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Active substance(s): OMEPRAZOLE

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Omeprazole 20mg Capsules


Omeprazole 20mg Capsules

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
• If you have any further questions, ask your doctor or pharmacist
• This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if their signs of illness 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 is in this leaflet:
1. What Omeprazole Capsule is and what it is used for
2. What you need to know before you take Omeprazole Capsules
3. How to take Omeprazole Capsule
4. Possible side effects
5. How to store Omeprazole Capsule
6. Contents of the pack and other information
1. What Omeprazole Capsule is and what it is used 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:
In adults:
• Reflux oesophagitis and Oesophageal reflux 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
• 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 NSAlDs
• 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
• 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
due to a growth in the pancreas
• Treatment of reflux oesophagitis and oesophageal reflux disease in
the children over I year old and weigh ≥10kg
In children:
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.
2. What you need to know before you take Omeprazole
Do not take Omeprazole Capsules:
If you are allergic to omeprazole or any of the other ingredients of this
medicine (listed in section 6). An allergic reaction may include a rash,
itching, difficulty breathing or swelling in the face lips throat or tongue
• If you are allergic to medicines containing other proton pump
inhibitors (eg pantoprazole, lansoprazole, rabeprazole, esomeprazole)
• If you are taking a medicine containing atazanavir, nelfinavir (used for
HIV infection)
Do not take Omeprazole Capsules if any of the above apply to you. If
you are not sure, talk to your doctor or pharmacist before taking
Omeprazole Capsules
Warnings and precautions
Talk to your doctor or pharmacist before taking Omeprazole Capsules:
• If you have liver problems
This is because your doctor may reduce the dose
• If you lose a lot of weight for no reason and have problems swallowing
• If you get stomach pain or indigestion
• If you begin to vomit food or blood
• If you pass black stools (blood-stained faeces)
• If you experience severe or persistent diarrhoea, as omeprazole has
been associated with a small increase in infectious diarrhoea
• If you are going to have an operation and anaesthetic (including at the
• 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)

• If you have ever had a skin reaction after treatment with a medicine
similar to Omeprazole that reduces stomach acid
If 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. Remember to also mention any other ill-effects like
pain in your joints.
Other medicines and Omeprazole Capsules
Tell your doctor or pharmacist if you are taking, have recently taken or
might take any other medicines.
Please tell your doctor if you are taking any of the following medicines:
• Diazepam (for anxiety)
• Phenytoin (for epilepsy)
• Warfarin or other vitamin K blockers (for thinning of blood)
• Digoxin (for the heart)
• Ketoconazole, Itraconazole, Posaconazole or Voriconazole (for
fungal infections)
• Clarithromycin (for bacterial infections)
• Tacrolimus (for immune suppression)
• Rifampicin (used to treat tuberculosis)
• Atazanavir (used to treat HIV infection)
• 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))
• Erlotinib (used to treat cancer)
• Methotrexate (a chemotherapy medicine used in high doses to treat
cancer) – if you are taking a high dose of methotrexate, your doctor
may temporarily stop your Omeprazole treatment
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.
Omeprazole with food and drink
You can take your capsules with food or on an empty stomach.
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. 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 may 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.
Omeprazole capsules contains sucrose
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 medicine.
3. How to take Omeprazole Capsules
Always take this medicine exactly as your doctor has told you. Check
with your doctor or pharmacist if you are not sure.
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 recommended 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 the dose to l0mg.
For children (I year and older): the usual dose is based on age and
weight. The recommended dose is l0mg 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 recommended dose is I0mg or 20mg 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 recommended 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 recommended dose is omeprazole I 0 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.
Treatment of Ulcers caused by infection with the bacteria called
Helicobacter Pylori
The recommended dose is omeprazole 40 mg once a day or 20 mg
taken twice a day fora period of I - 2 weeks. Your doctor will also tell
you to take one or two of the following antibiotics; amoxicillin,
clarithromycin, metronidazole or tinidazole. For children over 4 years
the dosage is based on weight and the recommended dose is l0mg or
20mg twice a day for I week. Your child will also be given the
followingantibioticstotakeatthesame 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
The recommended dose is omeprazole 40 mg taken the evening before
surgery, and another 40 mg dose two to six hours before surgery.
Zollinger - Ellison Syndrome
The recommended 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
If you forget to take Omeprazole capsules:
If you forget 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 a
forgotten dose.
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 this
medicine, ask your doctor or pharmacist.
4. Possible Side Effects
Like all medicines, this medicine 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 Johnsonsyndrome’ or ‘toxic epidermal necrolysis’. Yellow skin, dark urine and
tiredness which can be symptoms of liver problems.
These effects are rare, affecting less than I in I000 people.
Other Side effects
Common: may affect up to I in I0 people
• Headache
• Effects on your stomach or gut: diarrhoea, stomach pain, constipation,
wind (flatulence)
• Feeling sick (nausea) or being sick (vomiting)
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: may affect up to I in I00 people
• Disturbed sleep (Insomnia)
• Dizziness
• Tingling feelings such as ‘pins and needles‘
• Feeling sleepy
• Spinning feeling (Vertigo)
• Feeling light headed or faint
• 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 of the hip, wrist or spine
• Swelling of the feet and ankles
Rare: may affect up to I in I,000 people
• Dry or sore mouth
• An infection called ‘thrush‘ which can affect the mouth or gullet and
is caused by a fungus
• An inflammation of the inside of the mouth
• Taste changes
• Feeling anxious, confused or depressed
• 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 (interstitial nephritis)
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
Allergic reactions, sometimes very severe, including swelling of the
lips, tongue and throat, fever, wheezing
Suddenly feeling wheezy or short of breath (bronchospasm)

Very rare: may affect up to 1 in 10,000 people
• Changes in blood count including agranulocytosis (lack of white
blood cells)
• Aggression
• Seeing, feeling or hearing things that are not there (hallucinations)
• Severe liver problems leading to liver failure and inflammation of brain
• Sudden onset of a severe rash or blistering or peeling skin. This may
be associated with a high fever and joint pains (Erythema multiforme,
Stevens-Johnson syndrome, toxic epidermal necrolysis)
• Muscle weakness
• Enlarged breasts in men
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, 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.
• Rash, possibly with pain in the joints
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.
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: 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 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. Contents of the pack and other information
What Omeprazole Capsules contain
The active substance is omeprazole and each capsule contains 20mg of
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 (El7l),
quinoleine yellow (EI04), indigo carmine (El32) and erythrosine (E I 27).
The printing ink contains shellac, anhydrous ethyl alcohol, isopropyl
alcohol, propylene glycol, N-butyl alcohol, polyvinylpyrrolidone, sodium
hydroxide and titanium dioxide (El7l).
What Omeprazole 20mg Capsules look like and contents of the
The capsules have an orange body and blue cap and are marked with
The capsules are supplied in bottles of I 4 and 28 capsules.
Marketing Authorisation Holder and Manufacturer
Special Concept Development (UK) Limited, Units 1-7 Colonial Way,
Watford, Hertfordshire, WD24 4YR.
PL 36722/0025
This leaflet was last revised in: April 2016

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.