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DE^cel*

pharma laboratories

Omeprazole 20mg Gastro-Resistant Tablets

Omeprazole

(Referred to as OmeprazoleTablets throughout this leaflet)

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you.

-    Keep this leaflet. You may need to read it again.

-    Ask your pharmacist if you need more information or advice.

-    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.

-    You must contact a doctor if you are not free from symptoms after 14 days of treatment.

What is in this leaflet

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

2.    What you need to know before you take Omeprazole Tablets

3.    How to take Omeprazole Tablets

4.    Possible side effects

5.    How to store Omeprazole Tablets

6.    Contents of the pack and other information

1. WHAT OMEPRAzOLE TABLETs ARE AND WHAT Are They usED FOR

Omeprazole Tablets contain 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 Tablets are used in adults for the short-term treatment of reflux symptoms (for example, heartburn, acid regurgitation).

Reflux is the backflow of acid from the stomach into the gullet “foodpipe”, which may become inflamed and painful. This may cause you symptoms such as a painful burning sensation in the chest rising up to the throat (heartburn) and a sour taste in the mouth (acid regurgitation).

It might be necessary to take the tablets for 2-3 consecutive days to achieve improvement of symptoms.

2. WHAT YOu Need TO Know Before YOu TAKE OMEPRAzOLE TABLETs

Do not take Omeprazole Tablets

•    If you are allergic (hypersensitive) 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 (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 Tablets.

Warnings and precautions

Talk to your doctor or pharmacist before taking Omeprazole Tablets

Do not take Omeprazole Tablets for more than 14 days without consulting a doctor. If you do not experience relief, or if you experience a worsening of symptoms, consult your doctor.

Omeprazole Tablets may hide the symptoms of other diseases. Therefore, if any of the following happen to you before you start taking Omeprazole Tablets 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 had previous gastric ulcer or gastrointestinal

surgery.

•    You are on continuous symptomatic treatment of indigestion or heartburn for 4 or more weeks.

•    You continuously suffer from indigestion or heartburn for 4 or more weeks.

•    You have jaundice or severe liver disease.

•    You are aged over 55 years with new or recently changed symptoms.

Patients should not take omeprazole as a preventative

medication.

Other medicines and Omeprazole Tablets 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 Tablets can affect the way some medicines work and some medicines can have an effect on Omeprazole Tablets.

Do not take Omeprazole Tablets if you are taking a medicine containing nelfinavir (used to treat HIV infection).

You should specifically tell your doctor or pharmacist if you are taking clopidogrel (used to prevent blood clots (thrombi)).

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 Tablets

•    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 Tablets

•    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)

•    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

Omeprazole Tablets with food and drink

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

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Your doctor will decide whether you can take Omeprazole Tablets during this time.

Driving and using machines

Omeprazole Tablets are not likely to affect your ability to drive or use any tools or machines. Side effects such as dizziness and visual disturbances may occur (see section 4). If affected, you should not drive or operate machinery.

Omeprazole Tablets contains Lactose

Omeprazole Tablets 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 TABLETs

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you. Check with your doctor or pharmacist if you are not

sure.

The recommended dose is one 20 mg tablet once a day for 14 days. Contact your doctor if you are not free from symptoms after this period. It might be necessary to take the tablets for 2-3 consecutive days to achieve improvement of symptoms.

Taking this medicine

•    It is recommended that you take your tablets in the morning.

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

•    Swallow your tablets whole with half a glass of water. Do not chew or crush the tablets. This is because the tablets are coated with enteric coating which stops the medicine from being broken down by the acid in your stomach. The tablets release the active ingredient in the intestine, where it is absorbed by your body to give an effect.

If you take more Omeprazole Tablets than you should

If you take more Omeprazole Tablets than recommended, talk to your doctor or pharmacist straight away.

If you forget to take Omeprazole Tablets

If you forget to take a dose, take it as soon as you remember it. However, if it is almost time for your next dose, skip the missed dose. Do not take a double dose to make up for a forgotten dose.

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

•    Omeprazole Tablets 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.

Other side effects include:

Common side effects (affects 1 to 10 users in 100)

•    Headache.

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

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

uncommon side effects (affects 1 to 10 users in 1,000)

•    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 (affects 1 to 10 users in 10,000)

•    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

•    Inflammation in the gut (leading to diarrhoea).

Very rare side effects (affects less than 1 user in

10,000)

•    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 (low level of magnesium in the blood).

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.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www. mhra.gov.uk/yellowcard.

By reporting side effects you can help provide more information on the safety of this medicine.

5.    HOW TO sTORE OMEPRAzOLE TABLETs

•    Keep out of the reach and sight of children.

•    Do not use Omeprazole Tablets after the expiry date which is stated on the pack after EXP. The expiry date refers to the last day of that month.

•    Do not store above 30°C.

•    Store this blister in the original package in order 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 Tablets contains

The active substance is omeprazole. Omeprazole Tablets contain 20 mg of omeprazole.

The other ingredients are lactose monohydrate, sodium starch glycolate, sodium stearyl fumarate, sodium stearate, hypromellose acetate succinate, brownish pink colour [which contains propylene glycol, titanium dioxide (E-171), red iron oxide (E-172), hypromellose and yellow iron oxide (E-172)], talc, triethyl citrate, monoethanolamine, sodium lauryl sulfate and traces of carnauba wax.

What Omeprazole Tablets look like and contents of the pack

Omeprazole 20 mg Gastro-Resistant Tablets are brownish-pink film coated capsule shaped tablets. Blisters of 7, 14 tablets Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:

Dexcel® - Pharma Laboratories Ltd., Ashacres House, Ashacres Industrial Park, Draycott in the Clay, Ashbourne, Derbyshire, DE6 5GX, United Kingdom.

This Leaflet was last revised in December 2013

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