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LOSEC 20MG HARD CAPSULES

Active substance: OMEPRAZOLE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Losec® 20mg Capsules
(omeprazole)
This product is available in the above name and strength but will
be referred to as Losec Capsules 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.
- 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.

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

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.

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 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).

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

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.

Important information about some of the ingredients of Losec
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.

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 (used 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.

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
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.

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 capsules 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 4–8 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.

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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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