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OMEPRAZOLE 20 MG GASTRO-RESISTANT CAPSULES

Active substance: OMEPRAZOLE

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Sandoz Limited
Confidential
Omeprazole 10 mg, 20 mg and 40 mg Gastroresistant Capsules, hard
Package Leaflet: Information for the user

Page 1

PACKAGE LEAFLET : INFORMATION FOR THE USER
Omeprazole 10 mg Gastro-resistant Capsules, hard
Omeprazole 20 mg Gastro-resistant Capsules, hard
Omeprazole 40 mg Gastro-resistant Capsules, hard
Omeprazole

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 Omeprazole is and what it is used for
2. Before you take Omeprazole
3. How to take Omeprazole
4. Possible side effects
5. How to store Omeprazole
6. Further 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.
Omeprazole 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 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:

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Sandoz Limited
Confidential
Omeprazole 10 mg, 20 mg and 40 mg Gastroresistant Capsules, hard
Package Leaflet: Information for the user

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Children over 1 year of age and ≥ 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.

BEFORE YOU TAKE OMEPRAZOLE

Do not take Omeprazole

if you are allergic (hypersensitive) to omeprazole or any of the other ingredients of Omeprazole.

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 Omeprazole.
Take special care with Omeprazole
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 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 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 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 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).
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)

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Sandoz Limited
Confidential
Omeprazole 10 mg, 20 mg and 40 mg Gastroresistant Capsules, hard
Package Leaflet: Information for the user


Page 3

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))












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.
Taking Omeprazole with food and drink
You can take your capsules with food or on an empty stomach.
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 during this time.
Your doctor will decide whether you can take Omeprazole if you are breastfeeding.
Driving and using machines

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.
Important information about some of the ingredients of Omeprazole
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 Omeprazole 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:

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Sandoz Limited
Confidential
Omeprazole 10 mg, 20 mg and 40 mg Gastroresistant Capsules, hard
Package Leaflet: Information for the user

Page 4

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.
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 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):

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 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:

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 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:
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.

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JH

Sandoz Limited
Confidential
Omeprazole 10 mg, 20 mg and 40 mg Gastroresistant Capsules, hard
Package Leaflet: Information for the user


Page 5

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 coated 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
If you take more Omeprazole than prescribed by your doctor, talk to your doctor or pharmacist
straight away.
If you forget to take Omeprazole
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 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.
Side effects may occur with certain frequencies, which are defined as follows:

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Sandoz Limited
Confidential
Omeprazole 10 mg, 20 mg and 40 mg Gastroresistant Capsules, hard
Package Leaflet: Information for the user

Very common:
Common:
Uncommon:
Rare:
Very rare:
Not known:

Page 6

affects more than 1 user in 10
affects 1 to 10 users in 100
affects 1 to 10 users in 1,000
affects 1 to 10 users in 10,000
affects less than 1 user in 10,000
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.

Fracture in the hip, wrist or spine.1

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.
Very rare side effects

Changes in blood count including agranulocytosis (lack of white blood cells).

Aggression.

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JH

Sandoz Limited
Confidential
Omeprazole 10 mg, 20 mg and 40 mg Gastroresistant Capsules, hard
Package Leaflet: Information for the user


Page 7

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.
Low levels of magnesium in the blood.2







1

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).

2

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.

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.
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 Omeprazole Capsules

Keep out of the reach and sight of children.
Do not use Omeprazole Capsules after the expiry date which is stated on carton, label, blister.
The expiry date refers to the last day of the month.
10 mg and 20 mg:
In – use shelf life in HDPE bottles
3 months
Do not store above 25ºC.
Store in the original package in order to protect from light and moisture.
Keep the tablet container tightly closed.
Keep the bottle tightly closed.

