LANSOPRAZOLO 15 mg Капсулы Твердые

Содержание инструкции

1. Lansoprazolo TecniGen 15 mg hard gastro-resistant capsules, 30 mg hard gastro-resistant capsules
   1. What is Lansoprazolo TecniGen and what it is used for
   2. What you need to know before taking Lansoprazolo TecniGen
   3. How to take Lansoprazolo TecniGen
   4. Possible side effects
   5. How to store Lansoprazolo TecniGen
   6. Contents of the pack and other information

Lansoprazolo TecniGen 15 mg hard gastro-resistant capsules, 30 mg hard gastro-resistant capsules

Lansoprazolo

Generic medicine

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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Lansoprazolo TecniGen and what it is used for

Lansoprazolo TecniGen is a medicine that contains the active substance lansoprazole, a proton pump inhibitor that reduces the amount of acid produced by the stomach.
Lansoprazolo TecniGen is used in the following cases:

• treatment of injury to the upper part of the small intestine (duodenum) (duodenal ulcer);
• treatment of injury to the inner wall of the stomach (gastric ulcer);
• treatment and prevention (prophylaxis) of inflammation of the esophagus (the tube between the mouth and the stomach) caused by a reflux of gastric juices from the stomach (reflux esophagitis);
• treatment of symptoms caused by inflammation of the esophagus accompanied by regurgitation of stomach acid (symptomatic gastroesophageal reflux disease);
• Elimination (eradication) of the bacterium Helycobacter Pyloriwhen administered in combination with antibiotics;
• treatment and prevention of gastric and duodenal ulcers in patients who require continuous treatment with non-steroidal anti-inflammatory drugs (NSAIDs), used against pain or inflammation;
• treatment of a disease that causes an excessive amount of acid in the stomach (Zollinger-Ellison syndrome).

2. What you need to know before taking Lansoprazolo TecniGen

Do not take Lansoprazolo TecniGen

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

Warnings and precautions
Talk to your doctor or pharmacist before taking Lansoprazolo TecniGen:

• if you have ever had a skin reaction after treatment with a medicine similar to Lansoprazolo TecniGen that reduces stomach acid.
• You must undergo a specific blood test (Chromogranin A).

If you notice the appearance of a skin rash, especially in areas exposed to sunlight, contact your
doctor as soon as possible, as it may be necessary to stop therapy with Lansoprazolo
TecniGen. Remember to also report any other undesirable effects such as joint pain.

• if you have a serious liver disease. The doctor in this case may need to adjust your dose or subject you to an examination called endoscopy to check your health conditions and/or exclude a malignant disease;
• if episodes of diarrhea occur during treatment with Lansoprazolo TecniGen, contact your doctor immediately, as this medicine has been associated with a small increase in infectious diarrhea.
• if your doctor has prescribed Lansoprazolo TecniGen in addition to antibiotics for the treatment of Helycobacter Pyloryinfection or together with anti-inflammatory drugs used to treat the

these medicines.

• if you take Lansoprazolo TecniGen for a long time (for more than 1 year) your doctor will probably keep you under regular observation. You should report any new and unusual symptom and circumstance every time you see your doctor.
• If you are taking a proton pump inhibitor such as Lansoprazolo TecniGen, especially for a period 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 can increase the risk of osteoporosis) consult your doctor. ChildrenThe use of Lansoprazolo TecniGen is not recommended in children because clinical data are limited.

Other medicines and Lansoprazolo TecniGen
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
In particular, tell your doctor if you are taking medicines containing one of the following active ingredients,
as Lansoprazolo TecniGen can affect their mechanism of action:

• ketoconazole, itraconazole, rifampicin (used in the treatment of bacterial and fungal infections);
• atzanavir and nelfinavir (for the treatment of HIV infections);
• digoxin (used in the treatment of heart problems);
• theophylline (used in the treatment of asthma);
• tacrolimus (used to prevent organ transplant rejection);
• fluvoxamine (used in the treatment of depression and other psychiatric illnesses);
• antacids (used in the treatment of heartburn or acid reflux);
• sucralfate (used to heal ulcers);
• St. John's wort (Hypericum perforatum) (used in the treatment of mild depression);
• methotrexate (anticancer drug):
• warfarin (drug used in blood coagulation disorders).

Lansoprazolo TecniGen with food and drink
To get the best results, take Lansoprazolo TecniGen at least 30 minutes before taking any
food.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, or if you are breastfeeding
ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
No clinical data are available for lansoprazole, therefore the use of Lansoprazolo TecniGen is
not recommended during pregnancy.
Breastfeeding
It is not known whether Lansoprazolo TecniGen is excreted in breast milk.
The decision whether to continue/interrupt breastfeeding or continue/interrupt therapy with Lansoprazolo TecniGen must be made taking into account the benefit
of breastfeeding for the child and the benefit of lansoprazole therapy for the
woman.

Driving and operating machinery
Dizziness, vertigo, visual disturbances and drowsiness may occur during therapy (see
Undesirable effects). In these conditions, the ability to react may be reduced.

Lansoprazolo TecniGen contains sucrose, lactose and sodium
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking
this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e. essentially ‘sodium-free’.

