Pantoprazole Apteo Med

Leaflet accompanying the packaging: patient information

Pantoprazole APTEO MED

20 mg, gastro-resistant tablets

Pantoprazolum

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

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

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• If after 2 weeks there is no improvement or you feel worse, contact your doctor.
• Do not take Pantoprazole APTEO MED for more than 4 weeks without consulting your doctor.

Table of contents of the leaflet:

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

1. What is Pantoprazole APTEO MED and what is it used for

The active substance of Pantoprazole APTEO MED is pantoprazole, which blocks the "pump" (enzyme) that produces stomach acid. This reduces the amount of acid in the stomach. Pantoprazole APTEO MED is used for short-term treatment of symptoms of gastroesophageal reflux disease (such as heartburn, acid regurgitation) 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 painful burning in the chest extending up to the throat (heartburn), sour taste in the mouth (acid regurgitation) may also appear. Pantoprazole APTEO MED can relieve symptoms of reflux disease after the first day of use, but it is not a medicine intended for immediate relief of symptoms. To achieve full relief of symptoms, it may be necessary to take tablets for 2 to 3 consecutive days. If after 2 weeks there is no improvement or you feel worse, consult your doctor.

2. Important information before taking Pantoprazole APTEO MED

When not to take Pantoprazole APTEO MED

• If you are allergic to pantoprazole or any of the other ingredients of the medicine (listed in section 6).
• If you are taking HIV protease inhibitors, such as atazanavir, nelfinavir (used to treat HIV infection). See "Pantoprazole APTEO MED and other medicines".

Warnings and precautions

Before taking Pantoprazole APTEO MED, discuss it with your doctor:

• If you have been treated for heartburn or indigestion continuously for 4 or more weeks,
• If you are over 55 years old and take over-the-counter antacids every day,
• If you are over 55 years old and have noticed new worrying symptoms or a change in the character of existing symptoms of reflux disease,
• If you have had stomach ulcers or stomach surgery,
• If you have liver problems or jaundice (yellowing of the skin and eyes),
• If you are under constant medical supervision due to other serious illnesses or conditions,
• If you are going to have an endoscopy or a breath test with urea,
• If you have ever had a skin reaction after taking a medicine similar to Pantoprazole APTEO MED, which reduces stomach acid production,
• If you are going to have a specific blood test (chromogranin A concentration),
• If you are taking HIV protease inhibitors, such as atazanavir or nelfinavir (used to treat HIV infection) at the same time as pantoprazole, ask your doctor for detailed instructions.

Do not take this medicine without consulting your doctor for a period longer than 4 weeks. If symptoms of reflux disease (heartburn or acid regurgitation) persist for more than 2 weeks, consult your doctor, who will decide on the need for long-term use of the medicine. Long-term use of Pantoprazole APTEO MED may be associated with additional risks, such as:

• reduced absorption of vitamin B and vitamin B deficiency in case of low vitamin B concentration 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. When taking the medicine for more than 4 weeks, consult your doctor. Your doctor may order regular blood tests to monitor magnesium levels.

Tell your doctor immediately if you notice the appearance of the following symptoms that may be a sign of other, more serious diseases:

• unintentional weight loss (not related to diet or exercise),
• vomiting, especially recurring,
• vomiting blood, 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 small increased risk of infectious diarrhea),
• If you experience a skin rash, especially in areas exposed to sunlight, tell your doctor as soon as possible, as it may be necessary to stop taking Pantoprazole APTEO MED. Also, tell 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, inform your doctor that you are taking this medicine. It is possible that you will notice relief from reflux symptoms and heartburn after just one day of taking Pantoprazole APTEO MED. However, this is not a medicine 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 constant medical supervision.

Children and adolescents

Pantoprazole APTEO MED 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.

Pantoprazole APTEO MED and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take. Pantoprazole APTEO MED may affect the effectiveness of other medicines, especially those containing one of the following active substances:

• HIV protease inhibitors, such as atazanavir, nelfinavir (used to treat HIV infection). Do not take Pantoprazole APTEO MED at the same time as HIV protease inhibitors. See "When not to take Pantoprazole APTEO MED";
• 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) in case of methotrexate use, your doctor may temporarily stop taking Pantoprazole APTEO MED, as pantoprazole may increase methotrexate levels in the blood.

Do not take Pantoprazole APTEO MED 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). Pantoprazole APTEO MED can be taken with antacids (e.g., magaldrate, alginic acid, sodium bicarbonate, aluminum hydroxide, magnesium carbonate, or their combinations) if necessary.

