Lansoprazole Flas Salvat 15 mg orodispersible tablet

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Lansoprazole Flas Salvat 15 mg orodispersible tablets

Lansoprazole

Read the entire 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet (see section 4).

Leaflet contents

1. What Lansoprazole Flas Salvat is and what it is used for
2. What you need to know before taking Lansoprazole Flas Salvat
3. How to take Lansoprazole Flas Salvat
4. Possible adverse effects
5. How to store Lansoprazole Flas Salvat
6. Contents of the pack and other information

1. What Lansoprazol Flas Salvat is and what it is used for

The active substance in Lansoprazol Flas Salvat is lansoprazole, a proton pump inhibitor. Proton pump inhibitors reduce the amount of acid produced by the stomach.

Your doctor may prescribe Lansoprazol Flas Salvat for the following indications:

• Treatment of duodenal and gastric ulcers
• Treatment of inflammation of the oesophagus (reflux esophagitis)
• Prevention of reflux esophagitis
• Treatment of heartburn and acid regurgitation
• Treatment of infections caused by the bacterium Helicobacter pylori, in combination with antibiotics
• Treatment or prevention of duodenal or gastric ulcers in patients requiring long-term treatment with non-steroidal anti-inflammatory drugs (NSAIDs) (NSAID therapy is used for pain or inflammation)
• Treatment of Zollinger-Ellison syndrome

Your doctor may have prescribed Lansoprazol Flas Salvat for an indication or at a dose different from that stated in this leaflet. Follow your doctor's instructions regarding how to take the medicine.

Consult a doctor if you worsen or do not improve after 14 days.

2. What you need to know before starting to take Lansoprazol Flas Salvat

Do not take Lansoprazol Flas Salvat:

• If you are allergic to lansoprazol or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

When taking lansoprazol, kidney inflammation may occur. Signs and symptoms may include decreased urine volume or blood in the urine and/or hypersensitivity reactions such as fever, skin rash, and joint stiffness. You should report these signs to your doctor.

Inform your doctor if you have severe liver disease. Your doctor may need to adjust your dose.

Your doctor may have performed or may perform an additional test called endoscopy to diagnose your condition and/or rule out malignant disease.

If you experience diarrhea during treatment with Lansoprazol Flas Salvat, contact your doctor immediately, as Lansoprazol Flas Salvat has been associated with a slight increase in infectious diarrhea.

If your doctor has prescribed Lansoprazol Flas Salvat along with other medicines for the treatment of Helicobacter pylori infection (antibiotics) or together with anti-inflammatory drugs for pain or rheumatism, please also read the package leaflets of these medicines carefully.

Taking a proton pump inhibitor such as Lansoprazol Flas Salvat, especially for more than one year, may slightly increase the risk of fractures of the hip, wrist, and spine. Inform your doctor if you have osteoporosis or if you are taking corticosteroids (which may increase the risk of osteoporosis).

If you have been taking Lansoprazol Flas Salvat for a long time (more than 1 year), your doctor will likely monitor you regularly. During visits to your doctor, you should report any new or unusual symptoms or circumstances.

Consult your doctor before starting Lansoprazol Flas:

• If you have reduced body stores of vitamin B12 or risk factors for this and are receiving long-term treatment with lansoprazol. Like all medicines that reduce acid levels, lansoprazol could reduce the absorption of vitamin B12.
• If you are scheduled to have a specific blood test (chromogranin A).
• If you have ever had a skin reaction after treatment with a medicine similar to Lansoprazol Flas used to reduce stomach acidity.
• If you develop a skin rash, especially in areas of skin exposed to sunlight, consult your doctor as soon as possible, as it may be necessary to discontinue treatment with Lansoprazol Flas. Remember to mention any other symptoms you may notice, such as joint pain.

Taking Lansoprazol Flas Salvat with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

In particular, inform your doctor if you are taking medicines containing any of the following active substances, as Lansoprazol Flas Salvat may affect their way of action:

• HIV protease inhibitors such as atazanavir and nelfinavir (used in HIV treatment)
• Methotrexate (used to treat autoimmune diseases and cancer)
• Ketoconazole, itraconazole, rifampicin (used to treat infections)
• Digoxin (used to treat heart problems)
• Warfarin (used to treat blood clots)
• Theophylline (used to treat asthma)
• Tacrolimus (used to prevent transplant rejection)
• Fluvoxamine (used to treat depression and other psychiatric disorders)
• Antacids (used to treat heartburn or acid regurgitation)
• Sucralfate (used to heal ulcers)
• St. John's wort (Hypericum perforatum) (used to treat mild depression)

Taking Lansoprazol Flas Salvat with food and drinks

For optimal effectiveness of this medicine, Lansoprazol Flas Salvat should be taken at least 30 minutes before meals.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before taking this medicine.

