ESTOMIL FLAS 15 mg ORALLY DISINTEGRATING TABLETS

Introduction

Patient Information Leaflet

Estomil Flas 15 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.

Contents of the pack

1. What Estomil Flas is and what it is used for
2. What you need to know before you take Estomil Flas
3. How to take Estomil Flas
4. Possible side effects
5. Storing Estomil Flas
6. Contents of the pack and other information

1. What Estomil Flas is and what it is used for

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

Your doctor may prescribe you Estomil Flas for the following indications:

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

Your doctor may have prescribed Estomil Flas for another indication or at a different dose than indicated in this leaflet. Follow your doctor's instructions regarding the administration of the medicine.

You should consult a doctor if you get worse or if you do not improve after 14 days.

2. What you need to know before you take Estomil Flas

Do not take Estomil Flas

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Estomil Flas:

• if you have reduced body stores of vitamin B12 or risk factors for this and receive long-term treatment with lansoprazole. Like all medicines that reduce acid, Estomil Flas 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 Estomil 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 Estomil Flas. Remember to mention any other symptoms you may notice, such as joint pain.

When taking lansoprazole, kidney inflammation may occur. The signs and symptoms may include decreased urine output 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 severe liver disease. Your 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.

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

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

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

Other medicines and Estomil Flas

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

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

• HIV protease inhibitors such as atazanavir and nelfinavir (used to treat 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 Estomil Flas with food and drinks

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

Pregnancy and breastfeeding

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

Driving and using machines

Patients taking Estomil Flas 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 ability to react may be reduced.

You are the only person responsible for deciding whether you are fit to drive or perform activities that require a high level of concentration. Due to its effects or adverse reactions, one of the factors that can 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 or pharmacist.

Estomil Flas contains sucrose and sodium hydroxide.

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

This medicine contains less than 23 mg of sodium (1 mmol) per orodispersible tablet; this is, essentially "sodium-free".

3. How to take Estomil Flas

Follow the instructions for administration of this medicine exactly as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist 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 via a syringe, in case you have serious difficulties swallowing.

Follow the following instructions in case of administration via a syringe:

It is important that you check that the selected syringe is suitable.

• 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 in the reservoir.
• Put the plunger back 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.
• Turn the syringe upside down and pull the plunger to allow 1 ml of air to enter.
• 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 remove any remaining residue from the syringe and empty it into the mouth.

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

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

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

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

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

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

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

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

The recommended combinations of antibiotics are as follows:

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

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

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

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

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

Use in children

Estomil Flas should not be administered to children.

If you take more Estomil Flas than you should

If you take more Estomil Flas than you have been told, consult your doctor immediately or contact the Toxicology Information Service, telephone 915 620 420.

If you forget to take Estomil Flas

If you forget to take a dose, take it as soon as you remember, unless it is almost time for your 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 missed doses.

If you stop taking Estomil Flas

Do not stop treatment early because your symptoms have improved. It is possible that your condition has not been completely cured and may recur if you do not complete the entire 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.

Common side effects.

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

Uncommon side effects.

May affect up to 1 in 100 people.

Rare side effects.

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 itching sensation under the skin, bruising, redness, and excessive sweating
• sensitivity to light
• hair loss
• tingling sensation (paresthesia), tremors
• 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, can 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

Very rare side effects.

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
• mouth inflammation (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, Estomil Flas 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:

• if you have been taking Estomil Flas for more than three months, it is possible that your blood magnesium levels may decrease. Low magnesium levels can cause fatigue, 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 your magnesium levels
• skin rash, possibly with joint pain
• visual hallucinations

Reporting of side effects:

If you experience any side effects, talk to your doctor or pharmacist, even if they are 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 Estomil Flas

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 is the last day of the month stated.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to a pharmacy for disposal. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Packaging Contents and Additional Information

Composition of Estomil Flas

The active ingredient is lansoprazole.

The other components (excipients) are: sugar spheres (sucrose and corn starch), magnesium carbonate, hypromellose, polysorbate 80, macrogol 6000, triethyl citrate, talc, titanium dioxide (E-171), methacrylic acid and ethyl acrylate copolymer, and sodium hydroxide. The gelatin capsule is composed of: titanium dioxide (E-171), erythrosine, red iron oxide, and gelatin.

Product Appearance and Packaging Contents

Estomil Flas is presented in the form of grayish-colored, orally dispersible tablets that contain microgranules. Each package contains 28 or 56 orally dispersible tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Merck, S.L.

María de Molina, 40

28006 Madrid

Manufacturer

Laboratorios Salvat, S.A.

C/Gall 30-36

08950 Esplugues de Llobregat (Barcelona)

Date of the Last Revision of thisProspectus: December 2022

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/