Lansoprazole 30 Mg Gastro-Resistant Capsules
Iteva UK Ref: 231-30-51036-D LEA LANSOPRAZOLE 15MG & 30MG GR CAPS TUK <ZAR Verson: 2 14 March 2016
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Lansoprazole 15 mg Gastro-resistant Capsules
Lansoprazole 30 mg Gastro-resistant Capsules
Lansoprazole
Package leaflet: Information for the user
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 Lansoprazole Gastro-resistant Capsules are and what they are used for
2. What you need to know before you take Lansoprazole Gastro-resistant Capsules
3. How to take Lansoprazole Gastro-resistant Capsules
4. Possible side effects
5. How to store Lansoprazole Gastro-resistant Capsules
6. Contents of the pack and other information
OWhat Lansoprazole Gastro-resistant Capsules are and what they are used for
Lansoprazole belongs to a group of medicines called proton pump inhibitors. Proton pump inhibitors like lansoprazole, reduce the amount of acid that your stomach makes.
You have been given lansoprazole because you have a condition caused by stomach acid.
Your doctor may prescribe Lansoprazole for:
• treatment of ulcers in your stomach or duodenum
• treatment or prevention of inflammation in your oesophagus (gullet). This is called Gastroesophageal Reflux Disease.
• treatment of infection caused by the bacteria Helicobacter pylori together with suitable antibiotics in the treatment of ulcers in the stomach or duodenum (eradication therapy)
• relieving you from the unpleasant symptoms that often occur with these conditions • stopping these conditions coming back • treatment or prevention of ulcers in stomach or duodenum in patients requiring continued NSAID treatment (NSAID treatment is used against pain or inflammation)
• treatment of heartburn and acid regurgitation • Lansoprazole is sometimes given to patients whose stomach makes too much acid; this includes a condition called Zollinger-Ellison syndrome.
Your doctor may have prescribed Lansoprazole Gastro-resistant Capsules for another indication or with a dose different from that which is written in this information leaflet. Please follow your doctor's instructions for taking your medicine.
^2 What you need to know before you take Lansoprazole Gastro-resistant Capsules Do not take Lansoprazole Gastro-resistant Capsules: • if you are allergic to lansoprazole or to any of the ingredients of this medicine (listed in section 6.)
• if you are taking a medicine containing the active substance atazanavir (used in the treatment of HIV).
Warning and precautions
Talk to your doctor or pharmacist before taking Lansoprazole Gastro-resistant Capsules:
• if you suffer from liver problems, the doctor may have to adjust your dosage • treatment with Lansoprazole may lead to a slightly increased risk of gastrointestinal infections such as Salmonella and Campylobacter, contact your doctor immediately if diarrhoea occurs during the treatment with Lansoprazole Gastro-resistant Capsules.
• if your doctor has given you Lansoprazole Gastro-resistant Capsules in addition to other medicines intended for the treatment of Helicobacter pylori infection (antibiotics) or together with anti-inflammatory medicines to treat your pain or rheumatic disease: please also read the package leaflets of these medicines carefully
• if you are going to have an operation and anaesthetic (including at the dentist). Tell your doctor or dentist that you are taking Lansoprazole Gastro-resistant Capsules.
• if you take lansoprazole on a long-term basis (longer than 1 year) your doctor will probably ask to see you regularly so he can check how well you are doing. Tell your doctor if you notice any symptoms concerning your sight or if any of your other symptoms are getting worse.
• if you have ever had a skin reaction after treatment with a medicine similar to Lansoprazole Gastro-resistant Capsules that reduces stomach acid.
If you get a rash on your skin, especially in areas exposed to the sun tell your doctor as soon as you can, as you may need to stop your treatment with Lansoprazole Gastro-resistant Capsules. Remember to also mention any other ill-effects like pain in your joints.
Taking a proton pump inhibitor like Lansoprazole Gastro-resistant Capsules, 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).
Your doctor may arrange for you to have an endoscopic examination (where a very small camera is inserted down your oesophagus (food pipe)) to look into your stomach. This will help find out what is causing your symptoms. It can help to exclude more serious causes of your symptoms such as stomach cancer.
Other medicines and Lansoprazole Gastro-resistant Capsules
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without prescription. In particular, tell your doctor if you are taking any of the following medicines:
• theophylline, which is sometimes used to treat asthma
• antacids, which are used to treat heartburn or acid regurgitation
• sucralfate, which is used for healing ulcers
• fluvoxamine, which is sometimes used to treat depression
• St John's Wort (Hypericum perforatum), which is sometimes used to treat mild depression
• ketoconazole and itraconazole, which are used to treat fungal infections
• rifampicin, which is used to treat infections
• digoxin, which is used to treat heart problems
• protease inhibitors, which are used to treat viral infections
• macrolides, which are used to treat bacterial infections
• tacrolimus, which is used to control body immune response after organ transplantation.
