Esomeprazole 20 mg and 40 mg, gastro-resistant capsules, hard

1.3.1.2 - Package Leaflet (English version)

Package leaflet: Information for the user Ventra 20 mg gastro-resistant capsules, hard Ventra 40 mg gastro-resistant capsules, hard

Esomeprazole

What is in this leaflet

1.    What VENTRA is and what it is used for

2.    What you need to know before you take VENTRA

3.    How to take VENTRA

4.    Possible side effects

5.    How to store VENTRA

6.    Contents of the pack and other information

1.    What VENTRA is and what it is used for

Ventra contains a medicine called esomeprazole, which belongs to a group of medicines called ’proton pump inhibitors’. They work by reducing the amount of acid that your stomach produces.

Ventra is used to treat the following conditions:

-    ‘Gastro-oesophageal reflux disease’ (GERD). 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.

-    Stomach ulcers caused by medicines called NSAIDs (Non-Steroidal Anti-Inflammatory Drugs). Ventra 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.

2.    What you need to know before you take VENTRA Do not take VENTRA:

-    if you are allergic to esomeprazole or any of the other ingredients of this medicine (listed in Section 6).

-    if you are allergic to other proton pump inhibitor medicines.

-    if you are taking a medicine containing nelfinavir (used to treat HIV).

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

Warnings and precautions

Check with your doctor or pharmacist before taking Ventra:

-    if you have severe liver problems.

-    if you have severe kidney problems.

Ventra may hide the symptoms of other diseases. Therefore, if any of the following happen to you before you start taking Ventra or while you are taking it, talk to your doctor straight away:

-    you lose a lot of weight 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) or if you have diarrhoea.

Taking a proton pump inhibitor like Ventra, especially over a period of more than one year, may slightly increase your risk of fracture in the hip, wrist or spine. Tell your doctor if you have osteoporosis or if you are taking corticosteroids (which can increase the risk of osteoporosis).

If you have been prescribed Ventra “on demand” you should contact your doctor if your symptoms continue or change in character.

Talk to your doctor, pharmacist or nurse before taking VENTRA.

Other medicines and VENTRA

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is because Ventra can affect the way some medicines work and some medicines can have an effect on Ventra.

Do not take Ventra 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 Ventra.

-    Medicines that are used to thin your blood, such as warfarin. Your doctor may need to monitor you when you start or stop taking Ventra.

-    Cisapride (used for indigestion and heartburn).

-    Digoxin (used for heart problems).

-    Rifampicin (used for treatment of tuberculosis).

-    St. John’s wort (Hypericumperforatum) (used to treat depression).

If your doctor has prescribed the antibiotics amoxicillin and clarithromycin as well as Ventra to treat ulcers caused by Helicobacter pylori infection, it is very important that you tell your doctor about any other medicines you are taking.

VENTRA with food and drink

You can take your capsules with food or on an empty stomach.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

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

Driving and using machines

Ventra is not likely to affect your ability to drive or use any tools or machines.

VENTRA contains sucrose and parahydroxybenzoates

Ventra contains sucrose, which is a type of sugar, propyl-p-hydroxybenzoate (E216) and methyl-p-hydroxybenzoate (E218):

-    If you have been told by your doctor that you have an intolerance to some sugars, talk to your doctor before taking this medicine,

-    Parahydroxybenzoates may cause allergic reactions (possibly delayed).

3. How to take VENTRA

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

-    Ventra is not recommended for children less than 12 years old.

-    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.

Taking this medicine

-    You can take your capsules at any time of the day.

-    You can take your capsules with food or on an empty stomach.

-    Swallow your capsules whole with a glass of water. Do not chew or crush the capsules or their contents. This is because the capsules contain coated granules which stop the medicine from being broken down by the acid in your stomach. It is important not to damage the granules.

What to do if you have trouble swallowing the capsules

-    If you have trouble swallowing the capsules:

1)    Open the capsule carefully above a glass of still (non-fizzy) water and empty the content of the capsule (granules) into the glass. Do not use any other liquids.

2)    Stir. Then drink the mixture straight away or within 30 minutes. Always stir the mixture just before drinking it.

3)    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 content of 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 much to take

-    Your doctor will tell you how many capsules to take and how long to take them for. This will depend on your condition and how well your liver works.

-    The usual doses are given below.

