LANSOPRAZOL ALMUS 30 mg HARD GASTRORESISTENT CAPSULES

Introduction

Package Leaflet: Information for the User

Lansoprazole Almus 30 mg Gastro-Resistant Hard Capsules EFG

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

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

The active substance 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 inflammation of the oesophagus (reflux oesophagitis)
• Prevention of reflux oesophagitis
• 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 Lansoprazole Almus for another indication or at a different dose than indicated in this leaflet. Follow your doctor's instructions regarding the taking of the medicine.

2. What you need to know before you take Lansoprazole Almus

Do not take Lansoprazole Almus:

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

Warnings and precautions

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 cancer.

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

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, skin rash, and joint stiffness. You should report these signs to your doctor.

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

If you are taking proton pump inhibitors like Lansoprazole 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 probably perform regular checks. During your visits to the doctor, you should report any new or abnormal symptoms and circumstances.

Consult your doctor before starting to take Lansoprazole Almus:

• if you have ever had a skin reaction after treatment with a medicine similar to Lansoprazole Almus 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 Lansoprazole Almus. Remember to mention any other symptoms you may notice, such as joint pain.

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

Using Lansoprazole Almus with other medicines

Tell your doctor or pharmacist if you are using or have recently used other medicines, even those obtained without a prescription.

In particular, tell your doctor if you are using medicines that contain any of the following active substances, as Lansoprazole 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 Lansoprazole Almus with food and drinks

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

Pregnancy and breastfeeding

Before taking any medicine, consult your doctor or pharmacist.

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

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

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

Driving and using machines

Patients taking Lansoprazole 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 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 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, nurse, or pharmacist.

Lansoprazole Almus 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 Lansoprazole 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 medicine. 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 Lansoprazole Almus once a day, try to take it at the same time every day. You may get better results if you take Lansoprazole Almus in the morning.

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

The dose of Lansoprazole Almus depends on your general condition. The usual doses of Lansoprazole Almus 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 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 oesophagus inflammation (reflux oesophagitis):one 30 mg capsule per day for 4 weeks.

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

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 at night. The usual treatment is once a day for 7 days.

The recommended antibiotic combinations are as follows:

• 30 mg of Lansoprazole Almus with 250-500 mg of clarithromycin and 1000 mg of amoxicillin
• 30 mg of Lansoprazole 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 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 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 usual initial dose is two 30 mg capsules per day; subsequently, based on your response to treatment with Lansoprazole Almus, the doctor will decide the best dose for you.

Use in children

Lansoprazole 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 Lansoprazole Almus than you should

If you take more Lansoprazole Almus than you have been prescribed, consult your doctor immediately or call the Toxicology Information Service immediately.

In case of overdose or accidental ingestion, consult the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount taken. It is recommended to bring the package and the package leaflet of the medicine to the healthcare professional.

If you forget to take Lansoprazole Almus

If you forget to take a dose, take it as soon as possible unless the time of 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 Lansoprazole Almus

Do not stop treatment before time 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 questions about the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Lansoprazole Almus 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
• 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 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

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

• fever
• restlessness, drowsiness, confusion, hallucinations, insomnia, visual disturbances, vertigo
• altered taste, 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
• anaemia (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.

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
• 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, Lansoprazole 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 have a blood test to check for a possible reduction in white blood cells (agranulocytosis).

Side effects with unknown frequency

If you are taking Lansoprazole 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 potassium and calcium levels in the blood. Your doctor may decide to perform periodic blood tests to monitor magnesium levels.

Skin rash, possibly with joint pain.

Visual hallucinations.

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

5. Storage of Lansoprazole Almus

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

Do not use Lansoprazole Almus after the expiry date stated on the blister and carton. The expiry date is the last day of the month indicated.

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

Medicines should not be disposed of via wastewater or household waste. Return the packages and medicines you no longer need to the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packages and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Lansoprazole Almus

• The active substance is lansoprazole
• The other ingredients are:

Contents of the capsules:sugar spheres (sucrose and corn starch), 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)

Cap capsule:gelatin, titanium dioxide (E171)

Appearance of the product and contents of the pack

These gastro-resistant capsules are also available in blister packs containing: 14, 28 capsules

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder:

Almus Pharmaceutical, S.A.U.

Marie Curie, 54

08840 Viladecans (Barcelona), Spain

Telephone: 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 medicine is authorised in the Member States of the European Economic Area under the following names:

Spain: Lansoprazole Almus 30 mg gastro-resistant hard capsules EFG

Date of last revision of this leaflet: 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/.