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OMEPRAZOL ACTAVIS 40 MG MAAGSAPRESISTENTE CAPSULES HARD

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PATIENT INFORMATION LEAFLET

Omeprazole 40 mg
gastro-resistant capsules
omeprazole
Read all of this leaflet carefully before
you start taking this medicine.
•   eep this leaflet. You may need to read
K
it again.
•  f you have any further questions, ask
I
your doctor or pharmacist.
•   his medicine has been prescribed for
T
you. Do not pass it on to others. It may
harm them, even if their symptoms are
the same as yours.
•  f any of the side effects gets serious, or
I
if you notice any side effects not listed
in this leaflet, please tell your doctor or
pharmacist.

In this leaflet
1  hat Omeprazole 40mg gastroW
resistant capsules is and what it is
used for
2  efore you take Omeprazole
B
40mg gastro-resistant capsules
3  ow to take Omeprazole 40mg
H
gastro-resistant capsules
4  ossible side effects
P
5  ow to store Omeprazole 40mg
H
gastro-resistant capsules
6  urther information
F
1  HAT OMEPRAZOLE 40MG
W

GASTRO-RESISTANT CAPSULES IS
AND WHAT IT IS USED FOR
Omeprazole 40mg 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 40mg is 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 40mg can also be used to
stop ulcers from forming if you are taking
NSAIDs.
•  oo much acid in the stomach caused by
T
a growth in the pancreas (Zollinger-Ellison
syndrome).
In children:
Children over 1 year of age weighing more than
10 kg
• ‘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.

2  EFORE YOU TAKE OMEPRAZOLE
B

40MG GASTRO-RESISTANT
CAPSULES

Do not take Omeprazole 40mg
gastro-resistant capsules

• f you are allergic (hypersensitive) to
i
omeprazole or any of the other ingredients
of Omeprazole 40mg.
• f you are allergic to medicines containing
i
other proton pump inhibitors (eg
pantoprazole, lansoprazole, rabeprazole,
esomeprazole).
• f you are taking a medicine containing
i
nelfinavir (used for HIV infection)
If you are not sure, talk to your doctor or
pharmacist before taking Omeprazole 40mg.

Take special care with Omeprazole
40mg gastro-resistant capsules

Omeprazole 40mg may hide the symptoms
of other diseases. Therefore, if any of the
following happen to you before you start
taking Omeprazole 40mg or while you are
taking it, talk to your doctor straight away:
•  ou lose a lot of weight for no reason and
Y
have problems swallowing.
• You get stomach pain or indigestion.
• You begin to vomit food or blood.
• You pass black stools (blood-stained faeces).
•  ou experience severe or persistent
Y
diarrhoea, as omeprazole has been
associated with a small increase in infectious
diarrhoea.
• You have severe liver problems.
•  aking a proton pump inhibitor like
T
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).
If you take Omeprazole 40mg on a longterm 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 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
Omeprazole 40mg can affect the way some

medicines work and some medicines can
have an effect on Omeprazole 40mg.
Do not take Omeprazole 40mg 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 40mg
• 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 40mg
• Rifampicin (used to treat tuberculosis)
• Atazanavir (used to treat HIV infection)
•  acrolimus (used to prevent transplant
T
rejection)
• St John’s wort (Hypericum perforatum)

(used to treat mild depression)
• Cilostazol (used to treat cramp-like pain in

your legs when you walk and is caused by
insufficient blood supply in your legs)
• Saquinavir (used to treat HIV infection)
• Clopidogrel (used to prevent blood clots )
If your doctor has prescribed the antibiotics
amoxicillin and clarithromycin as well as
Omeprazole 40mg 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 Omeprazole 40mg gastroresistant capsules with food and
drink

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

Pregnancy and breast-feeding

Before taking Omeprazole 40mg, tell your
doctor if you are pregnant or trying to get
pregnant. Your doctor will decide whether
you can take Omeprazole 40mg during this
time.
Your doctor will decide whether you can take
Omeprazole 40mg if you are breastfeeding.

