Lansoprazole ABC

PACKAGE LEAFLET: INFORMATION FOR THE USER

LANSOPRAZOLE ABC 15 mg gastro-resistant hard capsules, 30 mg gastro-resistant hard capsules

Equivalent medicine
Please read all of 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 may be harmful;
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

What is in this leaflet

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

1. What is Lansoprazolo ABC and what is it used for?

The active substance in Lansoprazolo ABC 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 ABC for the following indications in adults:

• 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 ongoing treatment with NSAIDs (non-steroidal anti-inflammatory drugs used for pain and inflammation)
• Treatment of Zollinger-Ellison syndrome

Your doctor may have prescribed Lansoprazolo ABC for another indication or at a different dosage than that stated in this leaflet. Always carry the medicine with you when visiting your doctor.
Contact your doctor if you do not feel better or if you feel worse after 14 days.

2. What you need to know before taking Lansoprazolo ABC

Do not take Lansoprazolo ABC
If you are allergic to lansoprazole or to any of the other ingredients of this medicine (listed in
section 6).

Warnings and precautions
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 exclude malignant disease.
If you develop diarrhoea during treatment with Lansoprazolo ABC, contact your doctor immediately, as Lansoprazolo ABC has been associated with a small increased risk of infectious diarrhoea.
If your doctor has prescribed Lansoprazolo ABC in combination with other medicines for the treatment of Helicobacter pylori infection (antibiotics) or together with anti-inflammatory medicines for pain or rheumatic diseases: please read the package leaflet of these medicines carefully as well.
If you take a proton pump inhibitor such as Lansoprazolo ABC, especially for more than one year, there may be a slight increase in the risk of fractures of the hip, wrist or spine. Consult your doctor if you have osteoporosis (reduced bone density) or if your doctor tells you that you are at risk of osteoporosis (for example, if you are taking corticosteroids).
If you take Lansoprazolo ABC long-term (for more than 1 year), your doctor will likely monitor you regularly. You should report any new or unusual symptoms and circumstances each time you see your doctor.
Talk to your doctor before taking lansoprazole:

• If you have low levels of vitamin B12 or have risk factors for low vitamin B12 levels and are receiving long-term treatment with lansoprazole. Like all agents that reduce acid, lansoprazole may lead to reduced absorption of vitamin B12;
• If you need to undergo a specific blood test (chromogranin A);
• If you have ever had a skin reaction after treatment with a medicine similar to lansoprazole that reduces gastric acidity. If you notice the appearance of a skin rash, especially in areas exposed to sunlight, contact your doctor as soon as possible, as it may be necessary to discontinue treatment with Lansoprazolo ABC. Remember to also report any other adverse effects such as joint pain.

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, rash and joint stiffness. These signs must be reported to your doctor.

Other medicines and Lansoprazolo ABC
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription.
In particular, tell your doctor or pharmacist if you are taking medicines containing any of the following active substances, as Lansoprazolo ABC may affect their mechanism of action:

• HIV protease inhibitors such as atazanavir and nelfinavir (used to treat HIV)
• methotrexate (used to treat autoimmune diseases and cancer)
• ketoconazole, itraconazole, rifampicin (used to treat infections)
• digoxin (used to treat heart problems)
• warfarin (used to treat blood clots)
• 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 reflux)
• sucralfate (used to heal ulcers)
• St. John’s wort (hypericum perforatum) (used to treat mild depression)

Lansoprazolo ABC with food and drinks
To achieve the best results, take Lansoprazolo ABC with a glass of water at least 30 minutes before eating.

Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Driving and using machines
Adverse effects such as dizziness, vertigo, fatigue and visual disturbances may occasionally occur in patients taking Lansoprazolo ABC.
If you experience such adverse effects, you should be cautious, as your ability to concentrate may be reduced.
You are solely responsible for deciding whether you are fit to drive a motor vehicle or perform other tasks requiring heightened concentration. The use of medicines represents one of the factors that may impair your ability to perform these activities 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 or pharmacist.

Lansoprazolo ABC 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 ABC

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
Swallow the capsule whole with a glass of water. If you have difficulty swallowing hard 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 will not work properly.
If you take Lansoprazole ABC once a day, try to take it at the same time every day. You may achieve better results if you take Lansoprazole ABC first thing in the morning.
If you take Lansoprazole ABC twice a day, you should take the first dose in the morning and the second dose in the evening.
The dose of Lansoprazole ABC depends on your condition. The usual doses of Lansoprazole ABC for adults are listed below. Your doctor may sometimes prescribe a different dose and will tell you how long your treatment should last.

