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OMEPRAZOLE MUPS 10MG TABLETS

Active substance(s): OMEPRAZOLE / OMEPRAZOLE MAGNESIUM

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Transcript
CUSTOMER:

Waymade

Ref:

PRODUCT:

Losec Mups

ARTWORKER:

10mg 20mg tabs

DATE OF PROOF: 23/09/13

DT

Q.A.
APPROVED:

CUSTOMER
APPROVED:

DATE:

DATE:

PROOF HISTORY:
v.4 - waymade - 23/09/13

ÄG¥FÞ±
Leaflet Flat Size = 296 x 317

06464/2903 2904E

CODE:

ARIAL REGULAR FONT SIZE 8
ARIAL BOLD FONT SIZE 10
BRIDGED TO
TRANSTEC 6464/2327 2328 2329

TO DECEMBER 2012

Pg 1

Pg 4

Very rare side effects

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

Inflammation in the gut (leading to diarrhoea).

If you are on Losec MUPS 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.
Losec MUPS 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.
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.

5. How to store Losec MUPS tablets
Keep out of the sight and reach of children.
Do not store above 25°C. Store in the original package. Protect from moisture.
Keep the tablets in the foil blister until you are ready to take them.
Do not take your tablets after the expiry date shown on the carton. 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 that are no longer required. These measures will help to protect the environment.
If the tablets become discoloured, or show any other signs of deterioration, you should consult your doctor
or pharmacist who will advise you what to do.

6. Further information

LOSEC®
LOSEC®

MUPS®
MUPS®

10mg TABLETS
20mg TABLETS

(omeprazole magnesium)
Patient Information Leaflet

This product is known as one of the above names but will be referred to as Losec MUPS tablets or Losec
MUPS throughout this leaflet. Another strength (40mg) is also available.
Please read all of this leaflet carefully before you start taking this medicine.

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. Do not pass it on to others. It 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 this leaflet,
please tell your doctor or pharmacist.
In this leaflet:
1. What Losec MUPS tablets are and what they are used for
2. Before you take Losec MUPS tablets
3. How to take Losec MUPS tablets
4. Possible side effects
5. How to store Losec MUPS tablets
6. Further information

1. What Losec MUPS tablets are and what they are used for

Losec MUPS gastro-resistant 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.
Losec MUPS 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).
Losec MUPS 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).

What Losec MUPS Tablets contain
Losec MUPS 10mg Tablets contain 10mg omeprazole (as omeprazole magnesium) as enteric coated
granules in a gastro-resistant tablet.
Losec MUPS 20mg Tablets contain 20mg omeprazole (as omeprazole magnesium) as enteric coated
granules in a gastro-resistant tablet.

In children:
Children over 1 year of age and ≥ 10 kg

‘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.

The other ingredients are microcrystalline cellulose, glycerol monostearate 40-55, hyprolose, hypromellose,
magnesium stearate, methylacrylic acid co-polymer 1:1, hard paraffin, sugar spheres (sucrose and maize
starch), macrogol 6000, polysorbate 80, crospovidone, sodium hydroxide, sodium stearyl fumarate, talc,
triethyl citrate, reddish brown iron oxide and titanium dioxide (E171).
Losec MUPS 10mg Tablets also contain yellow iron oxide.

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.

What Losec MUPS Tablets look like and contents of the pack
Losec MUPS 10mg Tablets are light pink, oblong, biconvex, gastro-resistant tablets, engraved with a
company logo on one side and ‘10mg’ on the other.
Losec MUPS 20mg Tablets are pink, oblong, biconvex, gastro-resistant tablets, engraved with a company
logo on one side and ‘20mg’ on the other.
The tablets are available in packs of 30 tablets.
POM

PL No: 06464/2903 Losec MUPS 10mg Tablets
PL No: 06464/2904 Losec MUPS 20mg Tablets

These products are manufactured by AstraZeneca GmbH, 22876 Wedel, Germany and procured from
within the EU and repackaged by the Product Licence holder:
Waymade plc, Miles Gray Road, Basildon, Essex SS14 3FR
Leaflet revision and issue date (Ref.) 22.09.2013
Losec and MUPS are registered trademarks of AstraZeneca AB

2. Before you take Losec MUPS tablets
Do not take Losec MUPS tablets:

If you are allergic (hypersensitive) to omeprazole or any of the other ingredients of Losec MUPS.

