ZOTON

Package leaflet: Information for the user

Zoton 15 mg orodispersible tablets, 30 mg orodispersible tablets

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

1. What Zoton is and what it is used for

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

• Treatment of duodenal and gastric ulcers
• Treatment of inflammation of the oesophagus (reflux oesophagitis)
• Prevention of reflux oesophagitis
• Treatment of heartburn and acid regurgitation
• 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 used for pain or inflammation)
• Treatment of Zollinger-Ellison syndrome

Your doctor may have prescribed Zoton for a different indication or at a dosage different from that stated in this patient information leaflet. Please consult your doctor for guidance on how to take 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 Zoton

Do not take Zoton:

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

Warnings and precautions
Inform your doctor if you have severe liver disease. Your doctor may need to adjust the dosage of
the medicine.
Your doctor may perform or may have already performed an additional examination called endoscopy to diagnose your condition and/or exclude malignant disease.
If you develop severe or persistent diarrhoea during treatment with Zoton, contact your doctor immediately, as Zoton has been associated with a small increased risk of infectious diarrhoea.
If your doctor has prescribed Zoton in combination with other medicines for the treatment of Helicobacter pylori infection (antibiotics) or together with anti-inflammatory medicines to treat pain or rheumatic diseases, read carefully the package leaflet of these medicines as well.
If you take Zoton for more than three months, your blood magnesium levels may decrease. Low magnesium levels may present as fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, and increased heart rate. If you experience any of these symptoms, inform your doctor immediately. Low magnesium levels may also lead to reduced levels of potassium or calcium in the blood. Your doctor may decide to perform regular blood tests to monitor your magnesium levels.
If you take a proton pump inhibitor such as Zoton, 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. Inform your doctor if you have osteoporosis (reduced bone density) or if your doctor has told you that you may be at risk of developing osteoporosis (for example, if you are taking steroids).
This medicine may affect how your body absorbs vitamin B12, particularly if you need to take it for a long time. Contact your doctor if you notice any of the following symptoms, which could indicate low vitamin B12 levels:

• Extreme tiredness or lack of energy
• Tingling sensations
• Sore or red tongue, mouth ulcers
• Muscle weakness
• Disturbed vision
• Memory problems, confusion, depression

If you take Zoton long-term (for more than 1 year), your doctor will likely monitor you regularly. At each visit, report any new or unusual symptoms or circumstances to your doctor.
Talk to your doctor before taking Zoton:

• If you need to undergo a specific blood test (Chromogranin A)
• If you have ever had a skin reaction after treatment with a medicine similar to Zoton that reduces stomach acidity.

Serious skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported in association with treatment with lansoprazole. Stop using Zoton and contact your doctor immediately if you notice any of the symptoms described in section 4.
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 Zoton. Remember to also report any other adverse effects such as joint pain.
During treatment with lansoprazole, inflammation of the kidneys may occur. Signs and symptoms may include decreased urine volume or blood in the urine and/or hypersensitivity reactions such as fever, skin rash, and joint stiffness. These signs must be reported to your physician.
Other medicines and Zoton
Inform 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, as Zoton 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 regurgitation)
• sucralfate (used to heal ulcers)
• St. John’s wort (Hypericum perforatum, used to treat mild depression)

Zoton with food and drink
To achieve the best results, you should take Zoton at least 30 minutes before eating.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you might be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Driving and using machines
Adverse effects such as dizziness, vertigo, fatigue, and visual disturbances may occasionally occur in patients taking Zoton. If you experience such adverse effects, you should be cautious, as your reaction ability may be reduced.
Only you are responsible for deciding whether you are fit to drive a motor vehicle or perform other tasks requiring increased concentration. The use of medicines is one of the factors that may reduce your ability to perform these activities safely due to their effects or side effects.
Descriptions of these effects can be found in other sections.
Read all the information in this leaflet as a guide.
If you have any doubts, discuss them with your doctor or pharmacist.
Zoton contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact your doctor or pharmacist before taking this medicine.
Zoton contains aspartame
Each Zoton 15 mg tablet contains 4.5 mg of aspartame
Each Zoton 30 mg tablet contains 9.0 mg of aspartame
Aspartame is a source of phenylalanine. Phenylalanine may be harmful if you have phenylketonuria (PKU), a rare genetic disorder causing accumulation of phenylalanine because the body cannot properly eliminate it.

3. How to take Zoton

Take this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Place the tablet on your tongue and suck it slowly. The tablet dissolves rapidly in the mouth, releasing microgranules which must be swallowed without chewing. Alternatively, you may swallow the tablets whole with a glass of water.

Your doctor may instruct you to take the tablet using a syringe if you have severe difficulty swallowing.

