LIMPIDEX

Patient Information Leaflet

Limpidex 15 mg hard capsules, 30 mg hard capsules

lansoprazole
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 pass it on to other people, 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.

Contents of this leaflet:

1. What Limpidex is and what it is used for
2. What you need to know before taking Limpidex
3. How to take Limpidex
4. Possible side effects
5. How to store Limpidex
6. Package contents and other information

1. What Limpidex is and what it is used for

Limpidex contains the active substance lansoprazole, a proton pump inhibitor.
Proton pump inhibitors reduce the amount of acid produced by your stomach.
Your doctor may prescribe Limpidex 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 given in combination with antibiotic therapy
• treatment or prevention of intestinal (duodenal) or gastric ulcers in patients requiring continuous treatment with NSAIDs (non-steroidal anti-inflammatory drugs) (NSAIDs are used to treat pain or inflammation)
• treatment of Zollinger-Ellison syndrome.

Your doctor may have prescribed Limpidex for an indication or dosage different from that stated in this leaflet. Always bring the medicine with you when visiting your doctor.

2. What you should know before taking Limpidex

Do not take Limpidex

• 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 before taking Limpidex:

• if you have ever had a skin reaction after treatment with a medicine similar to Limpidex that reduces gastric acidity.
• If you need to undergo a specific blood test (Chromogranin A).
• If you have low levels of vitamin B12 or risk factors for low vitamin B12 levels, as long-term treatment with lansoprazole, as with all agents that reduce gastric acidity, may lead to reduced absorption of vitamin B12.
• 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 Limpidex. 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 Limpidex. Stop using Limpidex and consult your doctor immediately if you notice any of the symptoms related to these serious skin reactions 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. You must report such signs to your doctor.

Tell your doctor if you have moderate or 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 a tumor before prescribing Limpidex.
If diarrhea occurs during treatment with Limpidex, contact your doctor immediately, as Limpidex has been associated with a slight increase in infectious diarrhea.
If your doctor has prescribed Limpidex 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, read carefully the package leaflet of these medicines as well.
If you take a proton pump inhibitor such as Limpidex, especially for more than one year, there may be a slight increase in the risk of fractures of the hip, wrist, or spine. If you suffer from osteoporosis (reduced bone density) or if your doctor tells you that you are at risk of osteoporosis (for example, if you are taking steroids).
If you take Limpidex 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.

Other medicines and Limpidex
Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicine.
In particular, tell your doctor if you are taking medicines containing any of the following active substances, as Limpidex 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)
• atazanavir or nelfinavir (used in the treatment of HIV)
• methotrexate (used for the treatment of autoimmune disorders and neoplasms)
• warfarin (used as an anticoagulant)

Limpidex with food and drinks
To achieve the best results, take Limpidex with a glass of water at least 30 minutes before eating (see section 3 “How to take Limpidex”).

Pregnancy, breastfeeding, and fertility
If you are pregnant, think you may be pregnant, plan to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
The use of lansoprazole during pregnancy is not recommended.

Breastfeeding
Your doctor will evaluate whether to continue/stop breastfeeding or to continue/stop treatment with lansoprazole, taking into account the benefit of breastfeeding for the child and the benefit of lansoprazole treatment for you.

Driving and using machines
Adverse effects such as dizziness, vertigo, fatigue, and visual disturbances may occasionally occur in patients taking Limpidex.
If you experience such adverse effects, 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 reduce 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.

Limpidex contains sucrose and sodium
This medicine contains sucrose.
If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.
Limpidex contains less than 1 mmol of sodium (23 mg) per capsule, i.e., essentially “sodium-free”.

