Pantoprazole aurovitas

Patient Information Leaflet

Pantoprazol Aurovitas, 40 mg, enteric-coated tablets
Pantoprazolum
Please read this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet Contents:

1. What Pantoprazol Aurovitas is and what it is used for
2. Important information before taking Pantoprazol Aurovitas
3. How to take Pantoprazol Aurovitas
4. Possible side effects
5. How to store Pantoprazol Aurovitas
6. Contents of the pack and other information

1. What Pantoprazol Aurovitas is and what it is used for

Pantoprazol Aurovitas contains the active substance pantoprazole. Pantoprazol Aurovitas is a selective proton pump inhibitor, a medicine that reduces the amount of acid produced in the patient's stomach. It is used in the treatment of stomach and intestinal disorders related to gastric acid.

Pantoprazol Aurovitas is used in the treatment of adults and adolescents aged 12 years and older for:

• Treatment of reflux esophagitis. This is inflammation of the esophagus (the tube connecting the throat to the stomach), associated with backflow of stomach acid.

Pantoprazol Aurovitas is used in the treatment of adults for:

• Treatment of infection with a bacterium called Helicobacter pylori in patients with peptic ulcer disease of the stomach and duodenum, in combination with two antibiotics (eradication therapy). The aim of this treatment is to eliminate the bacteria and reduce the risk of ulcer recurrence.
• Treatment of gastric and duodenal ulcers.
• Zollinger-Ellison syndrome and other conditions associated with excessive acid secretion in the stomach.

2. Information before using Pantoprazol Aurovitas

When not to use Pantoprazol Aurovitas

• If the patient is allergic to pantoprazole or any of the other ingredients of this medicine (listed in section 6).
• If the patient has previously experienced an allergic reaction to medicines containing other proton pump inhibitors.

Warnings and precautions
Before starting treatment with Pantoprazol Aurovitas, discuss this with your doctor or
pharmacist.

• If the patient has severe liver function impairment. The patient should inform the doctor if they have previously had liver problems. The doctor will monitor liver enzyme activity more frequently, especially if the patient is receiving long-term treatment with Pantoprazol Aurovitas. If liver enzyme activity increases, treatment should be discontinued.
• If the patient has vitamin B deficiency or risk factors for low vitamin B levels and is being treated long-term with pantoprazole. As with all medicines that reduce gastric acid secretion, pantoprazole use may lead to reduced absorption of vitamin B₁₂. Contact your doctor if you notice any of the following symptoms, which may indicate low vitamin B₁₂ levels:
  • Extreme fatigue or lack of energy
  • Tingling and burning sensations
  • Sore or red tongue, mouth ulcers
  • Muscle weakness
  • Blurred vision
  • Memory problems, confusion, depression
• If the patient is taking protease inhibitors for HIV, such as atazanavir, together with pantoprazole, medical advice should be sought.
• Taking proton pump inhibitors such as pantoprazole, particularly for more than one year, may slightly increase the risk of fractures of the hip, wrist, or spine. Inform your doctor if the patient has osteoporosis (reduced bone density) or has been told they are at risk of osteoporosis (for example, if the patient is taking steroids).
• If the patient takes Pantoprazol Aurovitas for longer than 3 months, a decrease in blood magnesium levels may occur. Low magnesium levels may cause symptoms such as fatigue, involuntary muscle spasms, confusion, seizures, dizziness, or rapid heartbeat. Seek immediate medical advice if any of these symptoms occur. Low magnesium levels may also lead to decreased potassium or calcium levels in the blood. The doctor may decide to perform regular blood tests to monitor magnesium levels.
• If the patient develops a skin rash, especially in areas exposed to sunlight, inform the doctor as soon as possible, as treatment with Pantoprazol Aurovitas may need to be discontinued. Also report any other adverse reactions such as joint pain.
• Serious skin reactions have been reported with pantoprazole treatment, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and erythema multiforme. Discontinue pantoprazole and contact your doctor immediately if any of the symptoms associated with these serious skin reactions (described in section 4) occur.
• If the patient is scheduled for a specific blood test (chromogranin A level).

Contact your doctor immediately, before or after taking the medicine, if the patient notices any of the following symptoms, which may indicate a different, more serious condition:

• Unintentional weight loss
• Vomiting, especially if recurrent
• Difficulty swallowing or pain when swallowing
• Vomiting blood, which may appear as dark, coffee-ground-like material
• Paleness or weakness (anaemia)
• Blood in the stool
• Chest pain
• Abdominal pain
• Severe and/or prolonged diarrhoea, as this medicine may slightly increase the risk of infectious diarrhoea.

The doctor may decide to carry out tests to rule out an underlying tumour, because treatment with pantoprazole may relieve symptoms of tumour-related disease and delay diagnosis. If symptoms persist despite treatment, further investigations should be considered.
If Pantoprazol Aurovitas is taken for a long period (longer than 1 year), the doctor will likely recommend regular monitoring. In such cases, report any new or unexpected symptoms and their circumstances during every doctor's visit.

