PANTOPRAZOL 40 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Pantoprazol Aurovitas, 40 mg, Gastro-Resistant Tablets
   1. Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.
   2. Table of Contents of the Package Leaflet:
3. What is Pantoprazol Aurovitas and what is it used for
4. Important information before taking Pantoprazol Aurovitas
   1. When not to take Pantoprazol Aurovitas
   2. Warnings and precautions
   3. Children and adolescents
   4. Pantoprazol Aurovitas and other medicines
   5. Pregnancy, breastfeeding, and fertility
   6. Driving and using machines
   7. Pantoprazol Aurovitas contains sodium
5. How to take Pantoprazol Aurovitas
   1. Method of administration
   2. Treatment of reflux oesophagitis
   3. Treatment of Helicobacter pyloriinfection in patients with duodenal and stomach ulcers, in combination with two antibiotics (eradication therapy)
   4. Treatment of stomach and duodenal ulcers
   5. Long-term treatment of Zollinger-Ellison syndrome and other conditions where too much acid is produced in the stomach
   6. Patients with kidney problems
   7. Patients with liver problems
   8. Children and adolescents
   9. Taking a higher dose of Pantoprazol Aurovitas than recommended
   10. Missing a dose of Pantoprazol Aurovitas
   11. Stopping treatment with Pantoprazol Aurovitas
6. Possible side effects
   1. If you experience any of the following side effects, stop taking the tablets and tell your doctor immediately or contact the emergency department of your nearest hospital:
   2. Severe skin reactions (frequency not known: frequency cannot be estimated from the available data): the patient may experience one or more of the following symptoms -
   3. Other severe reactions (frequency not known: frequency cannot be estimated from the available data):
   4. Other side effects:
   5. Side effects identified from blood tests:
   6. Reporting side effects
7. How to store Pantoprazol Aurovitas
8. Contents of the pack and other information
   1. What Pantoprazol Aurovitas contains
   2. What Pantoprazol Aurovitas looks like and contents of the pack
   3. Marketing authorization holder and manufacturer
   4. Marketing authorization holder:
   5. Manufacturer/Importer:
   6. This medicinal product is authorized in the Member States of the European Economic Area under the following names:
   7. Date of last revision of the package leaflet: 03.2023

Package Leaflet: Information for the Patient

Pantoprazol Aurovitas, 40 mg, Gastro-Resistant Tablets

Pantoprazolum

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet:

• 1. What is Pantoprazol Aurovitas and what is it 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 is Pantoprazol Aurovitas and what is it 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 stomach. It is used for the treatment of diseases of the stomach and intestines that are caused by acid.

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

• reflux oesophagitis. Inflammation of the oesophagus (the tube that connects the throat to the stomach) accompanied by the return of acid from the stomach.

Pantoprazol Aurovitas is used for the treatment of adults for:

• treatment of an infection with a bacterium called Helicobacter pylori, in patients with duodenal and stomach ulcers, in combination with two antibiotics (eradication therapy). The goal of such treatment is to get rid of the bacteria and reduce the risk of ulcer recurrence.
• treatment of stomach and duodenal ulcers.
• treatment of Zollinger-Ellison syndrome and other conditions where too much acid is produced in the stomach.

2. Important information before taking Pantoprazol Aurovitas

When not to take Pantoprazol Aurovitas

• If you are allergic to pantoprazole or any of the other ingredients of this medicine (listed in section 6).
• If you have previously been diagnosed with an allergy to other proton pump inhibitors.

Warnings and precautions

Before taking Pantoprazol Aurovitas, discuss it with your doctor or pharmacist.

• If you have severe liver problems. You should inform your doctor if you have had liver problems in the past. Your doctor will monitor your liver enzymes more frequently, especially if you are taking Pantoprazol Aurovitas for a long time. If your liver enzymes increase, you should stop taking the medicine.
• If you have a deficiency of vitamin B12 or risk factors for a reduced vitamin B12 level and you are taking pantoprazole for a long time. As with all medicines that reduce acid production in the stomach, taking pantoprazole may lead to reduced absorption of vitamin B12.
• If you are taking HIV protease inhibitors such as atazanavir, you should consult your doctor.
• Taking proton pump inhibitors like pantoprazole, especially for more than one year, may slightly increase the risk of hip, wrist, and spine fractures. You should tell your doctor if you have osteoporosis (reduced bone density) or if you are taking corticosteroids.
• If you take Pantoprazol Aurovitas for more than 3 months, it is likely that you will experience a decrease in magnesium levels in your blood. Low magnesium levels can cause fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, and rapid heartbeat. You should consult your doctor immediately if you experience any of these symptoms. Low magnesium levels can also cause a decrease in potassium or calcium levels in your blood. Your doctor may decide to perform regular blood tests to monitor your magnesium levels.
• If you experience a skin rash, especially in areas exposed to sunlight, you should tell your doctor as soon as possible, as you may need to stop taking Pantoprazol Aurovitas. You should also tell your doctor about any other side effects, such as joint pain.
• If you are scheduled for a specific blood test (chromogranin A).

