TANZOLAN 15 mg Enteric-Coated Hard Capsule

Зміст інструкції

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

Tanzolan 15 mg Hard gastro-resistant capsules, 30 mg Hard gastro-resistant capsules

Lansoprazole

Read this leaflet carefully before you start to take this medicine as 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 they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What is Tanzolan and what is it used for

The active ingredient of Tanzolan is lansoprazole, which is a proton pump inhibitor. Proton pump inhibitors work by reducing the amount of acid that the stomach produces.
Your doctor may prescribe Tanzolan for the indications in adults as follows:

• treatment of duodenal and stomach ulcers
• treatment of inflammation of the esophagus (reflux esophagitis)
• prevention of reflux esophagitis
• treatment of heartburn (pyrosis) and acid reflux
• treatment of infections caused by the bacterium Helicobacter pylori when administered in combination with antibiotic therapy
• treatment or prevention of duodenal or stomach ulcers in patients who require continuous therapy with non-steroidal anti-inflammatory drugs (NSAIDs) (NSAID therapy is used against pain or inflammation)
• treatment of Zollinger-Ellison syndrome

Your doctor may have prescribed Tanzolan for a different indication, or at a different dose than
prescribed by your doctor.
See your doctor if you do not feel better or if you feel worse after 14 days.

2. What you need to know before you take Tanzolan

Do not take Tanzolan

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

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

• if you suffer from severe liver disease. Your doctor may need to adjust your dose.
• if you have low levels of vitamin B12 or risk factors for low levels of vitamin B12and are being treated with Tanzolan. As with all acid-reducing agents, Tanzolan can lead to reduced absorption of vitamin B12.
• if you are going to undergo a specific blood test (Chromogranin A).
• if you have ever had a skin reactionafter treatment with a medicine similar to Tanzolan that reduces stomach acid. If you notice the appearance of a skin rash, especially in areas exposed to sunlight, contact your doctor as soon as possible, as you may need to stop treatment with Tanzolan. Remember to also report any other undesirable effects such as joint pain. Your doctor may decide to subject you to a further examination, called endoscopy, to diagnose your condition and/or exclude a malignant pathology
• if you experience diarrheaduring treatment with Tanzolan, contact your doctor immediately, because this medicine is associated with a slight increase in cases of infectious diarrhea.
• if your doctor has prescribed Tanzolan in combination with other medicines for the treatment of Helicobacter pyloriinfection (antibiotics) or together with anti-inflammatory medicines to treat painor
• taking a proton pump inhibitor such as lansoprazole, especially for a period longer than one year, may increase the risk of fracture of the hip, wrist or spine. Tell your doctor if you suffer from osteoporosis or are taking corticosteroids (which may increase the risk of osteoporosis).
• if you take Tanzolan for a long period (more than one year) your doctor will probably need to subject you to periodic checks. You must report any new and unusual symptom or circumstance every time you see your doctor
• if you have been taking Tanzolan for more than three months, it is possible that magnesium levels in the blood may decrease. Low levels of magnesium can manifest with symptoms such as fatigue, involuntary muscle contraction, disorientation, convulsions, dizziness, increased heart rate. If you experience these symptoms, inform your doctor immediately. Low levels of magnesium in the blood can also lead to a reduction in potassium or calcium. Your doctor may decide to subject you to periodic blood tests to monitor magnesium levels

Other medicines and Tanzolan
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicine.
In particular, tell your doctor or pharmacist if you are taking medicines containing any of the
following active ingredients, because Tanzolan may affect the way these medicines work:

• HIV protease inhibitors such as atazanavir and nelfinavir (used to treat HIV)
• methotrexate (used to treat autoimmune diseases and cancer)
• ketoconazole, itraconazole, rifampicin (used to treat infections)
• digoxin (used to treat heart problems)
• theophylline (used to treat asthma)
• warfarin (used to treat blood clots)
• 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 treat ulcers)
• St. John's Wort (Hypericum perforatum) (used to treat mild depression).

Tanzolan with food and drink
To get the best results you should take Tanzolan at least 30 minutes before a meal.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning a pregnancy, or if you are breastfeeding
ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines
Patients taking lansoprazole may sometimes experience undesirable effects such as dizziness,
vertigo, fatigue, weakness and visual disturbances (see section 4. “Possible side effects”). If you
experience side effects like these be careful, as they may reduce your ability to
react.
DO NOT drive if you do not feel well enough to drive a vehicle or perform other tasks that require
greater concentration.

