Lansoprol (Lansoprazole) 15 Mg 28 Capsules

• Active substance: Lansoprazole 15 mg

• Excipients: Sugar beads (Neutral micropellets (size26)), mannitol, sodium starch glycolate (explotab), magnesium carbonate, PVP K 30, crystal sugar, poloxamer 407, hydroxypropyl methyl cellulose (Pharmacoat 603) , Eudragit L 30 D 55, talc, triethyl citrate (citroflex), simethicone, odor opaque - opaque hard gelatin capsule no: 2 (titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172), gelatin .)

Please read this INSTRUCTIONS carefully before using this medicine, as it contains important information for you.

- Keep these instructions for use. You can need to read again. -If you have other questions, please talk your doctor or pharmacist. -This drug has been prescribed for you personally, please do not give to others. -When using this medicine, tell your doctor that you are taking this medicine when you go to the doctor or hospital. - Follow exactly what is written in this instruction. Do not use high or low doses other than the recommended dose for the drug.

In these operating instructions:

1. What is LANSOPROL and what is it used for? 2. Things to consider before using LANSOPROL 3. How to use LANSOPROL 4. What are the possible side effects? 5. LANSOPROL storage headers are included.

1. What is LANSOPROL and what is it used for?

• LANSOPROL contains the active substance lansoprazole. One capsule contains 15 mg of active ingredient. Lansoprazole is included in the drug group classified as proton pump inhibitor. Proton pump inhibitors reduce the amount of acid secreted by the stomach.

• LANSOPROL 15 mg Micropellet Capsule contains white, bejimsi-white spherical micropelleters in the intestine in hard gelatin capsules. LANSOPROL is available in boxes containing 28 capsules.

• LANSOPROL acts by preventing acid secretion from acid-secreting cells in the stomach.

• Duodenal (duodenum) and in the prevention and treatment of gastric ulcers,

• esophagitis of (reflux esophagitis) treatment,

• the stomach and duodenum in held responsible for ulceration ulcer caused by Helicobacter pylori infection,

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• non-steroidal inflammation-relieving drugs ( aspirin, ibuprofen, ketoprofen like, and piroxicam) Since the prevention and treatment of ulcer caused,

• Gastroesophageal reflux disease (avoiding the gastric acid esophagus disease damage and causes inflammation)

• in inhibiting secretion of excess acid in the stomach (Zollinger-Ellison Syndrome, including pathological hypersecretion conditions are used.

2. Cautions before using

LANSOPROL DO NOT use LANSOPROL in the following cases:If you

•have had any previous allergic reactions to any substance in the contents of lansoprazole or capsule,

• Do not use LANSOPROL if you use drugs containing atazanavir (for HIV treatment). .

CAREFULLY USE LANSOPROL in the following cases:

• If you have severe liver disease (you may need dose adjustment),,

• If you are pregnant or are planning to become pregnant• If you are

breastfeeding or planning to breastfeed,

• If you have low magnesium levels in the blood,If you have

•diarrhea during treatment.

Before starting gastric ulcer therapy with LANSOPROL, the possibility of malignant gastric cancer should be evaluated.

If you use a proton pump inhibitor such as lansoprazole for more than a year, there may be a slight increase in your risk of fracture in the hip, wrist or spine. Tell your doctor if you have osteoporosis (bone resorption and weakening) or if you use corticosteroid medications (which may increase the risk of osteoporosis).

One of the markers used to diagnose endocrine (hormonal) tumors in the blood as secondary (secondary) secondary to drug-induced reductions in gastric acid level increases the chromogranin A (CgA) levels. Increased CgA levels may lead to false positive results in diagnostic examinations for neuroendocrine tumors (cancers located between the hormonal system and the nervous system). In order to eliminate this condition, lansoprazole treatment should be interrupted and the test should be repeated in the same laboratory.

LANSOPROL may increase the number of bacteria normally present in the gastrointestinal tract and the risk of infection.

Please consult your doctor if these warnings are valid for you, even at any time in the past.

Use of LANSOPROL with food and drink

LANSOPROL should be taken on an empty stomach.

