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LOSEC 20MG HARD CAPSULES

Active substance(s): OMEPRAZOLE / OMEPRAZOLE / OMEPRAZOLE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Losec® 20mg Hard Capsules
(omeprazole)
This product is available in the above name and strength but will
be referred to as Losec throughout this leaflet.
This product is available in multiple strengths and all strengths
will be referred to throughout this leaflet.
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.
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 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 contain lactose
Losec 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 Anti-Inflammatory 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.

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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