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Esomeprazole

Esomeprazole Tablets contains a medicine called Esomeprazole. This belongs to a group of medicines called ‘proton pump inhibitors’


Generic Name

Esomeprazole


Packing

70


Therapeutic Category

Anti Ulcer


Storage

Store at room temperature (77 degrees F or 25 degrees C) away from light and moisture.


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Product Description

Product Overview


p style=”font-size:18px;color: #9B9D9E;”>What Esomeprazole tablets are and what they are used for

Esomeprazole Tablets 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.
Esomeprazole Tablets is used to treat the following conditions:

Adults and young people aged 12 years and above
‘Gastro-oesophageal reflux disease’ (GORD). 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.

Adults
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 rebreeding of ulcers with intravenous Esomeprazole.

BEFORE YOU TAKE ESOMEPRAZOLE TABLETS

Do not take Esomeprazole Tablets if you

Are allergic (hypersensitive) to Esomeprazole or any of the other ingredients of this medicine.
Are allergic to other proton pump inhibitor medicines.
Are taking a medicine containing nelfinavir (used to treat HIV).
Do not take Esomeprazole Tablets if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking Esomeprazole Tablets.

Take special care with Esomeprazole Tablets
Check with your doctor or pharmacist before taking Esomeprazole Tablets if you:

Have severe liver problems.
Have severe kidney problems.

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:

If you lose a lot of weight for no reason and have problems swallowing.
If you get stomach pain or indigestion.
If you begin to vomit food or blood.

If 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 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. 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).

Tell your doctor or pharmacist if you are taking any of the following
Medicines: Atazanavir (used to treat HIV).
Ketoconazole, itraconazole or voriconazole (used to treat infections caused by a fungus).
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.
Cisapride (used for indigestion and heartburn).

Clopidogrel (used to prevent blood clots (thrombi))

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.

Taking Esomeprazole Tablets with food and drink
You can take your tablets with food or on an empty stomach.

Pregnancy and breast-feeding
Before taking Esomeprazole Tablets tell your doctor if you are pregnant or trying to get pregnant. Ask your doctor or pharmacist for advice before taking any medicine. As a precautionary measure, it is preferable to avoid the use of Esomeprazole Tablets during pregnancy.

It is unknown if Esomeprazole passes into breast milk. Therefore, you should not take Esomeprazole Tablets if you are breast-feeding.

Driving and using machines
Esomeprazole Tablets is not likely to affect you being able to drive or use any tools or machines.

Important information about some of the ingredients of Esomeprazole Tablets
Esomeprazole Tablets contains sucrose and lactose, which are types of sugar. If you have been told by your doctor that you have intolerance to some sugars, talk to your doctor before taking this medicine.

HOW TO TAKE ESOMEPRAZOLE TABLETS

Always take Esomeprazole Tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Esomeprazole 20 mg gastro-resistant tablets are not recommended for the use in children less than 20 kg body weight.

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 Esomeprazole 40 mg gastro-resistant tablets are not indicated for the use in children younger than 12 years.
The experience of treatment with Esomeprazole in infants younger than 1 year is limited and treatment is therefore not recommended.
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.

Method of administration

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
syringe. It can then be given to you through a tube directly into your stomach (‘gastric tube’).

Dosage

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 usual doses are given below.

To treat heartburn caused by gastro-oesophageal reflux disease (GORD): Adult and children aged 12 or above:
If your doctor has found that your food pipe (gullet) has been slightly damaged, the usual 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 usual 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 usual 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 endoscopically proven erosive reflux oesophagitis

Children with body weight 20 kg and above: the usual dose is 10 mg or 20 mg once daily for 8 weeks. (Other Esomeprazole products are available for the treatment at a dose of 10 mg.)

To treat ulcers caused by Helicobacter pylori infection and to stop them coming back:

Adults and young people aged 12 or above: the usual 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):
Adults aged 18 and above: the usual 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):

Adults aged 18 and above: the usual 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):

Adults aged 18 and above: the usual dose is one Esomeprazole 40 mg gastro-resistant tablet 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 rebleeding of ulcers with intravenous Esomeprazole:
The usual dose is one Esomeprazole 40 mg gastro-resistant tablet once a day for 4 weeks.

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. 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 product, ask your doctor or pharmacist.

POSSIBLE SIDE EFFECTS

Like all medicines, Esomeprazole Tablets 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.

Spinning feeling (vertigo).
Dry mouth.

Changes in blood tests that check how your liver is working.
Skin rash, lumpy rash (hives) and itchy skin.

Rare

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 inside 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.

These effects are rare, affecting less than 1 in 1,000 people.

Other side effects include:

Common
Headache.
Effects on your stomach or gut: diarrhoea, stomach pain, constipation, wind (flatulence).
Feeling sick (nausea) or being sick (vomiting).

Uncommon
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 your liver is working.
Skin rash, lumpy rash (hives) and itchy skin.

Very rare

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 pain (Erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).
Muscle weakness.
Severe kidney problems.

HOW TO STORE

Store at room temperature (77 degrees F or 25 degrees C) away from light and moisture. Brief storage between 59-86 degrees F (15-30 degrees C) is permitted. Do not use Esomeprazole tablets after the expiry date as stated on the carton, blister foil or bottle. Keep all medicines away from children.

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