Patient leaflet - Omeprazole 20 mg gastro-resistant capsules
1 What Omeprazole capsules are and what they are used for
Omeprazole capsules contain the active
substance omeprazole. It belongs to a group
of medicines called ‘proton pump inhibitors’.
They work by reducing the amount of acid
that your stomach produces.
Omeprazole is used to treat the following
conditions:
In adults:
- ‘Gastro-oesophageal reflux disease’ (GORD).
This is where acid from the stomach escapes
into the gullet (the tube which connects
your throat to your stomach) causing pain,
inflammation and heartburn.
- Ulcers in the upper part of the intestine
(duodenal ulcer) or stomach (gastric ulcer),
prevention of reoccurrence of ulcers.
- Ulcers which are infected with bacteria
called ‘Helicobacter pylori’. If you have this
condition, your doctor may also prescribe
antibiotics to treat the infection and allow
the ulcer to heal.
- Ulcers caused by medicines called NSAIDs
(Non-Steroidal Anti-Inflammatory Drugs).
Omeprazole can also be used to stop ulcers
from forming if you are taking NSAIDs.
Too much acid in the stomach caused by
a growth in the pancreas (Zollinger-Ellison
syndrome).
In children:
Children over 1 year of age and 10kg
- ‘Gastro-oesophageal reflux disease’ (GORD).
This is where acid from the stomach escapes
into the gullet (the tube which connects
your throat to your stomach) causing pain,
inflammation and heartburn.
In children, the symptoms of the condition
can include the return of stomach contents
into the mouth (regurgitation), being sick
(vomiting) and poor weight gain.
Children and adolescents over 4 years of age
- Ulcers which are infected with bacteria
called ‘Helicobacter pylori’. If your child
has this condition, your doctor may also
prescribe antibiotics to treat the infection
and allow the ulcer to heal.
2 What you need to know before you take Omeprazole capsules
Do not take Omeprazole capsules if you:
- are allergic to omeprazole or any of the
other ingredients of this medicine (listed in
- are allergic to medicines containing other
proton pump inhibitors (e.g. pantoprazole,
lansoprazole, rabeprazole, esomeprazole).
- are taking a medicine containing nelfinavir
(used for HIV infection).
If you are not sure, talk to your doctor or
pharmacist before taking this medicine.
Warnings and precautions
Talk to your doctor or pharmacist
before taking Omeprazole capsules.
Serious skin reactions including Stevens-
Johnson syndrome, toxic epidermal
necrolysis, drug reaction with eosinophilia
and systemic symptoms (DRESS) and acute
generalised exanthematous pustulosis
(AGEP) have been reported in association
with Omeprazole treatment. Stop taking
Omeprazole capsules and seek medical
attention immediately if you notice any of
the symptoms related to these serious skin
reactions described in section 4.
Omeprazole may hide the symptoms of other
diseases. Therefore, if any of the following
happen to you before you start taking
Omeprazole or while you are taking it, talk to
your doctor straight away if:
- you lose a lot of weight for no reason and
have problems swallowing.
- you get stomach pain or indigestion.
- you begin to vomit food or blood.
- you pass black stools (blood-stained
faeces).
- you experience severe or persistent
diarrhoea, as omeprazole has been
associated with a small increase in
infectious diarrhoea.
- you have severe liver problems.
- you have ever had a skin reaction after
treatment with a medicine similar
to Omeprazole Capsules that reduces
stomach acid.
- you get a rash on your skin, especially in
areas exposed to the sun tell your doctor
as soon as you can, as you may need to stop
your treatment with Omeprazole Capsules.
Remember to also mention any other ill-
effects like pain in your joints.
- you take atazanavir.
- you are due to have a specific blood test
(Chromogranin A).
- this medicine may affect the way that your
body absorbs vitamin B12, particularly if
you need to take it for a long time. Please
contact your doctor if you notice any of the
following symptoms, which could indicate
low levels of Vitamin B12: extreme tiredness
or lack of energy, pins and needles, sore or
red tongue, mouth ulcers, muscle weakness,
disturbed vision, problems with memory,
confusion, depression.
