Omeprazole 40mg gastro-resistant capsules

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

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Active ingredient:
Omeprazole
Available from:
Genesis Pharmaceuticals Ltd
ATC code:
A02BC01
INN (International Name):
Omeprazole
Dosage:
40mg
Pharmaceutical form:
Gastro-resistant capsule
Administration route:
Oral
Class:
No Controlled Drug Status
Prescription type:
Valid as a prescribable product
Product summary:
BNF: 01030500; GTIN: 5060014442666

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Package leaflet: Information for the patient

Omeprazole 10mg gastro-resistant capsules

Omeprazole 20mg gastro-resistant capsules

Omeprazole 40mg 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 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:

What Omeprazole Capsules are and what they are used for

What you need to know before you take Omeprazole Capsules

How to take Omeprazole Capsules

Possible side effects

How to store Omeprazole Capsules

Contents of the pack and other information

1. What Omeprazole Capsules are and what they are used for

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 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 Capsules

Do not take Omeprazole

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 omeprazole if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist

before taking this medicine.

Warnings and precautions

Talk to your doctor or pharmacist before taking 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.

You have ever had a skin reaction after treatment with a medicine similar to omeprazole that reduces stomach

acid.

You get a rash on your skin, especially in areas exposed to the sun tell your doctor as soon as you can, as

you may need to stop your treatment with omeprazole. Remember to also mention any other ill-effects like pain

in your joints.

You are due to have a specific blood test (Chromogranin A)

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).

If you get a rash on your skin, especially in areas exposed to the sun tell your doctor as soon as you can, as you

may need to stop your treatment with Omeprazole. Remember to also mention any other ill-effects like pain in your

joints.

Children

Some children with chronic illnesses may require long-term treatment although it is not recommended. Do not give

this medicine to children under 1 year of age or < 10 kg.

Other medicines and Omeprazole Capsules

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).

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 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 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

See section 3.

Pregnancy, breast-feeding and fertility

If you are pregnant or breastfeeding, 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 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 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.

Omeprazole Capsules contain Sucrose

This medicine contains 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 this medicine exactly as your doctor or pharmacist 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 recommended dose is:

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

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

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

The recommended dose is 20 mg once a day.

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

The recommended 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 recommended 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.

Use in children and adolescents:

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.

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 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.

If you stop taking Omeprazole

Do not stop taking Omeprazole without first talking to your doctor or pharmacist.

If you have any further questions on the use of this medicine, 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 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.

Allergic reaction which causes joint pain, skin rashes and fever (Cutaneous lupus erythematosus).

Other side effects include:

Common side effects (may affect upto 1 in 10 people)

Headache.

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

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

Benign polyps in the stomach.

Uncommon side effects (may affect upto 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 wrist, hip or spine.

Rare side effects (may affect upto 1 in 1000 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 upto 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.

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

Rash, possibly with pain in the joints

Inflammation in the gut (leading to diarrhoea)

Bacterial infection in the gut (symptoms include bloating, diarrhoea, abdominal pain)

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.

Reporting of side effects

If you get any side effect, 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 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 and label after “EXP:”. The expiry

date refers to the last day of that month. HDPE bottle: Use within 100 days after opening.

Store below 25

Blisters: Store in the original package to protect from moisture.

HDPE bottle: Keep the bottle tightly closed to protect from moisture.

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.

6. Contents of the pack and other information

What Omeprazole capsules contain:

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 laurylsulfate, Disodium

phosphate, anhydrous, mannitol, hypromellose 6cP, macrogol 6000, talc, polysorbate 80, titanium dioxide

(E 171), and methacrylic acid-ethylacrylate 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 (E 132) and titanium dioxide

(E 171).

What Omeprazole 40mg capsules look like and contents of the pack.

10 mg: Opaque yellow capsule containing off-white to cream-white spherical microgranules.

20 mg: Opaque yellow capsule containing off-white to cream-white spherical microgranules.

40 mg:Opaque blue and opaque white capsule containing off-white to cream white spherical microgranules.

