20 mg and 40 mg enteric tablets are 
esomeprazole

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

  • Save this information, 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 give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

This leaflet contains information about: 
1. What Esomeprazole Actavis is and what it is used for 
2. What you need to know before you use Esomeprazole Actavis 
3. How to take Esomeprazole Actavis 
4. Possible side effects 
5. How to store Esomeprazole Actavis 
6. Contents of the pack and other information 

What Esomeprazole Actavis is and what it is used for

Esomeprazole Actavis contains a medicine called esomeprazole. It belongs to a group of medicines called “proton pump inhibitors”. These work by reducing the amount of acid produced in the stomach.

Esomeprazole Actavis is used to treat the following conditions:

Adults

  • Gastroesophageal reflux disease ( GERD ). This is when acid from the stomach leaks into the esophagus (the connection between the mouth and the stomach) and causes pain, inflammation, and heartburn.
  • Ulcers in the stomach or upper intestine are infected by a bacterium called “Helicobacter pylori”. If you have such wounds, your doctor may also prescribe antibiotics to treat the infection and to allow wound healing.
  • A gastric ulcer is caused by so-called NSAIDs (non-steroidal anti-inflammatory drugs). Esomeprazole Actavis can also be used to prevent stomach ulcers when you are taking NSAIDs.
  • Too much acid in the stomach is caused by a tumor in the pancreas (Zollinger-Ellison syndrome).
  • Continued treatment to prevent new bleeding from wounds after treatment with intravenous esomeprazole.

Young people from 12 years

  • Gastroesophageal reflux disease ( GERD ). This is when acid from the stomach leaks into the esophagus (the connection between the mouth and stomach) and causes pain, inflammation, and heartburn.
  • Ulcers in the stomach or upper intestine are infected by a bacterium called Helicobacter pylori. If you have such wounds, your doctor may also prescribe antibiotics to treat the infection and to allow wound healing.

Esomeprazole contained in Esomeprazole Actavis may also be authorized for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.

What you need to know before you use Esomeprazole Actavis

Do not use Esomeprazole Actavis

  • if you are allergic (hypersensitive) to esomeprazole or any of the other ingredients of this medicine (listed in section 6).
  • if you are allergic to other proton pump inhibitors (eg pantoprazole, lansoprazole, rabeprazole, omeprazole).
  • if you are taking a medicine containing nelfinavir (used to treat HIV – infection ).

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

Warnings and cautions

Talk to your doctor or pharmacist before taking Esomeprazole Actavis:

  • 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 Actavis that reduces stomach acid.
  • if you are going to have a specific blood test (chromogranin A)

Esomeprazole Actavis may mask the symptoms of other diseases. Therefore, if any of the following occur before you start taking Esomeprazole Actavis or while you are taking it, contact your doctor immediately:

  • you lose a lot of weight for no reason and have trouble swallowing
  • you get stomach pains or indigestion
  • you start vomiting food or blood
  • you get black (blood-mixed) stools.

If you have been prescribed Esomeprazole Actavis to take “as needed”, consult your doctor if your symptoms persist or change in nature.

Talk to your doctor if you have severe or persistent diarrhea; esomeprazole has been associated with a small increased risk of infectious diarrhea.

Using proton pump inhibitors such as Esomeprazole Actavis, and especially if you use it for more than a year, may increase the risk of a hip, wrist, or vertebral fracture (bone fracture). Tell your doctor if you have osteoporosis ( osteoporosis ) or if you use medicines called corticosteroids because they may increase the risk of osteoporosis.

If you get a rash, especially in areas exposed to the sun, tell your doctor as soon as possible as you may need to stop treatment with Esomeprazole Actavis. Also remember to mention any other side effects, such as joint pain.

Children under 12 years

Esomeprazole Actavis should not be used in children under 12 years of age. More suitable formulations of this drug may be available.

Other medicines and Esomeprazole Actavis

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 Actavis can affect the way other medicines work and other medicines can affect the effect of Esomeprazole Actavis.

