Pantorena

Package Leaflet: Information for the User

Pantorena, 20 mg, Gastro-Resistant Tablets

Pantoprazole

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

This medicine should always be taken exactly as described in the package leaflet or as directed by your doctor, pharmacist, or nurse.

• You should keep this leaflet, you may need to read it again.
• If you have any further questions, ask your pharmacist.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor, pharmacist, or nurse. See section 4.
• If after 2 weeks there is no improvement or you feel worse, you should consult a doctor.
• You should not take Pantorena for more than 4 weeks without consulting a doctor.

Table of Contents of the Package Leaflet

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

1. What is Pantorena and what is it used for

The active substance of Pantorena is pantoprazole, which blocks an enzyme that produces stomach acid. This reduces the amount of acid in the stomach. Pantorena is used for the short-term treatment of symptoms of gastroesophageal reflux disease (such as heartburn, acid reflux) in adults. Reflux occurs when stomach acid flows back into the esophagus, which can cause inflammation of the esophagus and pain. Symptoms may also include painful burning in the chest that can extend to the throat (heartburn), sour taste in the mouth (acid reflux). Pantorena can relieve symptoms of reflux disease (such as heartburn, acid reflux) as early as the first day of use, but it is not intended for immediate relief of symptoms. To achieve complete relief of symptoms, it may be necessary to take the tablets for 2-3 consecutive days. If after 2 weeks there is no improvement or you feel worse, you should consult a doctor.

2. Important information before taking Pantorena

When not to take Pantorena

• If you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6).
• If you are taking a medicine containing atazanavir or nelfinavir (for HIV infection).
• If you are under 18 years old.
• In case of pregnancy or breastfeeding.

Warnings and precautions

Before taking Pantorena, you should discuss it with your doctor, pharmacist, or nurse. You should consult a doctor if you:

• have been treated for heartburn or indigestion continuously for 4 or more weeks;
• are over 55 and have taken over-the-counter indigestion remedies every day for more than 3 months;
• are over 55 and have new or recently changed symptoms;
• have had stomach ulcers or stomach surgery;
• have liver or jaundice problems;
• are under regular medical supervision for other serious conditions;
• are going to have an endoscopy or a test for bleeding;
• have had a skin reaction after taking a medicine like Pantorena that reduces stomach acid production;
• are going to have a specific blood test (chromogranin A levels).

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

˗ reduced absorption of vitamin B12 and vitamin B12 deficiency if you have low vitamin B12 levels in your body;

˗ hip, wrist, or spine fractures, especially if you already have osteoporosis or are taking corticosteroids (which can increase the risk of osteoporosis);

˗ low magnesium levels in the blood (possible symptoms: fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, rapid heartbeat). Low magnesium levels can also lead to low potassium and calcium levels in the blood. If you take the medicine for more than 4 weeks, you should consult a doctor. Your doctor may order regular blood tests to monitor your magnesium levels.

You should immediately inform your doctorbefore 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;
• pale skin and weakness (anemia);
• chest pain;
• abdominal pain;
• severe and/or persistent diarrhea (as Pantorena use is associated with a small increased risk of infectious diarrhea).

If you experience a skin rash, especially in areas exposed to sunlight, you should inform your doctor as soon as possible, as it may be necessary to stop taking Pantorena. You should also inform your doctor about any other side effects, such as joint pain. Your doctor may decide to perform additional tests. 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 symptoms and heartburn as early as the first day of taking Pantorena, but this medicine is not intended for immediate relief of symptoms. You should not take it as a preventive measure. If you have had recurring heartburn or indigestion for some time, you should remain under regular medical supervision.

Children and adolescents

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

Pantorena and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have recently taken, as well as any medicines you plan to take, including herbal preparations and dietary supplements available in pharmacies, supermarkets, or health food stores, as these products may interact with Pantorena.

Pantorena may reduce the effectiveness of other medicines. You should tell your doctor or pharmacist about all the medicines you are taking, especially those containing any of the following active substances:

• ketokonazole (used in fungal infections).
• warfarin and phenprocoumon (affecting blood density and preventing blood clots). Additional blood tests may be necessary.
• atazanavir, nelfinavir (used in HIV treatment). You should not take Pantorena with atazanavir.
• methotrexate (used in the treatment of rheumatoid arthritis, psoriasis, and cancer). If you are taking methotrexate, your doctor may temporarily stop Pantorena, as pantoprazole may increase methotrexate levels in the blood.

You should not take Pantorena 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). Pantorena can be taken with antacids (e.g., magaldrate, alginic acid, sodium bicarbonate, aluminum hydroxide, magnesium carbonate, or their combinations) if necessary.

