Lansoprazole Sun

PACKAGE LEAFLET: INFORMATION FOR THE USER

Lansoprazole Sun 15 mg gastro-resistant hard capsules, 30 mg gastro-resistant hard capsules

Generic medicine
Please read all of 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.

Contents of this leaflet:

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

1. What Lansoprazole Sun is and what it is used for

The active ingredient of Lansoprazole Sun is lansoprazole, which is a proton pump inhibitor.
Proton pump inhibitors reduce the amount of acid produced by the stomach.
Your doctor may prescribe Lansoprazole Sun for the following indications:

• Treatment of gastric and duodenal 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 antibiotics.
• Treatment or prevention of duodenal or gastric ulcers in patients requiring continuous treatment with non-steroidal anti-inflammatory drugs (NSAIDs) (NSAID therapy is used to treat pain or inflammation).
• Treatment of Zollinger-Ellison syndrome.

2. What you need to know before taking Lansoprazole Sun

Do not take Lansoprazole Sun:

• 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 infections).

Warnings and precautions
Tell your doctor or pharmacist before taking Lansoprazole Sun.

• if you have ever had a skin reaction after treatment with a medicine similar to Lansoprazole Sun that reduces gastric acidity
• if you need to undergo a specific blood test (Chromogranin A).

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 stop treatment with Lansoprazole Sun. Remember to also report any other adverse effects such as joint pain.
Inform your doctor if you suffer from severe liver disease. Your doctor may need to adjust your dose.
Your doctor may have prescribed or may prescribe you an additional clinical investigation called "endoscopy" to diagnose your condition and/or to rule out the presence of malignant conditions.
If you develop diarrhoea during treatment with Lansoprazole Sun, contact your doctor immediately, as lansoprazole has been associated with a slight increase in infectious diarrhoea.
If your doctor has prescribed Lansoprazole Sun in combination with other medicines (antibiotics) for the treatment of Helicobacter pylori infection or together with anti-inflammatory medicines for treating pain or rheumatic diseases, carefully read the package leaflets of these medicines as well.
If you take Lansoprazole Sun for a long period (more than 1 year), your doctor will likely monitor you regularly. You must report any new or unusual symptoms at every visit to your doctor.
If you take a proton pump inhibitor such as Lansoprazole Sun, 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 suffer from osteoporosis or are taking corticosteroids (which may increase the risk of osteoporosis), consult your doctor.

Children
Lansoprazole Sun is not recommended in children, as further research is needed in this patient group.

Other medicines and Lansoprazole Sun
Inform your doctor if you are taking, have recently taken, or might take any other medicines.
In particular, inform your doctor if you are taking medicines containing any of the following active substances, as Lansoprazole Sun may interfere with how these drugs work:

• 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 and acid reflux).
• Sucralfate (used to heal ulcers).
• St John's Wort (Hypericum perforatum) (used to treat mild depression).

Lansoprazole Sun with food and drinks
To achieve the best results from this medicine, you must always take Lansoprazole Sun at least 30 minutes before food.

Pregnancy and breastfeeding
If you are pregnant, breastfeeding, or think you may be pregnant, consult your doctor before taking this medicine.

Driving and using machines
In patients taking Lansoprazole Sun, adverse effects such as dizziness, vertigo, fatigue, and visual disturbances may sometimes occur. If you experience such adverse effects, you should be cautious, as your ability to react may be impaired.
Only you are responsible for deciding whether you are fit to drive a vehicle or perform other activities requiring increased concentration. The use of medicines, due to their effects or side effects, is one of the factors that may reduce your ability to perform these activities safely. A description of these effects can be found in another section.
Read all the information in this leaflet for guidance.
If you have any doubts, consult your doctor, nurse, or pharmacist.

Lansoprazole Sun contains azorubine
Lansoprazole Sun 30 mg contains (among others) the inactive ingredient azorubine (E122). This substance may cause allergic reactions.

Lansoprazole Sun contains sucrose
Lansoprazole Sun 15 mg and Lansoprazole Sun 30 mg contain (among others) the inactive ingredient sucrose. If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.

3. How to take Lansoprazole Sun

Always take this medicine exactly as instructed by your doctor. If you have any doubts,
consult your doctor.
Swallow the capsule whole with a glass of water. If you find the capsules difficult to
swallow, your doctor may suggest alternative methods for taking this medicine. Do not break or chew
these capsules or the contents of an emptied capsule, as this would prevent the medicine from working properly.
If you take Lansoprazole Sun once daily, try to take it at the same time every day.
You may achieve better results if you take Lansoprazole Sun first thing in the morning, on an empty stomach,
at least 30 minutes before food.
If you take Lansoprazole Sun twice daily, you should take the first dose in the morning and the
second in the evening, on an empty stomach, at least 30 minutes before food.
The dose of Lansoprazole Sun depends on your condition. The usual dose of Lansoprazole Sun
for adults is given below. Your doctor may sometimes 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 for 4 weeks. If symptoms persist, inform your doctor.
If symptoms have not resolved within 4 weeks, consult 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 to one 30 mg capsule daily.
Treatment of Helicobacter pylori infections
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 is usually given daily for 7 days.
The recommended combinations with antibiotics are:

• 30 mg Lansoprazole Sun together with 250–500 mg clarithromycin and 1000 mg amoxicillin.
• 30 mg Lansoprazole Sun together with 250 mg clarithromycin and 400–500 mg metronidazole.

