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LOSEC 20MG HARD GASTRO-RESISTANT CAPSULES

Active substance(s): OMEPRAZOLE / OMEPRAZOLE / OMEPRAZOLE

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S1699 LEAFLET Losec 20170125

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.

Children
Some children with chronic illnesses may require long-term
treatment although it is not recommended. Do not give this
medicine to children under 1 year of age or < 10 kg.
Other medicines and Losec

Please note that information regarding strengths, 10mg and 40mg,
of Losec may also be present in the following leaflet.

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.

Read all of this leaflet carefully before you start taking this
medicine because it contains important information for you.

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

-

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 only. Do not pass it
on to others. It may harm them, even if their signs of illness are
the same as yours.

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

3. How to take Losec



Rifampicin (used to treat tuberculosis)

4. Possible side effects



Atazanavir (used to treat HIV infection)

5. How to store Losec



Tacrolimus (in cases of organ transplantation)

6. Contents of the pack and other information



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))

Losec is used to treat the following conditions:



Erlotinib (used to treat cancer)

In adults:



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 you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this leaflet.
See section 4.

What is in this leaflet:
1. What Losec is and what it is used for
2. What you need to know before you take Losec

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.



‘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.

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.



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.

Losec with food and drink



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.

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.



Too much acid in the stomach caused by a growth in the
pancreas (Zollinger-Ellison syndrome).

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.

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.

See section 3.
Pregnancy, breast-feeding and fertility

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

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

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

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
Do not take Losec:


If you are allergic to omeprazole or any of the other ingredients
of this medicine (listed in section 6).



If you are allergic to medicines containing other proton pump
inhibitors (eg pantoprazole, lansoprazole, rabeprazole,
esomeprazole).

Always take this medicine exactly as your doctor or pharmacist 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.

Do not take Losec if any of the above apply to you. If you are not
sure, talk to your doctor or pharmacist before taking Losec.



The recommended dose once the gullet has healed is 10 mg
once a day.

Warnings and precautions



If your gullet has not been damaged, the usual dose is 10 mg
once a day.



If you are taking a medicine containing nelfinavir (used for HIV
infection)

Talk to your doctor or pharmacist before taking 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:

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.



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.

To treat ulcers in the stomach (gastric ulcer):



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.

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.





You have severe liver problems.

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



You have ever had a skin reaction after treatment with a
medicine similar to Losec that reduces stomach acid.



You are due to have a specific blood test (Chromogranin A).

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).
If you get a rash on your skin, especially in areas exposed to the
sun tell your doctor as soon as you can, as you may need to stop
your treatment with Losec. Remember to also mention any other illeffects like pain in your joints.

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 (NonSteroidal 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):



Joint pains (arthralgia) or muscle pains (myalgia).



Severe kidney problems (interstitial nephritis).
Increased sweating.



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.

Very rare side effects (may affect up to 1 in 10,000 people)

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.



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 (frequency cannot be estimated from the available
data)


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.



Rash, possibly with pain in the joints.

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
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.

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

If you stop taking Losec



KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.

Do not stop taking Losec without first talking to your doctor or
pharmacist.



Do not store above 30°C.



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

If you have any further questions on the use of this medicine, ask
your doctor or pharmacist.



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.

4. POSSIBLE SIDE EFFECTS



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.

Like all medicines, this medicine 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.

6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Losec contains



Other side effects include:
Common side effects (may affect up to 1 in 10 people)


Headache.



Effects on your stomach or gut: diarrhoea, stomach pain,
constipation, wind (flatulence).



Feeling sick (nausea) or being sick (vomiting).

Uncommon side effects (may affect up to 1 in 100 people)

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.

What Losec looks like and contents of the pack
Losec 20 mg capsules have a pink body, marked 20 and
a reddish-brown cap marked A/OM.
Losec is available in blister packs containing 14 or 28 capsules.
Product Licence holder



Swelling of the feet and ankles.



Disturbed sleep (insomnia).



Dizziness, tingling feelings such as “pins and needles”, feeling
sleepy.



Spinning feeling (vertigo).

This product is manufactured by



Changes in blood tests that check how the liver is working.





Skin rash, lumpy rash (hives) and itchy skin.

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



Generally feeling unwell and lacking energy.



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



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



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

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


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.

Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Ltd, Chemilines House,
Alperton Lane, Wembley, HA0 1DX.
Manufacturer

POM

PL No: 19488/1699

Leaflet revision date: 25 January 2017

Blind or partially sighted? Is
this leaflet hard to see or read?
Call 02087997607 to obtain the
leaflet in large print, tape, CD
or Braille.
Losec is a registered trademark of AstraZeneca group of
companies.
S1699 LEAFLET Losec 20170125

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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