OMEPREX PLUS is a prescription medicine called a proton pump inhibitor (PPI). OMEPREX PLUS reduces the amount of acid in your stomach.

OMEPREX PLUS is used in adults:

• for 4 weeks to heal ulcers in the first part of the small bowel (duodenal ulcers). Your doctor may prescribe another 4 weeks of OMEPREX PLUS.

• for up to 8 weeks for healing stomach ulcers.

• for up to 4 weeks to treat heartburn and other symptoms that happen with

Gastro-oesophageal reflux disease (GORD). GORD happens when acid from the stomach backs up into the tube (esophagus) that connects your mouth to your stomach. This may cause a burning feeling in your chest or throat, sour taste, or burping.

• for up to 8 weeks to heal acid-related damage to the lining of the esophagus (called erosive esophagitis or EE).

• to maintain healing of the esophagus. It is not known if OMEPREX PLUS is safe and effective if used longer than 12 months (1 year).

Subacute cutaneous lupus erythematosus (SCLE)

Proton pump inhibitors are associated with very frequent 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 this medication. SCLE after previous treatment with a proton pump inhibitor may increase the risk of SCLE with other proton pump inhibitors.

Do not take OMEPREX PLUS if you

• are allergic to omeprazole or any of the other ingredients in OMEPREX PLUS (see section 6).

• are allergic to any other proton pump inhibitor (PPI) medicine.

Take Special care if you

• have been told that you have low magnesium, calcium, or potassium levels in your blood

• have liver problems

• have heart failure

• have Bartter’s syndrome (a rare kidney disorder)

• have any allergies

• have any other medical conditions

• are pregnant or plan to become pregnant. It is not known if OMEPREX PLUS can harm your unborn baby.

• are breastfeeding or plan to breastfeed. OMEPREX PLUS can pass into your breast milk and may harm your baby. You and your doctor should decide if you will take OMEPREX PLUS or breastfeed. You should not do both. Talk with your doctor about the best way to feed your baby if you take OMEPREX PLUS.

Other medicines and OMEPREX PLUS

Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, even those not prescribed.

This is important as using more than one medicine at the same time can strengthen or weaken the effects of the medicines.

Especially tell your doctor if you take:

• diazepam (Valium®)

• warfarin (Coumadin® Jantoven)

• phenytoin (Dilantin®)

• ciclosporin (Gengraf, Neoral, Sandimmune)

• disulfiram (Antabuse®)

• a benzodiazepine medicine

• ketoconazole (Nizoral®)

• an antibiotic that contains ampicillin

• products that contain iron

• digoxin (Lanoxin®)

• voriconazole (Vfend®)

• atazanavir (Reyataz®)

• nelfinavir (Viracept®)

• tacrolimus (Prograf®)

• saquinavir (Fortovase®)

• clarithromycin (Biaxin®, Biaxin XL)

• clopidogrel (Plavix®)

• St. John’s Wort (Hypericum perforatum)

• rifampin (Rifater, Rifamate, Rimactane, Rifadin)

• methotrexate

Ask your doctor or pharmacist for a list of these medicines, if you are not sure.

Know the medicines that you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.

OMEPREX PLUS with food and drink

OMEPREX PLUS should be taken before meals.

Pregnancy and breast-feeding and fertility

It is not known if OMEPREX PLUS can harm your unborn baby.

OMEPREX PLUS can pass into your breast milk and may harm your baby. You and your doctor should decide if you will take OMEPREX PLUS or breastfeed. You should not do both. Talk with your doctor about the best way to feed your baby if you take OMEPREX PLUS.

Driving and using machines

OMEPREX PLUS not likely to affect the ability to drive or use machines. Adverse drug reactions such as dizziness and visual disturbances may occur, If affected, patients should not drive or operate machinery.

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

• Take OMEPREX PLUS exactly as prescribed by your doctor.

• Do not change your dose or stop taking OMEPREX PLUS without talking to your doctor. Take OMEPREX PLUS on an empty stomach at least one hour before a meal.

• Swallow OMEPREX PLUS Capsules whole with water. Do not use other liquids. Do not crush or chew the capsule. Do not open the capsule and sprinkle contents into food.

• Do not substitute two 20 mg capsules for one 40 mg capsule of OMEPREX PLUS because you will receive twice the amount of sodium bicarbonate. Talk to your doctor if you have questions.

• Your doctor may prescribe antibiotic medicines with OMEPREX PLUS to help treat a stomach infection and heal stomach-area (duodenal) ulcers that are caused by bacteria called H. pylori. Make sure you read the patient information that comes with an antibiotic before you start taking it.

If you take more OMEPREX PLUS than you should

If you take more capsules than you have been told to take, or if someone else accidentally takes your medicine, contact a doctor, pharmacist or hospital as you may need medical attention.

If you forget to take OMEPREX PLUS

If you miss a dose of OMEPREX PLUS, take it as soon as you remember. If it is almost time for your next dose, do not take the missed dose. Take the next dose at your regular time. Do not take two doses to make up for a missed dose.

Do not change the prescribed dose by yourself unless your doctor tells you to.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Like all medicines, OMEPREX PLUS can cause side effects, although not everybody gets them.

• Chronic (lasting a long time) inflammation of the stomach lining (Atrophic Gastritis). Taking OMEPREX PLUS for a long period of time may increase the risk of inflammation to your stomach lining. You may or may not have symptoms. Tell your doctor if you have stomach pain, nausea, vomiting, or weight loss.

• Low magnesium levels in your body. This problem can be serious. Low magnesium can happen in some people who take a proton pump inhibitor medicine for at least 3 months. If low magnesium levels happen, it is usually after a year of treatment. You may or may not have symptoms of low magnesium.

Tell your doctor right away if you develop any of these symptoms:

• seizures

• dizziness

• abnormal or fast heartbeat

• jitteriness

• jerking movements or shaking (tremors)

• muscle weakness

• spasms of the hands and feet

• cramps or muscle aches

• spasm of the voice box

Your doctor may check the level of magnesium in your body before you start taking OMEPREX PLUS, or during treatment if you will be taking OMEPREX PLUS for a long period of time.

The most common side effects with OMEPREX PLUS include:

• headache

• abdominal pain

• nausea

• diarrhea

• vomiting

• gas

Other side effects:

- Serious allergic reactions. Tell your doctor if you get any of the following symptoms with OMEPREX PLUS.

• Rash

• face swelling

• throat tightness

• difficulty breathing

Your doctor may stop OMEPREX PLUS if these symptoms happen.

Using OMEPREX PLUS for a long time may cause problems such as swelling and weight gain. Tell your doctor if this happens.

If you are on a low-sodium diet or at risk of developing congestive heart failure (CHF), you and your doctor should decide if you will take OMEPREX PLUS.

Tell your doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of OMEPREX PLUS. For more information, ask your doctor or pharmacist.

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.

• Keep out of reach and sight of children.

• Store below 30°C.

• Keep in the original pack to protect from light and moisture.

• Do not use OMEPREX PLUS after the expiry date which is stated on the carton. The Expiry date refers to the last day of that month

• Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.