LANSOPRAZOL ALTER 15 mg HARD GASTRO-RESISTANT CAPSULES

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Lansoprazole Alter 15 mg hard gastro-resistant capsules EFG

Read the package leaflet carefully before starting to take the medicine.

• Keep this package 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, do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet.

Contents of the package leaflet:

1. What is Lansoprazole Alter and what is it used for
2. Before taking Lansoprazole Alter
3. How to take Lansoprazole Alter
4. Possible side effects
5. Storage of Lansoprazole Alter
6. Further information

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

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

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

• Treatment of duodenal and gastric ulcers
• Treatment of inflammation of the esophagus (reflux esophagitis)
• Prevention of reflux esophagitis
• Treatment of heartburn and acid regurgitation
• Treatment of infections caused by the bacteria 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 Alter for another indication or at a different dose than indicated in this package leaflet. Follow your doctor's instructions regarding the taking of the medicine.

2. Before taking Lansoprazole Alter

Do not take Lansoprazole Alter:

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

Be careful withLansoprazole Alter

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.

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

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

If you have been taking Lansoprazole Alter for a long time (more than 1 year), your doctor will probably perform regular check-ups. During visits to your doctor, you must inform him of any new or abnormal symptoms and circumstances.

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

If you suffer a skin rash, especially in areas exposed to the sun, consult your doctor as soon as possible, as it may be necessary to interrupt treatment with Lansoprazole Alter. Remember to mention any other symptoms you may notice, such as joint pain.

Before taking this medicine, inform your doctor if:

• A specific blood test (Chromogranin A) is scheduled for you.

When taking lansoprazole, 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 inform your doctor of these signs.

Use of other medicines

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

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

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

Pregnancy and breastfeeding

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

Driving and using machines

Patients taking Lansoprazole Alter may occasionally experience side effects, such as dizziness, drowsiness, 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 the information in this package leaflet carefully.

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

Important information about some of the components of Lansoprazole Alter

Lansoprazole Alter contains sucrose. If your doctor has told you that you have an intolerance to some sugars, consult with him before taking this medicine.

3. How to take Lansoprazole Alter

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

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

To extract the capsule properly, it is recommended:

1. Cut the blister by the marked cutting line.
2. Separate the two aluminum layers at the indicated place and extract the capsule.

The dose of Lansoprazole Alter depends on your general condition. The normal doses of Lansoprazole Alter for adults are indicated below. Sometimes, 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 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 esophagus 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 together with two different antibiotics in the morning and one 30 mg capsule together with two different antibiotics at night. The treatment will normally be daily for 7 days.

The recommended antibiotic combinations are as follows:

• 30 mg of Lansoprazole Alter with 250-500 mg of clarithromycin and 1000 mg of amoxicillin
• 30 mg of Lansoprazole Alter 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 come back if the infection is treated satisfactorily. To get the best results from your medicine, take it at the right time and do not forget 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 initial normal dose is two 30 mg capsules per day; subsequently, based on your response to treatment with Lansoprazole Alter, the doctor will decide the best dose for you.

Lansoprazole Alter should not be administered to children.

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

If you take more Lansoprazole Alter than you should

If you take more Lansoprazole Alter than indicated, consult your doctor immediately or contact the Toxicology Information Service, Telephone 915 620 420.

If you forget to take Lansoprazole Alter

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 stop taking Lansoprazole Alter

Do not stop treatment prematurely because the symptoms have improved. It is possible that your condition has not been completely cured and may come back if you do not finish the entire treatment.

If you have any other doubts about the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Lansoprazole Alter can cause side effects, although not everybody gets them.

The following side effects are common (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 uncommon (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 like Lansoprazole Alter, especially for more than a 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).

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

• fever
• restlessness, drowsiness, confusion, hallucinations, insomnia, visual disturbances, dizziness
• taste alteration, 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
• anemia (pallor)
• kidney problems
• pancreatitis
• liver inflammation (which can 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 side effects are very rare (occur in less than 1 in 10,000 patients):

• 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 serious skin reactions with redness, blisters, severe inflammation, and skin loss
• in very rare cases, Lansoprazole Alter 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. A blood test will be performed to check for a possible reduction in white blood cells (agranulocytosis).

The following side effects have an unknown frequency (cannot be estimated from the available data)

• If you are taking Lansoprazole for more than three months, it is possible that your 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, go to your doctor immediately. Low magnesium levels can also produce 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.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is a possible side effect not listed in this package leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Lansoprazole Alter

Do not store above 30°C.

Keep out of the reach and sight of children.

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

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the SIGRE Collection Point (or any other medicine waste collection system) at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Further information

Composition of Lansoprazole Alter

The active substance is lansoprazole.

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

Appearance of the product and package contents

Lansoprazole Alter 15 mg gastro-resistant capsules are presented in the form of hard gastro-resistant capsules, which contain spherical gastro-resistant granules of lansoprazole, in packages of 28 capsules.

Marketing authorization holder and manufacturer

The marketing authorization holder is:

Laboratorios ALTER, S.A.

C/Mateo Inurria, 30

28036 Madrid

The manufacturer is:

Laboratorios SALVAT, S.A.

C/Gall 30-36

08950 Esplugues de Llobregat, Barcelona

Date of the last revision of this package leaflet:

December 2022

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