Lansoprazole FG

Package leaflet: Information for the patient

Lansoprazole FG 15 mg hard capsules, 30 mg hard capsules

Equivalent medicine
Please read this leaflet carefully before taking this medicine as 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 effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

The active substance of LANSOPRAZOLO FG 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 FG 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 continuous treatment with NSAIDs (non-steroidal anti-inflammatory drugs, used for pain or inflammation)
• Treatment of Zollinger-Ellison syndrome

Your doctor may have prescribed LANSOPRAZOLO FG for a different indication or at a different dosage than those listed in this leaflet. Always follow your doctor's instructions on how to take the medicine.
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 FG

Do not take LANSOPRAZOLO FG:

• 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 LANSOPRAZOLO FG.
Inform 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 FG, contact your doctor immediately, as LANSOPRAZOLO FG has been associated with a small increased risk of infectious diarrhoea.
If your doctor has prescribed LANSOPRAZOLO FG 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 carefully the package leaflet of these medicines as well.
If you take a proton pump inhibitor such as LANSOPRAZOLO FG, especially for more than one year, there may be a slightly increased 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 (for example, if you are taking steroids).
If you take LANSOPRAZOLO FG for more than three months, your blood magnesium levels may decrease. Low magnesium levels may present as fatigue, involuntary muscle contractions, confusion, seizures, dizziness, or 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 magnesium levels in the blood is necessary.
If you take LANSOPRAZOLO FG long-term (for more than 1 year), your doctor will likely keep you under regular surveillance. You should report any new or unusual symptoms and circumstances at every medical visit.
Talk to your doctor before taking lansoprazole:

• 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 are scheduled for a specific blood test (Chromogranin A);
• if you have ever had a skin reaction after treatment with a medicine similar to LANSOPRAZOLO FG 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 LANSOPRAZOLO FG. Remember to report any other adverse effects such as joint pain.

Severe 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 LANSOPRAZOLO FG. Stop taking LANSOPRAZOLO FG and consult your doctor immediately if you notice any of the symptoms related to these severe 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. These signs must be reported to your doctor.
Children
The use of LANSOPRAZOLO FG is not recommended in children because clinical data are limited.
Other medicines and LANSOPRAZOLO FG
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, tell your doctor if you are taking medicines containing any of the following active substances, as LANSOPRAZOLO FG 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 thin the blood and prevent clot formation)
• 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)

LANSOPRAZOLO FG with food and drinks
To achieve the best results, take LANSOPRAZOLO FG with a glass of water at least 30 minutes before eating.
Pregnancy, breast-feeding and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breast-feeding, ask your doctor or pharmacist for advice 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 FG.
If you experience adverse effects such as these, 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 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 in this leaflet as a guide.
If you are unsure about anything, discuss it with your doctor or pharmacist.
LANSOPRAZOLO FG contains sucrose
If your doctor has diagnosed you with an intolerance to certain sugars, contact your doctor before taking this medicine.
LANSOPRAZOLO FG contains less than 1 mmol (23 mg) of sodium per capsule, i.e. essentially ‘sodium-free’.

3. How to take LANSOPRAZOLE FG

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The dose of LANSOPRAZOLE FG depends on your condition. The usual doses of LANSOPRAZOLE FG for adults are listed below. Sometimes your doctor will prescribe a different dose and will tell you how long the 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 (heartburn and acid regurgitation): 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 FG together with 250–500 mg clarithromycin and 1,000 mg amoxicillin
• 30 mg of LANSOPRAZOLE FG together with 250 mg clarithromycin and 400–500 mg 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 prescribed times and do not miss any dose.

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

Prevention of duodenal or gastric ulcer in patients requiring continuous NSAID therapy: 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 hard capsules daily; thereafter, depending on your response to LANSOPRAZOLE FG, your doctor will decide the most appropriate dose for you.

Use in children
Lansoprazole FG is indicated for adults and must not be administered to children.