If you take the medicine using a syringe, follow these instructions:
It is important that the suitability of the chosen syringe is carefully tested.

• Remove the plunger from the syringe (a syringe of at least 5 mL for a 15 mg tablet and 10 mL for a 30 mg tablet).
• Place the tablet into the barrel of the syringe.
• Reinsert the plunger into the syringe.
• For the 15 mg tablet: draw up 4 mL of tap water into the syringe.
• For the 30 mg tablet: draw up 10 mL of tap water into the syringe.
• Turn the syringe upside down and draw up an additional 1 mL of air.
• Gently shake the syringe for 10–20 seconds until the tablet is dissolved.
• The contents can be emptied directly into the mouth.
• Refill the syringe with 2–5 mL of tap water to flush out any remaining contents from the mouth.

If you take Zoton once daily, try to take it at the same time each day. You may achieve better results if you take Zoton first thing in the morning.
If you take Zoton twice daily, take the first dose in the morning and the second dose in the evening.

The dose of Zoton depends on your condition. The usual doses of Zoton for adults are listed below.
Sometimes your doctor may prescribe a different dose and will inform you of the duration of treatment.

Treatment of heartburn and acid regurgitation: one orodispersible tablet of 15 mg or 30 mg daily for 4 weeks. If symptoms are not relieved within 4 weeks, contact your doctor.
Treatment of duodenal ulcer: one orodispersible tablet of 30 mg daily for 2 weeks.
Treatment of gastric ulcer: one orodispersible tablet of 30 mg daily for 4 weeks.
Treatment of inflammation of the oesophagus (reflux oesophagitis): one orodispersible tablet of 30 mg daily for 4 weeks.
Long-term prevention of reflux oesophagitis: one orodispersible tablet of 15 mg daily; your doctor may adjust the dose up to one orodispersible tablet of 30 mg daily.
Treatment of Helicobacter pylori infection: the usual dose is one orodispersible tablet of 30 mg in combination with two different antibiotics in the morning and one orodispersible tablet of 30 mg in combination with two different antibiotics in the evening. The treatment is taken daily for 7 days.
The recommended antibiotic combinations are:

• 30 mg of Zoton together with 250–500 mg of clarithromycin and 1000 mg of amoxicillin;
• 30 mg of Zoton together with 250 mg of clarithromycin and 400–500 mg of metronidazole.

If you are being treated for your 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 prescribed times and never miss a dose.

Treatment of duodenal or gastric ulcer in patients requiring continuous treatment with NSAIDs: one orodispersible tablet of 30 mg daily for 4 weeks.
Prevention of duodenal or gastric ulcer in patients requiring continuous treatment with NSAIDs: one orodispersible tablet of 15 mg daily; your doctor may adjust the dose up to one orodispersible tablet of 30 mg daily.
Zollinger-Ellison syndrome: the usual initial dose is two orodispersible tablets of 30 mg daily. Subsequently, depending on your response to Zoton, your doctor will decide the most appropriate dose for you.

Use in children
Zoton must not be given to children.

If you take more Zoton than you should
If you take more Zoton than prescribed, seek immediate advice from your doctor.

If you forget to take Zoton
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 tablet.

If you stop taking Zoton
Do not stop taking the treatment early, even if your symptoms have improved. Your condition may not be fully healed and may recur if you do not complete the full course of treatment.

If you have any doubts about how to use Zoton, consult your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them. If you think you may be experiencing any of the following serious side effects, stop taking this medicine and contact your doctor or go immediately to the nearest hospital emergency department.

• Very rarely, Zoton may cause severe hypersensitivity (allergic) reactions. Symptoms of a hypersensitivity reaction may include fever, skin rash, swollen face, swollen lymph nodes, swollen tongue or throat, difficulty swallowing, hives, difficulty breathing, and sometimes a drop in blood pressure.
• Very rarely, severe skin reactions have been reported with Zoton, which may be life-threatening. Symptoms include red spots on the trunk, appearing as circular patches or target-like lesions, often with central blisters, skin peeling, mouth, throat, nose, genital or eye ulcers. These severe skin reactions may be preceded by fever and flu-like symptoms [Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN)].
• Widespread rash, high body temperature, and swollen lymph nodes [drug reaction with eosinophilia and systemic symptoms (DRESS, frequency not known)].
• If you take Zoton for more than three months, magnesium levels in your blood may decrease. Low magnesium levels may present as fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, and increased heart rate. If you experience any of these symptoms, inform your doctor immediately. Low magnesium levels may also lead to reduced potassium or calcium levels in the blood. Your doctor may decide to perform regular blood tests to monitor magnesium levels.
• Very rarely, Zoton may cause a reduction in the number of white blood cells (agranulocytosis), reducing your resistance to infections; or an abnormal reduction in the number of red blood cells, white blood cells, and platelets (pancytopenia). If you develop an infection with symptoms such as fever and severe worsening of your general condition, or fever with local infection symptoms such as sore throat/pharynx/mouth or urinary problems, or if you experience prolonged fatigue, pale skin with bruising or unexplained bleeding lasting longer than usual, you should consult your doctor immediately. A blood test will be performed to check for possible reduction in blood cells.
• Rarely, Zoton may cause inflammation of the pancreas (pancreatitis), with symptoms including sudden severe pain in the upper central abdomen that may radiate to the back, possibly leading to nausea and vomiting.
• If you develop severe or persistent diarrhoea during treatment with Zoton, contact your doctor immediately, as Zoton has been associated with a small increased risk of infectious diarrhoea.

