Lansoprazole Sun Pharma

Patient Information Leaflet: Information for the User

Lansoprazole SUN Pharma 15 mg orodispersible tablets, 30 mg orodispersible tablets

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 may 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:

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

1. What Lansoprazole SUN Pharma is and what it is used for

The active substance in Lansoprazole SUN Pharma is lansoprazole, a proton pump inhibitor.
Proton pump inhibitors reduce the amount of acid produced by the stomach.
Your doctor may prescribe Lansoprazole SUN Pharma 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 duodenal or gastric ulcers in patients requiring continuous treatment with non-steroidal anti-inflammatory drugs (NSAIDs used for pain or inflammation)
• Treatment of Zollinger-Ellison syndrome.

Your doctor may have prescribed Lansoprazole SUN Pharma for a different indication or at a dosage different from that stated in this leaflet. Consult your doctor for advice on taking the medicine.
Contact your doctor if you do not feel better or if you feel worse after 14 days.

2. What you should know before taking Lansoprazole SUN Pharma

Do not take Lansoprazole SUN Pharma:

• If you are allergic to lansoprazole or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Inform your doctor if you have severe liver disease. Your doctor may need to adjust the dosage of the medicine.
Your doctor may perform or may have already performed an additional examination called endoscopy to diagnose your condition and/or to exclude malignant disease.
If you develop severe or persistent diarrhoea during treatment with Lansoprazole SUN Pharma, contact your doctor immediately, as Lansoprazole SUN Pharma has been associated with a small increased risk of infectious diarrhoea.
If your doctor has prescribed Lansoprazole SUN Pharma 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 Lansoprazole SUN Pharma for more than three months, your blood magnesium levels may decrease. Low magnesium levels may present as 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 levels of potassium or calcium in the blood. Your doctor may decide to carry out regular blood tests to monitor your magnesium levels.
If you take a proton pump inhibitor such as Lansoprazole SUN Pharma, especially for longer 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 may be at risk of developing osteoporosis (for example, if you are taking steroids).
This medicine may affect how your body absorbs vitamin B12, particularly if you need to take it for a long time. Contact your doctor if you notice any of the following symptoms, which could indicate low vitamin B12 levels:

• Extreme tiredness or lack of energy
• Tingling sensations
• Sore or red tongue, mouth ulcers
• Muscle weakness
• Disturbed vision
• Memory problems, confusion, depression

If you take Lansoprazole SUN Pharma long-term (for more than 1 year), your doctor will likely monitor you regularly. At each visit, report any new or unusual symptoms or circumstances to your doctor.
Talk to your doctor before taking Lansoprazole SUN Pharma:

• If you are due to have a specific blood test (chromogranin A).
• If you have ever had a skin reaction after treatment with a medicine similar to Lansoprazole SUN Pharma that reduces gastric acidity.

Serious skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported in association with treatment with lansoprazole. Stop using Lansoprazole SUN Pharma and contact your doctor immediately if you notice any of the symptoms described in section 4.
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 discontinue treatment with Lansoprazole SUN Pharma. Remember also to report any other adverse 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, skin rash, and joint stiffness. These signs must be reported to your doctor.

Other medicines and Lansoprazole SUN Pharma
Inform your doctor or pharmacist if you are currently taking, have recently taken, or might take any other medicines.
In particular, inform your doctor or pharmacist if you are taking medicines containing any of the following active substances, as Lansoprazole SUN Pharma 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 cancers)
• 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 reflux)
• sucralfate (used to heal ulcers)
• St John’s wort (Hypericum perforatum, used to treat mild depression)

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

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

Driving and using machines
Adverse effects such as dizziness, vertigo, fatigue, and visual disturbances may occasionally occur in patients taking Lansoprazole SUN Pharma. If you experience such adverse effects, you should be cautious, as your reaction capability 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 the 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 as a guide.
If you have any doubts, discuss them with your doctor or pharmacist.

Lansoprazole SUN Pharma contains aspartame
Each 15 mg tablet of Lansoprazole SUN Pharma contains 4.5 mg of aspartame.
Each 30 mg tablet of Lansoprazole SUN Pharma contains 9.0 mg of aspartame.
Aspartame is a source of phenylalanine. Phenylalanine may be harmful to you if you have phenylketonuria (PKU), a rare genetic disorder causing accumulation of phenylalanine because the body cannot eliminate it properly.

