Lansoprazole Teva Italia

Package leaflet: Information for the user

Lansoprazolo Teva Italia 15 mg gastro-resistant hard capsules, 30 mg gastro-resistant hard capsules

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 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. See section 4.

Contents of this leaflet:

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

1. What Lansoprazole Teva Italia is and what it is used for

The active substance in Lansoprazole Teva Italia is lansoprazole, a proton pump inhibitor.
Proton pump inhibitors reduce the amount of acid produced by your stomach.
Your doctor may prescribe Lansoprazole Teva Italia for the following indications in adults:

• treatment of duodenal and gastric ulcers
• treatment of inflammation in the oesophagus (reflux oesophagitis)
• prevention of reflux oesophagitis
• treatment of heartburn and acid regurgitation
• treatment of an infection caused by the bacterium Helicobacter pylori, when used in combination with antibiotic therapy
• treatment or prevention of gastric or duodenal ulcers in patients requiring ongoing treatment with non-steroidal anti-inflammatory drugs (NSAIDs, used for pain or inflammation)
• treatment of Zollinger-Ellison syndrome.

Your doctor may have prescribed Lansoprazole Teva Italia for a different indication or at a dosage
different from that stated in this leaflet. Always follow your doctor's instructions when taking the
medicine.
Contact your doctor if you do not feel better or if you feel worse after 14 days.

2. What you need to know before taking Lansoprazolo Teva Italia

Do not take Lansoprazolo Teva Italia

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

Warnings and precautions
Talk to your doctor or pharmacist before taking Lansoprazolo Teva Italia.

• if you have severe liver disease. Your doctor may need to adjust the dosage
• if you have low levels of vitamin B12 or are at risk of low vitamin B12 levels and are undergoing long-term treatment with Lansoprazolo Teva Italia. Like all acid-reducing agents, Lansoprazolo Teva Italia may lead to reduced absorption of vitamin B12
• 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 Lansoprazolo Teva Italia that reduces stomach acidity.

If you develop 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 Teva Italia. Remember to also report any other side effects such as joint pain.
Your doctor may perform or may have already performed an additional examination called endoscopy to diagnose your condition and/or rule out malignant disease.
If you develop diarrhoea during treatment with Lansoprazolo Teva Italia, contact your doctor immediately, as Lansoprazolo Teva Italia has been associated with a small increased risk of infectious diarrhoea.
If your doctor has prescribed Lansoprazolo Teva Italia in combination with other medicines to treat Helicobacter pylori infection (antibiotics) or together with anti-inflammatory medicines to treat pain or rheumatic diseases, read the package leaflet of these medicines carefully as well.
If you take a proton pump inhibitor such as Lansoprazolo Teva Italia, especially for more 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.
If you take Lansoprazolo Teva Italia long-term (for more than 1 year), your doctor will likely monitor you regularly. At each visit, inform your doctor of any new or unusual symptoms or circumstances.
If you take Lansoprazolo Teva Italia for more than three months, your magnesium levels may decrease.
Low magnesium levels may present as fatigue, involuntary muscle contractions, confusion, seizures, dizziness, and increased heart rate. If you experience any of these symptoms, consult your doctor immediately. Low magnesium levels may also lead to reduced levels of potassium or calcium in the blood. Your doctor may decide to monitor your blood magnesium levels regularly.

Other medicines and Lansoprazolo Teva Italia
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines not requiring a prescription.
In particular, inform your doctor or pharmacist if you are taking medicines containing any of the following active substances, as Lansoprazolo Teva Italia 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 eliminate blood clots or prevent their formation)
• 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).

Lansoprazolo Teva Italia with food and drink
For best results, take Lansoprazolo Teva Italia at least 30 minutes before meals.

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

Driving and using machines
Side effects such as dizziness, vertigo, fatigue, and visual disturbances may occasionally occur in patients taking lansoprazole. If you experience side effects like these, exercise caution, as your reaction ability may be reduced.
For further information, contact your doctor.

Lansoprazolo Teva Italia contains sodium and sucrose.
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e. essentially “sodium-free”.
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 Teva Italia

Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
Lansoprazole Teva Italia should be taken at least 30 minutes before meals (see section 2).
The capsules should be swallowed whole with water. The capsules must not be chewed or crushed, as
this would impair their effectiveness.

• If you take Lansoprazole Teva Italia once daily, try to take it at the same time each day. You may achieve better results if you take Lansoprazole Teva Italia first thing in the morning.
• If you take Lansoprazole Teva Italia twice daily, you should take the first dose in the morning and the second in the evening. The dose of Lansoprazole Teva Italia depends on your condition. The recommended doses of Lansoprazole Teva Italia capsules for adults are given below. Sometimes your doctor may prescribe a different dose and will inform you of the duration of treatment.