Driving and using machines

Patients taking Lansoprazol Flas Salvat may occasionally experience side effects such as dizziness, vertigo, fatigue, and visual disturbances. If you experience any of these side effects, you should exercise caution, as your reaction ability may be reduced.

You are solely responsible for deciding whether you are fit to drive or to perform activities requiring a high level of concentration. Due to its side effects or adverse reactions, one of the factors that may reduce your ability to carry out these tasks safely is the use of medicines.

Descriptions of these effects can be found in the following sections.

Please read this leaflet carefully.

If you have any questions, ask your doctor, nurse, or pharmacist.

Lansoprazol Flas Salvat contains sucrose.

If your doctor has diagnosed you with an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Lansoprazol Flas Salvat

Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor again.

Place the tablet on the tongue and suck it slowly. The tablet dissolves rapidly in the mouth, releasing microgranules which must be swallowed without chewing.

Alternatively, you may swallow the tablet whole with a glass of water.

Your doctor may give you instructions for administering the tablet using a syringe if you have serious difficulty swallowing.

Follow the instructions below for oral administration using a syringe:

It is important to ensure that the syringe selected is appropriate.

• Remove the plunger from the syringe (at least a 5 ml syringe for the 15 mg tablet and a 10 ml syringe for the 30 mg tablet).
• Place the tablet into the barrel.
• Replace the plunger into the syringe.
• For the 15 mg tablet: fill the syringe with 4 ml of water.
• For the 30 mg tablet: fill the syringe with 10 ml of water.
• Invert the syringe and pull back the plunger to draw in 1 ml of air.
• Gently shake the syringe 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 water to rinse out any residue and empty it into the mouth.
• Repeat the previous step if necessary.

If you take Lansoprazol Flas Salvat once daily, try to take it at the same time each day. You may achieve better results if you take Lansoprazol Flas Salvat in the morning.

If you take Lansoprazol Flas Salvat twice daily, take the first dose in the morning and the second in the evening.

The dose of Lansoprazol Flas Salvat depends on your general condition. The usual doses of Lansoprazol Flas Salvat for adults are given below. Occasionally, your doctor may prescribe a different dose and indicate a different treatment duration.

Treatment of heartburn and acid regurgitation: one orodispersible tablet of 15 mg or 30 mg daily for 4 weeks. If symptoms persist, inform your doctor. If symptoms do not improve after 4 weeks, consult your doctor.

Treatment of duodenal ulcer: one orodispersible tablet of 30 mg daily for 2 weeks.

Treatment of gastric ulcer: one orodispersible tablet of 30 mg daily for 4 weeks.

Treatment of inflammation of the oesophagus (reflux oesophagitis): one orodispersible tablet of 30 mg daily for 4 weeks.

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

Treatment of Helicobacter pylori infection: The usual dose is one orodispersible tablet of 30 mg together with two different antibiotics in the morning and one orodispersible tablet of 30 mg together with two different antibiotics in the evening. The usual treatment duration is once daily for 7 days.

The recommended antibiotic combinations are as follows:

• 30 mg Lansoprazol Flas Salvat with 250–500 mg clarithromycin and 1,000 mg amoxicillin
• 30 mg Lansoprazol Flas Salvat with 250 mg clarithromycin and 400–500 mg metronidazole

If you are receiving anti-infective treatment for an ulcer, it is unlikely that the ulcer will recur if the infection is successfully treated. To achieve the best results with your medicine, take it at the correct time and do not miss any doses.

Treatment of duodenal or gastric ulcer in patients requiring continuous NSAID therapy: one orodispersible tablet of 30 mg daily for 4 weeks.

Prevention of duodenal or gastric ulcer in patients requiring continuous NSAID therapy: one orodispersible tablet of 15 mg daily; your doctor may adjust your dose to one orodispersible tablet of 30 mg daily.

Zollinger-Ellison syndrome: The usual initial dose is two orodispersible tablets of 30 mg daily. Subsequently, depending on your response to treatment with Lansoprazol Flas Salvat, your doctor will decide the most appropriate dose for you.

Use in children

Lansoprazol Flas Salvat must not be administered to children.

If you take more Lansoprazol Flas Salvat than you should

If you take more Lansoprazol Flas Salvat than prescribed, consult your doctor immediately or call the Toxicology Information Service immediately at telephone number 915 620 420.

If you forget to take Lansoprazol Flas Salvat

If you forget to take a dose, take it as soon as possible unless it is nearly time for your next dose.

In this case, skip the missed dose and take the next orodispersible tablets at the usual time. Do not take a double dose to make up for the missed dose.

