Lansoprazole Almus 15 mg gastro-resistant hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Lansoprazol Almus 15 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 and you should not give it to other people, even if they have the same symptoms as you. It may harm them.
• If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. See section 4.

What this leaflet contains

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

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

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

Your doctor may prescribe Lansoprazol Almus 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
• long-term 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 Lansoprazol Almus 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.

2. What you need to know before taking Lansoprazol Almus

Do not take Lansoprazol Almus:

• If you are allergic (hypersensitive) to lansoprazole or to any of the other ingredients of Lansoprazol Almus.
• If you are taking another medicine containing atazanavir (used in the treatment of HIV).

Warnings and precautions

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 to rule out cancer.

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

When taking Lansoprazole, inflammation of the kidney may occur. 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.

If your doctor has prescribed Lansoprazol Almus in combination 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.

If you are taking proton pump inhibitors such as Lansoprazol Almus, especially for more than one year, there may be a slight increase in the risk of fractures of the hip, wrist, and 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 Lansoprazol Almus for a long time (more than 1 year), your doctor will likely monitor you regularly. During visits to your doctor, you must report any new or unusual symptoms or circumstances.

Consult your doctor before starting Lansoprazol Almus:

• if you have ever had a skin reaction after treatment with a medicine similar to Lansoprazol Almus 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 discontinue treatment with Lansoprazol 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).

Taking Lansoprazol Almus with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines,
including those not requiring a prescription.

In particular, inform your doctor if you are taking medicines containing any of the following active substances, as Lansoprazol Almus may affect their 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 achieve the best results from your medicine, Lansoprazol Almus should be taken at least 30 minutes before meals.

Pregnancy and breastfeeding

Before taking any medicine, consult your doctor or pharmacist.

The use of Lansoprazol Almus during pregnancy is not recommended, as there is insufficient experience regarding the use of lansoprazole during pregnancy.

There is insufficient experience with the use of lansoprazole during breastfeeding. Based on animal studies, lansoprazole is expected to pass into breast milk.

When deciding whether to continue or discontinue 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 exercise caution, as your reaction capability may be reduced.

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

The descriptions of these effects can be found in the following sections.
Read the information in this leaflet carefully.
If you have any doubts, ask your doctor, nurse, or pharmacist.

Lansoprazol Almus contains sucrose. If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine.

This medicine contains less than 23 mg of sodium (1 mmol) per capsule; that 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. 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 Lansoprazole Almus once a day, try to take it at the same time every day. You may achieve 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 in the evening.

The dose of Lansoprazole Almus depends on your medical condition. The usual doses of Lansoprazole Almus for adults are listed below. Occasionally, your doctor may prescribe 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 taken in the morning together with two different antibiotics, and one 30 mg capsule taken in the evening together with two different antibiotics. The usual treatment duration is once daily for 7 days.

The recommended antibiotic combinations are as follows:

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

If you are receiving anti-infective treatment for an ulcer, it is unlikely that the ulcer will 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 Lansoprazole Almus, your doctor will decide the most appropriate dose for you.

Use in children

Lansoprazole Almus must not be given to children.

Always follow your doctor's instructions exactly. If you have any doubts, consult your doctor.

If you take more Lansoprazole Almus than you should

If you take more Lansoprazole Almus than prescribed, contact your doctor immediately or call the Poison Information Service right away.

In case of overdose or accidental ingestion, contact the Poison Information Service at telephone number 91 562 04 20, stating the name of the medicine and the amount taken. It is recommended to bring the medicine packaging and leaflet 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 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 Lansoprazole Almus

Do not stop treatment prematurely, even if your symptoms have improved. Your condition may not be completely healed, and symptoms may 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, Lansoprazol Almus may cause adverse effects, although not everyone experiences them.

The following adverse effects are common (may affect up to 1 in 10 people):

• headache, dizziness
• diarrhea, constipation, stomach pain, nausea and vomiting, flatulence, dryness or pain in mouth or throat
• skin rash, itching
• changes in liver function test values
• fatigue
• benign gastric 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, dizziness
• taste disturbances, loss of appetite, inflammation of the tongue (glossitis)
• skin reactions such as burning or itching sensation under the skin, bruising, redness, and excessive sweating
• light sensitivity
• hair loss
• tingling sensation (paresthesia), tremor
• anemia (pallor)
• kidney problems
• pancreatitis
• liver inflammation (may present as yellowing of the skin or eyes)
• breast swelling in males, impotence
• candidiasis (fungal infection, may affect skin or mucous membranes)
• angioedema; contact your doctor immediately if you experience symptoms of angioedema,
• such as swelling of the face, tongue or throat, difficulty swallowing, hives, and breathing difficulties.

The following adverse effects are very rare (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 occasionally low 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, Lansoprazol Almus may cause a reduction in the number of white blood cells, which may decrease your 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 localized 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).

Adverse effects with unknown frequency

If you are taking Lansoprazol Almus for more than three months, magnesium levels in the blood may decrease. Low magnesium levels may cause fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, palpitations, increased heart rate. If you experience any of these symptoms, seek medical advice immediately. Low magnesium levels may also lead to decreased levels of potassium and calcium 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 any adverse effects, consult your doctor or pharmacist, even if they are adverse effects 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 refers to the last day of the month indicated.

Do not store above 25 °C. Keep in the original container to protect from moisture.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point in your pharmacy. If you are in doubt, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the container and additional information

Composition of Lansoprazol Almus

• The active substance is lansoprazole.
• The other components are:

Capsule contents: 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)

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

Appearance of the product and contents of the container

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

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Almus Farmacéutica, S.A.U.

Marie Curie, 54

08840 Viladecans (Barcelona), Spain

Telephone: 93 739 71 80

Email: [email protected]

Manufacturer:

LABORATORIOS LICONSA, S.A.

Avda. Miralcampo, No. 7, Polígono Industrial Miralcampo,

19200 Azuqueca de Henares (Guadalajara)

Spain

This medicinal product 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 most recent review of this leaflet: December 2022

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