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OMEPRAZOLE 20 MG CAPSULES

Active substance(s): OMEPRAZOLE

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Colours Used

Artwork No.
Customer

Special Concept Development (UK) Limited

Description

Omprazole 20mg leaflet

Market

UK

Language

English

Size

160 x 280 mm

Min. Font Size

8 pt

Page No.

2 of 2

Date

14/04/2015

Omeprazole 20mg Capsules

Balck

(Omeprazole)

PACKAGE LEAFLET: INFORMATION FOR THE USER
Read all of this leaflet carefully before you start taking
these capsules
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Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or
pharmacist.
Your doctor has prescribed these capsules for you. Do not
pass them on to others. They may harm them even if their
symptoms are the same as yours.
If any of the side effects get serious, or if you notice any side
effects not listed in the leaflet, please tell your doctor or
pharmacist.

In this leaflet:
1. What Omeprazole Capsules are and what they are used
for
2. Before you take Omeprazole Capsules
3. How to take Omeprazole Capsules
4. Possible side effects
5. How to store Omeprazole Capsules
6. Further information
1. What Omeprazole Capsules are and what they are
used for
What are Omeprazole Capsules 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:
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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 discomfort.
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 NSAIDs.
Ulcers which are infected with bacteria called Helicobacter
pylori.
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 1 year old and weigh ≥10kg

2. Before you take Omeprazole Capsules
Do not take Omeprazole Capsules:
! If you are (hypersensitive) allergic to omeprazole or any of
the other ingredients in Omeprazole capsules. An allergic
reaction may include a rash, itching, difficulty breathing or
swelling in the face lips throat or tongue.
! If you are taking a medicine called atazanavir.
Take special care with Omeprazole Capsules:
Tell your doctor before you start taking these Capsules:
! If you have liver problems.
This is because your doctor may reduce the dose.
! If you are going to have an operation and anaesthetic
(including at the dentist).
! 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 skin reaction after treatment with
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.

Taking other medicines:
Please tell your doctor if you are taking any of the following
medicines: Diazepam (for anxiety), Phenytoin (for epilepsy),
Warfarin (for thining of the blood), Digoxin (for the heart)
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Ketoconazole, itraconazole or Voriconazole (for fungal
infections)
Clarithromycin (for bacterial infections)
Tacrolimus (for immune suppression)

Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines, including medicines
obtained without prescription.
Pregnancy and Breastfeeding:
Tell your doctor if you are, you think you might be or are
planning to become pregnant. 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 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.
Important information about some of the ingredients of
Omeprazole Capsules
The product contains 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 Omeprazole Capsules exactly as your doctor has
told you. You should check with your doctor or pharmacist if
you are not sure.
You can take your capsules with food or on an empty stomach
at any time of the day. 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 usual 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 10mg.
For children (1 year and older): the usual dose is based on age
and weight. The usual dose is 10mg 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 usual dose is 10 mg or 20 mg 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 usual 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 usual dose is
omeprazole 10 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.

Colours Used

Artwork No.
Customer

Special Concept Development (UK) Limited

Description

Omprazole 20mg leaflet

Market

UK

Language

English

Size

160 x 280 mm

Min. Font Size

8 pt

Page No.

2 of 2

Date

14/04/2015

Treatment of Ulcers caused by infection with the
bacteria called Helicobacter Pylori
The usual dose is omeprazole 40 mg once a day or 20 mg taken
twice a day for a period of 1 - 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 usual dose is
10mg or 20mg twice a day for 1 week. Your child will also be
given the following antibiotics to take at the same 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 anaesthetic
The usual dose is omeprazole 40 mg taken the evening before
surgery, and another 40mg dose two to six hours before
surgery.
Zollinger - Ellison Syndrome
The usual 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 away.
If forget to take Omeprazole capsules:
Try 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
forgotten individual doses.
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 Omeprazole
capsules ask your doctor or pharmacist.

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Balck

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.
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.

Frequency not known
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.
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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.

4. Possible Side Effects
5. How to store Omeprazole Capsules
Like all medicines, Omeprazole capsules 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 Jhonson- syndrome' or ' toxic epidermal
necrolysis'.
These effects are rare, affecting less than 1 in 1000 people.
Common: (affects less than 1 in 10 people)
! Headache.
! Diarrhoea or constipation.
! Feeling or being sick.
! Stomach ache or wind (sometimes with stomach pain).
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: (affects less than 1 in 100 people)
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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
Rare: (affects less than 1 in 1000 people)
! Dry or sore mouth
! An infection called 'thrush' which can affect the mouth or
gullet and is caused by a fungus.

Keep out of the reach and sight of children.
Do not store above 300C. 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. Further 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
(E171), quinoleine yellow (E104), indigo carmine (E132) and
erythrosine (E127).
The printing ink contains shellac, anhydrous ethyl alcohol,
isopropyl alcohol, propylene glycol, N-butyl alcohol,
polyvinylpyrrolidone, sodium hydroxide and titanium dioxide
(E171).
What Omeprazole 20mg Capsules look like and contents
of the pack
The capsules have an orange body and blue cap and are marked
with 020.
The capsules are supplied in bottles of 14 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
Date Leaflet approved: November 2015

POM

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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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