LOSEC 20MG CAPSULES

Active substance: OMEPRAZOLE

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CUSTOMER: Waymade

PRE-PRESS NO.: 02-1808
DT

CODE:

Losec

ARTWORKER:

20mg Capsules

PRODUCT:

DATE OF PROOF: 29/07/14

6464/0240E

Q.A.
APPROVED:

CUSTOMER
APPROVED:

DATE:

PROOF HISTORY:
v.4 - waymade - 29/07/14

DATE:

Leaflet Flat Size = 296 x 317

TVT CHECKED

ARIAL REGULAR FONT SIZE 8
ARIAL BOLD FONT SIZE 10
BRIDGED TO
TRANSTEC 6464/2327 2328 2329

NEW MANUFACTURER
NEW EXCIPIENTS

Pg 1

Pg 4

Very rare side effects

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

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.
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.

5. How to store Losec
Losec 20mg capsules should be stored below 30°C in the original packaging.
Do not remove a capsule from the blister packaging until you are ready to take the capsule.
Do not use after the expiry date printed on the carton or blister label. The expiry date refers to the last day
of that month.
KEEP ALL MEDICINES OUT OF THE 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 consult your
doctor or pharmacist who will advise you what to do.
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.

6. Further information
Your medicine is called Losec 20mg capsules. Each capsule contains 20mg of the active ingredient,
Omeprazole as enteric coated granules, in a hard gelatin capsule which has a reddish-brown cap marked
'AOM' and pink body marked '20'.
Losec 20mg capsules also contain the following:
lactose anhydrous, mannitol, hydroxypropyl cellulose, microcrystalline cellulose, sodium lauryl sulphate,
sodium dihydrogen phosphate dibasic, hypromellose, macrogol, magnesium stearate, gelatin, red iron oxide
(E172), titanium dioxide (E171) and copolymers of methacrylic acid.
Printing ink contains: shellac, ammonia, potassium hydroxide and black iron oxide (E172), silica colloidal
anhydrous, liquid paraffin.
Losec 20mg capsules are available as packs of 14 or 28 capsules in blister packs.
POM

PL No: 6464/0240

This product is manufactured by AstraZeneca AB, Sodertalje, Sweden and/or AstraZeneca GmbH, Tinsdaler
Weg 183, Wedel, D-22880 Germany and/or Recipharm Monts 18 rue de Montbazon F-37260, Monts,
France, and/or AstraZeneca AB, Mariehemsvägen 8, SE-906 54 Umeä, Sweden and is procured from within
the EUand repackaged by the Product Licence holder:
Waymade plc, Miles Gray Road, Basildon, Essex SS14 3FR
Leaflet revision and issue date (Ref.) 29.07.2014
LOSEC is a registered trademark of AstraZeneca AB

LOSEC®

20mg CAPSULES

(omeprazole)
Patient Information Leaflet

This product is known as the above name but will be referred to as Losec throughout this leaflet. There are
other strengths available.
Read all of this leaflet carefully before you start taking this medicine.

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

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.
In this leaflet:
1. What Losec is and what it is used for
2. Before you take Losec
3. How to take Losec
4. Possible side effects
5. How to store Losec
6. Further 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 Anti-Inflammatory 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. Before you take Losec
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 (e.g. pantoprazole,
lansoprazole, rabeprazole, esomeprazole).

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

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).
Taking other medicines
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).
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WARNING!

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

WARNING!

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

CUSTOMER: Waymade
PRODUCT:

Losec
20mg Capsules

CODE:

6464/0240E

PRE-PRESS NO.: 02-1808
ARTWORKER:
DT

Q.A.
APPROVED:

CUSTOMER
APPROVED:

DATE OF PROOF: 29/07/14
TVT CHECKED

DATE:

PROOF HISTORY:
v.4 - waymade - 29/07/14

DATE:

Leaflet Flat Size = 296 x 317

ARIAL REGULAR FONT SIZE 8
ARIAL BOLD FONT SIZE 10
BRIDGED TO
TRANSTEC 6464/2327 2328 2329

NEW MANUFACTURER
NEW EXCIPIENTS

Pg 2

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.
Taking Losec with food and drink
You can take your capsules with food or on an empty stomach.

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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.
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

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.

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

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.
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 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.

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 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 does 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 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 does 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.
To treat duodenal and stomach ulcers caused by NSAIDs (Non-Steroidal Anti-Inflammatory Drugs):

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

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

The usual 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 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.
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.

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

Rare:

affects 1 to 10 users in 10,000

Very rare:

affects less than 1 user in 10,000

Not known:

frequency cannot be estimated from the available data

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.
Rare side effects

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.

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.
Pg 3

WARNING!

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

WARNING!

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

Pg 4

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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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