Losec Mups 10mg Tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER
LOSEC® MUPS® 10MG TABLETS LOSEC® MUPS® 20MG TABLETS
(omeprazole magnesium)
Your medicine is available using the names Losec MUPS 10mg Tablets and Losec MUPS 20mg Tablets but will be referred to as Losec MUPS Tablets throughout this leaflet.
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 any further questions, ask your doctor or pharmacist.
■ This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
■ 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.
In this leaflet:
1. What Losec MUPS Tablets are and what they are used for
2. Before you take Losec MUPS Tablets
3. How to take Losec MUPS Tablets
4. Possible side effects
5. How to store Losec MUPS Tablets
6. Further information
1. What Losec MUPS Tablets are and what they are used for
Losec MUPS Tablets contain 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 MUPS Tablets are 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 MUPS Tablets 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. Before you take Losec MUPS Tablets Do not take Losec MUPS Tablets
■ If you are allergic (hypersensitive) to omeprazole or any of the other ingredients of Losec MUPS Tablets.
■ If you are allergic to medicines containing other proton pump inhibitors (e.g. pantoprazole, lansoprazole, rabeprazole, esomeprazole).
■ If you are taking a medicine containing nelfinavir (for HIV infection).
If you are not sure, talk to your doctor or pharmacist before taking Losec MUPS Tablets.
Take special care with Losec MUPS Tablets
Losec may hide the symptoms of other diseases. Therefore, if any of the following happen to you before you start taking Losec MUPS Tablets 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 MUPS Tablets 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 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 Losec MUPS Tablets can affect the way some medicines work and some medicines can have an effect on Losec MUPS Tablets.
Do not take Losec MUPS Tablets 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 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 MUPS Tablets.
■ 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 MUPS Tablets.
■ Rifampicin (used to treat tuberculosis).
■ Atazanavir (used to treat HIV infections).
■ 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)).
If your doctor has prescribed the antibiotics amoxicillin and clarithromycin as well as Losec MUPS 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 Losec MUPS Tablets with food and drink
You can take your tablets with food or on an empty stomach.
Pregnancy and breast-feeding
Before taking Losec MUPS Tablets, tell your doctor if you are pregnant or trying to get pregnant. Your doctor will decide whether you can take Losec MUPS Tablets during this time.
Your doctor will decide whether you can take Losec MUPS Tablets if you are breastfeeding.
Driving and using machines
Losec MUPS Tablets are 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.
Important information about some of the ingredients of Losec MUPS Tablets
Losec MUPS Tablets contain sucrose, which is a type of sugar. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
3. How to take Losec MUPS Tablets
Always take Losec MUPS Tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Your doctor will tell you how many tablets 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 usual dose is 20mg once a day for 4-8 weeks. Your doctor may tell you to take a dose of 40mg for a further 8 weeks if your gullet has not yet healed.
■ The usual dose once the gullet has healed is 10mg once a day.
■ If your gullet has not been damaged, the usual dose is 10mg once a day.
To treat ulcers in the upper part of the intestine (duodenal ulcer):
■ The usual dose is 20mg 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 ulcer do not fully heal, the dose can be increased to 40mg once a day for 4 weeks.
To treat ulcers in the stomach (gastric ulcer):
■ The usual dose is 20mg 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 ulcer do not fully heal, the dose can be increased to 40mg once a day for 8 weeks.
To prevent the duodenal and stomach ulcers from coming back:
■ The usual dose is 10mg or 20mg once a day. Your doctor may increase the dose to 40mg once a day.
To treat duodenal and stomach ulcers caused by NSAIDs (NonSteroidal Anti-Inflammatory Drugs):
■ The usual dose is 20 mg once a day for 4 to 8 weeks.
To prevent duodenal and stomach ulcers if you are taking NSAIDs:
■ The usual dose is 20mg once a day.
To treat ulcers caused by Helicobacter pylori infection and to stop them coming back:
■ The usual dose is 20mg Losec MUPS Tablets 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 usual dose is 60mg 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 MUPS Tablets. 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 MUPS Tablets. 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 tablets in the morning.