Children and adolescents
Pantoprazol Aurovitas is not recommended for use in children, as efficacy has not been demonstrated in children under 12 years of age.

Pantoprazol Aurovitas and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
Pantoprazol Aurovitas may affect the effectiveness of other medicines, so inform your doctor if the patient is taking:

• Medicines such as: ketoconazole, itraconazole, or posaconazole (used to treat fungal infections) or erlotinib (used to treat certain types of cancer), because Pantoprazol Aurovitas may inhibit the proper action of these and other medicines.
• Warfarin or phenprocoumon, which affect blood clotting or thinning. This may require additional monitoring.
• Medicines used to treat HIV infection, such as atazanavir.
• Methotrexate (used to treat rheumatoid arthritis, psoriasis, and cancer) – if the patient is receiving methotrexate, the doctor may advise temporarily stopping Pantoprazol Aurovitas, as pantoprazole may increase methotrexate levels in the blood.
• Fluvoxamine (used to treat depression and other psychiatric disorders) – if the patient is taking fluvoxamine, the doctor may reduce the dose.
• Rifampicin (used to treat infections).
• St John's wort (Hypericum perforatum) (used to treat mild depression).

Consult your doctor before starting pantoprazole if a urine test for THC (tetrahydrocannabinol) is planned.

Pregnancy, breastfeeding and fertility
There is insufficient data on the use of pantoprazole in pregnant women. It has been reported that the active substance passes into breast milk.
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.
The patient should use this medicine only if the doctor considers the benefit of treatment to outweigh the potential risk to the unborn child or infant.

Driving and operating machinery
Pantoprazole has no effect or negligible effect on the ability to drive motor vehicles or operate mechanical equipment. However, the patient should not drive or operate machinery if adverse effects such as dizziness or visual disturbances occur.

Pantoprazol Aurovitas contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning it is considered "sodium-free".

3. How to use Pantoprazol Aurovitas

This medicine should always be used exactly as directed by your doctor or pharmacist. If you are unsure,
you should consult your doctor or pharmacist.
Method of administration
Do not chew or crush the tablets; swallow them whole with a small amount of water, one hour before a meal.
Recommended dose:
Adults and adolescents aged 12 years and older:
Treatment of reflux esophagitis
The usual dose is one tablet per day. Your doctor may increase the dose to two tablets per day.
The treatment period for reflux esophagitis usually lasts from 4 to 8 weeks. Your doctor will decide how long you should take the medicine.
Adults:
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, together with two antibiotic tablets selected from the following: amoxicillin,
clarithromycin, and metronidazole (or tinidazole); each antibiotic should be taken twice daily together with a pantoprazole tablet.
The first pantoprazole tablet should be taken one hour before breakfast, and the second pantoprazole tablet one hour before dinner.
Follow your doctor's instructions and read the package leaflets of the antibiotics being taken.
The treatment period usually lasts one to two weeks.
Treatment of gastric and duodenal ulcers
The usual dose is one tablet per day. After consultation with your doctor, the dose may be doubled.
Your doctor will decide how long you should take the medicine. The treatment period for gastric ulcer usually lasts from 4 to 8 weeks.
The treatment period for duodenal ulcer usually lasts from 2 to 4 weeks.
Long-term treatment of Zollinger-Ellison syndrome and other conditions associated with excessive
production of hydrochloric acid in the stomach
The usual initial dose is two tablets per day. These two tablets should be taken one hour before a meal.
Your doctor may then adjust the dose depending on the amount of hydrochloric acid secreted in the stomach.
If more than two tablets per day are prescribed, the medicine should be taken twice daily.
If your doctor prescribes more than four tablets per day, you will be given specific instructions on when to stop taking the medicine.
Patients with kidney problems
If you have kidney problems, you should not take Pantoprazol Aurovitas for the eradication of Helicobacter pylori infection.
Patients with liver problems
If you have severe liver problems, you should not take more than one 20 mg pantoprazole tablet per day (tablets containing 20 mg
pantoprazole are available for this purpose).
If you have moderate to severe liver problems, you should not take Pantoprazol Aurovitas for the eradication of Helicobacter pylori infection.
Children and adolescents
The tablets are not recommended for use in children under 12 years of age.
Taking more than the recommended dose of Pantoprazol Aurovitas
Consult your doctor or pharmacist. Symptoms of overdose are not known.
Missing a dose of Pantoprazol Aurovitas
Do not take a double dose to make up for a missed dose. Take the next scheduled dose at the usual time.
Stopping Pantoprazol Aurovitas
Do not stop taking the tablets without first consulting your doctor or pharmacist.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If any of the following adverse reactions occur, stop taking these tablets immediately and inform your doctor
or contact the emergency department of your nearest hospital without delay:

