Patient Information Leaflet

Noacid, 40 mg, enteric-coated tablets
Pantoprazolum
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.
Keep this leaflet so that you can read it again if necessary.

If you have any questions, ask your doctor, pharmacist, or nurse.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, 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.

Leaflet Contents:

What Noacid 40 mg is and what it is used for
Important information before taking Noacid 40 mg
How to take Noacid 40 mg
Possible side effects
How to store Noacid 40 mg
Contents of the pack and other information

1. What Noacid 40 mg is and what it is used for

Noacid 40 mg tablets contain the active substance pantoprazole. Pantoprazole is a selective
"proton pump inhibitor," a medicine that reduces the production of stomach acid. It is used
in the treatment of stomach and intestinal disorders related to hydrochloric acid secretion.
Noacid 40 mg is used to treat:
Adults and adolescents aged 12 years and above:

Gastroesophageal reflux disease (GERD) with reflux esophagitis. This is inflammation of the esophagus (the tube connecting the throat to the stomach) associated with backflow of stomach acid.

Adults:

Helicobacter pylori infection in patients with peptic ulcer disease, in combination with two antibiotics (eradication therapy), to eliminate the bacteria and prevent ulcer recurrence.
Peptic ulcer disease of the stomach and duodenum.
Zollinger-Ellison syndrome and other conditions associated with excessive gastric acid secretion.

2. Information before using Noacid 40 mg

When not to use Noacid 40 mg tablets

If the patient is allergic to pantoprazole, soy nuts, or soy oil, 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 Noacid 40 mg, discuss this with your doctor or pharmacist.

If the patient is scheduled for a specific blood test (chromogranin A levels).
If the patient has severe liver function disorders. Inform the doctor if there has ever been liver dysfunction, especially if the patient has been taking Noacid 40 mg long-term. If liver enzyme activity increases, treatment should be discontinued.
If the patient has vitamin B deficiency or risk factors indicating possible reduced vitamin B levels, and the patient is being treated long-term with pantoprazole. Like all medicines reducing gastric hydrochloric acid secretion, pantoprazole may lead to reduced absorption of vitamin B(_{12}).
If the patient is taking HIV protease inhibitors such as atazanavir (used in HIV infection treatment) concomitantly with pantoprazole, the patient should seek detailed advice from the doctor.
Taking a proton pump inhibitor such as Noacid 40 mg, particularly for longer than one year, may slightly increase the risk of fractures of the hip, wrist, or spine. Inform the doctor if the patient has osteoporosis (reduced bone density) or if the doctor has informed the patient that they are at risk of developing osteoporosis (e.g. if the patient is taking steroid medicines).
If the patient takes Noacid 40 mg for longer than 3 months, magnesium levels in the blood may decrease. Low magnesium levels may manifest as fatigue, involuntary muscle spasms, disorientation, muscle twitching, seizures, dizziness, rapid heartbeat. If any of these symptoms occur, inform the doctor immediately. Low magnesium levels may also lead to reduced potassium or calcium levels in the blood. The doctor may decide to perform regular blood tests to monitor magnesium levels.
If the patient has ever had a skin reaction due to taking a medicine similar to Noacid 40 mg that reduces gastric acid secretion.
If the patient develops a skin rash, especially in areas exposed to sunlight, inform the doctor as soon as possible, as discontinuation of Noacid 40 mg may be necessary. Also report any other adverse effects occurring, such as joint pain.

Immediately inform the doctor before starting or during treatment
with the medicine if any of the following symptoms occur, which may indicate other,
more serious conditions:

Unintentional weight loss;
Vomiting, especially recurrent;
Vomiting blood, which may look like dark coffee grounds;
Blood in 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 use of Noacid 40 mg is associated with a small increased risk of infectious diarrhea.

The treating doctor may decide that diagnostic tests are necessary to rule out an underlying tumor disease, as treatment with pantoprazole may alleviate symptoms of malignancy and delay diagnosis. If symptoms persist despite treatment, further investigations should be considered.
If Noacid 40 mg is taken for a prolonged period (over 1 year), the patient will likely be under continuous medical supervision. In such cases, any new or unexpected symptoms and their circumstances should be reported during every doctor visit.

Children and adolescents
Noacid 40 mg is not recommended for use in children under 12 years of age due to limited data on safety and efficacy in this age group.

