LOSEC 10MG HARD CAPSULES

Active substance: OMEPRAZOLE

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Patient Information Leaflet
Losec® 10mg hard Capsules
(omeprazole)
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.
The name of your medicine is Losec 10mg hard Capsules
but will be referred to as Losec throughout the remainder of
the leaflet.
Losec is also available in 20mg and 40mg strengths.

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 (eg 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.








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.

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.

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

To prevent duodenal and stomach ulcers if you are
taking NSAIDs:
• The usual dose is 20 mg once a day.

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.

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.

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. 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 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.

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 is used to treat the following conditions:

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).

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.

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.

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.

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.

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)

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.

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.

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.

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).

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 does not fully heal, the dose can be
increased to 40 mg once a day for 8 weeks.

Your doctor will decide whether you can take Losec if you
are breast-feeding.

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 does not fully heal, the dose can be
increased to 40 mg once a day for 4 weeks.

To treat too much acid in the stomach caused by a growth
in the pancreas (Zollinger-Ellison syndrome):
• The usual 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 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 has 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.
4. Possible side effects
Like all medicines, Losec 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.
Side effects may occur with certain frequencies, which are
defined as follows:
Very common:
Common:
Uncommon:
Rare:
Very rare:
Not known:

affects more than 1
user in 10
affects 1 to 10 users in
100
affects 1 to 10 users in
1,000
affects 1 to 10 users in
10,000
affects less than 1
user in 10,000
frequency cannot be
estimated from the
available data

Other side effects include:
Common side effects
• Headache.
• Effects on your stomach or gut: diarrhoea, stomach
pain, constipation, wind (flatulence).
• Feeling sick (nausea) or being sick (vomiting).
Uncommon side effects
• 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
• 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
• 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
• 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.

Manufactured by AstraZeneca AB, S-151 85, Sodertalje,
Sweden or . Procured from within the EU. Product Licence
Holder: Quadrant Pharmaceuticals Ltd, Lynstock House,
Lynstock Way, Lostock, Bolton, BL6 4SA. Repackaged by
Maxearn Ltd, Bolton, BL6 4SA.
Date of preparation 2nd July 2014
Losec is a registered trademark of AstraZeneca group of
companies.

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.
Do not be concerned by this list of possible side effects.
You may not get any of them. If any of the side effects get
serious, or if you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.
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. 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 in original package.
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.
6. Further information
What Losec contains
Losec 10mg capsules have a pink body marked ‘10’ and a
pink cap marked ‘A OS’ in black ink. Each capsule
contains 10mg of the active ingredient omeprazole.
Also contains lactose anhydrous, magnesium stearate,
mannitol, hyprolose, sodium lauryl sulphate,
microcrystalline cellulose, disodium phosphate dihydrate,
hypromellose, methyacrylic acid copolymer, macrogol,
printing ink (shellac, ammonium hydroxide, potassium
hydroxide and black iron oxide), red iron oxide (E172),
titanium dioxide (E171),gelatine, silica colloidal anhydrous
and paraffin liquid
Losec capsules are available in blister packs of 14 and 28.
Losec 10mg hard Capsules

PL 20774/1200

POM

PP6/1200/V1

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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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