What Nexium is and what it is used for
Nexium contains a substance called esomeprazole. This belongs to a group of medicines called proton pump inhibitors. These work by reducing the amount of acid that your stomach produces. Nexium is used to treat the following conditions: Children over 1 year of age Nexium is used to treat a condition called “gastroesophageal reflux disease” (GERD).
• This is where acid from the stomach escapes into the gullet (esophagus) causing pain, inflammation and heartburn. Heartburn is a burning feeling rising from the stomach or lower chest up towards the neck.
• In children, the symptoms of the condition can include the return of stomach contents into the mouth (regurgitation), being sick (vomiting) and poor weight gain. Children over 4 years of age
• Ulcers which are infected with bacteria called ‘Helicobacter pylori’. If your child has this condition, your doctor may also prescribe antibiotics to treat the infection and allow the ulcer to heal.
How to take Nexium
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Your medicine comes as granules in individual sachets. Each sachet contains 10 mg of esomeprazole. Your doctor will tell you how many sachets to take each day. He or she will also tell you how long you should take them for.
• Empty the contents of the sachet or sachets into a glass containing some water. Do not use fizzy (carbonated) water. The amount of water depends on the number of sachets that your doctor has told you to take at one time.
• Use 15 millilitres (ml) of water (3 teaspoonfuls) for each sachet. This means that you will need 15 ml for one sachet and 30 ml for two sachets.
• Stir the granules in the water.
• Leave the mixture for a few minutes until it has thickened.
• Stir again and drink the mixture. The granules must not be chewed or crushed. Do not leave the mixture to stand for more than 30 minutes before you drink it.
• If anything remains in the glass, add some more water, stir and drink it immediately. Nexium gastro-resistant granules can be taken with or without food. If you are being fed using a feeding (gastric) tube, your doctor or nurse can give you Nexium through your tube. Information for your doctor or nurse is provided at the end of this leaflet. The recommended doses are given below: Use in children aged 1 to 11 years
• Nexium is not recommended for children younger than 1 year. To treat gastroesophageal reflux disease (GERD)
• The recommended dose is one sachet (10 mg) or two sachets (20 mg) once daily. The dose for children is based on the child’s weight and the doctor will decide the correct dose. Use in children aged 4 years and older To treat ulcers caused by Helicobacter pylori infection and to stop them coming back.
• The dose for children is based on the child’s weight and your doctor will decide the correct dose. The doctor will also prescribe two antibiotics for your child. Use in adults and adolescents Nexium oral suspension may also be used by patients having difficulty swallowing dispersed Nexium gastro-resistant tablets. Information on dosing for patients from the age of 12 years is in Nexium gastro-resistant tablet product information (ask your doctor or pharmacist if you require further information). Elderly There is no need to alter the dose if you are elderly. People with liver problems
• For people with severe liver problems, the maximum daily dose of Nexium is two sachets (20 mg). For children 1-11 years with severe liver problems, a maximum dose of 10 mg should not be exceeded. People with kidney problems
• There are no special dosage restrictions for people with kidney problems. However, if you have severe kidney problems your doctor may decide to carry out regular tests. If you take more Nexium than you should If you have taken more Nexium than prescribed by your doctor, seek medical advice. If you forget to take Nexium If you forget to take a dose, take it as soon as you remember. If it is almost time to take the next dose, wait until then. Do not take a double dose to make up for the forgotten dose. If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Allergic reactions A severe allergic reaction (anaphylaxis) is a rare side effect, affecting less than 1 in 1,000 people taking Nexium. You may notice sudden wheezing, swelling of your face or body, rash, fainting or difficulties in swallowing. If this happens to you, stop taking Nexium and contact a doctor immediately.
Other side effects include:
Common (may affect up to 1 in 10 people)
• Effects on your stomach or gut: diarrhoea, stomach pain, constipation, wind (flatulence).
• Feeling sick (nausea) or being sick (vomiting).
• Benign polyps in the stomach.
Uncommon (may affect up to 1 in 100 people)
• Swelling of the feet and ankles.
• Disturbed sleep (insomnia).
• Dizziness, tingling feelings such as “pins and needles”, feeling sleepy.
• Spinning feeling (vertigo).
• Dry mouth.
• Changes in blood tests that check how the liver is working.
• Skin rash, lumpy rash (hives) and itchy skin.
• Fracture of the hip, wrist or spine (if Nexium is used in high doses and over long duration).
Rare (may affect up to 1 in 1,000 people)
• Blood problems such as a reduced number of white cells or platelets.
• Low levels of sodium in the blood.
• Feeling agitated, confused or depressed.
• Taste changes.
• Eyesight problems such as blurred vision.
• Suddenly feeling wheezy or short of breath (bronchospasm).
• An inflammation of the inside of the mouth.
• An infection called “thrush” which can affect the gut and is caused by a fungus.
• Hepatitis with our without jaundice
• Hair loss (alopecia).
• Skin rash on exposure to sunshine.
• Joint pains (arthralgia) or muscle pains (myalgia).
• Generally feeling unwell and lacking energy.
• Increased sweating.
Very rare (may affect up to 1 in 10,000 people)
• Changes in blood count including agranulocytosis (lack of white blood cells)
• 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.
• Severe kidney problems.
• Enlarged breasts in men.
Not known (frequency cannot be estimated from the available data)
• If you are on Nexium for more than three months it is possible that the levels of magnesium in your blood may fall. Low levels of magnesium can be seen as fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness or increased heart rate. If you get any of these symptoms, please tell your doctor promptly. Low levels of magnesium can also lead to a reduction in potassium or calcium levels in the blood. Your doctor may decide to perform regular blood tests to monitor your levels of magnesium.
• Inflammation in the gut (leading to diarrhoea).
• Rash, possibly with pain in the joints. Nexium 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 medication at this time.
Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine. United Kingdom Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard Ireland HPRA Pharmacovigilance Earlsfort Terrace IRL
•Dublin 2 Tel: +353 1 6764971 Fax: +353 1 6762517 Website: www.hpra.ie e-mail: [email protected] Malta ADR Reporting Website: www.medicinesauthority.gov.mt/adrportal
How to Store Nexium
This medicinal product does not require any special storage conditions.
• Keep out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the carton and sachet after EXP. The expiry date refers to the last day of that month.
• The reconstituted suspension should be used within 30 minutes. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
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