The capsules are available in blister packs of 7, 14, 15, 28, 30, 50, 56, 60, 90, 100, 140, 280 and 500 and

HDPE bottles of 15, 28, 30, 50, 60, 90, 100, and 500 capsules. Not all pack sizes may be marketed.

Marketing Authorisation Holder

Name and address:

Bristol Laboratories Ltd,

Unit 3, Canalside, Northbridge Road, Berkhamsted,

Hertfordshire, HP4 1EG, United Kingdom

Telephone:

0044 (0)1442 200922

F a x :

0044 (0)1442 873717

Email:

info@bristol-labs.co.uk

Manufacturer

LABORATORIOS LICONSA, S.A.

Av. Miralcampo, Nº 7, Polígono Industrial Miralcampo,

19200, Azuqueca de Henares (Guadalajara), Spain.

Omeprazole 10mg gastro-resistant Capsules; PL 17907/0252

Omeprazole 20mg gastro-resistant Capsules; PL 17907/0253

Omeprazole 40mg gastro-resistant Capsules; PL 17907/0254

This leaflet was last revised in May 2019

To request a copy of this leaflet in Braille, large print or audio format, please contact the marketing authorisation

holder at the address (or telephone, fax, email) above.

IXXXXX

540 mm

140 mm

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT

Omeprazole 40mg gastro-resistant capsules, hard

2

QUALITATIVE AND QUANTITATIVE COMPOSITION

Omeprazole 40 mg capsules: one capsule contains 40 mg of omeprazole.

Excipient(s) with known effect:

Each 40mg capsule contains 203 to 233mg of sucrose

For the full list of excipients, see section 6.1.

3

PHARMACEUTICAL FORM

Gastro-resistant capsule, hard

Omeprazole 40 mg capsules: opaque yellow capsule containing off-white to

cream-white spherical microgranules.

4.1

Therapeutic indications

Omeprazole is indicated for:

Adults

Treatment of duodenal ulcers

Prevention of relapse of duodenal ulcers

Treatment of gastric ulcers

Prevention of relapse of gastric ulcers

In combination with appropriate antibiotics, Helicobacter pylori (H. pylori)

eradication in peptic ulcer disease

Treatment of NSAID-associated gastric and duodenal ulcers

Prevention of NSAID-associated gastric and duodenal ulcers in patients at

risk

Treatment of reflux oesophagitis

Long-term management of patients with healed reflux oesophagitis

Treatment of symptomatic gastro-oesophageal reflux disease

Treatment of Zollinger-Ellison syndrome

Paediatric use

Children over 1 year of age and

10 kg

Treatment of reflux oesophagitis

Reflux

oesophagitis.

Symptomatic

treatment

heartburn

acid

regurgitation in gastro-esophageal reflux disease

Children and adolescents over 4 years of age

In combination with antibiotics in treatment of duodenal ulcer caused by H.

pylori

4.2

Posology and method of administration

Posology

Adults

Treatment of duodenal ulcers

The recommended dose in patients with an active duodenal ulcer is Omeprazole

20 mg once daily. In most patients healing occurs within two weeks. For those

patients who may not be fully healed after the initial course, healing usually

occurs during a further two weeks treatment period. In patients with poorly

responsive duodenal ulcer Omeprazole 40 mg once daily is recommended and

healing is usually achieved within four weeks.

Prevention of relapse of duodenal ulcers

For the prevention of relapse of duodenal ulcer in H. pylori negative patients or

when H. pylori eradication is not possible the recommended dose is Omeprazole

20 mg once daily. In some patients a daily dose of 10 mg may be sufficient. In

case of therapy failure, the dose can be increased to 40 mg.

Treatment of gastric ulcers

The recommended dose is Omeprazole 20 mg once daily. In most patients

healing occurs within four weeks. For those patients who may not be fully

healed after the initial course, healing usually occurs during a further four weeks

treatment period. In patients with poorly responsive gastric ulcer Omeprazole 40

mg once daily is recommended and healing is usually achieved within eight

weeks.

Prevention of relapse of gastric ulcers

For the prevention of relapse in patients with poorly responsive gastric ulcer the

recommended dose is Omeprazole 20 mg once daily. If needed the dose can be

increased to Omeprazole 40 mg once daily.