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 (for HIV infection).
If you are not sure, talk to your doctor or pharmacist before taking Losec MUPS.
Take special care with Losec MUPS
Losec MUPS may hide the symptoms of other diseases. Therefore, if any of the following happen to you
before you start taking Losec MUPS 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.
If you take Losec MUPS 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 Losec MUPS 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).
Taking other medicines
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 Losec MUPS can affect the way some
medicines work and some medicines can have an effect on Losec MUPS.
Do not take Losec MUPS if you are taking a medicine containing nelfinavir (used to treat HIV infection).
Pg 2 !

WARNING!

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

:G»GUN
G­¥$<

h»­$Ã

WARNING!

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

CUSTOMER:
PRODUCT:
CODE:

Waymade

Ref:

Losec Mups

ARTWORKER:

10mg 20mg tabs

DATE OF PROOF: 23/09/13

DT

Q.A.
APPROVED:

CUSTOMER
APPROVED:

DATE:

DATE:

PROOF HISTORY:
v.4 - waymade - 23/09/13

ÄG¥FÞ±
Leaflet Flat Size = 296 x 317

06464/2903 2904E

ARIAL REGULAR FONT SIZE 8
ARIAL BOLD FONT SIZE 10
BRIDGED TO
TRANSTEC 6464/2327 2328 2329

Pg 2

Pg 3

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 Losec MUPS.

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 Losec MUPS.

Rifampicin (used to treat tuberculosis).

Atazanavir (used to treat HIV infections).

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 Losec treatment.

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 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.

If your doctor has prescribed the antibiotics amoxicillin and clarithromycin as well as Losec MUPS to
treat ulcers caused by Helicobacter pylori infection, it is very important that you tell your doctor about any
other medicines you are taking.

If you take more Losec MUPS than you should
If you take more Losec MUPS than prescribed by your doctor, talk to your doctor or pharmacist straight
away.

Taking Losec MUPS with food and drink
You can take your tablets with food or on an empty stomach.

If you forget to take Losec MUPS
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.

Pregnancy and breast-feeding
Before taking Losec MUPS, tell your doctor if you are pregnant or trying to get pregnant. Your doctor will
decide whether you can take Losec MUPS during this time.

What to do if you or your child have trouble swallowing the tablets

If you or your child have trouble swallowing the tablets:
- Break the tablet and disperse it in a spoonful of water (non-fizzy), any acidic fruit juice (e.g.
apple, orange or pineapple) or apple sauce.
- Always stir the mixture just before drinking (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.
Do not use milk or fizzy water. The solid pieces contain the medicine - do not chew or crush
them.

4. Possible side effects

Your doctor will decide whether you can take Losec MUPS if you are breastfeeding.

Like all medicines, Losec MUPS tablets can cause side effects, although not everybody gets them.

Driving and using machines
Losec MUPS 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.

If you notice any of the following rare but serious side effects, stop taking Losec MUPS tablets 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.

Important information about some of the ingredients of Losec MUPS
Losec MUPS gastro-resistant tablets 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 Losec MUPS tablets

Side effects may occur with certain frequencies, which are defined as follows:

Always take Losec MUPS exactly as your doctor has told you. You should check with your doctor or
pharmacist if you are not sure.

Very common:

affects more than 1 user in 10

Your 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 usual doses are given below.

Common:

affects 1 to 10 users in 100

Uncommon:

affects 1 to 10 users in 1,000

Rare:

affects 1 to 10 users in 10,000

Very rare:

affects less than 1 user in 10,000

Not known:

frequency cannot be estimated from the available data

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 usual dose is
20 mg once a day for 4-8 weeks. Your doctor may tell you to take a dose of 40mg 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.

Other side effects include:

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 ulcers do not fully heal, the dose can be increased to 40 mg once a day for 4 weeks.

Common side effects

Headache.

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

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

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 ulcers do not fully heal, the dose can be increased to 40 mg once a day for 8 weeks.

Uncommon side effects

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.

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 Losec MUPS 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.
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 Losec MUPS.
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 Losec MUPS. 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.

Rare side effects

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.

Pg 4 !

Pg 3 !

WARNING!