Other possible side effects:
Common: may affect up to 1 in 10 people

• headache, dizziness
• constipation, stomach pain, feeling unwell, intestinal gas (flatulence), dry or inflamed mouth or throat
• skin rash, itching
• changes in liver function tests
• fatigue
• benign polyps in the stomach

Uncommon: may affect up to 1 in 100 people

• depression
• joint and muscle pain
• fluid retention or swelling
• changes in red blood cell count
• risk of fracture of the hip, wrist, and spine

Rare: 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
• sensitivity to light
• hair loss
• tingling sensation on the skin (paresthesia), tremor
• anaemia (pallor)
• kidney inflammation (tubulo-interstitial nephritis); possible symptoms include changes in urine output, blood in urine
• liver inflammation (possible yellowing of the skin or eyes)
• breast swelling in men, impotence
• candidiasis (fungal infection, may affect the oesophageal mucosa)

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

• inflammation of the mouth (stomatitis)
• inflammation of the colon (colitis)
• increased laboratory values such as sodium, cholesterol, and triglyceride levels
• low sodium levels in the blood; symptoms include nausea and vomiting, headache, drowsiness and fatigue, confusion, weakness or muscle spasms, irritability, seizures, coma. Your doctor may decide to perform regular blood tests to monitor sodium levels.
  Frequency not known: frequency cannot be estimated from the available data
• lupus-related skin manifestations or lupus erythematosus rash
• skin rash, possible joint pain
• visual hallucinations

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly via 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 Zoton

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack and carton. The expiry date refers to the last day of the month.
Do not store above 25°C. Keep in the original packaging to protect the medicine from moisture.
Do not dispose of this 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 Zoton contains

• The active substance is lansoprazole.
• The other ingredients are: lactose monohydrate, microcrystalline cellulose, heavy magnesium carbonate, low-substituted hydroxypropylcellulose, hydroxypropylcellulose, hypromellose, titanium dioxide, talc, mannitol, methacrylic acid-ethyl acrylate copolymer (1:1) dispersion 30%, polyacrylate dispersion 30%, macrogol 8000, glyceryl monostearate, polysorbate 80, triethyl citrate, anhydrous citric acid, crospovidone, magnesium stearate, aspartame (E951) (see section 2 “Zoton contains aspartame”), strawberry flavour, red iron oxide (E172) and yellow iron oxide (E172).

Description of the appearance of Zoton and contents of the pack
Zoton 15 mg: Orodispersible tablets, white to off-white in colour, flat, circular with bevelled edges, marked “15” on one side. Each orodispersible tablet contains gastro-resistant granules of orange to dark brown colour.
Zoton 30 mg: Orodispersible tablets, white to off-white in colour, flat, circular with bevelled edges, marked “30” on one side. Each orodispersible tablet contains gastro-resistant granules of orange to dark brown colour.
Zoton 15 mg orodispersible tablets – 14 and 28 orodispersible tablets
Zoton 30 mg orodispersible tablets – 14 and 28 orodispersible tablets

Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation Holder is:
Pfizer Italia S.r.l. - Via Isonzo, 71 – 04100 Latina
under licence from Takeda Pharmaceutical Company Ltd - Osaka – Japan

The manufacturers are:
Pfizer Ireland Pharmaceuticals (PIP) Little Connell Newbridge - Co. Kildare – Ireland.
Pfizer Manufacturing Deutschland GmbH, Betriebsstätte Freiburg,
Mooswaldallee 1, 79090 Freiburg, Germany

This medicinal product is authorised in the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
Iceland: LANZO
Ireland: ZOTON, ZOTON FASTAB
Italy: ZOTON
Norway: LANZO MELT
Sweden: LANZO
United Kingdom (Northern Ireland): ZOTON, ZOTON FASTAB.