Lansoprazole Gastro-resistant Capsules with food and drink
Lansoprazole Gastro-resistant Capsules should be taken on an empty stomach (at least 30 minutes before food).
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby ask your doctor or pharmacist for advice before taking this medicine.
Your doctor will decide if you should take Lansoprazole Gastro-resistant Capsules.
Driving and using machines
If you experience side effects such as dizziness, vertigo, tiredness and visual disturbances, your ability to react may be decreased.
This should be taken into account when driving or using machines.
You alone are responsible to decide if you are in a fit condition to drive a motor vehicle or perform other tasks that demand increased concentration.
Because of their effects or undesirable effects, one of the factors that can reduce your ability to do these things safely is your use of medicines. Descriptions of these effects can be found in other sections.
Read all the information in this leaflet for guidance. Discuss with your doctor, nurse or pharmacist if you are unsure about anything.
Lansoprazole Gastro-resistant Capsules contains sucrose
Lansoprazole Gastro-resistant Capsules contain sucrose.
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 Lansoprazole Gastro-resistant Capsules Swallow the capsule whole. If you find the capsules difficult to take, a drink of water at the same time might make it easier. DO NOT crush or chew these capsules because this will stop them from working properly.
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
If you are taking Lansoprazole Gastro-resistant Capsules once a day, try to take it at the same time each day. You may get best results if you take Lansoprazole Gastro-resistant Capsules first thing in the morning.
If you are taking Lansoprazole Gastro-resistant Capsules twice a day, you should have the first dose in the morning and the second dose in the evening. The usual doses of Lansoprazole Gastro-resistant Capsules for adults are given below. Sometimes your doctor will prescribe you a different dose and will tell you how long your treatment will last.
If you have liver problems your doctor may limit your dose to one capsule a day.
The recommended dose is:
Healing of stomach ulcers
The recommended dose is one 30 mg capsule every day for 4 weeks.
Prevention of an ulcer and relief of symptoms while you take an NSAID
The recommended dose is one 15 mg every day; your doctor may adjust your dose to one 30 mg capsule every day.
Treatment of inflammation of your oesophagus (Gastroesophageal reflux disease)
The recommended dose is one 30 mg capsule a day for 4 weeks to heal your oesophagus and/or relieve symptoms.
Long term prevention of reflux oesophagitis
The recommended dose is one 15 mg capsule every day; your doctor may adjust your dose to one 30 mg capsule every day.
Duodenal ulcers
The recommended dose is one 30 mg capsule every day for 2 weeks. Your doctor might prescribe a further 15 mg capsule every day to prevent your ulcer coming back.
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Treatment of stomach and duodenal ulcers caused by an NSAID
The recommended dose is one 30 mg capsule every day for 4 weeks.
Treatment of heartburn and acid regurgitation
The recommended dose is one 15 mg or 30 mg capsule for 4 weeks. If symptoms persist you should report to your doctor. If your symptoms are not relieved within 4 weeks, please contact your doctor.
Zollinger-Ellison syndrome (a condition where your stomach makes too much acid)
The usual dose is two 30 mg capsules every day to start with. Your doctor may then change your dose depending on how you respond to the dose that your doctor decides is best for you.
Eradication of Helicobacter pylori bacterium The recommended dose is one 30 mg capsule twice daily for 1 week in combination with one of the following three combinations with two different antibiotics in the evening:
• amoxicillin 1 g twice daily + clarithromycin 250-500 mg twice daily
• clarithromycin 250 mg twice daily + metronidazole 400-500 mg twice daily
• amoxicillin 1 g twice daily + metronidazole 400-500 mg twice daily.
Treatment will usually be every day for 7 days.
If you are being treated for infection because you have an ulcer, it is unlikely that your ulcer will return if the infection is successfully treated. To give your medicine the best chance of working, take it at the right time and do not miss a dose.
Please read the package leaflet of the antibiotics for further information.
Use in children
Lansoprazole capsules are not recommended for children, ask your doctor for advice.
If you take more Lansoprazole Gastro-resistant Capsules than you should
If you take more Lansoprazole Gastro-resistant Capsules than you have been told to, consult your doctor or pharmacist immediately.
If you forget to take Lansoprazole Gastro-resistant Capsules
Do not take a double dose to make up for a forgotten dose. If you forget to take a dose, take it as soon as you remember unless it is nearly time for your next dose and continue as normal.
If you stop taking Lansoprazole Gastro-resistant Capsules
You should continue to take this medicine for as long as your doctor has told you. DO NOT stop treatment early because your symptoms have got better. Your condition may not have been fully healed and may reoccur if you do not finish your course of treatment. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. These are usually mild and go away when you stop taking this medicine.
The following are very serious and if you experience it you should seek urgent medical attention: Uncommon: may affect up to 1 in 100 people
• changes in the blood count with reduction in the blood platelet count, an increase in the number of certain white blood cells (eosinophilia), a reduction in the number of all white blood cells
Rare: may affect up to 1 in 1,000 people
• An allergic reaction (angioedema): e.g. swelling of the face, lips, tongue or throat, or difficulty breathing or swallowing.