Pregnancy and breastfeeding

Do not take this medicine if you are pregnant or breastfeeding. If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.

Driving and using machines

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

Pantoprazole APTEO MED contains sodium

The medicine contains less than 1 mmol of sodium (23 mg) per tablet, which means the medicine is considered "sodium-free".

3. How to take Pantoprazole APTEO MED

This medicine should always be taken exactly as described in this patient leaflet or as directed by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist. The recommended dose is 1 tablet per day. Do not take a daily dose greater than 20 mg. The medicine should be taken for at least 2 to 3 consecutive days. Stop taking Pantoprazole APTEO MED after complete relief of symptoms. It is possible to notice relief from reflux symptoms and heartburn after just one day of taking Pantoprazole APTEO MED. However, remember that this medicine is not intended for immediate relief of symptoms. Consult your doctor if after 2 weeks of taking this medicine, symptoms do not improve. Do not take Pantoprazole APTEO MED for more than 4 weeks without consulting your doctor. Take the tablets before a meal, once a day, at the same time. Swallow the tablets whole, with plenty of water, do not chew or divide them.

Taking a higher dose of Pantoprazole APTEO MED than recommended

Immediately inform your doctor or pharmacist if you have taken a higher dose of Pantoprazole APTEO MED than recommended. If possible, bring the medicine and the leaflet with you.

Missing a dose of Pantoprazole APTEO MED

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 further doubts about taking this 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 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, and angioedema. Typical symptoms are: swelling of the face, lips, tongue, and/or throat, which may cause difficulty swallowing or breathing, hives, severe dizziness with rapid heartbeat and profuse sweating.
• Severe skin reactions (frequency not known: frequency cannot be estimated from 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 after sun exposure.
• Other serious reactions (frequency not known: frequency cannot be estimated from available data):yellowing of the skin and whites of the eyes (jaundice) caused by severe liver damage, kidney problems manifested by 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 activity of liver enzymes (found in blood tests); hip, wrist, or spine fractures.
• Rare (may occur in less than 1 in 1000 people):disturbances or complete loss of taste; vision disturbances, such as blurred vision; joint pain; muscle pain; weight changes; elevated body temperature; swelling of 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 predispose to more frequent infections, concurrent, abnormal decrease in the number of red and white blood cells, as well as platelets (found in blood tests).
• Frequency not known (frequency cannot be estimated from available data):hallucinations, confusion (especially in patients who have previously experienced such symptoms), decreased sodium levels in the blood, decreased magnesium levels in the blood, rash that may be accompanied by joint pain, sensation of tingling, prickling, burning, or numbness, inflammatory bowel disease causing persistent watery diarrhea.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 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 Pantoprazole APTEO MED

Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date stated on the label, blister, and carton. The expiry date refers to the last day of the month. Aluminum/Aluminum blisters - Store below 30°C. HDPE bottle - No special precautions for storage. After first opening the HDPE bottle, the shelf life of the medicine is 28 days. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Pantoprazole APTEO MED contains

• The active substance of the medicine is pantoprazole. Each gastro-resistant tablet contains 20 mg of pantoprazole (in the form of pantoprazole sodium sesquihydrate).
• The medicine also contains: anhydrous disodium phosphate, mannitol, microcrystalline cellulose, sodium croscarmellose, magnesium stearate, hypromellose (type 6cP), triethyl citrate, sodium carboxymethylcellulose (type A), methacrylic acid, and ethyl acrylate copolymer (1:1) dispersion 30%, yellow iron oxide (E 172).

What Pantoprazole APTEO MED looks like and contents of the pack

Pantoprazole APTEO MED is an oval, yellow tablet available in aluminum blisters containing 7 and 14 tablets* or in HDPE bottles with a child-resistant closure containing 28 tablets*. *Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder: Synoptis Pharma Sp. z o.o., ul. Krakowiaków 65, 02-255 Warsaw, tel. 607 696 231, e-mail: infodn@synoptispharma.pl

Manufacturer:

Teva Pharma S.L.U., Poligono Industrial Malpica, calle C, No. 4, 50016 Zaragoza, Spain

Date of last revision of the leaflet:

The following lifestyle and dietary recommendations can also help alleviate heartburn or other acid-related symptoms:

• Avoiding large meals,
• Eating slowly,
• Quitting smoking,
• Limits alcohol and caffeine consumption,
• 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),
• Limits consumption of foods that usually cause heartburn, such as: chocolate, peppermint, spearmint, fatty and fried foods, acidic, spicy, citrus fruits, fruit juices, and tomatoes.