Esomeprazole Actavis

Esomeprazole Actavis

esomeprazole

Manufacturer:

Teva

Distributor:

Zuellig
Full Prescribing Info
Contents
Esomeprazole.
Description
The active substance is esomeprazole magnesium dihydrate.
Each Esomperazole Actavis 20 mg gastro-resistant tablet contains 20 mg of esomeprazole (corresponding to 21.75 mg esomperazole magnesium dihydrate).
Each Esomperazole Actavis 40 mg gastro-resistant tablet contains 40 mg of esomeprazole (corresponding to 43.5 mg esomperazole magnesium dihydrate).
Excipients/Inactive Ingredients: Tablet Content: Methacrylic acid-ethyl acrylate copolymer (1:1) dispersion 30%, talc, triethyl citrate, hypromellose, sugar spheres, magnesium stearate, hydroxypropyl cellulose, glycerol monostearate 40-55, polysorbate 80, microcystalline cellulose, povidone, macrogol 6000, crospovidone, sodium stearyl fumarate.
Tablet Coating: Hypromellose, titanium dioxide (E171), macrogol/PEG 400, red iron oxide (E172), yellow iron oxide (E172).
Indications/Uses
Esomeprazole Actavis 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 the stomach produces.
Esomeprazole Actavis is used to treat the following conditions:
Adults and Young People 12 Years and Above: Gastro-oesophageal reflux disease (GORD): This is where acid from the stomach escapes into the gullet (the tube which connects the throat to the 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 the patient has this condition, the physician may also prescribe antibiotics to treat the infection and allow ulcer to heal.
Adults: Stomach ulcers caused by medicines called NSAIDs (Non-steroidal Anti-inflammatory Drugs). Esomeprazole Actavis can also be used to stop stomach ulcers from forming if the patient is 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.
Dosage/Direction for Use
How Much to Take: The physician will the tell the patient how many tablets should be taken and how long to take them for. This will depend on the patient's condition, how old the patient is and how well the liver works.
To Treat Heartburn Caused by Gastro-oesophageal Reflux Disease: Adults and Children Aged 12 Years and Above: If the physician has found that the food pipe (gullet) has been slightly damaged, the usual dose is one tablet of Esomeprazole Actavis 40 mg once a day for 4 weeks. The physician may tell the patient to take the same dose for a further 4 weeks if the gullet has not yet healed.
The usual dose once the gullet has healed is one tablet of Esomeprazole Actavis 20 mg once a day.
If the gullet has not been damaged, the usual dose is one tablet of Esomeprazole Actavis 20 mg each day. Once the condition has been controlled, the physician may tell the patient to take the medicine as and when needed, up to a maximum of one tablet of Esomperazole Actavis 20 mg each day.
If the patient has severe liver problems, the physician may give the patient a lower dose.
To Treat Ulcers Caused by Helicobacter pylori Infection and to Stop Them from Coming Back: Adult and Young People Aged 12 or Above: The usual dose is one tablet of Esomeprazole Actavis 20 mg twice a day for one week.
The physician will also tell the patient 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 tablet of Esomperazole Actavis 20 mg once a day for 4 to 8 weeks.
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 tablet of Esomeprazole Actavis 40 mg twice a day.
The physician will adjust the dose depending on the needs of the patient and will also decide how long the patient may need to take Esomeprazole Actavis for. The maximum dose is 80 mg twice a day.
To Be Used as Prolonged Treatment After Prevention of Rebleeding of Ulcers with Intravenous Esomeprazole: Adults Aged 18 Years and Above: The usual dose is one tablet of Esomeprazole Actavis 40 mg once a day for 4 weeks.
Administration: The patient can take Esomeprazole Actavis at any time of the day.
The patient can take Esomeprazole Actavis with food or on an empty stomach.
Swallow the tablets whole with a drink of water. Do not chew or crush. This is because the tablets contain coated pellets which stop the medicine from being broken down by the acid in the stomach. It is important not to damage the pellets.
What to do if the patient has trouble in swallowing the tablets: Put them into half 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 the patient has drunk all 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 the patient cannot swallow at all, the tablet can be mixed with some water and put into a syringe. It can then be given to the patient through a tube directly into the stomach (gastric tube).
Children Under the Age of 12 Years: Esomeprazole Actavis should not be used in children younger than 12 years. More appropriate pharmaceutical forms of this medicine may be available.
Older People: Dose adjustment is not required in the elderly.
If the patient takes more Esomeprazole Actavis than necessary: If the patient takes more Esomeprazole Actavis than prescribed by the physician, talk to the physician or pharmacist straight away.