3. How to take Limpidex

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 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 would not work
properly.
If you take Limpidex once daily, try to take it at the same time each day. You may achieve
better results if you take Limpidex first thing in the morning.
If you take Limpidex twice daily, you should take the first dose in the morning and the second dose
in the evening.
The dose of Limpidex depends on your condition. The recommended doses of Limpidex for adults
are listed below. Your doctor will prescribe the dose most suitable for you and will tell you how long
you should take Limpidex.
Treatment of heartburn and acid regurgitation: one 15 mg or 30 mg capsule daily for 4 weeks. If symptoms
are not relieved within 4 weeks, contact your doctor.
Treatment of duodenal ulcer: one 30 mg capsule once daily for 2 weeks.
Your doctor will assess whether to continue treatment at the same dose for a further 2 weeks if healing has not occurred.
Treatment of gastric ulcer: one 30 mg capsule daily for 4 weeks.
Your doctor will assess whether to continue treatment at the same dose for a further 4 weeks if healing has not occurred.
Treatment of inflammation of the oesophagus (reflux oesophagitis): one 30 mg capsule once
daily for 4 weeks.
Your doctor will assess whether to continue treatment at the same dose for a further 4 weeks if healing has not occurred.
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 for 7 days.
The recommended antibiotic combinations are:
30 mg of Limpidex together with 250–500 mg of clarithromycin and 1 g of amoxicillin
30 mg of Limpidex 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 do not miss any dose.
Treatment of duodenal or gastric ulcer in patients requiring continuous treatment with NSAIDs: one 30 mg capsule daily for 4 weeks.
Your doctor will assess whether to continue treatment for a further 4 weeks or whether to use a higher dose.
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, based on your response to Limpidex, your doctor will decide the most appropriate dose for you.

Use in children
Limpidex must not be given to children.
Take exactly the medicine as directed by your doctor. If you have any doubts about how to take the
medicine, consult your doctor.

Use in patients with liver problems
In patients with moderate or severe liver disease, it may be necessary to halve the daily dose. Your doctor will tell you how much Limpidex you should take (see section “Warnings and Precautions”).

Use in elderly patients
In elderly patients, it may be necessary to adjust the dose. Your doctor will tell you how much Limpidex you should take.

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

If you forget to take Limpidex
If you forget to take a dose, take it as soon as you remember, unless it is almost time for the next dose. If this is the case, do not take the missed dose and take the remaining capsules as usual. Do not take a double dose to make up for a forgotten capsule.

If you stop taking Limpidex
Do not stop treatment prematurely even if your symptoms improve. 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 Limpidex, consult your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop using Limpidex and consult your doctor immediately if you notice any of the following
symptoms:

• Flat, reddish patches on the skin that look like a target or are circular in shape, appearing on the trunk, often with blisters in the center, 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 side effects (may affect up to 1 in 10 people)

• Headache, dizziness
• Benign gastric polyps, nausea, vomiting, diarrhoea, constipation, stomach pain, malaise, flatulence, dry or inflamed mouth or throat
• Skin rash, urticaria, itching
• Abnormal liver function tests, fatigue.

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

• Depression
• Joint and muscle pain
• Fluid retention or swelling
• Decrease in the number of platelets in the blood (thrombocytopenia)
• Decrease in the number of white blood cells in the blood (leucopenia)
• Increase in the number of certain white blood cells in the blood (eosinophilia).

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

• Fever
• Restlessness, drowsiness, confusion, hallucinations, insomnia, vision disorders, dizziness
• Altered taste sensation, loss of appetite (anorexia), 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
• Decrease in the number of red blood cells in the blood (anaemia)
• Kidney problems (interstitial nephritis)
• Inflammation of the pancreas (pancreatitis)
• Inflammation of the liver (hepatitis); yellowing of the skin or eyes (jaundice) may occur
• Breast swelling in men, impotence
• Candidiasis (fungal infection, may affect the skin or mucosa)
• 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 and breathing difficulties.

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

• Severe allergic 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 (Stevens-Johnson syndrome, toxic epidermal necrolysis)
• Decrease in the number of white blood cells, which may therefore reduce 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 problems urinating, seek immediate medical attention. A blood test will be performed to check for a possible decrease in white blood cells (agranulocytosis)
• Decrease in all blood cell types (pancytopenia).

Frequency not known

• If you take Limpidex 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 to regularly monitor magnesium levels in your blood.
• Low sodium levels in the blood. Common symptoms include nausea and vomiting, headache, headache, drowsiness and fatigue, confusion, muscle weakness or spasms, irritability, seizures, coma.
• Erythema, 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 Limpidex

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 carton after "Exp.".
The expiry date refers to the last day of that month.
Store below 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 Limpidex contains

• The active substance is lansoprazole. Each hard capsule contains 15 mg or 30 mg of lansoprazole.
• The other components are inert microgranules, sucrose, methacrylic acid-ethyl acrylate copolymer (1:1) dispersion 30%, low-substituted hydroxypropylcellulose, corn starch, magnesium carbonate, talc, macrogol 8000, titanium dioxide, hydroxypropylcellulose, polysorbate 80, anhydrous colloidal silica, gelatin, titanium dioxide (E171), iron oxide red (E172).

