Pamyl 40 mg

Package leaflet: information for the patient

Pamyl 40 mg, 40 mg, enteric-coated tablets
Pantoprazole
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, so you can read it again if necessary.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform 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 pack 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 in the treatment of stomach and intestinal disorders related
to gastric acid.
Pamyl 40 mg is used for the treatment of:
Adults and adolescents from the age of 12:

• Gastro-oesophageal reflux disease – inflammation of the oesophagus (the tube connecting the throat to the stomach), associated with regurgitation of gastric acid.

Adults:

• Infection with a bacterium called Helicobacter pylori in patients with duodenal and gastric ulcers, in combination with two antibiotics (eradication therapy). The aim is to eliminate the bacteria and thereby reduce the likelihood of ulcer recurrence.
• Gastric and duodenal ulcers.
• Zollinger-Ellison syndrome and other conditions characterized by excessive production of gastric acid.

2. Important information before using Pamyl 40 mg

When not to use Pamyl 40 mg

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

Warnings and precautions
Before starting treatment with Pamyl 40 mg, discuss the following with your doctor or pharmacist:

• if the patient has severe liver disease. If there has ever been a history of liver disease, inform the doctor. The doctor will monitor liver enzymes more frequently, especially if Pamyl 40 mg is used for a prolonged period. If liver enzyme levels increase, treatment should be discontinued
• if the patient has low vitamin B levels in the body or risk factors for reduced vitamin B levels and is receiving Pamyl 40 mg for a long period. Like all acid-reducing medicines, Pamyl 40 mg may lead to reduced absorption of vitamin B. Contact your doctor if any of the following symptoms occur, which may indicate low vitamin B levels:
• extreme fatigue or lack of energy
• numbness and tingling sensations
• pain or redness of the tongue, mouth ulcers
• muscle weakness
• vision disturbances
• memory problems, disorientation, depression
• if a medicine containing atazanavir (used in the treatment of HIV infection) is being used at the same time as Pamyl 40 mg, consult your doctor
• use of a proton pump inhibitor such as pantoprazole, especially for more than 1 year, may slightly increase the risk of fractures of the hip, wrist, or spine. Inform your doctor if the patient has osteoporosis (reduced bone density) or if the doctor has informed the patient of being at risk of developing osteoporosis (for example, if the patient is taking steroid medicines)
• if the patient takes pantoprazole for longer than three months, there may be a decrease in blood magnesium levels. Low magnesium levels may cause fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, and rapid heartbeat. If any of these symptoms occur, inform the doctor immediately. Low magnesium levels may also lead to reduced blood potassium or calcium levels. The doctor may decide to carry out periodic blood tests to monitor magnesium levels
• if the patient has ever had a skin reaction after taking a medicine similar to pantoprazole that reduces stomach acid secretion
• serious skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and erythema multiforme, have been reported with the use of pantoprazole. Discontinue pantoprazole and seek immediate medical advice if any symptoms of these serious skin reactions described in section 4 occur
• if the patient is scheduled for a blood test to determine chromogranin A levels

Tell your doctor immediately if any of the following symptoms occur:

• unintentional weight loss
• recurrent vomiting
• difficulty swallowing
• vomiting blood
• paleness and weakness (anaemia)
• presence of blood in stool
• severe and/or persistent diarrhoea, as use of pantoprazole is associated with a slight increase in the risk of infectious diarrhoea

If the patient develops a skin rash, especially in areas exposed to sunlight, inform the doctor as soon as possible, as treatment with Pamyl 40 mg may need to be discontinued. Remember to also report any other adverse reactions, such as joint pain.
The doctor may decide to perform certain tests to rule out tumour disease, as pantoprazole may relieve tumour symptoms and could delay diagnosis. If symptoms persist despite treatment, further diagnostic investigations will be considered.
If the patient is taking Pamyl 40 mg for a long time (over one year), the doctor will likely recommend regular check-ups. During every doctor's visit, report any new or unusual symptoms or conditions.

