CAUTION

• Caution is advised when consuming alcohol with Exium 40 (10). Please consult your doctor.

CONSULT YOUR DOCTOR

• Exium 40 (10) may be unsafe to use during pregnancy. Although there are limited studies in humans, animal studies have shown harmful effects on the developing baby. Your doctor will weigh the benefits and any potential risks before prescribing it to you. Please consult your doctor.

CONSULT YOUR DOCTOR

• Exium 40 (10) is probably unsafe to use during breastfeeding. Limited human data suggests that the drug may pass into the breastmilk and harm the baby.

CONSULT YOUR DOCTOR

• It is not known whether Exium 40 (10) alters the ability to drive. Do not drive if you experience any symptoms that affect your ability to concentrate and react.

SAFE IF PRESCRIBED

• Exium 40 (10) is safe to use in patients with kidney disease. No dose adjustment of Exium 40 (10) is recommended. However, inform your doctor if you have any kidney disease.

CAUTION

• Exium 40 (10) should be used with caution in patients with severe liver disease. Dose adjustment of Exium 40 (10) may be needed. Please consult your doctor.

Medicine Overview of Exium 40 (10) 40mg Capsule

Introduction

• Exium 40 (10) is a medicine which reduces the amount of acid produced in your stomach. It is used to treat heartburn, acid reflux and problems in your food pipe. It is also used to prevent and treat stomach ulcers. You should take Exium 40 (10) as your doctor advises. The dose will depend on what you are being treated for, but it should be the lowest dose for the shortest amount of time needed to treat your condition. Normally it should be swallowed whole about an hour before a meal and at the same time each day. It may take up to a few weeks to work properly but your doctor will tell you how long you need to be taking it for. You should keep on taking it as prescribed even if your symptoms disappear quickly. If you are taking this medicine for a long time, your doctor may carry out regular tests to check your levels of magnesium which can fall with this medicine. Common side effects include headache, constipation or diarrhoea, stomach pain and feeling or being sick. These tend to be mild but talk to your doctor if they bother you or do not go away. The risk of side effects may increase the longer you take this medicine. Serious side effects are rare, but some need immediate medical attention. Ask your doctor what these are. You may be more likely to have a broken bone if you take it for a long time. It is best to avoid foods that seem to make your symptoms worse, such as rich, spicy and fatty foods. It also helps to cut down on caffeinated drinks, such as tea, coffee and cola, as well as alcohol. Exium 40 (10) is not suitable for some people. Before taking this medicine, you need to tell your doctor if you have severe liver problems, are taking medicines for HIV, have had an allergic reaction to similar medicines in the past or have osteoporosis. Alcohol does not interfere with the way Exium 40 (10) works. However, drinking alcohol makes your stomach produce more acid than normal. This medicine can make you feel dizzy, sleepy, or affect your vision. If this happens, do not drive, cycle or use machinery or tools until you feel better. It is not usually recommended during pregnancy and breastfeeding.

Uses of Exium 40 (10)

• Gastroesophageal reflux disease (Acid reflux)
• Peptic ulcer disease

Side effects of Exium 40 (10)

Common

• Headache
• Dizziness
• Dryness in mouth
• Nausea
• Abdominal pain
• Constipation
• Flatulence
• Diarrhea

How to use Exium 40 (10)

• Take this medicine in the dose and duration as advised by your doctor. Swallow it as a whole. Do not chew, crush or break it. Exium 40 (10) is to be taken empty stomach.

How Exium 40 (10) works

• Exium 40 (10) is a proton pump inhibitor (PPI). It works by reducing the amount of acid in the stomach which helps in relief of acid related indigestion and heartburn.

What if you forget to take Exium 40 (10)?

• If you miss a dose of Exium 40 (10), take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular schedule. Do not double the dose.

Quick Tips

• It is a well-tolerated medicine and provides relief for a long time.
• Avoid eating late at night or before bedtime.
• Inform your doctor if you get watery diarrhea, fever or stomach pain that does not go away.
• Long-term use of Exium 40 (10) can cause weak bones and a deficiency of minerals such as magnesium. Take adequate dietary intake of calcium and magnesium or their supplements as prescribed by your doctor.
• Consult your doctor right away if you develop decreased urination, edema (swelling due to fluid retention), lower back pain, nausea, fatigue, and rash or fever. These could be signs of a kidney problem.

Brief Description

Indication

• Heartburn, Acid Related Dyspepsia, Peptic ulcer disease, Zollinger-Ellison syndrome, Gastroesophageal reflux disease (GERD), Helicobacter pylori infection, Erosive Esophagitis, Gouty arthritis, Duodenal and Gastric Ulcer.

Administration

• Delayed-release cap: Should be taken on an empty stomach. Take on an empty stomach 1 hr before meals. Tab: May be taken with or without food.

