Skip to Content

UK Edition. Click here for US version.

LOSEC 20MG CAPSULES

Active substance(s): OMEPRAZOLE

View full screen / Print PDF » Download PDF ⇩
Transcript
Losec® 20mg Capsules/
Omeprazole 20mg Capsules
(omeprazole)
Your medicine is known by one of the above names, but will be referred to
as Losec throughout this:
Patient Information 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 is and what it is used for
2) What you need to know before you take Losec
3) How to take Losec
4) Possible side effects
5) How to store Losec
6) Contents of the pack and other 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.
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).
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
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).
• 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.
Warnings and precautions
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.
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).
Other medicines and Losec
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.

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)
• 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
You can take your capsules with food or on an empty stomach.
Pregnancy, breast-feeding 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 if you are breastfeeding.
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 contains 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 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 (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.
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 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.

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 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 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, 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

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.

• Do not use after the expiry date printed on the carton, blister pack or
glass container label.
• Losec 20mg capsules/Omeprazole 20mg capsules should be stored
below 30°C in the original container.
• If your capsules are supplied in a bottle always replace the cap firmly
after use.
• If your capsules are supplied in a bottle, use within three months of
opening the bottle.
• If your capsules are supplied in blister packs, do not take your capsules
out of the blister strip until it is time to take your dose. To remove the
capsule, use the flap to peel back and open the blister.
• Keep out of sight and reach of children.
• If your doctor tells you to stop taking the capsules, please take them
back to the pharmacist for safe disposal. Only keep the capsules if your
doctor tells you to.
• If the capsules become discoloured or show any other signs of
deterioration, you should seek the advice of your pharmacist who will tell
you what to do.
• 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.

Other side effects include:

6) Contents of the pack and other information

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

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.
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.
• Joint pains (arthralgia) or muscle pains (myalgia).
• Severe kidney problems (interstitial nephritis).
• Increased sweating.

What Losec contains:
Each capsule contains 20mg of the active ingredient omeprazole as
enteric coated granules.
Losec capsules also contain the following: lactose anhydrous, mannitol,
hydroxypropyl cellulose, microcrystalline cellulose, sodium lauryl sulphate,
sodium phosphate dihydrate, methylhydroxypropyl cellulose, polyethylene
glycol, gelatin, titanium dioxide (E171), iron oxide (E172), magnesium
stearate and copolymers of methacrylic acid.
What Losec looks like and contents of the pack
Enteric coated granules, in a hard gelatin capsule with an opaque pink
body marked '20' and a reddish-brown cap marked 'A/OM' printed on it.
Losec capsules are available as packs of 10 capsules in a glass container
or 10, 14 or 28 capsules in blister packs.
PL 10383/0227

POM

Who makes and repackages your medicine?
Your medicine is manufactured by Astra Pharmaceutical Production, 151
85 Sodertaje Sweden. Procured from within the EU and repackaged by
Product Licence Holder: Primecrown Ltd., 4/5 Northolt Trading Estate,
Belvue Road, Northolt, Middlesex, UB5 5QS.
Leaflet date: 13.07.2015
Losec® is a registered trademark of the AstraZeneca group of companies.

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