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LOSEC MUPS 20MG TABLETS

Active substance(s): OMEPRAZOLE / OMEPRAZOLE MAGNESIUM / OMEPRAZOLE / OMEPRAZOLE MAGNESIUM / OMEPRAZOLE / OMEPRAZOLE MAGNESIUM

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Package leaflet: Information for the patient
Losec® Mups® 10mg Tablets
Losec® Mups® 20mg Tablets
(omeprazole magnesium)
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.
The name of your medicine is Losec Mups 10mg
Tablets/Losec Mups 20mg Tablets but will be referred to as
Losec throughout the remainder of the leaflet.
This product is also available as a 40mg strength.
What is in this leaflet
1. What Losec is and what it is used for
2. What you need to know before you take Losec
3. How to take Losec
4. Possible side effects
5. How to store Losec
6. Contents of the pack and other information
1. What Losec is and what it is used for
Losec 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 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 (NonSteroidal Anti-Inflammatory Drugs). Losec 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.

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 Losec
Do not take Losec
• If you are allergic 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 (for
HIV infection).
Do not take Losec if any of the above apply to you. If you
are not sure, talk to your doctor or pharmacist before taking
Losec.
Warnings and precautions
Talk to your doctor or pharmacist before taking Losec.
Losec may hide the symptoms of other diseases.
Therefore, if any of the following happen to you before you
start taking Losec or while you are taking it, talk to your
doctor straight away:
• You lose a lot of weight for no reason and have
problems swallowing.
• You get stomach pain or indigestion.
• You begin to vomit food or blood.
• You pass black stools (blood-stained faeces).
• You experience severe or persistent diarrhoea, as
omeprazole has been associated with a small increase
in infectious diarrhoea.
• You have severe liver problems.
• You have ever had a skin reaction after treatment with a
medicine similar to Losec that reduces stomach acid.
• You are due to have a specific blood test
(Chromogranin A).
If you take Losec 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, especially over a
period of more than one year, may slightly increase your
risk of fracture in the hip, wrist or spine. Tell your doctor if
you have osteoporosis or if you are taking corticosteroids
(which can increase the risk of osteoporosis).
If you get a rash on your skin, especially in areas exposed
to the sun tell your doctor as soon as you can, as you may
need to stop your treatment with Losec. Remember to also
mention any other ill-effects like pain in your joints.
Children
Some children with chronic illnesses may require long-term
treatment although it is not recommended. Do not give this
medicine to children under 1 year of age or < 10 kg.
Other medicines and Losec
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 Losec can affect the way some medicines work
and some medicines can have an effect on Losec.

Do not take Losec 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 Losec
• 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
• 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.
If your doctor has prescribed the antibiotics amoxicillin and
clarithromycin as well as Losec to treat ulcers caused by
Helicobacter pylori infection, it is very important that you tell
your doctor about any other medicines you are taking.
Losec with food and drink
See section 3.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be
pregnant or are planning to have a baby, ask your doctor or
pharmacist for advice before taking this medicine.
Omeprazole is excreted in breast milk but is not likely to
influence the child when therapeutic doses are used. Your
doctor will decide whether you can take Losec if you are
breast-feeding.
Driving and using machines
Losec 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.
Losec tablets contain sucrose
Losec 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
Always take this medicine exactly as your doctor or
pharmacist has told you. 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 recommended dose is:
Adults
To treat symptoms of GORD such as heartburn and acid
regurgitation:
• If your doctor has found that your food pipe (gullet) has
been slightly damaged, the recommended dose is 20
mg once a day for 4-8 weeks. Your doctor may tell you
to take a dose of 40 mg for a further 8 weeks if your
gullet has not yet healed.
• The recommended dose once the gullet has healed is
10 mg once a day.
• If your gullet has not been damaged, the usual dose is
10 mg once a day.
To treat ulcers in the upper part of the intestine
(duodenal ulcer):
• The recommended dose is 20 mg once a day for 2
weeks. Your doctor may tell you to take the same dose
for a further 2 weeks if your ulcer has not yet healed.
• If the ulcers do not fully heal, the dose can be increased
to 40 mg once a day for 4 weeks.
To treat ulcers in the stomach (gastric ulcer):
• The recommended dose is 20 mg once a day for 4
weeks. Your doctor may tell you to take the same dose
for a further 4 weeks if your ulcer has not yet healed.
• If the ulcers do not fully heal, the dose can be increased
to 40 mg once a day for 8 weeks.
To prevent the duodenal and stomach ulcers from
coming back:
• The recommended dose is 10 mg or 20 mg once a day.
Your doctor may increase the dose to 40 mg once a
day.
To treat duodenal and stomach ulcers caused by NSAIDs
(Non-Steroidal Anti-Inflammatory Drugs):
• The recommended dose is 20 mg once a day for 4 to 8
weeks.
To prevent duodenal and stomach ulcers if you are
taking NSAIDs:
• The recommended dose is 20 mg once a day.
To treat ulcers caused by Helicobacter pylori infection
and to stop them coming back:
• The recommended dose is 20 mg Losec twice a day for
one week.
• Your doctor will also tell you to take two antibiotics
among amoxicillin, clarithromycin and metronidazole.
To treat too much acid in the stomach caused by a growth
in the pancreas (Zollinger-Ellison syndrome):
• The recommended dose is 60 mg daily.
• Your doctor will adjust the dose depending on your
needs and will also decide how long you need to take
the medicine for.