Description of the appearance of Limpidex and contents of the pack
Limpidex hard capsules are white and pink in colour. Each hard capsule contains gastro-resistant granules ranging in colour from white to pale brownish white.
Each pack of Limpidex 15 mg hard capsules contains 14, 28 or 35 hard capsules.
Each pack of Limpidex 30 mg hard capsules contains 14, 28 or 35 hard capsules.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Alfasigma S.p.A.
Via Ragazzi del ’99, n. 5 – 40133 Bologna (BO)

Manufacturers
Delpharm Novara S.r.l - Via Crosa, 86 - 28065 Cerano (NO)
Alfasigma S.p.A. - Via Pontina km 30,400 - 00071 Pomezia (RM)
Pharmaloop, S.L. – Calle Bolivia, 15 – 28006 Alcalà de Henares (Madrid)

Patient Information Leaflet

Limpidex 15 mg orodispersible tablets, 30 mg orodispersible tablets

lansoprazole
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, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Limpidex is and what it is used for

Limpidex contains the active substance lansoprazole, a proton pump inhibitor.
Proton pump inhibitors reduce the amount of acid produced by your stomach.
Your doctor may prescribe Limpidex 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 intestinal (duodenal) or gastric ulcers in patients requiring continuous treatment with NSAIDs (non-steroidal anti-inflammatory drugs) (NSAIDs are used against pain or inflammation)
• treatment of Zollinger-Ellison syndrome.

Your doctor may have prescribed Limpidex for an indication or dosage different from that stated in this leaflet. Always bring the medicine with you when visiting your doctor.

2. What you need to know before taking Limpidex

Do not take Limpidex

• 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 before taking Limpidex:

• if you have ever had a skin reaction after treatment with a medicine similar to Limpidex that reduces gastric acidity.
• If you need to undergo a specific blood test (Chromogranin A).
• If you have low levels of vitamin B12 or risk factors for low vitamin B12 levels, as long-term treatment with lansoprazole, like all agents that reduce gastric acidity, may lead to reduced absorption of vitamin B12.
• 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 therapy with Limpidex. 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 Limpidex treatment. Stop using Limpidex and contact your doctor immediately if you experience any of the symptoms related to these serious skin reactions 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. You must report these signs to your doctor.

Tell your doctor if you have moderate or 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 the presence of a tumor before prescribing Limpidex.
If you develop diarrhea during treatment with Limpidex, contact your doctor immediately, as Limpidex has been associated with a slight increase in infectious diarrhea.
If your doctor has prescribed Limpidex in combination with other medicines for the treatment of Helicobacter pylori infection (antibiotics) or together with anti-inflammatory medicines for pain or rheumatic diseases, read the package leaflet of these medicines carefully as well.
If you take a proton pump inhibitor such as Limpidex, especially for more 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 if your doctor tells you that you are at risk of osteoporosis (e.g., if you are taking steroids), discuss this with your doctor.
If you take Limpidex long-term (for more than 1 year), your doctor will likely monitor you regularly. You must report any new or unusual symptoms or circumstances at every visit to your doctor.

Other medicines and Limpidex
Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.
In particular, tell your doctor if you are taking medicines containing any of the following active substances, as Limpidex 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)
• atazanavir or nelfinavir (used in the treatment of HIV)
• methotrexate (used for the treatment of autoimmune disorders and neoplasms)
• warfarin (used as an anticoagulant)

Limpidex with food and drink
To achieve the best results, take Limpidex with a glass of water at least 30 minutes before eating (see section 3 “How to take Limpidex”).

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.

Pregnancy
The use of lansoprazole during pregnancy is not recommended.

Breastfeeding
Your doctor will assess whether to continue/stop breastfeeding or to continue/stop treatment with lansoprazole, taking into account the benefit of breastfeeding for the child and the benefit of lansoprazole therapy for you.

Driving and using machines
Adverse effects such as dizziness, vertigo, fatigue, and visual disturbances may occasionally occur in patients taking Limpidex.
If you experience such adverse effects, you should be cautious, as your attention may be impaired.
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 reduce 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 in this leaflet carefully.
If you are unsure about anything, discuss it with your doctor, nurse, or pharmacist.

