Lansoprazole Alter

Patient Information Leaflet: Information for the User

Lansoprazole Alter 15 mg gastro-resistant hard capsules, 30 mg gastro-resistant hard capsules

Lansoprazole
Generic Medicine
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. 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 others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist.

Contents of this leaflet:

1. What Lansoprazole Alter is and what it is used for
2. What you need to know before taking Lansoprazole Alter
3. How to take Lansoprazole Alter
4. Possible side effects
5. How to store Lansoprazole Alter
6. Contents of the pack and other information

1. WHAT LANSOPRAZOLO ALTER IS AND WHAT IT IS USED FOR

The active substance of Lansoprazolo Alter is lansoprazole, which is a proton pump inhibitor.
Proton pump inhibitors reduce the amount of acid produced by your stomach.
Your doctor may prescribe Lansoprazolo Alter for the following indications:

• Treatment of duodenal and gastric ulcers
• Treatment of inflammation of the oesophagus (reflux oesophagitis)
• Prevention of reflux oesophagitis
• Treatment of heartburn and acid regurgitation
• Treatment of infections caused by the bacterium Helicobacter pylori, when administered in combination with antibiotic therapy
• Treatment or prevention of duodenal or gastric ulcers in patients requiring continuous treatment with non-steroidal anti-inflammatory drugs (NSAIDs, used for pain or inflammation)
• Treatment of Zollinger-Ellison syndrome

Your doctor may have prescribed Lansoprazolo Alter for another indication or at a dosage different from that stated in this patient information leaflet. Follow your doctor's instructions for taking the medicine.

2. WHAT YOU SHOULD KNOW BEFORE TAKING LANSOPRAZOLE ALTER

Do not take Lansoprazole Alter:

• if you are allergic (hypersensitive) to lansoprazole or to any of the other ingredients of this medicine (listed in section 6).
• if you are taking a medicine containing the active substance atazanavir (used in the treatment of HIV).

Take special care with Lansoprazole Alter
Warnings and precautions
During treatment with lansoprazole, inflammation of the kidneys may occur.
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 such signs to your doctor.
Talk to your doctor before taking Lansoprazole Alter:

• if you have ever had a skin reaction after treatment with a medicine similar to Lansoprazole Alter that reduces gastric acidity;
• if you need to undergo a specific blood test (Chromogranin A).

If you develop a skin rash, especially in areas exposed to sunlight, consult your doctor as soon as possible, because treatment with Lansoprazole Alter may need to be discontinued. Remember to also report any other adverse effects such as joint pain.
Tell your doctor if you have severe liver disease. Your doctor may need to adjust the dosage. Your doctor may perform or may have already performed an additional examination called endoscopy to diagnose your condition and/or rule out malignant disease.
If you develop 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 Lansoprazole Alter in combination with other medicines for the treatment of Helycobacter pylori infection (antibiotics) or together with anti-inflammatory medicines to treat pain or rheumatic diseases: please read carefully the package leaflet of these medicines as well.
If you take Lansoprazole Alter long-term (for more than 1 year), your doctor will likely monitor you regularly. You must report any new or unusual symptoms and circumstances each time you see your doctor.

Other medicines and Lansoprazole Alter
“Inform your doctor or pharmacist if you have recently taken any other medicines, including those without a prescription.”
In particular, tell your doctor if you are taking medicines containing any of the following active substances, since Lansoprazole Alter may affect their mechanism 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)

Lansoprazole Alter with food and drink
To achieve the best results, you should take Lansoprazole Alter at least 30 minutes before eating.

Pregnancy and breastfeeding
“Ask your doctor or pharmacist for advice before taking any medicine.”
If you are pregnant, think you might be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor before taking this medicine.

Driving and using machines
Adverse effects such as dizziness, vertigo, fatigue, and visual disturbances may occasionally occur in patients taking Lansoprazole Alter.
If you experience effects like these, you should be cautious, as your ability to concentrate may be reduced.
Only you are responsible for deciding whether you are fit to drive a motor vehicle or perform other tasks requiring increased concentration. The use of medicines is one of the factors that may impair your ability to perform these tasks safely, due to their effects or side effects.
Descriptions of these effects can be found in other sections.
Read all the information contained in this leaflet as a guide.
If you are unsure about anything, discuss it with your doctor, nurse, or pharmacist.

Important information about some excipients of Lansoprazole Alter
Lansoprazole Alter contains sucrose. If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.

3. HOW TO TAKE LANSOPRAZOLE ALTER

Swallow the capsule whole with a glass of water. If you have difficulty swallowing the capsules, your doctor
may advise you on an alternative way to take the medicine. Do not crush or chew these
capsules or the contents of emptied capsules, as the medicine would not work
properly.
If you take Lansoprazole Alter once daily, 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 daily, you should take the first dose in the morning and the second dose in the
evening.
The dose of Lansoprazole Alter depends on your condition. The usual doses of Lansoprazole Alter for
adults are listed below. Sometimes your doctor may prescribe a different dose and will inform you of
how long the treatment should last.
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 are not relieved within 4 weeks, contact 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 up to one 30 mg capsule daily
Treatment of Helicobacter pylori infection: the usual dose is one 30 mg capsule in
combination with two different antibiotics in the morning and one 30 mg capsule in combination with
two different antibiotics in the evening. The treatment lasts for 7 days.
The recommended antibiotic combinations are:
30 mg Lansoprazole Alter together with 250–500 mg clarithromycin and 1,000 mg amoxicillin
30 mg Lansoprazole Alter together with 250 mg clarithromycin and 400–500 mg
metronidazole
If you are being treated for this infection because you have an ulcer, the ulcer is unlikely to recur
if the infection is successfully treated. To achieve the best results from this therapy,
take the medicine at the scheduled times and never miss a dose.
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 up to one 30 mg capsule daily.
Zollinger-Ellison syndrome: the usual starting dose is two 30 mg capsules daily; thereafter, based on your response to Lansoprazole Alter, your doctor will determine the most appropriate dose for you.

