Lansoprazole Zentiva

Package leaflet: Information for the user

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

Generic medicine
Please read all of this leaflet carefully before you start 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 they have the same symptoms as you, because 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 this leaflet contains:

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

1. What LANSOPRAZOLO ZENTIVA is and what it is used for

The active substance in LANSOPRAZOLO ZENTIVA is lansoprazole, which is a proton pump inhibitor.
Proton pump inhibitors reduce the amount of acid produced in your stomach.
Your doctor may prescribe LANSOPRAZOLO ZENTIVA 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 ZENTIVA 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 need to know before taking LANSOPRAZOLE ZENTIVA

Do not take LANSOPRAZOLE ZENTIVA:

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

Warnings and precautions
Talk to your doctor before taking LANSOPRAZOLE ZENTIVA:

• If you have ever had a skin reaction after treatment with a medicine similar to LANSOPRAZOLE ZENTIVA that reduces stomach acid.
• If you develop a skin rash, especially in areas exposed to sunlight, contact your doctor as soon as possible, as treatment with LANSOPRAZOLE ZENTIVA may need to be stopped. Remember to also report any other adverse effects such as joint pain.
• If you have severe liver disease. Your doctor may need to adjust your dose. Your doctor may perform or may have already performed an additional test called endoscopy to diagnose your condition and/or rule out malignant disease.
• If you experience severe or persistent diarrhoea during treatment with LANSOPRAZOLE ZENTIVA, as LANSOPRAZOLE ZENTIVA has been associated with a small increased risk of infectious diarrhoea.
• If your doctor has prescribed LANSOPRAZOLE ZENTIVA 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: please read the package leaflet of these medicines carefully as well.
• If you take LANSOPRAZOLE ZENTIVA long-term (for more than 1 year), your doctor will likely monitor you regularly. You should report any new or unusual symptoms and circumstances at every visit.
• If you are taking a proton pump inhibitor such as LANSOPRAZOLE ZENTIVA, 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 (reduced bone density) or are taking corticosteroids (which may increase the risk of osteoporosis), consult your doctor.
• If you are scheduled to undergo a specific blood test (Chromogranin A).
• If you have ever had a skin reaction after treatment with a medicine similar to LANSOPRAZOLE ZENTIVA that reduces stomach acidity.

This medicine may affect how your body absorbs vitamin B12, particularly if you need to take it for a long time. Contact your doctor if you notice any of the following symptoms, which could indicate low vitamin B12 levels:

• Extreme tiredness or lack of energy
• Tingling sensations
• Sore or red tongue, mouth ulcers
• Muscle weakness
• Disturbed vision
• Memory problems, confusion, depression

Severe skin reactions including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported in association with lansoprazole treatment. Stop using LANSOPRAZOLE ZENTIVA 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, rash, and joint stiffness. These signs must be reported to your doctor.
Other medicines and LANSOPRAZOLE ZENTIVA
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 ZENTIVA 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 tumours)
• ketoconazole, itraconazole, rifampicin (used to treat infections)
• digoxin (used to treat heart problems)
• warfarin (used to eliminate blood clots or prevent their formation)
• theophylline (used to treat asthma)
• tacrolimus (used to prevent organ 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 ZENTIVA with food and drink
For best results, take LANSOPRAZOLE ZENTIVA at least 30 minutes before eating.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Driving and using machines
LANSOPRAZOLE ZENTIVA may impair your ability to drive or operate machinery.
Adverse effects such as dizziness, vertigo, fatigue, and visual disturbances may occasionally occur in patients taking LANSOPRAZOLE ZENTIVA. If you experience any of these adverse effects, you should be cautious, as your reaction ability may be reduced.
It is your responsibility to decide whether you are fit to drive a motor vehicle or perform tasks requiring increased concentration. The use of medicines is one of the factors that may reduce your ability to safely perform these activities due to their effects or side effects.
Descriptions of these effects can be found in other sections.
Read all the information in this leaflet as a guide.
Consult your doctor or pharmacist if you have any doubts about any topic.
LANSOPRAZOLE ZENTIVA contains sucrose
Each capsule of LANSOPRAZOLE ZENTIVA contains sugar spheres (sucrose).
If your doctor has told you that you have an intolerance to certain sugars, contact your doctor before taking this medicine.

3. How to take LANSOPRAZOLE ZENTIVA

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Swallow the capsule whole with a glass of water. If you find it difficult to swallow 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 will not work properly.
If you take LANSOPRAZOLE ZENTIVA once daily, try to take it at the same time each day. You may achieve
better results if you take LANSOPRAZOLE ZENTIVA first thing in the morning.
If you take LANSOPRAZOLE ZENTIVA twice daily, you should take the first dose in the morning and the
second dose in the evening.
The dose of LANSOPRAZOLE ZENTIVA depends on your condition. The usual doses of
LANSOPRAZOLE ZENTIVA for adults are listed below. Sometimes your doctor will prescribe a different
dose and will tell you how long the treatment should last.
The recommended dose is:
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 of LANSOPRAZOLE ZENTIVA together with 250–500 mg of clarithromycin and 1 g of amoxicillin;
• 30 mg of LANSOPRAZOLE ZENTIVA together with 250 mg of clarithromycin and 400–500 mg of 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 treatment with NSAIDs: one 30 mg capsule daily for 4 weeks.
Prevention of duodenal or gastric ulcer in patients requiring continuous treatment with NSAIDs: one 15 mg capsule daily; your doctor may adjust the dosage 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 ZENTIVA, your doctor will decide the most appropriate dose for you.
Use in children
LANSOPRAZOLE ZENTIVA must not be given to children.
Treatment of infants under one year of age should be avoided, as available clinical data have not shown beneficial effects in the treatment of gastro-oesophageal reflux disease.
If you take more LANSOPRAZOLE ZENTIVA than you should
In case of accidental ingestion or overdose of LANSOPRAZOLE ZENTIVA, contact your doctor immediately or go to the nearest hospital.
If you forget to take LANSOPRAZOLE ZENTIVA
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 take the next dose at the usual time. Do not take a double dose to make up for the forgotten capsule.
If you stop taking LANSOPRAZOLE ZENTIVA
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 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 everyone gets them. If you think you may be experiencing any of the following serious side effects, stop taking this medicine and contact your doctor or go immediately to the nearest hospital emergency department.