Noacid 40 mg and other medicines
Inform the doctor about all medicines currently or recently taken, as well as any medicines the patient plans to take, because Noacid 40 mg may affect the effectiveness of other medicines, therefore inform the doctor if the patient is taking:

Medicines such as ketoconazole, itraconazole, posaconazole (used to treat fungal infections), or erlotinib (used in certain types of cancer), as Noacid 40 mg may inhibit the proper action of these and other medicines;
Warfarin and phenprocoumon (medicines used to inhibit blood clotting and prevent thrombosis). Further testing may be required;
Medicines used to treat HIV infection, such as atazanavir;
Methotrexate (used to treat rheumatoid arthritis, psoriasis, and cancers) – if the patient is taking methotrexate, the doctor may temporarily discontinue treatment with Noacid, as pantoprazole may increase methotrexate blood levels;
Fluvoxamine (used to treat 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.

Pregnancy, breastfeeding, and fertility
There are insufficient data on the use of pantoprazole in pregnant women. It has been shown that the active substance passes into human breast milk.
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.
The medicine may be used only if the doctor considers that the benefits to the patient outweigh the potential risk to the unborn child or infant.

Driving and operating machinery
Pantoprazole has no effect or a negligible effect on the ability to drive and operate machinery.
Do not drive motor vehicles or operate mechanical equipment if the patient experiences adverse effects such as dizziness or visual disturbances.

Noacid 40 mg contains hydrogenated soybean lecithin, maltitol, and sodium
Do not use this medicine if the patient is allergic to peanuts or soy.
If a doctor has previously informed the patient of intolerance to certain sugars, consult the doctor before using this medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Noacid 40 mg

This medicine should always be taken as instructed by your doctor or pharmacist. If in doubt,
consult your doctor or pharmacist.
When and how to take Noacid 40 mg
Take the medicine one hour before a meal, without chewing or dividing the tablet. Swallow the tablet
whole with water.
If your doctor has not advised otherwise, the recommended dose is:
Adults and adolescents aged 12 years and above:
For treatment of reflux esophagitis:
The recommended dose is one tablet per day. Your doctor may recommend increasing the dose to two tablets per
day. The treatment period for reflux esophagitis usually lasts from 4 to 8 weeks. Your doctor
will decide how long you should take the medicine.
Adults:
For treatment of infection with the bacterium called Helicobacter pylori, in patients with duodenal
and gastric ulcers, in combination with two antibiotics (eradication therapy):
One tablet twice daily plus two antibiotic tablets: amoxicillin, clarithromycin,
or metronidazole (or tinidazole), each taken twice daily together with pantoprazole tablets.
The first pantoprazole tablet should be taken one hour before breakfast, and the second pantoprazole tablet
one hour before dinner. Follow your doctor's instructions and
read the patient leaflets included in the antibiotic packaging. Treatment is usually
administered for one to two weeks.
For treatment of gastric and duodenal ulcers:
The recommended dose is one tablet per day. After consultation with your doctor, the dose may be doubled. Your doctor
will decide how long you should take the medicine. The treatment period for gastric ulcers usually lasts
from 4 to 8 weeks. The treatment period for duodenal ulcers usually lasts
from 2 to 4 weeks.
For long-term treatment of Zollinger-Ellison syndrome and other medical conditions
associated with excessive hydrochloric acid secretion:
The usual initial dose is two tablets per day.
Both tablets should be taken one hour before a meal. Later, the dosage may be adjusted appropriately by your doctor, depending on the amount of hydrochloric acid secreted in the stomach. If more than two tablets per day are prescribed, they should be taken twice daily.
If your doctor prescribes a daily dose exceeding four tablets per day, you will be clearly informed when to discontinue taking the medicine.
Special patient groups:
Patients with impaired kidney function

If a patient has kidney disease, Noacid 40 mg should not be used for the eradication of Helicobacter pylori.

Patients with impaired liver function

If a patient has moderate or severe liver disease, Noacid 40 mg should not be used for the eradication of Helicobacter pylori.
If a patient has severe liver disease, no more than one 20 mg pantoprazole tablet per day should be taken (for this purpose, tablets containing 20 mg pantoprazole are available).

Use in children and adolescents
Noacid 40 mg is not recommended for use in children under 12 years of age.
Taking more Noacid 40 mg than recommended
Consult your doctor or pharmacist. Symptoms of overdose are not known.
Missing a dose of Noacid 40 mg
Do not take a double dose to make up for a missed dose. Take the next dose at the usual time.
Stopping Noacid 40 mg
Do not stop taking the tablets 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

If any of the following adverse reactions occur, you should immediately contact your doctor or go to the nearest hospital providing emergency care:

Severe allergic reactions (rare – may affect up to 1 in 1,000 patients): swelling of the tongue and/or throat, difficulty swallowing, hives (skin rash resembling nettle rash), breathing difficulties, angioedema of the face (Quincke's oedema/angio-oedema), severe dizziness with rapid heartbeat and profuse sweating.
Severe skin reactions (frequency unknown – frequency cannot be estimated from available data): the patient may notice one or more of the following symptoms – blistering of the skin and sudden worsening of general condition, erosions (with slight bleeding) of the eyes, nose, oral cavity/mouth or genital organs, or rash, particularly in areas of skin exposed to 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 (Stevens-Johnson syndrome, Lyell's syndrome, erythema multiforme, subacute cutaneous lupus erythematosus, drug rash with eosinophilia and systemic symptoms (DRESS syndrome), photosensitivity).
Other severe reactions (frequency unknown): yellowing of the skin and eyes (severe liver cell damage, jaundice) or fever, rash, and kidney problems manifested by kidney enlargement, sometimes with pain during urination and pain in the lower back (severe kidney inflammation, potentially leading to kidney failure).

