Lansoprazole 15 Mg Gastro-Resistant Capsules
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Lansoprazole I5mg and 30mg Capsules RclOTI " \CtH
(Lansoprazole)
PACKAGE LEAFLET: INFORMATION FOR THE USER
Pregnancy and Breastfeeding:
Tell your doctor ifyou are, you thinkyou might be or are planning to become pregnant. You should not take lansoprazole capsules if you are breast-feeding or are planning to breast-feed your baby.
Read all of this leaflet carefully before you start
taking these capsules
• Keep this leaflet. You may need to read it again.
• If you have any further questions, askyour doctor or pharmacist.
• Your doctor has prescribed these capsules foryou. Do not pass them on to others. They 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 the leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Lansoprazole Capsules are and what they are used for
2. Before you take Lansoprazole Capsules
3. How to take Lansoprazole Capsules
4. Possible side effects
5. Howto store Lansoprazole Capsules
6. Further information
I. What Lansoprazole Capsules are and what they are used for
What are Lansoprazole Capsules for?
The active ingredient, lansoprazole, belongs to a group of medicines called “proton pump inhibitors”. Proton pump inhibitors like lansoprazole reduce the amount of acid thatyourstomach makes.
Lansoprazole is used to treat the following conditions:
• Refiux oesophog/t/s and Oesophagea/ reflux disease, where acid from the stomach escapes into the food pipe causing pain, inflammation and heartburn.
• Acid indigestion (dyspepsia) which can cause stomach pain and/or discomfort.
• Ulcers in the upper part of the intestine (duodenal ulcer) or stomach (gastric ulcer). For patients who have had previous trouble with an ulcer and need to continue therapy with a non-steroidal antiinflammatory drug (NSAID), lansoprazole can heal ulcers or prevent an ulcer developing. In such patients, lansoprazole protects the stomach or duodenum whilst they are taking NSAIDs.
• Zo//inger-£//ison syndrome, when excess stomach acids are produced due to a growth in the pancreas.
2. Before you take Lansoprazole Capsules
Do not take Lansoprazole Capsules:
i • If you are (hypersensitive) allergic to lansoprazole or i any of the other ingredients in lansoprazole capsules. An allergic reaction may include a rash, ! itching, difficulty breathing or swelling in the face lips
throatortongue.
• Ifyou are taking Atazanavir containing medicine.
Take special care with Lansoprazole Capsules:
Tell your doctor before you start taking these Capsules:
• Ifyou have liver problems.
• If you have been told by your doctor that you have an intolerance to some sugars.
• Ifyou are going to have an operation and anaesthetic (including at the dentist).
• Taking a proton pump inhibitor like Lansoprazole, 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).
Taking other medicines:
Please tell your doctor if you are taking any of the following medicines:
• Warfarin (forthinningofthe blood)
• Theophyllin which is used to treat asthma
• The contraception pill
• Other indigestion remedies
• Ketaconazole or Itraconazole
• Atazanavir
• Digoxin
• Sucralfate
• NSAIDs
Please tell your doctor or pharmacist ifyou are taking or have recently taken any other medicines, including medicines obtained without prescription.
Driving and using machines:
Do not drive or operate machinery when taking this medication as it reduces the ability to react.
Important information about some of the ingredients of Lansoprazole Capsules
The product contains sucrose. Ifyou have been told by your doctor thatyou have an intolerance to some sugars contact your doctor before taking this medicine.
3. How to take Lansoprazole Capsules
Always take lansoprazole capsules exactly as your doctor has told you. You should check with your doctor or pharmacist ifyou are not sure.
The capsules should not be chewed or crushed as it will stop them working properly. They should be swallowed whole with a drink of water. If you have trouble swallowing the capsules, open the capsule and mix the granules with some fruit juice or yoghurt and then take immediately.
The dose depends on your condition:-
Treatment for heartburn (Reflux oesophagitis and oesophageal reflux disease)
Take one I5mg or 30mg capsule every day for as long as the doctor prescribes.
Relief of Acid Indigestion (Dyspepsia)
Take one I5mg or 30mg capsule every day for 2 to 4 weeks. If your symptoms do not get better after this time go backtoyourdoctor.
Healing of stomach ulcers
Take one 30mg capsule every day for 8 weeks.
Treatment of ulcers in the upper part of the intestine (duodenal ulcer)
Take one 30mg capsule every day for 4 weeks. Your doctor might prescribe a further I5mg capsules every day to prevent your ulcer coming back.
Gastric ulcer: Take one 30mg capsule daily for 4 weeks and may be continued at a same dose for another two weeks if its not fully healed with in four weeks.
