LANSOPRAZOL FLAS SALVAT 30 mg ORALLY DISINTEGRATING TABLETS

2. What you need to know before you take Lansoprazole Flas Salvat

Do not take Lansoprazole Flas Salvat:

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

Warnings and precautions

When taking lansoprazole, kidney inflammation may occur. The signs and symptoms may include decreased urine volume or the presence of blood in the urine and/or hypersensitivity reactions such as fever, skin rash, and joint stiffness. You should inform your doctor of these signs.

Tell your doctor if you have a severe liver disease. It is possible that the doctor may need to adjust the dose.

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

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

If your doctor has prescribed you Lansoprazole Flas Salvat in addition to other medicines intended for the treatment of Helicobacter pyloriinfection (antibiotics) or together with anti-inflammatory drugs to treat pain or rheumatism, also read carefully the package leaflets of these medicines.

Taking a proton pump inhibitor like Lansoprazole Flas Salvat, especially for a period of more than one year, may slightly increase the risk of hip, wrist, and spine fractures. 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 Lansoprazole Flas Salvat for a long time (more than 1 year), your doctor will probably have you checked regularly. During your visits to the doctor, you should inform them of any new or abnormal symptoms and circumstances.

Consult your doctor before starting to take Lansoprazole Flas:

• If you have decreased body stores of vitamin B12 or risk factors for it and you receive long-term treatment with lansoprazole. Like all medicines that reduce acid, lansoprazole may 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 Lansoprazole Flas to reduce stomach acidity.
• If you suffer from a skin rash, especially in areas of the skin exposed to the sun, consult your doctor as soon as possible, as it may be necessary to interrupt treatment with Lansoprazole Flas. Remember to mention any other symptoms you may notice, such as joint pain.

Taking Lansoprazole Flas Salvat with other medicines

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

In particular, inform your doctor if you are using medicines that contain any of the following active substances, as Lansoprazole Flas Salvat may affect their mode of action:

• HIV protease inhibitors such as atazanavir and nelfinavir (used in the treatment of HIV)
• 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 Lansoprazole Flas Salvat with food and drinks

To get the best results from your medicine, you should take Lansoprazole Flas Salvat at least 30 minutes before meals.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.

Driving and using machines

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

You are the only person responsible for deciding whether you are in a fit state to drive vehicles or perform activities that require a high level of concentration. Due to its effects or adverse reactions, one of the factors that may reduce your ability to perform these operations safely is the use of medicines.

In the following sections, you will find descriptions of these effects.

Read this leaflet carefully.

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

Lansoprazole Flas Salvat contains sucrose.

If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

3. How to take Lansoprazole Flas Salvat

Follow the instructions for administration of this medicine exactly as indicated by your doctor. In case of doubt, consult your doctor again.

Place the tablet on the tongue and suck it slowly. The tablet dissolves quickly in the mouth, releasing microgranules that should be swallowed without chewing.

You can also swallow the tablet whole with a glass of water.

Your doctor may give you instructions to administer the tablet through a syringe, in case you have serious difficulties swallowing.

Follow these instructions in case of oral administration through a syringe:

It is important that you check that the selected syringe is the appropriate one.

• Remove the plunger from the syringe (at least a 5 ml syringe for the 15mg tablet and a 10 ml syringe for the 30mg tablet).
• Place the tablet in the reservoir.
• Put the plunger back in the syringe.
• For the 15mg tablet: fill the syringe with 4ml of water.
• For the 30mg tablet: fill the syringe with 10ml of water.
• Turn the syringe upside down and pull the plunger to allow 1ml of air to enter.
• Gently shake the syringe for 10-20 seconds until the tablet has dispersed.
• The contents can be emptied directly into the mouth.
• Refill the syringe with 2-5ml of water to remove any remaining residue from the syringe and empty it into the mouth.
• Repeat the previous step if necessary.

If you take Lansoprazole Flas Salvat once a day, try to take it always at the same time. You may get better results if you take Lansoprazole Flas Salvat in the morning.

If you take Lansoprazole Flas Salvat twice a day, you should take the first dose in the morning and the second dose at night.

The dose of Lansoprazole Flas Salvat depends on your general condition. The normal doses of Lansoprazole Flas Salvat for adults are indicated below. Sometimes, your doctor may prescribe you a different dose and indicate a different duration of treatment.

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

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

Treatment of inflammation of the esophagus (reflux esophagitis):one 30mg orodispersible tablet per day for 4 weeks.

Long-term prevention of reflux esophagitis:one 15mg orodispersible tablet per day; your doctor may adjust the dose to one 30mg orodispersible tablet per day.

Treatment of Helicobacter pyloriinfection:The normal dose is one 30mg orodispersible tablet together with two different antibiotics in the morning and one 30mg orodispersible tablet together with two different antibiotics in the evening. The normal treatment is once a day for 7 days.