■ You can take your tablets with food or on an empty stomach.
■ Swallow your tablets whole with half a glass 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 or your child have trouble swallowing the tablets
■ If you or your child have trouble swallowing the tablets:
■ Break the tablet and disperse it in a spoonful of water (nonfizzy), any acidic fruit juice (e.g. apple, orange or pineapple) or apple sauce.
■ Always stir the mixture just before drinking (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. Do not use milk or fizzy water. The solid pieces contain the medicine - do not chew or crush them.
If you take more Losec MUPS Tablets than you should
If you take more Losec MUPS Tablets than prescribed by your doctor, talk to your doctor or pharmacist straight away.
If you forget to take Losec MUPS Tablets
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.
POM
4. Possible side effects
Like all medicines, Losec MUPS Tablets can cause side effects, although not everybody gets them.
If you notice any of the following rare but serious side effects, stop taking Losec MUPS 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.
Side effects may occur with certain frequencies, which are defined as follows:
|
Very common: |
affects more than 1 user in 10 |
|
Common: |
affects 1 to 10 users in 100 |
|
Uncommon: |
affects 1 to 10 users in 1,000 |
|
Rare: |
affects 1 to 10 users in 10,000 |
|
Very rare: |
affects less than 1 user in 10,000 |
|
Not known: |
frequency cannot be estimated from the available data |
Other side effects include:
Common side effects
■ Headache.
■ Effects on your stomach or gut: diarrhoea, stomach pain, constipation, wind (flatulence).
■ Feeling sick (nausea) or being sick (vomiting).
Uncommon side effects
■ 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
■ 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
■ 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.
■ Hypomagnesaemia.
Losec MUPS 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 medicine 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.
5. How to store Losec MUPS Tablets
■ Keep all medicines out of the reach and sight of children.
■ Do not store above 25°C.
■ Store in the original container.
■ Do not use after the expiry date printed on the carton or blister strip. The expiry date refers to the last day of that month.
■ Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer required. These measures will help to protect the environment.
6. Further information
What Losec MUPS Tablets contain
Losec MUPS Tablets contain the active ingredient omeprazole magnesium.
Each film-coated tablet also contains microcrystalline cellulose, glyceryl monostearate, hyprolose, hypromellose, magnesium stearate, methylacrylic acid copolymer C, sugar spheres (containing sucrose), paraffin, macrogol, polysorbate, crospovidone, sodium stearyl fumarate, talc, triethyl citrate, iron oxide (E172), titanium dioxide (E171), sodium hydroxide.
Each film-coated tablet of Losec MUPS 10mg Tablets contains 10.3mg of omeprazole magnesium equivalent to 10mg omeprazole as enteric coated granules.
Each film-coated tablet of Losec MUPS 20mg Tablets contains 20.6mg of omeprazole magnesium equivalent to 20mg omeprazole as enteric coated granules.
What Losec MUPS Tablets look like and contents of the pack
Losec MUPS 10mg Tablets are pale pink, film-coated, capsule shaped, marked '10mg' on one side and a logo on the other.
Losec MUPS 20mg Tablets are pink, film-coated, capsule shaped, marked '20mg' on one side and a logo on the other.
Your tablets come in blister packs containing 28 tablets.
Manufacturer
Manufactured by: AstraZeneca AB, S-151 85, Sodertalje, Sweden.
Procured from within the EU and repackaged by: Doncaster Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3 1QR.
Product Licence holder: Landmark Pharma Ltd., 7 Regents Drive, Prudhoe, Northumberland, NE42 6PX.
PL No: 21828/0151: Losec MUPS 10mg Tablets PL No: 21828/0152: Losec MUPS 20mg Tablets
To listen to or request a copy of this leaflet in Braille, large print or audio please call: 01302 365000 and ask for Regulatory Department.
Please be ready to give the following information:
Product name Reference number
Losec MUPS 10mg Tablets 21828/0151
Losec MUPS 20mg Tablets 21828/0152
LOSEC® and MUPS® are registered trademarks of the AstraZeneca group of companies.
Leaflet revision date: 03.11.11.
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