Treatment of heartburn and acid regurgitation
15 mg or 30 mg of lansoprazole daily for 4 weeks. If symptoms persist, inform your doctor.
If symptoms are not relieved within 4 weeks, contact your doctor.
Treatment of duodenal ulcer
30 mg of lansoprazole daily for 2 weeks.
Treatment of gastric ulcer
30 mg of lansoprazole daily for 4 weeks.
Treatment of inflammation of the oesophagus (reflux oesophagitis)
30 mg of lansoprazole daily for 4 weeks.
Long-term prevention of reflux oesophagitis
15 mg of lansoprazole daily; your doctor may adjust the dose up to 30 mg of lansoprazole
daily.
Treatment of Helicobacter pylori infection
The recommended dose is 30 mg of lansoprazole in combination with two different antibiotics in the morning and 30 mg of lansoprazole 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 Teva Italia together with 250–500 mg of clarithromycin and 1000 mg of amoxicillin;
• 30 mg of Lansoprazole Teva Italia 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 do not miss any dose.
Treatment of duodenal or gastric ulcer in patients requiring continuous treatment with NSAIDs
30 mg of lansoprazole daily for 4 weeks.
Prevention of duodenal or gastric ulcer in patients requiring continuous treatment with NSAIDs
15 mg of lansoprazole daily; your doctor may adjust the dose up to 30 mg of lansoprazole daily.
Zollinger-Ellison syndrome
The recommended initial dose is 60 mg of lansoprazole daily, and subsequently, depending on your response to Lansoprazole Teva Italia, the dose may be changed according to what your doctor considers most appropriate for you.
Use in children
Lansoprazole Teva Italia must not be given to children.
If you take more Lansoprazole Teva Italia than you should
If you take more Lansoprazole Teva Italia than prescribed, contact your doctor, pharmacist or nearest hospital immediately.
If you forget to take Lansoprazole Teva Italia
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, 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 dose.
If you stop taking Lansoprazole Teva Italia
Do not stop treatment prematurely, even if your symptoms have improved. Your condition may not be fully healed and symptoms may return if you do not complete the full course of treatment.
If you have any 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 everyone will experience them.
If you experience any of the following side effects, stop taking Lansoprazole
Teva Italia and contact your doctor immediately, or go to the nearest hospital emergency department:

• Angioedema (symptoms may include swelling of the face, tongue or throat, difficulty swallowing, hives and breathing difficulties)
• Severe hypersensitivity reactions including anaphylactic shock (symptoms may include fever, rash, swelling and sometimes low blood pressure)
• Very severe skin reactions with redness, blisters, severe inflammation and skin loss (Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme)
• Liver inflammation (possible onset of yellowing of the skin or eyes).

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

• headache, dizziness
• diarrhoea, constipation, stomach pain, feeling unwell, flatulence, dry or inflamed mouth or throat, benign stomach polyps
• skin rash, itching
• changes in liver function tests
• fatigue.

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

• depression
• joint and muscle pain
• fluid retention or swelling
• changes in red blood cell count
• fractures of the hip, wrist or spine (see section 2 “Warnings and precautions”).

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

• fever
• restlessness, drowsiness, confusion, hallucinations, insomnia, visual disturbances, dizziness
• altered sense of taste, 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 problems
• pancreatitis
• breast enlargement in men, impotence
• candidiasis (fungal infection, may affect the skin or mucous membranes).

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

• inflammation of the mouth (stomatitis)
• colitis (inflammation of the colon)
• changes in laboratory values such as sodium, cholesterol and triglyceride levels
• Lansoprazole Teva Italia may very rarely cause a reduction in white blood cell count, leading to decreased resistance to infections. If you develop an infection with symptoms such as fever and severe worsening of your general condition, or fever with signs of local infection such as inflamed throat/pharynx/mouth or urinary problems, seek immediate medical attention. A blood test will be performed to check for a possible reduction in white blood cells (agranulocytosis).

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

• skin rash, possible joint pain
• low levels of magnesium in the blood (hypomagnesaemia) (see section 2 “Warnings and precautions”); severe hypomagnesaemia may lead to low levels of calcium in the blood (hypocalcaemia)
• visual hallucinations.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist.
You can also report side effects directly via the national reporting system at 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 Teva Italia

Keep this medicine out of the sight and reach of children.
Do not store above 30°C.
Do not use this medicine after the expiry date stated on the carton and blister after “EXP”.
The expiry date refers to the last day of the month.
Do not dispose of any medicine 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 Teva Italia Contains

• The active substance is lansoprazole. Each gastro-resistant hard capsule of Lansoprazolo Teva Italia contains 15 mg of lansoprazole. Each gastro-resistant hard capsule of Lansoprazolo Teva Italia contains 30 mg of lansoprazole.
• The excipients are: sugar granules (sucrose, maize starch), sodium carboxymethylcellulose, sodium lauryl sulfate, povidone, trisodium phosphate, hypromellose, methacrylic acid-ethyl acrylate copolymer 1:1, triethyl citrate, titanium dioxide (E171), talc.
• The capsule shell contains: gelatin, titanium dioxide (E171).
• The printing ink contains: shellac, propylene glycol, ammonium hydroxide, potassium hydroxide, black iron oxide (E172).

Description of the Appearance of Lansoprazolo Teva Italia and Contents of the Package

• The hard gelatin capsule has an opaque white cap printed in black ink with the letter "L" and an opaque white body printed in black ink with the number "15". It contains white-beige gastro-resistant microgranules of 15 mg lansoprazole.
• The hard gelatin capsule has an opaque white cap printed in black ink with the letter "L" and an opaque white body printed in black ink with the number "30". It contains white-beige gastro-resistant microgranules of 30 mg lansoprazole.
• Lansoprazolo Teva Italia is supplied in blisters or bottles containing 7, 14, 28 or 56 (2x28) gastro-resistant hard capsules.

It is possible that not all pack sizes are marketed.
Marketing Authorization Holder
Teva Italia S.r.l. – Piazzale Luigi Cadorna, 4 - 20123 Milano
Manufacturer
Teva Pharma S.L.U. Poligono Industrial Malpica, calle C,
50016 Zaragoza (Spain)
Teva UK Ltd
Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG
United Kingdom
Teva Pharmaceutical Works Private Limited Company
Pallagi str. 13, 4042 Debrecen
Hungary
Teva Operations Poland Sp. z o.o.,
Mogilska 80 Str. - 31-546 Kraków
Poland
Merckle GmbH
Ludwig-Merckle-Straße 3, 89143 Blaubeuren
Germany
Teva Pharma B.V.
Swensweg 5, Haarlem, 2031 GA
The Netherlands