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Pregnancy

Consult your doctor or pharmacist before using the medication. It is not recommended to use LANSOPROL during pregnancy. If you discover that you are pregnant during your treatment, consult your doctor or pharmacist immediately.

Breastfeeding

Consult your doctor or pharmacist before using the medicine.

It is not recommended to use LANSOPROL during breastfeeding.

Driving andmachine When using

using theLANSOPROL, you may experience problems with dizziness, fatigue, sickness, headache or vision. Do not use a vehicle or machine in this case.

LANSOPROL contains important information about some of the ingredients of

LANSOPROL. If you have been told by your doctor that you are not susceptible to some sugars, contact your doctor before taking this medicinal product.

Since LANSOPROL contains mannitol, it may have a mild laxative effect.

This medicinal product contains less than 1 mmol (23 mg) of sodium per dose; no effect on sodium is expected.

The use ofcombination with other drugs

LANSOPROL inis indicated below.doctor if you are using one of these drugs:

Tell your• Atazanavir (used in the treatment of HIV)

• Theophylline (used in the treatment of lung diseases such as asthma)

• Ketoconazole, itraconazole, rifampicin (used in the treatment of infections)

• Digoxin (used in the treatment of heart diseases))

• Tacrolimus (to prevent organ rejectionused)

• fluvoxamine (used to treat depression and other psychiatric problems)

• St. John's wort (Hypericum perforatum, Hypericum herb) (mild is used to treat depression)

• Antacids (used for indigestion and heartburn)

• Sucralfat (used to treat ulcers)

If prescription Please inform your doctor or pharmacist if you are currently using or have recently used any medication without a prescription.

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3. How to use LANSOPROL

Instructions for proper use and dose / frequency of administration:

• If you use LANSOPROL once a day, take it before breakfast each morning at the same time.

• If you use LANSOPROL twice a day, take the first dose in the morning before breakfast and the second dose in the evening.

Stomach ulcer: 30 mg once a day for 4 weeks.

Twelve finger intestinal ulcer: 30 mg once a day for 2 weeks.

Reflux esophagitis: 30 mg once daily for 4 weeks.

In the prevention of reflux esophagitis: 15 mg once daily.

In the treatment of NSAID drug-associated duodenal and benign gastric ulcer in patients requiring continuous non-steroidal anti-inflammatory (NSAID) drug treatment: up to 4 weeks, 30 mg once daily.

NSAIDs in patients at risk for long-term NSAID drug therapy (> 65 years of age or history of gastric or duodenal ulcer): prevention of gastric and duodenal ulcer associated with drug use: 15 mg once daily.

In gastroesophageal reflux disease: 15 mg or 30 mg once daily for 4 weeks.

Zollinger-Ellison syndrome: The initial dose is 60 mg once a day, the dose can be administered up to 180 mg / day, depending on the patient's need.

Treatment of H.pylori-induced ulcers The recommended dose of lansoprazole in combination with the following antibiotics is 30 mg twice daily for 7 days: clarithromycin 250-500 mg twice daily + amoxicillin 1 g 2 times a day clarithromycin 250 mg twice daily + metronidazole 400-500 mg 2 times a dayadministration

Method and method of: Do not

swallow, crush or chew the capsules with a glass of water.

In patients with difficulty in capsule swallowing, capsules according to studies and clinical applications can be used as follows:

• The capsule opens. Micropellets are mixed with a small amount of water, apple / tomato juice or sprinkled on a soft food (eg yogurt, apple puree).

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• The capsule opens. The micropellets are mixed with 40 ml of apple juice for administration with a nasogastric tube (especially in patients with swallowing difficulties when the oral feeding cannot be provided, from the nostril to the stomach). After preparing the mixture, the drug should be administered immediately. Micropellet should not be chewed and crushed. It is not recommended for use in other beverages and liquids as it is not clinically studied.

Different age groups:

Use in children: Not recommended for use in children.

Use in the elderly: If you are over 65, your doctor will continue to monitor you closely.

Specific Use Conditions

Kidney failure: Patients with renal failure do not need to be adjusted.

Liver failure: Patients with moderate or severe hepatic impairment should be kept under regular observation and the daily dose should be reduced by half.