To treat heartburn caused by gastro-oesophageal reflux disease (GERD):

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 capsule of Ventra 40 mg 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 capsule of Ventra 20 mg once a day.

-    If your gullet has not been damaged, the usual dose is one capsule Ventra 20 mg 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 capsule of Ventra 20 mg each day.

-    If you 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 aged 18 or above: the usual dose is one capsule of Ventra 20 mg twice a day for one week.

-    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 capsule of Ventra 20 mg 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 capsule of Ventra 20 mg 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 capsule of Ventra 40 mg 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 capsule of Ventra 40 mg once a day for 4 weeks.

If you take more VENTRA than you should

Talk to your doctor or pharmacist straight away.

If you forget to take VENTRA

-    If you forget to take a dose, take it as soon as you remember it. 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.

4. Possible side effects

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

If you notice any of the following serious side effects, stop taking Ventra and contact a doctor immediately:

-    Sudden wheezing, swelling of your 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 1 to 10 users in 10,000.

Other side effects include:

Common (may affect up to 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 (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.

Rare (may affect up to 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 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

-    Low levels of magnesium in the blood. This may cause weakness, being sick (vomiting), cramps, tremor and arrhythmias (heart rhythm disturbances).

If you are on Ventra for more than three months it is possible that the levels of magnesium in your 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 monitor your levels of magnesium.

Ventra 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.

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.

5.    How to store VENTRA

-    Keep this medicine out of the sight and reach of children.

-    Do not store above 25°C

-    Keep this medicine in the original container (blister) or keep the container tightly closed (bottle) in order to protect from moisture.

-    Do not use Ventra after the expiry date shown on the carton or bottle or blister foil. The expiry date refers to the last day of that month.

-    After opening of the bottle, the capsules should be used within 3 months.

-    Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What VENTRA contains

-    The active substance is esomeprazole.

Ventra capsules come in two strengths containing 20 mg or 40 mg of esomeprazole (as magnesium dihydrate).

-    The other ingredients are:

Capsule content:

sugar spheres (sucrose and maize starch), hypromellose, dimethicone emulsion 35% (containing dimethicone, propyl-p-hydroxybenzoate (E216), methyl-p-hydroxybenzoate (E218), sorbic acid, sodium benzoate, polyethylene glycol sorbitan monolaureate, octylphenoxy polyethoxy ethanol and propylene glycol), polysorbate 80, mannitol, diacetylated monoglycerides, talc, methacrylic acid-ethyl acrylate copolymer (1:1) dispersion 30 % (containing copolymer of methacrylic acid and ethyl acrylate, sodium lauryl sulfate and polysorbate 80), triethyl citrate and stearoyl macrogolglycerides.

Capsule shell:

black iron oxide (E 172), shellac, gelatin, yellow iron oxide (E 172) and titanium dioxide (E 171)

What VENTRA looks like and contents of the pack

-    Ventra 20 mg capsules have an opaque yellow cap and an opaque white body. “20 mg” is printed in black both on the cap and on the body.

-    Ventra 40 mg capsules have an opaque yellow cap and an opaque yellow body. “40 mg” is printed in black both on the cap and on the body.

-    Your capsules will come in packs of:

Bottles of 28, 30, 90 or 98 capsules

Blisters of 3, 7, 14, 15, 25, 28, 30, 50, 56, 60, 90, 98, 100 or 140 capsules Not all pack size may be marketed.

Marketing Authorisation Holder

Ethypharm

194, Bureaux de la Colline - Batiment D 92213 Saint-Cloud Cedex - FRANCE

Manufacturer

ETHYPHARM Z.I. de Saint-Arnoult

28170 Chateauneuf-en-Thymerais - FRANCE

Or

ETHYPHARM

Chemin de la Poudriere

76120 Grand-Quevilly - FRANCE

Or

FAMAR L'AIGLE

Zone industrielle N°1, Route de Crulai 61300 L'Aigle - FRANCE

Or

LAPHAL INDUSTRIES 248 avenue de la Victoire 13106 Rousset - FRANCE

Or

ROTTENDORF PHARMA Zone industrielle N°2 de Prouvy - Rouvignies 1, rue de Nungesser 59121 Prouvy - FRANCE

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

Iceland Esoprax UK    Ventra

This leaflet was last revised in 05/2012.

Edition 05/2012 7/7