H. pylori eradication in peptic ulcer disease

For the eradication of H. pylori the selection of antibiotics should consider the

individual patient’s drug tolerance, and should be undertaken in accordance

with national, regional and local resistance patterns and treatment guidelines.

Omeprazole 20 mg + clarithromycin 500 mg + amoxicillin 1,000 mg, each

twice daily for one week, or

Omeprazole 20 mg + clarithromycin 250 mg (alternatively 500 mg) +

metronidazole 400 mg (or 500 mg or tinidazole 500 mg), each twice daily

for one week or

Omeprazole 40 mg once daily with amoxicillin 500 mg and metronidazole

400 mg (or 500 mg or tinidazole 500 mg), both three times a day for one

week.

In each regimen, if the patient is still H. pylori positive, therapy may be

repeated.

Treatment of NSAID-associated gastric and duodenal ulcers

For the treatment of NSAID-associated gastric and duodenal ulcers, the

recommended dose is Omeprazole 20 mg once daily. In most patients healing

occurs within four weeks. For those patients who may not be fully healed after

the initial course, healing usually occurs during a further four weeks treatment

period.

Prevention of NSAID-associated gastric and duodenal ulcers in patients at risk

For the prevention of NSAID-associated gastric ulcers or duodenal ulcers in

patients at risk (age> 60, previous history of gastric and duodenal ulcers,

previous history of upper GI bleeding) the recommended dose is Omeprazole 20

mg once daily.

Treatment of reflux oesophagitis

The recommended dose is Omeprazole 20 mg once daily. In most patients

healing occurs within four weeks. For those patients who may not be fully

healed after the initial course, healing usually occurs during a further four weeks

treatment period.

In patients with severe oesophagitis Omeprazole 40 mg once daily is

recommended and healing is usually achieved within eight weeks.

Long-term management of patients with healed reflux oesophagitis

For the long-term management of patients with healed reflux oesophagitis the

recommended dose is Omeprazole 10 mg once daily. If needed, the dose can be

increased to Omeprazole 20-40 mg once daily.

Treatment of symptomatic gastro-esophageal reflux disease

The recommended dose is Omeprazole 20 mg daily. Patients may respond

adequately to 10 mg daily, and therefore individual dose adjustment should be

considered.

If symptom control has not been achieved after four weeks treatment with

Omeprazole 20 mg daily, further investigation is recommended.

Treatment of Zollinger-Ellison syndrome

In patients with Zollinger-Ellison syndrome the dose should be individually

adjusted and treatment continued as long as clinically indicated. The

recommended initial dose is Omeprazole 60 mg daily. All patients with severe

disease and inadequate response to other therapies have been effectively

controlled and more than 90% of the patients maintained on doses of

Omeprazole 20-120 mg daily. When dose exceed Omeprazole 80 mg daily, the

dose should be divided and given twice daily.

Paediatric population

Children over 1 year of age and

10 kg

Reflux oesophagitis: The treatment time is 4-8 weeks.

Symptomatic treatment of heartburn and acid regurgitation in gastro-

esophageal reflux disease: The treatment time is 2–4 weeks. If symptom control

has not been achieved after 2–4 weeks the patient should be investigated further.

The dosage recommendations are as follows:

Weight

Posology

1 year of age

10-20 kg

10 mg once daily. The dose can be increased to 20 mg

once daily if needed

2 years of

> 20 kg

20 mg once daily. The dose can be increased to 40 mg

once daily if needed

Children and adolescents over 4 years of age

In combination with antibiotic in treatment of duodenal ulcer caused by

Helicobacter pylori

When selecting appropriate combination therapy, consideration should be given

to official national, regional and local guidance regarding bacterial resistance,

duration of treatment (most commonly 7 days but sometimes up to 14 days),

and appropriate use of antibacterial agents.

The treatment should be supervised by a specialist.

The posology recommendations are as follows:

Weight

Posology

15–

Combination with two antibiotics: Omeprazole 10 mg, amoxicillin

25 mg/kg body weight and clarithromycin 7.5 mg/kg body weight are

all administrated together 2 times daily for 1 week.

