Lansoprazole 15 Mg Gastro-Resistant Capsules
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Lansoprazole 15 mg Gastro-resistant Capsules Lansoprazole 30 mg Gastro-resistant Capsules Lansoprazole
Read all of this leaflet carefully before you start using 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. Do not pass it on to others. It may harm them,
even if their symptoms 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.
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
1. WHAT LANSOPRAZOLE GASTRO-RESISTANT CAPSULES ARE AND WHAT THEY ARE USED FOR
Lansoprazole Gastro-resistant Capsules is a medicine which reduces the amount of acid made by the stomach (selective proton pump inhibitor).
Lansoprazole Gastro-resistant Capsules is given
• To treat ulcers in the duodenum and stomach (diagnosed through gastroscopy or X-ray)
• To treat inflammation of the gullet caused by reflux of stomach acid into the gullet (reflux oesophagitis)
• As long-term treatment to prevent a recurrence of inflammation of the gullet due to reflux of stomach acid
• To remove the bacterium Helicobacter pylori together with suitable antibiotics in the treatment of ulcers in the stomach or duodenum (eradication therapy) and to prevent the recurrence of ulcers in patients with Helicobacter pylori-related ulcers in the stomach and intestines
• In the treatment of Zollinger-Ellison syndrome (ulcer formation in the stomach and duodenum, due to increased production of a hormone which secretes stomach acid, caused by a certain type of tumour).
• To treat and prevent ulcers in the duodenum and stomach caused by the use of nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or aspirin.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE LANSOPRAZOLE GASTRO-RESISTANT CAPSULES
Do not take Lansoprazole Gastro-resistant Capsules
• If you are allergic (hypersensitive) to lansoprazole or any of the other ingredients of this medicine.
• If you are taking a medicine called atazanavir, which is used in the treatment of HIV infection.
Take special care with Lansoprazole Gastro-resistant Capsules
• If you have impaired liver function (see section 3. How to take Lansoprazole Gastro-resistant Capsules).
• If you use Lansoprazole Gastro-resistant Capsules in combination with antibiotics to eradicate Helicobacter pylori, you should carefully read the package leaflet of these antibiotics too.
• If you take Lansoprazole Gastro-resistant Capsules for longer than 1 year, therapy should be regularly monitored and the doctor should carefully consider the benefit versus risk ratio.
• If you experience any problems with your eyesight following long-term use (longer than 1 year), treatment with Lansoprazole Gastro-resistant Capsules should be promptly discontinued and you should consult an ophthalmologist.
If diarrhoea occurs during the treatment with your medicine contact your doctor immediately, as your medicine has been associated with a small increase in infectious diarrhoea.
Before treatment with Lansoprazole Gastro-resistant Capsules,
• the diagnosis of ulcers in the duodenum or stomach and inflammation of the gullet due to reflux of stomach acid should be confirmed by gastroscopy or other appropriate diagnostic measures (e.g. X-ray with contrast media)
• for a stomach ulcer, the possiblity of a malignant stomach tumour should be excluded. Intake of Lansoprazole Gastro-resistant Capsules may mask the symptoms of a tumour and delay diagnosis of this condition.
Lansoprazole reduces the acid content of the stomach. This can lead to an increase in the number of natural bacteria present in the gastrointestinal tract. Treatment with Lansoprazole Gastro-resistant Capsules therefore leads to a slightly increased risk of infections in the gastrointestinal tract, such as with Salmonella or Campylobacter.
Other medicines and Lansoprazole Gastro-resistant Capsules:
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
In particular, tell your doctor if you are taking any of the following medicines:
• atazanavir (medicine for the treatment of HIV/AIDS)
• ketoconazole and itraconazole (medicines for treatment of fungal infections)
• digoxin (used to treat heart problems)
• tacrolimus (medicine used to prevent rejection of a transplant)
• theophylline, (medicine used to treat asthma)
• phenytoin or carbamazepine, (medicines used to treat epilepsy)
• warfarin (medicine used to prevent blood clotting)
• fluvoxamine (medicine for the treatment of depression)
• St Johns wort (Hypericum perforatum), used to treat mild depression
• antacids (used to treat heartburn or acid regurgitation)
• sucralfate (used for healing ulcers)
The effects of simultaneous administration of lansoprazole and various antibiotics (particularly clarithromycin) has not been systematically investigated. Increased interactions with other medicines are likely. Monitoring of the plasma levels of other medicines administered during simultaneous treatment with lansoprazole and antibiotics is therefore recommended.
Interactions have been observed when lansoprazole was combined with certain antibiotics such as clarithromycin and amoxicillin and in a combination of all three medicines. These affect the absorption, availability to the body, the breakdown and the elimination of these medicines. The effect of clarithromycin on lansoprazole is increased if the patient is a so-called slow metaboliser.
Caution should be exercised when combining lansoprazole with drugs which have a narrow therapeutic index, as the effect of lansoprazole on the metabolism of other drugs has not been extensively investigated.
Taking Lansoprazole Gastro-resistant Capsules with food and drink
Lansoprazole Gastro-resistant Capsules should be taken on an empty stomach. For the best results you should take Lansoprazole at least 30 minutes before food.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.
