Pantosis Max

Package Leaflet: Information for the User

Pantosis Max, 20 mg, Gastro-Resistant Tablets

Pantoprazole

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in the package leaflet or as directed by your doctor or pharmacist. However, to achieve good treatment results, Pantosis Max should be taken with caution.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult your pharmacist or doctor.
• If you experience any side effects, including any possible side effects not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• If after 14 days there is no improvement or you feel worse, contact your doctor.
• Do not take Pantosis Max for more than 4 weeks without consulting your doctor.

Table of Contents of the Leaflet

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

1. What is Pantosis Max and what is it used for

The active substance of Pantosis Max is pantoprazole, which blocks the enzyme that produces stomach acid. This reduces the amount of acid in the stomach.
Pantosis Max is used for short-term treatment of symptoms of gastroesophageal reflux disease (such as heartburn, acid reflux) in adults. Reflux occurs when acid from the stomach flows back into the esophagus, which can lead to inflammation of the esophagus and cause pain. Symptoms such as burning chest pain (heartburn), sour taste in the mouth (acid reflux), and others may also occur.
Pantosis Max can relieve symptoms of reflux disease (such as heartburn, acid reflux) after the first day of use, but it is not a medicine intended for immediate relief of symptoms. To achieve complete relief of symptoms, it may be necessary to take the tablets for 2 to 3 consecutive days.

2. Important information before taking Pantosis Max

When not to take Pantosis Max:

• if you are allergic to pantoprazole or any of the other ingredients of this medicine (listed in section 6);
• if you are taking HIV protease inhibitors, such as atazanavir, nelfinavir (used to treat HIV infection). See "Pantosis Max and other medicines";
• in children and adolescents under 18 years of age;
• in pregnant or breastfeeding women.

Warnings and precautions

Before starting treatment with Pantosis Max, discuss it with your doctor if you:

• have been treated for heartburn or indigestion continuously for 4 or more weeks;
• are over 55 years old and take over-the-counter indigestion medicines every day;
• are over 55 years old and have noticed new or changed symptoms;
• have had stomach ulcers or stomach surgery;
• have liver problems or jaundice (yellowing of the skin and eyes);
• are under regular medical supervision for other serious conditions or diseases;
• are going to have an endoscopy or urease test (test for the presence of Helicobacter pylori bacteria);
• have ever had a skin reaction after taking a medicine similar to Pantosis Max that reduces stomach acid production;
• are scheduled for a specific blood test (chromogranin A levels);
• are taking HIV protease inhibitors, such as atazanavir or nelfinavir (used to treat HIV infection), you should ask your doctor for specific advice.

Do not take this medicine without consulting your doctor for a period longer than 4 weeks. If symptoms of reflux disease (heartburn or acid reflux) persist for more than 2 weeks, you should consult your doctor, who will decide whether long-term use of the medicine is necessary.
Long-term use of Pantosis Max may be associated with additional risks, such as:

• reduced absorption of vitamin B and vitamin B deficiency in case of low vitamin B levels in the body;
• hip, wrist, or spine fractures, especially if you already have osteoporosis or are taking corticosteroids (which can increase the risk of osteoporosis);
• decreased magnesium levels in the blood (possible symptoms: fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, rapid heartbeat). Low magnesium levels can also lead to decreased potassium and calcium levels in the blood. If you are taking this medicine for more than 4 weeks, you should consult your doctor. Your doctor may order regular blood tests to monitor magnesium levels.

Tell your doctor immediatelybefore or after taking this medicine if you notice the occurrence of the following symptoms, which may be signs of other, more serious diseases:

• unintentional weight loss (not related to diet or exercise);
• vomiting, especially recurring;
• bloody vomiting, which may look like dark coffee grounds;
• blood in the stool, black or tarry stools;
• difficulty swallowing or pain when swallowing;
• pallor and weakness (anemia);
• chest pain;
• abdominal pain;
• severe and/or persistent diarrhea (as the use of this medicine is associated with a slight increase in the risk of infectious diarrhea);

If you are going to have a blood test, you should inform your doctor that you are taking this medicine.
It is possible that you may experience relief from reflux and heartburn symptoms after just one day of taking Pantosis Max. However, this medicine is not intended for immediate relief of symptoms.
Do not use it as a preventive measure.
If you have been suffering from recurring heartburn or indigestion for some time, you should remain under regular medical supervision.

