Skip to Content

UK Edition. Click here for US version.

LOSEC 20MG HARD CAPSULES

Active substance(s): OMEPRAZOLE

View full screen / Print PDF » Download PDF ⇩
Transcript
PACKAGE LEAFLET: INFORMATION FOR THE USER
Losec® 20mg Hard Capsules
(omeprazole)
This product is available in the above name and strength but
will be referred to as Losec Capsules throughout this leaflet.
This product is available in multiple strengths and all strengths
will be referred to throughout this leaflet.
Read all of this leaflet carefully before you start taking this
medicine because it contains important information for you.
- 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.
- 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 Capsules is and what it is used for
2. What you need to know before you take Losec Capsules
3. How to take Losec Capsules
4. Possible side effects
5. How to store LosecCapsules
6. Contents of the pack and other information
1.

What Losec Capsules is and what it is used for

Losec Capsules 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.

Other medicines and Losec Capsules
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 Capsules.
Do not take Losec Capsules 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 Capsules
 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 Capsules
 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

Losec Capsules 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
Anti-Inflammatory Drugs). Losec Capsules 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.
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 Capsules

Do not take Losec Capsules
 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 (e.g. pantoprazole, lansoprazole, rabeprazole,
esomeprazole).
 If you are taking a medicine containing nelfinavir (used for HIV
infection)
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
Capsules.
Warnings and precautions
Losec Capsules may hide the symptoms of other diseases.
Therefore, if any of the following happen to you before you start
taking Losec Capsules 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.
If you take Losec Capsules 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 Capsules, 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 your doctor has prescribed the antibiotics amoxicillin and
clarithromycin as well as Losec Capsules 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 Capsules 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 Capsules if you are breastfeeding.
Driving and using machines
Losec Capsules 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 Capsules

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.
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 (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):
 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 Capsules. 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 Capsules than you should
If you take more Losec Capsules than prescribed by your doctor, talk
to your doctor or pharmacist straight away.
If you forget to take Losec Capsules
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.
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.
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)
 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.

 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.
Not known (frequency cannot be estimated from the available
data)
 Inflammation in the gut (leading to diarrhoea).
 If you are on Losec Capsules 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.
Losec Capsules 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 Capsules







KEEP OUT OF THE SIGHT AND REACH OF CHILDREN
Do not take this medication after the expiry date.
Do not store above 30ºC.
Store in the original package to protect from moisture.
Do not take your capsules after the expiry date shown on the
carton. 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 that are 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 who
will tell you what to do.
6.

Contents of the pack and other information

What Losec Capsules contain
 Each capsule contains 20mg of the active ingredient omeprazole.
 Each capsule also contains: disodium phosphate dihydrate,
hydroxypropylcellulose, hypromellose, lactose anhydrous,
magnesium stearate, mannitol, methacrylic acid – ethyl acrylate
copolymer (1:1) dispersion 30%, microcrystalline cellulose,
macrogol (polyethylene glycol 400), sodium laurel sulfate, iron
oxide E172, titanium dioxide,E171, gelatin, printing ink
(containing shellac, ammonia, potassium hydroxide and black
iron oxide E172), silica colloidal anhydrous and paraffin liquid.
What Losec Capsules look like and contents of the pack
Losec Capsules are capsules with an opaque pink body, marked 20
and a opaque reddish-brown cap marked A/OM.
Losec Capsules are available in blister cartons containing 14 or 28
capsules.
Manufacturer
Manufactured by AstraZeneca AB, Gärtunavägen, SE-151 85
Södertälje, Sweden. Procured from within the EU and repackaged
by the Product Licence holder: G Pharma Ltd, Salford M50 2PU.
PL 16369/1518 Losec 20mg Hard Capsules

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.

POM

Leaflet revision: 26/03/2015
‘LOSEC’ is a registered trademark belonging to the
AstraZeneca Group.

Expand view ⇕

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.

Hide