PATIENT INFORMATION LEAFLET

Lansoprazol Alter 15 mg Hard Gastroresistant Capsules EFG

Read this leaflet carefully before you start taking this medicine.

• 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. Do not pass it on to others even if their symptoms are the same. It may harm them.
• If you think you have suffered a side effect, you can help us by reporting it directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

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

Your doctor may prescribe youLansoprazol Alterfor 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 youLansoprazol Alterfor another indication or a different dose than indicated in this leaflet. Follow your doctor's instructions for taking the medication

Do not take Lansoprazol Alter:

• If you are allergic (hypersensitive) to lansoprazol or to any of the other components of Lansoprazol Alter.
• If you are taking another medicine whose active ingredient is atazanavir (used in the treatment of HIV).

Be especially careful with Lansoprazol Alter:

Inform your doctor if you have a serious liver disease. Your 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 exclude cancer.

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

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

If you have been taking Lansoprazol Alter for a long time (over 1 year), your doctor will probably perform regular checks. During your doctor's visits, you must inform them of any new or abnormal symptoms and circumstances.

Consult your doctor before starting to take Lansoprazol Alter if you have ever had a skin reaction after treatment with a similar medicine to Lansoprazol Alter for reducing stomach acid.

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 Alter. Remember to mention any other symptoms you may notice, such as joint pain.

Before taking this medicine, inform your doctor if:

• You are scheduled to have a specific blood test (Cromogranina A).

When taking lansoprazol, inflammation in the kidneys may occur. 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. Inform your doctor of these signs.

Use of other medicines:

Inform your doctor or pharmacist if you are using or have recently used other medicines, including those purchased without a prescription.

Especially, inform your doctor if you are using medicines containing any of the following active ingredients, as Lansoprazol Alter may affect their action:

• ketoconazol, itraconazol, rifampicina (used to treat infections)
• digoxina (used to treat heart problems)
• teofilina (used to treat asthma)
• tacrolimús (used to prevent transplant rejection)
• fluvoxamina (used to treat depression and other psychiatric disorders)
• anti-acids (used to treat stomach burning or acid regurgitation)
• sucralfato (used to heal ulcers)
• St. John's Wort (Hypericum perforatum) (used to treat mild depression)

Taking Lansoprazol Alter with food and drinks:

To get the best results from your medicine, take Lansoprazol Alter at least 30 minutes before meals.

Pregnancy and breastfeeding:

If you are pregnant, or think you may be, or are breastfeeding, consult your doctor before taking this medicine.

Driving and operating machinery:

Patients taking Lansoprazol Alter 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 perform these operations safely is the use of medicines.

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.

Important information about some of the components of Lansoprazol Alter:

Lansoprazol Alter contains sacarosa. If your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking this medicine.

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 takeLansoprazol Alteronce a day, try to take it at the same time every day. You may get better results if you takeLansoprazol Alterin the morning.

If you takeLansoprazol Altertwice a day, you should take the first dose in the morning and the second at night.

To extract the capsule properly, it is recommended:

1. Cut along the scored line.

2. Separate the two aluminum layers at the indicated place and extract the capsule.

The dose ofLansoprazol Alterdepends on your general condition. The normal doses ofLansoprazol Alterfor adults are indicated below. In some cases, your doctor may prescribe a different dose and 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 with two different antibiotics in the morning and one capsule of 30 mg with two different antibiotics at night.The treatment, usually, will be daily for 7 days.

The recommended antibiotic combinations are as follows:

• 30 mg ofLansoprazol Alterwith 250–500 mg of clarithromycin and 1,000 mg of amoxicillin
• 30 mg ofLansoprazol Alterwith 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: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, your doctor will decide the best dose for you based on your response to treatment withLansoprazol Alter.

Lansoprazol Altershould not be administered to children.

Follow exactly the administration instructions given by your doctor. Consult your doctor if you have any doubts.

If you take more Lansoprazol Alter than you should

If you take moreLansoprazol Alterthan indicated, consult your doctor immediately or contact the Toxicology Information Service, Teléfono 915 620 420.

If you forget to take Lansoprazol Alter

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 make up for the missed dose.

If you interrupt treatment with Lansoprazol Alter

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

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

The following side effects are frequent (occur in more than 1 in 100 patients):

• 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 (occur in less than 1 in 100 patients):

• depression
• joint or muscle pain
• fluid retention or swelling
• changes in blood cell count
• If you are taking proton pump inhibitors such as Lansoprazol Alter, especially for more than a year, you may have a slightly increased risk of hip, wrist, and spinal fractures. Inform your doctor if you have osteoporosis or if you are taking corticosteroids (which can increase the risk of osteoporosis).

The following side effects are rare (occur in less than 1 in 1,000 patients):

• 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, hematomas, redness, and excessive sweating
• light sensitivity
• hair loss
• tingling sensation (paresthesia), tremor
• anemia (pallor)
• renal problems
• pancreatitis
• inflammation of the liver (may manifest as yellowish 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 swelling, tongue, or throat inflammation, difficulty swallowing, urticaria, and difficulty breathing.

The following side effects are very rare (occur in less than 1 in 10,000 patients):

• severe hypersensitivity reactions, including anaphylactic shock. Symptoms of hypersensitivity reactions 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 Alter may cause a reduction in the number of white blood cells, which can lead to 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 sore throat/pharynx/mouth or urinary problems, consult your doctor immediately. A blood test will be performed to check for possible leukopenia (agranulocytosis).

The following side effects are of unknown frequency (cannot be estimated from available data)

• If you are taking Lansoprazol 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.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Do not store at a temperature above30ºC.

Keep out of the reach and sight of children.

Do not useLansoprazol Alterafter the expiration date that appears on theblister andthebox.The expiration date is the last day of the month indicated.

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

Lansoprazol CompositionAlter

The active ingredient is lansoprazol.

The other components are: sugar spheres (saccharose and cornstarch), magnesium carbonate,hypromellose,polysorbate 80, macrogol 6000, triethyl citrate, talc, titanium dioxide(E-171),polymer of methacrylic acid and ethyl acrylate and sodium hydroxide. The gelatin capsule is composed of: titanium dioxide (E-171), erythrosine, iron oxide red and gelatin.

Product Appearance and Packaging Content

Lansoprazol Alter 15 mg gastro-resistant capsules are presented in the form of hard gastro-resistant capsules, containing gastro-resistant spherical granules of lansoprazol, in packs of 28 capsules.

Marketing Authorization Holder and Responsible Manufacturer

The marketing authorization holder is:

ALTER Laboratories, S.A.

C/Mateo Inurria, 30

28036 Madrid

The manufacturer is:

SALVAT Laboratories, S.A.

C/Gall 30-36

08950 Esplugues de Llobregat, Barcelona

Last Review Date of this Prospectus:

December 2022

The detailed and updated information of this medication is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.es/