Children and Adolescents

Pantosis Max should not be used in children and adolescents under 18 years of age due to the lack of data on the safety of this medicine in this age group.

Pantosis Max and Other Medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.
Pantosis Max may affect the efficacy of other medicines. This is especially true for medicines containing the following active substances:

• HIV protease inhibitors, such as atazanavir, nelfinavir (used to treat HIV infection). Do not take Pantosis Max with HIV protease inhibitors. See "When not to take Pantosis Max";
• ketokonazole (used to treat fungal infections);
• warfarin and phenprocoumon (affecting blood density and preventing blood clots). Additional blood tests may be necessary;
• methotrexate (used to treat rheumatoid arthritis, psoriasis, and cancer). If you are taking methotrexate, your doctor may temporarily discontinue the use of Pantosis Max, as pantoprazole may increase methotrexate levels in the blood.

Do not take Pantosis Max with medicines that reduce the amount of acid produced in the stomach, such as other proton pump inhibitors (omeprazole, lansoprazole, or rabeprazole) or H2 antagonists (e.g., ranitidine, famotidine).
Pantosis Max can be taken with antacids (e.g., magaldrate, alginic acid, sodium bicarbonate, aluminum hydroxide, magnesium carbonate, or their combinations) if necessary.

Pantosis Max with Food and Drink

Take the tablets before a meal, swallow them whole, and wash them down with water.

Pregnancy and Breastfeeding

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.
Do not take Pantosis Max if you are pregnant, if pregnancy is not ruled out, or if you are breastfeeding.

Driving and Using Machines

If you experience side effects such as dizziness or vision disturbances, do not drive or operate machinery.

Pantosis Max Contains Lactose and Sodium

The medicine contains lactose. If you have been diagnosed with intolerance to some sugars, you should contact your doctor before taking the medicine.
The medicine contains 1.34 mg of sodium per dose. This should be taken into account in patients with reduced kidney function and in patients controlling their sodium intake.

3. How to Take Pantosis Max

This medicine should always be taken exactly as described in the package leaflet or as directed by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist.
The recommended dose is one tablet per day. Do not take a daily dose greater than 20 mg.
The medicine should be taken for at least 2-3 consecutive days. You should stop taking Pantosis Max after complete relief of symptoms. It is possible to experience relief from reflux and heartburn symptoms after just one day of taking Pantosis Max, but remember that this medicine is not intended for immediate relief of symptoms.
Consult your doctor if, after taking this medicine for 2 weeks, symptoms do not improve.
Do not take Pantosis Max for more than 4 weeks without consulting your doctor.
Take the tablets before a meal, every day at the same time. Swallow the tablets whole, with plenty of water, do not chew or divide them.

Use in Children and Adolescents

Do not use in children and adolescents under 18 years of age.

Taking More Than the Recommended Dose of Pantosis Max

Immediately inform your doctor or pharmacist if you have taken more than the recommended dose of Pantosis Max. If possible, bring the medicine and the package leaflet with you.

Missing a Dose of Pantosis Max

Do not take a double dose to make up for a missed dose. Take the next scheduled dose the next day at the usual time.
If you have any further doubts about taking the medicine, consult your doctor or pharmacist.

4. Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell your doctor immediatelyor contact the nearest hospital if you experience any of the following serious side effects.At the same time, stop taking this medicine, but bring the package leaflet and/or tablets with you.

• Severe allergic reactions (rare: may occur in less than 1 in 1000 people):hypersensitivity reactions, so-called anaphylactic reactions, anaphylactic shock, angioedema. Typical symptoms include: swelling of the face, lips, tongue, and/or throat, which may cause difficulty swallowing or breathing, hives, severe dizziness with rapid heartbeat and excessive sweating.
• Severe skin reactions (frequency not known: frequency cannot be estimated from the available data):rash with swelling, blisters, or peeling of the skin, patchy skin peeling, bleeding from the eyes, nose, mouth, or genitals, and rapid deterioration of general condition. Rash on sun exposure.
• Other serious reactions (frequency not known):yellowing of the skin and whites of the eyes (due to severe liver damage), kidney problems with painful urination, back pain with fever.

