Pamil 40 mg

Leaflet accompanying the packaging: patient information

Pamyl 40 mg, 40 mg, enteric-coated tablets

Pantoprazole

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

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

Table of contents of the leaflet:

• 1. What is Pamyl 40 mg and what is it used for
• 2. Important information before taking Pamyl 40 mg
• 3. How to take Pamyl 40 mg
• 4. Possible side effects
• 5. How to store Pamyl 40 mg
• 6. Contents of the packaging and other information

1. What is Pamyl 40 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 intestinal diseases related to stomach acid.

Pamyl 40 mg is used to treat:

Adults and adolescents from 12 years:

• Reflux esophagitis - esophagitis (the section connecting the throat to the stomach), accompanied by gastric acid reflux.

Adults:

• Infections with a bacterium called Helicobacter pyloriin patients with duodenal and gastric ulcers in combination with 2 antibiotics (eradication therapy). The goal is to eliminate the bacteria and thus reduce the likelihood of ulcer recurrence.
• Gastric and duodenal ulcers.
• Zollinger-Ellison syndrome and other conditions with excessive acid production in the stomach.

2. Important information before taking Pamyl 40 mg

When not to take Pamyl 40 mg

Warnings and precautions

Before starting treatment with Pamyl 40 mg, discuss it with your doctor or pharmacist:

• extreme fatigue or lack of energy
• numbness or tingling
• pain or redness of the tongue, oral ulcers
• muscle weakness
• vision disturbances
• memory problems, disorientation, depression
• taking a proton pump inhibitor like pantoprazol, especially for a period of more than 1 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 informed you that you are at risk of osteoporosis (e.g., if you are taking steroid medicines)
• severe skin reactions have been reported with pantoprazol, including Stevens-Johnson syndrome, toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and polymorphic erythema. Stop taking pantoprazol and seek medical attention immediately if you notice any symptoms of these severe skin reactions described in section 4.

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

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

If you develop a skin rash, especially in areas exposed to sunlight, inform your doctor as soon as possible, as it may be necessary to discontinue treatment with Pamyl 40 mg. Also, mention any other side effects, such as joint pain. Your doctor may decide to perform certain tests to rule out cancer, as pantoprazol 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 40 mg for a long period (more than a year), your doctor will likely recommend regular check-ups. At each doctor's visit, report any new or unusual symptoms and situations.

Pamyl 40 mg and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take. Pamyl 40 mg may affect the effectiveness of other medicines, so tell your doctor if you are taking:

• Medicines such as ketoconazole, itraconazole, and posaconazole (used to treat fungal infections) or erlotinib (used to treat certain types of cancer), as pantoprazol 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)
• Methotrexate (used to treat rheumatoid arthritis, psoriasis, and cancer), as pantoprazol 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 starting pantoprazol, discuss it with your doctor if you are going to have a specific urine test (for tetrahydrocannabinol (THC)).

Pregnancy, breastfeeding, and fertility

There are no adequate data on the use of Pamyl 40 mg in pregnant women. The active substance of the medicine passes into human milk. 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. The medicine should be used only if the doctor considers that the benefits of use outweigh the potential risk to the unborn child or newborn.

Driving and using machines

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

Pamyl 40 mg contains sodium

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

3. How to take Pamyl 40 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 40 mg

Take the tablets 1 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 prescribed otherwise, the recommended dose is:

In the treatment of reflux esophagitis

The recommended dose is 1 tablet per day. Your doctor may prescribe a higher dose of up to 2 tablets per day. The duration of treatment for reflux esophagitis is usually 4 to 8 weeks. Your doctor will determine how long you should take the medicine. Adults:

In the treatment of Helicobacter pylori infection in patients with duodenal and gastric ulcers, in combination with 2 antibiotics (eradication therapy)

1 tablet twice a day plus 2 antibiotics in tablets (among the following: amoxicillin, clarithromycin, and metronidazole (or tinidazole)), which should be taken twice a day with the Pamyl 40 mg tablet. Take the first Pamyl 40 mg tablet 1 hour before breakfast and the second tablet 1 hour before the evening meal. Follow your doctor's instructions and read the information leaflets of the antibiotics used. Treatment usually lasts 1 to 2 weeks.

