Esomeprazole 40 Mg Gastro-Resistant Capsules Hard
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ESOMEPRAZOLE 20 mg
GASTRO-RESISTANT CAPSULES, HARD ESOMEPRAZOLE 40 mg
GASTRO-RESISTANT CAPSULES, HARD
Read all of this leaflet carefully before you start taking
this medicine.
• Keep this leaflet. You may need to read it again.
• If you have ary further questions, askyour doctor or
•This medicine has been prescribedfor you. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If any of the side effects gets serious, talk toyour doctor or pharmacist or nurse.This includes any possible side effects not listed in this leaflet.
In this leaflet:
1. What Esomeprazole Capsules are and what they are
2. What you need to know before you take Esomeprazole Capsules.
3. How to take Esomeprazole Capsules.
4. Possible side effects.
5. How to store Esomeprazole Capsules.
6. Contents of the pack and other information.
1. WHAT ESOMEPRAZOLE CAPSULES ARE AND WHAT THEY ARE USED FOR
• Phenytoin (used in epilepsy). If you are taking phenytoin, your doctor will need to monitor you when you start or stop taking Esomeprazole Capsules.
• Medicines that are used to thin your blood, such as warfarin. Your doctor may need to monitoryou when you start or stop taking Esomeprazole Capsules.
• Cisapride (usedfor indigestion and heartburn).
• Clopidogrel (used to prevent blood clots (thrombi)).
• Digoxin (used for heart problems).
• Rifampicin (used for treatment of tuberculosis).
• St. John's wort (Hypericumperforatum) (used to treat depression).
Ifyour doctor has prescribed the antibiotics amoxicillin and clarithromycin as well as Esomeprazole Capsules to treat ulcers caused by Helicobacter pylori infection, it is very important thatyou tell your doctor about any other medicines you are taking.
Esomeprazole with food and drink
You can takeyour capsules withfood or on an empty stomach.
Pregnancy and breast-feeding
Before taking Esomeprazole Capsules, tell your doctor if you are pregnant or trying to get pregnant.Askyour doctor or pharmacist for advice before taking any medicine. Your doctor will decide whether you can take Esomeprazole Capsules during this time.
It is notknown if Esomeprazole passes into breast milk. Therefore, you should not take Esomeprazole Capsules if you are breast-feeding.
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 mgCapsuletwice a day.
• Your doctor will adjust the dose depending onyour needs and will also decide how long you need to take the medicine for. The maximum dose is 80 mg twice
To be used as prolonged treatmentafter prevention ofrebleeding of ulcers with intravenous esomeprazole:
• Adults aged 18 and above: the usual dose is one Esomeprazole 40 mg Capsule once daily for 4 weeks.
Ifyou take more EsomeprazoleCapsules than you should
If you take more Esomeprazole Capsules than prescribed by your doctor, talktoyour doctor or pharmacist straight away.
Ifyouforget to take Esomeprazole Capsules:
• If you forget to take a dose, take it as soon as you remember it. However, if it is almost time foryour 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.
f you have any further questions on the use of this product, ask your doctor or pharmacist or nurse.
eaflet
s includes any possible side effects not listed in
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Esomeprazole Capsules contain a medicine called esomeprazole.This belongs to a group of medicines called 'proton pump inhibitors'. They work by reducing the amount of acid thatyour stomach produces.
Esomeprazole Capsules are used to treat the following conditions:
Adults and young people aged 12 years and above:
• 'Gastro-esophageal reflux disease' (GERD).This is where acid from the stomach escapes into the gullet (the tube which connectsyour throat toyour stomach) causing pain, inflammation and heartburn.
• Ulcers in the stomach or upper part of the gut (intestine) that are infected with bacteria called 'Helicobacterpylori'. Ifyou 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 Capsules can also be used to stop stomach ulcers from forming ifyou are taking NSAIDs.
•Too much acid in the stomach caused by a growth in the pancreas (Zollinger-Ellison syndrome).
• Prolonged treatment after prevention ofrebleeding of ulcers with intravenous esomeprazole.
2. WHATYOU NEEDTO KNOW BEFOREYOUTAKE ESOMEPRAZOLE CAPSULES
Do not take Esomeprazole Capsules:
• Ifyou are allergic (hypersensitive) to esomeprazole or any of the other ingredients of this medicine (listed in section 6: Further information).
• Ifyou are allergic to other proton pump inhibitor medicines.(pantoprazole, lansoprazole, rabeprazole, omeprazole).
• Ifyou are taking a medicine containing nelfinavir (used to treat HIV).
Do not take Esomeprazole Capsules if any of the above apply to you. If you are not sure, talk toyour doctor or pharmacist before taking EsomeprazoleCapsules.