Other side effects include:

• Common (may occur in less than 1 in 10 people):mild stomach polyps.
• Uncommon (may occur in less than 1 in 100 people):headache; dizziness; diarrhea; nausea; vomiting; bloating and gas; constipation; dry mouth; abdominal pain and discomfort; skin rash or hives; itching; weakness, fatigue, or malaise; sleep disturbances; increased liver enzyme activity (found in blood tests); hip, wrist, or spine fractures.

biodra, nadgarstka lub kręgosłupa.

• Rare (may occur in less than 1 in 1000 people):taste disturbances or complete loss of taste; vision disturbances, such as blurred vision; joint pain; muscle pain; weight changes; elevated body temperature; swelling of the limbs; depression; increased bilirubin and lipid levels in the blood (found in blood tests); breast enlargement in men; high fever and sudden decrease in the number of circulating granulocytes - white blood cells (found in blood tests)..
• Very Rare (may occur in less than 1 in 10,000 people):disorientation; decreased platelet count, which may cause increased tendency to bleeding and bruising; decreased white blood cell count, which may lead to more frequent infections; concurrent, abnormal decrease in red and white blood cell count, as well as platelet count (found in blood tests).
• Frequency Not Known (frequency cannot be estimated from the available data):hallucinations (perceiving non-existent objects or people); confusion (especially in patients who have experienced such symptoms), decreased sodium levels in the blood; decreased magnesium levels in the blood; rash that may be accompanied by joint pain, feeling of tingling, pricking, burning, or numbness, colitis causing persistent watery diarrhea.

Reporting Side Effects

If you experience any side effects, including any possible side effects not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products;
Jerozolimskie Avenue 181C; PL-02-222 Warsaw
Phone: +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.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to Store Pantosis Max

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister (after the EXP date). The expiry date refers to the last day of the month.
Do not store above 30°C.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the Pack and Other Information

What Pantosis Max Contains

• The active substance of Pantosis Max is pantoprazole. One tablet contains 20 mg of pantoprazole (in the form of pantoprazole sodium sesquihydrate).
• Other ingredients are: Core:microcrystalline cellulose; lactose monohydrate; sodium croscarmellose; colloidal anhydrous silica; magnesium stearate. Yellow coating (Opadry II 85F32081 Yellow):polyvinyl alcohol; macrogol 3350; titanium dioxide (E171); talc; yellow iron oxide (E172); quinoline yellow (E104). Enteric coating:triethyl citrate; talc; methacrylic acid and ethyl acrylate copolymer (1:1), 30% dispersion, containing: sodium lauryl sulfate, polysorbate 80, methacrylic acid and ethyl acrylate copolymer.

What Pantosis Max Looks Like and Contents of the Pack

Pantosis Max is a prolonged-release tablet, yellow to ochre in color.
The pack contains 7, 14, or 28 gastro-resistant tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Mercapharm Sp. z o.o.
Świętopełka 39
81-524 Gdynia, Poland

Manufacturer

Dose Innova, S.L.C/ de Sant Martí, 75-97,
Martorelles, 08107 Barcelona, Spain
Date of last revision of the leaflet:05/2020
The following lifestyle and dietary recommendations may also help alleviate heartburn or other acid-related symptoms:

• Avoiding large meals.
• Eating slowly.
• Quitting smoking.
• Limited consumption of alcohol and caffeine.
• Weight loss (in case of overweight).
• Avoiding tight clothing or belts.
• Avoiding eating meals later than three hours before bedtime.
• Sleeping with your head elevated (in case of nighttime symptoms).
• Limited consumption of foods that usually cause heartburn, such as: chocolate, peppermint, green mint, fatty and fried foods, acidic, spicy, citrus fruits and juices, tomatoes.