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

:G»GUN
G­¥$<

h»­$Ã

WARNING!

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

CUSTOMER: Waymade
PRODUCT:
CODE:

Ref:

Omeprazole Mups

ARTWORKER:

10mg 20mg tabs

DATE OF PROOF: 23/09/13

06464/2903 2904E

DT

Q.A.
APPROVED:

CUSTOMER
APPROVED:

DATE:

DATE:

PROOF HISTORY:
v.3 - waymade - 23/09/13

g7Tn„Ò
Leaflet Flat Size = 296 x 317
ARIAL REGULAR FONT SIZE 8
ARIAL BOLD FONT SIZE 10
BRIDGED TO
TRANSTEC 6464/2327 2328 2329

TO DECEMBER 2012

Pg 1

Pg 4

Very rare side effects

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

Inflammation in the gut (leading to diarrhoea).

If you are on Omeprazole MUPS 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 MUPS 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.
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.

5. How to store Omeprazole MUPS tablets
Keep out of the sight and reach of children.
Do not store above 25°C. Store in the original package. Protect from moisture.
Keep the tablets in the foil blister until you are ready to take them.
Do not take your tablets after the expiry date shown on the carton. 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 that are no longer required. These measures will help to protect the environment.
If the tablets become discoloured, or show any other signs of deterioration, you should consult your doctor
or pharmacist who will advise you what to do.

6. Further information
What Omeprazole MUPS Tablets contain
Omeprazole MUPS 10mg Tablets contain 10mg omeprazole (as omeprazole magnesium) as enteric coated
granules in a gastro-resistant tablet.
Omeprazole MUPS 20mg Tablets contain 20mg omeprazole (as omeprazole magnesium) as enteric coated
granules in a gastro-resistant tablet.

OMEPRAZOLE
OMEPRAZOLE

MUPS®
MUPS®

10mg TABLETS
20mg TABLETS

(omeprazole magnesium)
Patient Information Leaflet

This product is known as one of the above names but will be referred to as Omeprazole MUPS tablets or
Omeprazole MUPS throughout this leaflet. Another strength (40mg) is also available.
Please read all of this leaflet carefully before you start taking this medicine.

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. Do not pass it on to others. It 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 this leaflet,
please tell your doctor or pharmacist.
In this leaflet:
1. What Omeprazole MUPS tablets are and what they are used for
2. Before you take Omeprazole MUPS tablets
3. How to take Omeprazole MUPS tablets
4. Possible side effects
5. How to store Omeprazole MUPS tablets
6. Further information

1. What Omeprazole MUPS tablets are and what they are used for

Omeprazole MUPS gastro-resistant 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 MUPS 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 MUPS 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-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.

The other ingredients are microcrystalline cellulose, glycerol monostearate 40-55, hyprolose, hypromellose,
magnesium stearate, methylacrylic acid co-polymer 1:1, hard paraffin, sugar spheres (sucrose and maize
starch), macrogol 6000, polysorbate 80, crospovidone, sodium hydroxide, sodium stearyl fumarate, talc,
triethyl citrate, reddish brown iron oxide and titanium dioxide (E171).
Omeprazole MUPS 10mg Tablets also contain yellow iron oxide.

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.

What Omeprazole MUPS Tablets look like and contents of the pack
Omeprazole MUPS 10mg Tablets are light pink, oblong, biconvex, gastro-resistant tablets, engraved with a
company logo on one side and ‘10mg’ on the other.
Omeprazole MUPS 20mg Tablets are pink, oblong, biconvex, gastro-resistant tablets, engraved with a
company logo on one side and ‘20mg’ on the other.

Do not take Omeprazole MUPS tablets:

If you are allergic (hypersensitive) to omeprazole or any of the other ingredients of Omeprazole
MUPS.

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 (for HIV infection).

The tablets are available in packs of 30 tablets.

If you are not sure, talk to your doctor or pharmacist before taking Omeprazole MUPS.