Limpidex contains lactose and sodium
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.
Limpidex contains less than 1 mmol of sodium (23 mg) per tablet, i.e., essentially “sodium-free”.

Limpidex contains aspartame
This medicine contains 4.5 mg of aspartame in 15 mg tablets and 9.0 mg in 30 mg tablets.
Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria, a rare genetic disorder causing accumulation of phenylalanine because the body cannot properly eliminate it.

3. How to take Limpidex

Take this medicine exactly as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
Place the Limpidex tablet on your tongue and suck it slowly. The tablet dissolves rapidly in the mouth, releasing microgranules which must be swallowed without chewing. You may also swallow the tablets whole with a glass of water.
Your doctor may instruct you to take the tablet using a syringe if you have serious swallowing difficulties.

The following instructions should be followed if taking via a syringe:
It is important that the suitability of the syringe used is carefully tested:

• Remove the plunger from the syringe (use at least a 5 mL syringe for a 15 mg tablet and 10 mL for a 30 mg tablet)
• Place the tablet into the syringe
• Replace the plunger into the syringe
• For the 15 mg tablet: draw up 4 mL of tap water into the syringe
• For the 30 mg tablet: draw up 10 mL of tap water into the syringe
• Turn the syringe upside down and draw in an additional 1 mL of air
• Gently shake the syringe for 10–20 seconds until the tablet is dissolved
• The contents can be emptied directly into the mouth
• Refill the syringe with 2–5 mL of tap water to ensure complete emptying of the syringe into the mouth

If you take Limpidex once daily, try to take it at the same time each day. You may achieve better results if you take Limpidex first thing in the morning.
If you take Limpidex twice daily, take the first dose in the morning and the second dose in the evening.

The dose of Limpidex depends on your condition. The recommended doses of Limpidex for adults are listed below. Your doctor will prescribe the most appropriate dose for you and will tell you how long you should take Limpidex.

Treatment of heartburn and acid regurgitation: one orodispersible tablet of 15 mg or 30 mg daily for 4 weeks. If symptoms are not relieved within 4 weeks, contact your doctor.

Treatment of duodenal ulcer: one orodispersible tablet of 30 mg daily for 2 weeks.
Your doctor will assess whether to continue treatment at the same dose for another 2 weeks if healing has not occurred.

Treatment of gastric ulcer: one orodispersible tablet of 30 mg once daily for 4 weeks.
Your doctor will assess whether to continue treatment at the same dose for another 4 weeks if healing has not occurred.

Treatment of inflammation of the oesophagus (reflux oesophagitis): two orodispersible tablets of 15 mg or one orodispersible tablet of 30 mg once daily for 4 weeks.
Your doctor will assess whether to continue treatment at the same dose for another 4 weeks if healing has not occurred.

Prevention of recurrence of reflux oesophagitis: one orodispersible tablet of 15 mg once daily. Your doctor may adjust the dose up to one orodispersible tablet of 30 mg daily.

Treatment of Helicobacter pylori infection: the usual dose is one orodispersible tablet of 30 mg in combination with two different antibiotics in the morning, and one orodispersible tablet of 30 mg in combination with two different antibiotics in the evening. Treatment should be taken daily for 7 days.
The recommended antibiotic combinations are:
30 mg of Limpidex together with 250–500 mg of clarithromycin and 1 g of amoxicillin
30 mg of Limpidex 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 do not miss any dose.

Treatment of duodenal or gastric ulcer in patients requiring continuous NSAID therapy: one orodispersible tablet of 30 mg daily for 4 weeks.
Your doctor will assess whether to continue treatment for another 4 weeks or whether to use a higher dose.

Prevention of intestinal (duodenal) or gastric ulcer in patients requiring continuous NSAID therapy: one orodispersible tablet of 15 mg daily. Your doctor may adjust the dosage up to one orodispersible tablet of 30 mg daily.

Zollinger-Ellison syndrome: the usual initial dose is two orodispersible tablets of 30 mg daily. Based on your response to Limpidex, your doctor will decide the most appropriate dose for you.

Use in children
Limpidex must not be given to children.

Use in patients with liver problems
In patients with moderate or severe liver disease, the daily dose may need to be halved. Your doctor will tell you how much Limpidex to take (see section “Warnings and Precautions”).

