Lansoprazole 15 mg orodispersible tablets

lansoprazole

The active ingredient in Lansoprazole is lansoprazole, which is a proton pump inhibitor. Proton pump inhibitors reduce the amount of acid that your stomach makes.

Your doctor may prescribe Lansoprazole 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.

Your doctor may have prescribed Lansoprazole 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.

You must talk to a doctor if you do not feel better or if you feel worse after 14 days.

Always take this medicine exactly as your doctor has told you. Check with your doctor if you are not sure.

Place the tablet on your tongue and suck gently. The tablet rapidly dissolves in the mouth, releasing microgranules which you should swallow without chewing with the help of a glass of water.

Your doctor might instruct you to take the tablet with a syringe, in case you have serious difficulties with swallowing.

The following instructions should be followed if administered via an oral syringe:

It is important that the appropriateness of the selected oral syringe is carefully tested.

• Remove the plunger of the syringe (at least 5 ml syringe for the 15 mg tablet and 10 ml syringe for the 30 mg tablet).
• Put the tablet into the barrel.
• Put the plunger back onto the syringe.
• For the 15 mg tablet: Draw 4 ml tap water into the syringe.
• For the 30 mg tablet: Draw 10 ml tap water into the syringe.
• Invert the syringe and draw an additional 1 ml of air into it.
• Shake the syringe gently for 10-20 seconds until the tablet is dispersed.
• The contents can be emptied directly into the mouth.
• Refill the syringe with 2-5 ml of tap water to flush the remnants out of the syringe into the mouth
• Repeat the precedent step if necessary

If you are taking Lansoprazole once a day, try to take it at the same time each day. You may get best results if you take Lansoprazole first thing in the morning.

If you are taking Lansoprazole twice a day, you should have the first dose in the morning and the second dose in the evening.

The dose of Lansoprazole depends on your condition. The usual doses of Lansoprazole for adults are given below. Your doctor will sometimes prescribe you a different dose and will tell you how long your treatment will last.

Treatment of heartburn and acid regurgitation: one 15 mg or 30 mg orodispersible tablet every day 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: one 30 mg orodispersible tablet every day for 2 weeks

Treatment of stomach ulcer: one 30 mg orodispersible tablet every day for 4 weeks

Treatment of inflammation in your oesophagus (reflux oesophagitis): one 30 mg orodispersible tablet every day for 4 weeks

Long-term prevention of reflux oesophagitis: one 15 mg orodispersible tablet every day, your doctor may adjust your dose to one 30 mg orodispersible tablet every day.

Treatment of infection of Helicobacter pylori: The usual dose is one 30 mg orodispersible tablet in combination with two different antibiotics in the morning and one 30 mg orodispersible tablet 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.

Treatment of duodenal or stomach ulcer in patients requiring continued NSAID treatment: one 30 mg orodispersible tablet every day for 4 weeks.

Prevention of duodenal or stomach ulcer in patients requiring continued NSAID treatment: one 15 mg orodispersible tablet every day, your doctor may adjust your dose to one 30 mg orodispersible tablet every day.

Zollinger-Ellison syndrome: The usual dose is two 30 mg orodispersible tablets every day to start with, then depending on how you respond to Lansoprazole the dose that your doctor decides is best for you.

If you have any further questions on the use of this medicine, ask your doctor.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following side effects are common (occur in more than 1 in 100 patients):

• 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
• benign polyps in the stomach.

The following side effects are uncommon (occur in less than 1 in 100 patients):

• depression
• joint or muscle pain
• fluid retention or swelling
• changes in blood cell counts.
• risks of fracture in the hip, wrist or spine.

The following side effects are rare (occur in less than 1 in 1000 patients):

• fever
• restlessness, drowsiness, confusion, hallucinations, insomnia, visual disturbances, vertigo
• a change in the way things taste, loss of appetite, inflammation of your tongue (glossitis)
• skin reactions such as burning or pricking feeling under the skin, bruising, reddening and excessive sweating
• sensitivity to light
• hair loss
• feelings of ants creeping over the skin (paresthesiae), trembling
• anaemia (paleness)
• kidney problems
• pancreatitis
• inflammation of the liver (may be seen as yellow skin or eyes)
• breast swelling in males, impotence
• candidiasis (fungal infection, may affect skin or the mucosa)
• angioedema; You should see your doctor immediately if you experience symptoms of angioedema, such as swollen face, tongue or pharynx, difficulty to swallow, hives and difficulties to breathe.

The following side effects are very rare (occur in less than 1 in 10000 patients):

• severe hypersensitivity reactions including shock. Symptoms of a hypersensitivity reaction may include fever, rash, swelling and sometimes a fall in blood pressure
• inflammation of your mouth (stomatitis)
• colitis (bowel inflammation)
• changes in test values such as sodium, cholesterol and triglyceride levels
• very severe skin reactions with reddening, blistering, severe inflammation and skin loss
• very rarely Lansoprazole may cause a reduction in the number of white blood cells and your resistance to infection may be decreased. If you experience an infection with symptoms such as fever and serious deterioration of your general condition, or fever with local infection symptoms such as sore throat/pharynx/mouth or urinary problems you should see your doctor immediately. A blood test will be taken to check possible reduction of white blood cells (agranulocytosis).

The following side effect occurs with 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 monitor your levels of magnesium.
• rash, possibly with pain in the joints
• visual hallucinations

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the blister and carton after ‘EXP’. The expiry date refers to the last day of that month.

Do not store above 30°C.

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.

This medicinal product is authorised in the Member States of the EEA under the following names:

ES Lansoprazol Flas Salvat 15 mg comprimidos bucodispersables

Lansoprazol Flas Salvat 30 mg comprimidos bucodispersables

FR Lansoprazole Salvat 15 mg comprimés orodispersibles

Lansoprazole Salvat 30 mg comprimés orodispersibles

IT Lansoprazolo Laboratori Alter 15 mg compresse orodispersibili

Lansoprazolo Laboratori Alter 30 mg compresse orodispersibili

UK Lansoprazole 15 mg orodispersible tablets

Lansoprazole 30 mg orodispersible tablets

SE Lansoprazol SUN 15 mg munsönderfallande tablett

Lansoprazol SUN 30 mg munsönderfallande tablett