• Severe allergic reactions (rare: affecting fewer than 1 in 1,000 people): swelling of the tongue and/or throat, difficulty swallowing, urticaria (rash resembling nettle rash), breathing difficulties, angioedema of the face (Quincke's disease/angioedema), severe dizziness with very rapid heartbeat and profuse sweating.
• Severe skin reactions (frequency unknown: frequency cannot be estimated from available data): the patient may experience one or more of the following symptoms – formation of skin blisters and rapid deterioration in general condition, erosions (with slight bleeding) of the eyes, nose, mouth/oral cavity or genital organs, or skin hypersensitivity/rash, particularly in areas of skin exposed to light/sunlight. Joint pain or flu-like symptoms, fever, swollen lymph nodes (e.g. under the arm) may also occur, and blood tests may show changes in certain white blood cells or liver enzymes.
• Reddish, flat, target-like or round spots on the trunk, often with central blisters, skin peeling, ulceration of the mouth, throat, nose, genital organs and eyes. These serious skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Widespread rash, high body temperature and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).
• Other severe reactions (frequency unknown: frequency cannot be estimated from available data): yellowing of the skin or whites of the eyes (severe liver cell damage, jaundice) or fever, rash and enlarged kidneys, sometimes accompanied by painful urination and back pain (severe kidney inflammation), which may lead to kidney failure.

Other adverse reactions include:

• Common (affecting fewer than 1 in 10 people): Benign gastric polyps.
• Uncommon (affecting fewer than 1 in 100 people): Headache; dizziness; diarrhoea; nausea; vomiting; flatulence (passing wind); constipation; dryness of the mouth; abdominal pain and discomfort; skin rash, eruption, skin lesions; itching; feeling of weakness, exhaustion and general malaise; sleep disturbances, fractures of the hip, wrist or spine.
• Rare (affecting fewer than 1 in 1,000 people): Taste disturbances or complete loss of taste; visual disturbances such as blurred vision; urticaria; joint pain; muscle pain; changes in body weight; elevated body temperature; high fever; swelling of limbs (peripheral oedema); allergic reactions; depression; breast enlargement in males.
• Very rare (affecting fewer than 1 in 10,000 people): Disorientation.
• Frequency not known (frequency cannot be estimated from available data): hallucinations, confusion (particularly in patients who have previously experienced such symptoms); tingling sensation, pricking, pins and needles, burning and numbness; rash associated with joint pain; colitis causing persistent watery diarrhoea.

Adverse reactions identified from blood tests:

• Uncommon (affecting fewer than 1 in 100 people): increased liver enzyme activity.
• Rare (affecting fewer than 1 in 1,000 people): increased bilirubin levels; increased blood lipid levels; acute decrease in white blood cell (granulocyte) count accompanied by high fever.
• Very rare (affecting fewer than 1 in 10,000 people): decreased platelet count, which may cause bleeding or bruising more easily than usual; decreased white blood cell count, which may lead to more frequent infections; concurrent abnormal decrease in red blood cells, white blood cells and platelets.
• Frequency not known (frequency cannot be estimated from available data): decreased blood sodium, magnesium, calcium or potassium levels (see section 2).

Reporting of adverse reactions
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: + 48 22 49 21 301, fax: + 48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Pantoprazol Aurovitas

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after: EXP. The expiry date refers to the last day of the stated month.
This medicine does not require any special storage conditions.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the packaging and other information

What Pantoprazol Aurovitas contains

• The active substance is pantoprazole. Each enteric-coated tablet contains 40 mg of pantoprazole (as sodium pantoprazole sesquihydrate).

The other ingredients are:
Tablet core: sodium carbonate, mannitol, crospovidone (type B), hydroxypropylcellulose, calcium stearate.
Coating: hypromellose, iron oxide yellow (E 172), copolymer of methacrylic acid and ethyl acrylate (1:1) dispersion 30%, sodium lauryl sulfate, polysorbate 80, triethyl citrate.

What Pantoprazol Aurovitas looks like and contents of the pack

Enteric-coated tablet.
Yellow, oval, biconvex, coated enteric tablet, smooth on both sides.

Blister: Poliamide/Aluminium/PVC-Aluminium in a cardboard box.
Pack sizes: 7, 14, 15, 28, 30, 56, 60, 98, 100 and 500 enteric-coated tablets.

HDPE bottle: White, opaque, round HDPE container with a white, opaque polypropylene closure.
Pack sizes: 14, 28, 56, 60, 98, 100 and 500 enteric-coated tablets.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:
Aurovitas Pharma Polska Sp. z o.o.
ul. Sokratesa 13D lok.27
01-909 Warszawa

Manufacturer/Importer:
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
FRN 1913
Malta

This medicinal product is authorised in the European Economic Area member states under the following names:
Cyprus: Pantoprazole Aurobindo 40 mg γαστροανθεκτικό δισκία
France: Pantoprazole Aurobindo 40 mg comprimé gastro-resistant
Netherlands: Pantoprazole Aurobindo 40 mg maagsapresistente tabletten
Malta: Pantoprazole 40 mg gastro-resistant tablets
Germany: Pantoprazol Aurobindo 40 mg magensaftresistente Tablette
Poland: Pantoprazol Aurovitas
Italy: Pantoprazolo Aurobindo