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LOSEC 20MG CAPSULES

Active substance(s): OMEPRAZOLE / OMEPRAZOLE / OMEPRAZOLE

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Package leaflet: Information for the patient

Losec® 20mg Capsules / Omeprazole 20mg Capsules
(omeprazole)
This medicine is available under the above names but will be referred to as Losec
throughout the following leaflet. Please note that the leaflet also contains information about
other strengths (Losec 10mg and 40mg Capsules).
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.
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 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. 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 (eg pantoprazole,
lansoprazole, rabeprazole, esomeprazole).
 If you are taking a medicine containing nelfinavir (used 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.

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 infection)
 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 capsules contain lactose
Losec capsules contain lactose. 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 capsules 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 AntiInflammatory Drugs):
 The recommended dose is 20 mg once a day for 4–8 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 (ZollingerEllison 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.

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.

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.

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.

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 capsules in the morning.
 You can take your capsules with food or on an empty stomach.
 Swallow your capsules whole with half a glass of water. Do not chew or crush the
capsules. This is because the capsules 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 capsules
 If you or your child have trouble swallowing the capsules:
- Open the capsules and swallow the contents directly with half a glass of water or put
the contents into a glass of still (non-fizzy) water, any acidic fruit juice (e.g. apple,
orange or pineapple) or apple sauce.
- Always stir the mixture just before drinking it (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. 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 ‘Stevens-Johnson
syndrome’ or ‘toxic epidermal necrolysis’.
 Yellow skin, dark urine and tiredness which can be symptoms of liver problems.

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.
Losec Capsules should be stored in the original container.
Do not store above 30°C.
Store in the original package in order to protect from moisture.
Do not take your capsule out of the blister strip until it is time to take your dose. To
remove the capsules use the flap to peel back and open the blister.
 Do not take the capsules after the expiry date printed on the carton or blister strip. The
expiry date refers to the last day of that month.
 Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. These measures will help to
protect the environment.
 If the capsules become discoloured, or show any other signs of deterioration you should
seek the advice of your pharmacist who will tell you what to do.
6. Contents of the pack and other information
Each capsule contains 20mg of the active ingredient omeprazole as enteric coated
granules, in a pink and reddish brown, hard gelatine capsule with ‘AOM 20’ printed on it.
Losec Capsules also contain the following inactive ingredients:
lactose anhydrous, mannitol, hydroxypropyl cellulose, microcrystalline cellulose, sodium
lauryl sulphate, dibasic sodium phosphate dihydrate, methylhydroxypropyl cellulose,
polyethylene glycol, gelatin, titanium dioxide (E171), iron oxide (E172), magnesium
stearate and copolymers of methacrylic acid.
Losec Capsules are available as a bottle of 10 and blister packs of 10, 14 or 28 capsules.
PL No: 15814/0018

POM

Manufactured by AstraZeneca AB, 151 85 Sodertalje, Sweden and is procured within the
EU and repackaged by the Product Licence holder: OPD Laboratories Ltd, Unit 6 Colonial
Way, Watford, Herts WD24 4PR.

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.

Leaflet revision and issue date: 08.02.2017.
Losec is a trademark of the AstraZeneca group of companies.

To request a copy of this leaflet in Braille, large
print or audio please call 01923 332 796.

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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