Taking a proton pump inhibitor like Esomeprazole, especially over a period of more than oneyear, may slightly increase your risk of fracture in the hip, wrist or spine. Tell your doctor ifyou have osteoporosis or ifyou are taking corticosteroids (which can increase the risk of osteoporosis.
Esomeprazole may also reduce the absorption of vitamin B12, especially on long-term therapy.
Warnings and Precautions
Check withyour doctor, pharmacist or nurse before taking Esomeprazole Capsules:
• Ifyou have severe liver problems.
• Ifyou have severe kidney problems.
Esomeprazole Capsules may hide the symptoms ofother diseases. Therefore, if any of the following happen to you before you start taking Esomeprazole Capsules or while you are taking them, talkto your doctor straight away:
• You lose a lot ofweight 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).
Ifyou have been prescribed Esomeprazole 'on demand' you should contactyour doctor ifyour symptoms continue or change in character.
Other medicines and esomeprazole
Please tell your doctor or pharmacist ifyou are taking, or have recently taken, or might take any other medicines. This includes medicines that you buy without a prescription. This is because Esomeprazole Capsules can affect the way some medicines work and some medicines can have an effect on Esomeprazole Capsules.
Do not take Esomeprazole Capsules ifyou are taking a medicine containing nelfinavir (used to treat HIV).
Tell your doctor or pharmacist ifyou are taking any of the following medicines:
•Atazanavir (used to treat HIV).
• Ketoconazole, itraconazole orvoriconazole (used to treat infections caused by a fungus).
• Citalopram, imipramine or clomipramine (used to treat depression).
•Diazepam (usedto treat anxiety, relax muscles or in epilepsy).
Driving and using machines
Esomeprazole Capsules are not likelyto affect you being able to drive or use any tools or machines.
Important information about some of the ingredients of Esomeprazole Capsules
Esomeprazole Capsules contain sucrose, which is a type of sugar. If you have been told by your doctor thatyou have an intoleranceto some sugars, talktoyour doctor before taking this medicine.
3. HOWTOTAKE ESOMEPRAZOLE CAPSULES
Always take EsomeprazoleCapsulesexactly as your doctor has told you. You should check with your doctor or pharmacist ifyou are not sure.
• Esomeprazole Capsules are not recommendedfor children less than 12 years old.
• Ifyou are taking this medicinefor a long time, your doctor will want to monitor you (particularly ifyou are taking it for more than a year).
• Ifyour doctor has told you to take this medicine as and whenyou need it, tell your doctor ifyour symptoms change.
Taking this medicine
• You can takeyour capsules at any time of the day.
• You can takeyour capsules with food or on an empty stomach.
• Swallow your capsules whole with a drink ofwater.
Do not chew or crush the capsules.This is because the capsules 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 capsules If you have trouble swallowing the capsules:
• Open the capsule and empty the pellets into half a glass of still (non-fizzy) water. Do not use any other liquid.
• Drink the mixture straight away or within 30 minutes. Always stir the mixture just before drinking it.
•To make sure thatyou have drunk all of the medicine, rinse the glass verywell with half a glass ofwater and drink it.The solid pieces contain the medicine - do not chew or crush them.
Ifyou cannot swallow at all, the capsule 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').
How muchto take
Your doctor will tell you how many capsules to take and how long to take them for. This will depend onyour condition, how old you are and how well your liver works. The usual doses are given below.
To treat heartburn caused by gastro-esophageal reflux disease (GERD):
Adults and children aged 12 or above:
• Ifyour doctor has found that your food pipe (gullet) has been slightly damaged, the usual dose is one Esomeprazole 40 mg Capsule once a dayfor 4 weeks.
Your doctor may tell you to take the same dosefor a further 4weeks ifyour gullet has notyet healed.
• The usual dose once the gullet has healed is one Esomeprazole 20 mg Capsule once a day.
• Ifyour gullet has not been damaged, the usual dose is one Esomeprazole 20 mg Capsule each day. Once the condition has been controlled, your doctor may tell you to takeyour medicine as and whenyou need it, up to a maximum of one Esomeprazole 20 mg Capsule each day.
• Ifyou have severe liver problems,your doctor may give you a lower dose.
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 Capsule twice a dayfor oneweek.
• Your doctor will also tell you to take antibiotics called 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 Capsule once a dayfor 4 to 8 weeks.
To prevent stomach ulcers if you are taking NSAIDs (Non-Steroidal Anti-InflammatoryDrugs):
• Adults aged 18 and above: the usual dose is one Esomeprazole 20 mgCapsule once a day.
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4. POSSIBLE SIDE EFFECTS
Like all medicines, Esomeprazole Capsules can cause side effects, although not everybody gets them.
