OMEPRAZOLE 10MG GASTRO-RESISTANT CAPSULES

Active substance: OMEPRAZOLE

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PATIENT INFORMATION LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE USER
Omeprazole 10mg gastro-resistant capsules
Omeprazole 20mg gastro-resistant capsules
Omeprazole 40mg gastro-resistant capsules
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 Capsules are and what they are used for
2. Before you take Omeprazole Capsules
3. How to take Omeprazole Capsules
4. Possible side effects
5. How to store Omeprazole Capsules
6. Further information
1. WHAT Omeprazole Capsules are AND WHAT are they USED FOR
Omeprazole capsules contain the active substance in 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 oesophagitis’ (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 pylor’. 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 (ZollingerEllison syndrome).

In children:
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 Capsules
Do not take Omeprazole Capsules
• if you are allergic (hypersensitive) to omeprazole or to any of the other ingredients
of Omeprazole Capsules.
• if you are allergic to medicines containing other proton pump inhibitors (eg
pantoprazole, lansoprazole, rabeprazole, esomeprazole).
• if you are taking a medicine containing nelfinavir (drug used for treatment of HIV)
If you are not sure, talk to your doctor or pharmacist before taking Onmeprazole
capsules.
Take special care with Omeprazole Capsules
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 it, talk to your doctor straight away:









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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.
You have reduced body stores or risk factors for reduced vitamin B12 and receive
omeprazole long-term treatment. As with all acid reducing agents, omeprazole
may lead to a reduced absorption of vitamin B12.
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 orticosteroids
(which can increase the risk of osteoporosis)

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.
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 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 capsules
• 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 capsules
• 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 capsules 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 empty stomach.
Pregnancy and breast-feeding
Before taking Omeprazole capsules, 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.
Your doctor will decide whether you can take Omeprazole capsules if you are
breastfeeding.
Driving and using machines

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Omeprazole is not likely to affects 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 Capsules
Omeprazole 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. HOW TO TAKE Omeprazole Capsules
Always take Omeprazole Capsules exactly as your doctor has told you. You should
check with your doctor or pharmacist if you are not sure. The usual doses are
summarised below:
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.
• 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 ulcers 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 AntiInflammatory 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:
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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 capsules 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 capsules. 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 capsules. 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 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 Capsules than you should
If you take more Omeprazole than prescribed by your doctor, talk to your doctor or
pharmacist straight away.

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If you forget to take Omeprazole Capsules
If you have 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 capsules 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 ‘StevensJohnson syndrome’ or ‘toxic epidermal necrolysis’.
• Yellow skin, dark urine and tiredness which can be symptoms of liver problems.
Side effects may occur with certain frequencies, which are defined as follows:
Very common:
affects more than 1 user in 10
Common:
affects 1 to 10 users in 100
Uncommon:
affects 1 to 10 users in 1,000
Rare:
affects 1 to 10 users in 10,000
Very rare:
affects less than 1 user in 10,000
Not known:
frequency cannot be estimated from the available data
Other side effects include:
Common side effects
• Headache.
• Effects on your stomach or gut: diarrhoea, stomach pain, constipation, wind
(flatulence).
• Feeling sick (nausea) or being sick (vomiting).
Uncommon side effects
• Swelling of the feet and ankles.
• Disturbed sleep (insomnia).
• Dizziness, tingling feelings such as “pins and needles”, feeling sleepy.
• Spinning feeling (vertigo).
• Changes in blood tests that check how the liver is working.
• Skin rash, lumpy rash (hives) and itchy skin.
• Generally feeling unwell and lacking energy.
Rare side effects
• Blood problems such as a reduced number of white cells or platelets. This can
cause weakness, bruising or make infections more likely.

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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.
• 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.
• Hypomagnesaemia
Frequency not known
• If you are on 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 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 capsules may in very rarae 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 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 gets 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 the pack after
“EXP:” The expiry date refers to the last day of that month.
Store below 25°C.
OPA/Al blister: Store in the original package to protect from moisture.
HDPE bottle: Keep the bottle tightly closed 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
to protect the environment.

6. FURTHER INFORMATION
What Omeprazole Capsules contains:
- The active substance is omeprazole. Omeprazole capsules contain 10 mg, 20 mg or
40 mg of omeprazole
- The other ingredients are:
- Capsule content: sugar spheres (consisting of maize starch and sucrose), sodium
laurilsulfate, Disodium phosphate, anhydrous, mannitol, hypromellose 6 cP, macrogol
6000, talc, polysorbate 80, titanium dioxide (E 171), and methacrylic acid-ethyl
acrylate copolymer (1:1).
- Capsule shell: gelatin. The 10 and 20 mg capsules also contain the colouring agents
quinoline yellow (E 104) and titanium dioxide (E 171). The 40 mg capsules contain
indigo carmine (E132) and titanium dioxide (E171).
What Omeprazole Capsules looks like and contents of the pack:
Omeprazole Capsules 10 mg: Opaque yellow capsule containing off-white to creamwhite spherical microgranules
Omeprazole Capsules 20 mg: Opaque yellow capsule containing off-white to creamwhite spherical microgranules
Omeprazole Capsules 40 mg: Opaque blue and opaque white capsule containing offwhite to cream white spherical microgranules.
The capsules are supplied in blisters of 7, 14, 15, 28, 30, 50, 56, 60, 100, 140, 280 and
500 capsules; and in HDPE bottles of 28, 30 and 100 capsules (only 10 mg and 40 mg
strengths) and bottles of 28, 30, 60 (2x 30) and 100 capsules (only 20 mg strength).

Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer:
Marketing Authorisation Holder: PLIVA Pharma Ltd, Vision House, Bedford Road,
Petersfield, GU32 3QB, UK
Manufacturer LABORATORIOS LICONSA, S.A.
Av. Miralcampo,
19200 Azuqueca de Henares (Guadalajara) SPAIN
This leaflet was last revised in November 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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