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LOSEC 20MG GASTRO-RESISTANT CAPSULES

Active substance(s): OMEPRAZOLE

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Package leaflet: Information for the patient
®

Losec 20mg gastro-resistant capsules
(omeprazole)
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 get any side effects talk to your doctor or pharmacist. This includes any possible side effects
not listed in this leaflet. (See section 4.)

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.

The name of your medicine is Losec 20mg gastro-resistant capsules, but it will be referred to as Losec
or Losec capsules throughout this leaflet. This medicine is also available in other strengths such as
Losec 10mg and 40mg gastro-resistant capsules.

What is in this leaflet:
1.
2.
3.
4.
5.
6.

What Losec is and what it is used for
What you need to know before you take Losec
How to take Losec
Possible side effects
How to store Losec
Contents of the pack and other information














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

1. What Losec is and what it is used for

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.

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.

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.

Losec is used to treat the following conditions:

Driving and using machines

In adults:

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.







‘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. 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.

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
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 20mg once a day for 4-8 weeks. Your doctor may tell you to take a dose of 40mg for a
further 8 weeks if your gullet has not yet healed.
The recommended dose once the gullet has healed is 10mg once a day.
If your gullet has not been damaged, the usual dose is 10mg once a day.

To treat ulcers in the upper part of the intestine (duodenal ulcer):




The recommended dose is 20mg 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 40mg once a day for 4 weeks.

To treat ulcers in the stomach (gastric ulcer):




The recommended dose is 20mg 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 40mg once a day for 8 weeks.

Warnings and precautions

To prevent the duodenal and stomach ulcers from coming back:

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:




The recommended dose is 10mg or 20mg once a day. Your doctor may increase the dose to 40mg
once a day.

Ketoconazole, itraconazole, posaconazole or voriconazole (used to treat infections caused by a
fungus)
Digoxin (used to treat heart problems)

To treat duodenal and stomach ulcers caused by NSAIDs (Non-Steroidal Anti-Inflammatory Drugs):
The recommended dose is 20mg once a day for 4–8 weeks.

To prevent duodenal and stomach ulcers if you are taking NSAIDs:



The recommended dose is 20mg once a day.

To treat ulcers caused by Helicobacter pylori infection and to stop them coming back:




The recommended dose is 20mg 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 60mg 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.

Not known (frequency cannot be estimated from the available data)




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.

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 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


Keep out of the sight and reach of children.

If you take more Losec than prescribed by your doctor, talk to your doctor or pharmacist straight away.



Do not take your capsules after the expiry date which is stated on the carton or blister label after
‘Exp’, expiry date refers to the last day of the month.

If you forget to take Losec



Do not store above 30°C.



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



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 protect the environment.

If you take more Losec than you should

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.

6. Contents of the pack and other information
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.

What Losec contains
Each capsule contains 20mg omeprazole as the active ingredient.
The excipients are disodium hydrogen phosphate dihydrate, hydroxypropylcellulose, hydroxypropyl
methylcellulose, lactose anhydrous, magnesium stearate, mannitol, methacrylic acid copolymer,
cellulose microcrystalline, macrogol (polyethylene glycol), sodium lauryl sulphate, red iron oxide,
titanium dioxide and gelatin.
Printing ink contains shellac, ammonium hydroxide, potassium hydroxide and black iron oxide.

Other side effects include:

What Losec capsules looks like and contents of the pack

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

The 20mg capsules are hard gelatin capsules with an opaque pink body, marked ‘20’ and an opaque
reddish brown cap marked ‘A/OM’ in black ink.





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

The 20mg capsules are available in a blister pack containing 14 capsules.

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

Manufactured by: AstraZeneca AB, Gartunavagen, SE-151 85, Sodertalje, Sweden.
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.

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.

Procured from within the EU and repackaged by the Product Licence holder:
B&S Healthcare, Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK.
Losec 20mg gastro-resistant capsules

PL No: 18799/2225

Leaflet date: 24.02.2015
Losec is a trade mark of the AstraZenca group of companies.

POM

Package leaflet: information for the patient

Omeprazole 20mg gastro-resistant capsules
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 get any side effects talk to your doctor or pharmacist. This includes any possible side effects
not listed in this leaflet. (See section 4.)

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.

The name of your medicine is Omeprazole 20mg gastro-resistant capsules, but it will be referred to as
Omeprazole or Omeprazole capsules throughout this leaflet. This medicine is also available in other
strengths such as Omeprazole 10mg and 40mg gastro-resistant capsules.

What is in this leaflet:
1.
2.
3.
4.
5.
6.

