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Lansoprazole 30mg Orodispersible Tablets

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Document: leaflet MAH GENERIC_PL 11204-0315 change

Package leaflet: Information for the user Lansoprazole 30 mg Orodispersible Tablets

Lansoprazole

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 30 mg Orodispersible Tablets are and what they are used for

2.    What you need to know before you take Lansoprazole 30 mg Orodispersible Tablets

3.    How to take Lansoprazole 30 mg Orodispersible Tablets

4.    Possible side effects

5.    How to store Lansoprazole 30 mg Orodispersible Tablets

6.    Contents of the pack and other information

1. What Lansoprazole 30 mg Orodispersible Tablets are and what they are used for

The active ingredient in Lansoprazole 30 mg orodispersible tablets is lansoprazole, which is a proton pump inhibitor. Proton pump inhibitors reduce the amount of acid that your stomach makes.

Lansoprazole 30 mg Orodispersible Tablets are used to treat adults.

Your doctor may prescribe Lansoprazole 30 mg Orodispersible Tablets 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 30 mg Orodispersible Tablets 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.

2. What you need to know before you take Lansoprazole 30 mg Orodispersible Tablets DO NOT take Lansoprazole 30 mg Orodispersible Tablets:

• 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 atazanavir (used in the treatment of HIV).

Warnings and precautions

Talk to your doctor or pharmacist before taking Lansoprazole 30 mg Orodispersible Tablets

•    if you have serious liver disease. The doctor may have to adjust your dosage.

•    if you have ever had a skin reaction after treatment with a medicine similar to Lansoprazole 30 mg Orodispersible Tablets 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 30 mg Orodispersible Tablets. Remember to also mention any other ill-effects like pain in your joints.

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 30 mg Orodispersible Tablets contact your doctor immediately, as Lansoprazole 30 mg Orodispersible Tablets have been associated with a small increase in infectious diarrhoea.

If your doctor has given you Lansoprazole 30 mg Orodispersible Tablets 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.

Taking a proton pump inhibitor like Lansoprazole 30 mg Orodispersible Tablets, 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 take Lansoprazole 30 mg Orodispersible Tablets 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.

Other medicines and Lansoprazole 30 mg Orodispersible Tablets

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.

In particular tell your doctor if you are taking medicines containing any of the following active substances as Lansoprazole 30 mg Orodispersible Tablets 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)

Lansoprazole 30 mg Orodispersible Tablets with food and drink

For the best results from your medicines you should take Lansoprazole 30 mg Orodispersible Tablets at least 30 minutes before food.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you might be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Side effects such as dizziness, vertigo, tiredness and visual disturbances sometimes occur in patients taking Lansoprazole 30 mg Orodispersible Tablets. 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 30 mg Orodispersible Tablets contain aspartame

Contains a source of phenylalanine. May be harmful for people with phenylketonuria.

3. How to take Lansoprazole 30 mg Orodispersible Tablets

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

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

If you are taking Lansoprazole 30 mg Orodispersible Tablets once a day, try to take it at the same time each day. You may get best results if you take Lansoprazole 30 mg Orodispersible Tablets first thing in the morning.

If you are taking Lansoprazole 30 mg Orodispersible Tablets twice a day, you should have the first dose in the morning and the second dose in the evening.

The dose of Lansoprazole 30 mg Orodispersible Tablets depends on your condition. The usual doses of Lansoprazole 30 mg Orodispersible Tablets 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 (for this dose appropriate dosage strengths are available) 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 (for this dose appropriate dosage strengths are available) 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 30 mg Orodispersible Tablets together with 250-500 mg clarithromycin and 1000 mg amoxicillin.

•    30 mg Lansoprazole 30 mg Orodispersible Tablets 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 (for this dose appropriate dosage strengths are available) 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 30 mg Orodispersible Tablets the dose that your doctor decides is best for you.

Use in children and adolescents

Lansoprazole 30 mg Orodispersible Tablets should not be given to children.

If you take more Lansoprazole 30 mg Orodispersible Tablets than you should

If you take more Lansoprazole 30 mg Orodispersible Tablets than you have been told to, seek medical advice quickly.

If you forget to take Lansoprazole 30 mg Orodispersible Tablets

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 orodispersible tablets as normal. Do not take a double dose to make up for a forgotten orodispersible tablet.

If you stop taking Lansoprazole 30 mg Orodispersible Tablets

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 medicine, ask your doctor or pharmacist.

4. Possible side effects

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

If diarrhoea occurs during the treatment with Lansoprazole contact your doctor immediately, as lansoprazole has been associated with a small increase in infectious diarrhoea.

The following side effects are common (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

The following side effects are uncommon (may affect up to 1 in 100 people):

•    depression

•    joint or muscle pain

•    fluid retention or swelling

•    changes in blood cell counts

•    risk of fracture in the hip, wrist or spine

The following side effects are rare (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)

•    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 (paraesthesiae), 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 (may affect up to 1 in 10,000 people):

•    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 (frequency cannot be 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 (subacute cutaneous lupus erythematosus)

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 in UK. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Lansoprazole 30 mg Orodispersible Tablets

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

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

Store below 25° C. Store in the original package in order to protect from moisture.

Do not throw away any medicines via waste water 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 30 mg Orodispersible Tablets contain

•    The active substance is lansoprazole. One (1) 30 mg orodispersible tablet contains 30 mg of lansoprazole.

•    The other ingredients are:

Table core: microcrystalline cellulose, light magnesium carbonate, low-substituted hydroxypropyl cellulose, hydroxypropyl cellulose (E463).

Coating: hypromellose 3 cps (E464), low substituted hydroxypropyl cellulose, talc (E553b), titanium dioxide (E171), mannitol (E421), methacrylic acid ethyl acrylate copolymer dispersion (1:1), polyacrylate dispersion, glycerol monostearate, polyethylene glycol 6000, triethyl citrate, polysorbate 80, anhydrous citric acid (E330), ferric oxide yellow (E172), ferric oxide red (E172), talc (E553b), F-melt type C (Mannitol, Xylitol, Microcrystalline Cellulose,

Crospovidone, Dibasic Calcium Phosphate Anhydrous), crospovidone, microcrystalline cellulose, aspartame(E951), strawberry flavour (Flavouring, Maize maltodextrin, Propylene glycol (E1520)), magnesium stearate (vegetable grade) (E470b).

What Lansoprazole 30 mg Orodispersible Tablets look like and contents of the pack

Lansoprazole 30 mg orodispersible tablets are white to yellowish white uncoated tablets, speckled with orange to dark brown pellets. Lansoprazole 30 mg orodispersible tablets are debossed with "30” on one side of the tablet. Each Lansoprazole 30 mg orodispersible tablet is strawberry flavoured.

Lansoprazole 30 mg orodispersible tablets are available in blister packs of 7, 14, 28, 30 and 56 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

STADA Arzneimittel AG StadastraBe 2-18 61118 Bad Vilbel Gernany

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

Austria    Lansoprazole STADA 30 mg Schmelztabletten

Italy    LANSOPRAZOLEO EUROGENERICI 30 mg compresse orodispersibili

Portugal    Lansoprazole Ciclum

Spain    Lansoprazole Flas STADA Genericos 30 mg comprimidos bucodispersables EFG

This leaflet was last revised in December 2015.