The following side effects are common (may affect up to 1 in 10 people):

• Headache, dizziness;
• Diarrhoea, constipation, stomach pain, feeling unwell, gas (flatulence), dry or inflamed mouth or throat;
• Benign polyps in the stomach;
• Skin rash, itching;
• Changes in liver function tests;
• Fatigue.

The following side effects are uncommon (may affect up to 1 in 100 people):

• Depression;
• Joint and muscle pain;
• Fluid retention or swelling;
• Changes in red blood cell count;
• Fractures of the hip, wrist, or spine (see section 2, Before taking LANSOPRAZOLE ZENTIVA). If you take a proton pump inhibitor such as LANSOPRAZOLE ZENTIVA, especially for more than one year, there may be a slight increase in the risk of hip, wrist, or spine fractures. If you have osteoporosis or are taking corticosteroids (which may increase the risk of osteoporosis), consult your doctor.

The following side effects are rare (may affect up to 1 in 1,000 people):

• 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);
• Inflammation of the kidneys (tubulointerstitial nephritis); possible symptoms include changes in the amount of urine, blood in the urine;
• Inflammation of the pancreas (pancreatitis); symptoms include sudden severe pain in the upper middle part of the abdomen that may radiate to the back, possibly leading to nausea and vomiting;
• Inflammation of the liver (may cause yellowing of the skin or eyes);
• Breast swelling in men, impotence;
• Candidiasis (fungal infection, may affect the skin or mucous membranes);
• Angioedema; you must go to the doctor immediately if you experience symptoms of angioedema such as swelling of the face, tongue or pharynx, difficulty swallowing, hives, or difficulty breathing.

The following side effects are very rare (may affect up to 1 in 10,000 people):

• Very rarely, LANSOPRAZOLE ZENTIVA may cause severe hypersensitivity (allergic) reactions, including shock. Symptoms of hypersensitivity reactions may include fever, rash, swollen face, swollen lymph nodes, swollen tongue or pharynx, difficulty swallowing, hives, difficulty breathing, 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;

• Low levels of sodium in the blood; symptoms include nausea and vomiting, headache, drowsiness and fatigue, confusion, weakness or muscle spasms, irritability, seizures, coma. Your doctor may decide to perform regular blood tests to monitor your sodium levels.

• Severe skin reactions that may be life-threatening. Symptoms include red spots on the trunk, which may appear as circular patches or target-like macules, often with central blisters, skin peeling, mouth, throat, nose, genital or eye ulcers; these severe skin reactions may be preceded by fever and flu-like symptoms [Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN)]; Decreased number of white blood cells (agranulocytosis), which may reduce resistance to infections; or abnormal reduction in the number of red blood cells, white blood cells, and platelets (pancytopenia). If you develop an infection with symptoms such as fever and severe worsening of your general condition, or fever with symptoms of local infection such as sore throat/pharynx/inflamed mouth or urinary problems, or if you experience fatigue, pale skin with bruising or unexplained bleeding lasting longer than normal, go immediately to your doctor. A blood test will be performed to check for possible reduction in blood cells.

If you experience severe or persistent diarrhoea while taking LANSOPRAZOLE ZENTIVA, contact your doctor immediately, as LANSOPRAZOLE ZENTIVA has been associated with a small increased risk of infectious diarrhoea.

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

• Skin manifestations related to lupus or lupus erythematosus;
• Hypomagnesaemia: if you take LANSOPRAZOLE ZENTIVA for more than three months, your blood magnesium levels 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 levels of potassium or calcium in the blood. Your doctor may decide to perform regular blood tests to monitor your magnesium levels;
• Skin rash, possible joint pain;
• Visual hallucinations;
• Widespread rash, high body temperature, and swollen lymph nodes [Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)].

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please talk to your doctor, pharmacist, or nurse. 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 ZENTIVA

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after "exp". The expiry date refers to the last day of that month.
Do not store above 25°C. Store in the original packaging.
Do not dispose of this 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 ZENTIVA contains

• The active substance is 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) dispersion 30%, triethyl citrate (E-1505), sugar spheres. Capsule: gelatin, titanium dioxide (E-171), black ink, purified water.

Description of the appearance of LANSOPRAZOLO ZENTIVA and package contents

LANSOPRAZOLO ZENTIVA 15 mg gastro-resistant hard capsules
White, opaque hard gelatin capsules with the imprint "LAN 15". Each capsule contains gastro-resistant granules ranging in colour from slightly pinkish to beige.
Pack sizes of 14 and 28 capsules in blister packs and bottles.

LANSOPRAZOLO ZENTIVA 30 mg gastro-resistant hard capsules
White, opaque hard gelatin capsules with the imprint "LAN 30". Each capsule contains gastro-resistant granules ranging in colour from slightly pinkish to beige.
Pack sizes of 14 and 28 capsules in blister packs and bottles.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Zentiva Italia S.r.l. - Via P. Paleocapa 7, 20121 Milano, Italy
Manufacturer
TOWA Pharmaceutical Europe S.L.
C/ Sant Martí, 75-97,
Martorelles, 08107 Barcelona, Spain