If you stop taking Lansoprazol Flas Salvat

Do not stop treatment prematurely even if symptoms have improved. Your condition may not be completely healed and may recur if you do not complete the full course of treatment.

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

4. Possible adverse effects

Like all medicines, this medicine can have adverse effects, although not everyone experiences them.

The following adverse effects are common (may affect up to 1 in 10 people):

• headache, dizziness
• diarrhoea, constipation, stomach pain, nausea and vomiting, flatulence, dryness or pain in mouth or throat
• skin rash, itching
• changes in liver function test values
• fatigue
• benign polyps in the stomach

The following adverse 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 hip, wrist, and spinal fractures

The following adverse effects are rare (may affect up to 1 in 1,000 people):

• fever
• restlessness, drowsiness, confusion, hallucinations, insomnia, visual disturbances, dizziness
• altered taste, loss of appetite, inflammation of the tongue (glossitis)
• skin reactions such as burning or itchy sensation under the skin, bruising, redness and excessive sweating
• sensitivity to light
• hair loss
• tingling sensation (paraesthesia), tremor
• anaemia (pallor)
• kidney problems
• pancreatitis
• liver inflammation (may present as yellowing of the skin or eyes)
• breast swelling in men, impotence
• candidiasis (fungal infection, may affect skin or mucous membranes)
• angioedema; contact your doctor immediately if you experience symptoms of angioedema, such as swelling of the face, tongue or pharynx, difficulty swallowing, urticaria, and breathing difficulties.

The following adverse effects are very rare (may affect up to 1 in 10,000 people):

• severe hypersensitivity reactions, including anaphylactic shock. Symptoms of hypersensitivity reactions may include fever, rash, swelling and, occasionally, low blood pressure
• inflammation of the mouth (stomatitis)
• colitis (inflammation of the intestine)
• changes in laboratory test values, such as levels of sodium, cholesterol and triglycerides
• very severe skin reactions with redness, blisters, severe swelling and skin loss
• in very rare cases, lansoprazole may cause a reduction in the number of white blood cells, which can lead to decreased resistance to infections. If you develop an infection with symptoms such as fever and severe deterioration in your general condition, or fever with local infection symptoms such as sore throat/pharynx/mouth or urinary problems, consult your doctor immediately. A blood test will be performed to check for possible reduction in white blood cells (agranulocytosis).

Frequency not known (cannot be estimated from available data):

• if you have been taking Lansoprazol Flas Salvat for more than three months, your blood magnesium levels may decrease. Low magnesium levels may cause fatigue, involuntary muscle contractions, disorientation, seizures, dizziness and increased heart rate. If you experience any of these symptoms, inform your doctor immediately. Low magnesium levels may also lead to decreased levels of potassium or calcium in the blood. Your doctor will likely request regular blood tests to monitor magnesium levels.
• skin rash, possibly with joint pain
• visual hallucinations

If you notice any adverse effects not mentioned in this leaflet, or if you experience any of the described adverse effects severely, inform your doctor or pharmacist.

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet.

You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es.

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Lansoprazole Flas Salvat

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the container and packaging. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point in your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the container and additional information

Composition of Lansoprazol Flas Salvat

• The active substance is lansoprazole.

• The other components are sugar spheres (sucrose and corn starch); magnesium carbonate; hypromellose; polysorbate 80; macrogol 6000; triethyl citrate; talc; methacrylic acid and ethyl acrylate copolymer; methyl methacrylate, methacrylic acid methyl ester and methacrylic acid copolymer; microcrystalline cellulose; hydroxypropylcellulose; sodium saccharin; mannitol (E-421); tropical flavor; malic acid; magnesium stearate.

Appearance of the product and contents of the container

Lansoprazol Flas Salvat 15 mg are greyish-white tablets containing microgranules.

Lansoprazol Flas Salvat 15 mg is available in packs of 14, 28 or 56 tablets.

Not all pack sizes are marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorios SALVAT, S.A.

Gall 30-36

08950 Esplugues de Llobregat

Barcelona - Spain

Manufacturer

Laboratorios SALVAT, S.A.

Gall 30-36

08950 Esplugues de Llobregat

Barcelona - Spain

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132JH, Hoofddorp

The Netherlands

(Only for United Kingdom and Sweden)

This medicinal product is authorized in the European Economic Area member states under the following names:

Lansoprazole Salvat 15 mg orodispersible tablets France

Lansoprazolo Salvat 15 mg compresse orodispersibili Italy

Monolitum 15 mg comprimidos orodispersíveis Portugal

Lansoprazole 15 mg orodispersible tablets United Kingdom

Lansoprazol SUN 15 mg munsönderfallande tablet Sweden

Date of the most recent review of this leaflet: December 2022

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS):

http://www.aemps.gob.es/