POM

PL No: 06464/2903 Omeprazole MUPS 10mg Tablets
PL No: 06464/2904 Omeprazole MUPS 20mg Tablets

These products are manufactured by AstraZeneca GmbH, 22876 Wedel, Germany and procured from
within the EU and repackaged by the Product Licence holder:
Waymade plc, Miles Gray Road, Basildon, Essex SS14 3FR
Leaflet revision and issue date (Ref.) 22.09.2013
MUPS is a registered trademarks of AstraZeneca AB

2. Before you take Omeprazole MUPS tablets

Take special care with Omeprazole MUPS
Omeprazole MUPS may hide the symptoms of other diseases. Therefore, if any of the following happen to
you before you start taking Omeprazole MUPS 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.
If you take Omeprazole MUPS 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 MUPS 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).
Taking other medicines
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 MUPS can affect the way some
medicines work and some medicines can have an effect on Omeprazole MUPS.
Do not take Omeprazole MUPS if you are taking a medicine containing nelfinavir (used to treat HIV
infection).

WARNING!

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

-7Æ7»³
û¬ET).

XÆE)f

WARNING!

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

Pg 2 !

CUSTOMER: Waymade
PRODUCT:
CODE:

Ref:

Omeprazole Mups

ARTWORKER:

10mg 20mg tabs

DATE OF PROOF: 23/09/13

06464/2903 2904E

DT

Q.A.
APPROVED:

CUSTOMER
APPROVED:

DATE:

DATE:

PROOF HISTORY:
v.3 - waymade - 23/09/13

g7Tn„Ò
Leaflet Flat Size = 296 x 317
ARIAL REGULAR FONT SIZE 8
ARIAL BOLD FONT SIZE 10
BRIDGED TO
TRANSTEC 6464/2327 2328 2329

TO DECEMBER 2012

Pg 2

Pg 3

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 MUPS.

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 MUPS.

Rifampicin (used to treat tuberculosis).

Atazanavir (used to treat HIV infections).

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 MUPS treatment.

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 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.

If your doctor has prescribed the antibiotics amoxicillin and clarithromycin as well as Omeprazole MUPS to
treat ulcers caused by Helicobacter pylori infection, it is very important that you tell your doctor about any
other medicines you are taking.

If you take more Omeprazole MUPS than you should
If you take more Omeprazole MUPS than prescribed by your doctor, talk to your doctor or pharmacist
straight away.

Taking Omeprazole MUPS with food and drink
You can take your tablets with food or on an empty stomach.

If you forget to take Omeprazole MUPS
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.

Pregnancy and breast-feeding
Before taking Omeprazole MUPS, tell your doctor if you are pregnant or trying to get pregnant. Your doctor
will decide whether you can take Omeprazole MUPS during this time.

What to do if you or your child have trouble swallowing the tablets

If you or your child have trouble swallowing the tablets:
- Break the tablet and disperse it in a spoonful of water (non-fizzy), any acidic fruit juice (e.g.
apple, orange or pineapple) or apple sauce.
- Always stir the mixture just before drinking (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.
Do not use milk or fizzy water. The solid pieces contain the medicine - do not chew or crush
them.

4. Possible side effects

Your doctor will decide whether you can take Omeprazole MUPS if you are breastfeeding.

Like all medicines, Omeprazole MUPS tablets can cause side effects, although not everybody gets them.

Driving and using machines
Omeprazole MUPS 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.

If you notice any of the following rare but serious side effects, stop taking Omeprazole MUPS tablets
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.

Important information about some of the ingredients of Omeprazole MUPS
Omeprazole MUPS gastro-resistant tablets 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 MUPS tablets
Always take Omeprazole MUPS 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 tablets 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 usual dose is
20 mg once a day for 4-8 weeks. Your doctor may tell you to take a dose of 40mg 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 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 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 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 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 MUPS 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.
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
MUPS. 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 MUPS. 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.

Side effects may occur with certain frequencies, which are defined as follows:
Very common:

affects more than 1 user in 10

Common:

affects 1 to 10 users in 100

Uncommon:

affects 1 to 10 users in 1,000

Rare:

affects 1 to 10 users in 10,000

Very rare:

affects less than 1 user in 10,000

Not known:

frequency cannot be estimated from the available data

Other side effects include:
Common side effects

Headache.

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

Feeling sick (nausea) or being sick (vomiting).
Uncommon side effects

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.
Rare side effects

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.

Pg 4 !

Pg 3 !

WARNING!

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

-7Æ7»³
û¬ET).

XÆE)f

WARNING!

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

Expand view ⇕

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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