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Sandoz Limited
Confidential
Omeprazole 10 mg, 20 mg and 40 mg Gastroresistant Capsules, hard
Package Leaflet: Information for the user

Page 8

40mg:
Do not store above 30ºC.
Blister: Store in the original package in order to protect from moisture.
Bottle: Keep the bottle tightly closed.
Medicines should not be disposed 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 Capsules contain
The active substance is omeprazole.
Each gastro-resistant capsule, hard contains 10 mg, 20 mg or 40 mg of omeprazole.
10 mg and 20 mg:
The other ingredients are:
Granules:
Low-substituted hydroxypropyl cellulose
Microcrystalline cellulose
Lactose anhydrous
Povidone
Polysorbate 80
Talc
Magnesium Oxide
Methacrylic Acid Copolymer Dispersion Type C
Triethyl Citrate
Magnesium Stearate

Capsule shell:
Cap and body omeprazole 10 mg:
Gelatine
Titanium dioxide (E171)
Yellow iron oxide (E172)
Red iron oxide (E172)
Black iron oxide (E172)
Cap and body omeprazole 20 mg:
Gelatine
Titanium dioxide (E171)

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Sandoz Limited
Confidential
Omeprazole 10 mg, 20 mg and 40 mg Gastroresistant Capsules, hard
Package Leaflet: Information for the user

Page 9

Printing ink: Shellac, Propylene glycol, Ammonium hydroxide, Black iron oxide (E172) or
Shellac, Black iron oxide (E172), Propylene glycol, Strong ammonia solution, Potassium hydroxide
40 mg:
- The other ingredients are:
Capsule content: low-substituted hydroxypropyl cellulose, microcrystalline cellulose, lactose
anhydrous, croscarmellose sodium, Povidone (K 25), Polysorbate 80, hypromellose phthalate, dibutyl
sebacate, talc.
Capsule shell:
Cap and body omeprazole 10 mg and 40 mg: carrageenan, potassium chloride, titanium dioxide
(E171), yellow iron oxide (E172), red iron oxide (E172), hypromellose.
Cap and body omeprazole 20 mg: carrageenan, potassium chloride, titanium dioxide (E171),
hypromellose.
Printing ink: shellac, propylene glycol, ammonium hydroxide, potassium hydroxide, black iron oxide
(E172).

What Omeprazole Capsules look like and contents of the pack
Omeprazole 10 mg Gastro-resistant Capsule, hard:
Light brown cap, light brown body, each imprinted with OME 10 containing white to beige coated
pellets (granules).
Omeprazole 20 mg Gastro-resistant Capsule, hard:
White cap, white body, each imprinted with “OME 20” containing white to beige coated pellets
(granules).
Omeprazole 40 mg Gastro-resistant Capsule, hard:
White cap, light brown body, each imprinted with “OME 40” containing dull yellowish brown
granules.
Pack sizes:
• Blister: 14 gastro-resistant capsules, hard.
• White plastic tablet container with tamper-evident screw cap with (integrated) desiccant: 14,
28 gastro-resistant capsules, hard.
• White plastic tablet container with tamper-evident screw cap with (integrated) desiccant: 14,
28 gastro-resistant capsules, hard.
• Bottle: 15 gastro-resistant capsules, hard.

Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing authorisation holder:
Sandoz Limited

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Sandoz Limited
Confidential
Omeprazole 10 mg, 20 mg and 40 mg Gastroresistant Capsules, hard
Package Leaflet: Information for the user

Page 10

Frimley Business Park,
Frimley,
Camberley,
Surrey,
GU16 7SR.
United Kingdom
Manufacturer:
Lek Pharmaceuticals d.d.
Verovškova 57,
1526 Ljubljana
Slovenia
or
LEK S.A.
ul. Domaniewska 50 C,
02-672 Warsaw
Poland
or
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
39179 Barleben
Germany
or
Salutas Pharma GmbH
Dieselstrasse 5
70839 Gerlingen
Germany
Or

Sandoz S.R.L.
Str. Livezeni nr. 7A
RO-540472 TarguMures
Romania

This leaflet was last revised in 12/2012

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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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