If you are being treated for an infection because you have an ulcer, it is unlikely that the ulcer will return if
the infection has been successfully treated. To give the medicine the best chance of working,
take it always at the right time and do not miss any doses.
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 dose to one 30 mg capsule daily.
Zollinger-Ellison syndrome
The usual starting dose is two 30 mg capsules daily, followed by the dose your doctor considers appropriate for you, depending on your response to Lansoprazole Sun.
Use in children
Lansoprazole Sun is not recommended in children, as clinical studies are limited. Use should be avoided in children under one year of age, as available clinical data have not shown benefit in the treatment of reflux oesophagitis.
If you take more Lansoprazole Sun than you should
If you take more Lansoprazole Sun than you should, or if someone known to you takes more
Lansoprazole Sun than they should, contact your doctor immediately.
If you forget to take Lansoprazole Sun
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, skip the missed dose and take the remaining capsules at the usual times.
Do not take a double dose to make up for a missed dose.
If you stop taking Lansoprazole Sun
Do not stop treatment early just because your symptoms have improved. Your condition may not
be fully healed and may recur if you do not complete the treatment.
If you have any further 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 everybody gets them.
The following side effects are common (may affect up to 1 in 10 people):

• headache, dizziness
• diarrhoea, constipation, stomach pain, feeling unwell or nausea, gas in the intestine, dryness of the mouth or throat, skin rashes, itching
• changes in liver function test values
• fatigue
• benign polyps in the stomach.

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

• depression
• muscle or joint pain
• fluid retention or swelling
• changes in blood cell count.

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

• fever
• restlessness, drowsiness, confusion, hallucinations, insomnia, visual disturbances, dizziness
• taste disturbances, loss of appetite, inflammation of the tongue (glossitis), skin reactions such as burning or mild pricking sensations under the skin, bruising, redness, excessive sweating
• sensitivity to light
• hair loss
• tingling sensation on the skin (paraesthesia), tremors
• anaemia (pallor)
• kidney problems
• pancreatitis
• inflammation of the liver (may be indicated by yellowing of the skin and whites of the eyes)
• breast enlargement in men, impotence
• candidiasis (fungal infection affecting the skin or mucous membranes)
• angioedema. You must consult your doctor immediately if symptoms of angioedema occur, such as swelling of the face, tongue or pharynx, difficulty swallowing, hives, and breathing difficulties.

The following side effects are very rare (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 a drop in blood pressure
• inflammation of the mouth (stomatitis)
• colitis (inflammation of the intestine)
• changes in laboratory test values such as levels of sodium, cholesterol and triglycerides
• very severe skin reactions with redness, blistering, severe inflammation and skin loss
• very rarely, Lansoprazolo Sun may cause a reduction in the number of white blood cells, leading to decreased resistance to infections. If you develop an infection with symptoms such as fever and severe deterioration in general condition, or fever with local signs of infection such as sore throat/pharynx/mouth or urinary problems, you must contact your doctor immediately. A blood test should be performed to check for a possible reduction in white blood cells (agranulocytosis).

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

• erythema, possible joint pain.
• visual hallucinations

If you take Lansoprazolo Sun 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,
consult 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.
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:
http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Lansoprazole Sun

Keep this medicine out of the sight and reach of children.
Do not store above 25°C. Store in the original packaging to protect the medicine from moisture.
Do not use this medicine after the expiry date stated on the pack after the word “Expiry”. The expiry date is also printed on the blister after the word “Expiry” (= expiry date) followed by a month and a year.
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 you no longer use. This will help protect the environment.

6. Package contents and other information

What Lansoprazolo Sun contains

• The active substance is: lansoprazole. One gastro-resistant hard capsule of Lansoprazolo Sun 15 mg contains 15 mg of lansoprazole. One gastro-resistant hard capsule of Lansoprazolo Sun 30 mg contains 30 mg of lansoprazole.
• The other components are: Capsule contents Hypromellose, methacrylic acid/ethyl acrylate copolymer (1:1) dispersion 30%, talc (E553b), titanium dioxide (E171), macrogol 300, anhydrous colloidal silica, sugar spheres (containing sucrose and starch). Capsule shell The 30 mg capsules also contain: gelatin, azorubine (E122), indigo carmine (E132), titanium dioxide (E171). The 15 mg capsules also contain: gelatin, quinoline yellow (E104), yellow iron oxide (E172), titanium dioxide (E171). The ink used for printing on the capsules contains: shellac, black iron oxide (E172), propylene glycol, ammonium hydroxide (E527).

Description of the appearance of Lansoprazolo Sun and contents of the pack
The 15 mg capsules are yellow with "L15" printed on both halves of the capsule.
The 30 mg capsules are purple-red/blue with "L30" printed on both halves of the capsule.
The capsules contain white to off-white acid-resistant granules.
Lansoprazolo Sun is available in the following pack sizes:
15 mg capsules: 14, 28, 30, 56, 84, 98 or 100 capsules in aluminium blisters packed in
carton boxes.
30 mg capsules: 2, 7, 14, 28, 30, 42, 56, 98 or 100 capsules in aluminium blisters packed in
carton boxes.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Sun Pharmaceutical Industries (Europe) B.V.
Polaris Avenue 87
2132 JH
B.V. 1441408 The Netherlands

Manufacturers
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH Hoofddorp – The Netherlands
ABC Farmaceutici S.p.A.
Cantone Moretti, 29 - Località San Bernardo
10090 IVREA (TO), Italy
Terapia S.A.
124 Fabricii Str.
400 635 Cluj-Napoca – Romania

This medicinal product is authorized in the European Economic Area countries under the
following names:
Italy: Lansoprazolo Sun 15 mg gastro-resistant hard capsules,
Lansoprazolo Ranbaxy 30 mg gastro-resistant hard capsules
Lithuania: Lanobax 30 mg skrandyje nevirios kietos kapsules