PANTOPRAZOLO 20 mg Enteric-Coated Tablet

Содержание инструкции

1. Pantoprazolo Zentiva Italia 20 mg gastro-resistant tablets
   1. What is Pantoprazolo Zentiva Italia and what is it used for
   2. What you need to know before taking Pantoprazolo Zentiva Italia
   3. How to take Pantoprazolo Zentiva Italia
   4. Possible side effects
   5. How to store Pantoprazolo Zentiva Italia
   6. Contents of the pack and other information

Pantoprazolo Zentiva Italia

Pantoprazolo Zentiva Italia 20 mg gastro-resistant tablets

Generic medicine

Read this leaflet carefully before you start taking 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, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

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

Pantoprazolo Zentiva Italia contains the active ingredient pantoprazole. Pantoprazolo Zentiva Italia is a
“proton pump inhibitor” selective, 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 intestines.

Pantoprazolo Zentiva Italia is used

For the treatment of adults and adolescents 12 years of age and over for:

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

For the treatment of adults for:

• Prevention of duodenal and stomach ulcers caused by non-steroidal anti-inflammatory drugs (NSAIDs, for example, ibuprofen) in patients at risk who require continuous treatment with NSAIDs.

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

Do not take Pantoprazolo Zentiva Italia

• If you are allergic to pantoprazole, peanuts, soy 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 Pantoprazolo Zentiva Italia

• If you have severe liver problems. Tell your doctor if you have had liver problems in the past. Your doctor will arrange for more frequent monitoring of your liver enzymes, especially if you are taking Pantoprazolo Zentiva Italia for long-term therapy. If liver enzymes increase, treatment should be discontinued.
• If you need continuous treatment with medicines called NSAIDs and are taking Pantoprazolo Zentiva Italia because you have an increased risk of developing gastric and intestinal complications. Any increased risk will be assessed based on your personal risk factors such as age (65 years and over), a history of gastric or duodenal ulcers or gastrointestinal bleeding.
• If you have reduced body stores or risk factors for reduced vitamin B12 and are undergoing long-term treatment with pantoprazole. As with all agents that reduce acidity, pantoprazole can lead to reduced absorption of vitamin B12. Talk to your doctor if you notice any of the following symptoms, which may indicate low levels of vitamin B12:
• Extreme fatigue or lack of energy
• Tingling or numbness
• Red and sore tongue, mouth ulcers
• Muscle weakness
• Vision problems
• Memory problems, confusion, depression.
• If you are simultaneously taking HIV protease inhibitors such as atazanavir (for the treatment of HIV infection), ask your doctor for specific advice.
• Taking a proton pump inhibitor such as pantoprazole, especially for a period longer than one year, may slightly increase the risk of fractures of the hip, wrist or spine. Tell your doctor if you have osteoporosis (reduced bone density) or if your doctor has told you that you are at risk of developing osteoporosis (for example, if you are taking steroids).
• If you have been taking Pantoprazolo Zentiva Italia for more than three months, the levels of magnesium in your blood may decrease. Low levels of magnesium can cause fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, increased heart rate. Tell your doctor immediately if you experience any of these symptoms. Low levels of magnesium can also lead to a reduction in potassium or calcium levels 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 Pantoprazolo Zentiva Italia 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 Pantoprazolo Zentiva Italia. Remember to report any other unwanted effects such as joint pain.

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

Tell your doctor immediatelybefore or after taking this medicine, if you notice any of the
following symptoms, which may be a sign of a more serious illness:

• unintentional weight loss
• vomiting, especially if repeated
• presence of blood in the vomit; this may appear as dark coffee grounds in the vomit
• appearance of blood in the stool which may appear dark or tarry
• difficulty swallowing or pain when swallowing
• appear pale and feel weak (anemia)
• chest pain
• stomach pain
• severe and/or persistent diarrhea, as this medicine has been associated with a modest increase in infectious diarrhea.