30–

Combination with two antibiotics: Omeprazole 20 mg, amoxicillin

750 mg and clarithromycin 7.5 mg/kg body weight are all

administrated 2 times daily for 1 week.

> 40 kg

Combination with two antibiotics: Omeprazole 20 mg, amoxicillin 1

g and clarithromycin 500 mg are all administrated 2 times daily for 1

week.

Special populations

Renal impairment

Dose adjustment is not needed in patients with impaired renal function (see

section 5.2).

Hepatic impairment

In patients with impaired hepatic function a daily dose of 10–20 mg may be

sufficient (see section 5.2).

Elderly

Dose adjustment is not needed in the elderly (see section 5.2).

Method of administration:

It is recommended to take Omeprazole capsules in the morning, preferably

without food, swallowed whole with half a glass of water. The capsules must

not be chewed or crushed.

For patients with swallowing difficulties and for children who can drink or

swallow semi-solid food

Patients can open the capsule and swallow the contents with half a glass of non-

carbonated water or after mixing the contents in a slightly acidic fluid e.g., fruit

juice or applesauce. Patients should be advised that the dispersion should be

taken immediately (or within 30 minutes) and always be stirred just before

drinking and rinsed down with half a glass of water.

Alternatively patients can suck the capsule and swallow the granules with half a

glass of water. The enteric-coated granules must not be chewed.

4.3. Contraindications

Hypersensitivity to the active substance, substituted benzimidazoles or to any of

the excipients listed in section 6.1.

Omeprazole

like

other

proton

pump

inhibitors

(PPIs)

must

used

concomitantly with nelfinavir (see section 4.5).

4.4 Special warnings and precautions for use

In the presence of any alarm symptom (e.g. significant unintentional weight

loss, recurrent vomiting, dysphagia, haematemesis or melena) and when gastric

ulcer is suspected or present, malignancy should be excluded, as treatment may

alleviate symptoms and delay diagnosis.

Co-administration of atazanavir with proton pump inhibitors is not

recommended (see section 4.5). If the combination of atazanavir with a proton

pump inhibitor is judged unavoidable, close clinical monitoring (e.g virus load)

is recommended in combination with an increase in the dose of atazanavir to

400 mg with 100 mg of ritonavir; omeprazole 20 mg should not be exceeded.

Omeprazole, as all acid-blocking medicines, may reduce the absorption of

vitamin B

(cyanocobalamin) due to hypo- or achlorhydria. This should be

considered in patients with reduced body stores or risk factors for reduced

vitamin B

absorption on long-term therapy.

Omeprazole is a CYP2C19 inhibitor. When starting or ending treatment with

omeprazole, the potential for interactions with drugs metabolised through

CYP2C19 should be considered. An interaction is observed between clopidogrel

and omeprazole (see section 4.5). The clinical relevance of this interaction is

uncertain. As a precaution, concomitant use of omeprazole and clopidogrel

should be discouraged.

Severe hypomagnesaemia has been reported in patients treated with PPIs like

omeprazole for at least three months, and in most cases for a year. Serious

manifestations

hypomagnesaemia

such

fatigue,

tetany,

delirium,

convulsions, dizziness and ventricular arrhythmia can occur but they may begin

insidiously and be overlooked. In most affected patients, hypomagnesaemia

improved after magnesium replacement and discontinuation of the PPI.

For patients expected to be on prolonged treatment or who take PPIs with

digoxin or drugs that may cause hypomagnesaemia (e.g., diuretics), health care

professionals should consider measuring magnesium levels before starting PPI

treatment and periodically during treatment.

Proton pump inhibitors, especially if used in high doses and over long durations

(>1 year), may modestly increase the risk of hip, wrist and spine fracture,

predominantly in the elderly or in presence of other recognised risk factors.

Observational studies suggest that proton pump inhibitors may increase the

overall risk of fracture by 10–40%. Some of this increase may be due to other

risk factors. Patients at risk of osteoporosis should receive care according to

current clinical guidelines and they should have an adequate intake of vitamin D

and calcium.