Driving and using machines

Omeprazole 40mg 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 Omeprazole 40mg
gastro-resistant capsules:
Omeprazole 40mg capsules contain 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  OW TO TAKE OMEPRAZOLE
H

40MG GASTRO-RESISTANT
CAPSULES

Always take Omeprazole 40mg 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 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.
•  he usual dose once the gullet has healed is
T
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):
•  he usual dose is 20 mg once a day for 2
T
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 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):
•  he usual dose is 20 mg once a day for 4
T
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 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:
•  he usual dose is 10 mg or 20 mg once a
T
day. Your doctor may increase the dose to
40 mg once a day.
To treat duodenal and stomach ulcers
caused by NSAIDs (Non-Steroidal AntiInflammatory Drugs):
•  he usual dose is 20 mg once a day for 4–8
T
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:
•  he usual dose is 20 mg Omeprazole
T
twice a day for one week.
•  our doctor will also tell you to take
Y
two antibiotics among amoxicillin,
clarithromycin and metronidazole.
To treat too much acid in the stomach caused
by a growth in the pancreas (ZollingerEllison syndrome):
• The usual dose is 60 mg daily.

Continued top of next column
AAAF1130

Continued over page

Omeprazole Gastro-resistant 40mg Capsules PIL - UK

colours/plates:
1. Black

item no: AAAF1130

dimensions: 140 x 540

print proof no: 2

pharmacode:

origination date: 18.03.13

min pt size: 8pt

3.
4.
5.
6.

originated by: SA
approved for print/date

2.

revision date: 22.02.13

Technical Approval

revised by: SA

date sent: 18.03.13

supplier: Liconsa

technically app. date: 19.03.13

Non Printing Colours
1.
2.
3.

•  our doctor will adjust the dose depending
Y
on your needs and will also decide how long
you need to take the medicine for.
Children:
To treat symptoms of GERD such as
heartburn and acid regurgitation:
•  hildren over 1 year of age and with a
C
body weight of more than 10 kg may take
Omeprazole 40mg. 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:
•  hildren aged over 4 years may take
C
Omeprazole 40mg. The dose for children is
based on the child’s weight and the doctor
will decide the correct dose.
•  our doctor will also prescribe two
Y
antibiotics called amoxicillin and
clarithromycin for your child.

Taking this medicine

•  t is recommended that you take your
I
capsules in the morning.
•  ou can take your capsules with food or on
Y
an empty stomach.
•  wallow your capsules whole with half a
S
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

•  f you or your child have trouble swallowing
I
the capsules:
•  pen the capsules and swallow the
O
contents directly with half a glass of water,
or mix the contents with a small amount
of yoghurt, any acidic fruit juice (e.g. apple,
orange or pineapple) or apple sauce.
•  lways stir the mixture just before drinking
A
it (the mixture will not be clear). Then drink
the mixture straight away or within 30
minutes.
•  o make sure that you have drunk all of the
T
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 40mg
gastro-resistant capsules than you
should

If you take more Omeprazole 40mg than
prescribed by your doctor, talk to your doctor
or pharmacist straight away.

If you forget to take Omeprazole
40mg gastro-resistant 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.

4 POSSIBLE SIDE EFFECTS
Like all medicines, Omeprazole 40mg can
cause side effects, although not everybody
gets them.
If you notice any of the following
rare but serious side effects, stop
taking Omeprazole 40mg gastroresistant capsules and contact a doctor
immediately:
•  udden wheezing, swelling of your lips,
S
tongue and throat or body, rash, fainting
or difficulties in swallowing (severe allergic
reaction).
•  eddening of the skin with blisters or
R
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’.
•  ellow skin, dark urine and tiredness which
Y
can be symptoms of liver problems.
•  meprazole 40mg may in very rare cases
O
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.
Other side effects include:
Common (affects less than 1 in 10 people)
• Headache.
•  ffects on your stomach or gut: diarrhoea,
E
stomach pain, constipation, wind
(flatulence).
•  eeling sick (nausea) or being sick
F
(vomiting).
Uncommon (affects less than 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 or spine.