Prevention of an ulcer and associated symptoms whileyoutake NSAIDs
Take one l5mgor 30mg capsule every day for as long as your doctor prescribes.
Stomach ulcers caused by NSAIDs
Take one I5mg or 30mg capsule every day for 4 or 8 weeks. Your doctor might prescribe a further I5mg or
30mg capsules every day to prevent your ulcer or your symptoms coming back.
Zollinger - Ellison Syndrome
Take two 30mg capsules every day. The depending on howyou respond your doctor may change your dose.
If you have liver problems your doctor may limit your dose to one capsule a day.
Lansoprazole capsules are not recommended in children.
If you take more Lansoprazole capsules than you should:
If you swallow too many tablets or someone else accidentally takes your medicine, contact your doctor, pharmacist or nearest hospital straightaway.
If forget to take Lansoprazole capsules:
It is important to remember to take your medicine. If you forget to take a dose, take it as soon as you remember. If it is nearly time for your next dose just take the next dose and forget about the one you missed. Do not take a double dose to make up for forgotten individual doses.
If you stop taking Lansoprazole capsules:
Do not stop taking Lansoprazole capsules without first discussing it with your doctor.
If you have any further questions on the use of Lansoprazole capsules askyour doctor or pharmacist.
• Sweating
• Hair loss
• Tremors
• Electrolyte disturbances
Very rare: (less than I in 10,000 patients)
• Sleepy, confused or hallucinations
• Soreness of mouth and throat or dry mouth
• Sensitivity to light
The natural acid in your stomach helps kill bacteria. Taking medicines like Lansoprazole capsules, which reduce the amount of acid in the stomach, can lead to certain stomach infections. You should see your doctor as soon as possible if you
• Get a very bad or persistent diarrhoea
• Keep being sick (vomiting)
Frequency not known:
If you are on Lansoprazole 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 monitoryour levels of magnesium.
If any of the side effects gets serious or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
4. Possible Side Effects
5. Howto store Lansoprazole Capsules
Like all medicines, Lansoprazole capsules can cause side effects, although not everyone gets them. These side effects are usually mild and go away when you stop taking this medicine.
If any of the following happens, stop taking the capsules and tell your doctor immediately or go to the casualty department atyour nearest hospital:
• An allergic reaction (angioedema) e.g swelling of the face, lips, tongue or throat or difficulty breathing or swallowing.
• Colitis (persistant and severe diarrhoea leading to significant weight loss)
• Jaundice (yellowing of the skin or whites ofthe eyes)
• Severe reddeningand blistering of the skin
• Unexpected bruising or bleeding. The side effects listed above, although serious and requiring medical attention, are extremely rare.
Common: (between I in 10 and I in 100 patients)
Headache, dizziness, tiredness and generally feeling unwell
Abdominal pain, vomiting, sore throat, itching
incommon (Between I in 100 and I in 1000):
Joint pain,swollen limbs, depression, Muscle pain Fracture ofthe hip, wrist or spine.
Rare: (between I in 1000 and I in 10,000 patients)
• Joint and muscle pain, swollen limbs
• Blurred vision
• Larger breasts in women and breast development n men, impotence
• Taste disorders
• Kidney and liver problems
• Pins and needles and numbness
• Skin reactions including skin blistering, urticaria (an itchy rash)
• Stomach upsets including diarrhoea or constipation, feeling or being sick, wind and stomach ache
• Anaemia
• Difficulty in sleeping
• Restless ness
• Fever
Keep out ofthe reach and sight of children.
Do not store above 30°C. Store in the original package. Do not use Lansoprazole Capsules after the expiry date which is stated on the label. The expiry date refers to the lastday of that month.
Medicines should not be disposed of via wastewater or household waste. Askyour pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Further information
What Lansoprazole Capsules contain
The active ingredient is lansoprazole.
The other ingredients are sugar spheres (sucrose and maize starch), sodium starch glycolate, sodium laurilsulfate, povidone, potassium oleate, oleic acid, hypromellose, methacrylic acid, ethyl acrylate copolymer 1:1, triethyl citrate, titanium dioxide (EI7I), talc and gelatine.
The printing ink contains shellac, propylene glycol, ammonium hydroxide, potassium hydroxide, black iron oxide (EI72).
What Lansoprazole I5mg and 30mg Capsules look like and contents of the pack
Each capsule is a gastro resistant hard capsule has a white cap marked with L and white body marked with 15 or 30 contains white and beige gastro-resistant microgranules and I5mgor 30mg lansoprazole.
Marketing Authorisation Holder and Manufacturer
Relonchem Limited, 27, Old Gloucester Street, London, WCI 3XX.
PL20395/0058
PL20395/0059
Date leaflet last revised: May 2012 [POM]