Pamil 20 mg

Leaflet attached to the packaging: patient information

Pamyl 20 mg, 20 mg, gastro-resistant tablets

Pantoprazole

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Pamyl 20 mg and what is it used for
• 2. Important information before taking Pamyl 20 mg
• 3. How to take Pamyl 20 mg
• 4. Possible side effects
• 5. How to store Pamyl 20 mg
• 6. Contents of the pack and other information

1. What is Pamyl 20 mg and what is it used for

Pantoprazole is a selective "proton pump inhibitor", a medicine that reduces the amount of acid produced in the stomach. It is used to treat stomach and gut diseases related to stomach acid.

It can be used in:

Adults and adolescents from 12 years:

• Treatment of symptoms (such as heartburn, acid reflux, pain when swallowing) associated with gastroesophageal reflux disease caused by stomach acid flowing back up into the esophagus.
• Long-term treatment of reflux esophagitis (esophagitis accompanied by stomach acid reflux) and prevention of its recurrence.

Adults:

• Prevention of duodenal and stomach ulcers caused by non-steroidal anti-inflammatory drugs (NSAIDs, such as ibuprofen) in patients at risk of developing them and requiring continuous NSAID treatment.

2. Important information before taking Pamyl 20 mg

When not to take Pamyl 20 mg

• -if you are allergic to pantoprazole or any of the other ingredients of this medicine (listed in section 6)
• -if you are allergic to medicines containing other proton pump inhibitors.

Warnings and precautions

Before taking Pamyl 20 mg, discuss with your doctor or pharmacist:

• if you have severe liver disease. If you have ever had liver disease, tell your doctor. Your doctor will monitor your liver enzymes more closely, especially if you are taking Pamyl 20 mg for a long time. If your liver enzymes increase, treatment should be stopped
• if you need to take medicines called NSAIDs continuously and are taking Pamyl 20 mg because of an increased risk of stomach and gut problems. The increased risk will be assessed based on individual risk factors, such as age (65 years or older), history of stomach or duodenal ulcers, stomach or gut bleeding
• if you have low levels of vitamin B in your body or risk factors for low vitamin B levels and are taking Pamyl 20 mg for a long time. Like all acid-suppressing medicines, Pamyl 20 mg may reduce the absorption of vitamin B. You should contact your doctor if you notice any of the following symptoms, which may indicate low vitamin B levels:
• extreme fatigue or lack of energy
• numbness or tingling
• pain or redness of the tongue, mouth ulcers
• muscle weakness
• vision problems
• memory problems, disorientation, depression
• if you are taking a medicine called atazanavir (used to treat HIV infection), consult your doctor (see section 2 "Warnings and precautions")
• taking a proton pump inhibitor like pantoprazole, especially for more than one year, may slightly increase the risk of hip, wrist, or spine fractures. Tell your doctor if you have osteoporosis (reduced bone density) or if your doctor has told you that you are at risk of osteoporosis (e.g., if you are taking corticosteroids)
• if you take pantoprazole for more than three months, it may lead to a decrease in magnesium levels in the blood. Low magnesium levels can cause fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, and rapid heartbeat. If you experience any of these symptoms, tell your doctor immediately. Low magnesium levels can also lead to low potassium or calcium levels in the blood. Your doctor may decide to check your magnesium levels regularly
• if you have ever had a skin reaction after taking a medicine that reduces stomach acid
• severe skin reactions have been reported with pantoprazole, including Stevens-Johnson syndrome, toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and erythema multiforme. Stop taking pantoprazole and seek medical attention immediately if you notice any of the symptoms associated with these severe skin reactions described in section 4
• if you are going to have a blood test to check the level of chromogranin A

Tell your doctor immediatelyif you experience any of the following symptoms:

• unintentional weight loss
• repeated vomiting
• difficulty swallowing
• vomiting blood
• pallor and weakness (anemia)
• blood in the stool
• severe and/or prolonged diarrhea, as pantoprazole use is associated with a slight increase in the incidence of infectious diarrhea

If you develop a rash on your skin, especially in areas exposed to the sun, tell your doctor as soon as possible, as it may be necessary to stop treatment with Pamyl 20 mg. Also, mention any other side effects, such as joint pain. Your doctor may decide to perform certain tests to rule out cancer, as pantoprazole can also alleviate cancer symptoms and may delay its diagnosis. If symptoms persist despite treatment, further diagnostic tests will be considered. If you take Pamyl 20 mg for a long time (more than a year), your doctor will probably recommend regular check-ups. At each medical visit, report any new or unusual symptoms and situations to your doctor

Pamyl 20 mg and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take, as Pamyl 20 mg may affect the effectiveness of other medicines