What Omeprazole is and what it is used for
What you need to know before you take Omeprazole
How to take Omeprazole
Possible side effects
How to store Omeprazole
Contents of the pack and other information

1. What Omeprazole is and what it is used for
Omeprazole 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.

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 Omeprazole
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 Omeprazole
Rifampicin (used to treat tuberculosis)
Atazanavir (used to treat HIV i7nfection)
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 Omeprazole treatment

If your doctor has prescribed the antibiotics amoxicillin and clarithromycin as well as Omeprazole to
treat ulcers caused by Helicobacter pylori infection, it is very important that you tell your doctor about
any other medicines you are taking.

Omeprazole 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 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.

Omeprazole 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). Omeprazole
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 Omeprazole
Do not take Omeprazole





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

Omeprazole 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.

Omeprazole capsules contain lactose
Omeprazole 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 Omeprazole
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 you are taking a medicine containing nelfinavir (used for HIV infection)



Omeprazole may hide the symptoms of other diseases. Therefore, if any of the following happen to
you before you start taking Omeprazole 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 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 Omeprazole 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 Omeprazole, 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).

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

The recommended dose is 20mg 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 40mg once a day for 4 weeks.

To treat ulcers in the stomach (gastric ulcer):




The recommended dose is 20mg 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 40mg once a day for 8 weeks.

To prevent the duodenal and stomach ulcers from coming back:



You begin to vomit food or blood.
You pass black stools (blood-stained faeces).

If your doctor has found that your food pipe (gullet) has been slightly damaged, the usual dose is
20mg once a day for 4-8 weeks. Your doctor may tell you to take a dose of 40mg for a further 8
weeks if your gullet has not yet healed.

To treat ulcers in the upper part of the intestine (duodenal ulcer):



Warnings and precautions



Driving and using machines

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

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 Omeprazole.







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 Omeprazole if you are breast-feeding.

The recommended dose is 10mg or 20mg once a day. Your doctor may increase the dose to 40mg
once a day.

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



The recommended dose is 20mg once a day for 4–8 weeks.

To prevent duodenal and stomach ulcers if you are taking NSAIDs:



The recommended dose is 20mg once a day.

To treat ulcers caused by Helicobacter pylori infection and to stop them coming back:




The recommended dose is 20mg Omeprazole twice a day for one week.
Your doctor will also tell you to take two antibiotics among amoxicillin, clarithromycin and
metronidazole.

Other medicines and Omeprazole

To treat too much acid in the stomach caused by a growth in the pancreas (Zollinger-Ellison
syndrome):

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 Omeprazole can affect
the way some medicines work and some medicines can have an effect on Omeprazole.




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

The recommended dose is 60mg 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 Omeprazole. 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 Omeprazole. 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.





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 Omeprazole than you should

Muscle weakness.
Enlarged breasts in men.

Not known (frequency cannot be estimated from the available data)




Taking this medicine





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).

Inflammation in the gut (leading to diarrhoea).
If you are on Omeprazole 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.

Omeprazole 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 Omeprazole


Keep out of the sight and reach of children.



Do not take your capsules after the expiry date which is stated on the carton or blister label after
‘Exp’, expiry date refers to the last day of the month.

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.



Do not store above 30°C.



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

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 protect the environment.

If you take more Omeprazole than prescribed by your doctor, talk to your doctor or pharmacist straight
away.

If you forget to take Omeprazole

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

















What Omeprazole capsules looks like and contents of the pack
The 20mg capsules are hard gelatin capsules with an opaque pink body, marked ‘20’ and an opaque
reddish brown cap marked ‘A/OM’ in black ink.
The 20mg capsules are available in a blister pack containing 14 capsules.

Manufactured by: AstraZeneca AB, Gartunavagen, SE-151 85, Sodertalje, Sweden.
Procured from within the EU and repackaged by the Product Licence holder:

Disturbed sleep (insomnia).

B&S Healthcare, Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK.

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.

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.

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






Each capsule contains 20mg omeprazole as the active ingredient .
The excipients are also contains disodium hydrogen phosphate dihydrate, hydroxypropylcellulose,
hydroxypropyl methylcellulose, anhydrous lactose, magnesium stearate, mannitol, methacrylic acid
copolymer, cellulose microcrystalline, macrogol (polyethylene glycol), sodium lauryl sulphate, red iron
oxide, titanium dioxide, gelatin.
Printing ink contains shellac, ammonium hydroxide, potassium hydroxide and black iron oxide.

Swelling of the feet and ankles.

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



What Omeprazole contains

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

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









6. Contents of the pack and other information

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.

Omeprazole 20mg gastro-resistant capsules
Leaflet date: 24.02.2015

PL No: 18799/2225

POM

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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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