Pantoprazole Zentiva: detailed information

PACKAGE LEAFLET: INFORMATION FOR THE USER

Pantoprazole Zentiva 40 mg gastro-resistant tablets

Equivalent medicine
Please read all of this 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 others, even if they have the same symptoms as you, because it could 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:

What Pantoprazole Zentiva is and what it is used for
What you need to know before taking Pantoprazole Zentiva
How to take Pantoprazole Zentiva
Possible side effects
How to store Pantoprazole Zentiva
Contents of the pack and other information

1. WHAT PANTOPRAZOLE ZENTIVA IS AND WHAT IT IS USED FOR

Pantoprazole Zentiva contains the active substance pantoprazole. Pantoprazole Zentiva 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.
Pantoprazole Zentiva is used for the treatment of adults and adolescents aged 12 years and older for:

Gastroesophageal reflux disease (oesophagitis). An inflammation of the oesophagus (the tube connecting the throat to the stomach) accompanied by regurgitation of gastric acid.
Pantoprazole Zentiva is used for the treatment of adults for:
Infection with a bacterium called Helicobacter pylori in patients with duodenal ulcer and gastric ulcer, in combination with two antibiotics (eradication therapy). The aim is to eliminate the bacteria in order to reduce the risk of recurrence of these ulcers.
Stomach and duodenal ulcers.
Zollinger-Ellison syndrome and other conditions in which excessive stomach acid is produced.

2. WHAT YOU SHOULD KNOW BEFORE TAKING PANTOPRAZOLE ZENTIVA

Do not take Pantoprazole Zentiva

If you are allergic to pantoprazole, peanuts, soy, or any of the other ingredients of this medicine listed in section 6, or to medicines taken as part of combination therapy.
If you are allergic to medicines containing other proton pump inhibitors.

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

If you have severe liver problems. Inform your doctor if you have previously had liver problems. Your doctor may arrange for more frequent monitoring of your liver enzymes, especially if you are taking Pantoprazole Zentiva for long-term treatment. If your liver enzymes increase, treatment should be discontinued.
If you have low body reserves or risk factors for vitamin B12 deficiency and are undergoing long-term treatment with pantoprazole. As with all agents that reduce acidity, pantoprazole may lead to reduced absorption of vitamin B12.
If you are taking protease inhibitors for HIV, such as atazanavir (for the treatment of HIV infection), consult your doctor for specific advice.
Taking a proton pump inhibitor such as pantoprazole, especially for more than one year, may slightly 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 have been taking Pantoprazole Zentiva for more than three months, your blood magnesium levels may decrease. Low magnesium levels can cause fatigue, involuntary muscle contractions, confusion, seizures, dizziness, 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 that reduces gastric 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. Remember to also report any other adverse effects such as joint pain.
If you are scheduled for a specific blood test (Chromogranin A). Inform your doctor immediately before or after taking this medicine if you notice any of the following symptoms, which could be signs of a more serious condition:
unintentional weight loss
vomiting, particularly if repeated
presence of blood in vomit; this may appear as dark coffee-ground material in the vomit
appearance of blood in stools, which may look dark or tarry
difficulty swallowing or pain when swallowing
you look pale and feel 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 malignant disease, as pantoprazole may also relieve symptoms of cancer and could lead to a delay in diagnosis. If your symptoms persist despite treatment, further investigations should be considered. If you are taking Pantoprazole Zentiva for long-term treatment (over 1 year), your doctor will likely monitor you regularly. You must report any new or unusual symptoms or circumstances each time you see your doctor.

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

Other medicines and Pantoprazole Zentiva
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines without a prescription.
Pantoprazole Zentiva may affect the effectiveness of other medicines, so 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 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 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).

Pregnancy, breastfeeding, and fertility
There are insufficient data on the use of pantoprazole in pregnant women. Excretion into human breast milk has been reported. If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
You should use this medicine only if your doctor considers the benefit to you to outweigh the potential risk to the fetus or infant.

Driving and using machines
Pantoprazole Zentiva does not affect or affects negligibly the ability to drive and use machines. However, if you experience adverse effects such as dizziness or visual disturbances, you should not drive or use machinery.

