Lansoprazole 15mg Gastro-Resistant Capsules
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
The active ingredient in Lansoprazole gastro-resistant capsules is lansoprazole, which is a proton pump inhibitor. Proton pump inhibitors reduce the amount of acid that your stomach makes.
Your doctor may prescribe this medicine for the following indications:
- Treatment of duodenal and stomach ulcer
- Treatment of inflammation in your oesophagus (reflux oesophagitis)
- Prevention of reflux oesophagitis
- Treatment of heartburn and acid regurgitation
- Treatment of infections caused by the bacteria Helicobacter pylori when given in combination with antibiotic therapy
- Treatment or prevention of duodenal or stomach ulcer in patients requiring continued NSAID treatment (NSAID treatment is used against pain or inflammation)
- Treatment of Zollinger-Ellison Syndrome.
Do not take Lansoprazole gastro-resistant capsules:
- if you are allergic to lansoprazole or any of the other ingredients of this medicine (listed in section 6)
- if you are taking a medicine containing the active substance atazanivir (used in the treatment of HIV).
Warnings and precautions
Talk to your doctor of pharmacist before taking Lansoprazole gastro-resistant capsules
♦ If you have serious liver disease. The doctor may have to adjust your dosage.
♦ Your doctor may perform or have performed an additional investigation called an endoscopy in order to diagnose your condition and/or exclude malignant disease.
♦ If diarrhoea occurs during the treatment with Lansoprazole contact your doctor immediately, as this medicine has been associated with a small increase in infectious diarrhoea.
♦ If your doctor has given you this medicine 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 take this medicine 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 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.
♦ If you think any of these apply to you or you are unsure, talk to your doctor or pharmacist before taking lansoprazole. Do this even if they applied only in the past.
♦ Treatment with lansoprazole may lead to a slightly increased risk of gastrointestinal infections such as Salmonella and Campylobacter.
♦ If you are due to have a specific blood test (Chromogranin A).
The treatment for the prevention of peptic ulceration of patients in need of continuous NSAID treatment should be restricted to high risk patients (e.g. previous gastrointestinal bleeding, perforation or ulcer, advanced age, concomitant use of medication known to increase the likelihood of upper GI adverse events [e.g. corticosteroids or anticoagulants], the presence of a serious co-morbidity factor or the prolonged use of NSAID maximum recommended doses).
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).
Other medicines and Lansoprazole
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
In particular tell your doctor if you are taking medicines containing any of the following active substances, as Lansoprazole may affect the way these drugs work:
- ketoconazole, itraconazole, rifampicin (used to treat infections)
- digoxin (used to treat heart problems)
- theophylline (used to treat asthma)
- tacrolimus (used to prevent transplant rejection)
- fluvoxamine (used to treat depression and other psychiatric diseases)
- antacids (used to treat heartburn or acid regurgitation)
- sucralfate (used for healing ulcers)
- St John's wort (Hypericum perforatum) (used to treat mild depression)
- atazanivir (used to treat HIV)
Lansoprazole with food and drink and alcohol
For the best results from your medicines you should take Lansoprazole gastro-resistant capsules at least 30 minutes before food.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
There is insufficient experience with use of lansoprazole during breast-feeding. Based on the results of animal studies, it is thought that lansoprazole crosses into the breast milk. When making a decision as to whether breast-feeding or therapy with Lansoprazole should be continued or discontinued, your treating physician will consider the benefits of breast-feeding for your child and the benefits of therapy with Lansoprazole for you.
Driving and using machines
Side effects such as dizziness, vertigo, tiredness and visual disturbances sometimes occur in patients taking Lansoprazole. If you experience side effects like these you should take caution as your ability to react may be decreased.
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 capsules contain 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 medicine.
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Swallow the capsule whole with a glass of water. If you find the capsules difficult to swallow your doctor may advise on alternative ways to take your medicine. Do not crush or chew these capsules or the content of an emptied capsule because this will stop them from working properly.
If you are taking this medicine once a day, try to take it at the same time each day. You may get best results if you take this medicine first thing in the morning.
If you are taking this medicine twice a day, you should have the first dose in the morning and the second dose in the evening.
The dose of Lansoprazole gastro-resistant capsules depends on your condition. The usual doses for adults are given below. Your doctor will sometimes prescribe you a different to those stated below. Please check with your doctor or pharmacist if you are unsure about the dose.
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.
Treatment of duodenal ulcer: the recommended dose is one 30 mg capsule every day for 2 weeks.
Treatment of stomach ulcer: the recommended dose is one 30 mg capsule every day for 4 weeks.
Treatment of inflammation in your oesophagus (reflux oesophagitis): the recommended dose is one 30 mg capsule every day for 4 weeks.
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.
Treatment of infection of Helicobacter pylori: The recommended dose is one 30 mg capsule in combination with two different antibiotics in the morning and one 30 mg capsule 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 gastro-resistant capsules together with 250-500 mg clarithromycin and 1000 mg amoxicillin
- 30 mg Lansoprazole gastro-resistant capsules 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.
Treatment of duodenal or stomach ulcer in patients requiring continued NSAID treatment: the recommended dose is one 30 mg capsule every day for 4 weeks.
Prevention of duodenal or stomach ulcer in patients requiring continued NSAID treatment: the recommended dose is one 15 mg capsule every day, your doctor may adjust your dose to one 30 mg capsule every day.
Zollinger-Ellison Syndrome: the recommended dose is two 30 mg capsules every day to start with, then depending on how you respond to Lansoprazole the dose that your doctor decides is best for you.
Use in Children
This medicine should not be given to children, especially in children below one year of age.
