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ESOMEPRAZOLE 40 MG TABLETS,NEXIUM 40 MG TABLETS - patient leaflet, side effects, dosage

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Patient leaflet - ESOMEPRAZOLE 40 MG TABLETS,NEXIUM 40 MG TABLETS

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly in UK via the Yellow Card Scheme at: or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

6. Contents of the pack and other information

  • Each gastro-resistant tablet contains 40mg of the active ingredient, esomeprazole (as the magnesium trihydrate).
  • Nexium also contain the following inactive ingredients: glyceryl monostearate 40–55, hyprolose, hypromellose, magnesium stearate, methacrylic acid ethyl acrylate copolymer (1:1) dispersion 30%, microcrystalline cellulose, paraffin synthetic, macrogol, polysorbate 80, crospovidone, sodium stearyl fumarate, sucrose and maize starch microgranules, talc, titanium dioxide (E 171) triethyl citrate, red ferric oxide (E172) and brown iron oxide(E172).

What Nexium looks like and contents of the pack

Nexium is a pink oval film-coated tablet marked ‘A El’ on one side and '40 mg’ on the other.

Nexium is available as blister packs containing 14 or 28 tablets.

Product Licence holder

Procured from within the EU and repackaged by the Product Licence holder: S&M Medical Ltd, Chemilines House, Alperton Lane, Wembley, HAO 1DX.

Manufacturer

This product is manufactured by AstraZeneca AB, S-151 85 Sodertalje, Sweden.

| POM | PL: 19488/1210

Leaflet revision date: 01 August 2019

Blind or partially sighted? Is this leaflet hard to see or read? Call 02087997607 to obtain the leaflet in large print, tape, CD or Braille.

Nexium® is a registered trade mark of AstraZeneca AB, Sweden.

S1210 LEAFLET Nexium 20190801

5. how to store nexium

. KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.

  • Nexium should not be stored above 30°C. Store in the original package to protect it from moisture.
  • Do not use after the expiry date printed on the carton label or blister strip.
  • If the medicine becomes discoloured or shows any other signs of deterioration, you should seek the advice of your pharmacist who will tell you what to do
  • Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer required. These measures will help to protect the environment.

2.

What you need to know before you take Nexium

PACKAGE LEAFLET: INFORMATION FOR THE USER NEXIUM® 40mg TABLETS (esomeprazole magnesium)

The name of your medicine is Nexium " 40mg Tablets but will be referred to as Nexium throughout the following leaflet.

Information for other strength of Nexium (Nexium 20mg Tablets) also may be present in this leaflet.

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

  • 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
  • If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

  • 1. What Nexium is and what it is used for

  • 2. What you need to know before you take Nexium

  • 3. How to take Nexium

  • 4. Possible side effects

  • 5. How to store Nexium

  • 6. Contents of the pack and other information

1. 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’. They work by reducing the amount of acid that your stomach produces.

Nexium is used to treat the following conditions:

Adults

  • ‘Gastroesophageal reflux disease’ (GERD). This is where acid from the stomach escapes into the gullet (the tube which connects your throat to your stomach) causing pain, inflammation and heartburn.
  • Ulcers in the stomach or upper part of the gut (intestine) that are infected with bacteria called ‘Helicobacter pylori’. If you have this condition, your doctor may also prescribe antibiotics to treat the infection and allow the ulcer to heal.
  • Stomach ulcers caused by medicines called NSAIDs (Non-Steroidal Anti-Inflammatory Drugs). Nexium can also be used to stop stomach ulcers from forming if you are taking NSAIDs.
  • Too much acid in the stomach caused by a growth in the pancreas (Zollinger-Ellison syndrome).
  • Prolonged treatment after prevention of rebleeding of ulcers with intravenous Nexium.

Adolescents aged 12 years and above

  • ‘Gastroesophageal reflux disease’ (GERD). This is where acid from the stomach escapes into the gullet (the tube which connects your throat to your stomach) causing pain, inflammation and heartburn.
  • Ulcers in the stomach or upper part of the gut (intestine) that are infected with bacteria called ‘Helicobacter pylori’. If you have this condition, your doctor may also prescribe antibiotics to treat the infection and allow the ulcer to heal.

