Napizole contain the active substance (Omeprazole). It belongs to a group of medicines called (proton pump inhibitors- PPIs). Napizole works by decreasing the amount of acid made by the stomach, to give relief of symptoms and allow healing to take place. This does not stop food being digested in the normal way. Napizole indicated for:
Acid Related Dyspepsia: Napizole is used to treat acid-related dyspepsia. Dyspepsia describes any regular upper abdominal pain or discomfort that is often, but not always, related to eating.
Peptic Ulcers: Napizole is used to treat peptic ulcers. Depending on the position of the ulcer it is called a gastric or duodenal ulcer. A gastric ulcer occurs in the stomach. A duodenal ulcer occurs in the duodenum which is the tube leading out from the stomach. These ulcers can be caused by too much acid being made in the stomach. Napizole is also used to help stop gastric or duodenal ulcers coming back.
GERD disease: Napizole used, in adults and children to treat gastroesophageal reflux disease (GERD), in which the contents of the stomach come back up (reflux) into the food pipe (esophagus). This is often painful and it can damage the food pipe. Omeprazole reduces the amount of acid in the stomach, which reduces the symptoms of (GERD) and helps protect the food pipe. Napizole is also used to maintenance of healing of erosive esophagitis.
Peptic Ulcers Associated with Helicobacter pylori Infection: Most people who have a peptic ulcer also have a bacteria called Helicobacter pylori in their stomach. When Napizole is taken with antibiotics, they will kill Helicobacter pylori and let your peptic ulcer heal.
Peptic Ulcers Associated with Non-steroidal Anti-Inflammatory Drugs (NSAIDs): Some peptic ulcers are caused by taking medicines called (non-steroidal anti-inflammatory drugs) which have analgesic effect. These medicines are commonly taken to treat joint disease or arthritis. Napizole is used to heal and prevent ulcers associated with (NSAIDs).
Zollinger-Ellison Syndrome: Napizole is used to treat a rare condition called Zollinger-Ellison syndrome, where the stomach produces large amounts of acid, much more than in ulcers or reflux disease.
How to use Napizole
NAPIZOLE VIAL
Napizole is usually given once each day. This is usually in the morning.
Your doctor may have told you to take it twice a day. take one dose in the morning and one in the evening. Ideally, these times are 10 12 hours apart, for example sometime between 7 and 8 am, and between 7 and 8 pm.
Take the medicine at about the same time(s) each day so that this becomes part of your daily routine, which will help you to remember.
What if I forget to take my dose?
If you usually take it once a day: take the missed dose when you remember during the day, as long as this is at least 12 hours before the next dose is due.
If you usually take it twice a day: If you remember up to 4 hours after you should have given a dose, take the missed dose. For example, if you usually take a dose at about 7 am, you can take the missed dose at any time up to 11 am. If you remember after that time, do not take the missed dose. take the next dose as usual.
When should Napizole start working?
Omeprazole (Napizole) starts working straight away and you should start to have less discomfort and less reflux. It may take up to 4 weeks for omeprazole to work fully so you may still have some symptoms during this time. If you are not sure whether the medicine is working, contact your doctor.
What if you are sick (vomit) after taking the dose?
If you vomit less than 30 minutes after having a dose of omeprazole, take the same dose again.
If you vomit more than 30 minutes after having a dose of omeprazole, you do not need to take another dose. Wait until the next normal dose.
For How long shall I take Napizole?
Napizole starts to work on the very first day of treatment, but may take 1 to 4 days for full effect (although some people get complete relief within 24 hours). Taking Napizole every day for 14 days helps to ensure that acid production is consistently controlled.
If your frequent heartburn continues or returns after 14 days of treatment, stop use and talk to your doctor. Your doctor will take steps to ensure Napizole is not masking any potentially serious underlying conditions behind your frequent heartburn, and determine if Napizole continues to be right for you. Do not take Napizole for more than 14 days or more often than every 4 months unless directed by a doctor.
نابيزول NAPIZOL
Possible side-effects
We use medicines to make our body health better, but sometimes they have other effects that we don’t want (side-effects). Omeprazole is a safe medicine and most patients can take it without having any side-effects.
Side-effects you must do something about: If you develop a rash, swelling of the face, lips, tongue or throat, or has difficulty breathing or swallowing, you may be allergic to omeprazole. Contact your doctor or go to hospital straight away.
Other side-effects you need to know about: You may get the following side-effects when you first start taking omeprazole. They should wear off as your body gets used to the medicine. If they are still a problem after a week or so, contact your doctor.
stomach pain, feel sick or be sick (vomit) or you may get diarrhoea, wind (flatulence) or constipation (difficulty doing a poo). It may help to take each dose with some food.
Feel light-headed or dizzy.
Feel sleepy but some find it hard to get to sleep at night. If this is still a problem after about 2 weeks, contact your doctor.