Subacute cutaneous lupus erythematosus (SCLE)

Proton pump inhibitors are associated with very infrequent cases of SCLE. If

lesions occur, especially in sun-exposed areas of the skin, and if accompanied

by arthralgia, the patient should seek medical help promptly and the health care

professional

should

consider

stopping

Omeprazole.

SCLE

after

previous

treatment with a proton pump inhibitor may increase the risk of SCLE with

other proton pump inhibitors.

Interference with laboratory tests

Increased Chromogranin A (CgA) level may interfere with investigations for

neuroendocrine tumours.

To avoid this interference Omeprazole treatment should be stopped for at least 5

days before CgA measurements (see section 5.1). If CgA and gastrin levels have

not returned to reference range after initial measurement, measurements should

be repeated 14 days after cessation of proton pump inhibitor treatment

Some children with chronic illnesses may require long-term treatment although

it is not recommended.

This medicinal product contains sucrose. Patients with rare hereditary problems

of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase

insufficiency should not take this medicine.

Treatment with proton pump inhibitors may lead to slightly increased risk of

gastrointestinal infections such as Salmonella and Campylobacter and, in

hospitalised patients, possibly also Clostridium difficile (see section 5.1).

As in all long-term treatments, especially when exceeding a treatment period of

1 year, patients should be kept under regular surveillance.

4.5

Interaction with other medicinal products and other forms of interaction

Effects of omeprazole on the pharmacokinetics of other active substances

Active substances with pH dependent absorption

The decreased intragastric acidity during treatment with omeprazole might increase or

decrease the absorption of active substances with a gastric pH dependent absorption.

Nelfinavir,

Atazanavir

plasma

levels

nelfinavir

atazanavir

decreased

case

administration with omeprazole.

Concomitant

administration

omeprazole

with

nelfinavir

contraindicated

(see

section 4.3).

Co-administration of omeprazole (40 mg once daily) reduced mean nelvinavir exposure

by ca. 40% and the mean exposure of the pharmacologically active metabolite M8 was

reduced by ca. 75 –90%. The interaction may also involve CYP2C19 inhibition.

Concomitant administration of omeprazole with atazanavir is not recommended (see

section 4.4).

Concomitant administration of omeprazole (40 mg once daily) and atazanavir 300

mg/ritonavir 100 mg to healthy volunteers resulted in a 75% decrease of the atazanavir

exposure. Increasing the atazanavir dose to 400 mg did not compensate for the impact

of omeprazole on atazanavir exposure. The co-administration of omeprazole (20 mg

once daily) with atazanavir 400 mg/ritonavir 100 mg to healthy volunteers resulted in a

decrease of approximately 30% in the atazanavir exposure as compared to atazanavir

300 mg/ritonavir 100 mg once daily.

Digoxin

Concomitant treatment with omeprazole (20 mg daily) and digoxin in healthy subjects

increased the bioavailability of digoxin by 10%. Digoxin toxicity has been rarely

reported. However caution should be exercised when omeprazole is given at high doses

in elderly patients. Therapeutic drug monitoring of digoxin should then be reinforced.

Clopidogrel

In a crossover clinical study, clopidogrel (300 mg loading dose followed by 75 mg/day)

alone and with omeprazole (80 mg at the same time as clopidogrel) were administered

for 5 days. The exposure to the active metabolite of clopidogrel was decreased by 46%

(Day 1) and 42% (Day 5) when clopidogrel and omeprazole were administered

together. Mean inhibition of platelet aggregation (IPA) was diminished by 47% (24

hours) and 30% (Day 5) when clopidogrel and omeprazole were administered together.

In another study it was shown that administering clopidogrel and omeprazole at

different times did not prevent their interaction that is likely to be driven by the

inhibitory effect of omeprazole on CYP2C19.

Inconsistent data on the clinical implications of this PK/PD interaction in terms of

major cardiovascular events have been reported from observational and clinical studies.

Other active substances

The absorption of posaconazole, erlotinib, ketoconazol and itraconazol is significantly

reduced and thus clinical efficacy may be impaired. For posaconazol and erlotinib

concomitant use should be avoided.