Do not take Nexium:

  • If you are allergic to esomeprazole or any of the other ingredients of this medicine (listed in section 6).
  • If you are allergic to other proton pump inhibitor medicines (e.g. pantoprazole, lansoprazole, rabeprazole, omeprazole).
  • If you are taking a medicine containing nelfinavir (used to treat HIV infection).

Do not take Nexium if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Nexium.

Warnings and precautions

Talk to your doctor or pharmacist before taking Nexium:

  • If you have severe liver problems.
  • If you have severe kidney problems.
  • If you have ever had a skin reaction after treatment with a medicine similar to Nexium that reduces stomach acid.
  • If you are due to have a specific blood test (Chromogranin A).

Nexium may hide the symptoms of other diseases. Therefore, if any of the following happen to you before you start taking Nexium or while you are taking it, talk to your doctor straight away:

  • You lose a lot of weight for no reason and have problems swallowing.
  • You get stomach pain or indigestion.
  • You begin to vomit food or blood.
  • You pass black stools (blood-stained faeces).

If you have been prescribed Nexium “on demand” you should contact your doctor if your symptoms continue or change in character.

Taking a proton pump inhibitor like Nexium, especially over a period of more than one year, may slightly increase your risk of fracture in the hip, wrist or spine. Tell your doctor if you have osteoporosis or if you are taking corticosteroids (which can increase the risk of osteoporosis).

If you get a rash on your skin, especially in areas exposed to the sun tell your doctor as soon as you can, as you may need to stop your treatment with Nexium. Remember to also mention any other ill-effects like pain in your joints.

Children under the age of 12 years

Information on dosing for children aged 1 to 11 years is provided in Nexium sachet product information (ask your doctor or pharmacist if you require further information).

Other medicines and Nexium

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines that you buy without a prescription. This is because Nexium can affect the way some medicines work and some medicines can have an effect on Nexium.

Do not take Nexium Tablets if you are taking a medicine containing nelfinavir (used to treat HIV infection).

Tell your doctor or pharmacist if you are taking any of the following medicines:

  • Atazanavir (used to treat HIV infection).
  • Clopidogrel (used to prevent blood clots).

The following information is intended for healthcare professionals only:

Administration through gastric tube

  • 1. Put the tablet into an appropriate syringe and fill the syringe with approximately 25 ml water and approximately 5 ml air. For some tubes, dispersion in 50 ml water is needed to prevent the pellets from clogging the tube.

  • 2. Immediately shake the syringe for approximately 2 minutes to disperse the tablet.

  • 3. Hold the syringe with the tip up and check that the tip has not clogged.

  • 4. Attach the syringe to the tube whilst maintaining the above position.

  • 5. Shake the syringe and position it with the tip pointing down. Immediately inject 5 – 10 ml into the tube. Invert the syringe after injection and shake (the syringe must be held with the tip pointing up to avoid clogging of the tip)

  • Ketoconazole, itraconazole or voriconazole (used to treat infections caused by a fungus).
  • Erlotinib (used to treat cancer).
  • Citalopram, imipramine or clomipramine (used to treat depression).
  • Diazepam (used to treat anxiety, relax muscles or in epilepsy).
  • Phenytoin (used in epilepsy). If you are taking phenytoin, your doctor will need to monitor you when you start or stop taking Nexium.
  • Medicines that are used to thin your blood, such as warfarin. Your doctor may need to monitor you when you start or stop taking Nexium.
  • Cilostazol (used to treat intermittent claudication – a pain in your legs when you walk which is caused by an insufficient blood supply).
  • Cisapride (used for indigestion and heartburn).
  • Digoxin (used for heart problems).
  • Methotrexate (a chemotherapy medicine used in high doses to treat cancer) – if you are taking a high dose of methotrexate, your doctor may temporarily stop your Nexium treatment.
  • Tacrolimus (organ transplantation).
  • Rifampicin (used for treatment of tuberculosis).
  • St. John’s wort (Hypericum perforatum) (used to treat depression).

If your doctor has prescribed the antibiotics amoxicillin and clarithromycin as well as Nexium to treat ulcers caused by Helicobacter pylori infection, it is very important that you tell your doctor about any other medicines you are taking.

Nexium with food and drink

You can take your tablets with food or on an empty stomach.

Pregnancy, breast-feeding and fertility

If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Your doctor will decide whether you can take Nexium during this time. It is not known if Nexium passes into breast milk. Therefore, you should not take Nexium if you are breastfeeding.

