Tanzolan

Package leaflet: Information for the user

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

Lansoprazole
Please read all of this leaflet carefully before you start 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 other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to 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 taking 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 Tanzolan is and what it is used for

The active substance of Tanzolan is lansoprazole, which is a proton pump inhibitor.
Proton pump inhibitors work by reducing the amount of acid produced by the stomach.
Your doctor may have prescribed Tanzolan for the following indications in adults:

• treatment of duodenal and gastric ulcers
• treatment of inflammation of the oesophagus (reflux oesophagitis)
• prevention of reflux oesophagitis
• 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 gastric ulcers in patients requiring continuous treatment with non-steroidal anti-inflammatory drugs (NSAIDs) (NSAID therapy is used to treat pain or inflammation)
• treatment of Zollinger-Ellison syndrome

Your doctor may have prescribed Tanzolan for an indication or at a dose different from those stated in this leaflet. Always take this medicine exactly as instructed by your doctor.
Consult your doctor if you do not feel better or if you feel worse after 14 days.

2. What you need to know before taking Tanzolan

Do not take Tanzolan

• 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 Tanzolan:

• if you have severe liver disease. Your doctor may need to adjust your dose.
• if you have low levels of vitamin B12 or are at risk of low vitamin B12 levels and are being treated with Tanzolan. As with all acid-reducing agents, Tanzolan 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 Tanzolan that reduces stomach acid. If you notice the appearance of a skin rash, especially in sun-exposed areas, contact your doctor as soon as possible, as it may be necessary to stop treatment with Tanzolan. Remember to also report any other side effects such as joint pain. Your doctor may decide to perform a further examination, called an endoscopy, to diagnose your condition and/or rule out malignancy.
• if you develop diarrhoea while taking Tanzolan, contact your doctor immediately, as this medicine is associated with a slight increase in infectious diarrhoea.
• if your doctor has prescribed Tanzolan in combination with other medicines to treat Helicobacter pylori infection (antibiotics) or together with anti-inflammatory medicines to treat pain or rheumatic disease, read carefully the package leaflet of these other medicines as well.
• taking a proton pump inhibitor such as lansoprazole, especially for more than one year, may increase the risk of fractures of the hip, wrist, or spine. Inform your doctor if you have osteoporosis or are taking corticosteroids (which may increase the risk of osteoporosis).
• if you are taking Tanzolan for a long period (more than one year), your doctor will likely need to perform periodic check-ups. You must report any new or unusual symptoms or circumstances each time you see your doctor.
• if you have been taking Tanzolan for more than three months, your blood magnesium levels may decrease. Low magnesium levels may cause symptoms such as fatigue, involuntary muscle contractions, confusion, seizures, dizziness, and increased heart rate. If you experience these symptoms, inform your doctor immediately. Low blood magnesium levels may also lead to reduced potassium or calcium levels. Your doctor may decide to perform periodic blood tests to monitor your magnesium levels.

Other medicines and Tanzolan
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, inform your doctor or pharmacist if you are taking medicines containing any of the following active substances, because Tanzolan may affect how 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, take Tanzolan at least 30 minutes before a meal.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
In patients taking lansoprazole, side effects such as dizziness, vertigo, fatigue, weakness, and visual disturbances may occasionally occur (see section 4. "Possible side effects"). If you experience such side effects, be cautious, as they could impair your reaction ability.
DO NOT drive if you do not feel well enough to drive a vehicle or perform other tasks requiring greater concentration.
For further information, read all the information provided in this leaflet.
For any questions, consult your doctor or pharmacist.
Tanzolan contains sodium and sucrose
If your doctor has told you that you have an intolerance 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 exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Swallow the capsule whole with a glass of water. If you find the capsules difficult to swallow, your doctor may suggest alternative ways to take the medicine. DO NOT break or chew the capsules or the contents of an emptied capsule, as this may prevent the medicine from working properly.

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

The dose of medicine you need depends on your condition. The recommended doses of Tanzolan for adults are listed below. In some cases, your doctor may prescribe a different dose and will inform you accordingly about the duration of treatment.

Treatment of heartburn (acid reflux) and acid regurgitation
15 mg or 30 mg of lansoprazole daily for 4 weeks. If symptoms persist, inform your doctor. If you experience no symptom relief after 4 weeks, consult 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 increase the dose to 30 mg of lansoprazole daily.