• a decrease in the volume of urine, darkening in colour of urine, blood in your urine, or having difficulty in passing urine (inflammation of the kidneys)
• yellow discolouration to white of eyes or yellowing of skin (jaundice)
• severe pain in the back (inflammation of the pancreas)
• inflammation of the liver (hepatitis)
• seeing things that are not there (hallucinations)
• confusion
• skin bleeding
Very rare: may affect up to 1 in 10,000 people
• target shaped rash which develops in to blistered skin that falls off in sheets (Stevens-Johnson syndrome)
• serious illness with blistering of the skin (toxic epidermal necrolysis)
• severe reduction in certain white blood cells (agranulocytosis), a reduced production of all blood cells (signs including sudden fever, sore throat, tiredness, unexplained bruising or bleeding, mouth ulcers).
• severe fever, difficulty in breathing, swelling of lips, face, mouth (allergic shock)
• severe pain in the abdomen (inflammation of the large intestine)
Not known: frequency cannot be estimated from available data
• 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.
• rash, possibly with pain in the joints Other side effects include:
Common: may affect up to 1 in 10 people
- nausea, vomiting, diarrhoea, stomach ache,
constipation, wind, dry or sore mouth or throat
- skin rash, nettle rash, itching
- headaches, dizziness
- changes in liver enzyme values
- tiredness
Uncommon: may affect up to 1 in 100 people
- depression
- fluid retention or swelling
- slight increase in the risk of hip, wrist or spine fractures if you take Lansoprazole Gastro-resistant Capsules over a period of more than one year
Rare: may affect up to 1 in 1,000 people
- fungal infections of the gullet, inflammation of the tongue (glossitis), a change in the way things taste
- hair loss, excessive sweating, reddening of the skin, nettle-like rash, bruising, sensitivity to light
- restlessness, drowsiness, light-headedness, trembling, numbness/pins and needles.
- sleep disturbances
- anaemia (reduction in a number of red blood cells)
- visual disturbances
- fever, loss of apetite, impotence
- muscle and joint pain
Very rare: may affect up to 1 in 10,000 people
- inflammation of the mucous membrane of the mouth.
- enlargement of the male breast gland, milky secretions from the nipple.
- increased cholesterol and blood lipid values.
If you are on Lansoprazole Gastro-resistant Capsules 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.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist.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.gov.uk/yellowcard By reporting side effects you can help provide more information on the safety of this medicine.
©How to store Lansoprazole Gastro-resistant capsules Do not store above 30°C.
Keep this medicine out of the sight and reach of children.
Do not use Lansoprazole Gastro-resistant capsules after the expiry date stated on the carton after EXP. The expiry date refers to the last day of that month. Do not use Lansoprazole Gastro-resistant Capsules if you notice any visible signs of deterioration.
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.
©Contents of the pack and other information
What Lansoprazole Gastro-resistant Capsules contain
• The active substance is lansoprazole.
• The other ingredients are sugar spheres (sucrose, corn starch), sodium starch glycolate, sodium laurilsulfate, povidone, trisodium phosphate, hypromellose, methacrylic acid -ethyl acrylate copolymer 1:1, triethyl citrate, titanium dioxide (E171), talc.
• The capsule shells contain: gelatine, titanium dioxide (E171), water.
• The printing ink on the capsules contains the following additional ingredients: shellac, ethyl alcohol anhydrous, isopropyl alcohol propylene glycol, N-butyl alcohol, ammonium hydroxide, potassium hydroxide, black iron oxide (E172). What Lansoprazole Gastro-resistant Capsules look like and contents of the pack
• A hard gelatine capsule with an opaque white cap marked using black ink with" L" and opaque white body marked using black ink with 15. It contains white to beige gastro-resistant microgranules of 15 mg lansoprazole.
• A hard gelatine capsule with an opaque white cap marked using black ink with "L" and opaque white body marked using black ink with 30. It contains white to beige gastro-resistant microgranules of 30 mg lansoprazole.
• Lansoprazole 15 mg Gastro-resistant Capsules are supplied in blisters and bottles of 7, 14, 28 or 56 (2 x 28) gastro-resistant capsules.
• Lansoprazole 30 mg Gastro-resistant Capsules are supplied in blisters and bottles of 7, 14, 28 or 56 (2 x 28) gastro-resistant capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder:
PLIVA Pharma Ltd Ridings Point, Whistler Drive Castleford, West Yorkshire,
WF10 5HX United Kingdom.
Manufacturer:
Teva Pharma S.L.U,
Poligono Industrial Malpica, calle C,
50016 Zaragoza,
Spain
This leaflet was last revised in March 2016
PL 10622/0308-9
■EHD
TEVA UK LI HI TED 000000000/P0
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