Your doctor may decide that you need to undergo some tests to rule out a malignant disease because pantoprazole also relieves the symptoms of cancer and may cause a delay in diagnosis. If your symptoms persist despite treatment, further investigations should be considered. If you take Pantoprazolo Zentiva Italia for long-term treatment (longer than 1 year), your doctor will probably keep you under regular control. You should report any new or unusual symptom or circumstance whenever you see your doctor.

Children and adolescents
The use of Pantoprazolo Zentiva Italia is not recommended in children, as its efficacy has not been demonstrated in children under 12 years of age.

Other medicines and Pantoprazolo Zentiva Italia
Tell 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 Pantoprazolo Zentiva Italia can affect the effectiveness of other medicines, so tell 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) because Pantoprazolo Zentiva Italia may prevent these and other medicines from working properly.
• warfarin and phenprocoumone ,which affect blood thickening or thinning. You may need further checks.
• 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 suspend treatment with Pantoprazolo Zentiva Italia because pantoprazole can increase methotrexate levels in the blood.
• fluvoxamine (used to treat depression and other psychiatric illnesses) - 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).

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Talk to your doctor before taking pantoprazole if you are to undergo a particular urine test
(for THC, tetrahydrocannabinol).

Pregnancy, breastfeeding and fertility
There are no adequate data regarding the use of pantoprazole in pregnant women. Excretion in human milk has been reported. If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking
this medicine.
You should only use this medicine if your doctor considers the benefit to you greater than the potential risk
to the fetus or the baby.

Driving and operating machinery
Pantoprazolo Zentiva Italia does not alter or negligibly alters the ability to drive vehicles and use
machinery. If you experience side effects such as dizziness or vision problems, you should not drive or use
machinery.

Pantoprazolo Zentiva Italia contains soy lecithin, maltitol and sodium
If you are allergic to peanuts or soy, do not use this medicine.
If you have been told by your doctor that you have an intolerance to certain sugars, contact 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 following exactly the instructions of your doctor or pharmacist. If you have
doubts, consult your doctor or pharmacist.

Method of administration
Take the tablets 1 hour before a meal without chewing or crushing them and swallow them whole with a little
water.
The recommended dose is:

Adults and adolescents 12 years and over

For the treatment of symptoms associated with gastroesophageal reflux disease (e.g. heartburn, acid regurgitation,
pain when swallowing)
The usual dose is one tablet a day. This dose normally provides relief in 2 - 4 weeks - at
most after another 4 weeks. Your doctor will tell you how long to continue taking the medicine.
After that, any recurrence of symptoms can be controlled by taking one tablet a day, as
needed.

For long-term treatment and prevention of recurrent reflux esophagitis
The usual dose is one tablet a day. If the disease recurs, your doctor may double the dose, in
which case you may instead use Pantoprazolo Zentiva 40 mg, one tablet a day. After healing, you
can reduce the dose back to one 20 mg tablet a day.

Adults

For the prevention of duodenal and gastric ulcers in patients who require continuous treatment
with NSAIDs
The usual dose is one tablet a day.

Patients with liver problems:

• If you suffer from severe liver problems, you should not take more than one 20 mg tablet a day. Use in children and adolescents

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• 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. No symptoms of overdose are known.

If you forget to take Pantoprazolo Zentiva Italia
Do not take a double dose to make up for a missed dose. Take the next normal dose
at the scheduled 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, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
manifest them.