For any questions, ask your doctor or pharmacist.
Tanzolan contains sodium and sucrose
If your doctor has told you that you are intolerant to certain sugars, ask your doctor for advice 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 Tanzolan

Take this medicine following the instructions of your doctor exactly. If you have any doubts, consult your
doctor or pharmacist.
Swallow the capsule whole with a glass of water. If you think the capsules are difficult to swallow, your
doctor may suggest alternative ways to take the medicine. DO NOTbreak or chew the capsules or the
contents of an emptied capsule, because this prevents the medicine from working properly.

• If you are taking Tanzolan once a day, try to take it at the same time each day. If you take Tanzolan first thing in the morning you may achieve the best results.
• If you are taking Tanzolan twice a day, you must take the first dose in the morning and the second dose in the evening.

The dose of medicine to be taken depends on your condition. The recommended doses of Tanzolan for
adults are indicated below. In some cases, your doctor may prescribe a different dose and inform you
accordingly about the duration of treatment.
Treatment of heartburn (pyrosis) and acid reflux
15 mg or 30 mg of lansoprazole per day for 4 weeks. If symptoms persist, inform your doctor. If you have
no relief of symptoms after 4 weeks, see your doctor.
Treatment of duodenal ulcer
30 mg of lansoprazole per day for 2 weeks.
Treatment of stomach ulcer
30 mg of lansoprazole per day for 4 weeks.
Treatment of esophageal inflammation (reflux esophagitis)
30 mg of lansoprazole per day for 4 weeks.
Long-term prevention of reflux esophagitis
15 mg of lansoprazole per day; your doctor may increase the dose to 30 mg of lansoprazole per day.
Treatment of stomach or duodenal ulcer in patients who require continuous therapy with
non-steroidal anti-inflammatory drugs (NSAIDs)
30 mg of lansoprazole per day for 4 weeks.
Prevention of stomach or duodenal ulcer in patients who require continuous therapy with
NSAIDs
15 mg of lansoprazole per day; your doctor may increase the dose to 30 mg of lansoprazole per day.
Treatment of Helicobacter pyloriinfection
The recommended dose is 30 mg of lansoprazole in association with two different antibiotics in the morning and 30
mg of lansoprazole in association with two different antibiotics in the evening. The usual treatment is daily for 7
days.
The recommended antibiotic combinations are:

• 30 mg of Tanzolan together with 250-500 mg of clarithromycin and 1000 mg of amoxicillin
• 30 mg of Tanzolan together with 250 mg of clarithromycin and 400-500 mg of metronidazole

If you are being treated for the infection because you have an ulcer, if the infection is treated successfully it
is unlikely that the ulcer will recur. To give the therapy the best chance of success, take the medicines
at the right time and do not miss any dose.
Zollinger-Ellison syndrome
The recommended dose is 60 mg of lansoprazole per day as a starting dose and then, depending on how
you respond to therapy with Tanzolan, the dose may change according to what your doctor deems best
for you.

Use in children
Tanzolan should NOT be given to children.

If you take more Tanzolan than you should
If you take more Tanzolan than you should, contact your doctor, pharmacist, or the nearest emergency room
immediately.

If you forget to take Tanzolan
If you forget to take a dose, take it as soon as you remember, unless it is almost time for the
next dose. If it is almost time for the next dose, skip the missed dose and take
the remaining capsules as usual. Do NOT take a double dose to make up for a missed dose.

If you stop taking Tanzolan
Do not stoptreatment prematurely because your symptoms have improved. Your condition may not
have been completely cured, and if you do not complete the treatment cycle it may recur.
If you have any doubts 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 everybody gets them.

If you experience any of the following side effects, stop taking Tanzolan and immediately contact your doctor or go to the nearest hospital emergency room:

• angioedema(symptoms may include swelling of the face, tongue or throat, difficulty swallowing, hives and difficulty breathing)
• severe hypersensitivity reactionsincluding anaphylactic shock (symptoms may include fever, rash, swelling and sometimes a sudden drop in blood pressure)
• very severe skin reactionswith redness, blisters, severe inflammation and skin loss (Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme)
• liver inflammation(may manifest as: yellowing of the skin and eyes).