If you have an impression that the effects of LANSOPROL are too strong or too weak, talk to your doctor or pharmacist.

If you used LANSOPROL more than you should use: In this case, your doctor will monitor you and apply treatment methods to your complaints.

Talk to a doctor or pharmacist if you have used more than you should use from LANSOPROL.

If you forget to use LANSOPROL: If you have neglected to take a dose and receive it regularly, take the missed dose as soon as possible. If the next dose time has almost arrived, skip the dose not taken. Then keep getting regular.

Do not take double doses to compensate for forgotten doses.

Effects upon termination of treatment with LANSOPROL: No adverse effects are expected with the termination of the use of LANSOPROL. However, it is important that you continue your treatment for the duration your doctor recommends for the full recovery of your illness.

4. What are the Possible Side Effects?

Like all medicines, LANSOPROL may have side effects in people who are sensitive to the substances contained in its contents.

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following side effects may result from the use of LANSOPROL.

Common side effects (Less than one in 10 treated patients, but more than one in 100 patients):

• Headache

• Dizziness

• Nausea

• Diarrhea

• Abdominal pain

• Constipation

• Vomiting

• Gas

• Dry mouth or throat

• Increase in liver enzyme levels

• Hives

• Itching

• Redness

• Fatigue

Uncommon side effects (Less than one of 100 patients treated, but more than one of 1000 patients):

• Thrombocytopenia (decrease in platelet-blood scales)

• Increase in the number of blood cells called eosinophils (eosinophilia)

• white blood cells (leukopenia) slight reduction

• Depression

• joint pain

• Myalgia

• the hip, wrist or spine fractures

• Edema

Rare side effects observed (treated 1000 least one patient, but can be seen more than a 10,000 patients):

• anemia

• Insomnia

• Dreaming

• Mind Confusion

• Restlessness

• Vertigo (dizziness caused by imbalance)

• numbness

• Sleepiness

• Flicker

• Visually impaired

• Tongue inflammation

• Esophagus candidiasis (some kind of fungal disease)

• Pancreatic inflammation

• Taste disorders

• Liver inflammation

• Jaundice

• Dot-shaped skin bleeding under

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• a characterized by bleeding condition of the skin

• hair loss

• erythema multiforme (usually spontaneously said, hands, forming similar redness of the face and standing lace, hypersensitivity status)

• Light from or painful to hear cases to be bothered by bright

• loss of appetite, excessive thirst , kidney inflammation associated with vomiting

• Male breast growth

• Fever

• Excessive sweating

• Allergies result of the face and throat swelling

• Loss of appetite

• Sexual impotence

• your face, particularly around your mouth (tongue and / or throat and / or difficulty swallowing), swelling or difficulty breathing I s with rash (angioedema)

side effects are very rare (Treated seen more than a 10,000 patients):

• agranulocytosis (white reduction in the number of blood cells)

• Pancytopenia (decrease in all cells in the blood)

• colitis (colon inflammation)

• inflammation in the mouth

• Steven-Johnson syndrome (inflammation of the skin and the skin around the eyes, swelling and redness)

• Toxic epidermal necrolysis (a serious disease with liquid bubbles in the skin)

• Anaphylactic shock (sudden hypersensitivity response)

• Cholesterol and triglycerides increased levels of substances

• Hyponatremia (below the normal low blood sodium levels)

Frequency affects the unknown side (can not be estimated from the data available)

• Hypomagnesemia (decrease below normal in the blood magnesium levels)

do If you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Report side effectsside effects that are

If you experience anyincluded in the instructions for use or not, talk to your doctor, pharmacist or nurse. Also located on the side effects www.titck.gov.t site you encounter "Drug Side Impact Statement" by clicking on the icon or 0800314 00 08 number of side effects by calling the notification line Turkey Pharmacovigilance Center (TÜFAM) 'What do you notice. By informing you of any side effects, you will contribute to further information on the safety of the drug you are using.

5. Storage of

LANSOPROL Keep LANSOPROL in a place where children cannot and cannot reach them.

Store LANSOPROL at room temperature below 25 ° C in its packaging, protected from light.

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Use in accordance with the expiration date.

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