Lansoprazole EG: detailed information

Package leaflet: Information for the user

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

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 other people, even if their
symptoms are the same as yours, as it may be harmful.
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Contents of this leaflet

What Lansoprazole EG is and what it is used for
What you need to know before taking Lansoprazole EG
How to take Lansoprazole EG
Possible side effects
How to store Lansoprazole EG
Contents of the pack and other information

1. What Lansoprazolo EG is and what it is used for

The active substance of Lansoprazolo EG 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 EG 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 long-term treatment with NSAIDs (non-steroidal anti-inflammatory drugs) (NSAIDs, used for pain or inflammation).
Treatment of Zollinger-Ellison syndrome.

Your doctor may have prescribed Lansoprazolo EG for a different indication or at a dosage different from that stated in this leaflet. Follow your doctor's instructions for taking the medicine.
Contact your doctor if you do not feel better or if you feel worse after 14 days.

2. What you should know before taking Lansoprazole EG

Do not take Lansoprazole EG

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 Lansoprazole EG, contact your doctor immediately, as Lansoprazole EG has been associated with a small increased risk of infectious diarrhoea.
If your doctor has prescribed Lansoprazole EG in combination with other medicines for the treatment of Helicobacter pylori infection (antibiotics) or together with anti-inflammatory medicines to treat pain or rheumatic diseases, it is recommended that you also read the patient information leaflet of these medicines carefully.
If you take a proton pump inhibitor such as Lansoprazole EG, especially for more than one year, there may be a slight increase in the risk of fractures of the hip, wrist, or spine. Inform your doctor if you have osteoporosis (reduced bone density) or if your doctor has told you that you are at risk of developing osteoporosis (for example, if you are taking steroids).
If you take Lansoprazole EG for a long time (for more than 1 year), your doctor will likely monitor you regularly. Report any new or unusual symptoms and circumstances each time you see your doctor.
Talk to your doctor before taking Lansoprazole EG:

If you have low levels of vitamin B or are at risk of low vitamin B levels and are receiving long-term treatment with lansoprazole. As with all agents that reduce acid, lansoprazole may lead to reduced absorption of vitamin B.
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, consult your doctor as soon as possible, as it may be necessary to discontinue treatment with Lansoprazole EG. Remember to also report any other adverse effects such as joint pain.
Serious skin reactions [Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS)] have been reported in association with treatment with lansoprazole. Stop using Lansoprazole EG and contact your doctor immediately if you notice any of the symptoms described in section 4.
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. These symptoms must be reported to your doctor.

Other medicines and Lansoprazole EG
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, tell your doctor or pharmacist if you are taking medicines containing any of the following active substances, as Lansoprazole EG 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 cancers);
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).

Lansoprazole EG with food and drinks
For best results, Lansoprazole EG should be taken with a glass of water at least 30 minutes before a meal.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Driving and using machines
Undesirable effects such as dizziness, vertigo, fatigue, and visual disturbances may occasionally occur in patients taking Lansoprazole EG. If you experience such side effects, exercise caution, as your reaction ability may be impaired.
Only you can decide whether you are fit to drive a motor vehicle or perform other tasks requiring increased concentration. Taking medicines is one of the factors that may reduce your ability to perform these activities safely, due to their effects or side effects.
These effects are described in other sections.
Read all the information in this leaflet as a guide.
If you have any doubts, discuss them with your doctor, nurse, or pharmacist.
Lansoprazole EG contains sucrose and sodium
If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per hard capsule, i.e. essentially 'sodium-free'.

3. How to take Lansoprazole EG

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
The capsule must be swallowed 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 EG once daily, try to take it at the same time each day. You may achieve better results if you take Lansoprazole EG first thing in the morning.
If you take Lansoprazole EG twice daily, take the first dose in the morning and the second dose in the evening.
The dose of Lansoprazole EG depends on your condition. The recommended doses of Lansoprazole EG for adults are listed below. In some cases, your doctor may prescribe a different dose and will inform you of the duration of treatment.

Treatment of heartburn and acid regurgitation
One 15 mg or 30 mg capsule 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 recommended dose is one 30 mg capsule in combination with two different antibiotics in the morning and one 30 mg capsule with two different antibiotics in the evening. Treatment usually lasts 7 days.
The recommended antibiotic combinations are:

30 mg Lansoprazole EG with 250–500 mg clarithromycin and 1,000 mg amoxicillin
30 mg Lansoprazole EG with 250 mg clarithromycin and 400–500 mg metronidazole

If your infection is associated with 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 do not miss any dose.

Treatment of duodenal or gastric ulcer in patients requiring continuous NSAID treatment
One 30 mg capsule daily for 4 weeks.