Driving and using machines

Nexium is not likely to affect you being able to drive or use any tools or machines. However, side effects such as dizziness and blurred vision may uncommonly or rarely occur (see section 4). If affected, you should not drive or use machines.

Nexium contains sucrose

Nexium contains sugar spheres which contain sucrose, a type of sugar. If you have been told by your doctor that you have an intolerance to some sugars, talk to your doctor before taking this medicine.

3. how to take nexium

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

  • If you are taking this medicine for a long time, your doctor will want to monitor you (particularly if you are taking it for more than a year).
  • If your doctor has told you to take this medicine as and when you need it, tell your doctor if your symptoms change.

How much to take

  • Your doctor will tell you how many tablets to take and how long to take them for. This will depend on your condition, how old you are and how well your liver works.
  • The recommended doses are given below.

Use in adults aged 18 and above

To treat heartburn caused by gastroesophageal reflux disease (GERD):

  • If your doctor has found that your food pipe (gullet) has been slightly damaged, the recommended dose is one Nexium 40 mg gastro-resistant tablet once a day for 4 weeks. Your doctor may tell you to take the same dose for a further 4 weeks if your gullet has not yet healed.
  • The recommended dose once the gullet has healed is one Nexium 20 mg gastro-resistant tablet once a day
  • If your gullet has not been damaged, the recommended dose is one Nexium 20 mg gastro-resistant tablet each day. Once the condition has been controlled, your doctor may tell you to take your medicine as and when you need it, up to a maximum of one Nexium 20 mg gastro-resistant tablet each day.
  • If you have severe liver problems, your doctor may give you a lower dose.

To treat ulcers caused by

  • The recommended dose is one Nexium 20 mg gastro-resistant tablet twice a day for one week.
  • Your doctor will also tell you to take antibiotics for example amoxicillin and clarithromycin.

To treat stomach ulcers caused by NSAIDs (Non-Steroidal Anti-Inflammatory Drugs):

  • The recommended dose is one Nexium 20 mg gastro-resistant tablet once a day for 4 to 8 weeks.

To prevent stomach ulcers if you are taking NSAIDs (Non-Steroidal Anti-Inflammatory Drugs):

  • The recommended dose is one Nexium 20 mg gastro-resistant tablet once a day.

To treat too much acid in the stomach caused by a growth in the pancreas (Zollinger-Ellison syndrome):

  • The recommended dose is Nexium 40 mg twice a day.
  • Your doctor will adjust the dose depending on your needs and will also decide how long you need to take the medicine for. The maximum dose is 80 mg twice a day.

Prolonged treatment after prevention of re-bleeding of ulcers with intravenous Nexium:

  • The recommended dose is one Nexium 40 mg tablet once a day for 4 weeks.

Use in adolescents aged 12 or above

To treat heartburn caused by gastroesophageal reflux disease (GERD):

  • If your doctor has found that your food pipe (gullet) has been slightly damaged, the recommended dose is one Nexium 40 mg gastro-resistant tablet once a day for 4 weeks. Your doctor may tell you to take the same dose for a further 4 weeks if your gullet has not yet healed.

  • 6. Turn the syringe with the tip down and immediately inject another 5 – 10 ml into the tube. Repeat this procedure until the syringe is empty.

  • 7. Fill the syringe with 25 ml of water and 5 ml of air and repeat step 5 if necessary to wash down any sediment left in the syringe. For some tubes, 50 ml water is needed.


  • The recommended dose once the gullet has healed is one Nexium 20 mg gastro-resistant tablet once a day.
  • If your gullet has not been damaged, the recommended dose is one Nexium 20 mg gastro-resistant tablet each day.
  • If you have severe liver problems, your doctor may give you a lower dose.

To treat ulcers caused by

  • The recommended dose is one Nexium 20 mg gastro-resistant tablet twice a day for one week.
  • Your doctor will also tell you to take antibiotics for example amoxicillin and clarithromycin.

Taking this medicine

  • You can take your tablets at any time of the day.
  • You can take your tablets with food or on an empty stomach.
  • Swallow your tablets whole with a drink of water. Do not chew or crush the tablets. This is because the tablets contain coated pellets which stop the medicine from being broken down by the acid in your stomach. It is important not to damage the pellets.

