Omepradex-Z

Active Ingredients

Each caplet contains:

Omeprazole 20 mg.

Indications

Therapeutic group:

Proton pump inhibitors (PPI).

Omepradex - Z inhibits acid secretion in the gastrointestinal tract.

Omepradex - Z is intended for:

• The treatment of severe gastric ulcer, severe duodenal ulcer, reflux oesophagitis, and Zollinger-Ellison syndrome.
• Maintenance treatment for the prevention of relapse in patients with poorly responsive peptic ulcer or with severe reflux oesophagitis.
• Treatment of severe reflux oesophagitis in children over 6 years of age.
• Treatment and prevention of gastric and duodenal ulcer caused by use of non-steroidal anti-inflammatory drugs (NSAIDs) in high risk patients.
• Combined treatment with antibiotics in Helicobacter pylori related peptic ulcer.

Instructions

Swallow the caplet whole with a glass of water.

Do not halve, crush or chew the caplet, in order to maintain the coating of the caplet (the coating prevents the digestive juices in the stomach from breaking down the caplet, so that the active ingredient will be released only in the intestine, where it is absorbed into the body).

Take the medicine before a meal, preferably in the morning.

The usual recommended dosage is:

Treatment of reflux oesophagitis:

Adults:

A 20 mg caplet once daily for 4-8 weeks. The physician may recommend that you continue to take the caplets or increase the dosage as needed.

Children:

Dosage will be determined according to weight.

Treatment of duodenal and gastric ulcer:

A 20 mg caplet once daily. Duration of treatment will be determined by the physician, usually for a period of 4 to 8 weeks. The physician may recommend that you continue to take the caplets or increase the dosage as needed, according to your response to the treatment. To prevent recurrence of the ulcer, the recommended dosage is a 10 or 20 mg caplet once daily. The physician may increase the dosage if the symptoms recur.

Treatment and prevention of NSAID-associated duodenal and gastric ulcers:

If you have suffered in the past from an ulcer and there is a need to continue taking non-steroidal anti-inflammatory drugs, the recommended dosage is a 20 mg caplet once daily. Duration of treatment will be determined by the physician.

Treatment of peptic ulcer caused by the bacterium Helicobacter pylori:

Adults:

A 20 mg caplet twice daily for a week. Additionally, the physician may recommend that you take one or two of the following antibiotics: amoxicillin, clarithromycin, metronidazole. Make sure to take the medicine accurately and according to the instructions and consult the physician if you have any doubt.

Treatment of excess gastric acid caused by a tumor in the pancreas (Zollinger-Ellison Syndrome):

The recommended dose is 60 mg once daily. The physician will adjust the dosage and duration of treatment, according to your condition.

Do not exceed the recommended dosage.

If there is no improvement in your condition, contact the physician.

Tests and follow up

Inform the physician if you are about to undergo lab tests, the physician may instruct you to stop the treatment with the medicine two weeks before the tests.

Consult the physician regarding monitoring of blood magnesium levels during treatment with this medicine.

If you are taking phenytoin or blood thinners, your physician will refer you for tests at the beginning and end of treatment.

If you forgot to take this medicine at the required time, take a dose as soon as you remember. However, if it is almost time for your next dose, skip the forgotten dose and resume your regular dosing schedule. Never take two doses together!

Continue with the treatment as recommended by the physician. Even if there is an improvement in your health, do not stop the treatment of this medicine without consulting the physician.

This medicine is not intended for children under 6 years of age.

Warnings

Do not use Omepradex - Z if you are hypersensitive (allergic) to the active ingredient (Omeprazole) or any of the additional ingredients the medicine contains or other proton pump inhibitors (PPI) (such as: pantoprazole, lansoprazole, rabeprazole, esomeprazole).

Do not use this medicine if you are taking nelfinavir (a medicine for treating HIV).

