Levogenix

Package leaflet: Information for the patient

Levogenix 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 other people, 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, contact your doctor or pharmacist. See section 4.

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

What Levogenix is and what it is used for
The active substance in Levogenix is lansoprazole, which is a proton pump inhibitor. Proton pump inhibitors reduce the amount of acid produced by your stomach.
Your doctor may prescribe Levogenix for the following conditions 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 non-steroidal anti-inflammatory drug (NSAID) therapy (NSAIDs are used for pain or inflammation)
Treatment of Zollinger-Ellison syndrome
Your doctor may have prescribed Levogenix for another indication or at a different dosage than that listed 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.

What you need to know before taking Levogenix
Do not take Levogenix:
if you are allergic to lansoprazole or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before taking Levogenix.
If you have severe liver disease. Your doctor may need to adjust your dose. Your doctor may have performed or may perform an additional examination called endoscopy to diagnose your condition and/or exclude malignant disease.
If you develop diarrhoea during treatment with Levogenix, contact your doctor immediately, as Levogenix has been associated with a slightly increased risk of infectious diarrhoea.
If your doctor has prescribed Levogenix in addition to other medicines for the treatment of Helicobacter pylori infection (antibiotics) or together with anti-inflammatory medicines for treating pain or rheumatic diseases: please read the package leaflet of these medicines carefully as well.
If you are taking a proton pump inhibitor such as Levogenix, 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 osteoporosis (e.g., if you are taking steroids).
If you take Levogenix 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.
Talk to your doctor before taking lansoprazole:
If you have low levels of vitamin B12 or risk factors for low vitamin B12 levels and are receiving long-term treatment with lansoprazole. As with all acid-reducing agents, lansoprazole may lead to reduced absorption of vitamin B12.
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 that reduces gastric acidity.
If you notice the appearance of a skin rash, especially in sun-exposed areas, contact your doctor as soon as possible, as it may be necessary to discontinue treatment with lansoprazole. Remember to report any other side 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 Levogenix
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 Levogenix 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 regurgitation)
sucralfate (used to heal ulcers)
St John's wort (hypericum perforatum) (used to treat mild depression)

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

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

Driving and using machines
Side effects such as dizziness, vertigo, fatigue, and visual disturbances may occasionally occur in patients taking Levogenix.
If you experience such side 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 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 in this leaflet carefully.
If you are unsure about anything, discuss it with your doctor or pharmacist.

Levogenix contains sucrose and lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

Levogenix contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per hard capsule, i.e., essentially “sodium-free”.

How to take Levogenix
Always take this medicine exactly as your doctor has instructed. 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 suggest 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 Levogenix once daily, try to take it at the same time every day. You may achieve better results if you take Levogenix first thing in the morning.
If you take Levogenix twice daily, take the first dose in the morning and the second dose in the evening.
The dose of Levogenix depends on your condition. The usual doses of Levogenix for adults are listed below. Your doctor may sometimes 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 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. Treatment lasts 7 days.
The recommended antibiotic combinations are:
30 mg Levogenix together with 250–500 mg clarithromycin and 1,000 mg amoxicillin
30 mg Levogenix together with 250 mg clarithromycin and 400–500 mg metronidazole
If you are being treated for infection due to 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 ongoing NSAID therapy: one 30 mg capsule daily for 4 weeks.
Prevention of duodenal or gastric ulcer in patients requiring ongoing NSAID therapy: one 15 mg capsule daily; your doctor may adjust the dose up to one 30 mg capsule daily.
Treatment of Zollinger-Ellison syndrome: the usual initial dose is two 30 mg capsules daily; thereafter, based on your response to Levogenix, your doctor will decide the most appropriate dose for you.

Use in children
Levogenix must not be given to children.

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

If you forget to take Levogenix
If you forget to take a dose, take it as soon as you remember, unless it is almost time for the 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 a forgotten capsule.

If you stop taking Levogenix
Do not stop treatment prematurely even if your symptoms improve. Your condition may not be fully healed and may recur if you do not complete the treatment course.
If you have any questions about the use of this medicine, contact your doctor or pharmacist.

Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.

Common side effects (may affect up to 1 in 10 people):
headache, dizziness
diarrhoea, constipation, stomach pain, feeling unwell (nausea), vomiting, intestinal gas (flatulence), dry or inflamed mouth or throat
rash, itchy red spots on the skin (urticaria), 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
changes in the number of certain blood cells (thrombocytopenia, eosinophilia, leucopenia)
fractures of the hip, wrist, or spine (see also “Warnings and precautions”)
fluid retention or swelling

Rare side effects (may affect up to 1 in 1,000 people):
fever
restlessness, drowsiness, confusion, hallucinations, insomnia, visual disturbances, vertigo
altered taste, loss of appetite, inflammation of the tongue (glossitis)
skin reactions such as burning or itching sensation under the skin (erythema multiforme), bruising, redness
excessive sweating
photosensitivity
hair loss
tingling sensation on the skin (paraesthesia), tremor
anaemia (pallor)
kidney problems
pancreatitis
inflammation of the liver (may cause yellowing of the skin or eyes)
breast enlargement in men, impotence
oesophageal candidiasis (fungal infection, may affect skin or mucosa)
angioedema; seek immediate medical attention if you experience symptoms of angioedema such as swelling of the face, tongue, or throat, difficulty swallowing, urticaria, or breathing difficulties

Very rare side effects (may affect up to 1 in 10,000 people):
severe hypersensitivity reactions including shock. Symptoms of hypersensitivity reactions may include fever, 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, blisters, severe inflammation, and skin loss (Stevens-Johnson syndrome, toxic epidermal necrolysis)
reduction in white blood cell count (reduced resistance to infections) and decrease in all blood cells (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 inflamed throat/pharynx/mouth or urinary problems, seek immediate medical attention. A blood test will be performed to check for possible reduction in white blood cells (agranulocytosis)

Frequency not known (frequency cannot be estimated from the available data):
If you take Levogenix for more than three months, your blood magnesium levels 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, contact your doctor immediately. Low magnesium levels may also lead to reduced blood levels of potassium or calcium.
Your doctor should decide whether to monitor your blood magnesium levels regularly.

• A disease characterised by skin lesions and inflammation (cutaneous lupus erythematosus).
  Low sodium levels in the blood. Common symptoms include nausea and vomiting, headache, drowsiness and fatigue, confusion, muscle weakness or spasms, irritability, seizures, coma, visual hallucinations.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, contact 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.

How to store Levogenix
Do not store above 25°C. Store in the original packaging.
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 on the pack. The expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer used. This will help protect the environment.

Contents of the pack and other information
What Levogenix contains
The active substance is lansoprazole.
Each gastro-resistant hard capsule contains 15 mg of lansoprazole or 30 mg of lansoprazole.
The other ingredients are:
Capsule contents: sucrose and maize starch spheres, lactose, disodium phosphate anhydrous, hypromellose, mannitol, hypromellose phthalate, diethyl phthalate, cetyl alcohol, talc, titanium dioxide (E171), sodium lauryl sulfate.
Capsule shell: gelatin, titanium dioxide (E171)

Description of the appearance of Levogenix and contents of the pack
Levogenix capsules are hard capsules containing gastro-resistant granules.
Levogenix is available in packs of 14 or 28 gastro-resistant hard capsules of 15 mg and 30 mg in PVC/PVDC/aluminium blisters.

Marketing Authorisation Holder
GENETIC S.p.A. - Via Della Monica, 26 - Castel S. Giorgio (SA)
Manufacturer:
Genetic S.p.A. Contrada Canfora – 84084 Fisciano (SA)