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). Your doctor will probably keep you under regular surveillance. You should report any new and exceptional symptoms and circumstances whenever you see your doctor.
When taking omeprazole, inflammation in your kidneys may occur. Signs and symptoms may include decreased volume of urine or blood in your urine and/or hypersensitivity reactions such as fever, rash, and joint stiffness. You should report such signs to the treating physician.
Children
Some children with chronic illnesses may require long-term treatment although it is not recommended. Do not give this medicine to children under 1 year of age or weigh less than 10kg.
Other medicines and Omeprazole capsules
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is because Omeprazole can affect the way some medicines work and some medicines can have an effect on Omeprazole.
Do not take Omeprazole if you are taking a medicine containing nelfinavir (used to treat HIV infection).
Tell your doctor or pharmacist if you are taking any of the following medicines:
- Ketoconazole, itraconazole, posaconazole or voriconazole (used to treat infections caused by a fungus)
- Digoxin (used to treat heart problems)
- Diazepam (used to treat anxiety, relax muscles or in epilepsy)
- Phenytoin (used in epilepsy). If you are taking phenytoin, your doctor will need to monitor you when you start or stop taking Omeprazole
- Medicines that are used to thin your blood, such as warfarin or other vitamin K blockers. Your doctor may need to monitor you when you start or stop taking Omeprazole
- Rifampicin (used to treat tuberculosis)
- Atazanavir (used to treat HIV infection)
- Tacrolimus (in cases of organ
transplantation)
- Methotrexate (used to treat arthritis, Crohn’s or psoriasis)
- St John’s wort (Hypericum perforatum) (used to treat mild depression)
- Cilostazol (used to treat intermittent claudication)
- Saquinavir (used to treat HIV infection)
- Clopidogrel (used to prevent blood clots (thrombi))
- Erltinib (used in some cancers)
- Clarithromycin (to treat infections). If your doctor has prescribed the antibiotics amoxicillin and clarithromycin as well as Omeprazole to treat ulcers caused by Helicobacter pylori infection, it is very important that you tell your doctor about any other medicines you are taking.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Your doctor will decide whether you can take Omeprazole during this time.
Your doctor will decide whether you can take Omeprazole if you are breast-feeding.
Driving and using machines
Omeprazole is not likely to affect your ability to drive or use any tools or machines. Side effects such as dizziness and visual disturbances may occur (see section 4). If affected, you should not drive or operate machinery.
Omeprazole capsules contain sucrose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
This medicine contains less than 1 mmol sodium (23 mg) per capsule, that is to say essentially ‘sodium-free’.
3 How to take Omeprazole capsules
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Your doctor will tell you how many capsules to take and how long to take them for. This will depend on your condition and how old you are.
Doses:
- Adult
To treat symptoms of GORD such as heartburn and acid regurgitation:
- If your doctor has found that your food pipe (gullet) has been slightly damaged, the recommended dose is 20mg once a day for 4-8 weeks. Your doctor may tell you to take a dose of 40mg for a further 8 weeks if your gullet has not yet healed.
- The recommended dose once the gullet has healed is 10mg once a day.
- If your gullet has not been damaged, the recommended dose is 10mg once a day.
To treat ulcers in the upper part of the intestine (duodenal ulcer):
- The recommended dose is 20mg once a day for 2 weeks. Your doctor may tell you to take the same dose for a further 2 weeks if your ulcer has not yet healed.
- If the ulcer does not fully heal, the dose can be increased to 40mg once a day for 4 weeks.
To treat ulcers in the stomach (gastric ulcer):
- The recommended dose is 20mg once a day for 4 weeks. Your doctor may tell you to take the same dose for a further 4 weeks if your ulcer has not yet healed.
