LANSOPRAZOL ALMUS 15 mg HARD GASTRORESISTENT CAPSULES

Introduction

Prospect: Information for the User

Lansoprazole Almus 15 mg Hard Gastro-Resistant Capsules EFG

Read the entire prospect carefully before starting to take this medication, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

Contents of the Prospect

1. What is Lansoprazole Almus and what is it used for
2. What you need to know before taking Lansoprazole Almus
3. How to take Lansoprazole Almus
4. Possible adverse effects
5. Storage of Lansoprazole Almus
6. Package contents and additional information

1. What is Lansoprazole Almus and what is it used for

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

Your doctor may prescribe you Lansoprazole Almus for the following indications:

• Treatment of duodenal and gastric ulcers
• Treatment of esophageal inflammation (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 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 you Lansoprazole Almus for another indication or at a different dose than indicated in this prospect. Follow your doctor's instructions regarding the administration of the medication.

2. What you need to know before taking Lansoprazole Almus

Do not take Lansoprazole Almus:

• If you are allergic (hypersensitive) to lansoprazole or any of the other components of Lansoprazole Almus.
• If you are taking another medication whose active ingredient is atazanavir (used in the treatment of HIV).

Warnings and precautions

Inform 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 cancer.

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

When taking Lansoprazol, 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 report these signs to your doctor.

If your doctor has prescribed you Lansoprazol Almus in addition to other medications intended for the treatment of Helicobacter pyloriinfection (antibiotics) or along with anti-inflammatory medications to treat pain or rheumatism, also read the prospectuses of these medications carefully.

If you are taking proton pump inhibitors like Lansoprazol Almus, especially for a period of more than one year, you may have a slightly increased risk of hip, wrist, and spine fractures. Inform your doctor if you have osteoporosis or if you are taking corticosteroids (which can increase the risk of osteoporosis).

If you have been taking Lansoprazol Almus for a long time (more than 1 year), your doctor will likely perform regular check-ups. During your doctor's visits, you should report any new or abnormal symptoms and circumstances.

Consult your doctor before starting to take Lansoprazol Almus:

• if you have ever had a skin reaction after treatment with a medication similar to Lansoprazol Almus to reduce stomach acid.

If you experience 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 Lansoprazol Almus. Remember to mention any other symptoms you may notice, such as joint pain.

• if you are scheduled to undergo a specific blood test (Chromogranin A).

Use of Lansoprazol Almus with other medications

Inform your doctor or pharmacist if you are using or have recently used other medications,

including those purchased without a prescription.

In particular, inform your doctor if you are using medications that contain any of the following active ingredients, as Lansoprazol Almus may affect their mode of action:

• ketoconazole, itraconazole, rifampicin (used to treat infections)
• digoxin (used to treat heart problems)
• 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 Almus with food and drinks

To get the best results from your medication, you should take Lansoprazol Almus at least 30 minutes before meals.

Pregnancy and breastfeeding

Before taking any medication, consult your doctor or pharmacist.

The use of Lansoprazol Almus is not recommended during pregnancy, as there is not enough experience with the use of lansoprazole during gestation.

There is not enough experience with the use of lansoprazole during breastfeeding. Based on animal studies, it is believed that lansoprazole passes into breast milk.

When deciding whether to continue or interrupt breastfeeding or treatment with Lansoprazol Almus, your doctor must consider the benefits of breastfeeding for your baby and the benefits of treatment with Lansoprazol Almus for you.

Driving and using machines

Patients taking Lansoprazol Almus 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 in a condition 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 medications.

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

Read the information in this prospect carefully.

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

Lansoprazol Almus contains sucrose.If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

This medication contains less than 23 mg of sodium (1 mmol) per capsule; that is, it is essentially "sodium-free".

3. How to take Lansoprazol Almus

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 medication. Do not crush or chew the capsules or the contents of an emptied capsule, as this will make them not work properly.

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

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

The dose of Lansoprazol Almus depends on your general condition. The normal doses of Lansoprazol Almus for adults are indicated below. Occasionally, 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 ulcer:one 30 mg capsule per day for 2 weeks.

