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LOSEC 10MG HARD GASTRO-RESISTANT CAPSULES

Active substance(s): OMEPRAZOLE / OMEPRAZOLE / OMEPRAZOLE

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S0533-14-IT-PIL-01.12.2016

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
Talk to your doctor or pharmacist before taking Losec.
not pass it on to others. It may harm them, even if
Losec may hide the symptoms of other diseases.
their signs of illness are the same as yours.
Therefore, if any of the following happen to you
 If you get any side effects talk to your doctor or
pharmacist. This includes any possible side effects before you start taking Losec or while you are taking
it, talk to your doctor straight away:
not listed in this leaflet. See section 4.
 You lose a lot of weight for no reason and have
What is in this leaflet:
problems swallowing.
1. What Losec is and what it is used for
 You get stomach pain or indigestion.
2. What you need to know before you take Losec
 You begin to vomit food or blood.
3. How to take Losec
 You pass black stools (blood-stained faeces).
4. Possible side effects
 You experience severe or persistent diarrhoea, as
5. How to store Losec
omeprazole has been associated with a small
6. Contents of the pack and other information
increase in infectious diarrhoea.
 You have severe liver problems.
1. What Losec is and what it is used for
 You have ever had a skin reaction after treatment
Losec contains the active substance omeprazole. It
with a medicine similar to Losec that reduces
belongs to a group of medicines called ‘proton pump
stomach acid.
inhibitors’. They work by reducing the amount of acid
If you take Losec on a long-term basis (longer than 1
that your stomach produces.
year) your doctor will probably keep you under regular
Losec is used to treat the following conditions:
surveillance. You should report any new and
exceptional symptoms and circumstances whenever
In adults:
you see your doctor.
 ‘Gastro-oesophageal reflux disease’ (GORD). This
is where acid from the stomach escapes into the
Taking a proton pump inhibitor like Losec, especially
gullet (the tube which connects your throat to your
over a period of more than one year, may slightly
stomach) causing pain, inflammation and
increase your risk of fracture in the hip, wrist or spine.
heartburn.
Tell your doctor if you have osteoporosis or if you are
 Ulcers in the upper part of the intestine (duodenal
taking corticosteroids (which can increase the risk of
ulcer) or stomach (gastric ulcer).
osteoporosis).
 Ulcers which are infected with bacteria called
‘Helicobacter pylori’. If you have this condition, your If you get a rash on your skin, especially in areas
exposed to the sun tell your doctor as soon as you
doctor may also prescribe antibiotics to treat the
can, as you may need to stop your treatment with
infection and allow the ulcer to heal.
Losec. Remember to also mention any other ill-effects
 Ulcers caused by medicines called NSAIDs (NonSteroidal Anti-Inflammatory Drugs). Losec can also like pain in your joints.
be used to stop ulcers from forming if you are
Other medicines and Losec
taking NSAIDs.
Tell your doctor or pharmacist if you are taking, have
 Too much acid in the stomach caused by a growth
recently taken, or might take any other medicines.
in the pancreas (Zollinger-Ellison syndrome).
This includes medicines that you buy without a
prescription. This is because Losec can affect the
In children:
way some medicines work and some medicines can
Children over 1 year of age and ≥ 10 kg
have an effect on Losec.
 ‘Gastro-oesophageal reflux disease’ (GORD). This
is where acid from the stomach escapes into the
Do not take Losec if you are taking a medicine
gullet (the tube which connects your throat to your
containing nelfinavir (used to treat HIV infection).
stomach) causing pain, inflammation and
Tell your doctor or pharmacist if you are taking any of
heartburn.
the following medicines:
In children, the symptoms of the condition can
 Ketoconazole, itraconazole, posaconazole or
include the return of stomach contents into the
voriconazole (used to treat infections caused by a
mouth (regurgitation), being sick (vomiting) and
fungus)
poor weight gain.

















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, breastfeeding 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 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.
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.
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.
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








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)













If you take more Losec than prescribed by your
doctor, talk to your doctor or pharmacist straight
away.



If you forget to take Losec






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.

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
Very rare side effects (may affect up to 1 in
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.

10,000 people)





Possible side effects

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



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).
 Rash, possibly with pain in the joints.
 Feeling sick (nausea) or being sick (vomiting).
Losec may in very rare cases affect the white blood
Uncommon side effects (may affect up to 1 in
cells leading to immune deficiency. If you have an
100 people)
infection with symptoms such as fever with a
 Swelling of the feet and ankles.

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,
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:
02082033203 (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: 01/12/2016
Losec® is a registered trademark of the AstraZeneca
group of companies.
S0533-14-IT-PIL-01.12.2016

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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