Do not take Esomeprazole Actavis 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 in the treatment of HIV – infection ).
  • clopidogrel (used to prevent blood clots)
  • ketoconazole , itraconazole or voriconazole (used to treat fungal infections)
  • erlotinib (used to treat cancer)
  • citalopram, imipramine, or clomipramine (used to treat depression)
  • diazepam (used to treat anxiety, for muscle relaxation, or epilepsy )
  • phenytoin (used in epilepsy ). If you are taking phenytoin, your doctor will need to monitor you when you start or stop taking Esomeprazole Actavis.
  • drugs used for blood thinning, such as warfarin. Your doctor may need to monitor you when you start or stop taking Esomeprazole Actavis.
  • cilostazol (used to treat window disease – pain in the legs when walking due to insufficient blood supply to the legs)
  • cisapride (used for digestive problems or heartburn)
  • digoxin (used for heart problems)
  • methotrexate (a chemotherapy drug used in the high dose you to treat cancer) – if you take high dose s of methotrexate, your doctor may do a temporary suspension of treatment with Esomeprazole Actavis gastro s
  • tacrolimus (organ transplant)
  • rifampicin (used to treat tuberculosis )
  • St. John’s wort (Hypericum perforatum) (used to treat depression).

If the doctor has prescribed the antibiotics amoxicillin and clarithromycin, coupled with Esomeprazole Actavis gastro you to treat ulcers caused by Helicobacter pylori – infection, you must tell your doctor if you are also taking other medicines.

Esomeprazole Actavis with food and drink

You can take your tablets with a meal or on an “empty stomach”.

Pregnancy, breastfeeding, 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 if you can take Esomeprazole Actavis during that time.

It is not known if esomeprazole passes into breast milk. Therefore, you should not take Esomeprazole Actavis if you are breast-feeding.

Driving and using machines

Esomeprazole Actavis is unlikely to affect your ability to drive or use tools or machines. However, side effects such as dizziness and visual disturbances may occur in less common cases. (see section 4). If you are affected, do not drive or use machines.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Esomeprazole Actavis contains sodium and sucrose

Esomeprazole Actavis contains sodium

This medicine contains less than 1 mmol (23 mg) sodium per enteric-tablet, ie essentially ‘sodium-free ‘.

Esomeprazole Actavis contains sucrose

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

How to use Esomeprazole Actavis

Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

  • If you use this medicine for a long time, your doctor will want to follow up on your treatment (especially if you are taking the medicine for more than a year).
  • If you have been told by your doctor that you must take this medicine, tell your doctor if your symptoms change.

How much should you take?

  • Your doctor will tell you how many tablets to take and how long to take them. Dosage one depends on your condition, how old you are, and how well your liver is working.
  • The recommended dose is listed below.

Use for adults over 18 years

For the treatment of heartburn caused by gastroesophageal reflux disease ( GERD ):

  • If your doctor has found that your esophagus is slightly damaged, the recommended dose is one Esomeprazole Actavis 40 mg enteric tablet once daily for 4 weeks. Your doctor may recommend that you take the same dose for another 4 weeks if the damage to your esophagus is not healed.
  • The recommended dose after the esophagus has healed is an Esomeprazole Actavis 20 mg enteric tablet once daily.
  • If your esophagus is not damaged, the recommended dose is one Esomeprazole Actavis 20 mg enteric tablet once daily. When your condition is under control, your doctor may recommend that you take the medicine up to a maximum of one Esomeprazole Actavis 20 mg enteric tablet once a day if necessary.
  • If you have a severe hepatic impairment, your doctor may recommend a lower dose.

To treat ulcers caused by Helicobacter pylori – infection and to prevent the ulcer from occurring again:

  • The recommended dose is an Esomeprazole Actavis 20 mg enteric tablet twice daily for one week.
  • Your doctor will also recommend that you take antibiotics such as amoxicillin and clarithromycin.

For the treatment of stomach ulcers caused by NSAIDs (non-steroidal anti-inflammatory drugs):

  • The recommended dose is an Esomeprazole Actavis 20 mg enteric tablet once daily for 4-8 weeks.

To prevent stomach ulcers if you are taking NSAIDs:

  • The recommended dose is an Esomeprazole Actavis 20 mg enteric tablet once daily.

For the treatment of excess acid in the stomach caused by a tumor of the pancreas (Zollinger-Ellison syndrome):

  • The recommended dose is an Esomeprazole Actavis 40 mg enteric-tablet twice daily.
  • Your doctor will adjust the dose according to your needs and will also decide how long you should take the medicine. The maximum dose is 80 mg twice daily.