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

Zollinger-Ellison syndrome
The recommended initial dose is two 30 mg capsules daily. Subsequently, based on your response to Lansoprazole EG, your doctor will determine the most appropriate dose for you.

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

If you take more Lansoprazole EG than you should
If you take more Lansoprazole EG than prescribed, contact your doctor immediately.

If you forget to take Lansoprazole EG
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, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a forgotten capsule.

If you stop taking Lansoprazole EG
Do not stop treatment prematurely if your symptoms have improved. Your condition may not be fully resolved and may recur if you do not complete the full course of treatment.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop treatment with Lansoprazole EG and consult a doctor immediately if you notice any of the following symptoms:

non-itchy red spots, target-shaped or circular rashes on the trunk, often with blisters in the centre, skin peeling, mouth, throat, nose, genital or eye ulcers. These serious skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis);
widespread rash, high body temperature and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

Common (may affect up to 1 in 10 people)

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

Uncommon (may affect up to 1 in 100 people)

depression;
joint or muscle pain;
fluid retention or swelling;
changes in red blood cell count.

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

fever;
restlessness, drowsiness, confusion, hallucinations, insomnia, vision disorders, 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 swelling 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, hives and breathing difficulties.

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

severe hypersensitivity reactions including shock. Symptoms of hypersensitivity reactions may include fever, skin rash, swelling and sometimes low blood pressure;
inflammation of the mouth (stomatitis);
inflammation of the colon (colitis);
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, Lansoprazole EG 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).

Not known (frequency cannot be estimated from the available data)

if you take Lansoprazole EG 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, increased heart rate. If you experience any of these symptoms, consult your doctor immediately. Low magnesium levels may also lead to reduced levels of potassium or calcium in the blood. 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, possible joint pain (subacute cutaneous lupus erythematosus);
visual hallucinations.

Reporting of side effects
If you experience any side effects, 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. Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Lansoprazole EG

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack and the carton. The expiry
date refers to the last day of that month.
Do not store above 30°C.
Keep in the original packaging to protect the medicine from moisture.
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. Package contents and other information

What Lansoprazolo EG contains

The active substance is lansoprazole.
The other components are: maize starch, sucrose, sodium lauryl sulfate, meglumine, mannitol, hypromellose, polyethylene glycol 6000, talc, polysorbate 80, titanium dioxide (E171), purified water, and methacrylic acid-ethyl acrylate copolymer (1:1) dispersion 30%.

The capsule shell contains gelatin, purified water, and the following colouring agents:
For 15 mg capsules: titanium dioxide (E171) and quinoline yellow (E104).
For 30 mg capsules: titanium dioxide (E171).

Description of the appearance of Lansoprazolo EG and package contents

Lansoprazolo EG 15 mg gastro-resistant hard capsules
Opaque, yellow, hard gelatin capsules containing enteric-coated granules.
Each capsule contains 15 mg of lansoprazole.
Lansoprazolo EG 15 mg gastro-resistant hard capsules are available in packs of 14, 28, 56, and 98 capsules.

Lansoprazolo EG 30 mg gastro-resistant hard capsules
Opaque, white, hard gelatin capsules containing enteric-coated granules.
Each capsule contains 30 mg of lansoprazole.
Lansoprazolo EG 30 mg gastro-resistant hard capsules are available in packs of 7, 14, 28, 56, 60, and 98 capsules.
Not all pack sizes may be marketed.

Marketing Authorization Holder
EG S.p.A. Via Pavia, 6 - 20136 Milan, Italy

Manufacturers
Laboratorios Liconsa S.A. - Avda. Miralcampo N. 7, Poligono Industrial - 19200 Azuqueca De Henares - Guadalajara (Spain)
Cosmo S.p.A. Via C. Colombo, 1 - 20045 Lainate - Milan (Italy)
Doppel Farmaceutici S.r.l. Via Volturno, 48 Quinto de’ Stampi - 20089 Rozzano - Milan (Italy)
Lamp San Prospero S.p.A., Via della Pace, 25/A - 41030 San Prospero (MO) (Italy)

This medicinal product is authorized in the European Economic Area Member States under the following names:
Denmark: Lansoprazol „Stada“
Estonia: Lanzostad 15 mg
Lanzostad 30 mg
Ireland: Zomel 15 mg gastro-resistant capsules, hard
Zomel 30 mg gastro-resistant capsules, hard
Italy: Lansoprazolo EG 15 mg capsule rigide gastroresistenti
Lansoprazolo EG 30 mg capsule rigide gastroresistenti
Latvia: Lanzostad
Lithuania: Lanzostad 15 mg skrandyje neirios kietos kapsulės
Lanzostad 30 mg skrandyje neirios kietos kapsulės