If the patient forgets to take Esomeprazole Actavis: If the patient forgets to take a dose, take it as soon as remembered. However, if it is almost time for the 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 the patient has any further questions on the use of this medicine, ask the physician or pharmacist.
Contraindications
Do not take Esomeprazole Actavis: If allergic to esomeprazole or any of the other ingredients of Esomeprazole Actavis (listed in Description); if allergic to other proton pump inhibitor medicines (e.g. pantoprazole, lanzoprazole, rabeprazole, omeprazole); if the patient is taking a medicine containing nelfinavir (used to treat HIV infection).
Special Precautions
Talk to the physician or pharmacist before taking Esomeprazole Actavis: If the patient has severe liver problems; if the patient has severe kidney problems.
Subacute Cutaneous Lupus Erythematosus (SCLE): Proton pump inhibitors are associated with very infrequent cases of SCLE. If lesions occur, especially in sun-exposed areas of the skin, and if accompanied by arthralgia, the patient should seek medical help promptly and the health care professional should consider stopping Esomeprazole Actavis. SCLE after previous treatment with a proton pump inhibitor may increase the risk of SCLE with other proton pump inhibitors.
Esomeprazole Actavis may hide the symptoms of other diseases. Therefore, if any of the following happen before the patient starts taking Esomeprazole Actavis or while the patient is taking it, talk to the physician straight away: If the patient loses a lot of weight for no reason and has problems swallowing; if the patient gets stomach pain or indigestion; if the patient begins to vomit food or blood; if the patient passes black stools (blood-stained faeces).
If the patient has been prescribed Esomeprazole Actavis "on demand" the patient should contact the physician if the symptoms continue or change in character.
Esomepazole is a CYP2C19 inhibitor. When starting or ending treatment with esomeprazole, the potential for interactions with drugs metabolised through CYP2C19 should be considered. An interactions is observed between clopidogrel and omperazole. The clinical relevance of this interaction is uncertain. As a precaution, concomitant use of esomeprazole and clopidogrel should be discouraged.
Taking a proton pump inhibitor like Esomeprazole Actavis, especially over a period of more than one year, may slightly increase the risk of fracture in the hip, wrist or spine. Tell the physician if the patient has osteoporosis or if the patient is taking corticosteroids (which can increase the risk of osteoporosis).
Long-term (a year or longer) and multiple daily dose PPI therapy may be associated with an increase for osteoporosis-related fractures of the hip, wrist or spine. Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated.
Hypomagnesemia, symptomatic and asymptomatic, has been reported rarely in patients treated with PPIs for at least three months, in most cases after a year of therapy. Serious adverse events include tetany, arrhythmias, and seizures. In most patients, treatment of hypomagnesemia required magnesium replacement and discontinuation of PPI.
For patients expected to be on prolonged treatment or who take PPIs with medications such as digoxin or drugs that may cause hypomagnesemia (e.g. diuretics), health care professionals may consider monitoring magnesium levels prior to initiation of PPI treatment and periodically.
Esomeprazole Actavis Contains Sucrose: Esomeprazole Actavis gastro-resistant tablets contain sugar spheres which contain sucrose, which is a type of sugar. If the patient has been told by the physician that the patient has intolerance to some sugars, talk to the physician before taking Esomeprazole Actavis.
Driving and Using Machines: Esomeprazole Actavis is not likely to affect the ability to drive or use any tools or machines. However, side effects such as dizziness and blurred vision may uncommonly or rarely occur (see Adverse Reactions). If affected, the patient should not drive or use machines.
Use in Children: Esomeprazole Actavis should not be used in children younger than 12 years. More appropriate pharmaceutical forms of this medicine may be available.
Use In Pregnancy & Lactation
If the patient is pregnant or breastfeeding, is suspecting pregnancy, or is planning to have a baby, ask the physician or pharmacist for advice before taking this medicine.
The physician will decide whether the patient can take Esomeprazole Actavis during this time.
It is not known if Esomeprazole Actavis passes into breast milk. Therefore, the patient should not take Esomeprazole Actavis if the patient is breastfeeding.
Adverse Reactions
Like all medicines, Esomeprazole Actavis can cause side effects, although not everybody gets them.
If the patient notices any of the following serious side effects, stop taking Esomeprazole Actavis and contact a physician immediately: Sudden wheezing, swelling of the 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 (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 the stomach or gut: diarrhoea, stomach pain, constipation, wind (flatulence); feeling sick (nausea) or being sick (vomiting).