3. How to take Lansoprazolo TecniGen

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
Lansoprazolo TecniGen must be taken once a day in the morning, except when used for the eradication of H. pylori; in this case it must be taken twice a day (once
in the morning and once in the evening).
Lansoprazolo TecniGen must be taken at least 30 minutes before meals.
Swallow the capsule whole with some liquid.
If you find it difficult to swallow the capsules, they can be opened and the granules mixed with a small
amount of water, apple/tomato juice or dispersed in a small amount of soft food (e.g.
yogurt, applesauce).
The dose of Lansoprazolo TecniGen depends on your health condition and age, therefore your doctor
may sometimes prescribe a different dose and tell you how long the treatment should last.
The recommended doses are as follows:

• Symptomatic gastroesophageal reflux disease:one 15 mg or 30 mg capsule daily for 4 weeks.
• 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 reflux esophagitis:one 30 mg capsule daily for 4 weeks.
• Prophylaxis of reflux esophagitis:one 15 mg capsule daily.

Eradication ofHelicobacter Pylori:one 30 mg capsule twice a day for 7 days in
combination with other medicines

Treatment of gastric and duodenal ulcers in patients requiring continuous treatment with
non-steroidal anti-inflammatory drugs( NSAIDs):one 30 mg capsule daily for 4 weeks.

Prophylaxis of gastric and duodenal ulcers in patients requiring continuous treatment with
non-steroidal anti-inflammatory drugs( NSAIDs):one 15 mg capsule daily.

Treatment of Zollinger-Ellison syndrome:two 30 mg capsules daily.

If you take more Lansoprazolo TecniGen than you should
In case of accidental intake of an excessive dose of Lansoprazolo TecniGen, immediately inform
your doctor or go to the nearest hospital.

If you forget to takeLansoprazolo TecniGen
If you forget to take a dose, take it as soon as you remember. If the forgotten dose should
be too close to the next one, do not take it and take the remaining capsules
normally. Do not take a double dose to make up for a missed dose.
If you have any doubts about the use of this medicine, ask 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 have been reported:

Common(may affect up to 1 in 10 people):

• headache, dizziness;
• nausea, diarrhoea, constipation, stomach pain, vomiting;
• fatigue;
• passage of gas (flatulence);
• dry mouth and/or throat;
• skin rash, itching, hives;
• increased levels of certain substances that indicate liver function;
• benign polyps in the stomach. Uncommon(may affect up to 1 in 100 people):
• depression;
• joint pain (arthralgia) and muscle pain (myalgia);
• fluid retention or swelling (edema);
• decreased number of white blood cells (leucopenia);
• decreased number of a type of white blood cells (eosinophilia);
• decreased number of platelets (thrombocytopenia). Rare(may affect up to 1 in 1,000 people):
• fever;
• restlessness, drowsiness, confusion, hallucination, insomnia, vision disturbances, vertigo;
• altered sense of taste, loss of appetite (anorexia), inflammation of the tongue (glossitis);
• pinpoint haemorrhages under the skin (petechiae);
• rupture of capillaries under the skin surface (purpura);
• appearance of skin lesions in a target shape, bright red in colour (erythema multiforme);
• sensitivity to light (photosensitivity);
• hair loss;
• tingling sensation on the skin (paresthesia), tremor;
• decreased amount of haemoglobin in the blood (anaemia);
• inflammation of the kidneys (interstitial nephritis);
• inflammation of the pancreas (pancreatitis);
• inflammation of the liver (hepatitis), yellowing of the skin and eyes (jaundice);
• impotence;
• infection of the esophagus caused by a fungus (candidiasis of the esophagus);
• swelling due to fluid accumulation around the mouth and eyes (angioedema).

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

• inflammation of the mouth (stomatitis);
• inflammation of the colon (colitis);
• severe decrease in the number of granulocytes (a type of white blood cells) in the blood (agranulocytosis),
• decrease of red blood cells, white blood cells and platelets (pancytopenia);
• severe skin reactions (Stevens-Johnson Syndrome and toxic epidermal necrolysis);
• abnormal development of the breasts (gynecomastia);
• severe allergic reaction (anaphylactic shock);
• increased amount of fats in the blood (cholesterol and triglycerides);
• decreased amount of sodium in the blood (hyponatremia).

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

• fracture of the hip, wrist or spine;
• visual hallucinations.

If you take Lansoprazolo TecniGen for more than three months, it is possible that your blood magnesium
levels may decrease. Low levels of magnesium can manifest as fatigue, involuntary muscle
contractions, disorientation, convulsions, dizziness, increased heart rate. If you have
any of these symptoms, consult your doctor immediately. Low levels of magnesium can also
lead to a decrease in blood levels of potassium or calcium. Your doctor should decide whether
to periodically check your blood magnesium levels.-erythema, possible joint pain

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects
not listed in this leaflet. You can also report side effects directly through 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 Lansoprazolo TecniGen

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister and the outer packaging after
“Exp”. The expiry date refers to the last day of that month.
Store in the original packaging at a temperature not exceeding 25°C.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Lansoprazolo TecniGen contains

• The active substance is lansoprazole.
• The other ingredients are: sucrose, corn starch, lactose, anhydrous disodium phosphate, hypromellose, mannitol, hypromellose phthalate, diethyl phthalate, cetyl alcohol, talc, titanium dioxide (E171), sodium lauryl sulfate.

Description of the appearance of Lansoprazolo TecniGen and contents of the pack
Lansoprazolo TecniGen is presented as hard capsules containing gastro-resistant granules.
It is available in the following packs:
15 mg: pack of 14 capsules and 28 capsules
30 mg: pack of 14 capsules and 28 capsules

Marketing Authorisation Holder and Manufacturer
Tecnigen S.r.l. - Via Galileo Galilei, 40 - 20092 Cinisello Balsamo (MI)

Manufacturer
Genetic S.p.A. - Contrada Canfora - 84084 Fisciano (SA)