Lansocel

PACKAGE LEAFLET: INFORMATION FOR THE USER

LANSOCEL 15 mg gastro-resistant hard capsules, 30 mg gastro-resistant hard capsules

Equivalent 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 effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What LANSOCEL is and what it is used for

The active substance in LANSOCEL is lansoprazole, which is a proton pump inhibitor.
Proton pump inhibitors reduce the amount of acid produced by your stomach.
Your doctor may prescribe LANSOCEL for the following conditions:

• 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 duodenal or gastric ulcers in patients requiring ongoing treatment with non-steroidal anti-inflammatory drugs (NSAIDs, used for pain or inflammation)
• Treatment of Zollinger-Ellison syndrome

Your doctor may have prescribed LANSOCEL for a different condition or at a dosage different from
that stated in this leaflet. Follow your doctor's instructions on how to take the medicine.

2. What you need to know before taking LANSOCEL

Do not take LANSOCEL:

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

Warnings and precautions
Tell your doctor before taking LANSOCEL:
If you have ever had a skin reaction after treatment with a medicine similar to LANSOCEL
that reduces gastric acidity.
If you develop a skin rash, especially in areas exposed to sunlight, contact your
doctor as soon as possible, as it may be necessary to stop treatment with
LANSOCEL. Remember to also report any other adverse effects such as joint pain.
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 rule out malignant disease.
If you develop diarrhoea during treatment with LANSOCEL, contact your doctor immediately,
as LANSOCEL has been associated with a slight increase in infectious diarrhoea.
If your doctor has prescribed LANSOCEL in combination with other medicines for the treatment
of Helicobacter pylori infection (antibiotics) or together with anti-inflammatory medicines for
treating pain or rheumatic diseases: please read carefully the package leaflet of
these medicines as well.
If you take LANSOCEL 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.
If you take a proton pump inhibitor such as LANSOCEL, 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 or are taking corticosteroids (which may increase the risk of osteoporosis), consult your doctor.
If you need to undergo a specific blood test (Chromogranin A).
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 signs must be reported to your doctor.

Other medicines and LANSOCEL
Tell 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 LANSOCEL 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 reflux)
• sucralfate (used to heal ulcers)
• St John’s wort (Hypericum perforatum) (used to treat mild depression)

LANSOCEL with food and drink
To achieve the best results, take LANSOCEL at least 30 minutes before eating food.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding,
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 LANSOCEL.
If you experience such adverse effects, you should be cautious, as your ability to concentrate may be reduced.
You alone 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 contained in this leaflet as a guide.
If you are unsure about anything, discuss it with your doctor, nurse, or pharmacist.

Important information about some excipients of LANSOCEL
LANSOCEL contains 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 LANSOCEL

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Swallow the capsule whole with a glass of water. If you have difficulty swallowing the capsules, your doctor may suggest an alternative way of taking the medicine. Do not crush or chew the capsules or the contents of emptied capsules, as the medicine will not work properly.
If you take LANSOCEL once daily, try to take it at the same time every day. You may achieve better results if you take LANSOCEL first thing in the morning.
If you take LANSOCEL twice daily, take the first dose in the morning and the second dose in the evening.
The dose of LANSOCEL depends on your condition. The usual doses of LANSOCEL 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 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. Treatment lasts for 7 days.
The recommended antibiotic combinations are:

• 30 mg LANSOCEL together with 250–500 mg clarithromycin and 1,000 mg amoxicillin
• 30 mg LANSOCEL 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 scheduled times and never miss a 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 usual initial dose is two 30 mg capsules daily; thereafter, based on your response to LANSOCEL, your doctor will decide the most appropriate dose for you.

Use in children
The use of LANSOCEL is not recommended in children, as clinical data are limited. Treatment of infants under one year of age should be avoided, as available data have not demonstrated benefit in treating gastro-oesophageal reflux disease.

Take the medicine exactly as prescribed by your doctor. If you have any doubts about how to take the medicine, consult your doctor.

If you take more LANSOCEL than you should
In case of accidental ingestion or overdose, contact your doctor immediately or go to the nearest hospital.

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

If you stop taking LANSOCEL
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.

4. Possible side effects

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

The following side effects are common (may affect more than 1 in 100 patients):

• headache, dizziness
• diarrhoea, constipation, stomach pain, feeling unwell, gas (flatulence), dry or inflamed mouth or throat
• skin rash, itching
• changes in liver function tests
• tiredness
• benign stomach polyps

The following side effects are uncommon (may affect less than 1 in 100 patients):

• depression
• joint and muscle pain
• fluid retention or swelling
• changes in red blood cell count
• hip, wrist or spine fractures (see section 2. BEFORE YOU TAKE LANSOCEL)

The following side effects are rare (may affect less than 1 in 1,000 patients):

• 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)
• kidney problems
• pancreatitis
• liver inflammation (may present with yellowing of the skin or eyes)
• breast enlargement in men, impotence
• candidiasis (fungal infection, may affect the skin or mucous membranes)
• angioedema; you must immediately contact your doctor if you experience symptoms of angioedema such as swelling of the face, tongue or throat, difficulty swallowing, hives, or breathing difficulties.

The following side effects are very rare (may affect less than 1 in 10,000 patients):

• severe hypersensitivity reactions including shock. Symptoms of hypersensitivity reactions may include fever, rash, swelling and sometimes low blood pressure
• inflammation of the mouth (stomatitis)
• colitis (inflammation of the colon)
• changes in laboratory values such as sodium, cholesterol and triglyceride levels
• very severe skin reactions with redness, blisters, severe inflammation and skin loss
• very rarely, LANSOCEL 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 symptoms of local infection such as inflamed throat/pharynx/mouth or urinary problems, you must contact your doctor immediately. A blood test will be performed to check for a possible reduction in white blood cells (agranulocytosis).

Frequency not known (cannot be estimated from the available data):

• low levels of magnesium in the blood
• visual hallucinations. If you take LANSOCEL 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 periodically monitor your blood magnesium levels.
• erythema, possible joint pain

Following the instructions contained in this leaflet reduces the risk of side effects.

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 the following website: 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 LANSOCEL

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. 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 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 LANSOCEL 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, purified water. Capsule: gelatin, titanium dioxide (E171), black ink.

Description of the appearance of LANSOCEL and contents of the pack
Gastro-resistant hard capsules.
LANSOCEL 15 mg: white, opaque hard capsule containing spherical microgranules ranging in colour from white to off-white.
LANSOCEL 30 mg: white, opaque hard capsule containing spherical microgranules ranging in colour from white to off-white.
The capsules are packed in blisters of 14, 28 and 56 capsules.
Not all pack sizes may be marketed.

Marketing Authorization Holder
TOWA PHARMACEUTICAL EUROPE S.L.
CALLE SANT MARTI’, 75-97, 08107 MARTORELLES, BARCELONA, SPAIN

Manufacturer
Towa Pharmaceutical Europe S.L. - C/San Martì, 75-97 - 08107 Martorelles, Barcelona – Spain