Pantorena

Patient Information Leaflet

Pantorena, 20 mg, enteric-coated tablets
Pantoprazole
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by
your doctor, pharmacist, or nurse.

• Keep this leaflet for future reference.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
• If there is no improvement after 2 weeks, or if your condition worsens, contact your doctor.
• Do not take Pantorena for longer than 4 weeks without consulting your doctor.

Table of Contents

1. What Pantorena is and what it is 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 Pantorena is and what it is used for

The active substance in Pantorena is pantoprazole, which blocks the enzyme responsible for producing gastric acid. This way, the medicine reduces the amount of acid in the stomach.
Pantorena 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 acid from the stomach 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) and sour taste in the mouth (acid regurgitation).
Pantorena may relieve symptoms associated with reflux disease (such as heartburn, acid regurgitation) as early as on the first day of treatment, but it is not intended for immediate symptom relief.
For complete symptom resolution, it may be necessary to take the tablets for 2–3 consecutive days.
If there is no improvement after 2 weeks, or if your condition worsens, consult your doctor.

2. Important information before using Pantorena

When not to take Pantorena

• If the patient is allergic to the active substance or any of the other ingredients of this medicine (listed in section 6).
• If the patient is taking a medicine containing atazanavir or nelfinavir (used in the treatment of HIV infection).
• If the patient has not completed 18 years of age.
• During pregnancy or breastfeeding.

Warnings and precautions
Before starting to take Pantorena, discuss this with your doctor, pharmacist, or nurse. You should consult your doctor if:

• you have been treated for heartburn or indigestion continuously for 4 weeks or longer;
• you are over 55 years old and take over-the-counter medicines for indigestion daily;
• you are over 55 years old and have noticed new or changing symptoms;
• you have had a stomach ulcer or undergone stomach surgery;
• you have liver problems or jaundice (yellowing of the skin and eyes);
• you are under ongoing medical supervision due to other serious conditions or diseases;
• you are scheduled for an endoscopic examination or biopsy;
• you have ever experienced a skin reaction while taking a medicine similar to Pantorena that reduces stomach acid secretion;
• a specific blood test (chromogranin A level) is planned.

Do not take this medicine for longer than 4 weeks without consulting a doctor. If symptoms of reflux disease (heartburn or acid regurgitation) persist for more than 2 weeks, consult your doctor, who will decide whether long-term treatment is necessary.
Long-term use of Pantorena may be associated with additional risks, such as:
˗ reduced absorption of vitamin B12 and vitamin B12 deficiency in case of low vitamin B12 levels in the body;
˗ fractures 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 contractions, disorientation, seizures, dizziness, rapid heartbeat). Low magnesium levels may also lead to reduced potassium and calcium levels in the blood.
If taking the medicine for longer than 4 weeks, consult your doctor. Your doctor may recommend regular blood tests to monitor magnesium levels.
Contact your doctor immediately before or after taking this medicine if you notice any of the following symptoms, which may indicate other, more serious conditions:

• unintentional weight loss (not related to diet or exercise);
• vomiting, especially recurrent;
• vomiting blood, which may look like dark coffee grounds;
• blood in stool, black or tarry stools;
• difficulty swallowing or pain when swallowing;
• paleness and weakness (anemia);
• chest pain;
• abdominal pain;
• severe and/or persistent diarrhea (because use of Pantorena is associated with a small increased risk of infectious diarrhea).

If the patient develops a skin rash, especially in areas exposed to sunlight, inform the doctor as soon as possible, as discontinuation of Pantorena may be necessary. Also report any other adverse reactions such as joint pain.
The doctor may decide that additional tests are needed.
If the patient is scheduled for a blood test, they should inform the doctor about taking this medicine.
It is possible that the patient will notice improvement in reflux and heartburn symptoms as early as one day after starting Pantorena. However, this is not a medicine intended for immediate symptom relief.
Do not use it preventively.
If the patient has recurrent heartburn or indigestion symptoms over time, regular medical monitoring should be maintained.

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

Pantorena and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take, including herbal remedies 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. Inform your doctor or pharmacist about all medicines you are taking, especially those containing any of the following active substances:

• ketoconazole (used for fungal infections).
• warfarin and phenprocoumon (affect blood clotting and prevent thrombosis). Additional blood testing may be required.
• atazanavir, nelfinavir (used in the treatment of HIV). Pantorena must not be taken together with atazanavir.
• methotrexate (used in the treatment of rheumatoid arthritis, psoriasis, and cancer). When methotrexate is used, the doctor may temporarily discontinue Pantorena, as pantoprazole may increase methotrexate blood levels.

Do not take Pantorena 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).
Pantorena may be used if necessary together with antacids (e.g., magaldrate, alginic acid, sodium bicarbonate, aluminum hydroxide, magnesium carbonate, or their combinations).