• Medicines such as ketoconazole, itraconazole, and posaconazole (used to treat fungal infections) or erlotinib (used to treat certain types of cancer), as pantoprazole may inhibit the proper functioning of these and other similar medicines
• Warfarin and phenprocoumon, which affect blood clotting or thinning. Additional monitoring tests may be necessary
• Atazanavir (used to treat HIV infection) (see section 2 "Warnings and precautions")
• Methotrexate (used to treat rheumatoid arthritis, psoriasis, and cancer), as pantoprazole may increase methotrexate levels in the blood
• Fluvoxamine (used to treat depression and other mental illnesses). If you are taking fluvoxamine, your doctor may reduce the dose
• Rifampicin (used to treat infections)
• St. John's Wort (Hypericum perforatum) (used to treat mild depression)

Before taking pantoprazole, discuss with your doctor if you are going to have a specific urine test (for the presence of tetrahydrocannabinol (THC))

Pregnancy, breastfeeding, and fertility

There are no adequate data on the use of Pamyl 20 mg in pregnant women. If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor or pharmacist for advice before taking this medicine. The medicine should be used only if the doctor considers that the benefits outweigh the potential risk to the unborn child or baby

Driving and using machines

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

Pamyl 20 mg contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet, which means it is essentially "sodium-free"

3. How to take Pamyl 20 mg

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist

When and how to take Pamyl 20 mg

Take the tablets one hour before a meal. Do not chew or crush them. Swallow the tablets whole with a small amount of water. If your doctor has not told you otherwise, the recommended dose is:

For the treatment of symptoms (such as heartburn, acid reflux, pain when swallowing) associated with gastroesophageal reflux disease

The recommended dose is one tablet per day. This dose usually leads to relief of symptoms within 2-4 weeks - at the latest after 4 more weeks. Your doctor will determine how long you should take the medicine. After this period, any recurring symptoms can be controlled by taking one tablet per day, as needed

For long-term treatment and prevention of reflux esophagitis recurrence:

The recommended dose is one tablet per day. If the disease recurs, your doctor may double this dose. In this case, you can take Pamyl 40 mg tablets once a day. After healing, you can reduce the dose to one 20 mg tablet per day

Special patient groups:

• If you have liver disease, do not take more than one 20 mg tablet per day
• Children under 12 years of age. This medicine is not recommended for children under 12 years of age

Taking a higher dose of Pamyl 20 mg than recommended

Consult your doctor or pharmacist. The symptoms of overdose are not known

Missing a dose of Pamyl 20 mg

Do not take a double dose to make up for a forgotten dose. Take the next dose at the usual time

Stopping treatment with Pamyl 20 mg

Do not stop taking this medicine without consulting your doctor or pharmacist. If you have any further questions on the use of this product, ask your doctor or pharmacist

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them

If you experience any of the following side effects, stop taking the medicine and consult your doctor or go to the emergency department of your nearest hospital:

Rare(may affect up to 1 in 1000 people)

• Severe allergic reactions: swelling of the tongue and/or throat, difficulty swallowing, hives, difficulty breathing, allergic swelling of the face (Quincke's edema/angioedema), severe dizziness with very rapid heartbeat and heavy sweating
• Decreased number of white and red blood cells and/or platelets, which may be visible in blood tests. You may notice more frequent infections, more frequent than normal bleeding or bruising

Frequency not known(frequency cannot be estimated from the available data)

• Severe skin changes:you may notice one or more of the following symptoms -blisters on the skin and rapid deterioration of general condition, ulcers (with minor bleeding) of the eyes, nose, mouth/lips, or genitals, or rash, especially on skin areas exposed to sunlight/sun. You may also experience joint pain or flu-like symptoms, fever, swelling of the glands (e.g., under the arms), and changes in some white blood cells or liver enzymes in blood tests
• red spots or patches on the torso, often with blisters in the center, skin peeling, mouth ulcers, throat, nose, genitals, and eye inflammation. The onset of such a severe skin rash may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis)
• widespread rash, high body temperature, and swollen lymph nodes (DRESS or drug hypersensitivity syndrome)
• Other severe disorders:yellowing of the skin and whites of the eyes (severe liver cell damage, jaundice) or fever, rash, kidney enlargement sometimes with painful urination and back pain (severe kidney inflammation, which can lead to kidney failure)

Other side effects include:

• Common(may affect up to 1 in 10 people) Mild stomach polyps
• - Uncommon(may affect up to 1 in 100 people) Headache, dizziness, diarrhea, nausea, vomiting, abdominal bloating and gas, constipation, dry mouth, abdominal pain and discomfort, rash, itching, skin eruptions, redness, weakness, feeling tired or unwell, sleep disorders, fractures of the hip, wrist, or spine
• - Rare(may affect up to 1 in 1000 people) Changes in taste or loss of taste, vision problems, such as blurred vision, hives, joint pain, muscle pain, weight changes, increased body temperature, swelling of the limbs (peripheral edema)
• - Frequency not known(frequency cannot be estimated from the available data) Hallucinations, confusion (especially in patients with a history of these symptoms), feeling of tingling, prickling, burning, or numbness, colitis (inflammation of the colon) causing persistent, watery diarrhea

Side effects detected in blood tests:

• - Uncommon(may affect up to 1 in 100 people) Increased liver enzyme activity
• - Rare(may affect up to 1 in 1000 people) Increased bilirubin levels, increased fat levels in the blood
• - Frequency not known(frequency cannot be estimated from the available data) Decreased sodium, magnesium, calcium, or potassium levels in the blood (see section 2)

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring 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 Pamyl 20 mg

Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month. Blisters: This medicine does not require any special storage precautions. Blisters PVC/PE/PVdC: Store in a temperature below 25°C. HDPE bottles: After first opening, use within 100 days. Store the bottle tightly closed to protect from moisture. 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 Pamyl 20 mg contains

• The active substance is pantoprazole sodium sesquihydrate, equivalent to 20 mg of pantoprazole
• The other ingredients are sodium carbonate anhydrous, mannitol, crospovidone, povidone (K-90), and calcium stearate. The coating contains methacrylic acid and ethyl acrylate copolymer (1:1), sodium lauryl sulfate, polysorbate 80, triethyl citrate, hypromellose, titanium dioxide (E171), macrogol 400, and yellow iron oxide (E172)

What Pamyl 20 mg looks like and contents of the pack

Pamyl 20 mg tablets are dark yellow, film-coated, oval, 4.3 mm x 8.4 mm in size, and convex on both sides, without any markings on either side of the tablet. The tablets are available in plastic bottles and blisters. White HDPE bottles with a PP cap, containing 14, 28, 30, 50, 56, 60, 90, 98, 100, or 250 tablets, placed in a cardboard box. The bottles also contain a small plastic container with silica gel or a sachet containing silica gel and activated carbon, which protect the tablets from moisture. The container or sachet is not intended for consumption and should not be removed from the bottle. Aluminum/Aluminum blisters with a moisture-absorbing layer or without it, packaged in cardboard boxes containing 7, 14, 14x1, 28, 28x1, 30, 56, 70, 70x1, 96, or 98 tablets. PVC/PE/PVDC blisters with an aluminum foil cover, packaged in cardboard boxes containing 7, 14, 14x1, 28, 28x1, 30, 56, 70, 70x1, 96, or 98 tablets. Not all pack sizes may be marketed

Marketing authorization holder

Viatris Limited, Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland

Manufacturer/Importer

McDermott Laboratories Limited trading as Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland, Mylan Hungary Kft, H-2900 Komárom, Mylan utca 1, Hungary, Mylan Germany GmbH, Zweigniederlassung Bad Homburg v. d. Höhe, Benzstrasse 1, 61352 Bad Homburg v. d. Höhe, Germany, Logiters, Logistica Portugal, S.A., Estrada dos Arneiros, 4, Azambuja, 2050-306, Portugal. For more detailed information and the names in the Member States of the European Economic Area, contact the local representative of the marketing authorization holder

Viatris Healthcare Sp. z o.o.

Tel. +48 22 546 64 00

This medicine is authorized in the Member States of the European Economic Area under the following names:

Belgium: Pantoprazole Viatris 20mg maagsapresistente tabletten, Denmark: Pantoprazol Viatris enterotabletter 20 mg, Finland: Pantoprazol Viatris 20mg, France: PANTOPRAZOLE VIATRIS 20mg comprimé gastro-resistant, Spain: Pantoprazol Viatris 20 mg comprimidos gastrorresistentes EFG, Netherlands: Pantoprazol Mylan 20mg maagsapresistente tabletten, Ireland: Pantoprazole Mylan 20mg Gastro-resistant tablets, Luxembourg: Pantoprazole Viatris 20 mg comprimé gastro-résistant, Malta: Pantoprazole Mylan 20mg Gastro-resistant tablets, Germany: Pantoprazol dura 20mg magensaftresistente Tabletten, Poland: Pamyl 20mg tabletki dojelitowe, Portugal: Pantoprazol Mylan 20mg Comprimido gastrorresistente, Slovakia: Pantomyl 20mg, Sweden: Pantoprazol Viatris 20mg enterotabletter

Date of last revision of the leaflet:August 2024