Method of administration
Swallow the capsule whole with a glass of water. If you have difficulty swallowing hard capsules, your doctor may suggest an alternative way of taking the medicine. Do not crush or chew these hard capsules or the contents of emptied hard capsules, as the medicine will not work properly.

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

If you take more LANSOPRAZOLE FG than you should
If you take more LANSOPRAZOLE FG than prescribed, seek immediate advice from your doctor. In case of accidental ingestion or overdose of this medicine, consult your doctor immediately or go to the nearest hospital.

If you forget to take LANSOPRAZOLE FG
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 capsule.

If you stop taking LANSOPRAZOLE FG
Do not stop treatment prematurely, even if your symptoms have improved. Your condition may not be fully 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.
Stop taking Lansoprazole FG and contact your doctor immediately if you notice any of the
following symptoms

• you must immediately inform your doctor if you experience symptoms of angioedema such as swelling of the face, tongue or throat, difficulty swallowing, hives and breathing difficulties.
• red, non-elevated skin patches resembling targets or circular rashes on the trunk, often with blisters in the center, skin peeling, ulcers in the mouth, throat, nose, genitals and eyes. 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
• nausea, diarrhoea, constipation, stomach pain, vomiting, intestinal gas (flatulence), dry or inflamed mouth or throat
• benign stomach polyps
• urticaria, skin rash, 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 (oedema)
• decrease in platelets and white blood cells (especially eosinophils)
• fractures of the hip, wrist or spine (see section 2).

Rare side effects (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 sensations under the skin, bruising, redness and excessive sweating
• light sensitivity
• hair loss
• tingling sensation on the skin (paraesthesia), tremor
• anaemia
• kidney problems
• pancreatitis
• liver inflammation (may cause yellowing of the skin or eyes)
• breast enlargement in men, impotence
• oesophageal candidiasis (fungal infection, may affect skin or mucous membranes)
• angioedema.

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

• severe allergic reactions including shock. Symptoms of allergic reactions may include fever, rash, swelling and sometimes low blood pressure
• inflammation of the mouth (stomatitis)
• inflammation of the colon (colitis)
• increased levels of cholesterol and triglycerides in the blood
• low sodium levels in the blood. Symptoms include nausea and vomiting, headache, drowsiness and fatigue, confusion, muscle weakness or cramps, irritability, seizures, coma
• very severe skin reactions with redness, blisters, serious inflammation and skin peeling
• reduction in the number of all blood cells, including a type of white blood cell, 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 urinary problems, go

immediately to your doctor. A blood test will be performed to check for a possible decrease in white blood cells (agranulocytosis).
Frequency not known (frequency cannot be estimated from the available data)

• hypomagnesaemia (low magnesium levels in the blood) (see section 2)
• erythema, possible joint pain
• visual hallucinations.

Reporting of side effects
If you get any side effects, including ones not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at 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 FG

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp.". The expiry date refers to the last day of that month.
Store below 30°C.
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 LANSOPRAZOLO FG contains

• The active substance is lansoprazole. LANSOPRAZOLO FG is available in two strengths containing 15 mg or 30 mg of lansoprazole.
• The other components are: Sucrose and maize starch spheres, heavy magnesium carbonate, hypromellose, polysorbate 80, macrogol 6000, triethyl citrate, talc, titanium dioxide (E171), methacrylic acid-ethyl acrylate copolymer (1:1) dispersion 30% (Eudragit L30 D-55), sodium hydroxide; capsule components: gelatin, titanium dioxide (E171), erythrosine (E127), iron oxide red (E172)

Description of the appearance of LANSOPRAZOLO FG and contents of the pack
Gastro-resistant granules in hard capsules
LANSOPRAZOLO FG is available in the following pack sizes: 14 and 28 hard capsules for both 15 mg and 30 mg strengths.

Marketing Authorization Holder
FG S.r.l – Via S. Rocco, 6 – Episcopia (PZ)

Manufacturer
Special Product’s Line S.p.a - Via Fratta Rotonda Vado Largo, 1 - 03012 Anagni (FR)