Lansoprazole Alter 30 mg gastro-resistant hard capsules EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Lansoprazole Alter 30 mg gastro-resistant hard capsules EFG

Read the entire 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 and must not be given to other people, even if they have the same symptoms, as it could be harmful to them.
• If you consider any of the side effects you experience to be serious, 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 taking 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 continuous 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 an 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 Lansoprazole Alter

Do not take Lansoprazole Alter:

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

Take special care with Lansoprazole Alter

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

Your doctor may have performed or may perform an additional test called endoscopy to diagnose your condition and/or rule out cancer.

If you experience diarrhea during treatment with Lansoprazole Alter, contact your doctor immediately, as Lansoprazole Alter has been associated with a slightly increased risk of infectious diarrhea.

If your doctor has prescribed Lansoprazole Alter together 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 have been taking Lansoprazole Alter 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 Lansoprazole Alter if you have ever had a skin reaction after treatment with a medicine similar to Lansoprazole Alter used to reduce stomach acid.

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 Lansoprazole 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).

Kidney inflammation may occur while taking lansoprazole. 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.

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 Lansoprazole Alter 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 Lansoprazole Alter with food and drink

For optimal effectiveness, Lansoprazole 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 Lansoprazole 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 capabilities may be reduced.

You are solely responsible for deciding whether you are fit to drive or perform activities requiring high concentration. Due to its potential side effects or adverse reactions, the use of this medicine may be one of the factors that reduces your ability to safely carry out such tasks.

The following sections contain descriptions of these effects.

Please read the information in this 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 diagnosed you with an intolerance to certain sugars, consult 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 other alternative ways to take the medicine. Do 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 Alter once a day, try to take it at the same time each day. You may achieve better results if you take Lansoprazole Alter first thing in the morning.

If you take Lansoprazole Alter twice a day, 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 marked cutting line.
2. Separate the two aluminium layers at the indicated place and remove the capsule.

The dose of Lansoprazole Alter depends on your general condition. The usual doses of Lansoprazole Alter for adults are indicated below. Occasionally, your doctor may prescribe you 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 after 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. Treatment is usually daily for 7 days.

The recommended antibiotic combinations are as follows:

• 30 mg Lansoprazole Alter with 250–500 mg clarithromycin and 1,000 mg amoxicillin
• 30 mg Lansoprazole 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 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 Alter, your doctor will decide the best dose for you.

Lansoprazole Alter must not be administered to children.

Follow exactly your doctor's instructions on how to take the medicine. Consult your doctor if you have any doubts.

If you take more Lansoprazole Alter than you should

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

If you forget to take Lansoprazole 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 the usual time. Do not take a double dose to make up for the missed dose.

If you stop taking Lansoprazole Alter

Do not stop treatment prematurely, even if your symptoms have improved. Your condition may not have been completely cured, 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, Lansoprazol Alter may cause adverse effects, although not everyone experiences them.

The following adverse effects are common (occur in more than 1 in every 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 every 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 Lansoprazol Alter, 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 are taking corticosteroids (which may increase the risk of osteoporosis).

The following adverse effects are rare (occur in less than 1 in every 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 pharynx, difficulty swallowing, hives, or breathing difficulties.

The following adverse effects are very rare (occur in less than 1 in every 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 sodium, cholesterol, and triglyceride levels
• very severe skin reactions with redness, blisters, severe swelling, and skin loss
• in very rare cases, Lansoprazol 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 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 reduction in white blood cells (agranulocytosis).

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

• If you are taking Lansoprazol for more than three months, your blood magnesium levels may decrease. Low magnesium levels can 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 your 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 through the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse 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 refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their packaging at the SIGRE Point (or any other medicine waste collection system) at your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Additional information

Composition of LansoprazolAlter

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 product and contents of the pack

Lansoprazol Alter 30 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 for Medicines and Health Products (AEMPS) http://www.aemps.es/