The following side effects are common (may affect up to 1 in 10 people):

• headache, dizziness
• dry mouth or sore throat, feeling nauseous, vomiting, diarrhea, stomach pain, constipation, flatulence, benign polyps in the stomach
• changes in liver function values
• rash, itching
• fatigue

The following side effects are uncommon (may affect up to 1 in 100 people):

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

The following side effects are rare (may affect up to 1 in 1,000 people):

• anemia (pallor)
• hallucinations, confusion and difficulty falling asleep (insomnia), visual disturbances, vertigo, restlessness and drowsiness
• candidiasis (fungal infection that can affect the skin or mucous membranes)
• changes in taste, loss of appetite, inflammation of the tongue (glossitis)
• skin reactions such as a burning or tingling sensation under the skin, bruising, redness and excessive sweating
• sensitivity to light
• hair loss
• breast enlargement in men, impotence
• fever
• tingling sensation on the skin (paresthesia), tremors
• kidney problems
• pancreatitis

The following side effects are very rare (may affect up to 1 in 10,000 people):

• reduction in the number of white blood cells, which may reduce your resistance to infections. If you develop an infection with symptoms such as fever and a worsening of your general condition, or fever with symptoms of a local infection such as sore throat/pharynx/mouth or urinary problems, immediately inform your doctor. You will be given a blood test to check for a possible reduction in white blood cells (agranulocytosis)
• colitis (inflammation of the intestine)
• inflammation of the mouth (stomatitis)
• changes in blood test values such as sodium, cholesterol and triglyceride levels

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

• rash, possible joint pain
• low levels of magnesium in the blood (hypomagnesemia) (see section 2 “Warnings and precautions”), severe hypomagnesemia can cause low levels of calcium in the blood (hypocalcemia)
• visual hallucinations.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through 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 Tanzolan

Keep this medicine out of the sight and reach of children.
Store at a temperature below 30º C.
Tanzolan 15 mg hard gastro-resistant capsules
Tanzolan must not be used for more than 56 days after the first opening of the bottle.
Tanzolan 30 mg hard gastro-resistant capsules
Bottles in HDPE - 7, 14 or 28 capsules
Tanzolan must not be used for more than 28 days after the first opening of the bottle.
Bottles in HDPE - 49, 50 or 56 capsules
Tanzolan must not be used for more than 56 days after the first opening of the bottle.
Do not use the medicine after the expiry date which is stated on the outer packaging and on the label
of the bottle after EXP. The expiry date refers to the last day of that month.
Do not dispose of any medicine in wastewater 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 Tanzolan contains

• The active ingredient is lansoprazole. Each capsule contains 15 mg of the active ingredient. Each capsule contains 30 mg of the active ingredient.
• The other ingredients are sugar spheres (sucrose, corn starch), povidone, sodium lauryl sulfate, sodium starch glycolate (type A), trisodium phosphate, hypromellose, talc, methacrylic acid and ethyl acrylate copolymer (1:1) at 30 percent, triethyl citrate, titanium dioxide (E171).
• The capsule shell contains: gelatin, titanium dioxide (E171).
• The printing ink contains shellac, propylene glycol, ammonium hydroxide, potassium hydroxide, iron oxide black (E172).

Description of the appearance of Tanzolan and contents of the pack

• A hard gelatin capsule with an opaque white cap and body, filled with granules from white to beige. The capsules bear the letter “L” in black ink on the cap and the number “15” on the body.
• A hard gelatin capsule with an opaque white cap and body, filled with granules from white to beige. The capsules bear the letter “L” in black ink on the cap and the number “30” on the body.

Tanzolan is available in blisters of 7, 7x1, 10, 10x1, 14, 14x1, 28, 28x1, 30, 30x1, 50, 50x1, 50x1 (hospital pack), 56, 56x1, 60, 60x1, 90, 90x1, 98, 98x1, 100, 100x1 with gastro-resistant capsules (blisters) or bottles
of 7, 14, 28, 49, 50, 56, 98 (2x49), 100 (2x50) with gastro-resistant capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
S.F Group srl
Via Tiburtina 1143
00156 Rome
Italy

Manufacturers responsible for batch release:
TEVA PHARMA S.L.U.
C/C, n. 4, Poligono Industrial Malpica, Zaragoza

• 50016 – Spain

Merckle GmbH
Ludwig-Merckle-Straße 3, Blaubeuren

• 89143 – Germany

Teva Pharma B.V.
Swensweg 5, Haarlem
2031 GA - Netherlands