Active substances metabolised by CYP2C19

Omeprazole is a moderate inhibitor of CYP2C19, the major omeprazole metabolising

enzyme. Thus, the metabolism of concomitant active substances also metabolised by

CYP2C19, may be decreased and the systemic exposure to these substances increased.

Examples of such drugs are R-warfarin and other vitamin K antagonists, cilostazol,

diazepam and phenytoin.

Cilostazol

Omeprazole, given in doses of 40 mg to healthy subjects in a cross-over study,

increased C

and AUC for cilostazol by 18% and 26% respectively, and one of its

active metabolites by 29% and 69% respectively.

Phenytoin

Monitoring phenytoin plasma concentration is recommended during the first two weeks

after initiating omeprazole treatment and, if a phenytoin dose adjustment is made,

monitoring and a further dose adjustment should occur upon ending omeprazole

treatment.

Unknown mechanism

Saquinavir

Concomitant administration of omeprazole with saquinavir/ritonavir resulted in

increased plasma levels up to approximately 70% for saquinavir associated with good

tolerability in HIV-infected patients.

Tacrolimus

Concomitant administration of omeprazole has been reported to increase the serum

levels of tacrolimus. A reinforced monitoring of tacrolimus concentrations as well as

renal function (creatinine clearance) should be performed, and dosage of tacrolimus

adjusted if needed.

Methotrexate

When given together with proton pump inhibitors, methotrexate levels have been

reported to increase in some patients. In high-dose methotrexate administration a

temporary withdrawal of omeprazole may need to be considered.

Effects of other active substances on the pharmacokinetics of omeprazole

Inhibitors CYP2C19 and/or CYP3A4

Since omeprazole is metabolised by CYP2C19 and CYP3A4, active substances known

to inhibit CYP2C19 or CYP3A4 (such as clarithromycin and voriconazole) may lead to

increased omeprazole serum levels by decreasing omeprazole’s rate of metabolism.

Concomitant voriconazole treatment resulted in more than doubling of the omeprazole

exposure. As high doses of omeprazole have been well-tolerated adjustment of the

omeprazole dose is not generally required. However, dose adjustment should be

considered in patients with severe hepatic impairment and if long-term treatment is

indicated.

Inducers of CYP2C19 and/or CYP3A4

Active substances known to induce CYP2C19 or CYP3A4 or both (such as rifampicin

and St John’s wort) may lead to decreased omeprazole serum levels by increasing

omeprazole’s rate of metabolism.

4.6 Fertility, pregnancy and lactation

Pregnancy

Results from three prospective epidemiological studies (more than 1000 exposed

outcomes) indicate no adverse effects of omeprazole on pregnancy or on the

health of the foetus/newborn child. Omeprazole can be used during pregnancy.

Breast-feeding

Omeprazole is excreted in breast milk but is not likely to influence the child

when therapeutic doses are used.

Fertility

Animal studies with the racemic mixture omeprazole, given by oral

administration do not indicate effects with respect to fertility.

4.7

Effects on ability to drive and use machines

Omeprazole is not likely to affect the ability to drive or use machines. Adverse

drug reactions such as dizziness and visual disturbances may occur (see

section 4.8). If affected, patients should not drive or operate machinery.

4.8

Undesirable effects

The most common side effects (1-10% of patients) are headache, abdominal pain,

constipation, diarrhoea, flatulence and nausea/vomiting.

The following adverse drug reactions have been identified or suspected in the clinical

trials programme for omeprazole and post-marketing. None was found to be dose-

related. Adverse reactions listed below are classified according to frequency and

System Organ Class (SOC). Frequency categories are defined according to the

following convention: Very common (

1/10), Common (

1/100 to < 1/10),

Uncommon (

1/1,000 to < 1/100), Rare (

1/10,000 to < 1/1,000), Very rare (<

1/10,000), Not known (cannot be estimated from the available data).

