Pantoprazole Zentiva Italia: detailed information

Pantoprazole Zentiva Italia

Package leaflet: Information for the user

Pantoprazole Zentiva Italia 20 mg gastro-resistant tablets

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, pharmacist, or nurse.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, because it could be harmful.
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

What Pantoprazole Zentiva Italia is and what it is used for
What you need to know before taking Pantoprazole Zentiva Italia
How to take Pantoprazole Zentiva Italia
Possible side effects
How to store Pantoprazole Zentiva Italia
Package contents and other information

1. What Pantoprazolo Zentiva Italia is and what it is used for

Pantoprazolo Zentiva Italia contains the active substance pantoprazole. Pantoprazolo Zentiva Italia is a
selective "proton pump inhibitor", a medicine that reduces the amount of acid produced in the
stomach. It is used for the treatment of acid-related diseases of the stomach and intestine.
Pantoprazolo Zentiva Italia is used
For the treatment of adults and adolescents aged 12 years and older:

Symptoms (e.g. heartburn, acid regurgitation, pain on swallowing) associated with gastroesophageal reflux disease caused by acid reflux from the stomach.
Long-term treatment of reflux esophagitis (inflammation of the oesophagus accompanied by acid regurgitation from the stomach) and prevention of its recurrence.

For the treatment of adults:

Prevention of duodenal and gastric ulcers induced by non-steroidal anti-inflammatory drugs (NSAIDs, e.g. ibuprofen) in patients at risk who require long-term NSAID therapy.

Pantoprazolo Zentiva Italia

2. What you need to know before taking Pantoprazole Zentiva Italia

Do not take Pantoprazole Zentiva Italia

If you are allergic to pantoprazole, peanuts, soya, or any of the other ingredients of this medicine listed in section 6.
If you are allergic to medicines containing other proton pump inhibitors.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking Pantoprazole Zentiva Italia

If you have severe liver problems. Inform your doctor if you have previously had liver problems. Your doctor will arrange for more frequent monitoring of your liver enzymes, especially if you are taking Pantoprazole Zentiva Italia for long-term treatment. If liver enzymes increase, treatment should be discontinued.
If you require ongoing treatment with medicines called NSAIDs and are taking Pantoprazole Zentiva Italia because you are at increased risk of developing gastric or intestinal complications. Any increased risk will be assessed based on your individual risk factors such as age (65 years and older), history of gastric or duodenal ulcers, or gastrointestinal bleeding.
If you have low body reserves or risk factors for low vitamin B12 and are undergoing long-term treatment with pantoprazole. As with all agents that reduce acidity, pantoprazole may lead to reduced absorption of vitamin B12. Consult your doctor if you notice any of the following symptoms, which may indicate low vitamin B12 levels:
Extreme tiredness or lack of energy
Tingling or numbness
Red and sore tongue, mouth ulcers
Muscle weakness
Vision disturbances
Memory problems, confusion, depression.
If you are simultaneously taking HIV protease inhibitors such as atazanavir (for treatment of HIV infection), ask your doctor for specific advice.
Taking a proton pump inhibitor such as pantoprazole, especially for longer than one year, may slightly increase 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 are at risk of developing osteoporosis (e.g., if you are taking steroids).
If you have been taking Pantoprazole Zentiva Italia for more than three months, your blood magnesium levels may decrease. Low magnesium levels can cause fatigue, involuntary muscle contractions, confusion, seizures, dizziness, and increased heart rate. Inform your doctor immediately if you experience any of these symptoms. 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 have ever had a skin reaction after treatment with a medicine similar to Pantoprazole Zentiva 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 Pantoprazole Zentiva Italia. Remember to also report any other adverse effects such as joint pain.

Pantoprazole Zentiva Italia

Serious skin reactions such as Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and erythema multiforme have been reported in association with treatment with pantoprazole. Stop using pantoprazole and contact your doctor immediately if you notice any symptoms related to these serious skin reactions, described in section 4.
If you are scheduled to undergo a specific blood test (chromogranin A).

Contact your doctor immediately before or after taking this medicine if you notice any of the following symptoms, which may be signs of a more serious underlying condition:

Unintentional weight loss
Vomiting, particularly if repeated
Blood in vomit; this may appear as dark coffee-ground-like material in the vomit
Appearance of blood in stools, which may appear dark or tarry
Difficulty swallowing or pain when swallowing
Looking pale and feeling weak (anaemia)
Chest pain
Stomach pain
Severe and/or persistent diarrhoea, as this medicine has been associated with a slight increase in infectious diarrhoea.