The recommended combinations of antibiotics are as follows:

• 30mg of Lansoprazole Flas Salvat with 250-500mg of clarithromycin and 1000mg of amoxicillin
• 30mg of Lansoprazole Flas Salvat with 250mg of clarithromycin and 400-500mg of metronidazole

If you receive anti-infective treatment due to an ulcer, it is unlikely that the ulcer will come back if the infection is treated satisfactorily. To get the best results from your medicine, take it at the right time and do not forget any dose.

Treatment of duodenal or gastric ulcers in patients who require continuous treatment with NSAIDs: one 30mg orodispersible tablet per day for 4 weeks.

Prevention of duodenal or gastric ulcers in patients who require continuous treatment with NSAIDs:one 15mg orodispersible tablet per day; your doctor may adjust the dose to one 30mg orodispersible tablet per day.

Zollinger-Ellison syndrome:The normal initial dose is two 30mg orodispersible tablets per day; subsequently, depending on your response to treatment with Lansoprazole Flas Salvat, the doctor will decide the best dose for you.

Use in children

Lansoprazole Flas Salvat should not be administered to children.

If you take more Lansoprazole Flas Salvat than you should

If you take more Lansoprazole Flas Salvat than you have been told, contact your doctor immediately or call the Toxicology Information Service. Telephone 915 620 420.

If you forget to take Lansoprazole Flas Salvat

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

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

If you stop taking Lansoprazole Flas Salvat

Do not stop treatment before time because the symptoms have improved. It is possible that your condition has not been completely cured and may come back if you do not finish all the treatment.

If you have any other questions about 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.

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

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

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 count
• risk of hip, wrist, and spine fractures

The following side 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 a burning sensation or itching under the skin, bruising, redness, and excessive sweating
• sensitivity to light
• hair loss
• tingling sensation (paresthesia), tremor
• anemia (pallor)
• kidney problems
• pancreatitis
• liver inflammation (may be manifested by yellowing of the skin or eyes)
• breast swelling in males, impotence
• candidiasis (fungal infection, may affect the 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, hives, and difficulty breathing.

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

• severe hypersensitivity reactions, including anaphylactic shock. The symptoms of a hypersensitivity reaction may include fever, rash, swelling, and, in some cases, a drop in blood pressure
• inflammation of the mouth (stomatitis)
• colitis (inflammation of the intestine)
• changes in analytical values, such as sodium, cholesterol, and triglyceride levels
• very severe skin reactions with redness, blisters, severe inflammation, and skin loss
• in very rare cases, lansoprazole may cause a reduction in the number of white blood cells, which can cause a decrease in your resistance to infections. If you experience an infection with symptoms such as fever and severe deterioration of your general condition, or fever with symptoms of local infection such as sore throat/pharynx/mouth or urinary problems, consult your doctor immediately. You will have a blood test to check for a possible reduction in white blood cells (agranulocytosis).

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

• if you have been taking Lansoprazole Flas Salvat for more than three months, it is possible that the magnesium levels in your blood may decrease. Low magnesium levels can cause fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, and increased heart rate. If you notice any of these symptoms, inform your doctor immediately. Low magnesium levels can also lead to a decrease in potassium or calcium levels in the blood. Your doctor will probably ask you to have regular blood tests to check magnesium levels.
• skin rash, possibly with joint pain
• visual hallucinations

If you notice any side effects not mentioned in this leaflet or if you suffer from any of the side effects described in a severe way, inform your doctor or pharmacist.

Reporting of side effects:

If you experience any side effects, consult your doctor or pharmacist, even if it is a possible side effect that is not listed in this leaflet.

You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es.

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

5. Storing Lansoprazole Flas Salvat

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 carton and blister after EXP. The expiry date refers to the last day of that month.

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 protect the environment.

6. Packaging Content and Additional Information

Composition of Lansoprazol Flas Salvat

• The active ingredient 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 acrylate, methyl methacrylate and methacrylic acid copolymer; microcrystalline cellulose; hydroxypropylcellulose; sodium saccharin; mannitol (E-421); tropical flavor; malic acid; magnesium stearate.

Appearance of the Product and Packaging Content

Lansoprazol Flas Salvat 15 mg are white-gray tablets that contain microgranules.

Lansoprazol Flas Salvat 15 mg is presented in packages of 14, 28 or 56 tablets.

Not all formats are marketed

Marketing Authorization Holder and Manufacturer

Holder

Laboratorios SALVAT, S.A.

Gall 30-36

08950 Esplugues de Llobregat

Barcelona - Spain

Manufacturing Responsible

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 the United Kingdom and Sweden)

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Lansoprazole Salvat 15 mg orodispersible tablets France

Lansoprazolo Salvat 15 mg orodispersible tablets Italy

Monolitum 15 mg orodispersible tablets Portugal

Lansoprazole 15 mg orodispersible tablets United Kingdom

Lansoprazol SUN 15 mg orodispersible tablets Sweden

Date of the Last Revision of this Prospectus:December 2022

Detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS)

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