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ANTRA 20MG MUPS TABLETS

Active substance: OMEPRAZOLE MAGNESIUM

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19.04.13[16]
Losec® 20mg Mups® Tablets
®
®
Antra 20mg Mups Tablets
Omeprazole Magnesium 20mg Mups®
Tablets
0255

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

(omeprazole)
PATIENT INFORMATION LEAFLET
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.
Your medicine is available using any of the above names but will be
referred to as Losec throughout the following leaflet.
This product is also available in other strengths.
In this leaflet:
1. What Losec is and what it is used for
2. Before you take Losec
3. How to take Losec
4. Possible side effects
5. How to store Losec
6. Further 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 (Non-Steroidal AntiInflammatory 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. BEFORE YOU TAKE LOSEC
Do not take Losec
- If you are allergic (hypersensitive) to omeprazole or any of the other
ingredients of Losec.
- 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.
Take special care with 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.
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).
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 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.

Pregnancy and breast-feeding
Before taking Losec, tell your doctor if you are pregnant or trying to get
pregnant. Your doctor will decide whether you can take Losec during this
time.
Your doctor will decide whether you can take Losec if you are breastfeeding.
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.
Important information about some of the ingredients of Losec
Losec 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 Losec 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 40 mg for a further 8 weeks if your
gullet has not yet healed.
- The usual dose once the gullet has healed is 10 mg once a day.
- If your gullet has not been damaged, the usual dose is 10 mg once a
day.
To treat ulcers in the upper part of the intestine (duodenal ulcer):
- The usual dose is 20 mg once a day for 2 weeks. Your doctor may tell
you to take the same dose for a further 2 weeks if your ulcer has not yet
healed.
- If the ulcer 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 ulcer 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 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 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. 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.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Losec 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 ‘Stevens-Johnson syndrome’ or ‘toxic epidermal necrolysis’.
- Yellow skin, dark urine and tiredness which can be symptoms of liver
problems.
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 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

Also contain glyceryl monostearate, magnesium stearate, microcrystalline
cellulose, methylacrylic acid copolymer C, hydroxypropyl cellulose,
hypromellose, paraffin, sucrose, maize starch, macrogol 6000, polysorbate,
crospovidone, sodium stearyl fumarate, talc, triethyl citrate, iron oxide
(E172) and titanium dioxide (E171).
What Losec look like and contents of the pack
Losec 20mg Mups Tablets come as pink/reddish brown oblong tablets
marked ‘20mg’ on one side and a logo on the reverse.
They come in blister packs containing 15, 30, 60 or 90 tablets.

affects 1 to 10 users in 100

Uncommon:

6. FURTHER INFORMATION
What Losec contain
Each tablet contains 20.6mg of the active ingredient omeprazole
magnesium equivalent to 20mg of omeprazole as enteric coated granules

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.
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 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 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
- Keep out of the sight and reach of children.
o
- Store below 25 C in the original container.
- 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 your tablets become discoloured or shown any other signs of
deterioration, please contact your doctor or pharmacist before taking
your medicine.

MANUFACTURER AND PRODUCT LICENCE HOLDER
Manufactured by AstraZeneca GmbH, 22880 Wedel, Germany and
procured from within the EU and repackaged by the Product Licence
Holder P.I.E. Pharma Ltd., 207 Kenton Road, Harrow, Middlesex HA3 0HD.
POM

PL 15361/0255

Leaflet revision and issue date (Ref) 19.04.13[16]
Losec, Antra and Mups are trademarks of AstraZeneca.

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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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