PACKAGE LEAFLET: INFORMATION FOR THE USER
OMEPRAZOLE 10mg / 20mg / 40mg GASTRO-RESISTANT TABLETS
Omeprazole
(Referred to as Omeprazole tablets throughout this leaet)
Read all of this leaet 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 leaet
1. What Omeprazole tablets are and what they are used
for
2. What you need to know before you take Omeprazole
tablets
3. How to take Omeprazole tablets
4. Possible side effects
5. How to store Omeprazole tablets
6. Contents of the pack and other information
1. WHAT OMEPRAZOLE TABLETS ARE AND WHAT
THEY ARE USED FOR
Omeprazole tablets contains 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 tablets are used to treat the following
conditions:
In adults:
• ‘Gastro-oesophageal reux disease’ (GORD). This is
where acid from the stomach escapes into the gullet
(the tube which connects your throat to your stomach)
causing pain, inammation and heartburn.
• Ulcers in the upper part of the intestine (duodenal
ulcer) or stomach (gastric ulcer).
• 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-Inammatory Drugs). Omeprazole
tablets 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).
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
OMEPRAZOLE TABLETS
Do not take Omeprazole tablets
• If you are allergic to omeprazole or any of the other
ingredients of Omeprazole tablets.
• If you are allergic to medicines containing other proton
pump inhibitors (e.g. pantoprazole, lansoprazole,
rabeprazole, esomeprazole).
• If you are taking a medicine containing nelnavir (used
for HIV infection).
Do
not take Omeprazole tablets if any of the above
apply to you. If you are not sure, talk to your doctor or
pharmacist before taking Omeprazole tablets.
Warnings and precautions
Talk to your doctor or pharmacist before taking
Omeprazole tablets.
Serious skin reactions including Stevens-Johnson
syndrome, toxic epidermal necrolysis, drug reaction
with eosinophilia and systemic symptoms (DRESS) and
acute generalized exanthematous pustulosis (AGEP)
have been reported in association with Omeprazole
tablets treatment. Stop using Omeprazole tablets and
seek medical attention immediately if you notice any of
the symptoms related to these serious skin reactions
described in section 4.
Omeprazole tablets may hide the symptoms of other
diseases. Therefore, if any of the following happen to
you before you start taking Omeprazole tablets or while
you are taking it, talk to your doctor straight away:
• 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 tablets that reduces
stomach acid.
• You are due to have a specic blood test (Chromogranin
A).
If
you take Omeprazole tablets on 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.
Taking a proton pump inhibitor like Omeprazole tablets,
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 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
tablets. Remember to also mention any other ill-effects
like pain in your joints.
When taking omeprazole, inammation 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 your doctor.
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
Other medicines and Omeprazole tablets
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines. This
includes medicines that you buy without a prescription.
This is because Omeprazole tablets can affect the way
some medicines work and some medicines can have an
effect on Omeprazole tablets.
Do not take Omeprazole tablets if you are taking a
medicine containing nelnavir (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 tablets
• 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 tablets
• Rifampicin (used to treat tuberculosis)
• Atazanavir (used to treat HIV infection)
• Tacrolimus (in cases of organ transplantation)
• 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 tablets treatment
If
your doctor has prescribed the antibiotics amoxicillin
and clarithromycin as well as Omeprazole tablets 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 tablets with food and drink
See section 3.
Pregnancy, breast-feeding and fertility
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.
Omeprazole is excreted in breast milk but is not likely
to inuence the child when therapeutic doses are used.
Your doctor will decide whether you can take Omeprazole
tablets if you are breast-feeding.
Driving and using machines
Omeprazole tablets 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 tablets contain lactose and sodium
Omeprazole tablets contain lactose. If you have been
told by your doctor that you have an intolerance to some
sugars, contact your doctor before taking this medicinal
product.
Omeprazole tablets contain less than 1 mmol sodium
(23 mg) per tablet, that is to say essentially ‘sodium-
free’.
3. HOW TO TAKE OMEPRAZOLE TABLETS
Always take this medicine exactly as your doctor or
pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.
Y
our doctor will tell you how many tablets to take and
how long to take them for. This will depend on your
condition and how old you are.
The recommended doses are given below.
Use in adults
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 20
mg once a day for 4-8 weeks. Your doctor may tell you
to take a dose of 40 mg for a further 8 weeks if your
gullet has not yet healed.
• The recommended dose once the gullet has healed is
10 mg once a day.
• If your gullet has not been damaged, the usual dose is
10 mg once a day.
To treat ulcers in the upper part of the intestine
(duodenal ulcer):
• The recommended dose is 20 mg 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 ulcers do not fully heal, the dose can be increased
to 40 mg once a day for 4 weeks.
To treat ulcers in the stomach (gastric ulcer):
• The recommended dose is 20 mg 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 ulcers do not fully heal, the dose can be increased
to 40 mg once a day for 8 weeks.
To prevent the duodenal and stomach ulcers from
coming back:
• The recommended dose is 10 mg or 20 mg once a
day. Your doctor may increase the dose to 40 mg once
a day.
