Lansoprazole 15 Mg Gastro-Resistant Capsules
Lansoprazole 15mg and 30mg Gastro-resistant Capsules
(Lansoprazole)
PACKAGE LEAFLET: INFORMATION FOR THE USER
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, ask your doctor or pharmacist.
• Your doctor has prescribed these capsules for you. Do not pass them on to others. They may harm them even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
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. How to store Lansoprazole Capsules
6. Further information
1 What Lansoprazole Capsules are and what they are used 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 that your stomach makes.
Lansoprazole is used for the following:
• Treatment and prevention of reflux oesophagitis (inflammation in your oesophagus) and treatment of gastroesophageal reflux disease, where acid from the stomach escapes into the food pipe causing pain, inflammation and heartburn
• Treatment of 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 anti- inflammatory 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
• Treatment of Zollinger-Ellison Syndrome, when excess stomach acids are produced due to a growth in the pancreas
• Treatment of infections caused by the bacteria Helicobacter pylori when given in combination with antibiotic therapy.
2 Before you take Lansoprazole Capsules Do not take Lansoprazole Capsules:
• If you are allergic (hypersensitive) to lansoprazole or to any of the other ingredients in Lansoprazole Capsules. An allergic reaction may include a rash, itching, difficulty breathing or swelling in the face lips throat or tongue
• If you are taking a medicine containing Atazanavir (used to treat HIV).
Take special care and check with your doctor before taking Lansoprazole Capsules:
• If you have liver problems
• If you have been given lansoprazole in addition to other medicines intended for the treatment of Helicobacter pylori infection (antibiotics): please also read the package leaflet of these medicines carefully
• If you have been told by your doctor that you have an intolerance to some sugars
• 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)
• If you have ever had a skin reaction after treatment with a medicine similar to lansoprazole 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. Remember to also mention any other
ill-effects like pain in your joints.
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.
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 new symptoms or if any of your symptoms are getting worse.
Taking other medicines:
Please tell your doctor if you are taking any of the following medicines:
• Theophylline which is used to treat asthma
• Other indigestion remedies (antacids)
• Ketaconazole, itraconazole, or rifampicin (used to treat infections)
• Atazanavir (used to treat HIV)
• Digoxin (used to treat heart problems)
• Sucralfate (used for healing ulcers)
• Tacrolimus (used to prevent transplant rejection)
• Fluvoxamine (used to treat depression and other psychiatric problems)
• St John’s Wort sometimes called Hypericum perforatum (used to treat mild depression).
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without prescription.
Taking Lansoprazole Capsules with food and drink:
You should take Lansoprazole Capsules at least 30 minutes before food.
Pregnancy and Breastfeeding:
Tell your doctor if you are, you think you might be or are planning to become pregnant or you are breast-feeding.
Driving and using machines: You may feel dizzy, tired, sick, have a headache or problems with your eyesight while taking Lansoprazole Capsules. If this happens, do not drive or use any tools or machines.
Important information about one of the ingredients of Lansoprazole Capsules
The product contains sucrose. If you have been told by your doctor that you 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 if you 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. The usual doses for adults are given below. Your doctor may sometimes prescribe you a different dose and will tell you how long your treatment will last.
If you are taking lansoprazole once a day, take it at the same time every morning before breakfast.
If you are taking lansoprazole twice a day, take the first dose in the morning before breakfast and the second dose in the evening.
Treatment of reflux oesophagitis
Take one 30mg capsule every day for 4 weeks.
Prevention of reflux oesophagitis
Take one 15mg capsule every day. Your doctor may adjust your dose to one 30mg capsule every day.
Treatment of gastroesophageal reflux disease
Take one 15mg or 30mg capsule every day for 4 weeks. If your symptoms do not get better after this time go back to your doctor.
Treatment of stomach ulcers
Take one 30mg capsule every day for 4 weeks.
Treatment of ulcers in the upper part of the intestine (duodenal ulcer)
Take one 30mg capsule every day for 2 weeks.
Prevention of a stomach or duodenal ulcer in patients requiring continued NSAID treatment
Take one 15mg or 30mg capsule every day for as long as your doctor prescribes.
Treatment of stomach or duodenal ulcers in patients requiring continued NSAID treatment
Take one 30mg capsule every day for 4 weeks.
