Package Leaflet: Information for the User

Lansoprazol Almus 30 mg Hard Capsules (Gastro-resistant, Enteric-coated)

Read 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. Do not pass it on to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist. See section 4.

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

2.What you need to know before you start taking Lansoprazol Almus

3.How to take Lansoprazol Almus

4.Possible side effects

5.Storage of Lansoprazol Almus

6.Contents of the pack and other information

The active ingredient of Lansoprazol Almus is lansoprazol, 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 esophagitis caused by acid reflux

-Prevention of esophagitis caused by acid reflux

-Treatment of stomach burning and acid regurgitation

-Treatment of infections caused by the bacteriaHelicobacter pylori, in combination with antibiotics

-Treatment or prevention of duodenal or gastric ulcers in patients requiring continuous treatment with nonsteroidal anti-inflammatory drugs (NSAIDs) (NSAIDs are used for pain or inflammation)

• Treatment of Zollinger-Ellison syndrome

Your doctor may have prescribed Lansoprazol Almus for another indication or a different dose than the one indicated in this leaflet. Follow your doctor's instructions for taking the medication.

Do not take Lansoprazol Almus:

-If you are allergic (hypersensitive) to lansoprazole or to any of the other components of Lansoprazol Almus.

-If you are taking another medicine whose active ingredient is atazanavir (used in the treatment of HIV).

Warnings and precautions

Inform your doctor if you have a severe liver disease. The doctor may need to adjust the dose.

Your doctor may perform or have performed a supplementary test called endoscopy

to diagnose your disease and/or rule out cancer.

In case of experiencing 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 Lansoprazol, inflammation in the kidney may occur. 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. Inform your doctor of these symptoms.

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

If you are taking proton pump inhibitors such as Lansoprazol Almus, especially during a period of more than one year, it may slightly increase the risk of hip, wrist, and spinal fractures. Inform your doctor if you have osteoporosis or if you are taking corticosteroids (they may 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 doctor's visits, inform them of 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 similar medicine to Lansoprazol Almus for reducing stomach acidity.

If you suffer from a skin rash, especially in sun-exposed areas, 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 (Cromogranin 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 obtained without a prescription.

Especially, inform your doctor if you are using medications containing 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, take Lansoprazol Almus at least 30 minutes before meals.

Pregnancy and breastfeeding

Before taking any medication, consult your doctor or pharmacist.

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 reaches breast milk.

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

Driving and operating machinery

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 time 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 may reduce your ability to carry out these operations safely is the use of medications.

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

Read this prospectus carefully.

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

Lansoprazol Almus contains saccharose.If your doctor has indicated that you have a certain sugar intolerance, consult with them before taking this medication.

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

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 empty capsule, as this will make them not work properly.

If you take Lansoprazol Almus once a day, try to take it at the same time every day. 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. In some cases, your doctor may prescribe a different dose and indicate a different duration of treatment.

Treatment of heartburn and acid regurgitation:one capsule of 15 mg or 30 mg 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 capsule of 30 mg per day for 2 weeks.

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

Treatment of esophagitis due to reflux:one capsule of 30 mg per day

for 4 weeks.

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

Treatment of Helicobacter pylori infection:The normal dose is one capsule of 30 mg

along with two different antibiotics in the morning and one capsule of 30 mg 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 1,000 mg of amoxicillin

-30 mg of Lansoprazol Almus with 250 mg of clarithromycin and 400–500 mg of metronidazole

If you receive antibiotic 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 anddo not forget any dose.

Treatment of duodenal or gastric ulcer in patients requiring continuous treatment with NSAIDs:

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

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

Zollinger-Ellison syndrome:The initial normal dose is two capsules of 30 mg per day;

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

Use in children:

Lansoprazol Almus should not be administered to children.

Follow your doctor's administration instructions 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 the medication leaflet to the healthcare professional.

If you forget to take Lansoprazol Almus:

If you forget to take a dose, take it as soon as you remember, unless the time for the next dose is near. In this case, skip the missed dose and take the capsules as usual. Do not take a double dose to compensate for the missed dose.

If you interrupt treatment with Lansoprazol Almus:

Do not interrupt treatment before time because symptoms have improved. It is possible that your condition has not been fully 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.

Like all medicines, Lansoprazol Almus can cause side effects, although not everyone will experience them.

The following side effects are frequent (can 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 side effects are infrequent (

can 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 (can affect up to 1 in 1,000 people):

• fever
• restlessness, drowsiness, confusion, hallucinations, insomnia, visual disturbances, vertigo
• alteration of taste, loss of appetite, inflammation of the tongue (glossitis)
• skin reactions such as burning or itching sensation under the skin, bruises, redness and excessive sweating
• sensitivity to light
• hair loss
• tingling sensation (paresthesia), tremor
• anemia (pale skin)
• kidney problems
• pancreatitis
• inflammation of the liver (may manifest as yellow skin or eyes)
• chest swelling in men, impotence
• candidiasis (fungal infection, may affect the skin or mucous membranes)
• angioedema; contact your doctor immediately if you experience symptoms of angioedema,
• such as facial inflammation, tongue or throat inflammation, difficulty swallowing, urticaria and difficulty breathing.

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

• severe hypersensitivity reactions, including anaphylactic shock. Symptoms of hypersensitivity reaction may include fever, rash, swelling, and, in some cases, a drop in blood pressure
• inflammation of the mouth (stomatitis)
• colitis (inflammation of the intestine)
• changes in analytical values, such as sodium, cholesterol, and triglyceride levels
• very severe skin reactions with redness, vesicles, 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 your 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 throat, pharynx, or mouth pain or urinary problems, consult your doctor immediately. A blood test will be performed to check for possible reduction in white blood cells (agranulocytosis).

Side effects of unknown frequency

If you are taking Lansoprazol Almus for more than three months, it is possible that blood magnesium levels may decrease. Low magnesium levels can cause fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, increased heart rate. If you experience any of these symptoms, see your doctor immediately. Low magnesium levels can also produce 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 side effects that do not appear in this prospectus.

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

Do not use Lansoprazol Almus after the expiration date that appears on the blister and the box. The expiration date is the last day of the month indicated.

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

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Lansoprazol Almus

- The active ingredient is lansoprazol

- The other components are:

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

Capsule coating:gelatin, titanium dioxide (E171)

Appearance of the product and contents of the packaging

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

Only some packaging sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Almus Farmacéutica, S.A.U.

Marie Curie, 54

08840 Viladecans (Barcelona), Spain

Phone: 93 739 71 80

Email: [email protected]

Responsible manufacturer:

Laboratorios Liconsa, S.A.

Avda. Miralcampo, Nº 7, Industrial Estate Miralcampo,

19200 Azuqueca de Henares (Guadalajara)

Spain

This medicine is authorized in the member states of the European Economic Area with the following names:

Spain:Lansoprazol Almus 30 mg gastro-resistant capsules EFG

Last review date of this leaflet: December 2022

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