LOSEC®
Omeprazole 10 mg, 20 mg and 40 mg capsules.
What is in this leaflet
This leaflet answers some of the common questions people ask about Losec.
It does not contain all the information that is known about Losec.
It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor will have weighed the
risks of you taking Losec against the benefits they expect it will have
for you.
If you have any concerns about taking this medicine, ask your doctor or
pharmacist.
Keep this leaflet with the medicine. You may need to read it again.
What Losec is used for
Reflux Oesophagitis
Losec is used to treat the symptoms of reflux oesophagitis or reflux
disease in adults and in children. This can be caused by "washing back" (reflux)
of food and acid from the stomach into the gullet (oesophagus).
Reflux can cause a burning sensation in the chest rising up to the throat,
also known as heartburn.
Losec is also used to help stop reflux oesophagitis coming back or
relapsing.
Acid-Related Dyspepsia
Losec is used to treat acid-related dyspepsia.
Dyspepsia describes any regular upper abdominal pain or discomfort that is
often, but not always, related to eating.
Peptic Ulcers
Losec is used to treat peptic ulcers. Depending on the position of the
ulcer it is called a gastric or duodenal ulcer.
A gastric ulcer occurs in the stomach. A duodenal ulcer occurs in the
duodenum which is the tube leading out from the stomach.
These ulcers can be caused by too much acid being made in the stomach.
Losec is also used to help stop gastric or duodenal ulcers coming
back.
Peptic Ulcers Associated with Helicobacter pylori Infection
Most people who have a peptic ulcer also have a bacteria called
Helicobacter pylori in their stomach. When Losec is taken with
antibiotics, they will kill Helicobacter pylori and let your peptic ulcer
heal. When Losec is taken together with two antibiotics, they are more
effective than taken one or two at a time. It is possible that the antibiotics
may not always kill Helicobacter pylori. You may need further treatment.
Peptic Ulcers Associated with Non-steroidal Anti-Inflammatory Drugs (NSAIDs)
Some peptic ulcers are caused by taking medicines called non-steroidal
anti-inflammatory drugs. These medicines are commonly taken to treat joint
disease or arthritis. Losec is also used to heal and prevent ulcers associated
with NSAIDs.
Zollinger-Ellison Syndrome
Losec is also used to treat a rare condition called Zollinger-Ellison
syndrome, where the stomach produces large amounts of acid, much more than in
ulcers or reflux disease.
How Losec works
Losec is a type of medicine called a proton-pump inhibitor.
Losec works by decreasing the amount of acid made by the stomach, to
give relief of symptoms and allow healing to take place. This does not stop food
being digested in the normal way.
Your doctor will have explained why you are being treated with Losec
and told you what dose to take.
Follow all directions given to you by your doctor carefully. They may
differ from the information contained in this leaflet.
Your doctor may prescribe this medicine for another use. Ask your doctor if
you want more information.
There is no evidence that Losec is addictive.
Before you use Losec
If you plan to become pregnant, are pregnant or if you are breast feeding,
you should always be very careful with the use of medicines.
You should tell your doctor if you become pregnant while using Losec
or if you are prescribed Losec if you are breast feeding.
When you must not use it
Do not use Losec after the use by (expiry) date printed on the pack.
Do not use Losec if the packaging is torn or shows signs of tampering.
Do not use it to treat any other complaints unless your doctor says to.
Do not give this medicine to anyone else, even if their symptoms seem
similar to yours.
Before you start to use it
You must tell your doctor if:
- you have any allergies to
- any medicine containing a proton-pump inhibitor
- ingredients listed at the end of this leaflet
- any other medicines, foods, dyes or preservatives.
If you have an allergic reaction, you may
get a skin rash, difficulty in breathing, hayfever, or feel faint. - you have any other medical conditions
Taking other medicines
Tell your doctor if you are taking any other medicines, including:
- phenytoin
- warfarin
- diazepam
- ketoconazole
- itraconazole
- other medicines that you buy at the chemist, supermarket or health food
shop
These medicines may be affected by Losec or may affect how well it
works.
Your doctor or pharmacist can tell you what to do if you are taking any other
medicines.
If you have not told your doctor about any of these things, tell them
before you take any Losec.
Using Losec
How to take it
Take one Losec capsule each day, unless your doctor has told you
otherwise.
Adults
The dose of Losec is usually 20 mg a day, but may vary from 10 mg to
40 mg a day depending on what condition you are being treated for and how severe
it is.
Children
The recommended dose in children with reflux oesophagitis is 10 mg once a day
in children weighing 10-20 kg and 20 mg in children weighing more than 20 kg.
Swallow Losec capsules whole with a glass of water.