Use of Lansoprazole Gastro-resistant Capsules is not recommended during pregnancy. Limited experience to date with the use of lansoprazole in pregnant women has produced no evidence of any side effects on the unborn child or on the pregnancy itself.
You should avoid breast-feeding while taking Lansoprazole Gastro-resistant Capsules, as there has been insufficient experience with its use during lactation. 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 Gastro-resistant Capsules should be continued or discontinued, the benefits of breast-feeding for the child and the benefits of therapy with Lansoprazole Gastro-resistant Capsules for the mother should be considered.
Driving and using machines
Side effects such as dizziness, vertigo, tiredness, fatigue 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.
Important information about some of the ingredients of Lansoprazole Gastro-resistant Capsules
This medicinal 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 medicinal product.
3. HOW TO TAKE LANSOPRAZOLE GASTRO-RESISTANT CAPSULES
Always take Lansoprazole Gastro-resistant Capsules exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Lansoprazole Gastro-resistant Capsules are swallowed whole with sufficient liquid (e.g. a glass of water). If you find the capsules difficult to swallow your doctor may advise on
alternative ways to take your medicine. The capsules may be opened but the granules inside may not be chewed or crushed because this will stop them from working properly. Lansoprazole Gastro-resistant Capsules should be taken on an empty stomach (at least 30 minutes before meals).
If you are taking your medicine once a day, try to take it at the same time each day. You may get best results if you take it first thing in the morning. If you are taking your medicine twice a day, you should have the first dose in the morning and the second dose in the evening.
The dose of your medicine depends on your condition. The usual doses of Lansoprazole capsules are given below. Your doctor will sometimes prescribe you a different dose and will tell you how long your treatment will last.
The usual dose is
Treatment of heartburn and acid regurgitation
One 15 mg and 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.
Prevention of a recurrence of inflammation of the gullet due to reflux of stomach acid
The recommended dose is 15 mg lansoprazole once daily. If required, the dose can be increased to 30 mg lansoprazole once daily.
Treatment of inflammation of the gullet due to reflux of stomach acid
The recommended dose is 15 mg or 30 mg lansoprazole once daily for 4 weeks. Relief of symptoms is obtained rapidly. If the symptoms are not relieved within 4 weeks with a daily dose of 30 mg, further examinations are recommended.
Treatment of duodenal ulcer
One 30 mg capsule every day for 2 weeks.
Treatment of stomach ulcer
One 30 mg capsule every day for 4 weeks.
Treatment of duodenal or stomach ulcer in patients requiring continued NSAID treatment
One 30 mg capsule every day for 4 weeks.
Prevention of stomach and duodenal ulcers caused by NSAIDs in patients who must continue taking NSAIDs:
The usual dose is 15 mg lansoprazole once daily. If the treatment fails, your doctor may adjust your dose to 30 mg once daily.
Treatment of infect of Helicobacter pylori
The usual 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 together with 500 mg clarithromycin and 1000 mg amoxicillin
- 30 mg Lansoprazole together with 250 mg clarithromycin and 400-500 mg metronidazole
- 30 mg Lansoprazole together with 400-500 mg metronidazole and 1000 mg amoxicillin
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
The usual dose is two 30 mg capsules every day to start with, and then depending on how you respond to Lansoprazole, the dose that your doctor decides is best for you.
Dosage in patients with impaired kidney or liver function
No dose adjustment is necessary in patients with impaired kidney function. A daily dose of 30 mg lansoprazole should not, however, be exceeded.
In patients with mildly impaired liver function, a daily dose of 30 mg lansoprazole should not be exceeded. In patients with moderately impaired liver function, a daily dose of 15 mg lansoprazole should not be exceeded. Patients with severely impaired liver function should not take Lansoprazole Gastro-resistant Capsules.
Children
Lansoprazole capsules are not recommended for children, ask your doctor for advice.
Elderly patients
In elderly patients, a dose adjustment may be necessary due to the slower elimination of lansoprazole. A daily dose of 30 mg should not be exceeded.
If you have the impression that the effect of Lansoprazole Gastro-resistant Capsules is too strong or too weak, please talk to your doctor.
If you take more Lansoprazole Gastro-resistant Capsules than you should
You should always consult a doctor. There has been no experience with the effects of lansoprazole overdose in humans. Daily doses of 180 mg were tolerated without any marked side effects. The side effects listed in section 4 may occur in a more severe form.
If you forget to take Lansoprazole Gastro-resistant Capsules
If you forget to take a dose, take it as soon as you 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 dose.
If you stop taking Lansoprazole Gastro-resistant Capsules
If you take too low a dose, if you take your medicine irregularly or if you stop your treatment prematurely, this may endanger the success of your treatment or may cause relapses which are more difficult to treat. Please follow your doctor’s recommendations.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Lansoprazole Gastro-resistant Capsules can cause side effects, although not everybody gets them.