What to do if you have trouble swallowing the tablets

  • If you have trouble swallowing the tablets:

Put them into a glass of still (non-fizzy) water. Do not use any other liquids.

Stir until the tablets break up (the mixture will not be clear). Then drink the mixture straight away or within 30 minutes. Always stir the mixture just before drinking it.

To make sure that you have drunk all of the medicine, rinse the glass very well with half a glass of water and drink it. The solid pieces contain the medicine – do not chew or crush them.

  • If you cannot swallow at all, the tablet can be mixed with some water and put into a syringe. It can then be given to you through a tube directly into your stomach (‘gastric tube’).

Use in children under the age of 12 years

Nexium gastro-resistant tablets are not recommended for children less than 12 years old. Information on dosing for children aged 1 to 11 years is provided in Nexium sachet product information (ask your doctor or pharmacist if you require further information).

Elderly

Dose adjustment is not required in the elderly.

If you take more Nexium than you should

If you take more Nexium than prescribed by your doctor, talk to your doctor or pharmacist straight away.

If you forget to take Nexium

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly in UK via the Yellow Card Scheme at: or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

6. Contents of the pack and other information

  • Each gastro-resistant tablet contains 40mg of the active ingredient, esomeprazole (as the magnesium trihydrate).
  • Esomeprazole Tablets also contain the following inactive ingredients: glyceryl monostearate 40–55, hyprolose, hypromellose, magnesium stearate, methacrylic acid ethyl acrylate copolymer (1:1) dispersion 30%, microcrystalline cellulose, paraffin synthetic, macrogol, polysorbate 80, crospovidone, sodium stearyl fumarate, sucrose and maize starch microgranules, talc, titanium dioxide (E 171) triethyl citrate, red ferric oxide (E172) and brown iron oxide(E172).

What Esomeprazole Tablets look like and contents of the pack

Esomeprazole Tablets are pink oval film-coated tablet marked ‘A El’ on one side and '40 mg’ on the other.

Esomeprazole Tablets are available as blister packs containing 14 or 28 tablets.

Product Licence holder

Procured from within the EU and repackaged by the Product Licence holder: S&M Medical Ltd, Chemilines House, Alperton Lane, Wembley, HAO 1DX.

Manufacturer

This product is manufactured by AstraZeneca AB, S-151 85 Sodertalje, Sweden.

| POM | PL: 19488/1210

Leaflet revision date: 01 August 2019

Blind or partially sighted? Is this leaflet hard to see or read? Call 02087997607 to obtain the leaflet in large print, tape, CD or Braille.

S1210 LEAFLET Esomeprazole 20190801

5.

How to store Esomeprazole Tablets


. KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.

  • Esomeprazole Tablets should not be stored above 30°C. Store in the original package to protect it from moisture.
  • Do not use after the expiry date printed on the carton label or blister strip.
  • If the medicine becomes discoloured or shows any other signs of deterioration, you should seek the advice of your pharmacist who will tell you what to do
  • Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer required. These measures will help to protect the environment.

S1210 LEAFLET Esomeprazole 20190801

PACKAGE LEAFLET: INFORMATION FOR THE USER

ESOMEPRAZOLE 40mg TABLETS (esomeprazole magnesium)

The name of your medicine is Esomeprazole 40mg Tablets but will be referred to as Esomeprazole Tablets throughout the following leaflet.

Information for other strength of Esomeprazole Tablets (Esomeprazole 20mg Tablets) also may be present in this leaflet.

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

  • 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
  • If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

  • 1. What Esomeprazole Tablets are and what they are used for

  • 2. What you need to know before you take Esomeprazole Tablets

  • 3. How to take Esomeprazole Tablets

  • 4. Possible side effects

  • 5. How to store Esomeprazole Tablets

  • 6. Contents of the pack and other information

1. What Esomeprazole Tablets are and what they are used for

Esomeprazole Tablets contain a medicine called esomeprazole. This belongs to a group of medicines called ‘proton pump inhibitors’. They work by reducing the amount of acid that your stomach produces.