Treatment of gastric or duodenal ulcer in patients requiring continuous treatment with non-steroidal anti-inflammatory drugs (NSAIDs)
30 mg of lansoprazole daily for 4 weeks.

Prevention of gastric or duodenal ulcer in patients requiring continuous treatment with NSAIDs
15 mg of lansoprazole daily; your doctor may increase the dose to 30 mg of lansoprazole daily.

Treatment of Helicobacter pylori infection
The recommended dose is 30 mg of lansoprazole taken in the morning in combination with two different antibiotics, and 30 mg of lansoprazole taken in the evening in combination with two different antibiotics. The usual treatment duration is 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 Helicobacter pylori infection due to an ulcer, successful treatment of the infection makes it unlikely that the ulcer will recur. To give the treatment the best chance of success, take the medicines at the correct times and do not miss any doses.

Zollinger-Ellison syndrome
The recommended starting dose is 60 mg of lansoprazole daily. Depending on your response to treatment with Tanzolan, the dose may be adjusted as your doctor considers appropriate.

Use in children
Tanzolan must 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 nearest emergency department 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 your next dose. If it is nearly 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 forgotten dose.

If you stop taking Tanzolan
Do not stop treatment early, even if your symptoms have improved. Your condition may not have been fully treated, and stopping treatment prematurely may cause your symptoms to return.

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

• Angioedema (symptoms may include swelling of the face, tongue or pharynx, difficulty swallowing, hives and breathing difficulties)
• Severe hypersensitivity reactions, including anaphylactic shock (symptoms may include fever, rash, swelling and sometimes a sudden drop in blood pressure)
• Very severe skin reactions with redness, blisters, severe inflammation and skin loss (Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme)
• Inflammation of the liver (may present 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 of nausea, vomiting, diarrhoea, stomach pain, constipation, flatulence, benign stomach polyps
• changes in liver function test values
• skin 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
• hip, wrist or spinal fracture (see section 2 “Warnings and precautions”)

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

• anaemia (pallor)
• hallucinations, confusion and difficulty sleeping (insomnia), visual disturbances, dizziness, restlessness and drowsiness
• candidiasis (fungal infection affecting the skin or mucous membranes)
• taste disturbances, loss of appetite, inflammation of the tongue (glossitis)
• skin reactions such as burning or prickling 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 (paraesthesia), 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 severe worsening of general condition, or fever with signs of local infection such as sore throat/pharynx/mouth or urinary problems, inform your doctor immediately. You may undergo 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 levels of sodium, cholesterol and triglycerides

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

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

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to 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 Tanzolan

Keep this medicine out of the sight and reach of children.
Store below 30º C.
Tanzolan 15 mg gastro-resistant hard capsules
Tanzolan must not be used more than 56 days after first opening of the bottle.
Tanzolan 30 mg gastro-resistant hard capsules
HDPE bottles - 7, 14 or 28 capsules
Tanzolan must not be used more than 28 days after first opening of the bottle.
HDPE bottles - 49, 50 or 56 capsules
Tanzolan must not be used more than 56 days after first opening of the bottle.
Do not use the medicine after the expiry date stated on the outer packaging and on the label of the bottle following EXP. The expiry date refers to the last day of that month.
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. Package contents and other information

What Tanzolan contains

• The active substance is lansoprazole. Each capsule contains 15 mg of active substance. Each capsule contains 30 mg of active substance.
• The other components are sugar spheres (sucrose, maize starch), povidone, sodium lauryl sulfate, sodium starch glycolate (type A), trisodium phosphate, hypromellose, talc, methacrylic acid and ethacrylate copolymer (1:1) 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, black iron oxide (E172).

Description of the appearance of Tanzolan and contents of the pack

• A hard gelatin capsule with opaque white cap and body, filled with white to beige microgranules. The capsules are printed with the letter “L” in black ink on the cap and the number “15” on the body.
• A hard gelatin capsule with opaque white cap and body, filled with white to beige microgranules. The capsules are printed with 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 containing gastro-resistant capsules (blister) or bottles of 7, 14, 28, 49, 50, 56, 98 (2x49), 100 (2x50) containing gastro-resistant capsules.
Not all pack sizes may be marketed.

Marketing Authorization 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 - The Netherlands