Lansoprazole Tecnigen

Package leaflet: Information for the user

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

Lansoprazole
Generic medicine
Please read all of this leaflet carefully before you take 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 adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Lansoprazolo TecniGen is 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 damage to the upper part of the small intestine (duodenum) (duodenal ulcer);
• treatment of damage to the inner lining of the stomach (gastric ulcer);
• treatment and prevention (prophylaxis) of inflammation of the oesophagus (the tube between the mouth and stomach) caused by reflux of gastric juices from the stomach (reflux oesophagitis);
• treatment of symptoms caused by inflammation of the oesophagus associated with regurgitation of stomach acid (symptomatic gastro-oesophageal reflux disease);
• Eradication of the bacterium Helicobacter pylori when administered in combination with antibiotics;
• treatment and prevention of gastric and duodenal ulcers in patients requiring continuous treatment with non-steroidal anti-inflammatory drugs (NSAIDs), used for pain or inflammation;
• treatment of a condition causing excessive acid production in the stomach (Zollinger-Ellison syndrome).

2. What you should know before taking Lansoprazolo TecniGen

Do not take Lansoprazolo TecniGen

• 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 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 gastric acidity.
• You should 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 discontinue treatment with Lansoprazolo TecniGen. Remember to also report any other adverse effects such as joint pain.

• if you have severe liver disease. In this case, your doctor may need to adjust your dose or perform an examination called endoscopy to assess your health status and/or rule out malignant disease;
• if episodes of diarrhea occur during treatment with Lansoprazolo TecniGen, contact your doctor immediately, as this medicine has been associated with a slightly increased risk of infectious diarrhea.
• if your doctor has prescribed Lansoprazolo TecniGen in combination with antibiotics for the treatment of Helicobacter pylori infection or together with anti-inflammatory medicines used to treat pain or rheumatic diseases. In this case, read carefully the package leaflet of these medicines as well.
• if you take Lansoprazolo TecniGen long-term (for more than 1 year), your doctor will likely monitor you regularly. You must report any new or unusual symptoms and circumstances each time you see your doctor.
• If you take a proton pump inhibitor such as Lansoprazolo TecniGen, 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 can increase the risk of osteoporosis), consult your doctor. Children The use of Lansoprazolo TecniGen is not recommended in children because clinical data are limited.

Other medicines and Lansoprazolo TecniGen
Inform your doctor or pharmacist 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 Lansoprazolo TecniGen may affect their mechanism of action:

• ketoconazole, itraconazole, rifampicin (used in the treatment of bacterial and fungal infections);
• atazanavir 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 disorders);
• antacids (used in the treatment of heartburn or acid regurgitation);
• sucralfate (used to heal ulcers);
• St. John’s wort (Hypericum perforatum) (used in the treatment of mild depression);
• methotrexate (an anticancer drug);
• warfarin (a drug used for blood clotting disorders).

Lansoprazolo TecniGen with food and drink
For best results, take Lansoprazolo TecniGen at least 30 minutes before eating.

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

Pregnancy
Clinical data on lansoprazole are not available; 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/stop breastfeeding or to continue/stop therapy with Lansoprazolo TecniGen should be made taking into account the benefit of breastfeeding for the child and the benefit of lansoprazole therapy for the woman.

Driving and using machines
During treatment, dizziness, vertigo, visual disturbances, and drowsiness may occur (see Undesirable effects). In such cases, your reaction ability 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 Lansoprazole TecniGen

Take this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

Lansoprazole TecniGen should be taken once daily in the morning, except when used for eradication of H. pylori, in which case it should be taken twice daily (once in the morning and once in the evening).

Lansoprazole TecniGen should be taken at least 30 minutes before meals.

Swallow the capsule whole with liquid.

If you have difficulty swallowing the capsules, they may be opened and the granules mixed with a small amount of water, apple juice/tomato juice, or dispersed in a small quantity of soft food (e.g. yoghurt, applesauce).

The dose of Lansoprazole TecniGen depends on your medical condition and age; therefore, your doctor may sometimes prescribe a different dose and will inform you of the duration of treatment.

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.

Helycobacter pylori eradication: one 30 mg capsule twice daily 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 Lansoprazole TecniGen than you should
If you accidentally take too high a dose of Lansoprazole TecniGen, contact your doctor immediately or go to the nearest hospital.

If you forget to take Lansoprazole TecniGen
If you forget to take a dose, take it as soon as you remember. However, if the next dose is due soon, skip the missed dose and continue with your regular schedule. Do not take a double dose to make up for the forgotten dose.

If you have any doubts about how to use 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 have been reported:
Common (may affect up to 1 in 10 people):

• headache (cephalaea), dizziness;
• nausea, diarrhoea, constipation, stomach ache, vomiting;
• fatigue;
• passing wind (flatulence);
• dry mouth and/or throat;
• skin rash, itching, urticaria;
• increased levels of certain substances indicating liver function;
• benign stomach polyps.

Uncommon (may affect up to 1 in 100 people):

• depression;
• joint pain (arthralgia) and muscle pain (myalgia);
• fluid retention or swelling (oedema);
• reduced number of white blood cells (leucopenia);
• reduced number of a type of white blood cells (eosinophilia);
• reduced number of platelets (thrombocytopenia).

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

• fever;
• restlessness, drowsiness, confusion, hallucination, insomnia, vision disorders, dizziness;
• altered sense of taste, loss of appetite (anorexia), inflammation of the tongue (glossitis);
• pinpoint bleeding under the skin (petechiae);
• rupture of capillaries beneath the skin surface (purpura);
• appearance of target-like red skin lesions (erythema multiforme);
• sensitivity to light (photosensitivity);
• hair loss;
• tingling sensation on the skin (paraesthesia), tremor;
• reduced 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;
• fungal infection of the oesophagus (oesophageal candidiasis);
• 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 in red blood cells, white blood cells and platelets (pancytopenia);
• severe skin reactions (Stevens-Johnson Syndrome and toxic epidermal necrolysis);
• abnormal development of the breasts (gynaecomastia);
• severe allergic reaction (anaphylactic shock);
• increased levels of fats in the blood (cholesterol and triglycerides);
• reduced levels of sodium in the blood (hyponatraemia).

Frequency not known (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, 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 levels of potassium or calcium in the blood.
Your doctor should decide whether periodic monitoring of blood magnesium levels is necessary.
— erythema, possible joint pain.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform 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 Lansoprazole TecniGen

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 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 via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. 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, maize 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 available as hard capsules containing gastro-resistant granules.
It is available in the following pack sizes:
15 mg: box containing 14 capsules and 28 capsules
30 mg: box containing 14 capsules and 28 capsules

Marketing Authorization 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)