Use in children
The use of Lansoprazole Alter is not recommended in children because clinical data are limited.
Treatment of infants under one year of age should be avoided, as available data do not demonstrate beneficial effects in the treatment of gastro-oesophageal reflux disease.

Take this medicine exactly as prescribed by your doctor. If you have any doubts about how to take the
medicine, consult your doctor.

If you take more Lansoprazole Alter than you should
“In case of accidental ingestion/overdose of Lansoprazole Alter, contact your doctor immediately or go to the nearest hospital.”
If you take more Lansoprazole Alter than prescribed, seek immediate advice from your doctor.

If you forget to take Lansoprazole Alter
If you forget to take a dose, take it as soon as you remember, unless it is almost time for your next dose. In that case, do not take the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a forgotten dose.

If you stop taking Lansoprazole Alter
Do not stop treatment prematurely even if your symptoms have improved. Your condition may not be fully healed and symptoms may return if you do not complete the full course of treatment.

If you have any questions about the use of this medicine, consult your doctor.

4. POSSIBLE ADVERSE EFFECTS

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

The following adverse effects are common (occur in more than 1 in 100 patients):

• headache, dizziness
• diarrhoea, constipation, stomach pain, feeling unwell, intestinal gas (flatulence), dry or inflamed mouth or throat
• skin rash, itching
• changes in liver function tests
• fatigue
• benign polyps in the stomach

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

• depression
• joint and muscle pain
• fluid retention or swelling
• changes in red blood cell count
• fractures of the hip, wrist, or spine. If you are taking a proton pump inhibitor such as Lansoprazolo Alter, especially for longer than one year, there may be a slight increase in the risk of fractures of the hip, wrist, or spine. If you have osteoporosis or are taking corticosteroids (which may increase the risk of osteoporosis), consult your doctor.

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

• fever
• restlessness, drowsiness, confusion, hallucinations, insomnia, vision disturbances, dizziness
• altered taste sensation, loss of appetite, inflammation of the tongue (glossitis)
• skin reactions such as burning or prickling sensation under the skin, bruising, redness, and excessive sweating
• light sensitivity
• hair loss
• tingling sensation on the skin (paraesthesia), tremor
• anaemia (pallor)
• kidney problems
• pancreatitis
• liver inflammation (may present as yellowing of the skin or eyes)
• breast enlargement in men, impotence
• candidiasis (fungal infection, may affect skin or mucous membranes)
• angioedema; you must immediately see a doctor if you experience symptoms of angioedema such as swelling of the face, tongue or pharynx, difficulty swallowing, urticaria, or breathing difficulties.

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

• severe hypersensitivity reactions including shock. Symptoms of hypersensitivity reactions may include fever, rash, swelling, and sometimes low blood pressure
• inflammation of the mouth (stomatitis)
• colitis (inflammation of the colon)
• changes in laboratory values such as sodium, cholesterol, and triglyceride levels
• very severe skin reactions with redness, blisters, severe inflammation, and skin loss
• very rarely, Lansoprazolo Alter may cause a reduction in the number of white blood cells, and therefore resistance to infections may decrease. If you develop an infection with symptoms such as fever and severe worsening of your general condition, or fever with signs of local infection such as inflamed throat/pharynx/mouth or urinary problems, seek immediate medical attention. A blood test will be performed to check for a possible reduction in white blood cells (agranulocytosis).

Frequency not known (frequency cannot be estimated from the available data)

• hypomagnesaemia: if you take Lansoprazolo Alter for more than three months, your blood magnesium levels may decrease. Low magnesium levels may present as fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, or increased heart rate. If you experience any of these symptoms, consult your doctor immediately. Low magnesium levels may also lead to reduced blood levels of potassium or calcium. Your doctor should decide whether periodic monitoring of blood magnesium levels is necessary.
• cutaneous lupus erythematosus (frequency not known)
• erythema, possible joint pain (frequency not known)
• visual hallucinations (frequency not known)

“Following the instructions provided in this leaflet reduces the risk of adverse effects.”

Reporting of adverse effects
If you experience any adverse effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report adverse effects directly via the national reporting system at the following website:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE LANSOPRAZOLE ALTER

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton. The expiry date refers to the last day of that month.
Do not store above 30°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. CONTENT OF THE PACKAGE AND OTHER INFORMATION

What Lansoprazolo Alter contains

• The active substance is lansoprazole
• The excipients are: sucrose and maize starch spheres, heavy magnesium carbonate, hypromellose, polysorbate 80, macrogol 6000, triethyl citrate, talc, titanium dioxide (E171), methacrylic acid-ethyl acrylate copolymer (1:1) dispersion 30% (Eudragit L30 D-55), sodium hydroxide; capsule components: gelatin, titanium dioxide (E171), erythrosine (E127), iron oxide red (E172)

Description of the appearance of Lansoprazolo Alter and contents of the pack
Hard capsules containing gastro-resistant granules
Lansoprazolo Alter 15 mg gastro-resistant hard capsules: Cartons containing 14 and 28 capsules
Lansoprazolo Alter 30 mg gastro-resistant hard capsules: Cartons containing 14 and 28 capsules
Marketing Authorization Holder and Manufacturer
Laboratori Alter S.r.l. – Via Egadi, 7, 20144 Milan
The manufacturer is:
Laboratorios Salvat, S.A. - C/Gall 30-36 - Esplugues del Llobregat - Barcelona (Spain)
This patient information leaflet was last approved on