Esomeprazole Tablets are used to treat the following conditions:

Adults

  • ‘Gastroesophageal reflux disease’ (GERD). This is where acid from the stomach escapes into the gullet (the tube which connects your throat to your stomach) causing pain, inflammation and heartburn.
  • Ulcers in the stomach or upper part of the gut (intestine) that are infected with bacteria called ‘Helicobacter pylori’. If you have this condition, your doctor may also prescribe antibiotics to treat the infection and allow the ulcer to heal.
  • Stomach ulcers caused by medicines called NSAIDs (Non-Steroidal Anti-Inflammatory Drugs). Esomeprazole Tablets can also be used to stop stomach ulcers from forming if you are taking NSAIDs.
  • Too much acid in the stomach caused by a growth in the pancreas (Zollinger-Ellison syndrome).
  • Prolonged treatment after prevention of rebleeding of ulcers with intravenous Esomeprazole Tablets.

Adolescents aged 12 years and above

  • ‘Gastroesophageal reflux disease’ (GERD). This is where acid from the stomach escapes into the gullet (the tube which connects your throat to your stomach) causing pain, inflammation and heartburn.
  • Ulcers in the stomach or upper part of the gut (intestine) that are infected with bacteria called ‘Helicobacter pylori’. If you have this condition, your doctor may also prescribe antibiotics to treat the infection and allow the ulcer to heal.

2. what you need to know before you take esomeprazole tablets

Do not take Esomeprazole Tablets:

  • If you are allergic to esomeprazole or any of the other ingredients of this medicine (listed in section 6).
  • If you are allergic to other proton pump inhibitor medicines (e.g. pantoprazole, lansoprazole, rabeprazole, omeprazole).
  • If you are taking a medicine containing nelfinavir (used to treat HIV infection).

Do not take Esomeprazole Tablets if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Esomeprazole Tablets.

Warnings and precautions

Talk to your doctor or pharmacist before taking Esomeprazole Tablets:

  • If you have severe liver problems.
  • If you have severe kidney problems.
  • If you have ever had a skin reaction after treatment with a medicine similar to Esomeprazole Tablets that reduces stomach acid.
  • If you are due to have a specific blood test (Chromogranin A).

Esomeprazole Tablets may hide the symptoms of other diseases.

Therefore, if any of the following happen to you before you start taking Esomeprazole Tablets or while you are taking it, talk to your doctor straight away:

  • You lose a lot of weight for no reason and have problems swallowing.
  • You get stomach pain or indigestion.
  • You begin to vomit food or blood.
  • You pass black stools (blood-stained faeces).

If you have been prescribed Esomeprazole Tablets “on demand” you should contact your doctor if your symptoms continue or change in character.

Taking a proton pump inhibitor like Esomeprazole Tablets, especially over a period of more than one year, may slightly increase your risk of fracture in the hip, wrist or spine. Tell your doctor if you have osteoporosis or if you are taking corticosteroids (which can increase the risk of osteoporosis).

If you get a rash on your skin, especially in areas exposed to the sun tell your doctor as soon as you can, as you may need to stop your treatment with Esomeprazole Tablets. Remember to also mention any other ill-effects like pain in your joints.

Children under the age of 12 years

Information on dosing for children aged 1 to 11 years is provided in Esomeprazole Tablets sachet product information (ask your doctor or pharmacist if you require further information).

Other medicines and Esomeprazole Tablets

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines that you buy without a prescription. This is because Esomeprazole Tablets can affect the way some medicines work and some medicines can have an effect on Esomeprazole Tablets.

Do not take Esomeprazole Tablets if you are taking a medicine containing nelfinavir (used to treat HIV infection).

The following information is intended for healthcare professionals only:

Administration through gastric tube

  • 1. Put the tablet into an appropriate syringe and fill the syringe with approximately 25 ml water and approximately 5 ml air. For some tubes, dispersion in 50 ml water is needed to prevent the pellets from clogging the tube.

  • 2. Immediately shake the syringe for approximately 2 minutes to disperse the tablet.

  • 3. Hold the syringe with the tip up and check that the tip has not clogged.

  • 4. Attach the syringe to the tube whilst maintaining the above position.