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

• unintentional weight loss
• vomiting, especially if it is repeated
• difficulty swallowing or pain when swallowing
• blood in vomit, which may appear as dark flecks
• pallor or weakness (anaemia)
• blood in stool
• chest pain
• abdominal pain
• severe and/or prolonged diarrhea, as this medicine may slightly increase the risk of infectious diarrhea.

Your doctor may decide to perform tests to rule out a malignant condition, as treatment with pantoprazole may alleviate the symptoms of the disease and delay its diagnosis. If your symptoms persist despite treatment, you should consider further testing.

Children and adolescents

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

Pantoprazol Aurovitas and other medicines

Tell your doctor or pharmacist about all the medicines you are taking, have recently taken, or might take.

• Medicines such as ketoconazole, itraconazole, and posaconazole (used to treat fungal infections) or erlotinib (used to treat certain types of cancer), as Pantoprazol Aurovitas may inhibit the proper functioning of these and other medicines.
• Warfarin or phenprocoumon, which affect blood clotting or thinning. This may require further monitoring.
• HIV medicines such as atazanavir.
• Methotrexate (used to treat rheumatoid arthritis, psoriasis, and cancer) - if you are taking methotrexate, your doctor may advise you to temporarily stop taking Pantoprazol Aurovitas, as pantoprazole may increase methotrexate levels in your blood.
• Fluvoxamine (used to treat depression and other mental disorders) - if you are taking fluvoxamine, your doctor may reduce the dose of the medicine.
• Rifampicin (used to treat infections).
• St. John's Wort (Hypericum perforatum) (used to treat mild depression).

Pregnancy, breastfeeding, and fertility

There is limited data on the use of pantoprazole in pregnant women. It has been reported that the active substance passes into breast milk.

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

You should only take this medicine if your doctor considers that the benefit of taking it is greater than the potential risk to the unborn child or baby.

Driving and using machines

Pantoprazole has no or negligible influence on the ability to drive and use machines. You should not drive or operate machines if you experience side effects such as dizziness or blurred vision.

Pantoprazol Aurovitas contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially “sodium-free”.

3. How to take Pantoprazol Aurovitas

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

Method of administration

Do not chew or crush the tablets; swallow them whole with a little water, 1 hour before a meal.

Recommended dose:

Treatment of reflux oesophagitis

The usual dose is one tablet per day. Your doctor may increase the dose to two tablets per day. The treatment period for reflux oesophagitis is usually 4 to 8 weeks. Your doctor will decide how long you should take the medicine.

Treatment of Helicobacter pyloriinfection in patients with duodenal and stomach ulcers, in combination with two antibiotics (eradication therapy)

One tablet twice a day, plus two antibiotic tablets from the following: amoxicillin, clarithromycin, and metronidazole (or tinidazole); each antibiotic should be taken twice a day with a pantoprazole tablet. The first pantoprazole tablet should be taken 1 hour before breakfast, and the second pantoprazole tablet 1 hour before dinner. You should follow the instructions given by your doctor and read the leaflets of the antibiotics you are taking.

Treatment period is usually 1 to 2 weeks.

Treatment of stomach and duodenal ulcers

The usual dose is one tablet per day. After consulting your doctor, the dose may be doubled. Your doctor will decide how long you should take the medicine. The treatment period for stomach ulcers is usually 4 to 8 weeks. The treatment period for duodenal ulcers is usually 2 to 4 weeks.

Long-term treatment of Zollinger-Ellison syndrome and other conditions where too much acid is produced in the stomach

The usual initial dose is two tablets per day. These two tablets should be taken 1 hour before a meal. Then, your doctor may adjust the dose of the medicine, depending on the amount of acid produced in your stomach. If your doctor prescribes more than two tablets per day, you should take the medicine twice a day.

If your doctor prescribes a dose greater than four tablets per day, he will inform you exactly when to stop taking the medicine.

Patients with kidney problems

If you have kidney problems, you should not take Pantoprazol Aurovitas to treat Helicobacter pyloriinfection.

Patients with liver problems

If you have severe liver problems, you should not take more than one 20 mg pantoprazole tablet per day (for this purpose, 20 mg pantoprazole tablets are available).

If you have moderate to severe liver problems, you should not take Pantoprazol Aurovitas to treat Helicobacter pyloriinfection.

Children and adolescents

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

Taking a higher dose of Pantoprazol Aurovitas than recommended

Consult your doctor or pharmacist. The symptoms of overdose are not known.