There may, sometimes, be other side-effects that are not listed above. If you notice anything unusual and are concerned, contact your doctor.
Warnings and Precautions
Treatment with Napizole(omeprazole) may mask Gastric cancer (a disease in which malignant (cancer) cells form in the lining of the stomach). Gastric cancer should be excluded, symptomatic response does not preclude the presence of gastric malignancy.
Long-term therapy with Omeprazole has been associated with Atrophic gastritis (Changes in the type of cells lining the stomach wall, characterized by chronic inflammation of the gastric mucosa).
PPI therapy (treatment with Napizole, especially for long period of time) may be associated with increased risk of Clostridium difficile associated diarrhea. Clostridium difficile is a germ (bacterium) that causes severe diarrhea and colitis (an inflammation of the colon).
Bone Fracture: Long-term and multiple daily dose PPIs therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist or spine.
Diminished anti-platelet activity of clopidogrel due to impaired CYP2C19 function by 80 mg omeprazole.
Hypomagnesemia has been reported rarely with prolonged treatment with PPIs.
Avoid concomitant use of Napizole with St John’s Wort or rifampin due to the potential reduction in omeprazole concentrations.
How Napizole interact with other medicines
Tell your doctor if you are taking any other medicines, including:
Phenytoin: Sold under the brand name Dilantin among others, is an anti-seizure medication).
Warfarin: Sold under the brand name Coumadin among others, is a medication that is used as an anticoagulant (blood thinner).
Diazepam: First marketed as Valium, is a medicine of the benzodiazepine family that acts as an anxiolytic. It is commonly used to treat a range of conditions, including anxiety, seizures, alcohol withdrawal syndrome, benzodiazepine withdrawal syndrome, muscle spasms, insomnia, and restless legs syndrome.
Ketoconazole: Sold under the brand name Nizoral among others, is an antifungal medication used to treat a number of fungal infections.
Itraconazole: Sold under the brand name Sporanox among others, is an antifungal medication used to treat a number of fungal infections.
Voriconazole: Sold under the brand name Vfend among others, is an antifungal medication used to treat a number of fungal infections.
Cilostazol: Sold under the brand name Pletal among others, is a medication used to help the symptoms of intermittent claudication in peripheral vascular disease.
Tacrolimus: Sold under the brand name Prograf among others, is an immunosuppressive drug. After allogeneic organ transplant, the risk of organ rejection is moderate. To lower the risk of organ rejection, tacrolimus is given. The drug can also be sold as a topical medication in the treatment of T-cell-mediated diseases such as eczema and psoriasis.
Digoxin: Sold under the brand name Lanoxin among others, is a medication used to treat various heart conditions. Most frequently it is used for atrial fibrillation, atrial flutter, and heart failure.
Clopidogrel: Sold under the brand name Plavix among others, is an antiplatelet medication used to reduce the risk of heart disease and stroke in those at high risk. It is also used together with aspirin in heart attacks and following the placement of a coronary artery stent (dual antiplatelet therapy).
Citalopram: Sold under the brand name Celexa/ Cipram among others, is an antidepressant. It is used to treat major depressive disorder, obsessive compulsive disorder, panic disorder, and social phobia.
Escitalopram: Sold under the brand name Cipralex among others, is an antidepressant. It is used to treat major depressive disorder, obsessive compulsive disorder, panic disorder, and social phobia.
Rifampicin: is an antibiotic used to treat several types of bacterial infections.
Atazanavir / Nelfinavir: antiretroviral medication used to treat HIV/AIDS.
St John’s Wort: Herbal dietary supplement, used commonly as sleep aid.
Erlotinib or related medicines used to treat cancer.
Methotrexate: It is a chemotherapy agent and immune-system suppressant. It is used to treat cancer, autoimmune diseases, and ectopic pregnancy and for medical abortions.
Other medicines that you buy at the chemist, supermarket or health food shop.
These medicines may be affected by Napizole or may affect how well it works. Your doctor or pharmacist can tell you what to do if you are taking any other medicines. If you have not told your doctor about any of these things, tell them before you take any Napizole.
General advice about medicines
Try to take medicines at about the same time(s) each day, to help you remember.
Only take this medicine as prescribed by your doctor to your child. Never give it to anyone else, even if their condition appears to be the same, as this could do harm.
If you think someone else may have taken the medicine by accident, contact your doctor straight away.
Make sure that the medicine you have at home has not reached the ‘best before’ or ‘use by’ date on the packaging. Give old medicines to your pharmacist to dispose of.
Where should I keep this medicine?
Keep the medicine in a cupboard, away from heat and direct sunlight. It does not need to be kept in the fridge.
Make sure that children cannot see or reach the medicine.
Keep the medicine in the container it came in.
Napizole Information Leaflet
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NAPIZOLE VIAL PATIENT INFORMATION LEAFLET PAGE 2
Napizole- Arabic Information
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