Package leaflet: Information for the patient

Pamyl 20 mg, 20 mg, enteric-coated tablets
Pantoprazole
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

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

Leaflet contents:

What Pamyl 20 mg is and what it is used for
What you need to know before taking Pamyl 20 mg
How to take Pamyl 20 mg
Possible side effects
How to store Pamyl 20 mg
Contents of the pack and other information

1. What Pamyl 20 mg is and what it is 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 disorders related to
stomach acid.
It may be used for:
Adults and adolescents from 12 years of age:

Treatment of symptoms (e.g. heartburn, acid regurgitation, pain when swallowing) associated with gastroesophageal reflux disease (GERD) caused by stomach acid flowing back into the oesophagus.
Long-term treatment of reflux oesophagitis (inflammation of the oesophagus associated with backflow of stomach acid) and prevention of its recurrence.

Adults:

Prevention of duodenal and gastric ulcers induced by non-steroidal anti-inflammatory drugs (NSAIDs, e.g. ibuprofen) in patients at risk of developing such ulcers who require continuous NSAID treatment.

2. Important information before using Pamyl 20 mg

When not to use Pamyl 20 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 20 mg, discuss the following with your doctor or pharmacist:

if the patient has severe liver disease. If liver disease has ever occurred in the past, inform the doctor. The doctor will monitor liver enzymes more frequently, especially if Pamyl 20 mg is used for a long time. If liver enzyme activity increases, treatment should be discontinued
if the patient is continuously taking medicines called NSAIDs and is receiving Pamyl 20 mg due to an increased risk of gastrointestinal complications. This increased risk will be assessed based on individual patient risk factors, such as age (65 years or older), history of gastric or duodenal ulcer disease, gastrointestinal bleeding
if the patient has low body stores of vitamin B or risk factors for reduced vitamin B levels and is receiving Pamyl 20 mg for a prolonged period. Like all acid-reducing medicines, Pamyl 20 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
visual disturbances
memory problems, disorientation, depression
if atazanavir (used in the treatment of HIV infection) is being taken together with Pamyl 20 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 about 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, a decrease in blood magnesium levels may occur. Low magnesium levels may cause fatigue, involuntary muscle contractions, confusion, seizures, dizziness, and rapid heartbeat. If any of these symptoms occur, inform your doctor immediately. Low magnesium levels may also lead to reduced levels of potassium or calcium in the blood. Your doctor may decide that periodic blood magnesium checks are necessary
if the patient has ever previously experienced 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 related to 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
repeated 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 slightly increased risk of infectious diarrhoea.

If a skin rash develops, especially in areas exposed to
sunlight, inform your doctor as soon as possible, as it may be necessary to discontinue
treatment with Pamyl 20 mg. Remember to report all other
adverse effects, such as joint pain.
Your doctor may decide to perform certain tests to rule out
tumour disease, because pantoprazole may relieve tumour symptoms and thus
delay diagnosis. If symptoms persist despite treatment, further diagnostic
evaluation will be considered.
If the patient takes Pamyl 20 mg for a long time (over one year), the doctor will likely recommend
regular check-ups. At each medical visit, report any new or unusual
symptoms or conditions to your doctor.
Pamyl 20 mg and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take, because 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 in certain types of cancer), because 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) (see section 2 "Warnings and precautions")
Methotrexate (used in the treatment of rheumatoid arthritis, psoriasis, and cancer), because 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 20 mg in pregnant women.
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 be used only if the doctor considers that the benefits outweigh the potential
risk to the unborn child or newborn.
Driving and operating machinery
Do not drive or operate machinery if adverse effects such as dizziness or visual disturbances occur.
Pamyl 20 mg contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet; therefore, this medicine is considered "sodium-free".

3. How to use Pamyl 20 mg

This medicine should always be taken as directed by a doctor or pharmacist. If in doubt,
consult a doctor or pharmacist.
When and how to take Pamyl 20 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 directed by a doctor, the recommended dose is:
Adults and adolescents aged 12 and over:
For treatment of symptoms (such as heartburn, acid regurgitation, pain when swallowing) associated
with gastro-oesophageal reflux disease
The recommended dose is 1 tablet per day. This dose usually relieves symptoms within 2–4 weeks –
at the latest after the next 4 weeks. Your doctor will determine how long you should continue treatment.
After this period, any recurring symptoms can be controlled by taking 1 tablet per day as needed.
For long-term treatment and prevention of relapse of reflux oesophagitis:
The recommended dose is 1 tablet per day. If the disease recurs, your doctor may double this dose.
In such cases, Pamyl 40 mg tablets may be taken once daily. After healing, the dose may be reduced again
to 1 tablet of 20 mg once daily.
Adults:
For prevention of gastric and duodenal ulcers in patients requiring continuous use of NSAIDs
The recommended dose is 1 tablet per day.
Special patient groups:

If the patient has liver disease, they should not take more than 1 tablet of 20 mg per day.
Children under 12 years of age: This medicine is not recommended for children under 12 years of age.

Taking more Pamyl 20 mg than recommended
Consult a doctor or pharmacist. Symptoms of overdose are not known.
If you forget to take Pamyl 20 mg
Do not take a double dose to make up for the missed dose. Take the next dose at the usual time.
Stopping Pamyl 20 mg
Do not stop taking this medicine without first consulting your doctor or pharmacist.
If you have any further questions 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 everyone will experience them.
If any of the following adverse symptoms 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, allergic facial swelling (Quincke's oedema/angioedema), severe dizziness with very rapid heartbeat and profuse sweating.
Decrease in the number of white and red blood cells and/or platelets, which may be evident in blood tests. In patients, this may manifest as more frequent infections, more frequent than normal bleeding or bruising.

Frequency unknown (frequency cannot be estimated from available data)

Severe skin reactions: the patient may notice one or more of the following symptoms – development of blisters on the skin and rapid deterioration in general condition, erosions (with slight bleeding) of the eyes, nose, mouth/lips or genital organs, or rash, particularly in areas of skin exposed to light/sunlight. Joint pain or flu-like symptoms, fever, swollen glands (e.g. under the arms) may also occur, and blood tests may show changes in certain white blood cells or liver enzymes.
Reddish, non-elevated spots or circular lesions 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).
Widespread rash, high body temperature and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).
Other severe 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, which may lead 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 general malaise, sleep disturbances, fracture of the hip, wrist or spine.
Rare (may affect 1 in 1,000 patients) Changes in taste perception or loss of taste, visual disturbances such as blurred vision, hives, joint pain, muscle pain, weight changes, elevated body temperature, swelling of limbs (peripheral oedema), depression, breast enlargement in men.
Frequency unknown (frequency cannot be estimated from available data) Hallucinations, confusion (particularly in patients with such symptoms in their history), sensations 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 unknown (frequency cannot be estimated from 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 Adverse Drug Reactions, Office for Registration 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the 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 stated month.
Blister packs: This medicine does not require any special precautions for storage.
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 in household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the package and other information

What Pamyl 20 mg contains

The active substance is sodium pantoprazole hemihydrate, corresponding to 20 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 20 mg looks like and contents of the pack
Pamyl 20 mg tablets are dark yellow, coated, oval-shaped, measuring 4.3 mm x 8.4 mm, biconvex, without any markings on either side. 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 to 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, 14, 14x1, 28, 28x1, 30, 56, 70, 70x1, 96 or 98 tablets.
PVC/PE/PVDC blisters with aluminium foil cover, 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 European Economic Area countries 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