LOSEC 20MG HARD GASTRO-RESISTANT CAPSULES

Active substance: OMEPRAZOLE

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S1699 LEAFLET Losec 20131212

PACKAGE LEAFLET: INFORMATION FOR THE USER

LOSEC 20mg HARD GASTRO-RESISTANT CAPSULES
(omeprazole)
The name of your medicine is Losec 20mg Hard Gastro-resistant
Capsules but will be referred to as Losec throughout the following
leaflet.
Please note that information regarding strengths, 10mg and 40mg,
of Losec may also be present in the following leaflet.
Read all of this leaflet carefully before you start taking this
medicine.

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



Keep this leaflet. You may need to read it again.





Rifampicin (used to treat tuberculosis)

If you have any further questions, ask your doctor or
pharmacist.



Atazanavir (used to treat HIV infection)



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.



Tacrolimus (in cases of organ transplantation)



St John’s wort (Hypericum perforatum) (used to treat mild
depression)



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.



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.

In this leaflet:
1. What Losec is and what it is used for
2. Before you take Losec
3. How to take Losec

6. Further information

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.

1. WHAT LOSEC IS AND WHAT IT IS USED FOR

Taking Losec with food and drink

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.

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

4. Possible side effects
5. How to store Losec

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 AntiInflammatory 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).

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.
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.
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.

Children over 1 year of age and ≥ 10 kg

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.

In children:
‘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.

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.

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

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):

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)

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):


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:



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.



You lose a lot of weight for no reason and have problems
swallowing.

To treat duodenal and stomach ulcers caused by NSAIDs (NonSteroidal Anti-Inflammatory Drugs):



You get stomach pain or indigestion.



You begin to vomit food or blood.



You pass black stools (blood-stained faeces).

 The usual dose is 20 mg once a day for 4–8 weeks.
To prevent duodenal and stomach ulcers if you are taking
NSAIDs:



You experience severe or persistent diarrhoea, as omeprazole
has been associated with a small increase in infectious
diarrhoea.

 The usual dose is 20 mg once a day.
To treat ulcers caused by Helicobacter pylori infection and to
stop them coming back:



You have severe liver problems.



The usual dose is 20 mg Losec twice a day for one week.

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.



Your doctor will also tell you to take two antibiotics among
amoxicillin, clarithromycin and metronidazole.

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).



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.

Taking other medicines

To treat symptoms of GORD such as heartburn and acid
regurgitation:

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.
Do not take Losec if you are taking a medicine containing nelfinavir
(used to treat HIV infection).

To treat too much acid in the stomach caused by a growth in the
pancreas (Zollinger-Ellison syndrome):

Children:



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.



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.



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.

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



Very rare side effects

What to do if you or your child have trouble swallowing the
capsules


If you or your child have trouble swallowing the capsules:
-



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.

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.

-

 Enlarged breasts in men.
Not known

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

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.

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.

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.

4. POSSIBLE SIDE EFFECTS

Reporting of side effects

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

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.

If you notice any of the following rare but serious side effects,
stop taking Losec and contact a doctor immediately:

By reporting side effects, you can help provide more information on
the safety of this medicine.



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’.



KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Do not store above 30°C.



Store in the original package in order to protect from moisture.

Yellow skin, dark urine and tiredness which can be symptoms
of liver problems.



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.



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.



Side effects may occur with certain frequencies, which are defined
as follows:

5. HOW TO STORE LOSEC

Very common:

affects more than 1 user in 10

Common:

affects 1 to 10 users in 100

Uncommon:

affects 1 to 10 users in 1,000

6. FURTHER INFORMATION

Rare:

affects 1 to 10 users in 10,000

What Losec contains

Very rare:

affects less than 1 user in 10,000



Not known:

frequency cannot be estimated from the
available data

The active substance is omeprazole. Each capsule contains
20mg 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, microcrystalline
cellulose, macrogol (polyethylene glycol 400), sodium
laurilsulfate, iron oxide E172, titanium dioxide E171, gelatine,
printing ink (containing shellac, ammonia, potassium hydroxide
and black iron oxide E172), colloidal anhydrous silica and
paraffin liquid.

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.

What Losec looks like and contents of the pack
Losec 20 mg capsules have a pink body, marked 20 and a reddishbrown cap marked A/OM.
Losec is available in blister packs containing 14 or 28 capsules.
Product Licence holder
Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Ltd, Chemilines House,
Alperton Lane, Wembley, HA0 1DX.

Rare side effects
Manufacturer



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.

AstraZeneca AB, Gartunavagen, SE-151 85 Södertälje,
Sweden.





Low levels of sodium in the blood. This may cause weakness,
being sick (vomiting) and cramps.

AstraZeneca AB, Mariehemsvagen 8, SE-906 54 Umea,
Sweden.





Feeling agitated, confused or depressed.

AstraZeneca GmbH, Tinsdaler Weg 183, Wedel, D-22880
Germany.



Taste changes.





Eyesight problems such as blurred vision.

Recipharm Monts, 18 rue de Montbazon, F-37260, Monts,
France.



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.

This product is manufactured by

POM

PL No: 19488/1699

Leaflet revision date: 12 December 2013
Losec is a registered trademark of AstraZeneca group of
companies.
S1699 LEAFLET Losec 20131212

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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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