Ifyou notice any of thefollowing serious side effects, stop taking Esomeprazole and contact a doctor immediately:
• Sudden wheezing, swelling ofyour lips, tongue and throat or body, rash, fainting or difficulties to swallow (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, affecting less than 1 in 1,000 people. Other side effects include:
Common (may affect upto 1 in 10 people):
• Headache.
• Effects onyour stomach or gut: diarrhoea, stomach pain, constipation, wind (flatulence).
• Feeling sick (nausea) or being sick (vomiting).
Uncommon (may affect upto 1 in 100 people):
• Swelling of the feet and ankles.
•Disturbed sleep (insomnia).
• Dizziness, tingling feelings such as 'pins and needles, feeling sleepy.
•Spinningfeeling (vertigo).
• Dry mouth.
• Changes in blood tests that check how the liver is working.
•Skin rash, lumpyrash (hives) and itchy skin.
• Fracture of the hip, wrist or spine.
Rare (may affect up to 1 in 1000 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).
• Generallyfeeling unwell and lacking energy.
•Increased sweating.
Veryrare (may affect up to 1 in 10,000 people):
•Changes in bloodcount 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.
Not known (frequency cannot be estimated from available data):
•If you are on esomeprazole for more than three months if it possible that the levels of magnesium inyour blood may fall.Low levels of magnesium can be seen as fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, increased heart rate. If you get any of these symptoms please tell your doctor promptly.
Low levels of magnesium can also lead to a reduction in potassium or calcium levels in the blood. Your doctor may decide to perform regular blood tests to monitoryour levels of magnesium.
Esomeprazole may in veryrare 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 symptoms of a local infection such as pain in the neck, throat or mouth or difficulties in urinating, you must consult your doctor as soon as possible so that a lack of white bloodcells (agranulocytosis) can be ruled outby a bloodtest.
It is important for you to give information about your medication at this time. Do not be concerned by this list of possible side effects. You may not get any of them. If you get any side effects, talk to your doctor or pharmacist or
5. HOW TO STORE ESOMEPRAZOLE CAPSULES
Keep this medicine out of the sight and reach of children.
Do not use Esomeprazole Capsules after the expiry date which is stated on the bottle label, carton or blister foil after 'EXP'. The expiry date refers to the last day of that month.
Blister: Do not store above 25° C. Store in the original package in order to protect from moisture.
Bottle: Do not store above 25° C. Keep the bottle tightly closed in order to protect from moisture.
Medicines should not be disposed of via wastewater or household waste. Askyour pharmacist how to dispose of medicines no longer required.These measures will help to protect the environment.
6. CONTENTS OFTHE PACK ANDOTHER INFORMATION
What Esomeprazole Capsulescontains
The active substance is esomeprazole. Esomeprazole gastro-resistant Capsules come in two strengths containing 20 mg or 40 mg of esomeprazole (as esomeprazole magnesium).
The other ingredients of the capsule content are:
• Core: sugar spheres (sucrose and maize starch), crospovidone,hydroxypropyl cellulose.
•Sub-coating: mannitol.
• Enteric coating: methacrylic acid - ethyl acrylate polymer (1:1) dispersion 30%, triethyl citrate, glycerol monostearate, polysorbate 80.
• Lubricant: talc
The other ingredients of the capsule shell are iron oxide red E172, Iron oxideyellow E172 (40mg only), titanium dioxide E171, gelatin, water, sodium lauryl sulphate.
The other ingredients of the printing ink are shellac, propylene glycol, concentrated ammonia solution, black iron oxide E172, potassium hydroxide, dehydrated alcohol, isopropyl alcohol, butyl alcohol and purified water.
What Esomeprazole Capsules looks like and contents of the pack
Esomeprazole 20 mg Capsules are hard gelatin capsules with pink cap and pink body, imprinted with 'Mylan' over 'EM 20' in black ink on cap and body filled with white to cream coloured pellets. Esomeprazole 40 mg Capsules are hard gelatin capsules with brown cap and brown body, imprinted with 'Mylan' over 'EM 40' in black ink on cap and body filled with white to cream coloured pellets.
Your capsules will come in blister packs containing
7. 14, 15, 28, 30, 50, 56, 60, 90, 98 and 100 capsules and
in bottles containing 7, 14, 28, 30, 56, 98 and 100 capsules. Not all pack sizes may be marketed.
Marketing Authorisation Holder
Mylan, Potters Bar, Hertfordshire,
EN6 1TL, United Kingdom.
Manufacturer
Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13,Ireland.
Generics [UK] Limited, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom
Mylan Hungary Kft, H-2900 Kom Mylan utca 1, Hungary.
MH/DRUGy25/NKJJ/89
10004714
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