If you take more Lansoprazole gastro-resistant capsules than prescribed
If you take more Lansoprazole gastro-resistant capsules than you have been told to, seek medical advice quickly.
If you forget to take Lansoprazole gastro-resistant capsules
If you forget to take a dose, take it as soon as your remember unless it is nearly time for your next dose. If this happens skip the missed dose and take the remaining capsules as normal. Do not take a double dose to make up for a forgotten capsule.
If you stop taking Lansoprazole gastro-resistant capsules
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 product, ask your doctor.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking lansoprazole and see your doctor or go to a hospital straightaway if you experience any of the following:
Uncommon side effects (may affect up to 1 in 100 people):
♦ Changes in blood cell numbers- symptoms include unexplained bruising and bleeding, infections, tiredness.
Rare side effects (may affect up to 1 in 1,000 people):
♦ Anaemia (paleness)
♦ Angioedema - symptoms include, swelling of hands, feet, ankles, face, lips or throat which may cause difficulty in swallowing or breathing.
♦ Severe allergic reactions- difficulty breathing, swelling of the face, tongue, mouth and throat, severe skin rash with intense itch, sometimes a fall in blood pressure.
♦ Reduction in white blood cells (agranulocytosis)- with signs such as fever. sore throat, tiredness, mouth ulcers.
♦ Liver problems e.g. hepatitis and jaundice (abdominal pain, dark urine, feeling sick, yellowing of the skin and whites of eyes).
♦ Inflammation of the pancreas.
♦ Kidney problems-symptoms include nausea, vomiting, changes in urine output, fatigue, weakness, loss of appetite, difficulty in breathing.
Very rare side effects (may affect up to 1 in 10,000 people):
♦ Colitis (Bowel inflammation) - symptoms include persistent diarrhoea, abdominal pain, bloody stools, weight loss, fever.
♦ Severe skin reactions such as:
- Stevens -Johnson syndrome - symptoms include blistering, peeling or bleeding of the skin around the lips, eyes, mouth, nose and genitals, flu-like symptoms, high temperature)
- Toxic epidermal necrolysis- symptoms include, severe blistering rash in which layers of the skin may peel off to leave large areas of raw exposed skin over the body & urticaria, nettle rash.
Other side effects:
Common side effects (may affect up to 1 in 10 people)
♦ headache, dizziness
♦ diarrhoea, constipation, stomach pains, feeling or being sick, wind, dry or sore mouth or throat
♦ skin rash, itching
♦ changes in liver function test values
♦ tiredness
Uncommon side effects (may affect up to 1 in 100 people)
♦ depression
♦ joint or muscle pain
♦ fluid retention or swelling
Rare side effects (may affect up to 1 in 1,000 people)
♦ fever
♦ restlessness, drowsiness, confusion, hallucinations, insomnia, visual disturbances, vertigo
♦ a change in the way things taste, loss of appetite, inflammation of your tongue (glossitis)
♦ sensitivity to light
♦ hair loss
♦ feelings of ants creeping over the skin (paresthesiae), trembling
♦ breast swelling in males, impotence
♦ candidiasis (fungal infection, may affect skin or the mucosa)
Very rare side effects (may affect up to 1 in 10,000 people)
- inflammation of your mouth (stomatitis)
- changes in test values such as sodium, cholesterol and triglyceride levels
Not known side effects (frequency cannot estimated from the available data)
♦ 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.
♦ rash, possibly with pain in the joints
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.
5. HOW TO STORE LANSOPRAZOLE GASTRO-RESISTANT CAPSULES
Keep this medicine out of the sight and reach of children.
Do not store above 25°C. Store in the original package in order to protect from moisture.
Do not use this medicine after the expiry date which is stated on the blister and carton. The expiry date refers to the last day of that month.
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.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Lansoprazole gastro-resistant capsules contain
♦ The active substance is 15 mg or 30 mg of lansoprazole.
♦ The other ingredients are:
Capsule content: Sugar spheres (sucrose and maize starch), Sodium laurilsulfate, Meglumine, Mannitol (E421), Hypromellose, Macrogol, Talc, Polysorbate 80, Titanium dioxide (E171), Methacrylic Acid-Ethyl Acrylate Copolymer (1:1), Dispersion 30%
Capsule shell: Gelatin, Titanium dioxide (E171)
Capsule shell of 15 mg also contains: Quinoline yellow (E104)
What Lansoprazole gastro-resistant capsules look like and contents of the pack
♦ Lansoprazole 15 mg gastro-resistant capsules are opaque yellow cap and body capsules.
Each capsule contains white or almost white spherical microgranules.
♦ Lansoprazole 30 mg gastro-resistant capsules are opaque white cap and body capsules.
Each capsule contains white or almost white spherical microgranules.
♦ These gastro-resistant capsules are available in blister packs containing 7, 14, 28, 56 or 98 capsules. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
The marketing authorisation holder is:
Bristol Laboratories Limited.
Unit 3, canalside, Northbridge Road Berkhamsted, Herts, HP4 1EG United Kingdom
Telephone: 0044 (0) 1442 200922 Fax: 0044 (0) 1442 873717
Email: info@bristol-labs.co.uk
The manufacturer is:
LABORATORIOS LICONSA, S.A.
Avda. Miralcampo, N° 7, Poligono Industrial Miralcampo,
19200 Azuqueca de Henares (Guadalajara),
Spain
Lansoprazole 15 mg gastro-resistant capsules; PL 17907/0333 Lansoprazole 30 mg gastro-resistant capsules; PL 17907/0334
This leaflet was last revised in August 2016
To request a copy of this leaflet in Braille, large print or audio format, contact the licence holder at the address (or telephone, fax, email) above.
V3 25-08-16 D0