S0533-14-IT-PIL-03.12.2014

PACKAGE LEAFLET:

INFORMATION FOR THE PATIENT

Losec® 10mg hard gastro-resistant capsules (omeprazole)

Your medicine is available by the above name, but will be referred to as Losec throughout the remainder of this leaflet.

Your medicine is available in other strengths -20mg and 40mg.

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

•    Keep this leaflet. 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 pass it on to others. It may harm them, even if their signs of illness are the same as yours.

•    If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. (See section 4).

What is in this leaflet:

1.    What Losec is and what it is used for

2.    What you need to know before you take Losec

3.    How to take Losec

4.    Possible side effects

5.    How to store Losec

6.    Contents of the pack and other information

1. What Losec is and what it is used for

Losec contains the active substance omeprazole. It

belongs to a group of medicines called ‘proton pump

inhibitors’. They work by reducing the amount of acid

that your stomach produces.

Losec is used to treat the following conditions:

In adults:

•    ‘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 upper part of the intestine (duodenal ulcer) or stomach (gastric ulcer).

•    Ulcers which 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.

•    Ulcers caused by medicines called NSAIDs (Non-Steroidal Anti-Inflammatory Drugs). Losec can also be used to stop ulcers from forming if you are taking NSAIDs.

•    Too much acid in the stomach caused by a growth in the pancreas (Zollinger-Ellison syndrome).

In children:

Children over 1 year of age and> 10 kg

•    ‘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.

In children, the symptoms of the condition can include the return of stomach contents into the mouth (regurgitation), being sick (vomiting) and poor weight gain.

Children and adolescents over 4 years of age • Ulcers which are infected with bacteria called ‘Helicobacter pylori’. If your child has this condition, your doctor may also prescribe antibiotics to treat the infection and allow the ulcer to heal.

2. What you need to know before you take Losec

Do not take Losec

•    If you are allergic to omeprazole or any of the other ingredients of this medicine (listed in section 6).

•    If you are allergic to medicines containing other proton pump inhibitors (eg pantoprazole, lansoprazole, rabeprazole, esomeprazole).

•    If you are taking a medicine containing nelfinavir (used for HIV infection)

Do not take Losec if any of the above apply to you.

If you are not sure, talk to your doctor or pharmacist before taking Losec.

Warnings and precautions

Losec may hide the symptoms of other diseases. Therefore, if any of the following happen to you before you start taking Losec 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).

•    You experience severe or persistent diarrhoea, as omeprazole has been associated with a small increase in infectious diarrhoea.

•    You have severe liver problems.

If you take Losec on a long-term basis (longer than 1 year) your doctor will probably keep you under regular surveillance. You should report any new and exceptional symptoms and circumstances whenever you see your doctor.

Taking a proton pump inhibitor like Losec, 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).

Other medicines and Losec

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

This includes medicines that you buy without a prescription. This is because Losec can affect the way some medicines work and some medicines can have an effect on Losec.

Do not take Losec 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:

•    Ketoconazole, itraconazole, posaconazole or voriconazole (used to treat infections caused by a fungus)

•    Digoxin (used to treat heart problems)

•    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 Losec

•    Medicines that are used to thin your blood, such as warfarin or other vitamin K blockers. Your doctor may need to monitor you when you start or stop taking Losec

•    Rifampicin (used to treat tuberculosis)

•    Atazanavir (used to treat HIV infection)

•    Tacrolimus (in cases of organ transplantation)

•    St John’s wort (Hypericum perforatum) (used to treat mild depression)

•    Cilostazol (used to treat intermittent claudication)

•    Saquinavir (used to treat HIV infection)

•    Clopidogrel (used to prevent blood clots (thrombi))

•    Erlotinib (used to treat cancer)

•    Methotrexate (a chemotherapy medicine used in high doses to treat cancer) - if you are taking a high dose of methotrexate, your doctor may temporarily stop your Losec treatment

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

Losec with food and drink

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

Pregnancy, breastfeeding and fertility

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

Omeprazole is excreted in breast milk but is not likely to influence the child when therapeutic doses are used. Your doctor will decide whether you can take Losec if you are breastfeeding.

Driving and using machines

Losec is not likely to affect your ability to drive or use any tools or machines. Side effects such as dizziness and visual disturbances may occur (see section 4). If affected, you should not drive or operate machinery.

Losec capsules contain lactose

Losec capsules contain lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

How to take Losec

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

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 old you are.

The usual doses are given below.

Adults:

To treat symptoms of GORD such as heartburn and acid regurgitation:

•    If your doctor has found that your food pipe (gullet) has been slightly damaged, the recommended dose is 20 mg once a day for 4-8 weeks. Your doctor may tell you to take a dose of 40 mg for a further 8 weeks if your gullet has not yet healed.

•    The recommended dose once the gullet has healed is 10 mg once a day.

•    If your gullet has not been damaged, the usual dose is 10 mg once a day.

To treat ulcers in the upper part of the intestine

(duodenal ulcer):

•    The recommended dose is 20 mg once a day for 2 weeks. Your doctor may tell you to take the same dose for a further 2 weeks if your ulcer has not yet healed.

•    If the ulcers do not fully heal, the dose can be increased to 40 mg once a day for 4 weeks.