Tell your doctor or pharmacist if you are taking any of the following medicines:

  • Atazanavir (used to treat HIV infection).
  • Clopidogrel (used to prevent blood clots).
  • Ketoconazole, itraconazole or voriconazole (used to treat infections caused by a fungus).
  • Erlotinib (used to treat cancer).
  • Citalopram, imipramine or clomipramine (used to treat depression).
  • Diazepam (used to treat anxiety, relax muscles or in epilepsy).
  • Phenytoin (used in epilepsy). If you are taking phenytoin, your doctor will need to monitor you when you start or stop taking Esomeprazole Tablets.
  • Medicines that are used to thin your blood, such as warfarin. Your doctor may need to monitor you when you start or stop taking Esomeprazole Tablets.
  • Cilostazol (used to treat intermittent claudication – a pain in your legs when you walk which is caused by an insufficient blood supply).
  • Cisapride (used for indigestion and heartburn).
  • Digoxin (used for heart problems).
  • Methotrexate (a chemotherapy medicine used in high doses to treat cancer) – if you are taking a high dose of methotrexate, your doctor may temporarily stop your Esomeprazole Tablets treatment.
  • Tacrolimus (organ transplantation).
  • Rifampicin (used for treatment of tuberculosis).
  • St. John’s wort (Hypericum perforatum) (used to treat depression).

If your doctor has prescribed the antibiotics amoxicillin and clarithromycin as well as Esomeprazole Tablets to treat ulcers caused by Helicobacter pylori infection, it is very important that you tell your doctor about any other medicines you are taking.

Esomeprazole Tablets with food and drink

You can take your tablets with food or on an empty stomach.

Pregnancy, breast-feeding and fertility

If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Your doctor will decide whether you can take Esomeprazole Tablets during this time. It is not known if Esomeprazole Tablets passes into breast milk. Therefore, you should not take Esomeprazole Tablets if you are breastfeeding.

Driving and using machines

Esomeprazole Tablets are not likely to affect you being able to drive or use any tools or machines. However, side effects such as dizziness and blurred vision may uncommonly or rarely occur (see section 4). If affected, you should not drive or use machines.

Esomeprazole Tablets contain sucrose

Esomeprazole Tablets contain sugar spheres which contain sucrose, a type of sugar. If you have been told by your doctor that you have an intolerance to some sugars, talk to your doctor before taking this medicine.

3. how to take esomeprazole tablets

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

  • If you are taking this medicine for a long time, your doctor will want to monitor you (particularly if you are taking it for more than a year).
  • If your doctor has told you to take this medicine as and when you need it, tell your doctor if your symptoms change.

How much to take

  • Your doctor will tell you how many tablets to take and how long to take them for. This will depend on your condition, how old you are and how well your liver works.
  • The recommended doses are given below.

Use in adults aged 18 and above

To treat heartburn caused by gastroesophageal reflux disease (GERD):

  • If your doctor has found that your food pipe (gullet) has been slightly damaged, the recommended dose is one Esomeprazole 40 mg gastro-resistant tablet once a day for 4 weeks. Your doctor may tell you to take the same dose for a further 4 weeks if your gullet has not yet healed.
  • The recommended dose once the gullet has healed is one Esomeprazole 20 mg gastro-resistant tablet once a day
  • If your gullet has not been damaged, the recommended dose is one Esomeprazole 20 mg gastro-resistant tablet each day. Once the condition has been controlled, your doctor may tell you to take your medicine as and when you need it, up to a maximum of one Esomeprazole 20 mg gastro-resistant tablet each day.
  • If you have severe liver problems, your doctor may give you a lower dose.

To treat ulcers caused by

  • The recommended dose is one Esomeprazole 20 mg gastro-resistant tablet twice a day for one week.
  • Your doctor will also tell you to take antibiotics for example amoxicillin and clarithromycin.

To treat stomach ulcers caused by NSAIDs (Non-Steroidal Anti-Inflammatory Drugs):

  • The recommended dose is one Esomeprazole 20 mg gastro-resistant tablet once a day for 4 to 8 weeks.

To prevent stomach ulcers if you are taking NSAIDs (Non-Steroidal Anti-Inflammatory Drugs):

  • The recommended dose is one Esomeprazole 20 mg gastro-resistant tablet once a day.

To treat too much acid in the stomach caused by a growth in the pancreas (Zollinger-Ellison syndrome):

  • The recommended dose is Esomeprazole 40 mg twice a day.
  • Your doctor will adjust the dose depending on your needs and will also decide how long you need to take the medicine for. The maximum dose is 80 mg twice a day.

Prolonged treatment after prevention of re-bleeding of ulcers with intravenous Esomeprazole Tablets:

  • The recommended dose is one Esomeprazole 40 mg tablet once a day for 4 weeks.