Pamyl 40 mg and other medicines
Inform your doctor or pharmacist about all medicines currently used, recently used, or planned for use. Pamyl 40 mg may affect the effectiveness of other medicines, so inform your doctor if you are taking:

• Medicines such as ketoconazole, itraconazole, and posaconazole (used to treat fungal infections) or erlotinib (used in certain types of cancer), as pantoprazole may inhibit the proper action of these and other similar medicines
• Warfarin and phenprocoumon, which affect blood clotting or thinning. Additional monitoring tests may be required
• Atazanavir (used in the treatment of HIV infection)
• Methotrexate (used in the treatment of rheumatoid arthritis, psoriasis, and cancer), as pantoprazole may increase methotrexate blood levels
• Fluvoxamine (used in the treatment of depression and other psychiatric disorders). If the patient is taking fluvoxamine, the doctor may reduce the dose
• Rifampicin (used to treat infections)
• St. John’s wort (Hypericum perforatum) (used to treat mild depression)

Discuss with your doctor before starting pantoprazole if a specific urine test for tetrahydrocannabinol (THC) is planned.

Pregnancy, breastfeeding, and fertility
There are insufficient data on the use of Pamyl 40 mg in pregnant women.
It has been established that the active substance passes into human milk. 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 using this medicine.
The medicine should only be used if the doctor considers that the benefits outweigh the potential risks to the unborn child or newborn.

Driving and operating machinery
If adverse effects such as dizziness or visual disturbances occur, do not drive or operate machinery.

Pamyl 40 mg contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. the medicine is considered "sodium-free".

3. How to take Pamyl 40 mg

This medicine should always be taken exactly as directed by your doctor or pharmacist. If you have any doubts,
you should consult your doctor or pharmacist.
When and how to take Pamyl 40 mg
The tablets should be taken one hour before a meal. They must not be chewed or crushed. The tablets
should be swallowed whole with a small amount of water.
Unless otherwise advised by your doctor, the recommended dose is:
Adults and adolescents from 12 years of age:
For the treatment of reflux esophagitis
The recommended dose is 1 tablet per day. Your doctor may recommend increasing the dose 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:
For the treatment of infection with a bacterium called Helicobacter pylori in patients with duodenal ulcers and gastric ulcers, in combination with 2 antibiotics (eradication therapy)
1 tablet twice daily plus 2 antibiotics in tablet form (selected from the following: amoxicillin,
clarithromycin, and metronidazole (or tinidazole)), which should be taken twice daily together
with the Pamyl 40 mg tablet. The first dose of Pamyl 40 mg should be taken one hour before breakfast, and the second dose one hour before the evening meal. You must follow your doctor's instructions and read the package leaflets of the antibiotics used. Treatment usually lasts 1 to 2 weeks.
For the treatment of gastric ulcers and duodenal ulcers
The recommended dose is 1 tablet per day. After consultation with your doctor, this dose may be doubled. Your doctor will determine how long you should take the medicine.
Treatment of gastric ulcers usually lasts 4 to 8 weeks.
Treatment of duodenal ulcers usually lasts 2 to 4 weeks.
For long-term treatment of Zollinger-Ellison syndrome and other conditions associated with excessive gastric acid production
The recommended initial dose is 2 tablets per day.
Both tablets should be taken one hour before a meal. Your doctor may later adjust the dose depending on the amount of acid produced in the stomach. If your doctor prescribes more than 2 tablets per day, the tablets should be taken twice daily.
If your doctor recommends a daily dose exceeding 4 tablets, you will be given specific instructions on when to discontinue the medicine.
Special patient groups:

• If the patient has kidney disease, moderate or severe liver disease, they should not take Pamyl 40 mg for the eradication of Helicobacter pylori.
• If the patient has severe liver disease, they should not take more than 1 tablet of Pamyl 20 mg per day (tablets containing 20 mg of pantoprazole are available for this purpose).
• Children under 12 years of age. This medicine is not recommended for children under 12 years of age.

Taking more Pamyl 40 mg than recommended
Consult your doctor or pharmacist. 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 Pamyl 40 mg
Do not stop taking this medicine without first consulting your doctor or pharmacist.
If you have any further doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
If any of the following adverse reactions occur, stop taking the medicine immediately
and consult a doctor or go to the emergency department of the nearest hospital:
Rare (may affect 1 in 1,000 patients):

• severe allergic reactions: swelling of the tongue and (or) throat, difficulty swallowing, hives, breathing difficulties, facial angioedema (Quincke's edema/angioedema), severe dizziness with very rapid heartbeat and profuse sweating
• decreased number of white and red blood cells and (or) platelets, which may be evident in blood tests. In patients, more frequent infections, more frequent than normal bleeding or bruising may be observed.