Pantorena with food and drink
Take tablets before a meal, swallow whole with water.

Pregnancy, breastfeeding, and fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before taking this medicine.
Do not use Pantorena in women who are pregnant, in women in whom pregnancy cannot be excluded, or in women who are breastfeeding.
Before taking any medicine, consult your doctor or pharmacist.

Driving and using machines
If the patient experiences adverse effects such as dizziness or visual disturbances, do not drive or operate machinery.

3. How to use Pantorena

This medicine should always be taken exactly as described in this patient leaflet or as directed by your doctor, pharmacist, or nurse. If in doubt, consult your doctor, pharmacist, or nurse.

Recommended dose
Take 1 tablet daily. Do not exceed a daily dose of 20 mg.
The medicine should be taken for at least 2–3 consecutive days. Treatment with Pantorena should be discontinued after symptoms have completely resolved. Relief of reflux and heartburn symptoms may occur as early as one day after starting Pantorena; however, bear in mind that this medicine is not intended for immediate symptom relief.

Consult your doctor if symptoms have not improved after taking this medicine for a full 2 weeks.
Do not take Pantorena for longer than 4 weeks without consulting your doctor.

Take tablets before a meal, every day at the same time. Swallow the tablets whole with plenty of water. Do not chew or divide the tablets.

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

Taking more Pantorena than recommended
Seek immediate advice from a doctor or pharmacist. If possible, bring the medicine and this leaflet with you. Symptoms of overdose are not known.

If you miss a dose of Pantorena
Do not take a double dose to make up for the missed dose. Take the next scheduled dose at the usual time the following day.

If you have any doubts concerning the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

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

• Severe 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.
• Severe skin reactions (frequency unknown: frequency cannot be determined from available data): Rash with swelling, blisters or peeling of the skin, widespread peeling of the skin, bleeding from the eyes, nose, mouth or genital areas, and rapid deterioration in general condition. Rash occurring after exposure to sunlight.
• Other severe 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.

The occurrence of adverse effects is defined based on their frequency:

• very common: more than 1 in 10 patients
• common: 1 to 10 in 100 patients
• uncommon: 1 to 10 in 1,000 patients
• rare: 1 to 10 in 10,000 patients
• very rare: less than 1 in 10,000 patients
• frequency not known: frequency cannot be determined from available data

Other adverse effects include:

• Common: benign gastric polyps.
• Uncommon: headache, dizziness, diarrhoea, nausea, vomiting, bloating and flatulence, constipation, dry mouth; abdominal pain and discomfort, skin rash or urticaria, itching, fatigue, exhaustion or malaise, sleep disturbances; increased liver enzyme activity in blood tests; fractures of the hip, wrist or spine.
• Rare: visual disturbances such as blurred vision, disturbances or complete loss of taste sensation, joint pain, muscle pain, changes in body weight, elevated body temperature, swelling of the limbs, depression, increased levels of bilirubin and lipids in blood (detected in blood tests), gynaecomastia in men; high fever and sudden decrease in circulating granulocytes – white blood cells (detected in blood tests).
• Very rare: disturbances in orientation, decreased platelet count, which may lead to increased tendency to bleeding 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 not known: sensation of tingling, pricking, numbness, burning or stinging; hallucinations; confusion (particularly in patients who have previously experienced such symptoms), decreased sodium levels in blood, rash possibly accompanied by joint pain. If Pantorena has been taken for longer than three months, there may be a decrease in magnesium levels in blood. Low magnesium levels may manifest as fatigue, involuntary muscle cramps, disorientation, seizures, dizziness, rapid heartbeat. If any of the above symptoms are observed, you should immediately inform your doctor. Low magnesium levels may lead to decreased potassium or calcium levels in blood. Your doctor may recommend regular blood tests to monitor magnesium levels. Inflammation of the large intestine causing persistent watery diarrhoea.

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

5. How to store Pantorena

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.
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 in use. This will help protect the environment.

6. Contents of the packaging and other information

What Pantorena contains

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

What Pantorena looks like and contents of the pack
Yellow, oval, biconvex, enteric-coated tablets, smooth on both sides.
Pantorena is available in blisters made of OPA/Aluminium/PVC/Aluminium, packed in a cardboard box.
The pack contains 7 or 14 enteric-coated tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Milapharm Sp. z o.o.
pl. Gen. Józefa Hallera 5/14A
03-464 Warsaw
Telephone number: (+48) 699 711 147

Manufacturer/Importer:
Medicofarma S.A
ul. Tarnobrzeska 13
26-613 Radom

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

• Avoid large meals.
• Eat slowly.
• Stop smoking.
• Limit alcohol and caffeine consumption.
• Reduce body weight (in case of 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 intake of foods that commonly trigger heartburn, such as: chocolate, peppermint, spearmint, fatty and fried foods, acidic and spicy foods, citrus fruits and fruit juices, tomatoes.