Use in children and adolescents
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. 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. 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 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.
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.
If you take more Losec than you should
If you take more Losec than prescribed by your doctor, talk
to your doctor or pharmacist straight away.
If you forget to take Losec
If you forget to take a dose, take it as soon as you
remember it. However, if it is almost time for your next
dose, skip the missed dose. Do not take a double dose to
make up for a forgotten dose.
If you stop taking Losec
Do not stop taking Losec without first talking to your doctor
or pharmacist.
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects,
although not everybody gets them.
If you notice any of the following rare but serious side
effects, stop taking Losec 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 ‘StevensJohnson 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 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 side effects (may affect up to 1 in 100
people)
• Swelling of the feet and ankles.
• Disturbed sleep (insomnia).
• Dizziness, tingling feelings such as “pins and needles”,
feeling sleepy.
• Spinning feeling (vertigo).
• Changes in blood tests that check how the liver is
working.
• Skin rash, lumpy rash (hives) and itchy skin.
• Generally feeling unwell and lacking energy.
Rare side effects (may affect up to 1 in 1,000 people)
• Blood problems such as a reduced number of white
cells or platelets. This can cause weakness, bruising or
make infections more likely.
• 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 side effects (may affect up to 1 in 10,000
people)
• Changes in blood count including agranulocytosis (lack
of white blood cells)
• Aggression.
• Seeing, feeling or hearing things that are not there
(hallucinations).
• Severe liver problems leading to liver failure and
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).
• If you are on Losec for more than three months it is
possible that the levels of magnesium in your blood may
fall. Low levels of magnesium can be seen as fatigue,
involuntary muscle contractions, disorientation,
convulsions, dizziness or increased heart rate. If you get
any of these symptoms, please tell your doctor
promptly.
Low levels of magnesium can also lead to a reduction in
potassium or calcium levels in the blood. Your doctor
may decide to perform regular blood tests to monitor
your levels of magnesium.
• Rash, possibly with pain in the joints.
Losec 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 any 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 Losec
Keep out of the sight and reach of children
Do not store above 25°C.
Store in the original package. Protect from moisture.
Do not use Losec 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 protect the environment.
6. Contents of the pack and other information
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.
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 startch),
macrogol 6000, polysorbate 80, crospovidone, sodium
stearyl fumarate, talc, triethyl citrate, reddish brown iron
oxide and titanium dioxide (E171).
Losec Mups 10mg Tablets also contain yellow iron oxide.
Losec Mups 10mg Tablets are light pink, oblong shaped,
biconvex, gastro-resistant tablets engraved with a company
logo on one side and '10mg' on the other.

Losec Mups 20mg Tablets are pink, oblong shaped,
biconvex, gastro-resistant tablets, engraved with a
company logo on one side and '20mg' on the other.
Losec Mups are available in packs of 30 tablets.
PL 20774/1215 Losec Mups 10mg Tablets
PL 20774/1216 Losec Mups 20mg Tablets

POM

Manufactured by AstraZeneca GmbH, 22876 Wedel,
Germany. Procured from within the EU. Product Licence
Holder: Quadrant Pharmaceuticals Ltd, Lynstock House,
Lynstock Way, Lostock, Bolton, BL6 4SA. Repackaged by:
Maxearn Ltd, Bolton, BL6 4SA.
Losec and Mups are registered trademarks of AstraZeneca
AB.
Leaflet revision date: 31st May 2017

Blind or partially sighted?
Is this leaflet hard to see or read?
Contact Quadrant
Pharmaceuticals Ltd,
Tel: 01204 473081
PP5/1215/16/V2

Expand Transcript

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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