OMEPRAZOLE 10MG GASTRO-RESISTANT CAPSULES HARD

Active substance: OMEPRAZOLE

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Package leaflet: information for the user

OMEPRAZOLE 10MG GASTRO-RESISTANT CAPSULES
OMEPRAZOLE 20MG GASTRO-RESISTANT CAPSULES
OMEPRAZOLE 40MG GASTRO-RESISTANT CAPSULES

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1. What omeprazole capsules are and what it
is used for

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2. What you need to know before you take
omeprazole capsules

Other medicines and omeprazole capsules
Tell your doctor or pharmacist if you are taking,
have recently taken any other medicines or might
take any other medicines. This is because
omeprazole capsules can affect the way some
medicines work and some medicines can have an
effect on omeprazole capsules.
Do not take omeprazole 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 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 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
omeprazole capsules 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.

Driving and using machines
Omeprazole capsules are 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 contains lactose
anhydrous and sucrose
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 capsules

To treat symptoms of GERD 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.

Taking a proton pump inhibitor like omeprazole
capsules, especially over a period of more than

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FOR
ZENTIVA USE
ONLY

Your doctor will decide whether you can take
omeprazole capsules if you are breast-feeding.

If you are not sure, talk to your doctor or
pharmacist before taking omeprazole capsules.

If you are on omeprazole 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, 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.

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Pregnancy and breast-feeding
Before taking omeprazole, tell your doctor if you
are pregnant or trying to get pregnant. Your doctor
will decide whether you can take omeprazole
capsules during this time.

Always take this medicine exactly as your doctor
has told you. Check with your doctor or
pharmacist if you are not sure.

If you take omeprazole 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.

OMEPRAZOLE 10MG, 20MG AND 40MG GASTRO-RESISTANT CAPSULES

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

Do not take omeprazole 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
(eg pantoprazole, lansoprazole,
rabeprazole, esomeprazole).
• if you are taking a medicine containing
nelfinavir (used for HIV infection).

Warnings and precautions
Omeprazole capsules may hide the symptoms of
other diseases. Therefore, if any of the following
happen to you before you start taking omeprazole
capsules or while you are taking them, 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 capsules have
been associated with a small increase in
infectious diarrhoea.
• You have severe liver problems.

Zentiva

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 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.

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The name of your medicine is Omeprazole 10mg,
20mg and 40mg gastro-resistant capsules (called
omeprazole capsules throughout this leaflet).
Omeprazole 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.
Omeprazole capsules are used to treat the
following conditions:
In adults:
• ‘Gastro-esophageal reflux disease’
(GERD). 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 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 weighing 10 kg or
more
• ‘Gastro-esophageal reflux disease’
(GERD). 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.

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).

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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 omeprazole capsules are and what it is
used for
2. What you need to know before you take
omeprazole capsules
3. How to take omeprazole capsules
4. Possible side effects
5. How to store omeprazole capsules
6. Contents of the pack and other information

Zentiva Regulatory
Approved: Yes
No
Date:
Signature:

N/A

THESE
SIGNATURES
Zentiva - Head of Regulatory ARE
Approved: Yes
No
N/A
Date:FOR ZENTIVA
Signature:
HEAD OFFICE USE
Other - as required
Approved: Yes
No
ONLY
Date:
Signature:

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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 omeprazole
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:

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To treat symptoms of GERD 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.
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 has 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.
Do not use milk or fizzy water. The solid
pieces contain the medicine - do not
chew or crush them.
If you take more omeprazole capsules than
you should
If you take more omeprazole capsules than
prescribed by your doctor, talk to your doctor or
pharmacist straight away.
If you forget to take omeprazole 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.
If you have any further questions on the use of
this product, ask your doctor or pharmacist.
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 omeprazole
capsules 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 which may occur are listed
below in groups according to the frequency.
Please tell your doctor or pharmacist if any of the
side effects get serious.
Common (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 (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.
• Fracture of the hip, wrist and spine (see
section 2 “Warnings and precautions”).
Rare (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.
Inflammation in the gut (leading to diarrhoea).
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 (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.

Zentiva
OMEPRAZOLE 10MG, 20MG AND 40MG GASTRO-RESISTANT CAPSULES

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Omeprazole 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.
Frequency not known
• Low magnesium levels in blood
(hypomagnesaemia) (see section 2
“Warnings and precaution”).
Do not be concerned by this list of possible
side effects. You may not get any of them.
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

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By reporting side effects you can help provide
more information on the safety of this medicine.
5. How to store omeprazole capsules
Keep this medicine out of the sight and reach of
children.
Do not use this medicine after the expiry date
which is stated on the carton after EXP. The
expiry date refers to the last day of that month.
Store below 25°C. Store in the original package in
order to protect from moisture.
After first opening the bottle, the product may be
stored for a maximum of 3 months below 25°C.
Do not throw away any medicines via wastewater
or household waste. Ask your pharmacist how to
throw away medicines you no longer use. These
measures will help protect the environment.

FOR
ZENTIVA USE
ONLY

6. Contents of the pack and other information
What omeprazole capsules contains
Each omeprazole capsule contains 10 mg, 20 mg or
40 mg of omeprazole (the active substance).
The excipients are:
Pellets: sugar spheres (contain sucrose and
maize starch), lactose anhydrous, hypromellose,
hydroxypropylcellulose, sodium lauryl sulfate,
disodium phosphate dodecahydrate,
methacrylic acid – ethylacrylate copolymer (1:1)
dispersion 30 per cent, macrogol 6000, talc.
Empty hard gelatinous capsule contains:
Body: black iron oxide (E 172), red iron oxide
(E 172), yellow iron oxide (E 172),
titanium dioxide (E 171), gelatin.
Cap: indigo carmine (only omeprazole
capsules 40 mg), red iron oxide (E 172), yellow iron
oxide (E172), titanium dioxide (E 171), gelatin.
What omeprazole capsules looks like and
contents of the pack
Omeprazole 10mg Gastro-resistant Capsules,
hard No.4 (length approximately 14.3 mm) with
light brown body and orange cap. Capsule
contains off white to slightly yellowish-brown
spherical pellets.
Omeprazole 20mg Gastro-resistant Capsules,
hard No.3 (length approximately 15.9 mm) with
light brown body and red cap. Capsule contains off
white to slightly yellowish-brown spherical pellets.
Omeprazole 40mg Gastro-resistant Capsules,
hard No.2 (length approximately 18.0 mm) with light
brown body and brown cap. Capsule contains off
white to slightly yellowish-brown spherical pellets.
Type of container
Brown-glass bottle with a white HD-PE screw
closure with desiccant or white HDPE bottle with
a white HDPE twist-off closure with desiccant or
Al - oPA/Al/HDPE/PE + desiccant/HDPE blister,
folding paper box.
Size of package: 7, 14, 15, 28, 30, 50, 60, 90,
100 capsules
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
Zentiva, One Onslow Street, Guildford, Surrey,
GU1 4YS, UK
Manufacturer
S.C. Zentiva S.A.
50, Theodor Pallady Blvd., 032266, Bucharest,
Romania.
This leaflet was last revised in July 2013
‘Zentiva’ is a registered trademark. © 2013 Zentiva.
00000

Zentiva Regulatory
Approved: Yes
No
Date:
Signature:

N/A

THESE
SIGNATURES
Zentiva - Head of Regulatory ARE
Approved: Yes
No
N/A
Date:FOR ZENTIVA
Signature:
HEAD OFFICE USE
Other - as required
Approved: Yes
No
ONLY
Date:
Signature:

00000000
00000000

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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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