3. How to take Lansoprazole SUN Pharma

Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
Place the 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.
If you take Lansoprazole SUN Pharma once daily, try to take it at the same time each day. You may
achieve better results if you take Lansoprazole SUN Pharma first thing in the morning.
If you take Lansoprazole SUN Pharma twice daily, you should take the first dose in the morning and the second
dose in the evening.
The dose of Lansoprazole SUN Pharma depends on your condition. The usual doses of Lansoprazole SUN
Pharma 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 orodispersible tablet of 15 mg or 30 mg daily for 4 weeks.
If symptoms have not improved within 4 weeks, contact your doctor.
Treatment of duodenal ulcer: one orodispersible tablet of 30 mg daily for 2 weeks.
Treatment of gastric ulcer: one orodispersible tablet of 30 mg daily for 4 weeks.
Treatment of inflammation of the oesophagus (reflux oesophagitis): one orodispersible tablet of 30 mg daily for 4 weeks.
Long-term prevention of reflux oesophagitis: one orodispersible tablet of 15 mg 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. The treatment will be taken daily for 7 days.
The recommended antibiotic combinations are:

• 30 mg of Lansoprazole SUN Pharma together with 250–500 mg of clarithromycin and 1000 mg of amoxicillin;
• 30 mg of Lansoprazole SUN Pharma 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 never forget a dose.
Treatment of duodenal or gastric ulcer in patients requiring continuous treatment with NSAIDs: one orodispersible tablet of 30 mg daily for 4 weeks.
Prevention of duodenal or gastric ulcer in patients requiring continuous treatment with NSAIDs: one orodispersible tablet of 15 mg daily; your doctor may adjust the dose up to one orodispersible tablet of 30 mg daily.
Zollinger-Ellison syndrome: the usual initial dose is two orodispersible tablets of 30 mg daily. Subsequently, depending on your response to Lansoprazole SUN Pharma, your doctor will decide the most appropriate dose for you.
Use in children
Lansoprazole SUN Pharma must not be given to children.
How to take it
1- Hold the blister strip by the edges and separate one blister cavity from the rest of the strip by gently
pulling along the perforated separation line.
2- Carefully remove the backing.
3- Gently push the tablet out.
4- Place the tablet in your mouth. It will dissolve directly in the mouth, so that it can be swallowed easily.

In case of swallowing difficulties
Your doctor may also instruct you to take the tablet dissolved using a syringe in the mouth if you have serious
difficulty swallowing.
If you take the medicine using a syringe, you must follow the instructions below:
It is important that the suitability of the syringe selected is carefully tested.

• Remove the plunger from the syringe (a syringe of at least 5 mL for a 15 mg tablet and 10 mL for a 30 mg tablet).
• Place the tablet into the barrel of 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 up 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 flush out any remaining contents in the mouth.

If using a nasogastric tube:
It is important that the suitability of the selected tube is carefully tested. The recommended diameter of the
nasogastric tube to be used is 3.3 mm (French size 10) or larger.

• Remove the plunger from the syringe (use at least a 25 mL syringe for the 15 mg tablet and a 50 mL syringe for the 30 mg tablet).
• Place the tablet into the barrel of the syringe.
• Replace the plunger into the syringe.
• For the 15 mg tablet: draw up 10 mL of tap water into the syringe.
• For the 30 mg tablet: draw up 25 mL of tap water into the syringe.
• Turn the syringe upside down and draw up an additional 5 mL of air.
• Gently shake the syringe for 10–20 seconds until the tablet disperses.
• Connect the syringe to the tube and empty the contents of the syringe into the nasogastric tube.
• For the 15 mg tablet: refill the syringe with 10 mL of tap water and flush the remaining contents into the tube.
• For the 30 mg tablet: refill the syringe with 25 mL of tap water and flush the remaining contents into the tube.

If you take more Lansoprazole SUN Pharma than you should
If you take more Lansoprazole SUN Pharma than prescribed, seek immediate advice from your doctor.
If you forget to take Lansoprazole SUN Pharma
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 orodispersible tablet.
If you stop taking Lansoprazole SUN Pharma
Do not stop treatment prematurely even if your symptoms have improved. Your condition may not be fully healed and could recur if you do not complete the full course of treatment.
If you have any doubts about how to use Lansoprazole SUN Pharma, consult your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. If you think you may be experiencing any of the following serious side effects, stop taking this medicine and contact your doctor or go immediately to the nearest hospital emergency department.

• Very rarely, Lansoprazole SUN Pharma may cause severe hypersensitivity (allergic) reactions. Symptoms of a hypersensitivity reaction may include fever, skin rash, swollen face, swollen lymph nodes, swollen tongue or throat, difficulty swallowing, hives, difficulty breathing, and sometimes low blood pressure.
• Very rarely, serious skin reactions, which may be life-threatening, have been reported with Lansoprazole SUN Pharma. Symptoms include red spots on the trunk, appearing as circular patches or target-like macules, often with central blisters, skin peeling, mouth, throat, nose, genital or eye ulcers. These severe skin rashes may be preceded by fever and flu-like symptoms [Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN)].
• Widespread rash, high body temperature, and swollen lymph nodes [drug reaction with eosinophilia and systemic symptoms (DRESS, frequency not known)].
• If you take Lansoprazole SUN Pharma for more than three months, your blood magnesium levels may decrease. Low 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 levels of potassium or calcium in the blood. Your doctor may decide to perform regular blood tests to monitor your magnesium levels.
• Very rarely, Lansoprazole SUN Pharma may cause a reduction in the number of white blood cells (agranulocytosis), reducing your resistance to infections; or an abnormal reduction in the number of red blood cells, white blood cells, and platelets (pancytopenia). If you develop an infection with symptoms such as fever and severe worsening of your general condition, or fever with local infection symptoms such as sore throat/pharynx/mouth or urinary problems, or if you experience fatigue, pale skin with bruising, or unexplained bleeding lasting longer than normal, you should consult your doctor immediately. A blood test will be performed to check for possible reduction in blood cells.
• Rarely, Lansoprazole SUN Pharma may cause inflammation of the pancreas (pancreatitis). Symptoms include sudden, severe pain in the upper central abdomen that may radiate to the back, possibly leading to nausea and vomiting.
• If you develop severe or persistent diarrhoea while taking Lansoprazole SUN Pharma, contact your doctor immediately, as Lansoprazole SUN Pharma has been associated with a small increased risk of infectious diarrhoea.

