EMANERA 20 mg. 14 capsules
Emanera contains a medicine called esomeprazole. It belongs to a group of medicines called proton pump inhibitors. They act by reducing the amount of gastric acid that your stomach produces.
Emanera use in:
• "Gastro-oesophageal reflux disease" (GERD). This is where acid from the stomach escapes into the gullet (the tube that connects the throat to the stomach) causing pain, inflammation and heartburn. This medicine is given for:
• Treatment of esophagus if it is damaged or inflamed.
• Stop these conditions of return acid.
• relieve unpleasant symptoms that often occur in these conditions.
• Ulcers in the stomach or upper intestine (duodenal), which are contaminated with bacteria called "Helicobacter Pylori". If you have this condition, your doctor may prescribe this drug in combination with some antibiotics to:
• Treats duodenal ulcers caused by the bacterium Helicobacter Pylori
• Preventing the recurrence of ulcers associated with this bacteria
• Stomach ulcers caused by medicines called nonsteroidal anti-inflammatory drugs (NSAIDs).
This medicine is given for:
• Treatment of gastric ulcers caused by NSAIDs
• Prevention of ulcers of the stomach and duodenum, if you take NSAIDs
• Prolonged treatment after prevention of rebleeding of ulcers with intravenous esomeprazole.
• Too much acid in the stomach caused by a growth in the pancreas (syndrome Zollinger - Ellison syndrome).
2. Before take Emanera
Do not take Emanera
• If you are allergic (hypersensitive) to esomeprazole or any of the other ingredients of Emanera.
• If you are allergic to other drugs, proton pump inhibitors.
• If you are taking atazanavir (a medicine used to treat AIDS).
Do not take Emanera if any of the above applies to you. If you are unsure, check with your doctor or pharmacist before taking Emanera.
Take special care with Emanera
Consult your doctor or pharmacist before taking Emanera if:
• have severe liver problems.
• have severe kidney problems,
Emanera may hide the symptoms of other diseases.
Therefore, if any of the following happen to you before you start taking Emanera or while you take, consult your doctor immediately:
• You lose a lot of weight for no reason and have problems swallowing.
• Have stomach pain or indigestion.
• You begin to vomit food or blood.
• have black stools (bloody stools).
If you have been prescribed Emanera "on demand" you should contact your doctor if symptoms continue or change in character.
If diarrhea occurs during treatment with Emanera, contact your doctor immediately, as treatment with proton pump inhibitors may lead to slightly increased risk of gastrointestinal infections such as Salmonella and Campylobacter.
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 Emanera can affect the way some medicines work and some medicines can affect Emanera.
Do not take Emanera if you are taking the following medicines:
• Atazanavir (used for the treatment of AIDS).
Tell your doctor or pharmacist if you are taking any of the following medications:
• ketoconazole, itraconazole or voriconazole (used to treat infections caused by fungi).
• 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 Emanera.
• Medicines that are used to thin the blood, such as warfarin. Your doctor may monitor you when you start or stop taking Emanera.
• Cisapride (used for indigestion and heartburn).
If your doctor has prescribed the antibiotics amoxicillin and clarithromycin as well as Emanera to treat ulcers caused by Helicobacter Pylori, is very important to tell your doctor about all other medicines you are taking.
Taking Emanera with food and drink
You can take the capsules with food or on an empty stomach.
Pregnancy and lactation
Before taking Emanera, tell your doctor if you are pregnant or trying to become pregnant. Ask your doctor or pharmacist before taking any medicine. Your doctor will decide whether you can take Emanera during this time. It is not known whether Emanera passes into breast milk. Therefore, you should not take Emanera if you are breastfeeding.
Driving and using machines
Emanera not likely to affect your ability to drive or operate any tools or machinery.
Important information about some of the ingredients of Emanera
Emanera contains sucrose. If you are told by your doctor that you have an intolerance to some sugars, contact him before taking this medicine.
3. How to take Emanera
Always take Emanera exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
• Emanera not recommended for children under the age of 12.
• 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 one year).
• If your doctor has told you to take this medicine only when you need it, tell your doctor if symptoms change.
Taking the medicine
• You can take the capsules at any time of day.
• You can take the capsules with food or on an empty stomach.
• Swallow the capsules whole with a glass of water. Capsules should not chew or crush. This is because the capsules contain coated pellets which stop the drug can be destroyed by the acid in the stomach. It is important not to damage the pellets.
What to do if you have trouble swallowing the capsules
• If you have problems with swallow capsules:
• Open the capsule and empty the pellets into half a cup (not carbonated) water. Do not use other liquids.
• Drink the mixture immediately 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 can not swallow the capsule can be mixed with some water and put into a syringe. Then it can make you through a tube directly into the stomach ('gastric tube').
How much to take
• Your doctor will tell you how many capsules to take and how long to take them. This will depend on your condition, how old you are and how well your liver works.
• usual doses are given below.
For the treatment of heartburn caused by gastro-oesophageal reflux disease (GERD):
Adults and children aged 12 years or older:
• If your doctor has found that the esophagus (the tube through which food goes from the mouth to the stomach) is slightly damaged, the usual dose is one capsule Emanera 40 mg once daily for 4 weeks. Your doctor may advise you to take the same dose for
further 4 weeks if the esophagus is not yet cured.
• The usual dose once the gullet has healed is one capsule Emanera 20 mg once daily.
• If the esophagus has not been damaged, the usual dose is one capsule Emanera 20 mg daily. Once the condition is under control, your doctor may tell you to take your medicine and only when needed, to a maximum of one capsule Emanera 20 mg daily.