The following side effects are allergic reactions which need immediate medical attention:
- serious allergic reaction which causes swelling of the face or throat
- difficulty in breathing or wheezing
- serious allergic reaction which causes difficulty in breathing or dizziness (anaphylactic shock)
- generally feeling weak
The following side effects are common (occur in more than 1 in 100 patients):
- headache, dizziness
- dry or sore mouth or throat, feeling or being sick, diarrhoea, stomach pains, constipation, wind and indigestion
- changes in liver function test values
- skin rash, itching, hives
- tiredness
The following side effects are uncommon (occur in less than 1 in 100 patients):
- reduction in blood platelets, which increases risk of bleeding and bruising (thrombocytopenia)
- increase in the number of certain white blood corpuscles (eosinophilia)
- reduction in the number of white blood cells, which makes infection more likely (leucopenia)
- depression
- muscle and joint pain
- fluid retention or swelling
The following side effects are rare (occur in less than 1 in 1000 patients):
- reduction in red blood cells which can make the skin pale and cause weakness or breathlessness (anaemia)
- hallucinations, confusion and difficulty in sleeping (insomnia)
- drowsiness, a feeling of dizziness or “spinning”, restlessness, tingling or numbness in the hands and feet
- change in the way you see things
- palpitation and chest pain
- fluid retention or swelling mainly in the legs
- inflammation of the pancreas, which causes severe pain in the abdomen and back
- fungal infection of the gullet
- change in the way things taste
- inflammation of the tongue (glossitis)
- inflammation of the liver, yellowing of the skin or whites of the eyes caused by liver or blood problems (jaundice)
- skin reactions such as burning or pricking feeling under the skin, bruising, reddening and excessive sweating
- sensitivity to light
- hair loss
- coughing, wheezing, and shortness of breath
- inflammation of the kidneys (interstitial nephritis)
- abnormal enlargement of breast in men (gynaecomastia)
- impotence
- abnormal excessive sweating (hyperhidrosis)
- loss of appetite and inability to eat (anorexia)
- fever
The following side effects are very rare (occur in less than 1 in 10,000 patients):
- severe reduction in number of white blood cells which makes infections more likely (agranulocytosis)
- severe reduction in blood cells which can cause weakness, bruising or make infections more likely (pancytopenia)
- inflammation which causes abdominal pain or diarrhoea (colitis)
- inflammation of the mouth (stomatitis)
- dark discolouration of the tongue (black tongue)
- serious illness with blistering of the skin, mouth, eyes and genitals (Stevens-Johnson syndrome)
- serious illness with blistering of the skin (toxic epidermal necrolysis)
- spontaneous flow of milk from the nipple (galactorrhoea)
- general feeling of being unwell
- increase in test values such as sodium, cholesterol and triglyceride levels
The following side effects occurrence is not known (cannot be estimated from the available data):
- 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.
- non-itchy, dry, ring-shaped, scaly rash (cutaneous lupus erythematosus)
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).
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.
5. HOW TO STORE LANSOPRAZOLE GASTRO-RESISTANT CAPSULES
Keep out of the reach and sight of children. Do not store above 25° C. Store in the original package. Do not transfer to another container. Do not use Lansoprazole Gastro-resistant Capsules after the expiry date that is stated on the outer packaging and blister strip.
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. CONTENTS OF THE PACK AND OTHER INFORMATION What Lansoprazole Gastro-resistant Capsules contains
• The active ingredient is lansoprazole. Lansoprazole 15 mg, 30 mg Gastro-resistant Capsules Capsules contains 15 mg, 30 mg lansoprazole.
• The other ingredients are sugar spheres (sucrose, maize starch), hypromellose, talc, magnesium carbonate, methacrylic acid ethylacrylate copolymer (1:1) dispersion 30%, triethyl citrate, titanium dioxide (E171)
• The capsule shells contain: gelatin, titanium dioxide (E171) and red iron oxide (E172). In addition the 15 mg capsules contain brilliant blue FCF (E133) and the 30 mg capsules contain black iron oxide (E172)
• The printing ink contains shellac, black iron oxide (E172) and propylene glycol.
What Lansoprazole Gastro-resistant Capsules looks like and contents of the pack
• Lansoprazole 15 mg Gastro-resistant Capsules are hard gelatin capsules with a light blue opaque cap and flesh opaque body, filled with granules, and imprinted:
93 on the body
7350 on the cap
• Lansoprazole 30 mg Gastro-resistant Capsules are hard gelatin capsules with a light grey opaque cap and flesh opaque body, filled with granules and imprinted:
93 on the body
7351 on the cap
• The product is available in pack sizes* of 7, 14, 15, 28, 30, 50, 56, 98, and 100 capsules.
• Only marketed pack sizes will be included in the printed version of the PIL
Marketing Authorisation Holder Manufacturer
TEVA UK Ltd Brampton Road Hampden Park,
Eastbourne,
East Sussex BN22 9AG, England
Pharmachemie B.V.
Swensweg 5 Postbus 552 2003 RN Haarlem The Netherlands
TEVA Sante Rue Bellocier,
89107 Sens France
TEVA Pharmaceutical Works Private Limited Company
Pallagi ut 13, 4042 Debrecen
Hungary