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

Treatment of esophageal 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 normal dose is one 30 mg capsule

along with two different antibiotics in the morning and one 30 mg capsule along with two different antibiotics at night. The normal treatment is once a day for 7 days.

The recommended antibiotic combinations are as follows:

• 30 mg of Lansoprazol Almus with 250-500 mg of clarithromycin and 1000 mg of amoxicillin
• 30 mg of Lansoprazol Almus 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 medication, take it at the right time and do not forget any dose.

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

Prevention of duodenal or gastric ulcer 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 normal dose is two 30 mg capsules per day;

subsequently, based on your response to treatment with Lansoprazol Almus, the doctor will decide the best dose for you.

Use in children

Lansoprazol Almus should not be administered to children.

Follow your doctor's instructions for administration exactly. Consult your doctor if you have

doubts.

If you take more Lansoprazol Almus than you should

If you take more Lansoprazol Almus than indicated, consult your doctor immediately or call the Toxicology Information Service immediately.

In case of overdose or accidental ingestion, consult the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount taken. It is recommended to bring the packaging and prospectus of the medication to the healthcare professional.

If you forget to take Lansoprazol Almus

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 interrupt treatment with Lansoprazol Almus

Do not interrupt treatment prematurely because the 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 doubts about the use of this product, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medications, Lansoprazol Almus can cause adverse effects, although not all people experience them.

The following adverse effects are frequent (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 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 count

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

• fever
• restlessness, drowsiness, confusion, hallucinations, insomnia, visual disturbances, vertigo
• alteration of taste, loss of appetite, tongue inflammation (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), tremor
• anemia (pallor)
• kidney problems
• pancreatitis
• liver inflammation (may manifest as 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 facial swelling, tongue or pharynx swelling, difficulty swallowing, hives, and difficulty breathing.

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

• severe hypersensitivity reactions, including anaphylactic shock. The symptoms of hypersensitivity reaction may include fever, rash, swelling, and, occasionally, 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, Lansoprazol Almus 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 undergo a blood test to check for possible reduction of white blood cells (agranulocytosis).

Adverse effects with unknown frequency

If you are taking Lansoprazol Almus 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, increased heart rate. If you experience any of these symptoms, go to the doctor immediately. Low magnesium levels can also cause a decrease in blood potassium and calcium levels. Your doctor may decide to perform periodic blood tests to monitor magnesium levels.

Skin rash, possibly with joint pain.

Visual hallucinations.

If you experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect.

5. Storage of Lansoprazol Almus

Keep this medication out of sight and reach of children.

Do not use Lansoprazol Almus after the expiration date shown on the blister pack and carton. The expiration date is the last day of the month indicated.

Do not store above 25°C. Store in the original packaging to protect from moisture.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Lansoprazol Almus

• The active ingredient is lansoprazole
• The other components are:

Contents of the capsules:sugar spheres (sucrose and cornstarch), sodium lauryl sulfate, meglumine, mannitol (E421), hypromellose, macrogol, talc, polysorbate 80, titanium dioxide (E171), 30% dispersion of methacrylic acid and ethyl acrylate copolymer (1:1)

Capsule coating:gelatin, titanium dioxide (E171), quinoline yellow (E104)

Appearance of the product and package contents

These gastro-resistant capsules are also available in blister packs containing: 28 capsules.

It is possible that only some package sizes are marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Almus Pharmaceutical, S.A.U.

Marie Curie, 54

08840 Viladecans (Barcelona), Spain

Phone: 93 739 71 80

Email: farmacovigilancia@almusfarmaceutica.es

Manufacturer:

LABORATORIOS LICONSA, S.A.

Avda. Miralcampo, Nº 7, Polígono Industrial Miralcampo,

19200 Azuqueca de Henares (Guadalajara)

Spain

This medication is authorized in the member states of the European Economic Area under the following names:

Spain: Lansoprazol Almus 15 mg gastro-resistant capsules EFG

Date of the last revision of this prospect: 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/.