If you experience any of the following side effects, stop taking these tablets and
consult your doctor immediately, or contact the nearest hospital emergency room:

• Severe allergic reactions (rare frequency:can affect up to 1 in 1,000 people ):swelling of the tongue and/or throat, difficulty swallowing, hives, difficulty breathing, allergic swelling of the face (angioedema / Quincke's edema), severe dizziness with a very fast heartbeat and profuse sweating.
• Serious skin conditions (frequency not known:the frequency cannot be defined based on available data ):you may notice one or more of the following effects: 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, especially in areas of skin exposed to light/sun. You may also have joint pain or flu-like symptoms, fever, swollen glands (e.g. under the armpit) and blood tests may show changes in white blood cell count or liver enzymes.
• reddish, non-raised, circular or target-shaped spots on the trunk, often with blisters in the center, skin peeling, ulcers on 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 rash, high fever and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).
• Other serious conditions (frequency not known):yellowing of the skin or whites of the eyes (serious damage to liver cells, jaundice) or fever, rash, and enlargement of the kidneys sometimes with pain when urinating and lower back pain (serious kidney inflammation that can lead to possible kidney failure).

Other side effects are:

Common(may affect up to 1 in 10 people)

• benign polyps in the stomach.

Uncommon(may affect up to 1 in 100 people)

• headache; dizziness; diarrhea; nausea, vomiting; abdominal distension and flatulence (gas); constipation; dry mouth; abdominal pain and feeling unwell; rash,

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rash, eruption; itching; feeling of weakness, fatigue or general malaise; sleep disturbances, hip, wrist or spine fracture.

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

• alteration or complete loss of taste, visual disturbances such as blurred vision; hives; joint pain; muscle pain; weight changes; increased body temperature; high fever; swelling of the extremities (peripheral edema); allergic reactions; depression; increased breast volume in men.

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

• disorientation .

Frequency not known(the frequency cannot be defined on the basis of the available data)

• hallucinations, confusion (especially in patients with a history of these symptoms), tingling, pins and needles, burning or numbness, erythema, possible joint pain, inflammation of the colon, causing persistent watery diarrhea.

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

• an increase in liver enzymes.

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

• an increase in bilirubin; increased levels of fat in the blood; drastic decrease in circulating granulocytes, associated with high fever.

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

• a reduction in the number of platelets, which may cause more bleeding or bruising than normal; a reduction in the number of white blood cells, which may lead to more frequent infections; coexisting abnormal reduction in the number of red blood cells, white blood cells, and platelets.
• Frequency not known(the frequency cannot be estimated from available data)
• - decrease in the level of sodium, magnesium, calcium or potassium in the blood (see section 2).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist.
You can also report side effects directly through 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 on the carton after Scad.
The expiry date refers to the last day of that month.
For tablets packaged in plastic bottles: Pantoprazolo Zentiva Italia must be used within
three months of the first opening of the bottle.
Do not store at a temperature above 25°C
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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 Pantoprazolo Zentiva Italia contains:
The active ingredient is: pantoprazole.
Each gastro-resistant tablet contains 20 mg of pantoprazole (as pantoprazole sodium sesquihydrate).
The other ingredients are:

Tablet core
Maltitol (E 965), crospovidone type B, sodium carboxymethylcellulose, anhydrous sodium carbonate (E 500), calcium stearate.

Tablet coating
Polyvinyl alcohol, talc (E 553b), titanium dioxide (E 171), macrogol 3350, soybean lecithin (E 322), iron oxide
yellow (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 contents of the pack:
The gastro-resistant tablets of Pantoprazolo Zentiva Italia are oval, yellow.
Pantoprazolo Zentiva Italia is available in blister packs of 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 packs
in bottles of 14, 15, 28, 30, 50, 56, 60, 90, 100, 140, 140 (10x14) (5x28), 280 (20x14) (10x28), 500, 700
(5x140) gastro-resistant tablets.
*only marketed in Germany
Not all pack sizes may be marketed.

Marketing Authorisation 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 is authorised in the Member States of the European Economic Area (EEA) with the
following denominations
DE: Pantoprazol Winthrop 20 mg magensaftresistente Tabletten
FR: Pantoprazole Zentiva 20 mg, comprimé gastro-résistant
IT: Pantoprazolo Zentiva Italia
PT: Pantoprazol Zentiva
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