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

• serious skin reactions: the patient may notice one or more of the following symptoms – blistering of the skin and rapid deterioration in general condition, erosions (with slight bleeding) of the eyes, nose, oral cavity/lips or genital organs, or rash, particularly in areas of skin exposed to light/sunlight. Joint pain or flu-like symptoms, fever, gland swelling (e.g. under the arms) may also occur, and blood tests may show changes in certain white blood cells or liver enzymes.
• red, non-elevated spots or round patches on the trunk, often with blisters in the center, skin peeling, ulceration of the mouth, throat, nose, genital organs and eyes. The onset of such a severe skin rash may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• extensive rash, high body temperature and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome)
• other serious disorders: yellowing of the skin and whites of the eyes (severe liver cell damage, jaundice) or fever, rash, enlarged kidneys sometimes with painful urination and back pain (severe kidney inflammation, potentially leading to kidney failure).

Other adverse reactions include:

• Common (may affect 1 in 10 patients) Benign gastric polyps
• Uncommon (may affect 1 in 100 patients) Headache, dizziness, diarrhoea, nausea, vomiting, abdominal bloating and flatulence, constipation, dry mouth, abdominal pain and discomfort, rash, urticaria, skin eruptions, itching, weakness, feeling of exhaustion or generally poor well-being, sleep disturbances, fracture of the hip, wrist or spine.
• Rare (may affect 1 in 1,000 patients) Changes in taste sensation or loss of taste, visual disturbances such as blurred vision, urticaria, joint pain, muscle pain, changes in body weight, elevated body temperature, limb swelling (peripheral oedema), depression, breast enlargement in men.
• Frequency not known (frequency cannot be estimated from the available data) Hallucinations, confusion (particularly in patients with such symptoms in their history), sensation of tingling, pricking, burning or numbness, inflammation of the large intestine causing persistent watery diarrhoea.

Adverse reactions observed in blood tests:

• Uncommon (may affect 1 in 100 patients) Increased liver enzyme activity.
• Rare (may affect 1 in 1,000 patients) Increased bilirubin concentration, increased blood lipid levels.
• Frequency not known (frequency cannot be estimated from the available data) Decreased concentration of sodium, magnesium, calcium or potassium in blood (see section 2).

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions 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
Tel.: 22 49 21 301
Fax: 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Pamyl 40 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 following EXP.
The expiry date refers to the last day of the stated month.
Blister packs: This medicine does not require any special storage precautions.
PVC/PE/PVdC blisters: Store below 25°C.
HDPE bottles: After first opening, use within 100 days. Keep the bottle tightly closed to protect from moisture.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Pamyl 40 mg contains

• The active substance is sodium pantoprazole sesquihydrate, equivalent to 40 mg of pantoprazole.
• The other ingredients are: anhydrous sodium carbonate, mannitol, crospovidone, povidone (K-90) and calcium stearate. The coating contains methacrylic acid-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 pack
Pamyl 40 mg tablets are yellow, film-coated, oval-shaped, measuring 5.7 mm x 11.6 mm, biconvex, with no engravings on either side of the tablet. Tablets are available in plastic bottles and blisters.
White HDPE bottles with PP screw caps containing 14, 28, 30, 50, 56, 60, 90, 98, 100 or 250 tablets, packed in a cardboard box. The bottles also contain a small plastic container with silica gel or a sachet containing silica gel and activated charcoal, which protect the tablets from moisture. The container or sachet is not intended for consumption and should not be removed from the bottle.
Aluminium/Aluminium blisters with or without a moisture-absorbing layer, packed in cardboard boxes containing 7, 7x1, 14, 14x1, 28, 28x1, 30, 56, 70, 70x1, 96 or 98 tablets.
PVC/PE/PVDC blisters with aluminium foil lidding, packed 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 Authorisation 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 further information and contact details in the European Economic Area countries, please contact the local representative of the Marketing Authorisation Holder:
Viatris Healthcare Sp. z o.o.
Tel. +48 22 546 64 00

This medicinal product is authorised 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