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 Actavis is used in high doses and over long duration).
Rare (may affect up to 1 in 1,000 people): Blood problems such as reduced number of white blood 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.
Very Rare (may affect up to 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.
Esomeprazole may in very rare cases affect the white blood cells leading to immune deficiency. If the patient has 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, the patient must consult the physician 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 the patient to give information about the medication at this time.
Not Known (frequency cannot be estimated from the available data): If the patient is on Esomeprazole for more than three months it is possible that the levels of magnesium in the blood may fall. Low levels of magnesium can be seen as fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, increased heart rate. If the patient gets any of these symptoms, please tell the physician promptly. Low levels of magnesium can also lead to a reduction in potassium or calcium levels in the blood. The physician may decide to perform regular blood tests to monitor the levels of magnesium.
Inflammation in the gut (leading to diarrhoea).
Drug Interactions
Other Medicines and Esomeprazole Actavis: Tell the physician or pharmacist if the patient is taking, have recently taken or might take any other medicines. This is because Esomeprazole Actavis can affect the way some medicines work and some medicines can have an effect on Esomeprazole Actavis.
Do not take Esomeprazole Actavis if the patient is taking a medicine containing nelfinavir (used to treat HIV infection).
Tell the physician or pharmacist if the patient is 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, clomipramine (used to treat depression).
Diazepam (used to treat anxiety, relax muscles or in epilepsy).
Phenytoin (used in epilepsy). If the patient is taking phenytoin, the physician will need to monitor the patient when starting or stopping Esomeprazole Actavis.
Cilostazol (used to treat intermittent claudication- a pain in the legs when the patient walks 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 the patient is taking a high dose of methotrexate, the physician may temporarily stop Esomeprazole Actavis treatment.
Concomitant Use of Proton Pump Inhibitors (PPIs) with Methotrexate: Literature suggests that concomitant use of PPIs with methotrexate (primarily at high dose) may elevate and prolong serum levels of methotrexate and/or its metabolite, possibly leading to methotrexate toxicities. A temporary withdrawal of PPI may be considered in some patients receiving treatments with high dose of methotrexate.
Case reports, published population pharmacokinetic studies, and retrospective analyses suggest that concomitant administration of PPIs and methotrexate (primarily at high dose) may elevate and prolong serum levels of methotrexate and/or its metabolite hydroxymethotrexate. However, no formal drug interaction studies of methotrexate with PPIs have been conducted.
Tacrolimus (organ transplantation).
Rifampicin (used for treatment of tuberculosis).
St. John's wort (Hypericum perforatum) (used to treat depression).
If the physician prescribed the antibiotics amoxicillin and clarithromycin as well as Esomeprazole Actavis to treat ulcers caused by Helicobacter pylori infection, it is very important that the patient tells the physician about any other medicines he/she is taking.
Other Effects Related to Acid Inhibition: Decreased gastric acidity due to any means, including proton pump inhibitors, increases gastric counts of bacteria normally present in the gastrointestinal tract. Treatment with proton pump inhibitors may lead to slightly increased risk of gastrointestinal infections such as Salmonella and Campylobacter and possibly Clostridium difficile.
Esomperazole Actavis with Food and Drink: The patient can take tablets with food or an empty stomach.
Caution For Usage
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 until tablet has disintegrated.
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 to 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 to 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.
Storage
Keep Esomeprazole Actavis out of the sight and reach of children.
Store below 25°C.
Do not use Esomeprazole Actavis after the expiry date.
Do not throw away any medicines via wastewater or household waste. Ask the pharmacist on how to throw away medicines the patient no longer use. These measures will help protect the environment.
ATC Classification
A02BC05 - esomeprazole ; Belongs to the class of proton pump inhibitors. Used in the treatment of peptic ulcer and gastro-oesophageal reflux disease (GERD).
Presentation/Packing
Gastro-resistant tab 20 mg (light pink, elliptically shaped, biconvex film-coated tablet, 6.55 x 13.6 mm) x 14's. 40 mg (pink, elliptically shaped, biconvex film-coated tablet, 8.2 x 17 mm) x 14's.
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