Before treatment with Omepradex - Z, tell the physician if:

• You are pregnant, might be pregnant, planning to become pregnant or you are breastfeeding.
• You have suffered in the past from a gastric ulcer or you have previously undergone gastrointestinal surgery.
• You suffer, or have suffered in the past, from liver problems, heartburn for a period longer than 3 months or if you are taking medicines for treatment of heartburn or indigestion for a prolonged period of time.
• You are above 55 years of age with new symptoms or symptoms that have recently changed.
• You have been told that you have low levels of magnesium in the blood. Consult the physician regarding monitoring of blood magnesium levels during the treatment with this medicine.
• You suffer from nausea, from heartburn accompanied by blurriness, sweating or dizziness; chest or shoulder pain accompanied by shortness of breath, sweating, pain radiating to the arms, neck or shoulders, blurriness or dizziness; from frequent chest pain; from frequent wheezing (breathing difficulties), mainly if accompanied by heartburn.

If you are using Omepradex- Z for a prolonged period (more than a year) your physician may monitor your medical condition regularly. Report any new and exceptional symptoms and medical circumstances every time you have a visit to the physician.

The use of a preparation from the proton pump inhibitors (PPI) group such as Omepradex- Z, especially for more than a year, may slightly increase the risk of hip, wrist and spine fractures. Tell the physician if you suffer from osteoporosis or you are taking corticosteroids (that may increase the risk of osteoporosis).

Omepradex- Z reduces the level of gastric acidity. Gastric acidity is required for the absorption of vitamin B12. If you are taking the medicine for a prolonged period, consult the physician regarding the possibility of vitamin B12 deficiency.

Omepradex- Z may hide the symptoms of other diseases, therefore, if you suffer from the following symptoms before or during the treatment, refer to a physician immediately and inform him of this:

• Weight loss with no apparent reason, problem swallowing (such as difficulty or pain)
• Abdominal pain or indigestion
• Vomiting food or blood
• Black stools (bloody stools)
• Severe or persistent diarrhea (omeprazole has been associated with small increase in infectious diarrhea)

If you are taking, have recently taken or are planning to take any other medicines, including non-prescription drugs and nutrition supplements, please tell your doctor or pharmacist. Especially if you are taking:

• Nelfinavir (a medicine for treating HIV)
• Clopidogrel { for the prevention of blood clots(thrombosis)}, it has been reported that medicines of this group (PPI), such as omeprazole, may reduce the activity of clopidogrel and therefore, avoid taking the medicine with clopidogrel
• Atazanavir, saquinavir, ritonavir (medicines for treating HIV)
• Ketoconazole, itraconazole, posaconazole and voriconazole (medicines for treating fungal infections)
• Digoxin (for heart diseases)
• Medicines that affect the central nervous system ( such as phenytoin, for epilepsy, diazepam, for treatment of anxiety or epilepsy and muscle relaxation ). If you are taking phenytoin, medical surveillance will be necessary at the beginning of treatment with Omepradex- Z caplets and at the end of it
• Blood thinners such as warfarin and other vitamin K blockers. Medical surveillance will be necessary at the beginning of treatment and at the end of it
• Cilostazol (for leg pain)
• Tacrolimus, mycophenolatemofetil (immunosuppressants)
• Iron containing preparations
• Disulfiram (for withdrawal)
• A herbal medicine containing hypericum perforatum (St. John's wort, used for the treatment of depression)
• Erlotinib (for treating cancer)
• Methotrexate-your physician may temporarily stop the treatment with Omepradex - Z caplets
• Antibiotics such as clarithromycin, ampicillin
• Rifampicin (for the treatment of tuberculosis)

If the physician has instructed you to take Omepradex - Z with antibiotics (clarithromycin, amoxicillin) for a combined treatment of gastric ulcer associated with Helicobacter pylori, it is especially important to report to the physician about any additional medicine you are taking.

Do not take the medicine without consulting a physician if you are pregnant, might be pregnant, planning pregnancy or if you are breastfeeding.

This medicine contains lactose. If you have been told in the past by a physician that you have an intolerance to certain sugars, consult a physician before starting treatment with this medicine.

Please do not consider this information as an alternative to consulting your physician or pharmacist.

For further information on instructions for use, risks and side effects, please read the patient package insert and consult your doctor or pharmacist.
Read the patient package insert carefully before starting to take any medication.