Other adverse reactions:

Common (may affect up to 1 in 10 patients): benign gastric polyps.
Uncommon (may affect up to 1 in 100 patients): headache, dizziness, diarrhoea, nausea, vomiting, feeling of fullness in the abdomen and bloating with flatulence (passing wind), constipation, dry mouth, abdominal pain and discomfort, skin rash, flushing, skin eruptions (caused by infection), itching, weakness, exhaustion or general malaise, sleep disturbances, fracture of the hip, wrist or spine.
Rare (may affect up to 1 in 1,000 patients): taste disturbances or complete loss of taste perception, visual disturbances such as blurred vision, urticaria, joint pain, muscle pain, changes in body weight, elevated body temperature, limb swelling (peripheral oedema), allergic reactions, depression, gynaecomastia (breast enlargement in males).
Very rare (may affect up to 1 in 10,000 patients):
Disorientation.
Frequency not known (frequency cannot be estimated from available data): hallucinations, confusional state (particularly in patients who have previously experienced such symptoms), sensations of tingling, pricking and numbness, burning or anaesthetic sensations, rash sometimes with joint pain. Inflammation of the large intestine causing persistent watery diarrhoea.

Adverse reactions detected by blood tests occurring:

Uncommon (may affect up to 1 in 100 patients): increased liver enzyme activity.
Rare (may affect up to 1 in 1,000 patients): increased bilirubin concentration, increased blood lipid levels, sudden decrease in granulocyte count associated with high fever.
Very rare (may affect up to 1 in 10,000 patients): decreased platelet count, which may lead to more frequent bleeding and bruising, decreased white blood cell count, which may increase susceptibility to infections, simultaneous abnormal decrease in red blood cells, white blood cells and platelets.
Frequency not known (frequency cannot be estimated from available data): decreased concentration of sodium, magnesium, calcium or potassium in the 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 of the 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 authorisation holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Noacid 40 mg

Keep this medicine out of sight and reach of children.
No special storage conditions are required for this medicinal product.
Tablets packed in plastic bottles: Noacid 40 mg can be used for 3 months after opening the
packaging.
Do not use this medicine after the expiry date (month and year) stated on the blister and
carton after "Expiry date (EXP)". The expiry date refers to the last day of the stated month.
Do not use this medicine if visible signs of deterioration are observed.
Medicines must not be disposed of via wastewater or household waste. Ask a pharmacist how to
dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Noacid 40 mg contains
The active substance is pantoprazole. Each enteric-coated tablet contains 40 mg of pantoprazole (as
pantoprazole sodium sesquihydrate).
The other ingredients are:
Tablet core:
Maltitol (E 965), crospovidone type B, sodium carmellose, anhydrous sodium carbonate (E 500),
magnesium stearate.
Tablet coating:
Polyvinyl alcohol, talc (E 553b), titanium dioxide (E 171), macrogol 3350, soybean lecithin (E 322),
yellow iron oxide (E 172), anhydrous sodium carbonate (E 500), methacrylic acid and ethyl acrylate
copolymer (1:1), triethyl citrate (E 1505).
What Noacid 40 mg looks like and contents of the pack
Noacid 40 mg tablets are yellow, oval enteric-coated tablets, 10.3 mm long and 5.5 mm in diameter.
Noacid 40 mg is available in packs containing 7, 14, or 28 tablets in blisters, and in packs containing 7, 14, or 28 tablets in bottles.
Not all pack sizes may be marketed.
Marketing Authorization Holder:
Egis Pharmaceuticals PLC
Keresztúri út 30-38
1106 Budapest
Hungary
Manufacturer:
Egis Pharmaceuticals PLC
1165 Budapest, Bökényföldi út 118-120.
Hungary
This medicinal product is authorized for marketing in the European Economic Area countries under the following names:
Hungary (RMS): Noacid 40 mg gyomornedv-ellenálló tabletta
Bulgaria: Ноацид 40 mg стомашно-устойчиви таблетки
Noacid 40 mg gastro-resistant tablets
Poland: Noacid
Romania: Noacid 40 mg comprimate gastro-rezistente