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OMEPRAZOLE GASTRO-RESISTANT CAPSULES 40MG

Active substance(s): OMEPRAZOLE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
OMEPRAZOLE 10 mg GASTRO-RESISTANT CAPSULES
OMEPRAZOLE 20 mg GASTRO-RESISTANT CAPSULES
OMEPRAZOLE 40 mg GASTRO-RESISTANT 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 is and what it is used for
2.
What you need to know before you take Omeprazole
3.
How to take Omeprazole
4.
Possible side effects
5.
How to store Omeprazole
6.
Contents of the pack and other information

1. WHAT OMEPRAZOLE IS AND WHAT IT IS USED FOR
Omeprazole 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 is used to treat the following conditions:
In adults:
 ‘Gastro-esophageal reflux disease’ (GERD). 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).
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 ≥ 10 kg
 ‘Gastro-esophageal reflux disease’ (GERD). 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
Do not take Omeprazole
 If you are allergic (hypersensitive) to omeprazole or to any of the other ingredients of Omeprazole
(listed in section 6).
 if you are allergic to medicines containing other proton pump inhibitors (e.g.


pantoprazole, lansoprazole, rabeprazole, esomeprazole).
If you are taking a medicine containing nelfinavir (used for HIV infection)

Warning and precautions
If you are not sure, talk to your doctor or pharmacist before taking Omeprazole.
Take special care with Omeprazole

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:
 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 reduced body stores or risk factors for reduced vitamin B12 and receive
omeprazole long-term treatment. As with all acid reducing agents, omeprazole may lead
to a reduced absorption of vitamin B12.
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 take Omeprazole on a 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.

Omeprazole may interfere with some test (chromogranin A). To avoid this interference the
omeprazole should be temporarily stopped five days before testing.
Other medicines and Omeprazole

Please tell your doctor or pharmacist if you are taking or have recently taken any other
medicines, including medicines obtained without a prescription. 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).

Erlotinib (used for certain types of cancer)

Clarithromycin (antibiotic)

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 infections)

Tacrolimus (in cases of organ transplantation)

Methotrexate (used to treat rheumatoid arthritis and some cancers)

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))
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

Before taking Omeprazole, tell your doctor if you are pregnant or trying to get pregnant. 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 contains sucrose:
This medicine contains the sugar 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.
3. HOW TO TAKE OMEPRAZOLE
Always take Omeprazole exactly as your doctor has told you. You should 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.

The usual doses are given below.
Adults:
To treat symptoms of GERD such as heartburn and acid regurgitation:
 If your doctor has found that your food pipe (gullet) has been slightly damaged, the usual 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 usual 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 usual 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 ulcer does 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 usual 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 ulcer does 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 usual 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-Inflammatory Drugs):
 The usual dose is 20 mg once a day for 4 to 8 weeks.
To prevent duodenal and stomach ulcers if you are taking NSAIDs:
 The usual dose is 20 mg once a day.
To treat ulcers caused by Helicobacter pylori infection and to stop them coming back:
 The usual dose is 20 mg 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 usual 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.
Use in children:
To treat symptoms of GERD such as heartburn and acid regurgitation:
 Children over 1 year of age and with a body weight of more than 10 kg 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.
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 granules which stop the medicine from being broken down by
the acid in your stomach. It is important not to damage the granules.
What to do if you or your child have trouble swallowing the capsules
 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 any acidic fruit juice (e.g. apple, orange or pineapple) or apple
sauce.
Then drink the mixture straight away or within 30 minutes.
If you take more Omeprazole than you should
If you take more Omeprazole than prescribed by your doctor, talk to your doctor or pharmacist straight
away.
If you forget to take Omeprazole
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.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Omeprazole can cause side effects, although not everybody gets them.
If you notice any of the following rare but serious side effects, stop taking Omeprazole and
contact a doctor immediately:

 Sudden wheezing, swelling of your lips, tongue and throat or body, rash, fainting or difficulties in
swallowing (severe allergic reaction).
 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’.
 Yellow skin, dark urine and tiredness which can be symptoms of liver problems.
Other side effects include:
Common side effects (may affect upto 1 in 10 users)
 Headache.
 Effects on your stomach or gut: diarrhoea, stomach pain, constipation, wind (flatulence).
 Feeling sick (nausea) or being sick (vomiting).
Uncommon side effects (may affect upto 1 in 100 users)
 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.
 Fracture of the wrist, hip or spine
Rare side effects (may affect upto 1 in 1000 users)
 Blood problems such as a reduced number of 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.
 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 inflammation of the inside of the mouth.
 An infection called “thrush” which can affect the gut and is caused by a fungus.
 Chronic watery diarrhoea
 Liver problems, including jaundice which can cause yellow skin, dark urine, and tiredness.
 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 upto 1 in 10000 users)
 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 the 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.
 Hypomagnesaemia
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.
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.

Reporting of side effects
Do not be concerned by this list of possible side effects. You may not get any of them. If any
of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your
doctor or pharmacist.

You can also report side effects directly via Yellow Card Scheme, website:
www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more
information on the safety of this medicine
5. HOW TO STORE OMEPRAZOLE
Keep this medicine out of the sight and reach of children.
Do not use Omeprazole capsules after the expiry date which is stated on the carton after “EXP:”. The
expiry date refers to the last day of that month.
Store below 25°C
Aluminium/Aluminium blister: Store in the original package to protect from moisture.
HDPE bottle: Keep the bottle tightly closed 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 contains:
- The active substance is omeprazole 10 mg, 20 mg, or 40 mg
-

The other ingredients are:
 Capsule content: sugar spheres (consisting of corn starch and sucrose), sodium laurilsulfate,
anhydrous disodium phosphate, mannitol (E421), hypromellose, macrogol 6000, talc,
polysorbate 80, titanium dioxide (E171), and methacrylic acid-ethyl acrylate copolymer (1:1)
 Capsule shell: gelatine. The 10 and 20 mg capsules also contain the colouring agents
quinoline yellow aluminium lake (E104) and titanium dioxide (E171). The 40 mg capsules
contain indigo carmine aluminium lake (E132) and titanium dioxide (E171).

What Omeprazole capsules looks like and contents of the pack:
Gastro-resistant capsule, hard.
Omeprazole 10 mg: Opaque yellow capsule containing off-white to cream-white spherical
microgranules
Omeprazole 20 mg: Opaque yellow capsule containing off-white to cream-white spherical
microgranules
Omeprazole 40 mg: Opaque blue and opaque white capsule containing off-white to cream white
spherical microgranules.
The capsules are supplied in blisters of 7, 14, 15, 28, 30, 50, 56, 60, 90, 100, 140, 280 and 500
capsules; and in HDPE bottles of 7, 14, 28, 30, 56, 60, 90, 98 and 100 capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer:

The Marketing Authorisation Holder is Chemo Ibérica, S.A.
Company responsible for manufacture is LICONSA, Avda. Miralcampo No 7, Pol. Industrial
Miralcampo, 19200 Azuqueca de Henares (Guadalajara) – Spain.
This leaflet was last revised: August 2015

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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.

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