Use in elderly patients
In elderly patients, the dose may need to be adjusted. Your doctor will tell you how much Limpidex to take.

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

If you forget to take Limpidex
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 but continue with your regular dosing schedule. Do not take a double dose to make up for a forgotten tablet.

If you stop taking Limpidex
Do not stop treatment prematurely even if your symptoms improve. 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, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop using Limpidex and consult your doctor immediately if you notice any of the following
symptoms:

• Flat, red spots on the skin that resemble a target or are circular in shape, usually on the trunk, often with blisters in the center, peeling of the skin, 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 side effects (may affect up to 1 in 10 people)

• Headache, dizziness
• Benign stomach polyps, nausea, vomiting, diarrhoea, constipation, stomach pain, malaise, flatulence, dry or inflamed mouth or throat
• Skin rash, urticaria, itching
• Changes in liver function tests
• Fatigue.

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

• Depression
• Joint and muscle pain
• Fluid retention or swelling
• Decrease in the number of platelets in the blood (thrombocytopenia)
• Decrease in the number of white blood cells in the blood (leucopenia)
• Increase in the number of certain white blood cells in the blood (eosinophilia).

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

• Fever
• Restlessness, drowsiness, confusion, hallucinations, insomnia, visual disturbances, dizziness
• Altered sense of taste, loss of appetite (anorexia), 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
• Decrease in the number of red blood cells in the blood (anaemia)
• Kidney problems (interstitial nephritis)
• Inflammation of the pancreas (pancreatitis)
• Inflammation of the liver (hepatitis); yellowing of the skin or eyes (jaundice) may occur
• Breast enlargement in men, impotence, candidiasis (fungal infection, may affect the 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.

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

• Severe allergic 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 (Stevens-Johnson syndrome, toxic epidermal necrolysis)
• Decrease in the number of white blood cells, which may therefore reduce 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 problems urinating, seek immediate medical attention. A blood test will be performed to check for a possible decrease in white blood cells (agranulocytosis)
• Decrease in all blood cells (pancytopenia)

Frequency not known

• If you take Limpidex for more than three months, blood magnesium levels may decrease. Low plasma magnesium levels may cause fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, and increased heart rate. If you experience any of these symptoms, inform your doctor immediately. Low magnesium levels may also lead to reduced plasma levels of potassium or calcium. Your doctor may decide to perform regular blood tests to monitor plasma magnesium levels.

• Low sodium levels in the blood. Common symptoms include nausea and vomiting, headache, drowsiness and fatigue, confusion, muscle weakness or spasms, irritability, seizures, coma.

• Erythema, 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 Limpidex

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 that month.
Store below 25°C. Keep in the original packaging.
Do not dispose of medicines 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 Limpidex contains

• The active substance is lansoprazole. Each orodispersible tablet contains 15 mg or 30 mg of lansoprazole.
• The other components are: monohydrate lactose, microcrystalline cellulose, magnesium carbonate, lightly substituted hydroxypropylcellulose, hydroxypropylcellulose, hypromellose, titanium dioxide, talc, mannitol, methacrylic acid-ethyl acrylate copolymer (1:1) dispersion 30%, polyacrylate dispersion 30%, macrogol 8000, glyceryl monostearate, polysorbate 80, triethyl citrate, anhydrous citric acid, yellow iron oxide (E172) and red iron oxide (E172), crospovidone, strawberry flavor, aspartame, magnesium stearate.

Description of the appearance of Limpidex and contents of the pack
Limpidex orodispersible tablets are white to off-white in colour, with specks ranging from orange to dark brown. Each orodispersible tablet contains gastro-resistant granules of orange to dark brown colour.
Each pack of Limpidex 15 mg orodispersible tablets contains 14 or 28 orodispersible tablets.
Each pack of Limpidex 30 mg orodispersible tablets contains 14 or 28 orodispersible tablets.
It is possible that not all pack sizes are marketed.

Marketing Authorization Holder
Alfasigma S.p.A.
Via Ragazzi del ’99, n. 5 – 40133 Bologna (BO)

Manufacturers
Delpharm Novara S.r.l. - Via Crosa, 86 - 28065 Cerano (NO)
Alfasigma S.p.A. - Via Pontina km 30,400 - 00071 Pomezia (RM)