Package leaflet: Information for the user

Pantosis Max, 20 mg, enteric-coated tablets
Pantoprazole
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.
This medicine should always be taken exactly as described in this patient leaflet or as directed by your
doctor or pharmacist. However, to achieve a good treatment outcome, Pantosis Max should be used carefully.

Keep this leaflet, as you may need to read it again.
If you need advice or further information, please consult your pharmacist or doctor.
If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement after 14 days, or if you feel worse, you should contact your doctor.
Do not take Pantosis Max for longer than 4 weeks without consulting your doctor.

Leaflet contents
1 What Pantosis Max is and what it is used for
2 What you need to know 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 Pantosis Max is and what it is used for

The active substance in Pantosis Max is pantoprazole, which blocks the enzyme responsible for producing gastric acid. In this way, the medicine 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 regurgitation) in adults. Reflux refers to the backflow of stomach acid into the oesophagus, which may lead to inflammation of the oesophagus and cause pain. Other symptoms may include: painful burning sensation in the chest rising up to the throat (heartburn), sour taste in the mouth (acid regurgitation).
Pantosis Max may relieve symptoms associated with gastroesophageal reflux (such as heartburn, acid regurgitation) as early as on the first day of treatment, but it is not intended for immediate relief of symptoms. To achieve full symptom relief, 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 the patient is allergic to pantoprazole or any of the other ingredients of this medicine (listed in section 6);
if the patient is taking protease inhibitors for HIV, such as atazanavir, nelfinavir (used in the treatment of HIV infection). See "Pantosis Max with other medicines";
in children and adolescents under 18 years of age;
in women who are pregnant or breastfeeding.

Warnings and precautions
Before starting Pantosis Max, discuss with the doctor if the patient:

is being treated for heartburn or indigestion continuously for 4 or more weeks;
is over 55 years old and takes over-the-counter antacids daily;
is over 55 years old and has noticed new or worsening symptoms;
has a history of peptic ulcer disease or previous stomach surgery;
has liver problems or jaundice (yellowing of the skin and eyes);
is under continuous medical supervision due to other serious conditions or diseases;
is scheduled for an endoscopic examination or urease test (test for Helicobacter pylori infection);
has ever had a skin reaction to a medicine similar to Pantosis Max that reduces gastric acid secretion;
has a planned specific blood test (chromogranin A level);
is taking protease inhibitors for HIV, such as atazanavir or nelfinavir (used in the treatment of HIV infection) together with pantoprazole, should consult the doctor for detailed advice.

This medicine should not be taken without consulting a doctor for longer than 4 weeks. If
symptoms of gastroesophageal reflux disease (heartburn or acid regurgitation) persist for more than 2 weeks, the patient should
consult a doctor, who will decide whether long-term treatment 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;
fracture of the hip, wrist, or spine, especially if the patient already has osteoporosis or is taking corticosteroids (which may increase the risk of osteoporosis);
decreased magnesium levels in the blood (possible symptoms: fatigue, involuntary muscle spasms, disorientation, seizures, dizziness, rapid heartbeat). Low magnesium levels may also lead to decreased potassium and calcium levels in the blood. If the medicine is taken for longer than 4 weeks, the patient should consult a doctor. The doctor may recommend regular blood tests to monitor magnesium levels.

The patient should immediately inform the doctor before or after taking this medicine if they
notice the appearance of the following symptoms, which may indicate other, more serious
conditions:

unintentional weight loss (not related to diet or exercise);
vomiting, especially recurrent;
bloody vomit, which may look like dark coffee grounds;
blood in stool, black or tarry stools;
difficulty swallowing or pain during swallowing;
pallor and weakness (anaemia);
chest pain;
abdominal pain;
severe and (or) persistent diarrhoea (because use of this medicine is associated with a slightly increased risk of infectious diarrhoea);
if the patient develops a skin rash, especially in areas exposed to sunlight, they should inform the doctor as soon as possible, as discontinuation of Pantosis Max may be necessary. The patient should also report any other adverse reactions such as joint pain. The doctor may decide that additional tests are necessary.

If the patient is scheduled for a blood test, they should inform the doctor about taking this
medicine.
The patient may notice improvement in reflux and heartburn symptoms as early as one day
after starting Pantosis Max. However, this is not a medicine intended for immediate relief of
symptoms.
It should not be used preventively.
If the patient has been suffering from recurrent heartburn or indigestion symptoms for some time,
they 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
lack of data on safety of use of this medicine in this age group.
Pantosis Max with other medicines
The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Pantosis Max may reduce the effectiveness of other medicines. This particularly applies to medicines containing one of the following active substances:

protease inhibitors for HIV, such as atazanavir, nelfinavir (used in the treatment of HIV infection). Pantosis Max must not be used together with protease inhibitors for HIV. See "When not to take Pantosis Max";
ketoconazole (used for fungal infections);
warfarin and phenprocoumon (affect blood clotting and prevent thrombosis). Additional blood testing may be necessary;
methotrexate (used in the treatment of rheumatoid arthritis, psoriasis, and cancer). When methotrexate is used, the doctor may temporarily discontinue Pantosis Max, as pantoprazole may increase methotrexate blood levels.