Adult Dose

• GERD Without Erosive Esophagitis 20 mg PO qDay for 4 weeks; consider an additional 4 weeks of treatment if symptoms do not resolve completely in the first 4 weeks GERD With Erosive Esophagitis 20-40 mg PO qDay for 4-8 weeks If oral therapy inappropriate or not possible: 20-40 mg qDay IV up to 10 days; switch to PO once patient able to swallow Maintenance: 20 mg PO qDay for up to 6 months Risk Reduction of NSAID-Associated Gastric Ulcer 20-40 mg PO qDay for up to 6 months NSAID-Induced Gastric Ulcer 20 mg PO qDay for 4-8 weeks Zollinger-Ellison Syndrome 80 mg PO divided q12hr (initial); adjust regimen to efficacy; up to 240 mg PO qDay, OR 120 mg PO q12hr administered to patients Elderly: No dosage adjustment needed. Hepatic Impairment Oral administration Mild to moderate (Child-Pugh A/B): No dosage adjustment required Severe (Child-Pugh C): Not to exceed 20 mg/day

Child Dose

• GERD Without Erosive Esophagitis Oral <1 year: Safety and efficacy not established 1-12 years: 10-20 mg PO qDay for up to 8 weeks >12 years: 20-40 mg PO qDay for up to 8 weeks GERD With Erosive Esophagitis (Healing) <1 month: Safety and efficacy not established 1 month to 1 year 3.5 kg: 2.5 mg PO qDay for up to 6 weeks >3.5-7.5 kg: 5 mg PO qDay for up to 6 weeks >7.5 kg: 10 mg PO qDay for up to 6 weeks 1-12 years <20 kg: 10 mg PO qDay for 8 weeks >20 kg: 10-20 mg qDay for 8 weeks >12 years 20-40 mg PO qDay for 4-8 weeks Maintenance: 20 mg PO qDay up to 6 months

Renal Dose

• Renal impairment: No dosage adjustment needed.

Contraindication

• Esomeprazole is contraindicated in patients with known hypersensitivity to any component of the formulation or to substituted Benzimidazoles.

Mode of Action

• Esomeprazole is a PPI that suppresses gastric acid secretion by inhibiting H+/K+ ATPase in the gastric parietal cell. It is the S-isomer of omeprazole.

Precaution

• Paediatric; pregnancy, lactation. Malignancy and hepatic impairment. Increased risk of developing certain infections such as community-acquired pneumonia. For patients with severe liver impairment, a dose of 20 mg should not be exceeded. Lactation Risk Summary Esomeprazole is the S-isomer of omeprazole and limited data suggest that omeprazole may be present in human milk. There are no clinical data on the effects of esomeprazole on the breastfed infant or on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Esomeprazole and any potential adverse effects on the breastfed infant from Esomeprazole or from the underlying maternal condition.

Side Effect

• >10% Headache (2-11%) 1-10% Flatulence (10%),Indigestion (6%),Nausea (6%),Abdominal pain (1-6%),Diarrhea (2-4%),Xerostomia (3-4%),Dizziness (2-3%),Constipation (2-3%),Somnolence (1-2%),Pruritus (1%) <1% Blood and lymphatic system disorders: Agranulocytosis, pancytopenia Blurred vision, GI disorders: Pancreatitis, stomatitis, microscopic colitis Hepatobiliary disorders: Hepatic failure, hepatitis with or without jaundice Anaphylactic reaction/shock GI candidiasis Hypomagnesemia Musculoskeletal disorders: Muscular weakness, myalgia, bone fracture Nervous system disorders: Hepatic encephalopathy, taste disturbance Psychiatric disorders: Aggression, agitation, depression, hallucination Interstitial nephritis Gynecomastia Bronchospasm Skin and subcutaneous tissue disorders: Alopecia, erythema multiforme, hyperhidrosis, photosensitivity, Stevens-Johnson syndrome, toxic epidermal necrolysis (sometimes fatal fatal)

Pregnancy Category Note

• Pregnancy There are no adequate and well-controlled studies in pregnant women; esomeprazole is the S-isomer of omeprazole; available epidemiologic data fail to demonstrate an increased risk of major congenital malformations or other adverse pregnancy outcomes with first trimester omeprazole use; reproduction studies in rats and rabbits resulted in dose-dependent embryo-lethality at omeprazole doses that were approximately 3.4 to 34 times an oral human dose of 40 mg (based on a body surface area for a 60 kg person) Lactation Esomeprazole is the S-isomer of omeprazole and limited data suggest that omeprazole may be present in human milk; there are no clinical data on effects of esomeprazole on breastfed infant or on milk production; developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on breastfed infant from treatment or from underlying maternal condition

Interaction

• Increased risk of digoxin-induced cardiotoxic effects. Increased risk of hypomagnesaemia w/ diuretics. May increase INR and prothrombin time w/ warfarin. May increase serum concentration of tacrolimus, saquinavir, methotrexate. May interfere the elimination of drugs metabolised by CYP2C19 (e.g. diazepam). May decrease the bioavailability of ketoconazole, erlotinib and Fe salts. Potentially Fatal: May decrease serum concentration and pharmacological effects of rilpivirine, atazanavir and nelfinavir. May decrease the antiplatelet effects of clopidogrel.