Continued treatment to prevent new bleeding from wounds after treatment with intravenous esomeprazole:

  • The recommended dose is an Esomeprazole Actavis 40 mg enteric tablet once daily for 4 weeks.

Use for young people from 12 years

For the treatment of heartburn caused by gastroesophageal reflux disease ( GERD ):

  • If your doctor has found that your esophagus is slightly damaged, the recommended dose is one Esomeprazole Actavis 40 mg enteric tablet once daily for 4 weeks. Your doctor may recommend that you take the same dose for another 4 weeks if the damage to your esophagus is not healed
  • The recommended dose one after the esophagus is healed is an Esomeprazole Actavis 20 mg enteric tablet once daily
  • If your esophagus is not damaged, the recommended dose is one Esomeprazole Actavis 20 mg enteric tablet once daily.
  • If you have a severe hepatic impairment, your doctor may recommend a lower dose

To treat ulcers caused by Helicobacter pylori – infection and to prevent the ulcer from occurring again:

  • The recommended dose is an Esomeprazole Actavis 20 mg enteric tablet twice daily for one week.
  • Your doctor will also recommend that you take antibiotics such as amoxicillin and clarithromycin

Taking the medicine

  • You can take the tablets at any time of the day.
  • You can take your tablets with a meal or on an “empty stomach”.
  • Swallow your tablets whole along with a glass of water. Do not chew or crush the tablets. This is because the tablets contain coated granules that prevent the medicine from being broken down by the acid in the stomach. The granules mustn’t be damaged.

What you can do if you have difficulty swallowing the tablets

  • If you have problems swallowing the tablets:
    • Put them in glass (not carbonated) water. Do not use other liquids.
    • Stir until the tablets fall apart ( mixture becomes cloudy). Drink the mixture immediately or within 30 minutes. Always stir the mixture immediately before drinking it.
    • To be sure that you have ingested all the medicine, rinse thoroughly with another half glass of water that you drink up. The solid particles contain the medicine – do not chew or crush them.
  • If you can not swallow at all, the tablets can be mixed with a little water and placed in a syringe. Mixture one can then be given directly into the stomach via a probe.

Use for children under 12 years

Esomeprazole Actavis should not be used in children under 12 years of age. More suitable formulations of this drug may be available.

Older

Dose adjustment is not necessary for elderly patients.

If you take more Esomeprazole Actavis then you should

If you have ingested too much medicine or if e.g. If a child has inadvertently ingested the medicine, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.

If you forget to take Esomeprazole Actavis gastro s

  • If you forget to take a dose , take it as soon as you notice it. If it is near the time of the next dose – skip the missed dose .
  • Do not take a double dose (two doses at the same time) to compensate for a missed dose .

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

4. Possible side effects

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

Stop taking Esomeprazole Actavis and contact your doctor immediately, if you notice any of the following serious side effects:

  • Sudden wheezing, swelling of the lips, tongue and throat or body, skin rash, fainting or difficulty swallowing (severe allergic reaction , rare).
  • Redness of the skin with blistering or flaking. Severe blistering and bleeding on the lips, eyes, mouth, nose and genitals may also occur. This can be “erythema multiforme”, “Stevens-Johnson syndrome” or “toxic epidermal necrolysis”, very rare.
  • Yellowed skin, dark urine and fatigue, which can be symptoms of liver problems, rare.

Other side effects include:

Common (affects up to 1 in 10 people)

  • headache.
  • effects on the stomach or intestines: diarrhea, abdominal pain, constipation, flatulence.
  • nausea or vomiting.
  • benign polyps in the stomach.

Uncommon (affects up to 1 in 100 people)

  • swelling in the feet and ankles
  • sleep disorders (insomnia).
  • dizziness, tingling, drowsiness
  • vertigo ( vertigo )
  • dry mouth
  • changes in the blood picture that show the function of the liver
  • skin rash, hives and itching .
  • hip, wrist or vertebral fractures (if Esomeprazole Actavis enteric-tablet is used in high doses and for a long time).