Very rare (affects less than 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.
Frequency not known
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,
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.Do not be concerned by
this list of possible side effects. You may not
get any of them. If any of the side effect gets
serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or
pharmacist.

5  OW TO STORE OMEPRAZOLE
H

40MG GASTRO-RESISTANT
CAPSULES

• Keep out of the reach and sight of children.
• Do not use Omeprazole 40mg after the

expiry date which is stated on the pack after
EXP. The expiry date refers to the last day
of that month. HDPE bottle: Use within 3
monthns of opening.
• Store below 25°C.
• Store this blister in the original package or

keep the bottle tightly closed in order to
protect from moisture. Replace cap firmly
after use.
• 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.

6 FURTHER INFORMATION
What Omeprazole 40mg gastroresistant capsules contains:

•  he active substance is omeprazole.
T
Omeprazole 40mg capsules contain 40 mg
of omeprazole.
• The other ingredients are:
• Capsule content: sugar spheres (consisting

of corn starch and sucrose), sodium
laurilsulfate, Disodium phosphate,
anhydrous, mannitol, hypromellose 6
cP, macrogol 6000, talc, polysorbate 80,
titanium dioxide (E 171), and methacrylic
acid-ethylacrylate copolymer (1:1).
• Capsule shell: gelatine, the colouring agent

indigo carmine (E 132) and titanium dioxide
(E 171).

What Omeprazole 40mg gastroresistant capsules looks like and
contents of the pack
Opaque blue and opaque white capsule
containing off-white to cream white spherical
microgranules.
Pack sizes:
Blisters of 7, 14, 15, 28, 30, 50, 56, 60, 90, 98,
100, 140 or 280 capsules; hospital pack of 500
capsules.
HDPE bottles of 5, 7, 14, 15, 28, 30, 50, 56, 60,
90 or 100 capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer:
Marketing Authorisation Holder:
CHEMO IBÉRICA, S.A.
Gran Vía Carlos III, 98, 7th,
08028 Barcelona
SPAIN
Manufacturer
LABORATORIOS LICONSA, S.A.
Av. Miralcampo, Nº 7, Polígono Industrial
Miralcampo
19200 Azuqueca de Henares (Guadalajara)
SPAIN

This leaflet was last approved in 11/2012.

If you would like a
leaflet with larger
text, please contact
01271 311257.

Rare (affects less than 1 in 1,000 people)
•  lood problems such as a reduced number
B
of white cells or platelets. This can cause
weakness, bruising or make infections more
likely.
•  llergic reactions, sometimes very severe,
A
including swelling of the lips, tongue and
throat, fever, wheezing.
•  ow levels of sodium in the blood. This may
L
cause weakness, being sick (vomiting) and
cramps.
• Feeling agitated, confused or depressed.
• Taste changes.
• Eyesight problems such as blurred vision.
•  uddenly feeling wheezy or short of breath
S
(bronchospasm).
• Dry mouth.
• An inflammation of the inside of the mouth.
•  n infection called “thrush” which can affect
A
the gut and is caused by a fungus.
•  iver problems, including jaundice which
L
can cause yellow skin, dark urine, and
tiredness.
• Hair loss (alopecia).
• Skin rash on exposure to sunshine.
•  oint pains (arthralgia) or muscle pains
J
(myalgia).
•  evere kidney problems (interstitial
S
nephritis).
• Increased sweating.

Actavis, Barnstaple, EX32 8NS, UK

Continued top of next column
AAAF1130

Omeprazole Gastro-resistant 40mg Capsules PIL - UK

colours/plates:
1. Black

item no: AAAF1130

dimensions: 140 x 540

print proof no: 2

pharmacode:

origination date: 18.03.13

min pt size: 8pt

3.
4.
5.
6.

originated by: SA
approved for print/date

2.

revision date: 22.02.13

Technical Approval

revised by: SA

date sent: 18.03.13

supplier: Liconsa

technically app. date: 19.03.13

Non Printing Colours
1.
2.
3.

+ Expand Transcript

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