- If the ulcer does not fully heal, the dose can be increased to 40mg once a day for 8 weeks.
To prevent the duodenal and stomach ulcers from coming back:
- The recommended dose is 10mg or 20mg once a day. Your doctor may increase the dose to 40mg once a day.
Package leaflet: Information for the patient
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To treat duodenal and stomach ulcers caused by NSAIDs (Non-Steroidal Anti-Inflammatory Drugs):
- The recommended dose is 20mg once a day for 4–8 weeks.
To prevent duodenal and stomach ulcers if you are taking NSAIDs:
- The recommended dose is 20mg once a day.
To treat ulcers caused by Helicobacter pylori infection and to stop them coming back:
- The recommended dose is 20mg Omeprazole twice a day for one week.
- Your doctor will also tell you to take two antibiotics among amoxicillin, clarithromycin and metronidazole.
To treat too much acid in the stomach caused by a growth in the pancreas (Zollinger-Ellison syndrome):
- The recommended dose is 60mg daily.
- Your doctor will adjust the dose depending on your needs and will also decide how long you need to take the medicine for.
Use in children
To treat symptoms of GORD such as heartburn and acid regurgitation:
- Children over 1 year of age and with a body weight of more than 10kg may take Omeprazole. The dose for children is based on the child’s weight and the doctor will decide the correct dose.
To treat ulcers caused by Helicobacter pylori infection and to stop them coming back:
- Children aged over 4 years may take Omeprazole. The dose for children is based on the child’s weight and the doctor will decide the correct dose.
- Your doctor will also prescribe two antibiotics called amoxicillin and clarithromycin for your child.
Patients with kidney or liver problems
- Dose adjustment is not required in patients with kidney problems
- Patients with liver problems may require a smaller dose of 10-20mg a day.
Taking this medicine
- It is recommended that you take your capsules in the morning.
You can take your capsules with food or on an empty stomach.
- Swallow your capsules whole with half a glass of water. Do not chew or crush the capsules. This is because the capsules contain coated pellets which stop the medicine from being broken down by the acid in your stomach. It is important not to damage the pellets.
What to do if you or your child have trouble swallowing the capsules
- Open the capsules and swallow the contents directly with half a glass of water or put the contents into a glass of still (non-fizzy) water, any acidic fruit juice (e.g. apple, orange or pineapple) or apple sauce.
- Always stir the mixture just before drinking it (the mixture will not be clear). Then drink the mixture straight away or within 30 minutes.
- To make sure that you have drunk all of the medicine, rinse the glass very well with half a glass of water and drink it. The solid pieces contain the medicine - do not chew or crush them.
- Alternatively you or your child can suck the capsule and swallow the pellets with half a glass of water. The pellets must not be chewed.
If you take more Omeprazole capsules 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.
Symptoms of an overdose may include feeling or being sick, dizziness, stomach pain, diarrhoea, headache, depression and confusion.
If you forget to take Omeprazole 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 Omeprazole capsules
Do not stop treatment early otherwise your symptoms may reappear. Talk to your doctor before you stop taking the capsules and follow their advice.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4 Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you notice any of the following serious side effects, stop taking Omeprazole and contact a doctor immediately:
Rare (may affect up to 1 in 1,000 people):
- Sudden wheezing, swelling of your lips, tongue and throat or body, rash, fainting or difficulties in swallowing (severe allergic reaction).
- Widespread rash, high body temperature and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).
- A red, scaly widespread rash with bumps under the skin and blisters accompanied by fever. The symptoms usually appear at the initiation of treatment (acute generalised exanthematous pustulosis).
Very rare (may affect up to 1 in 10,000 people):
- Reddening of the skin with blisters or peeling. There may also be severe blisters and bleeding in the lips, eyes, mouth, nose and genitals. This could be ‘erythema multiforme’, ‘Stevens-Johnson syndrome’ or ‘toxic epidermal necrolysis’.
- Yellow skin, dark urine and tiredness which can be symptoms of liver failure.
