Nexium
Nexium 10 mg gastro-resistant granules for oral suspension, sachet
Esomeprazole
Read all of this leaflet carefully before you start taking this medicine.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
- 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.
In this leaflet:
- 1. What Nexium is and what it is used for
- 2. Before you take Nexium
- 3. How to take Nexium
- 4. Possible side effects
- 5. How to store Nexium
- 6. Further information
What Nexium Is And What It Is Used For
Nexium contains a medicine 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 a condition called “gastro-oesophageal reflux disease”.
- This is where acid from the stomach escapes into the gullet (oesophagus) 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.
Before You Take Nexium
Do not take Nexium
- if you are allergic (hypersensitive) to esomeprazole or other similar proton pump inhibitors, or any other ingredients in Nexium gastro-resistant granules
- if you are taking a medicine containing nelfinavir (used to treat HIV).
Take special care with Nexium
- if you have liver problems, you should talk to your doctor as he or she might want to prescribe a lower dose.
- if you have kidney problems, you should discuss this with your doctor.
Nexium may hide the symptoms of other diseases. Therefore, if any of the following happen to you while you are taking Nexium, you should talk to your doctor immediately:
- You lose a lot of weight for no reason.
- You get stomach pain or indigestion.
- You begin to vomit repeatedly.
- You have problems swallowing.
- You vomit blood or pass black (blood-stained) motions (faeces).
If you have been prescribed Nexium “on demand” you should contact your doctor if the symptoms are persistent or change character. “On demand” treatment has not been investigated in children and is therefore not recommended in this patient group.
Taking other medicines
Please tell your doctor or pharmacist if you are taking, or have recently taken, any other medicines including medicines obtained without a prescription. Nexium can affect the way some other medicines work and some medicines can have an effect on Nexium.
In particular, tell your doctor or pharmacist if you are taking any of the following medicines:
- Atazanavir (used to treat HIV). Do not take Nexium if you are taking nelfinavir.
- Ketoconazole, itraconazole or voriconazole (used to treat infections caused by a fungus).
- Diazepam (used to treat anxiety or relax muscles).
- Citalopram, imipramine or clomipramine (used to treat depression).
- Phenytoin (used in epilepsy).
- Warfarin or coumarin (medicines called anticoagulants that are used to thin your blood).
- Cisapride (used for indigestion and heartburn).
- Clarithromycin (used to treat infections).
Taking Nexium gastro-resistant granules with food and drink
Nexium gastro-resistant granules can be taken with or without food.
Pregnancy and breast-feeding
Before taking Nexium, ask your doctor or pharmacist for advice if you are pregnant or trying to become pregnant. Your doctor will assess whether you can take Nexium during this time. Nexium should not be used during breast-feeding.
Driving and using machines
Nexium is not likely to affect you being able to drive or use tools or machines.
Important information about some of the ingredients of Nexium
Nexium contains sucrose and glucose which both are types of sugars. Careful oral hygiene and regular tooth brushing are therefore important.
If you have been told by your doctor, that you have an intolerance to some sugars, contact your doctor before taking Nexium.
How To Take Nexium
Always take Nexium exactly as your doctor has told you. You should 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 and when to take them. 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.
Children
- Nexium must not be given to children younger than 1 year or with a body weight lower than 10 kg.
- Children aged between 1 and 11 years may take Nexium. The usual 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.
Adults and young people aged 12 and older
The usual dose is two sachets (20 mg) or four sachets (40 mg) once daily.
Older people
There is no need to alter the dose if you are elderly.
People with liver or kidney 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.
- 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, Nexium 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 (affects less than 1 in 10 people)
- Headache.
- Effects on your stomach or gut: stomach pain, constipation, diarrhoea, wind (flatulence).
- Feeling sick (nausea) or being sick (vomiting).
Uncommon (affects less than 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.
Rare (affects less than 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 (affects less than 1 in 10,000 people)
- Changes in blood count including agranulocytosis (lack of white blood cells)
- Aggression.
- 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.
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.
Do not be concerned by this list of possible side effects. You may not get any of them. If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
How To Store Nexium
- Keep out of the reach and sight of children.
- Do not use Nexium after the expiry date which is stated on the carton and sachet.
The expiry date refers to the last day of the month. - The reconstituted suspension should be used within 30 minutes.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Further Information
What Nexium gastro-resistant granules for oral suspension contains
The active substance is esomeprazole. Each sachet contains 10 mg of esomeprazole.
The other ingredients are:
Esomeprazole granules:
Glycerol monostearate 40-55
Hydroxypropyl cellulose
Hypromellose
Magnesium stearate
Methacrylic acid – ethyl acrylate copolymer (1:1) 30% dispersion
Polysorbate 80
Sugar spheres (sucrose and maize starch)
Talc
Triethyl citrate
Excipient granules:
Citric acid anhydrous (for pH adjustment)
Crospovidone
Glucose
Hydroxypropyl cellulose
Yellow iron oxide (E172)
Xanthan gum
What Nexium looks like and contents of the pack
Each sachet of Nexium contains pale yellow fine granules. Brownish granules may be visible.
The oral suspension is a thick yellow liquid containing suspended pellets.
Each carton contains 28 sachets.
Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation Holder is
Nexium is manufactured by
To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge:
0800 198 5000 (UK only)
Please be ready to give the following information:
Product name: Nexium Sachet 10 mg
Reference number: 17901/0253
This is a service provided by the Royal National Institute of Blind People.
This medicine is authorised in the Member States of the EEA under the following names: Nexium, Nexiam, Inexium.
Austria (AT): Nexium
Belgium (BE): Nexiam
Cyprus (CY): Nexium
Czech Republic (CZ): Nexium
Denmark (DK): Nexium
Finland (FI): Nexium
France (FR): Inexium
Germany (DE): Nexium
Greece (EL): Nexium
Hungary (HU): Nexium
Iceland (IS): Nexium
Ireland (IE): Nexium
Latvia (LV): Nexium
Lithuania (LT): Nexium
Luxembourg (LU): Nexiam
The Netherlands (NL): Nexium
Norway (NO): Nexium
Poland (PL): Nexium
Portugal (PT): Nexium
Romania (RO): Nexium
Slovakia (SK): Nexium
Slovenia (SL): Nexium
Spain (ES): Nexium
United Kingdom (UK): Nexium
Leaflet prepared: September 2009
GI 08 0047a
© AstraZeneca 2009
Nexium is a trademark of the AstraZeneca group of companies.
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