SOC/frequency

Adverse reaction

Blood and lymphatic system disorders

Rare:

Leukopenie, Thrombozytopenie

Very rare:

Agranulocytosis, pancytopenia

Immune system disorders

Rare::

Hypersensitivity reactions e.g. fever, angioedema and anaphylactic

reaction/shock

Metabolism and nutrition disorders

Rare:

Hyponatraemia

Not known:

Hypomagnesaemia (see section 4.4)

Psychiatric disorders

Uncommon:

Insomnia

Rare:

Agitation, confusion, depression

Very rare:

Aggression, hallucinations

Nervous system disorders

Common::

Headache

Uncommon:

Dizziness, paraesthesia, somnolence

Rare:

Taste disturbance

Eye disorders

Rare:

Blurred vision

Ear and labyrinth disorders

Uncommon:

Vertigo

Respiratory, thoracic and mediastinal disorders

Rare:

Bronchospasm

Gastrointestinal disorders

Common:

Abdominal pain, constipation, diarrhoea, flatulence, nausea/vomiting,

fundic gland polyps (benign)

Rare:

Dry mouth, stomatitis, gastrointestinal candidiasis, microscopic

colitis

Hepatobiliary disorders

Uncommon:

Increased liver enzymes

Rare:

Hepatitis with or without jaundice

Very rare:

Hepatic failure, encephalopathy in patients with pre-existing liver

disease

Skin and subcutaneous tissue disorders

Uncommon:

Dermatitis, pruritus, rash, urticaria

Rare:

Alopecia, photosensitivity

Very rare:

Erythema multiforme, Stevens-Johnson syndrome, toxic epidermal

necrolysis (TEN)

Not known:

Subacute cutaneous lupus erythematosus (see section 4.4).

Musculoskeletal and connective tissue disorders

Uncommon:

Fracture of the hip, wrist or spine (see section 4.4)

Rare:

Arthralgia, myalgia

Very rare:

Muscular weakness

Renal and urinary disorders

Rare:

Interstitial nephritis

Reproductive system and breast disorders

Very rare:

Gynaecomastia

General disorders and administration site conditions

Uncommon:

Malaise, peripheral oedema

Rare:

Increased sweating

Paediatric population

The safety of omeprazole has been assessed in a total of 310 children aged 0 to 16 years

with acid-related disease. There are limited long term safety data from 46 children who

received maintenance therapy of omeprazole during a clinical study for severe erosive

Read the complete document

MHRA PAR; OMEPRAZOLE 10MG, 20MG AND 40MG GASTRO-RESISTANT CAPSULES,

HARD, PL 17780/0523-0525 AND 0583

Public Assessment Report

Decentralised Procedure

Omeprazole 10mg Gastro-resistant Capsules, hard

Omeprazole 20mg Gastro-resistant Capsules, hard

Omeprazole 40mg Gastro-resistant Capsules, hard

(UK/H/4423/001-003/DC)

Omeprazole 20mg Gastro-resistant Capsules, hard

(UK/H/5144/001/DC)

PL 17780/0523

PL 17780/0524

PL 17780/0525

PL 17780/0583

Winthrop Pharmaceuticals UK Limited

MHRA PAR; OMEPRAZOLE 10MG, 20MG AND 40MG GASTRO-RESISTANT CAPSULES,

HARD, PL 17780/0523-0525 AND 0583

Lay summary

The Medicines and Healthcare products Regulatory Agency (MHRA) granted Winthrop

Pharmaceuticals UK Limited (trading as Zentiva) Marketing Authorisations for the

medicinal products Omeprazole 10mg Gastro-resistant Capsules, hard (product licence

number: PL 17780/0523), Omeprazole 20mg Gastro-resistant Capsules, hard (PL

17780/0524), Omeprazole 40mg Gastro-resistant Capsules, hard (PL 17780/0525) and

Omeprazole 20mg Gastro-resistant Capsules, hard (PL 17780/0583) on 7 May 2013. These

medicines are available on prescription only.

Omeprazole Capsules belong to a group of medicines known as the 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.

No new or unexpected safety concerns arose from these applications. It was judged that the

benefits of taking Omeprazole Capsules outweigh the risks; hence Marketing

Authorisations have been granted.