- Shortness of breath, tiredness, dizziness, bleeding or bruising may be caused by a reduction in red, white blood cells and platelets (pancytopenia). A blood test may be required.
Omeprazole may in very rare cases affect the white blood cells leading to immune deficiency. If you have an infection with symptoms such as fever with a severely reduced general condition or fever with symptoms of a local infection such as pain in the neck, throat or mouth or difficulties in urinating, you must consult your doctor as soon as possible so that a lack of white
blood cells (agranulocytosis) can be ruled out by a blood test. It is important for you to give information about your medicine at this time.
Tell your doctor if you notice any of the following side effects or notice any other effects not listed:
Common (may affect up to 1 in 10 people):
- Headache.
- Diarrhoea, stomach pain, constipation, wind (flatulence).
- Feeling sick (nausea) or being sick (vomiting).
- Benign polyps in the stomach.
Uncommon (may affect up to 1 in 100 people):
- Swelling of the feet and ankles.
- Disturbed sleep (insomnia).
- Dizziness, tingling feelings such as “pins and needles”, feeling sleepy.
- Spinning feeling (vertigo).
- Changes in blood tests that check how the liver is working.
- Skin rash, lumpy rash (hives) and itchy skin.
- Generally feeling unwell and lacking energy.
- Increased risk of fracture of the hip, wrist or spine.
Rare (may affect up to 1 in 1,000 people):
- Blood problems such as a reduced number of white cells or platelets. This can cause weakness, bruising or make infections more likely.
- Low levels of sodium in the blood. This may cause weakness, being sick (vomiting) and cramps.
- Feeling agitated, confused or depressed.
- Taste changes.
- Blurred vision.
- Suddenly feeling wheezy or short of breath (bronchospasm).
- Dry mouth.
- An inflammation of the inside of the mouth.
- Hair loss (alopecia).
- Skin rash on exposure to sunshine.
- Joint pains (arthralgia) or muscle pains (myalgia).
- Severe kidney problems (interstitial nephritis).
- Increased sweating.
- Liver problems, including jaundice which can cause yellow skin, dark urine, and tiredness.
- An infection called “thrush” which can affect the gut and is caused by a fungus.
Very rare (may affect up to 1 in 10,000 people):
- Aggression.
- Seeing, feeling or hearing things that are not there (hallucinations).
- Severe liver problems leading to liver failure and inflammation of the brain.
- Muscle weakness.
- Enlarged breasts in men.
Do not be concerned by this list of possible side effects. You may not get any of them.
Not known (frequency cannot be estimated from the available data):
- 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 or 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.
- Inflamed colon causing watery diarrhoea (microscopic colitis).
- Rash, possibly with pain in the joints.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. 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 or search for MHRA Yellow Card in the Google Play or Apple App Store.
By reporting side effects you can help provide more information on the safety of this medicine.
5 How to store Omeprazole capsules
Keep this medicine out of the sight and reach of children.
Do not take this medicine after the expiry date stated on the carton. The expiry date refers to the last day of that month. Store below 25°C. Store in the original package to protect from moisture. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6 Contents of the pack and other information
What Omeprazole capsules contain
- The active substance (the ingredient that makes the capsule work) is Omeprazole. Each capsule contains either 10mg or 20mg of omeprazole.
- The other ingredients are sugar spheres (consisting of corn starch and sucrose), sodium laurilsulfate, 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 7, 10, 14, 15, 20, 21, 28, 30, 50, 56, 60, 84, 90, 98, 100 capsules (blister packs); 30, 90 (tablet containers).
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Accord, Barnstaple, EX32 8NS, UK
Manufacturer
Laboratorios Liconsa S.A., Avda. Miralcampo, No. 7, Poligono Industrial Miralcampo, 19200 Azuqueca de Henares (Guadalajara), Spain
This leaflet was last revised in June 2023.
If you would like a leaflet with larger text, please contact
01271 385257.