Pantorena with food and drink

Tablets should be taken before meals, swallowed whole, and washed down with water.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor or pharmacist for advice before taking this medicine. You should not take Pantorena if you are pregnant, if pregnancy cannot be ruled out, or if you are breastfeeding. Before taking any medicine, ask your doctor or pharmacist for advice.

Driving and using machines

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

3. How to take Pantorena

This medicine should always be taken exactly as described in the package leaflet or as directed by your doctor, pharmacist, or nurse. If you are unsure, ask your doctor, pharmacist, or nurse. Recommended dose: Take 1 tablet per day. Do not take more than 20 mg per day. You should take the medicine for at least 2-3 consecutive days. You should stop taking Pantorena after complete relief of symptoms. It is possible that you may experience relief from reflux symptoms and heartburn as early as the first day of taking Pantorena, but remember that this medicine is not intended for immediate relief of symptoms. You should consult a doctor if, after taking this medicine for 2 weeks, symptoms do not improve. You should not take Pantorena for more than 4 weeks without consulting a doctor. Take the tablets before meals, at the same time every day. Swallow the tablets whole, with plenty of water, do not chew or divide them.

Use in children and adolescents

Pantorena should not be used in children and adolescents under 18 years of age.

Overdose of Pantorena

Immediately consult a doctor or pharmacist. If possible, take the medicine and the package leaflet with you. Symptoms of overdose are not known.

Missed dose of Pantorena

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. You should immediately inform your doctoror contact the nearest hospital if you experience any of the following serious side effects.At the same time, you should stop taking this medicine, but take the package leaflet and/or the 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 in 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 severe 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.

The occurrence of side effects is defined based on the frequency of their occurrence:

• very common: more than 1 in 10 treated patients
• common: between 1 and 10 in 100 treated patients
• uncommon: between 1 and 10 in 1,000 treated patients
• rare: between 1 and 10 in 10,000 treated patients
• very rare: less than 1 in 10,000 treated patients
• frequency not known: frequency cannot be estimated from the available data

Other side effects include:

• Common:mild stomach polyps.
• Uncommon: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 in blood tests; hip, wrist, or spine fractures.
• Rare:vision disturbances, such as blurred vision, taste disturbances, or complete loss of taste, joint pain, muscle pain, weight changes, elevated body temperature, limb swelling, depression, elevated bilirubin and lipid levels in blood tests; gynecomastia in men; high fever and rapid decrease in circulating granulocytes - white blood cells (found in blood tests).
• Very rare:disorientation, decreased platelet count, which may cause increased tendency to bleeding and bruising; decreased white blood cell count, which may cause 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:sensation of tingling, prickling, burning, or numbness; hallucinations; confusion (especially in patients who have experienced such symptoms before), decreased sodium levels in the blood, rash that may be accompanied by joint pain. If you have taken Pantorena for more than three months, there is a possibility of decreased magnesium levels in the blood. Low magnesium levels may cause fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, rapid heartbeat. If you experience any of these symptoms, you should immediately inform your doctor. Low magnesium levels can lead to low potassium or calcium levels in the blood. Your doctor may order regular blood tests to monitor your magnesium levels. Inflammatory bowel disease causing persistent watery diarrhea.

If any of the side effects get worse or if you experience any side effects not listed in this leaflet, you should inform your doctor or pharmacist.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, you should inform your doctor or pharmacist. Side effects can be reported directly to the Department of Post-Marketing Surveillance of Adverse Reactions to Medicinal Products of the 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 Pantorena

Keep this medicine out of the 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 that 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 Pantorena contains

• The active substance of Pantorena is pantoprazole. One tablet contains 20 mg of pantoprazole (as pantoprazole sodium sesquihydrate).
• Other ingredients of the medicine are:
• Core of the tablet: mannitol, crospovidone (type A), anhydrous sodium carbonate, calcium stearate.
• Coating of the tablet: hydroxypropylcellulose (5 cP), povidone (K-25), propylene glycol, titanium dioxide (E 171), yellow iron oxide (E 172).
• Enteric coating: methacrylic acid and ethyl acrylate copolymer (1:1) dispersion 30%, triethyl citrate.

What Pantorena looks like and contents of the pack

Yellow, oval, biconvex, gastro-resistant tablets, smooth on both sides. Pantorena is available in OPA/Aluminum/PVC/Aluminum blisters in a cardboard box. The pack contains 7 or 14 gastro-resistant tablets. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Milapharm Sp. z o.o., pl. Gen. Józefa Hallera 5/14A, 03-464 Warsaw, Phone: (+48) 699 711 147

Manufacturer/Importer:

Medicofarma S.A, ul. Tarnobrzeska 13, 26-613 Radom

Date of revision of the package leaflet:

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, spearmint, fatty and fried foods, acidic, spicy, citrus fruits and juices, tomatoes.