Treatment of infection of Helicobacter pylori: The usual dose is one 30 mg capsule or two 15 mg capsules in combination with two different antibiotics in the morning and one 30 mg capsule or two 15 mg capsules in combination with two different antibiotics in the evening. Treatment will usually be every day for 7 days.
The recommended combinations of antibiotics are:
• 30 mg lansoprazole together with 250-500 mg clarithromycin and 1000 mg amoxicillin
• 30 mg lansoprazole together with 250 mg clarithromycin and 400-500 mg metronidazole.
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.
Zollinger - Ellison Syndrome
Take two 30mg capsules every day. Then depending on how you respond your doctor may change your dose.
Patients with Liver Problems
If you have moderate or severe liver problems your doctor may keep your dose to one capsule a day. Children
Do not give Lansoprazole to children.
If you take more Lansoprazole Capsules than you should:
If you swallow too many capsules or someone else accidentally takes your medicine, contact your doctor, pharmacist or nearest hospital straight away. Remember to take with you any lansoprazole capsules that are left and the pack. This is so the doctor knows what you have taken.
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 ask your doctor or pharmacist.
4. Possible Side Effects
Like all medicines, Lansoprazole Capsules can cause side effects, although not everyone gets them.
If any of the following happens, stop taking the capsules and tell your doctor immediately or go to the casualty department at your nearest hospital:
• An allergic reaction (angioedema) e.g. swelling of the face, lips, tongue or throat or difficulty breathing or swallowing
• Colitis (persistent and severe diarrhoea leading to significant weight loss)
• Jaundice or hepatitis (yellowing of the skin or whites of the eyes)
• Severe reddening, blistering and peeling of the skin
Unexpected bruising or bleeding.
The side effects listed above, although serious and requiring medical attention, are rare or very rare.
Common: (may affect up to 1 in 10 people)
• Headache, dizziness, tiredness and generally feeling unwell
• Abdominal pain, nausea, diarrhoea, constipation, wind, vomiting, dry mouth or throat
• Itching, hives, rash.
Uncommon (may affect up to 1 in 100 people):
• Joint pain, muscle pain
• Swollen limbs due to water retention
• Depression
• Fracture of the hip, wrist or spine.
Rare: (may affect up to 1 in 1000 people)
• Blurred vision
• Larger breasts in women and breast development in men, impotence
• Taste disorders
• Swollen tongue
• Fungal infection of the oesophagus
• Inflammation of the kidneys which can cause swollen ankles and high blood pressure
• Pins and needles and numbness
• Skin reactions including skin blistering, urticaria (an itchy rash), red or purple spots
• Anaemia
• Difficulty in sleeping or sleepiness
• Hallucinations
• Confusion
• Restlessness
• Vertigo
• Fever
• Sweating
• Loss of appetite
• Hair loss
• Tremors
• Sensitivity to light.
Very rare: (may affect up to 1 in 10,000 people)
• Soreness or inflammation of your mouth
• Increased cholesterol and triglyceride levels or low sodium levels.
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 very bad or persistent diarrhoea
• Keep being sick (vomiting).
Frequency not known:
• Rash, possibly with pain in the joints
• 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 monitor your levels of magnesium.
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.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
Keep out of the sight and reach of children.
Do not store above 30oC. Store in the original package. Keep the bottle tightly closed to protect from moisture.
Do not use Lansoprazole Capsules after the expiry date which is stated on the label. 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 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 (E171), talc and gelatin.
The printing ink contains shellac, propylene glycol, ammonium hydroxide, potassium hydroxide, black iron oxide (E172).
What Lansoprazole 15mg and 30mg Capsules look like and contents of the pack
Each Lansoprazole 15mg Gastro-resistant Capsule has a white cap marked with ‘L’ and a white body marked with ‘15’, and contains white to beige gastro-resistant micro pellets.
Each Lansoprazole 30mg Gastro-resistant Capsule has a white cap marked with ‘L’ and a white body marked with ‘30’, and contains white to beige gastro-resistant micro pellets.
They are supplied in bottle packs of 7, 14, 28 or 56 capsules. Not all pack sizes are marketed.
Marketing authorization holder and Manufacturer
Crescent Pharma Limited, Units 3 & 4, Quidhampton Business Units, Polhampton Lane, Overton, Hampshire, RG25 3ED, UK.
PL 20416/0418 PL 20416/0419
Date leaflet last revised: July 2016