To treat duodenal and stomach ulcers caused by
NSAIDs (Non-Steroidal Anti-Inammatory Drugs):
• The recommended dose is 20 mg once a day for 4–8
weeks.
To prevent duodenal and stomach ulcers if you are
taking NSAIDs:
• The recommended dose is 20 mg once a day.
To treat ulcers caused by Helicobacter pylori infection
and to stop them coming back:
• The recommended dose is 20 mg Omeprazole tablets
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 60 mg daily.
• Your doctor will adjust the dose depending on your
needs and will also decide how long you need to take
the medicine for.
Children
This formulation is not suitable for children.
Taking this medicine
• It is recommended that you take your tablets in the
morning.
• You can take your tablets with food or on an empty
stomach.
• Swallow your tablets whole with half a glass of water.
Do not chew or crush the tablets. This is because the
tablets are coated with enteric coating which stops the
medicine from being broken down by the acid in your
stomach. It is important not to damage the tablets
If you take more Omeprazole tablets than you should
If you take more Omeprazole tablets than prescribed
by your doctor, talk to your doctor or pharmacist
straight away.
If you forget to take Omeprazole tablets
If you forget to take a dose, take it as soon as you
remember it. However, if it is almost time for your next
dose, skip the missed dose. Do not take a double dose
to make up for a forgotten dose.
If you stop taking Omeprazole tablets
Do not stop taking Omeprazole tablets without rst
talking to your doctor or pharmacist.
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 rare (may
affect
up to 1 in 1,000 people) or very rare (may affect up
to 1 in 10,000 people) but serious side effects, stop
taking Omeprazole tablets and contact a doctor
immediately:
• Sudden wheezing, swelling of your lips, tongue and
throat or body, rash, fainting or difculties in swallowing
(severe allergic reaction). (rare)
• 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
‘Stevens-Johnson syndrome’ or ‘toxic epidermal
necrolysis’. (very rare)
• Widespread rash, high body temperature and
enlarged lymph nodes (DRESS syndrome or drug
hypersensitivity syndrome). (rare)
• 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
generalized exanthematous pustulosis). (rare)
• Yellow skin, dark urine and tiredness which can be
symptoms of liver problems. (rare)
Other side effects include:
Common side effects (may affect up to 1 in 10
people)
• Headache.
• Effects on your stomach or gut: diarrhoea, stomach
pain, constipation, wind (atulence).
• Feeling sick (nausea) or being sick (vomiting).
• Benign polyps in the stomach.
Uncommon side effects (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.
• Fractures of the hip, wrist or spine.
Rare side effects (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.
• Eyesight problems such as blurred vision.
• Suddenly feeling wheezy or short of breath
(bronchospasm).
• Dry mouth.
• An inammation of the inside of the mouth.
• An infection called "thrush" which can affect the gut
and is caused by a fungus.
• Hair loss (alopecia).
• Skin rash on exposure to sunshine.
• Joint pains (arthralgia) or muscle pains (myalgia).
• Severe kidney problems (interstitial nephritis).
• Increased sweating.
Very rare side effects (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
inammation of the brain.
• Erythema multiforme.
• Muscle weakness.
• Enlarged breasts in men.
Not known (frequency cannot be estimated from the
available data)
• Inammation in the gut (leading to diarrhoea).
• If you are on Omeprazole Capsules 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.
• Rash, possibly with pain in the joints.
Omeprazole tablets may in very rare cases affect the
white blood cells leading to immune deciency.
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 difculties 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.
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 leaet. You can also report side effects
directly via the Yellow Card Scheme Website: 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 TABLETS
• Keep out of the sight and reach of children.
• Do not use Omeprazole tablets after the expiry date
which is stated on the pack after EXP. The expiry date
refers to the last day of that month.
• Do not store above 25°C.
• Store the tablets in the original package in order to
protect from moisture.
• 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 tablets contains
The active substance is omeprazole. Omeprazole
tablets contain 10 mg, 20 mg and 40 mg of omeprazole.
The other ingredients are lactose monohydrate, sodium
starch glycolate, sodium stearyl fumarate, sodium
stearate, hypromellose acetate succinate, brownish
pink colour [contains propylene glycol, titanium
dioxide (E171), red iron oxide (E172), hypromellose
and yellow iron oxide (E172)], talc, triethyl citrate,
monoethanolamine, sodium laurilsulfate and traces of
carnauba wax.
What Omeprazole tablets looks like and contents of
the pack
1. Omeprazole 10 mg gastro-resistant tablets are
brownish-pink lm coated capsule shaped tablets.
Blisters of 28 tablets
2. Omeprazole 20 mg gastro-resistant tablets are
brownish-pink lm coated capsule shaped tablets.
Blisters of 28 tablets
3. Omeprazole 40 mg gastro-resistant tablets are
brownish-pink lm coated capsule shaped tablets.
Blisters of 7, 28 tablets
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer:
Dexcel
®
- Pharma Ltd., 7 Sopwith Way, Drayton Fields,
Daventry, Northamptonshire, NN11 8PB,
UK.
This leaflet was last revised in February 2023
