole capsules if you are pregnant, planning to become pregnant or are breast-feeding. Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Omeprazole capsules may make you hallucinate or feel confused or light-headed. Other possible effects include sleepiness and visual disturbance. Make sure you are not affected before you drive or operate machinery.
Sugar intolerance
If you have been told you have an intolerance to some sugars, contact your doctor before taking this medicine, as it contains a type of sugar called sucrose.
This medicine contains mannitol, which may have a mild laxative effect.
Tests
Your doctor will try to find out what is causing your symptoms before prescribing Omeprazole capsules. You may be given an endoscopic examination (looking down the stomach through a small camera inserted down the gullet) in order to exclude the possibility of stomach cancer, or to confirm reflux oesophagitis. You may also have tests to check if you have Helicobacter pylori infection, and if these are positive you will be given treatment to clear if it possible.
Special considerations
Omeprazole may reduce the absorption of vitamin B12 (cobalamin), which should be taken into account in patients with cobalamin shortage.
How to take
Always take Omeprazole capsules exactly as your doctor has told you. If you are not sure, check with your doctor or
pharmacist.
Swallow these capsules whole with a glass of water regardless of food at the same time(s) each day.
Doses:
- Adult
Duodenal ulcer: 20mg once a day for 2 to 4 weeks
Non-cancerous Gastric ulcer: 20mg once a day for 4 to 8 weeks
Reflux oesophagitis (Heartburn): Treatment dose is 20mg once a day for 4 to 8 weeks
To prevent a relapse the dose is 10-20mg daily.
Gastro-oesophageal reflux: 10-20mg dailyfor 2 to 4 weeks
Zollinger-Ellison syndrome: The recommended starting dose is 60mg daily. Doses higher than 80mg daily should be divided into two doses.
Treating and Preventing Ulcers caused by NSAIDs: 20mg daily for 4 to 8 weeks
Ulcers associated with the bacteria Helicobacter pylori: 20mg twice daily, with antibiotics that your doctor will choose. The course of treatment is usually for one week. Do not stop treatment early unless advised by your doctor as this could result in the infection returning in a more severe form.
- Children over two years and adolescents with severe reflux oesophagitis (heartburn):
Treatment will be started by a hospital paediatrician (child specialist). The dose will depend on the weight of the
child. Treatment is normally for 4 to 8 weeks, and not more than 12 weeks. Regular tests will be carried out during
treatment. - Liver problems: Your doctor will prescribe a reduced dose.
If you take more than you should
If you (or someone else) swallow a lot of capsules at the same time, or you think a child may have swallowed any, contact your nearest hospital casualty department or tell your doctor immediately. Take this leaflet and any remaining capsules that you have to show the doctor.
If you forget to take the capsules
Do not take a double dose to make up for a forgotten dose. If you forget to take a dose take it as soon as you remember it and then take the next dose at the right time.
If you stop taking the capsules
Do not stop treatment early otherwise your symptoms may reappear. Talk to your doctor before you stop taking the capsules and follow his advice.
Possible side effects
Like all medicines, Omeprazole capsules can cause side effects, although not everybody gets them.
Contact your doctor at once if you notice sign of an allergic reaction: swelling and redness of the skin, skin
blistering, swelling of the mouth and throat, difficulty breathing, collapse, shock and fever.
Tell your doctor if you notice any of the following side effects or notice any other effects not listed:
Common (occurs in less than 1 in 10 users): Headache, drowsiness, vertigo, sleepiness and disturbed sleep, nausea or vomiting (feeling or being sick), diarrhoea, flatulence (possibly with abdominal pain), and constipation. In a majority of these cases the symptoms improve on continuation of the treatment.
Uncommon (occurs in less than 1 in 100 users): Itching, skin eruptions, hair loss, sensitivity to sunlight and increased sweating, widespread reddening and blistering of the skin (erythema multiforme).
Visual disturbance (blurred vision, impaired vision), and disturbances of taste and hearing (e.g. tinnitus, or ringing
in the ears) are usually reversible on termination of treatment.
Swelling of parts of the body especially the ankles (resolves on termination of treatment).
Omeprazole may cause changes in liver enzymes detected through blood tests (usually reversible on stopping treatment)
Rare (occurs in less than 1 in 1,000 users): Pins and needles sensation, light-headedness, muscle weakness, muscle and/or joint pain; when taken with clarithromycin, an antibiotic, a brownish-black discolouration of the tongue
or harmless glandular cysts. Both effects are reversible after the termination of treatment.
Rarely anaemia (decreased number of red blood cells) occurs in children
Mental confusion and hallucinations occur predominantly in the severely ill or the elderly.
Very rare (occurs in less than 1 in 10,000 users): Dry mouth, inflamed (red or sore) gums, pancreatitis (inflammation of the pancreas), candidiasis (fungal infection by a type of yeast), development of breast tissue in men, impotence, hepatitis with and without jaundice, as well as liver failure and encephalopathy (a type of brain disorder) in patients with pre-existing severe liver disease.
A decrease in the blood sodium level or a decrease in the numbers of certain blood cells may cause lesions of the skin, gut, throat and other mucous membranes or it may take longer for a cut to stop bleeding.
Stevens-Johnson-syndrome and toxic epidermal necrolysis (peeling or loss of the skin ), nephritis (inflammation of the
kidney), agitation or depression, mainly in elderly or very ill patients, fever, severe allergic reaction (see the beginning
of this section)
If you notice any side effects, they get worse, or if you notice any not listed, please tell your doctor or pharmacist.
How to store
Keep out of the reach and sight of children.
Do not use Omeprazole capsules after the expiry date stated on the label/carton/bottle. 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.
Further information
What Omeprazole capsules contain
- The active substance (the ingredient that makes the tablet work) is omerprazole. Each capsule contains either 10mg or 20mg of the active.
- The other ingredients are sugar spheres (consisting of corn starch and sucrose), sodium lauryl sulphate, disodium phosphate, mannitol, hypromellose, polyethylene glycol 6000, talc, polysorbate 80, titanium dioxide, Eudragit
L30-D55 (poly(methacrylic acid, ethyl acrylate)). Capsules consist of gelatin and contain the colours quinoline yellow
(E104) and titanium dioxide (E171).
What Omeprazole capsules look like and contents of the pack
10mg capsules are hard gelatine capsules of size 3, Opaque yellow cap and body, containing white to off-white spherical pellets.
20mg capsules are hard gelatin capsules of size 2, Opaque yellow cap and body, containing white to off-white spherical
pellets.
Pack sizes are 28 capsules.
Marketing Authorisation Holder
Manufacturer
Date of revision: March 2010
LICPL008
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