Lansoprazole Alter 15 mg gastro-resistant hard capsules EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Lansoprazole Alter 15 mg gastro-resistant hard capsules EFG

Read all of 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 only. Do not give it to other people, even if they have the same symptoms as you, as it may harm them.
• If you think any of the side effects you experience is severe or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Leaflet contents:

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

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

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

Your doctor may have prescribed Lansoprazol Alter 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 ongoing 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 Alter for a different indication or at a dosage different from that stated in this leaflet. Follow your doctor's instructions regarding how to take the medicine.

2. Before taking Lansoprazol Alter

Do not take Lansoprazol Alter:

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

Take special care with Lansoprazol Alter

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 exclude cancer.

If 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 together with other medicines used to treat Helicobacter pylori infection (antibiotics) or together with anti-inflammatory medicines for pain or rheumatism, please also read carefully the package leaflets of these medicines.

If you have been taking Lansoprazol Alter for a long time (more than 1 year), your doctor will likely monitor you regularly. During your visits, you must inform your doctor of any new or unusual symptoms or circumstances.

Consult your doctor before starting Lansoprazol Alter if you have ever had a skin reaction after treatment with a medicine similar to Lansoprazol Alter used to reduce stomach acidity.

If you develop a skin rash, especially in areas exposed to sunlight, consult your doctor as soon as possible, as it may be necessary to discontinue 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 (chromogranin A).

Use of lansoprazole may lead to inflammation of the kidney. Signs and symptoms may include decreased urine volume or presence of blood in the urine and/or hypersensitivity reactions such as fever, skin rash, and joint stiffness. You must report these signs to your doctor.

Use of other medicines

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

In particular, inform your doctor if you are taking medicines containing any of the following active substances, as Lansoprazol Alter may affect their way 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 Alter with food and drinks

For optimal results, Lansoprazol Alter should be taken 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 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 capacity 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 impair your ability to carry out these tasks safely.

The following sections contain descriptions of these effects.

Please read this leaflet carefully.

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

Important information about some of the components of Lansoprazol Alter

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

3. How to take Lansoprazol 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. 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 Lansoprazol Alter once daily, try to take it at the same time every day. You may achieve better results if you take Lansoprazol Alter in the morning.

If you take Lansoprazol Alter twice daily, you should take the first dose in the morning and the second in the evening.

To properly remove the capsule from the blister pack, it is recommended to:

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

The dose of Lansoprazol Alter depends on your medical condition. The usual doses of Lansoprazol Alter 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 esophagus (reflux esophagitis): One 30 mg capsule daily for 4 weeks.

Long-term prevention of reflux esophagitis: 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. Treatment is usually given daily for 7 days.

The recommended antibiotic combinations are as follows:

• 30 mg Lansoprazol Alter with 250–500 mg clarithromycin and 1,000 mg amoxicillin
• 30 mg Lansoprazol Alter with 250 mg clarithromycin and 400–500 mg metronidazole

If you are receiving anti-infective treatment for an ulcer, the ulcer is unlikely to 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 ongoing NSAID therapy: One 30 mg capsule daily for 4 weeks.

Prevention of duodenal or gastric ulcer in patients requiring ongoing 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. Afterwards, depending on your response to treatment with Lansoprazol Alter, your doctor will decide the best dose for you.

Lansoprazol Alter must not be administered to children.

Always follow your doctor's instructions exactly. Consult your doctor if you have any doubts.

If you take more Lansoprazol Alter than you should

If you take more Lansoprazol Alter than prescribed, contact your doctor immediately or call the Toxicology Information Service at telephone number 915 620 420.

If you forget to take Lansoprazol Alter

If you forget to take a dose, take it as soon as possible unless it is almost time for your next dose. In this case, skip the missed dose and take the next capsules at your usual time. Do not take a double dose to make up for a missed dose.

If you stop taking Lansoprazol Alter

Do not stop treatment prematurely, even if 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 product, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Lansoprazole Alter may cause adverse effects, although not everyone experiences them.

The following adverse 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 polyps in the stomach.

The following adverse effects are uncommon (occur in less than 1 in 100 patients):

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

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

• fever
• restlessness, drowsiness, confusion, hallucinations, insomnia, visual disturbances, dizziness
• altered taste, loss of appetite, inflammation of the tongue (glossitis)
• skin reactions such as burning or itching sensation under the skin, bruising, redness, and excessive sweating
• sensitivity to light
• 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 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 swelling of the face, tongue or throat, difficulty swallowing, hives, or breathing difficulties.

The following adverse 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 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, Lansoprazole Alter may cause a reduction in the number of white blood cells, which could 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).

The following adverse effects have unknown frequency (cannot be estimated from available data):

• If you are taking Lansoprazole for more than three months, magnesium levels in the blood may decrease. Low magnesium levels may cause fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, and increased heart rate. If you experience any of these symptoms, contact your doctor 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.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Lansoprazol Alter

Do not store above 30°C.

Keep out of the reach and sight of children.

Do not use Lansoprazol Alter after the expiry date stated on the blister pack and carton. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater drains or household waste. Unused containers and medicines should be taken to the SIGRE collection point (or any other medicine waste collection system) at your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and unused medicines. This will help protect the environment.

6. Additional Information

Composition of Lansoprazole Alter

The active substance is lansoprazole.

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

Appearance of the medicinal product and contents of the pack

Lansoprazole Alter 15 mg gastro-resistant capsules are presented as hard gastro-resistant capsules containing spherical gastro-resistant granules of lansoprazole, in packs 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 most recent revision 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.es/