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LOSEC 10MG HARD GASTRO-RESISTANT CAPSULES

Active substance(s): OMEPRAZOLE

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S0533-14-IT-PIL-03.12.2014

PACKAGE LEAFLET:
INFORMATION FOR THE PATIENT

Losec® 10mg hard gastro-resistant
capsules
(omeprazole)

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

Your medicine is available by the above name, but Do not take Losec
 If you are allergic to omeprazole or any of the other
will be referred to as Losec throughout the
ingredients of this medicine (listed in section 6).
remainder of this leaflet.
 If you are allergic to medicines containing other
Your medicine is available in other strengths –
proton pump inhibitors (eg pantoprazole,
20mg and 40mg.
lansoprazole, rabeprazole, esomeprazole).
Read all of this leaflet carefully before you start
 If you are taking a medicine containing nelfinavir
taking this medicine because it contains
(used for HIV infection)
important information for you.
Do not take Losec if any of the above apply to you.
 Keep this leaflet. You may need to read it again.
If you are not sure, talk to your doctor or pharmacist
 If you have any further questions, ask your doctor
before taking Losec.
or pharmacist.
Warnings and precautions
 This medicine has been prescribed for you only. Do
Losec may hide the symptoms of other diseases.
not pass it on to others. It may harm them, even if
Therefore, if any of the following happen to you
their signs of illness are the same as yours.
before you start taking Losec or while you are taking
 If you get any side effects talk to your doctor or
pharmacist. This includes any possible side effects it, talk to your doctor straight away:
 You lose a lot of weight for no reason and have
not listed in this leaflet. (See section 4).
problems swallowing.
What is in this leaflet:
 You get stomach pain or indigestion.
1. What Losec is and what it is used for
 You begin to vomit food or blood.
2. What you need to know before you take Losec
 You pass black stools (blood-stained faeces).
3. How to take Losec
 You experience severe or persistent diarrhoea, as
4. Possible side effects
omeprazole has been associated with a small
5. How to store Losec
increase in infectious diarrhoea.
6. Contents of the pack and other information
 You have severe liver problems.

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 (NonSteroidal 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.











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
You can take your capsules with food or on an empty
stomach.

Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, 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 breastfeeding.

Driving and using machines

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.

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.

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).

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.

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

Losec capsules contain lactose

3.

How to take Losec

Always take this medicine exactly as your doctor 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 usual doses are given below.

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.
To treat too much acid in the stomach caused by a
growth in the pancreas (Zollinger-Ellison
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:
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
Adults:
infection and to stop them coming back:
To treat symptoms of GORD such as heartburn and  Children aged over 4 years may take Losec. The
acid regurgitation:
dose for children is based on the child’s weight and
 If your doctor has found that your food pipe (gullet)
the doctor will decide the correct dose.
has been slightly damaged, the recommended
 Your doctor will also prescribe two antibiotics called
amoxicillin and clarithromycin for your child.
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
Taking this medicine
further 8 weeks if your gullet has not yet healed.
 It is recommended that you take your capsules in
 The recommended dose once the gullet has healed
the morning.
is 10 mg once a day.
 You can take your capsules with food or on an
 If your gullet has not been damaged, the usual
empty stomach.
dose is 10 mg once a day.



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

Rare side effects (may affect up to 1 in 1,000
people)


















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, this medicine can cause side
effects, although not everybody gets them.

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.

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).
Not known (frequency cannot be estimated
 Reddening of the skin with blisters or peeling.
from the available data)
There may also be severe blisters and bleeding in
 Inflammation in the gut (leading to diarrhoea).
the lips, eyes, mouth, nose and genitals. This could  If you are on Losec for more than three months it is
be ‘Stevens-Johnson syndrome’ or ‘toxic epidermal
possible that the levels of magnesium in your blood
necrolysis’.
may fall. Low levels of magnesium can be seen as
 Yellow skin, dark urine and tiredness which can be
fatigue, involuntary muscle contractions,
symptoms of liver problems.
disorientation, convulsions, dizziness or increased
heart rate. If you get any of these symptoms,
Other side effects include:
please tell your doctor promptly. Low levels of
Common side effects (may affect up to 1 in 10
magnesium can also lead to a reduction in
people)
potassium or calcium levels in the blood. Your
 Headache.
doctor may decide to perform regular blood tests to
 Effects on your stomach or gut: diarrhoea, stomach
monitor your levels of magnesium.
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.

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.
S0533-14-IT-PIL-03.12.2014

Reporting of side effects
If you get any side effects, talk to your doctor,
pharmacist or nurse. 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.









6.

How to store Losec
Keep out of the sight and reach of children.
Do not use Losec after the expiry date which is
stated on the pack after EXP. The expiry date
refers to the last day of that month.
Do not store above 30°C.
Store this blister in the original package 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.
If your medicine becomes discoloured or shows
any signs of deterioration, you should seek the
advice of your pharmacist.

Contents of the pack and other
information

What Losec contains



Each hard gastro-resistant capsule contains 10 mg
of omeprazole.
The other ingredients are disodium phosphate
dihydrate, hydroxypropylcellulose, hypromellose,
lactose anhydrous, magnesium stearate, mannitol,
methacrylic acid – ethyl acrylate copolymer (1:1)
dispersion 30 per cent, cellulose microcrystalline,
macrogol (polyethylene glycol 400), sodium
laurilsulfate, iron oxide E172, titanium dioxide
E171, gelatine, printing ink (containing shellac,
ammonia, potassium hydroxide, black iron oxide
E172), silica colloidal anhydrous and liquid paraffin.

What Losec looks like and contents of the pack
Hard gelatine capsules with an opaque pink body,
marked 10 and an opaque pink cap marked A/OS,
containing enteric coated pellets.
Pack sizes:
Blisters of 14 capsules.


Manufacturer
AstraZeneca AB, Gärtunavägen, SE-151 85,
Södertälje, Sweden.
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:
Product name Reference number
Losec 10 mg Capsules 33902/0533
This is a service provided by the Royal National
Institute of Blind People.
Procured from within the EU and repackaged by:
Amimed Direct Ltd, Hendon, London, NW9 6AQ.
Product Licence Holder: Sam Pharma Ltd, Unit 20
Garrick Industrial Estate, Irving Way, Hendon,
London, NW9 6AQ.
PL No: 33902/0533
POM
Leaflet revision date: 03/12/2014
Losec® is a registered trademark of the AstraZeneca
group of companies.

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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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