Pantosis Max should not be taken together with medicines that reduce stomach acid production,
such as other proton pump inhibitors (omeprazole, lansoprazole or rabeprazole) or
H2 antagonists (e.g. ranitidine, famotidine).
Pantosis Max may be taken, if necessary, together with antacids (e.g. magaldrate, alginic acid, sodium bicarbonate, aluminium hydroxide, magnesium carbonate, or their combinations).
Pantosis Max with food and drink
Tablets should be taken before a meal, swallowed whole with water.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult a doctor or pharmacist before taking this medicine.
Pantosis Max should not be used in pregnant women, in women in whom pregnancy cannot be excluded, or in women who are breastfeeding.
Driving and operating machinery
If the patient experiences adverse effects such as dizziness or visual disturbances, they should not drive or operate machinery.
Pantosis Max contains lactose and sodium
This medicine contains lactose. If the patient has previously been diagnosed with intolerance to certain sugars, they should contact their doctor before taking this medicine.
This medicine contains 1.34 mg of sodium per dose. This should be taken into account in patients with impaired kidney function and in patients controlling sodium intake in their diet.

3. How to use Pantosis MAX

This medicine should always be taken exactly as described in the patient information leaflet or as directed by a doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
The recommended dose is 1 tablet per day. The daily dose should not exceed 20 mg.
The medicine should be taken for at least 2–3 consecutive days. Treatment with Pantosis MAX should be discontinued after complete resolution of symptoms. Relief of reflux and heartburn symptoms may occur already on the first day of taking Pantosis MAX; however, bear in mind that this medicine is not intended for immediate symptom relief.
Consult your doctor if symptoms do not improve after taking this medicine for a full period of 2 weeks.
Do not take Pantosis MAX for longer than 4 weeks without consulting a doctor.
Take the tablets before a meal, at the same time each day. Swallow the tablets whole with plenty of water. Do not chew or divide the tablets.

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

Taking more Pantosis MAX than recommended
If you take more medicine than recommended, inform your doctor or pharmacist immediately. If possible, bring the medicine and the package leaflet with you.

If you forget to take Pantosis MAX
Do not take a double dose to make up for a forgotten dose. Take the next scheduled dose at the usual time the following day.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone will experience them.
You should immediately inform your doctor or contact the nearest hospital if
any of the following serious adverse reactions occur. You should also stop using
this medicine, but take the package leaflet and (or) tablets with you.

Serious allergic reactions (rare: may occur in no more than 1 in 1,000 people): hypersensitivity reactions, so-called anaphylactic reactions, anaphylactic shock, angioedema. Typical symptoms include: swelling of the face, lips, mouth, tongue and (or) throat, which may cause difficulty in swallowing or breathing, urticaria, severe dizziness with rapid heartbeat and excessive sweating.
Serious skin reactions (frequency unknown: frequency cannot be estimated based on available data): rash with swelling, blisters or peeling of the skin, sheet-like peeling of the skin, bleeding from the eyes, nose, mouth or genital organs, and rapid deterioration of general condition. Rash after exposure to sunlight.
Other serious reactions (frequency unknown): yellowing of the skin and whites of the eyes (due to severe liver damage), kidney problems manifested by painful urination, pain in the lower back accompanied by fever.

Other adverse reactions include:

Common (may occur in no more than 1 in 10 people): benign gastric polyps.
Uncommon (may occur in no more than 1 in 100 people): headache; dizziness; diarrhoea; nausea; vomiting; bloating and flatulence; constipation; dryness of the mouth; abdominal pain and discomfort; skin rash or urticaria; itching of the skin; weakness, fatigue or malaise; sleep disturbances; increased liver enzyme activity (detected in blood tests); fracture of the hip, wrist or spine.
Rare (may occur in no more than 1 in 1,000 people): disturbances or complete loss of taste sensation; visual disturbances such as blurred vision; joint pain; muscle pain; changes in body weight; elevated body temperature; swelling of the limbs; depression; increased levels of bilirubin and lipids in the blood (detected in blood tests); breast enlargement in men; high fever and sudden decrease in circulating granulocytes – white blood cells (detected in blood tests).
Very rare (may occur in no more than 1 in 10,000 people): disturbances in orientation; decreased platelet count, which may lead to increased tendency to bleed and development of skin petechiae (bruises); decreased white blood cell count, which may predispose to more frequent infections; concurrent abnormal decrease in red blood cells, white blood cells and platelets (detected in blood tests).
Frequency unknown (frequency cannot be estimated based on available data): hallucinations (perception of non-existent objects or people); confusion (particularly in patients who have previously experienced such symptoms); decreased sodium concentration in the blood; decreased magnesium concentration in the blood; rash which may be accompanied by joint pain, tingling, pricking, burning or numbness sensations, inflammation of the large intestine causing persistent watery diarrhoea.

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

5. How to store Pantosis MAX

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister
(indicated after the EXP mark). The expiry date refers to the last day of the specified month.
Do not store above 30°C.
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 pack and other information

What Pantosis Max contains

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

What Pantosis Max looks like and contents of the pack
Pantosis Max is an elongated yellow to ochre film-coated tablet.
The pack contains 7, 14 or 28 enteric-coated tablets.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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

The following lifestyle recommendations and dietary changes may also help relieve heartburn or other symptoms related to gastric acid:

Avoid large meals.
Eat slowly.
Stop smoking.
Limit alcohol and caffeine intake.
Reduce body weight (if overweight).
Avoid tight clothing or belts.
Avoid eating meals less than three hours before lying down.
Sleep with the head elevated (in case of nocturnal symptoms).
Limit consumption of foods that commonly trigger heartburn, such as: chocolate, peppermint, spearmint, fatty and fried foods, spicy foods, citrus fruits and fruit juices, tomatoes.