Estomil 15 mg gastro-resistant hard capsules EFG

Package leaflet: Information for the user

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 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 may 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.

Contents of the leaflet

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

1. What Estomil is and what it is 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 Estomil 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 ongoing 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 Estomil 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 your condition worsens or does not improve after 14 days.

2. What you need to know before taking Estomil

Do not take Estomil

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

Warnings and precautions

Talk to your doctor or pharmacist before taking Estomil:

• if you have low body stores of vitamin B12 or risk factors for this and are receiving 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 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 stop treatment with Estomil. Remember to mention any other symptoms you may notice, such as joint pain.

Kidney inflammation may occur when taking lansoprazole. 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 must 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 Estomil, contact your doctor immediately, as Estomil has been associated with a slight increase in infectious diarrhea.

If your doctor has prescribed Estomil 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 Estomil, especially for 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 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 likely monitor you regularly. During visits to your doctor, you should report any new or unusual symptoms or circumstances.

Other medicines and Estomil

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

In particular, inform your doctor if you are taking medicines containing any of the following active substances, as Estomil may affect their 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 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, breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using 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 exercise caution, as your reaction ability may be reduced.

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

The following sections contain descriptions of these effects.

Please read the information in this leaflet carefully.

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

Estomil contains sucrose and sodium hydroxide.

This medicine contains sucrose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

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

3. How to take Estomil

Follow exactly the instructions for using this medicine given by your doctor or pharmacist. If in 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 must not crush or chew the capsules or the contents of an emptied capsule, as this will prevent the medicine from working properly.

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

If you take Estomil twice daily, you should take the first dose in the morning and the second in the evening.

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

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

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

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

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

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

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

The recommended antibiotic combinations are as follows:

• 30 mg Estomil with 250–500 mg clarithromycin and 1,000 mg amoxicillin
• 30 mg Estomil with 250 mg clarithromycin and 400–500 mg metronidazole

If you are receiving anti-infective treatment for an ulcer, the ulcer is unlikely to recur if the infection is successfully treated. To achieve the best results from 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 30 mg capsule daily for 4 weeks.

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

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

Use in children

Estomil must not be given to children.

If you take more Estomil than you should

If you take more Estomil than prescribed, contact your doctor immediately or call 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 it is almost time for your next dose. In that case, skip the missed dose and take the next capsules at the usual time.

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

If you stop taking Estomil

Do not stop treatment prematurely because symptoms have improved. Your condition may not have been completely cured and could return 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 cause adverse effects, although not everyone experiences them.

Frequent adverse effects

May affect up to 1 in 10 people.

• headache, dizziness
• diarrhoea, 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 polyps in the stomach

Uncommon adverse effects

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 of the hip, wrist, and spine

Rare adverse 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 (paraesthesia), tremor
• anaemia (pallor)
• kidney problems
• pancreatitis
• inflammation of the liver (may present as yellowing of the skin or eyes)
• breast swelling in males, impotence
• candidiasis (fungal infection, may affect the skin or mucosa)
• angioedema; contact your doctor immediately if you experience symptoms of angioedema, such as swelling of the face, tongue or throat, difficulty swallowing, hives, and difficulty breathing

Very rare adverse effects

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 sometimes a drop in blood pressure
• inflammation of the mouth (stomatitis)
• colitis (inflammation of the intestine)
• changes in laboratory 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, Estomil may cause a reduction in the number of white blood cells, which can lead to a decreased resistance to infections. If you develop an infection with symptoms such as fever and severe deterioration in your general condition, or fever with signs of local infection 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

• if you have been taking Estomil for more than three months, magnesium levels in the blood may decrease. Low magnesium levels can cause fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, and increased heart rate. If you notice 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

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 Medicinal Products: https://www.notificaram.es.

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

5. Storage of Estomil

Keep this medicine out of sight and reach of children.

Do not store above 30°C.

Do not use this medicine after the expiry date stated on the blister and carton after EXP. 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 empty containers and unused medicines at the SIGRE collection point at 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 pack and other information

Composition of Estomil

The active substance is lansoprazole.

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

Appearance of the product and contents of the pack

Estomil 15 mg gastro-resistant hard capsules are presented as gastro-resistant hard capsules containing spherical gastro-resistant granules of lansoprazol, in packs of 28 and 56 capsules.

Only certain pack sizes may be commercially available.

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 most recent review of this leaflet: December 2022

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