To treat ulcers in the stomach (gastric ulcer):

•    The recommended dose is 20 mg once a day for 4 weeks. Your doctor may tell you to take the same dose for a further 4 weeks if your ulcer has not yet healed.

•    If the ulcers do not fully heal, the dose can be increased to 40 mg once a day for 8 weeks.

To prevent the duodenal and stomach ulcers from coming back:

•    The recommended dose is 10 mg or 20 mg once a day. Your doctor may increase the dose to 40 mg once a day.

To treat duodenal and stomach ulcers caused by NSAIDs (Non-Steroidal Anti-Inflammatory Drugs):

•    The recommended dose is 20 mg once a day for 4-8 weeks.

To prevent duodenal and stomach ulcers if you are taking NSAIDs:

•    The recommended dose is 20 mg once a day.

To treat ulcers caused by Helicobacter pylori

infection and to stop them coming back:

•    The recommended dose is 20 mg Losec twice a day for one week.

•    Your doctor will also tell you to take two antibiotics among amoxicillin, clarithromycin and metronidazole.

To treat too much acid in the stomach caused by a growth in the pancreas (Zollinger-Ellison syndrome):

•    The recommended dose is 60 mg daily.

•    Your doctor will adjust the dose depending on your needs and will also decide how long you need to take the medicine for.

Children:

To treat symptoms of GORD such as heartburn and acid regurgitation:

•    Children over 1 year of age and with a body weight of more than 10 kg may take Losec. The dose for children is based on the child’s weight and the doctor will decide the correct dose.

To treat ulcers caused by Helicobacter pylori

infection and to stop them coming back:

•    Children aged over 4 years may take Losec. The dose for children is based on the child’s weight and the doctor will decide the correct dose.

•    Your doctor will also prescribe two antibiotics called amoxicillin and clarithromycin for your child.

Taking this medicine

•    It is recommended that you take your capsules in the morning.

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

•    Swallow your capsules whole with half a glass of water. 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 or your child have trouble swallowing the capsules

•    If you or your child have trouble swallowing the capsules:

Open the capsules and swallow the contents directly with half a glass of water or put the contents into a glass of still (non-fizzy) water, any acidic fruit juice (e.g. apple, orange or pineapple) or apple sauce.

Always stir the mixture just before drinking it (the mixture will not be clear). Then drink the mixture straight away or within 30 minutes.

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 take more Losec than you should

If you take more Losec than prescribed by your doctor, talk to your doctor or pharmacist straight away.

If you forget to take Losec

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 to make up for a forgotten dose.

Possible side effects

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

If you notice any of the following rare but serious side effects, stop taking Losec 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.

Other side effects include:

Common side effects (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 side effects (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).

•    Changes in blood tests that check how the liver is working.

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

•    Generally feeling unwell and lacking energy.

Rare side effects (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.

•    Allergic reactions, sometimes very severe, including swelling of the lips, tongue and throat, fever, wheezing.

•    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).

•    Dry mouth.

•    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).

•    Severe kidney problems (interstitial nephritis).

•    Increased sweating.

Very rare side effects (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.

•    Enlarged breasts in men.

Not known (frequency cannot be estimated from the available data)

•    Inflammation in the gut (leading to diarrhoea).

•    If you are on Losec 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 or 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.

Losec 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 medicine at this time.

S0533-14-IT-PIL-03.12.2014

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.aov.uk/vellowcard. By reporting side effects, you can help provide more information on the safety of this medicine.

How to store Losec

•    Keep out of the sight and reach of children.

•    Do not use Losec after the expiry date which is stated on the pack after EXP. The expiry date refers to the last day of that month.

•    Do not store above 30°C.

•    Store this blister in the original package in order to protect from moisture.

•    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.

•    If your medicine becomes discoloured or shows any signs of deterioration, you should seek the advice of your pharmacist.

6. Contents of the pack and other information

What Losec contains

•    Each hard gastro-resistant capsule contains 10 mg of omeprazole.

•    The other ingredients are disodium phosphate dihydrate, hydroxypropylcellulose, hypromellose, lactose anhydrous, magnesium stearate, mannitol, methacrylic acid - ethyl acrylate copolymer (1:1) dispersion 30 per cent, cellulose microcrystalline, macrogol (polyethylene glycol 400), sodium laurilsulfate, iron oxide E172, titanium dioxide E171, gelatine, printing ink (containing shellac, ammonia, potassium hydroxide, black iron oxide E172), silica colloidal anhydrous and liquid paraffin.

What Losec looks like and contents of the pack

•    Hard gelatine capsules with an opaque pink body, marked 10 and an opaque pink cap marked A/OS, containing enteric coated pellets.

Pack sizes:

Blisters of 14 capsules.

Manufacturer

AstraZeneca AB, Gartunavagen, SE-151 85, Sodertalje, Sweden.

To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge: 0800 198 5000 (UK only)

Please be ready to give the following information:

Product name Reference number

Losec 10 mg Capsules 33902/0533

This is a service provided by the Royal National

Institute of Blind People.

Procured from within the EU and repackaged by:

Amimed Direct Ltd, Hendon, London, NW9 6AQ.

Product Licence Holder: Sam Pharma Ltd, Unit 20 Garrick Industrial Estate, Irving Way, Hendon, London, NW9 6AQ.

PL No: 33902/0533    POM

Leaflet revision date: 03/12/2014

Losec® is a registered trademark of the AstraZeneca group of companies.