Your doctor may decide that you need certain tests to rule out malignancy, as pantoprazole relieves symptoms of cancer and could delay diagnosis. If your symptoms persist despite treatment, further investigations should be considered.
If you are taking Pantoprazole Zentiva Italia for long-term treatment (more than 1 year), your doctor will likely monitor you regularly. You must report any new or unusual symptoms or circumstances whenever you see your doctor.
Children and adolescents
The use of Pantoprazole Zentiva Italia is not recommended in children, as efficacy has not been demonstrated in children under 12 years of age.
Other medicines and Pantoprazole Zentiva Italia
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including over-the-counter medicines.
This is because Pantoprazole Zentiva Italia may affect the effectiveness of other medicines; therefore, inform your doctor if you are taking

Medicines such as ketoconazole, itraconazole, and posaconazole (used to treat fungal infections) or erlotinib (used for certain types of cancer), as Pantoprazole Zentiva Italia may prevent these and other medicines from working properly.
Warfarin and fenprocoumon, which affect blood clotting or thinning. You may need additional monitoring.
Medicines used to treat HIV infection, such as atazanavir.
Methotrexate (used to treat rheumatoid arthritis, psoriasis, and cancer) – if you are taking methotrexate, your doctor may temporarily discontinue treatment with Pantoprazole Zentiva Italia because pantoprazole may increase methotrexate levels in the blood.
Fluvoxamine (used to treat depression and other psychiatric disorders) – if you are taking fluvoxamine, your doctor may reduce the dose.
Rifampicin (used to treat infections).
St John’s wort (Hypericum perforatum) (used to treat mild depression).

Pantoprazole Zentiva Italia
Talk to your doctor before taking pantoprazole if you are scheduled to undergo a specific urine test (for THC, tetrahydrocannabinol).
Pregnancy, breastfeeding, and fertility
There are insufficient data on the use of pantoprazole in pregnant women. Excretion in human breast milk has been reported. If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
You should use this medicine only if your doctor considers the benefit to you greater than the potential risk to the foetus or infant.
Driving and using machines
Pantoprazole Zentiva Italia does not affect or affects negligibly the ability to drive and use machines. However, if you experience adverse effects such as dizziness or vision disturbances, you must not drive or use machinery.
Pantoprazole Zentiva Italia contains soya lecithin, maltitol, and sodium
If you are allergic to peanuts or soya, do not use this medicine.
If your doctor has told you that you have an intolerance to certain sugars, consult your doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e., it is essentially “sodium-free”.

3. How to take Pantoprazolo Zentiva Italia

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Method of administration
Take the tablets 1 hour before a meal, without chewing or crushing them, swallowing them whole with some
water.
The recommended dose is:
Adults and adolescents from 12 years of age
For the treatment of symptoms associated with gastroesophageal reflux disease (e.g. heartburn, acid
regurgitation, pain on swallowing)
The usual dose is one tablet per day. This dose usually provides relief within 2–4 weeks – at most after a further 4 weeks. Your doctor will tell you how long you should continue taking the medicine.
Thereafter, any recurrence of symptoms may be managed by taking one tablet per day, as needed.
For long-term treatment and prevention of recurrence of reflux oesophagitis
The usual dose is one tablet per day. If the disease recurs, your doctor may double the dose; in this case, you may alternatively use Pantoprazolo Zentiva 40 mg, one tablet per day. After healing, the dose may be reduced back to one 20 mg tablet per day.
Adults
For prevention of duodenal and gastric ulcers in patients requiring continuous treatment with NSAIDs
The usual dose is one tablet per day.
Patients with liver problems:

If you have severe liver problems, you must not take more than one 20 mg tablet per day. Use in children and adolescents

Pantoprazolo Zentiva Italia

These tablets are not recommended for use in children under 12 years of age.

If you take more Pantoprazolo Zentiva Italia than you should
Consult your doctor or pharmacist. Symptoms of overdose are not known.
If you forget to take Pantoprazolo Zentiva Italia
Do not take a double dose to make up for the missed dose. Take your next dose at the usual time.
If you stop taking Pantoprazolo Zentiva Italia
Do not stop treatment with these tablets without first consulting your doctor or pharmacist.
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 this medicine immediately and
contact your doctor, or go to the nearest hospital emergency department:

Severe allergic reactions (rare frequency: may affect up to 1 in 1,000 people): swelling of the tongue and/or throat, difficulty swallowing, hives, breathing difficulties, allergic swelling of the face (Quincke's edema / angioedema), severe dizziness with very rapid heartbeat and profuse sweating.
Serious skin disorders (frequency not known: frequency cannot be estimated from available data): you may notice one or more of the following: appearance of skin blisters and rapid deterioration of your general condition, erosion (including mild bleeding) of the eyes, nose, mouth/lips or genitals, or skin sensitivity/rash, particularly in areas of skin exposed to light/sun. You may also experience joint pain or flu-like symptoms, fever, swollen glands (e.g. under the arm), and blood tests may show changes in white blood cell count or liver enzymes.
Red, flat, circular or target-shaped rashes on the trunk, often with blisters in the center, skin peeling, ulcers in the mouth, throat, nose, genitals and eyes. These serious skin reactions may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
Widespread skin rash, high fever and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).
Other serious disorders (frequency not known): yellowing of the skin or whites of the eyes (severe liver cell damage, jaundice), or fever, skin rash, and kidney enlargement sometimes with pain when urinating and lower back pain (severe kidney inflammation which may lead to possible kidney failure).