Pantoprazole Zentiva contains soybean lecithin, maltitol, and sodium
If you are allergic to peanuts or soy, 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 PANTOPRAZOLE ZENTIVA

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. Do not chew or crush them; swallow the tablets whole with a little water.
The recommended dose is:
For Adults and adolescents aged 12 years and older
For the treatment of reflux esophagitis
The usual dose is one tablet per day. Your doctor may instruct you to increase the dose to 2 tablets per day. The treatment period for reflux esophagitis is usually between 4 and 8 weeks. Your doctor will tell you how long to take the medicine.
For Adults
For the treatment of infection with a bacterium called Helicobacter pylori in patients with
duodenal ulcer and gastric ulcer, in combination with two antibiotics (eradication therapy).
One tablet twice daily plus two tablets of an antibiotic—either amoxicillin, clarithromycin, or metronidazole (or tinidazole)—each taken twice daily together with the pantoprazole tablet. Take the first pantoprazole tablet 1 hour before breakfast and the second pantoprazole tablet 1 hour before the evening meal. Follow your doctor’s instructions and make sure to read the package leaflet for these antibiotics. The usual treatment duration is one or two weeks.
For the treatment of gastric and duodenal ulcers
The usual dose is one tablet per day. After consulting your doctor, the dose may be doubled.
Your doctor will tell you how long to take the medicine. The treatment period for gastric ulcers is generally between 4 and 8 weeks. The treatment period for duodenal ulcers is generally between 2 and 4 weeks.
For long-term treatment of Zollinger-Ellison syndrome and other conditions in which excess stomach acid is produced
The recommended initial dose is usually two tablets per day.
Take both tablets 1 hour before a meal. Your doctor may subsequently adjust the dosage depending on the amount of gastric acid produced. If more than two tablets per day are prescribed, the tablets should be taken in two divided doses.
If your doctor prescribes a daily dosage exceeding four tablets, you will be given specific instructions on when to stop taking the medicine.
Patients with kidney problems

If you have kidney problems, you must not take Pantoprazole Zentiva 40 mg for Helicobacter pylori eradication.
Patients with liver problems
If you have severe liver problems, do not take more than one 20 mg pantoprazole tablet per day (tablets containing 20 mg of pantoprazole are available for this purpose).
If you have severe or moderate liver problems, you must not take Pantoprazole Zentiva for Helicobacter pylori eradication.
Use in children and adolescents
These tablets are not recommended for use in children under 12 years of age.

If you take more Pantoprazole Zentiva than you should
Consult your doctor or pharmacist. Symptoms of overdose are not known.
If you forget to take Pantoprazole Zentiva
Do not take a double dose to make up for the missed dose. Take your next dose at the usual scheduled time.
If you stop taking Pantoprazole Zentiva
Do not stop treatment with these tablets without first consulting your doctor or pharmacist.
If you have any doubts about how to use this product, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
If you experience any of the following adverse reactions, stop treatment with these tablets immediately and consult your doctor immediately, or contact 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 rapid heartbeat and profuse sweating.
Severe skin disorders (frequency not known: frequency cannot be estimated from the available data): appearance of skin blisters and rapid deterioration of general condition, erosion (including mild bleeding) of the eyes, nose, mouth/lips or genitals (Stevens-Johnson syndrome, Lyell syndrome, erythema multiforme), and photosensitivity.
Other severe disorders (frequency not known: frequency cannot be estimated from the available data): yellowing of the skin or whites of the eyes (severe liver cell damage, jaundice), or fever, skin rash, and kidney enlargement sometimes accompanied by painful urination and lower back pain (severe kidney inflammation which may lead to possible kidney failure).

Other adverse reactions are:
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, exanthema, eruption; pruritus; feeling of weakness, fatigue or general malaise; sleep disturbances; fractures 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 men.

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

disorientation.

Not known (frequency cannot be estimated from the available data)

hallucinations, confusion (especially in patients with prior experience of these symptoms); decreased sodium levels in the blood, decreased magnesium levels in the blood (see section 2), tingling sensation, pins and needles, burning sensation or numbness, erythema, possible joint pain, inflammation of the large intestine causing persistent watery diarrhoea.

Adverse reactions 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; marked decrease 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 and white blood cells as well as platelets.

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, please inform your doctor, pharmacist or nurse.
You may also report adverse reactions directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. HOW TO STORE PANTOPRAZOLE ZENTIVA

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.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. PACKAGING CONTENTS AND OTHER INFORMATION

What Pantoprazolo Zentiva contains
The active substance is: pantoprazole.
Each gastro-resistant tablet contains 40 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, soya 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 and packaging contents
Pantoprazolo Zentiva gastro-resistant tablets are oval-shaped and yellow.
Pantoprazolo Zentiva is available in packages of 14 and 28 tablets in blisters.
Marketing Authorization Holder
Zentiva Italia S.r.l. - Viale Bodio 37/b, 20158 Milan
Manufacturers
Sanofi-Aventis Sp. z o.o.
ul. Lubelska, 52 - 35-233 Rzeszów (Poland)