Missing a dose of Pantoprazol Aurovitas

Do not take a double dose to make up for a forgotten dose. Take the next planned dose at the usual time.

Stopping treatment with Pantoprazol Aurovitas

Do not stop taking the tablets without consulting your doctor or pharmacist first.

4. Possible side effects

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

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

• Severe allergic reactions (rare: less than 1 in 1,000 people):swelling of the tongue and/or throat, difficulty swallowing, hives (nettle rash), breathing difficulties, allergic swelling of the face (Quincke's oedema/angioedema), severe dizziness with very rapid heartbeat and profuse sweating.

Severe skin reactions (frequency not known: frequency cannot be estimated from the available data): the patient may experience one or more of the following symptoms -

blistering of the skin and rapid deterioration of the general condition, erosion (with minor bleeding) of the eyes, nose, mouth/throat, or genitals, or skin hypersensitivity/reaction, especially in areas of skin exposed to sunlight. Joint pain or flu-like symptoms, fever, swelling of lymph nodes (e.g., under the arm), and changes in some white blood cells or liver enzymes (Stevens-Johnson syndrome, Lyell's syndrome, erythema multiforme, subacute cutaneous lupus erythematosus, drug reaction with eosinophilia and systemic symptoms, DRESS, hypersensitivity to light).

Other severe reactions (frequency not known: frequency cannot be estimated from the available data):

jaundice (severe liver cell damage, jaundice) or fever, rash, and kidney enlargement, sometimes with painful urination and back pain (severe kidney inflammation), which can lead to kidney failure.

Other side effects:

• Frequent(less than 1 in 10 people): mild polyps in the stomach.
• Infrequent(less than 1 in 100 people): headache; dizziness; diarrhea; nausea; vomiting; bloating with gas (flatulence); constipation; dry mouth; abdominal pain and discomfort; skin rash, pruritus, erythema; feeling weak, tired, and unwell; sleep disturbances, fractures of the hip, wrist, or spine.
• Rare(less than 1 in 1,000 people): disturbance or loss of taste; visual disturbances, such as blurred vision; urticaria; arthralgia; myalgia; changes in body weight; elevated body temperature; high fever; peripheral oedema; allergic reactions; depression; gynaecomastia.
• Very rare(less than 1 in 10,000 people): disorientation.
• Frequency not known(frequency cannot be estimated from the available data): hallucinations, confusion (especially in patients who have experienced such symptoms before); feeling of tingling, prickling, tingling, burning, and numbness; rash that may be accompanied by joint pain, colitis (inflammatory bowel disease) causing persistent watery diarrhea.

Side effects identified from blood tests:

• Infrequent(less than 1 in 100 people): increased liver enzyme activity.
• Rare(less than 1 in 1,000 people): increased bilirubin levels; increased fat levels in the blood; acute decrease in white blood cell count (granulocytopenia) with high fever.
• Very rare(less than 1 in 10,000 people): decreased platelet count, which can cause bleeding or bruising more easily than usual; decreased white blood cell count, which can lead to more frequent infections; concurrent abnormal decrease in red and white blood cell and platelet counts.
• Frequency not known(frequency cannot be estimated from the available data): decreased sodium, magnesium, calcium, or potassium levels in the blood (see section 2).

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, 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

Side effects can also be reported to the marketing authorization holder.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Pantoprazol Aurovitas

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 carton after EXP. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Pantoprazol Aurovitas contains

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

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

What Pantoprazol Aurovitas looks like and contents of the pack

Gastro-resistant tablet.

Yellow, oval, biconvex, coated tablet, smooth on both sides.

Polyamide/Aluminium/PVC-Aluminium blister pack in a cardboard box.

Available pack sizes: 7, 14, 15, 28, 30, 56, 60, 98, 100, and 500 gastro-resistant tablets.

HDPE bottle: White, opaque, round HDPE container with a white, polypropylene, opaque closure.

Available pack sizes: 14, 28, 56, 60, 98, 100, and 500 gastro-resistant tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Aurovitas Pharma Polska Sp. z o.o.

ul. Sokratesa 13D lok.27

01-909 Warsaw

Manufacturer/Importer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

FRN 1913

Malta

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Cyprus:

Pantoprazole Aurobindo 40 mg γαστροανθεκτικό δισκία

France:

Pantoprazole Aurobindo 40 mg comprimé gastro-résistant

Netherlands:

Pantoprazole Aurobindo 40 mg maagsapresistente tabletten

Malta:

Pantoprazole 40 mg gastro-resistant tablets

Germany:

Pantoprazol Aurobindo 40 mg magensaftresistente Tablette

Poland:

Pantoprazol Aurovitas

Romania:

Pantoprazol Aurobindo 40 mg comprimate gastrorezistente

Italy:

Pantoprazolo Aurobindo

Date of last revision of the package leaflet: 03.2023