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

benign gastric polyps.

Uncommon (may affect up to 1 in 100 people)

headache; dizziness; diarrhoea; nausea, vomiting; abdominal distension and flatulence (gas); constipation; dry mouth; abdominal pain and feeling unwell; skin rash,
Pantoprazolo Zentiva Italia
exanthema, eruption; pruritus; feeling of weakness, fatigue or general malaise; sleep disturbances, fracture of the hip, wrist or spine.

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

altered or complete loss of taste sensation; visual disturbances such as blurred vision; urticaria; joint pain; muscle pain; weight changes; increased body temperature; high fever; swelling of extremities (peripheral oedema); allergic reactions; depression; breast enlargement in males.

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

disorientation.

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

hallucinations, confusion (especially in patients with prior history of these symptoms), tingling sensation, pins and needles, burning or numbness; erythema; possible joint pain; inflammation of the large intestine causing persistent watery diarrhoea.

Side effects identified through blood tests:
Uncommon (may affect up to 1 in 100 people)

increased liver enzymes.

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

increased bilirubin; increased blood lipid levels; drastic reduction in circulating granulocytes, associated with high fever.

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

reduced platelet count, which may cause increased bleeding or bruising; reduced white blood cell count, which may lead to more frequent infections; concomitant abnormal reduction in red blood cells, white blood cells, and platelets.
Frequency not known (frequency cannot be estimated from available data)
- decreased levels of sodium, magnesium, calcium or potassium in the blood (see section 2).

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 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 Pantoprazolo Zentiva Italia

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister and the carton after Exp.
The expiry date refers to the last day of that month.
For tablets packed in plastic bottles: Pantoprazolo Zentiva Italia must be used within three months of first opening the bottle.
Do not store above 25°C.
Pantoprazolo Zentiva Italia
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 Pantoprazolo Zentiva Italia contains:
The active substance is: pantoprazole.
Each gastro-resistant tablet contains 20 mg of pantoprazole (as sodium pantoprazole sesquihydrate).
The other components are:
Tablet core
Maltitol (E 965), crospovidone type B, sodium carmellose, anhydrous sodium carbonate (E 500), calcium stearate.
Tablet coating
Polyvinyl alcohol, talc (E 553b), titanium dioxide (E 171), macrogol 3350, soybean lecithin (E 322), yellow iron oxide (E 172), anhydrous sodium carbonate (E 500), methacrylic acid/ethyl acrylate copolymer (1:1), triethyl citrate (E 1505).

Description of the appearance of Pantoprazolo Zentiva Italia and package contents:
Pantoprazolo Zentiva Italia gastro-resistant tablets are oval-shaped and yellow.
Pantoprazolo Zentiva Italia is available in blister packs containing 7, 14, 15, 28, 30, 50, 56, 60, 90, 98*, 100, 140, 140 (10x14) (5x28), 280 (20x14) (10x28), 500, 700 (5x140) gastro-resistant tablets, and in bottles containing 14, 15, 28, 30, 50, 56, 60, 90, 100, 140, 140 (10x14) (5x28), 280 (20x14) (10x28), 500, 700 (5x140) gastro-resistant tablets.
*marketed only in Germany
Not all pack sizes may be marketed.

Marketing Authorization Holder
Zentiva Italia S.r.l. Via P. Paleocapa 7, 20121 Milano

Manufacturers
Opella Healthcare Poland Sp. z o. o.
Oddział w Rzeszowie
ul. Lubelska, 52 - 35-233 Rzeszów (Poland)
Winthrop Arzneimittel GmbH
Brüningstraße 50, K703
65926 Frankfurt am Main (Germany)
SC Zentiva SA
Theodor Pallady Bvd no 50 , 3 district
032266 Bucharest (Romania)

This medicinal product has been authorised in the Member States of the European Economic Area (EEA) under the following names:
DE: Pantoprazol Winthrop 20 mg magensaftresistente Tabletten
FR: Pantoprazole Zentiva 20 mg, comprimé gastro-résistant
IT: Pantoprazolo Zentiva Italia
PT: Pantoprazol Zentiva