• If you have severe liver problems, your doctor may give you a lower dose.
To treat ulcers caused by Helicobscte Pylori and to stop them coming back:
• Adults aged 18 or older, the usual dose is one capsule Emanera 20mg twice a day for one week.
• Your doctor will advise you to take antibiotics amoxicillin and clarithromycin.
To treat stomach ulcers caused by NSAIDs (nonsteroidal anti-inflammatory drugs):
• Adults aged 18 years and above: the usual dose is one capsule Emanera 20 mg once daily for 4 to
For administration as a continuous treatment after prevention of rebleeding of ulcers with intravenous esomeprazole:
• Adults aged 18 and above: the usual dose is one capsule Emanera 40 mg once daily for 4 weeks.
For the treatment of excessive gastric acid caused by the growth in the pancreas (syndrome Zollinger - Ellison:
• Adults aged 18 years and above: the usual dose is one capsule Emanera 40 mg twice a day.
• Your doctor will adjust the dose depending on your needs and decide how long to take the drug. The maximum dose is 80 mg twice daily.
If you take more Emanera than you should
If you take more Emanera prescribed by your doctor, talk to your doctor or pharmacist.
If you forget to take Emanera
• 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 the 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, Emanera can cause side effects, although not everybody gets them.
If you notice any of the following serious side effects, stop taking Emanera and contact your doctor immediately:
• Sudden wheezing, swelling of the lips, tongue and throat or body, rash, fainting or difficulties in swallowing (severe allergic reaction).
• Redness of the skin with blisters or peeling. Can be severe blisters and bleeding in the lips, eyes, mouth, nose and genitals. This could be "Syndrome Stevens - Johnons" or "toxic epidermal necrolysis".
• Yellow skin, dark urine, and fatigue, which may be symptoms of liver problems.
These effects are rare and affect less than 1 in 1000 people.
Other side effects include:
Very common: Affects more than 1 user in 10
Common: Affects 1 to 10 users in 100
Uncommon: Affects 1 to 10 users in 1000
Rare: Affects 1 to 10 users in 10,000
Very rare: Affects less than 1 in 10,000 users
Not known: frequency can not be made from the available data
• Effects on the stomach and intestines, diarrhea, stomach pain, constipation, wind (flatulence).
• Nausea or vomiting.
• Swelling of the feet and ankles.
• Disturbed sleep (insomnia).
• Dizziness, tingling feelings such as "pins and needles", feeling sleepy.
• Dizziness (Vertigo).
• Dry mouth.
• Changes in blood tests that check how the liver is working.
• Skin rash, rash (hives) and itchy skin.
• Blood problems such as reduction in the number of white blood cells (leucopenia) and thrombocytes (thrombocytopenia). This can cause weakness, bruising or make infections more often.
• Low levels of sodium in the blood. This can cause weakness, being sick (vomiting) and cramps.
• Feeling agitated, confused or depressed.
• Changes in taste.
• Visual problems such as blurred vision.
• Suddenly feeling wheezy or short of breath (bronchospasm).
• Inflammation of the inner part of the mouth.
• 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 fatigue.
• Hair loss (alopecia).
• Skin rash on exposure to sunlight.
• Pain in the joints (arthralgia) or muscle pains (myalgia).
• Generally feeling unwell and lacking energy.
• Increased sweating.
• Changes in blood count, including a lack of white blood cells (agranulocytosis) and reduce the number of red and white blood cells and platelets (pancytopenia).
• Seeing, hearing or feeling 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 of the skin. This may be associated with fever and arthralgia (erythema multiforme syndrome, Stevens - Johnson, toxic epidermal necrolysis).
• Muscle weakness.
• Severe kidney problems.
• Enlarged breasts in men.
Emanera can 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 local infection symptoms such as pain in the neck, throat or mouth or difficulties in urinating, you must consult your doctor as soon as possible, so that eventually exclude the absence of white blood cells (agranulocytosis) by a blood test. It is important to give information about your medication at this time. Do not be alarmed by this list of possible side effects. You can not get any of them. If any side
effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. How to store Emanera
Keep out of reach of children.
Do not use Emanera after the expiry date stated on the packaging. The expiry date refers to the last day of that month.
Store in the original package to protect from moisture.
HDPE tablet container
Keep container tightly closed in order to
protect from moisture.
Medicines should not be disposed of in wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer are needed. These measures will help to protect the environment.
6. Further information
• The active ingredient is esomeprazole. Each gastro - resistant capsule, hard, contains 20 mg or 40 mg of esomeprazole (as magnesium dihydrate).
• The other ingredients are sucrose, corn starch, povidone the Compulsory, sodium lauryl sulfate, poly (vinyl alcohol), titanium dioxide (E 171), macrogol 3000, macrogol 6000, talc, magnesium carbonate heavy, methacrylic acid - ethyl acrylate copolymer (1: 1) dispersion 30%, and polysorbate 80 in the core of the pellets in a capsule and gelatin, titanium dioxide (E171) and red ferric oxide (E172) in the capsule shell.
Emanera looks like and contents of the pack
Body and cap of 20 mg gastro - resistant capsules are light pink. The capsules contain white to off-white granules. Body and cap of 40 mg gastro - resistant capsules are almost pink. The capsules contain white to off-white granules. The capsules are available in boxes of 7, 14, 15, 28, 30, 50, 56, 60, 90, 98 or 100 capsules in blister and tablet in plastic containers with 98 capsules.