In the treatment of gastric and duodenal ulcers

The recommended dose is 1 tablet per day. After consulting your doctor, this dose can be doubled. Your doctor will determine how long you should take the medicine. Treatment for gastric ulcers usually lasts 4 to 8 weeks. Treatment for duodenal ulcers usually lasts 2 to 4 weeks.

In long-term treatment of Zollinger-Ellison syndrome and other conditions with excessive acid production in the stomach

The initial recommended dose is 2 tablets per day. Take both tablets 1 hour before a meal. Your doctor may later adjust the dose based on the amount of acid produced in the stomach. If your doctor prescribes more than 2 tablets per day, take them twice a day. If your doctor prescribes a daily dose higher than 4 tablets, they will tell you exactly when to stop taking the medicine.

Special patient groups:

Taking a higher dose of Pamyl 40 mg than recommended

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

Missing a dose of Pamyl 40 mg

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

Stopping treatment with Pamyl 40 mg

Do not stop taking the medicine without consulting your doctor or pharmacist first. If you have any further questions about taking this medicine, 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 room immediately:

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/anaphylaxis), severe dizziness with very rapid heartbeat and sweating
• decrease in the number of white and red blood cells and/or platelets, which can be seen in blood tests. You may notice more frequent infections, more frequent bleeding than normal, 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 light/sun. You may also experience joint pain or flu-like symptoms, fever, swelling of the lymph nodes (e.g., under the arms), and changes in blood test results showing changes in certain white blood cells or liver enzymes.
• red, non-raised spots or round patches on the torso, often with blisters in the center, skin peeling, oral ulcers, throat, nose, genitals, and eye inflammation. The appearance of such a severe skin rash may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• widespread rash, high fever, 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 gastric 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, itching, weakness, feeling of tiredness or general malaise, sleep disturbances, hip, wrist, or spine fractures.
• - Rare(may affect up to 1 in 1000 people) Changes in taste or loss of taste, vision disturbances such as blurred vision, hives, joint pain, muscle pain, weight changes, elevated body temperature, peripheral edema (peripheral swelling).
• - 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 large intestine) 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 those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring 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.: 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 Pamyl 40 mg

Keep the 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 packaging and other information

What Pamyl 40 mg contains

• The active substance of the medicine is pantoprazole sodium sesquihydrate, equivalent to 40 mg of pantoprazole
• Other ingredients are: anhydrous sodium carbonate, 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 40 mg looks like and contents of the packaging

Pamyl 40 mg tablets are yellow, coated, oval, 5.7 mm x 11.6 mm in size, convex on both sides, without 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 for consumption and should not be removed from the bottle. Aluminum/Aluminum blisterswith a moisture-absorbing layer or without it, packaged in cardboard boxes containing 7, 7x1, 14, 14x1, 28, 28x1, 30, 56, 70, 70x1, 96, or 98 tablets. PVC/PE/PVDC blisterswith an aluminum foil cover, packaged in cardboard boxes containing 7, 14, 14 x 1, 28, 28 x 1, 30, 56, 70, 70 x 1, 96, 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 40 mg maagsapresistente tabletten, Czech Republic: Pantomyl 40mg, Denmark: Pantoprazol Viatris enterotabletter 40 mg, Finland: Pantoprazol Viatris 40 mg, France: PANTOPRAZOLE VIATRIS 40 mg comprimé gastro-resistant, Greece: Pantoprazole/ Mylan Generics gastro-resistant tablets 40mg/TAB, Spain: Pantoprazol Viatris 40 mg comprimidos gastrorresistentes EFG, Netherlands: Pantoprazol Mylan 40 mg maagsapresistente tabletten, Ireland: Pantoprazole Mylan 40 mg Gastro-resistant tablets, Luxembourg: Pantoprazole Viatris 40 mg comprimé gastro-résistant, Malta: Pantoprazole Mylan 40 mg Gastro-resistant tablets, Germany: Pantoprazol dura 40 mg magensaftresistente Tabletten, Poland: Pamyl 40 mg tabletki dojelitowe, Portugal: Pantoprazol Mylan 40 mg Comprimido gastrorresistente, Slovakia: Pantomyl 40 mg, Sweden: Pantoprazol Viatris 40 mg enterotabletter, Date of last revision of the leaflet:August 2024