If you have trouble swallowing Losec, open the capsule over an empty
glass or cup and swallow the content, or suspend the content in a slightly
acidic fluid e.g. fruit juice, yoghurt or soured milk and take within 30
minutes. Or, suck the capsule until it opens (1-2 minutes) and swallow the
content with liquid. Do not crush or chew the capsules. If the granules in the
capsules are chewed or crushed they won't work properly.
Take Losec at about the same time each day, preferably in the morning.
Keeping a regular time for taking Losec will help to remind you to
take it.
In most patients, Losec relieves symptoms rapidly and healing is
usually complete within 4 weeks.
Although Losec heals ulcers very successfully, it may not prevent them
coming back at a later date. Losec can be taken to prevent these
relapses.
If you are taking Losec with antibiotics, it is possible that the
antibiotics may not kill Helicobacter pylori. You may need treatment with
further antibiotics.
Tell your doctor if your symptoms return.
It does not matter whether you take Losec with food or on an empty
stomach.
If you forget to take it
If you forget to take a dose, take it as soon as you remember, and then go
back to taking it as you would normally.
If it is almost time for your next dose, skip the dose you missed and take
your next dose when you are meant to.
Do not take a double dose to make up for the dose that you missed.
If you have trouble remembering when to take your medicine, ask your
pharmacist for some hints.
Overdose
Telephone your doctor or the National Poisons and Hazardous Chemicals
Information Centre Ph: 0800 POISON (0800 764 766) or go to Accident & Emergency
at your nearest hospital immediately if you think that you or anyone else may
have taken too much Losec. Even if there are no signs of discomfort or
poisoning.
While you are using Losec
You must use Losec exactly as your doctor has prescribed.
Tell all doctors, dentists and pharmacists who are treating you that you
are taking Losec.
Tell your doctor if you become pregnant while you are taking Losec.
Side effects
Tell your doctor or pharmacist as soon as possible if you do not feel well
while you are taking Losec.
Losec helps most people with stomach or duodenal ulcers or reflux
disease, but it may have unwanted side effects in a few people.
All medicines can have side effects. Sometimes they are serious, most of the
time they are not. You may need medical treatment if you get some of the side
effects.
Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor if you notice any of the following and they worry you:
- constipation
- nausea & vomiting
- diarrhoea & wind (flatulence)
- headache
These are all mild side effects of Losec.
Some people may notice:
- skin rash
- muscle pain or weakness
- dizziness
- "pins and needles"
- changes in sleep patterns
- mood changes
- increase in breast size (males)
- fever
- increased bruising
Tell your doctor if you think you have any of these effects or notice
anything else that is making you feel unwell.
Some people may get other side effects while taking Losec.
Other problems are more likely to arise from the ulcer itself rather than the
treatment.
For this reason , contact your doctor immediately if you notice any of the
following:
- pain or indigestion occurs during treatment with Losec
- you begin to vomit blood or food
- you pass black (blood-stained) motions.
Important: This leaflet alerts you to some of the situations when you
should call your doctor. Other situations, which cannot be predicted, may arise.
Nothing in this leaflet should stop you from calling your doctor or pharmacist
with any questions or concerns you have about using Losec.
After using it
Storage
Keep your Losec capsules in the bottle with the lid firmly on until it is
time to take them. If you take Losec out of the bottle it will not
keep well.
Keep it in a cool, dry place where the temperature stays below 25°C.
Do not store it or any other medicine in the bathroom or near a sink.
Heat and dampness can destroy some medicines.
Keep it where young children cannot reach it. A locked cupboard at
least one-and-a-half metres above the ground is a good place to store medicines.
Do not leave it in the car on hot days.
Disposal
If your doctor tells you to stop taking Losec or the capsules have passed
their expiry date, ask your pharmacist what to do with any capsules you have
left over.
Product description
What Losec looks like
Losec 10 mg capsules are pink, marked 10 and A/OS in black ink.
Losec 20 mg capsules are pink and brown, marked 20 and A/OM in black
ink.
Losec 40 mg capsules are reddish-brown, marked 40 and A/OL in black
ink.
Ingredients
Each Losec capsule contains omeprazole 10, 20 or 40 mg as the active
ingredient; plus,
- Mannitol (E421)
- Hydroxypropyl cellulose
- Microcrystalline cellulose (E 460)
- Lactose-anhydrous
- Sodium lauryl sulphate
- Sodium phosphate - dibasic dihydrate
as enteric-coated granules in bottles of 30 capsules.
The enteric coating is hypromellose, macrogol 400 and methacrylic acid
copolymer.
The gelatine (E441) capsule is coloured with red iron oxide (E 172) and
titanium dioxide (E 171).
Losec does not contain gluten.