Treatment of heartburn and acid regurgitation: one 15 mg or 30 mg capsule daily for 4 weeks. If symptoms have not improved 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 ABC together with 250–500 mg clarithromycin and 1,000 mg amoxicillin
• 30 mg Lansoprazole ABC together with 250 mg clarithromycin and 400–500 mg metronidazole.

If you are being treated for an 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 prescribed times and do not miss any doses.

Treatment of duodenal or gastric ulcer in patients requiring ongoing NSAID treatment: one 30 mg capsule daily for 4 weeks.

Prevention of duodenal or gastric ulcer in patients requiring ongoing NSAID treatment: one 15 mg capsule daily; your doctor may adjust the dose up to one 30 mg capsule daily.

Zollinger-Ellison syndrome: the usual initial dose is two 30 mg capsules daily; thereafter, depending on your response to Lansoprazole ABC, your doctor will decide the most appropriate dose for you.

Use in children
Lansoprazole ABC must not be given to children.

If you take more Lansoprazole ABC than you should
If you take more Lansoprazole ABC than prescribed, seek immediate advice from your doctor.

If you forget to take Lansoprazole ABC
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 schedule. Do not take a double dose to make up for a forgotten capsule.

If you stop taking Lansoprazole ABC
Do not stop treatment prematurely even if your 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 doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.

Common side effects (may affect up to 1 in 10 people):

• 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 stomach polyps

Uncommon side effects (may affect up to 1 in 100 people):

• depression
• joint and muscle pain
• fluid retention or swelling
• changes in blood cell counts

Rare side effects (may affect up to 1 in 1,000 people):

• fever
• restlessness, drowsiness, confusion, hallucinations, insomnia, vision disorders, dizziness
• altered taste, 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 swelling in men, impotence
• candidiasis (fungal infection, may affect the skin or mucous membranes)
• angioedema; you must see a doctor immediately if you experience symptoms of angioedema such as swelling of the face, tongue or throat, difficulty swallowing, hives, or breathing difficulties

Very rare side effects (may affect up to 1 in 10,000 people):

• severe hypersensitivity reactions including shock. Symptoms of hypersensitivity 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, blistering, severe inflammation and skin loss
• very rarely, Lansoprazolo ABC may cause a reduction in white blood cell count, thereby decreasing resistance to infections. 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, you must see a doctor immediately. 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):

• if you take Lansoprazolo ABC for more than three months, magnesium levels in the blood may decrease. Low magnesium levels may present as fatigue, involuntary muscle contractions, disorientation, seizures, dizziness and 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
• low sodium levels in the blood. Common symptoms include nausea and vomiting, headache, drowsiness and fatigue, confusion, muscle weakness or spasms, irritability, seizures, coma
• skin rash, possibly associated with joint pain
• visual hallucinations

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

5. How to store Lansoprazole ABC

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 after "Exp.".
The expiry date refers to the last day of the month.
Do not store above 25 °C.
Keep in the original packaging.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of
medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Lansoprazolo ABC contains
Lansoprazolo ABC 15 mg gastro-resistant hard capsules
The active substance is lansoprazole. Each hard capsule contains 15 mg of lansoprazole.
The other components are:
Gastro-resistant granules: hypromellose (E-464), talc (E-553b), titanium dioxide (E-171), methacrylic acid-ethyl acrylate copolymer (1:1) 30% dispersion, triethyl citrate (E-1505), spheres of sucrose and maize starch, purified water.
Capsule shell: gelatin, titanium dioxide (E-171), black ink.

Lansoprazolo ABC 30 mg gastro-resistant hard capsules
The active substance is lansoprazole. Each hard capsule contains 30 mg of lansoprazole.
The other components are:
Gastro-resistant granules: hypromellose (E-464), talc (E-553b), titanium dioxide (E-171), methacrylic acid-ethyl acrylate copolymer (1:1) 30% dispersion, triethyl citrate (E-1505), spheres of sucrose and maize starch, purified water.
Capsule shell: gelatin, titanium dioxide (E-171), black ink.

Description of the appearance of Lansoprazolo ABC and contents of the pack
Hard capsules containing gastro-resistant granules.
Pack sizes of 14 and 28 hard capsules of 15 mg and 30 mg in blisters.
Pack sizes of 14 and 28 hard capsules of 15 mg and 30 mg in containers.

Marketing Authorization Holder
ABC Farmaceutici S.p.A. – Corso Vittorio Emanuele II, 72 – 10121 Turin (Italy)

Manufacturer
Towa Pharmaceutical Europe, S.L.
C/de San Martì, 75-97, Martorelles, 08107
Barcelona, Spain