ESTOMIL 15 mg HARD GASTRO-RESISTANT CAPSULES

Introduction

Package Leaflet: Information for the User

Estomil 15 mg Gastro-Resistant Hard Capsules EFG

Lansoprazole

Read all of this leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as 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 thepackage leaflet

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

1. What is Estomil and what is it used for

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

Your doctor may prescribe you Estomil 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

It is possible that your doctor has prescribed Estomil for another indication or at a different dose than indicated in this leaflet. Follow your doctor's instructions regarding the taking 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

Do not take Estomil

• 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:

• if you have reduced body stores of vitamin B12 or risk factors for this and you receive long-term treatment with lansoprazole. Like all medicines that reduce acid, Estomil 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 to reduce stomach acid,
• 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. 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 volume or the presence of blood in the urine and/or hypersensitivity reactions such as fever, rash, and joint stiffness. You should inform your doctor of these signs.

Inform your doctor if you have 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 Estomil, contact your doctor immediately, as Estomil has been associated with a slight increase in infectious diarrhea.

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

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

Other medicines and Estomil

Inform 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, inform your doctor if you are using medicines that contain any of the following active substances, as Estomil 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 with food and drinks

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

Pregnancy and breastfeeding

If you are pregnant, or 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 may occasionally experience side effects such as dizziness, vertigo, 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 one responsible for deciding whether you are fit 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 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 the information in this leaflet carefully.

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

Estomil contains sucrose and sodium hydroxide.

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

This medicine contains less than 23 mg of sodium (1 mmol) per capsule; this is, essentially “sodium-free”.

3. How to take Estomil

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.

Take the capsule whole with a glass of water. If you have difficulty swallowing the capsule, your doctor will inform you of alternative ways to take the medicine. You should not crush or chew the capsules or the contents of an emptied capsule, as this will make them not work properly.

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

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

The dose of Estomil depends on your general condition. The usual doses of Estomil 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 capsule 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 ulcers:one 30 mg capsule per day for 2 weeks.

Treatment of gastric ulcers:one 30 mg capsule per day for 4 weeks.

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

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

Treatment of Helicobacter pyloriinfection:The usual dose is one 30 mg capsule with two different antibiotics in the morning and one 30 mg capsule with two different antibiotics at night. The treatment is usually daily for 7 days.

The recommended antibiotic combinations are as follows:

• 30 mg of Estomil with 250-500 mg of clarithromycin and 1000 mg of amoxicillin
• 30 mg of Estomil 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 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 miss any doses.

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

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

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

Use in children

Estomil should not be administered to children.

If you take more Estomil than you should

If you take more Estomil than you should, consult your doctor immediately or contact the Toxicology Information Service: telephone 915 620 420.

If you forget to take Estomil

If you forget to take a dose, take it as soon as possible unless the time for the next dose is near. In this case, skip the missed dose and take the next capsules as usual.

Do not take a double dose to make up for the missed dose.

If you stop taking Estomil

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.

Frequent 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.

• depression
• joint or muscle pain
• fluid retention or swelling
• changes in blood cell count
• risk of hip, wrist, and spine fractures

Rare side effects.

May affect up to 1 in 1,000 people.

• fever
• restlessness, drowsiness, confusion, hallucinations, insomnia, visual disturbances, vertigo
• taste changes, loss of appetite, tongue inflammation (glossitis)
• skin reactions such as 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, 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 serious skin reactions with redness, blisters, severe inflammation, and skin loss
• in very rare cases, Estomil may cause a reduction in the number of white blood cells, which can cause a decrease in 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 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 for regular blood tests to check 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 it is possible side effects 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. Storage of Estomil

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

Do not store above 30°C.

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 indicated.

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. Contents of the pack and further information

Composition of Estomil

The active substance is lansoprazole.

The other ingredients (excipients) are: sugar spheres (sucrose and cornstarch), 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.

Appearance of the product and pack contents

Estomil 15 mg gastro-resistant hard capsules are presented in the form of gastro-resistant hard capsules, which contain spherical gastro-resistant lansoprazole granules, in packs of 28 and 56 capsules.

Not all pack 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 last revision of thisleaflet: December 2022

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