Other possible side effects:
Common: may affect up to 1 in 10 people

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

Uncommon: may affect up to 1 in 100 people

• depression
• joint and muscle pain
• fluid retention or swelling
• changes in red blood cell count
• risk of hip, wrist, and spine fractures

Rare: may affect up to 1 in 1,000 people

• fever
• restlessness, drowsiness, confusion, hallucinations, insomnia, visual 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 inflammation (tubulo-interstitial nephritis); possible symptoms include changes in urine output, blood in urine
• liver inflammation (possible yellowing of the skin or eyes)
• breast swelling in men, impotence
• candidiasis (fungal infection, may affect the oesophageal mucosa)

Very rare: may affect up to 1 in 10,000 people

• inflammation of the mouth (stomatitis)
• inflammation of the colon (colitis)
• increased laboratory values such as cholesterol and triglyceride levels
• low sodium levels in the blood; symptoms include nausea and vomiting, headache, drowsiness and fatigue, confusion, muscle weakness or spasms, irritability, seizures, coma. Your doctor may decide to perform regular blood tests to monitor your sodium levels.

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

• skin manifestations related to lupus or lupus erythematosus.
• skin rash, possible 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 Lansoprazole SUN Pharma

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 the month.
Do not store above 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 SUN Pharma contains

• The active substance is lansoprazole. Each orodispersible tablet of Lansoprazolo SUN Pharma 15 mg contains 15 mg of lansoprazole. Each orodispersible tablet of Lansoprazolo SUN Pharma 30 mg contains 30 mg of lansoprazole.

• The other components are: microcrystalline cellulose, magnesium carbonate, low-substituted hydroxypropylcellulose, hydroxypropylcellulose, talc, mannitol, maize starch, methacrylic acid-ethyl acrylate copolymer, macrogol, glyceryl monostearate, polysorbate 80, citric acid, triethyl citrate, hypromellose, red iron oxide (E172) and yellow iron oxide (E172), crospovidone, aspartame (E951), strawberry flavour, colloidal anhydrous silica and magnesium stearate.

Description of the appearance of Lansoprazolo SUN Pharma and contents of the pack
Lansoprazolo SUN Pharma 15 mg are round, white to off-white tablets, 9 mm in diameter, with orange to dark brown specks, marked '15' on one side and smooth on the other.
Lansoprazolo SUN Pharma 30 mg are round, white to off-white tablets, 12 mm in diameter, with orange to dark brown specks, marked '30' on one side and smooth on the other.
The 15 mg orodispersible tablets of Lansoprazolo SUN Pharma are packaged in perforated unit dose blisters (AL/HDPE/PE with desiccant (attached to the foil) calcium oxide in OPA/AL/HDPE/PE film), in packs containing 14x1, 28x1, 56x1, 98x1 orodispersible tablets.
The 30 mg orodispersible tablets of Lansoprazolo SUN Pharma are packaged in perforated unit dose blisters (AL/HDPE/PE with desiccant (attached to the foil) calcium oxide in OPA/AL/HDPE/PE film), in packs containing 14x1, 28x1, 56x1, 98x1 orodispersible tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Sun Pharmaceutical Industries Europe B.V., Polarisavenue 87, 2132JH, Hoofddorp, The Netherlands

Local representative:
Sun Pharma Italia Srl - Viale Giulio Richard, 3 - 20143 Milano, Italy

Manufacturers
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH Hoofddorp – The Netherlands
Terapia S.A.
124 Fabricii Str.
400 635 Cluj-Napoca – Romania

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Sweden: Lansoprazole SUN Pharma 15 mg munsönderfallande tablett
Lansoprazole SUN Pharma 30 mg munsönderfallande tablett
Spain: Lansoprazol SUN 15 mg comprimidos bucodispersables EFG
Lansoprazol SUN 30 mg comprimidos bucodispersables EFG
France: Lansoprazol SUN 15 mg comprimé orodispersible
Lansoprazol SUN 30 mg comprimé orodispersible
Italy: Lansoprazolo SUN Pharma