Rare (affects up to 1 in 1,000 people):

  • altered blood count such as reduced number of white blood cells or platelets . This may cause weakness, bruising or susceptibility to infection
  • low levels of sodium in the blood. This can cause weakness, vomiting and cramps
  • feeling of upset, confusion or depression
  • taste changes
  • vision problems, such as blurred vision
  • sudden wheezing or shortness of breath ( bronchospasm )
  • inflammation of the oral cavity
  • a fungal infection called “cod” that can affect the gut
  • liver problems including jaundice, which can cause yellowing of the skin, dark urine and fatigue
  • hair loss ( alopecia )
  • skin rash when sunbathing
  • joint pain ( arthralgia ) or muscle pain ( myalgia )
  • general malaise and lack of 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
  • hallucinations (see, feel or hear things that do not exist)
  • severe liver problems leading to liver failure and encephalitis
  • sudden onset of severe rash, blistering or flaky skin. This may be associated with high fever and joint pain (Erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis )
  • muscle weakness
  • severe kidney problems
  • enlargement of the mammary glands in men.

No known frequency (cannot be calculated from the available data)

  • If you use Esomeprazole Actavis for more than three months, your blood magnesium levels may drop. Low levels of magnesium can manifest as fatigue, involuntary muscle movements, confusion, cramps, dizziness and rapid heartbeat. If you get any of these symptoms, contact your doctor immediately. Low levels of magnesium can also lead to decreased levels of potassium or calcium in the blood. Your doctor may measure the level of magnesium in your blood using regular blood tests.
  • Inflammation of the intestine (causes diarrhea).
  • Skin rash, possibly with joint pain.

Esomeprazole Actavis can in very rare cases affect the white blood cells so that the immune system is weakened. If you get an infection with symptoms such as fever and severe general malaise or fever with symptoms of local infection such as pain in the neck, throat or mouth or difficulty urinating, you must contact a doctor as soon as possible so that any lack of white blood cells ( agranulocytosis ) can excluded by a blood test. It is important that you then inform about your medication.

5. How to store Esomeprazole Actavis

  • Keep out of sight and reach of children.
  • Do not store above 30 ° C.
  • Esomeprazole Actavis delivered in plastic cans must be used within 6 months of first opening.
  • Do not use this medicine after the expiry date which is stated on the carton, jar or blister after EXP. The expiration date is the last day of the specified month.
  • 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

6. Contents of the packaging and other information

Content declaration

  • The active substance is esomeprazole magnesium dihydrate.An Esomeprazole Actavis 20 mg enteric- containing tablet contains 20 mg of esomeprazole (equivalent to 21.75 mg of esomeprazole magnesium dihydrate salt).An Esomeprazole Actavis 40 mg enteric- containing tablet contains 40 mg of esomeprazole (equivalent to 43.5 mg of esomeprazole magnesium dihydrate salt).
  • Other ingredients are:Tablet:Methacrylic acid-ethyl acrylate copolymer (1: 1), talc, triethyl citrate, hypromellose, sugar spheres, magnesium stearate, hydroxypropylcellulose, glycerol monostearate 40-55, polysorbate 80, microcrystalline cellulose, povidone, macrogol 6000, crospovidarum, sodium.Drag:Hypromellose, titanium dioxide (E171), macrogol / PEG 400, red iron oxide (E172), yellow iron oxide (E172).

What the medicine looks like and contents of the pack

Esomeprazole Actavis 20 mg enteric tablets are light pink, oblong, biconvex film-coated tablets, 6.55 x 13.6 mm.

Esomeprazole Actavis 40 mg enteric tablets are pink, oblong, biconvex film-coated tablets, 8.2 x 17 mm.

Pack sizes :

Plastic jar with tablets, desiccant and plastic lid: 30, 100, 250 or 500 tablets. Do not swallow the desiccant.

Blister packs: 7, 14, 28, 30, 50, 56, 60, 90, 98, 100 or 140 tablets. (Packages 7, 14 and 28 are over-the-counter)

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Actavis Group PTC ehf.

Reykjavikurvegur 76-78

220 Hafnarfjordur

Iceland

Manufacturer

Balkanpharma Dupnitsa AD

3 Samokovsko Shose Str.

Dupnitsa 2600

Bulgaria

Muhammad Nadeem

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