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OMEPRAZOLE 20 MG GASTRO-RESISTANT HARD CAPSULES

Active substance(s): OMEPRAZOLE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Omeprazole 10 mg gastro-resistant hard capsules
Omeprazole 20 mg gastro-resistant hard capsules
Omeprazole 40 mg gastro-resistant hard 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 capsule
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
Omeprazole capsule 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 capsule 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).

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 Capsules 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’ (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 capsule
Do not take Omeprazole capsule

if you are allergic (Hypersensitive) to omeprazole or any of the other ingredients of this
medicine (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).
Do not take Omeprazole capsule if any of the above apply to you. If you are not sure, talk to
your doctor or pharmacist before taking Omeprazole capsule.
Warnings and precautions
Talk to your doctor or pharmacist before taking Omeprazole capsule

if you have ever had a skin reaction after treatment with a medicine similar to
Omeprazole capsule 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 capsule. Remember to
also mention any other ill-effects like pain in your joints.
Omeprazole capsule may hide the symptoms of other diseases. Therefore, if any of the
following happen to you before you start taking Omeprazole capsule 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.
If you take Omeprazole capsule 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.

Taking a proton pump inhibitor like Omeprazole capsule 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).
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 capsule
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 capsule can affect the way some medicines work and some medicines can have
an effect on Omeprazole capsule.
Do not take Omeprazole capsule 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 capsule

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 capsule.

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
capsule treatment.
If your doctor has prescribed the antibiotics amoxicillin and clarithromycin as well as
Omeprazole capsule 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 capsule 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.
Omeprazole is excreted in breast milk but is not likely to influence the child when therapeutic
doses are used. Your doctor will decide whether you can take Omeprazole Capsules if you are
breast-feeding.
Driving and using machines
Omeprazole capsule 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
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
3. How to take Omeprazole capsule
Always take this medicine exactly as your doctor 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. The usual
doses are given below.
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 recommended 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-Inflammatory
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 usual 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 capsules 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 (ZollingerEllison 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.
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 10 kg may take
Omeprazole capsule. 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 capsule. 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 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
• 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.
If you take more Omeprazole capsule than you should
If you take more Omeprazole capsule than prescribed by your doctor, talk to your doctor or
pharmacist straight away.
If you forget to take Omeprazole capsule
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, this medicine can cause side effects, although not everybody gets them.
If you notice any of the following rare but serious side effects, stop taking name> 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 : may affect up to 1 in 10 people
Headache

Effects on your stomach or gut: diarrhoea, stomach pain, constipation, wind (flatulence)

Feeling sick (nausea) or being sick (vomiting).


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

Fracture of the hip, wrist or spine (see section 2).


Rare: may affect up to 1 in 1000 people


















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.
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: 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 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.


Not known: frequency cannot be estimated from the available data
• Inflammation in the gut (leading to diarrhoea).
• Rash, possibly with pain in the joints
• 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.

Omeprazole capsule 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.

Reporting of side effects
If you get 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:
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 capsule
Blister:
Do not store above 30oC. Store this blister in the original package in order to protect from
moisture
Container:
Do not store above 30oC. Keep the bottle tightly closed in order to protect from moisture.
10 & 40 mg strengths:
The in-use storage time after first opening is 50 days
20mg strength:
The in-use storage time after first opening is 56 days
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the outer and inner pack after
EXP. The expiry date refers to the last day of that month.
Do not use this medicine if you notice visible signs of deterioration.
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 capsule contains
- The active substance is omeprazole. Each capsule contains gastro-resistant granules of 10
mg, 20 mg or 40 mg omeprazole.
- The other ingredients are
Capsule core - Sugar spheres (sucrose and corn starch), Sodium starch glycolate, Sodium
laurilsulfate, Povidone K-30, Trisodium phosphate dodecahydrate, Hypromellose,
Methacrylic acid-ethyl acrylate copolymer, Triethyl citrate, Titanium dioxide (E171), Talc,
Sodium hydroxide
Capsule coating - Red iron oxide (E172) (10mg only), Erytrosine (E127), Indigo carmine
(E132) (20 & 40 mg only), Titanium dioxide (E171), water, gelatin, Quinoleine yellow
(E104)
Printing ink - Shellac, Propylene glycol, Sodium hydroxide, Polyvinylpyrollidone, Titanium
dioxide (E171)

What Omeprazole capsule looks like and contents of the pack
10 mg Capsules: have an orange body marked with ‘10’ and red cap marked with ‘O’
20 mg Capsules: have an orange body marked with ‘20’ and blue cap marked with ‘O’

40 mg Capsules: have an orange body marked with ‘40’ and blue cap marked with ‘O’
Pack sizes:
Blisters:
Packs of 5, 7, 14, 15, 20, 21, 25, 28, 30, 35, 42, 50, 50x1 hospital pack, 56, 60, 98, or 100
capsules
Not all pack sizes may be marketed.
Containers:
Packs of 5, 7, 14, 15, 20, 21, 28, 30, 42, 50, 56 (2x28), 60 (2x30), 84 (2x42), 90
(3x30), 98 (7x14), 100 (2x50), 250 (5x50) or 500 (10x50) capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Teva UK Limited, Eastbourne, BN22 9AG
Manufacturer
10, 20 & 40 mg strengths:
Teva Pharmaceutical Works Private Limited Company
Pallagi út 13, 4042 Debrecen
Hungary
Teva UK Ltd
Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG
United Kingdom
Pharmachemie B.V.
Swensweg 5, 2031 GA Haarlem
The Netherlands

Teva Pharma S.L.U.
C/C, n. 4, Poligono Industrial Malpica, 50016
Spain
Merckle GmbH
Ludwig-Merckle-Strasse 3, 89143 Blaubeuren
Germany

10 & 20 mg strengths:
Teva Santé
Rue Bellocier, 89100 Sens
France

This leaflet was last revised in 02/2016

PL00289/1658
PL00289/1659
PL00289/1660

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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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