Use in adolescents aged 12 or above

To treat heartburn caused by gastroesophageal reflux disease (GERD):

  • If your doctor has found that your food pipe (gullet) has been slightly damaged, the recommended dose is one Esomeprazole 40 mg gastro-resistant tablet once a day for 4 weeks. Your doctor may tell you to take the same dose for a further 4 weeks if your gullet has not yet healed.

  • 5. Shake the syringe and position it with the tip pointing down. Immediately inject 5 – 10 ml into the tube. Invert the syringe after injection and shake (the syringe must be held with the tip pointing up to avoid clogging of the tip)

  • 6. Turn the syringe with the tip down and immediately inject another 5 – 10 ml into the tube. Repeat this procedure until the syringe is empty.

  • 7. Fill the syringe with 25 ml of water and 5 ml of air and repeat step 5 if necessary to wash down any sediment left in the syringe. For some tubes, 50 ml water is needed.

  • The recommended dose once the gullet has healed is one Esomeprazole 20 mg gastro-resistant tablet once a day.
  • If your gullet has not been damaged, the recommended dose is one Esomeprazole 20 mg gastro-resistant tablet each day.
  • If you have severe liver problems, your doctor may give you a lower dose.

To treat ulcers caused by

  • The recommended dose is one Esomeprazole 20 mg gastro-resistant tablet twice a day for one week.
  • Your doctor will also tell you to take antibiotics for example amoxicillin and clarithromycin.

Taking this medicine

  • You can take your tablets at any time of the day.
  • You can take your tablets with food or on an empty stomach.
  • Swallow your tablets whole with a drink of water. Do not chew or crush the tablets. This is because the tablets contain coated pellets which stop the medicine from being broken down by the acid in your stomach. It is important not to damage the pellets.

What to do if you have trouble swallowing the tablets

  • If you have trouble swallowing the tablets:

Put them into a glass of still (non-fizzy) water. Do not use any other liquids.

Stir until the tablets break up (the mixture will not be clear). Then drink the mixture straight away or within 30 minutes. Always stir the mixture just before drinking it.

To make sure that you have drunk all of the medicine, rinse the glass very well with half a glass of water and drink it. The solid pieces contain the medicine – do not chew or crush them.

  • If you cannot swallow at all, the tablet can be mixed with some water and put into a syringe. It can then be given to you through a tube directly into your stomach (‘gastric tube’).

Use in children under the age of 12 years

Esomeprazole gastro-resistant tablets are not recommended for children less than 12 years old. Information on dosing for children aged 1 to 11 years is provided in Esomeprazole Tablets sachet product information (ask your doctor or pharmacist if you require further information).

Elderly

Dose adjustment is not required in the elderly.

If you take more Esomeprazole Tablets than you should

If you take more Esomeprazole Tablets than prescribed by your doctor, talk to your doctor or pharmacist straight away.

If you forget to take Esomeprazole Tablets

  • If you forget to take a dose, take it as soon as you remember it. However, if it is almost time for your next dose, skip the missed dose.
  • Do not take a double dose (two doses at the same time) to make up for a forgotten dose.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you notice any of the following serious side effects, stop taking Esomeprazole Tablets and contact a doctor immediately:

  • Sudden wheezing, swelling of your lips, tongue and throat or body, rash, fainting or difficulties in swallowing (severe allergic reaction).
  • Reddening of the skin with blisters or peeling. There may also be severe blisters and bleeding in the lips, eyes, mouth, nose and genitals. This could be ‘Stevens-Johnson syndrome’ or ‘toxic epidermal necrolysis’.
  • Yellow skin, dark urine and tiredness which can be symptoms of liver problems.

These effects are rare, and may affect up to 1 in 1,000 people.

Other side effects include:

Common (may affect up to 1 in 10 people)

  • Headache.
  • 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 Esomeprazole Tablets are 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. This can cause weakness, bruising or make infections more likely.
  • Low levels of sodium in the blood. This may cause weakness, being sick (vomiting) and cramps.
  • 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.
  • Liver problems, including jaundice which can cause yellow skin, dark urine, and tiredness.
  • Hair loss (alopecia).
  • Skin rash on exposure to sunshine.
  • Joint pains (arthralgia) or muscle pains (myalgia).
  • Generally feeling unwell and lacking energy.
  • Increased sweating.

Sources: Original (products.mhra.gov.uk)