LOSEC MUPS 40MG GASTRO-RESISTANT TABLETS

Active substance: OMEPRAZOLE MAGNESIUM

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PS01713

PACKAGE LEAFLET: INFORMATION FOR THE USER

Losec MUPS 10 mg gastro-resistant tablets
Losec MUPS 20 mg gastro-resistant tablets
Losec MUPS 40 mg gastro-resistant tablets
Omeprazole

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 gets 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 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 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. 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.
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.
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 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 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 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.
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 reach and sight of children.
• Do not use Losec after the expiry date which is stated on the outer and inner pack after EXP. The expiry date refers to
the last day of that month.
• Do not store above 25°C.
• Store this blister in the original package or keep the bottle tightly closed in order to protect from moisture.
• 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 Losec contains
• The active substance is omeprazole. Losec gastro-resistant tablets contain omeprazole magnesium corresponding to
10 mg, 20 mg or 40 mg omeprazole.
• The other ingredients are cellulose microcrystalline, glycerol monostearate 40-55, hydroxypropylcellulose,
hypromellose, magnesium stearate, methacrylic acid – ethyl acrylate copolymer (1:1) dispersion 30 per cent, sugar
spheres, synthetic paraffin (NF), macrogol (polyethylene glycol 6000), polysorbate 80, crospovidone, sodium hydroxide
(for pH-adjustment), sodium stearyl fumarate, talc, triethyl citrate, iron oxide E172, titanium dioxide E171.
What Losec looks like and contents of the pack
• Losec 10 mg gastro-resistant tablets are light-pink with
on one side and 10 mg on the other side.
• Losec 20 mg gastro-resistant tablets are pink with
on one side and 20 mg on the other side.
• Losec 40 mg gastro-resistant tablets are dark red-brown with
on one side and 40 mg on the other side.
Pack sizes:
• 10 mg:
- HDPE bottles of 7, 14, 15, 28, 30, 50, 100 tablets; hospital pack of 140 tablets.
- Blisters of 5, 7, 10, 14, 15, 25, 28, 30, 50, 56, 60, 84, 90, 100 tablets; hospital pack of 560 tablets.
- Perforated unit dose blisters (hospital packs) of 25 x 1, 28 x 1, 50 x 1, 56 x 1 tablets.
• 20 mg:
- HDPE bottles of 7, 14, 15, 28, 30, 50, 56, 100 tablets; hospital packs of 140 , 200, 280 tablets.
- Blisters of 5, 7, 14, 15, 25, 28, 30, 50, 56, 60, 84, 90, 98, 100 tablets; hospital pack of 560 tablets.
- Perforated unit dose blisters (hospital packs) of 25 x 1, 28 x 1, 50 x 1, 56 x 1, 100 x 1 tablets.
• 40 mg:
- HDPE bottles of 7, 14, 15, 28, 30, 100 tablets.
- Blisters of 5, 7, 14, 15, 25, 28, 30, 50, 56, 60, 100 tablets; hospital pack of 560 tablets.
- Perforated unit dose blisters (hospital packs) of 25 x 1, 28 x 1, 50 x 1 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
The Marketing Authorisations for Losec MUPS are held by AstraZeneca UK Ltd, 600 Capability Green, Luton, LU1 3LU,
United Kingdom.
Losec MUPS are manufactured by AstraZeneca AB, Gärtunavägen, SE-151 85, Södertälje, Sweden, AstraZeneca AB,
Mariehemsvägen 8, SE-906 54 Umeå, Sweden, N.V. AstraZeneca S.A, Schassestraat 15, B-9070 Destelbergen,
Belgium or AstraZeneca GmbH, Tinsdaler Weg 183, D-22880 Wedel, Germany.

To listen to or request a copy of this leaflet in Braille, large print or
audio please call, free of charge:
0800 198 5000 (UK only)
Please be ready to give the following information:
Reference number
Product name
Losec MUPS 10 mg 17901/0137
Losec MUPS 20 mg
17901/0138
Losec MUPS 40 mg 17901/0139
This is a service provided by the Royal National Institute of
Blind People.
This medicinal product is authorised in the Member States of the EEA under the following names:
Belgium: Losec
Cyprus: Losec
Denmark: Losec
Finland: Losec
Germany: Antra
Greece: Losec
Iceland: Losec
Ireland: Losec
Luxemburg: Losec
Malta: Losec
Netherlands: Losec
Norway: Losec
Romania; Losec
Sweden: Losec
UK: Losec
This leaflet was last updated in December 2012.
© AstraZeneca 2012
Losec and MUPS are trade marks of the AstraZeneca group of companies.
GI 12 0189

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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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