MHRA PAR; OMEPRAZOLE 10MG, 20MG AND 40MG GASTRO-RESISTANT CAPSULES,

HARD, PL 17780/0523-0525 AND 0583

TABLE OF CONTENTS

Module 1: Information about Decentralised Procedure

Page 4

Module 2: Summary of Product Characteristics

Page 5

Module 3: Product Information Leaflet

Page 6

Module 4: Labelling

Page 7

Module 5: Scientific Discussion During Initial Procedure

Page 28

Introduction

About the Products

Scientific Overview and Discussion

III.1

Quality aspects

III.2

Non-clinical aspects

III.3

Clinical aspects

Overall conclusion and Benefit-Risk Assessment

Module 6: Steps taken after initial procedure

Page 39

MHRA PAR; OMEPRAZOLE 10MG, 20MG AND 40MG GASTRO-RESISTANT CAPSULES,

HARD, PL 17780/0523-0525 AND 0583

Module 1

Information about Decentralised Procedure

Names

products

Reference

Member State

Omeprazole 10mg Gastro-resistant

Capsules, hard

Omeprazole 20mg Gastro-resistant

Capsules, hard

Omeprazole 40mg Gastro-resistant

Capsules, hard

Omeprazole 20mg Gastro-resistant

Capsules, hard

Type of application

Article 10 (1), generic

Name of the drug substance

Omeprazole

Pharmacotherapeutic classification

(ATC code) of the medicinal products

Drugs

peptic

ulcer

gastro-

oesophageal reflux disease (GORD),

proton pump inhibitors

(A02BC01)

Pharmaceutical

form

strengths

medicinal products

Gastro-resistant capsule, hard; 10 mg,

20 mg and 40 mg

Reference

numbers

Decentralised

Procedure

UK/H/4423/001-003/DC

UK/H/5144/001/DC

Reference Member State

United Kingdom

Member States concerned

UK/H/4423/001-003/DC: BG, CZ,

DE, ES, FR, HU, IT, PL, PT, RO, SI,

UK/H/5144/001/DC: DE

Start date of the Decentralised Procedure

19 March 2012

End date of the Decentralised Procedure

14 March 2013 (day 210)

Marketing Authorisation numbers

PL 17780/0523

PL 17780/0524

PL 17780/0525

PL 17780/0583

Name and address of the

authorisation holder

Winthrop

Pharmaceuticals

Limited (Trading as Zentiva)

One Onslow Street

Guildford

Surrey GU1 4YS

MHRA PAR; OMEPRAZOLE 10MG, 20MG AND 40MG GASTRO-RESISTANT CAPSULES,

HARD, PL 17780/0523-0525 AND 0583

Module 2

Summary of Product Characteristics

In accordance with Directive 2010/84/EU the Summaries of Product Characteristics

(SmPC) for products granted Marketing Authorisations at a national level are

available on the MHRA website.

MHRA PAR; OMEPRAZOLE 10MG, 20MG AND 40MG GASTRO-RESISTANT CAPSULES,

HARD, PL 17780/0523-0525 AND 0583

Module 3

Product Information Leaflet

In accordance with Directive 2010/84/EU the Patient Information Leaflets (PIL) for

products granted Marketing Authorisations at a national level are available on the

MHRA website.

MHRA PAR; OMEPRAZOLE 10MG, 20MG AND 40MG GASTRO-RESISTANT CAPSULES,

HARD, PL 17780/0523-0525 AND 0583

Module 4

Labelling

The following text is the approved label text for the products. No label mock-ups have

been provided. In accordance with medicines legislation, the products shall not be

marketed in the UK until approval of the label mock-ups has been obtained.

MHRA PAR; OMEPRAZOLE 10MG, 20MG AND 40MG GASTRO-RESISTANT CAPSULES,

HARD, PL 17780/0523-0525 AND 0583

Omeprazole 10mg Gastro-resistant Capsules, hard (

PL 17780/0523)

:

MHRA PAR; OMEPRAZOLE 10MG, 20MG AND 40MG GASTRO-RESISTANT CAPSULES,

HARD, PL 17780/0523-0525 AND 0583

MHRA PAR; OMEPRAZOLE 10MG, 20MG AND 40MG GASTRO-RESISTANT CAPSULES,

HARD, PL 17780/0523-0525 AND 0583

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