Esomeprazol ratiopharm 20 mg, maagsapresistente tabletten

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 rebleeding of ulcers with intravenous Esomeprazole.

Do not take Esomeprazole Tablets if you

• are allergic (hypersensitive) to esomeprazole or any of the other ingredients of this medicine (listed in Section 6: Further information).
• 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 apply 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 an intolerance to some sugars, talk to your doctor before taking this medicine.

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.

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:
  • 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 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):

Adults 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.

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.

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

Other side effects include:

Common (affects less than 1 in 10 people)

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

Uncommon (affects less than 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 your liver is working.

- Skin rash, lumpy rash (hives) and itchy skin.

Rare (affects less than 1 in 1,000 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 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.
• Hair loss (alopecia).
• Skin rash on exposure to sunshine.
• Joint pain (arthralgia) or muscle pain (myalgia).
• Generally feeling unwell and lacking energy.
• Increased sweating.

Very rare (affects less than 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 pain (Erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Muscle weakness.
• Severe kidney problems.
• Enlarged breasts in men.
• Low levels of magnesium in the blood. This may cause weakness, being sick (vomiting), cramps, tremor and arrhythmias (heart rhythm disturbances).

Esomeprazole Tablets may 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 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 blood cells (agranulocytosis) can be ruled out by a blood test.

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 any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Keep out of the reach and sight of children.

Do not use Esomeprazole Tablets after the expiry date which is stated on the carton and blister/bottle after EXP. The expiry date refers to the last day of that month.

Store in the original package in order to protect from light and moisture.

Bottle: Shelf life after first opening: 100 days

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.

What Esomeprazole Tablets contains

• The active substance is esomeprazole. Esomeprazole gastro-resistant tablets come in two strengths containing 20 mg or 40 mg of esomeprazole (as esomeprazole magnesium).
• The other ingredients are: cellulose, microcrystalline; talc; lactose monohydrate; maize starch; macrogol 8.000; methacrylic acid - ethyl acrylate copolymer (1:1); sodium laurilsulfate; polysorbate 80; copovidone; crospovidone type A; sugar spheres (sucrose and maize starch); povidone; hypromellose; light magnesium oxide; magnesium stearate; diethyl phthalate; silica, colloidal anhydrous; titanium dioxide (E171); ethylcellulose; iron oxide red (E172); Opacode S-1-17823 black ink containing iron oxide black (E 172), shellac, propylene glycol and ammonium hydroxide.

What Esomeprazole Tablets looks like and contents of the pack

Esomeprazole 20 mg gastro-resistant tablets:

Brick red coloured, round shape, biconvex, film-coated tablet, imprinted with “20” on one side.

Esomeprazole 40 mg gastro-resistant tablets:

Brick red coloured, round shape, bevelled edge, biconvex, film-coated tablet, imprinted with “40” on one side.

Pack sizes:

20 mg

• blisters: 7, 14, 15, 28, 30, 50, 56, 60, 90, 98, 100, 100x1
• bottles: 100, 150

40 mg

• blisters: 7, 14, 15, 28, 30, 50, 56, 60, 90, 98, 100, 100x1
• bottles: 100, 150

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

ratiopharm Nederland bv

Swensweg 5

2031 GA Haarlem

Manufacturer

Teva Pharma B.V.

Swensweg 5

2031 GA Haarlem

Merckle GmbH

Ludwig-Merckle-Strasse 3

D-89143 Blaubeuren

Germany

Teva Santé

Rue Bellocier

89107 Sens

France

Marketing authorisation numbers

Esomeprazol ratiopharm 20 mg, maagsapresistente tabletten 107382

Esomeprazol ratiopharm 40 mg, maagsapresistente tabletten 107383

This medicinal product is authorised in the Member States of the EEA under the following names:

This leaflet was last approved in december 2012

August 2011