Noacid

Patient Information Leaflet

Noacid, 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, pharmacist or nurse.
• 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 reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet Contents:

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

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

Noacid 20 mg tablets contain the active substance pantoprazole. Pantoprazole is a selective
"proton pump inhibitor", a medicine that reduces the secretion of acid in the stomach. It is used
in the treatment of stomach and intestinal disorders associated with hydrochloric acid secretion.
Noacid 20 mg is indicated for:
Adults and adolescents aged 12 years and above:

• Treatment of symptoms (e.g. heartburn, acid regurgitation, painful swallowing) associated with gastroesophageal reflux disease (GERD) caused by backflow of stomach acid.
• Long-term treatment of reflux esophagitis (inflammation of the esophagus accompanied by regurgitation of gastric acid) and prevention of its recurrence.

Adults:

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

2. Important information before using Noacid 20 mg

When not to use Noacid 20 mg

• If the patient is allergic to pantoprazole, soy nuts, or soy oil, or to 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 20 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 your doctor if you have ever had liver problems. Your doctor may recommend more frequent monitoring of liver enzyme activity, especially if long-term treatment with Noacid 20 mg is required. If liver enzyme activity increases, treatment should be discontinued.
• If the patient must continuously take NSAIDs and is also taking Noacid 20 mg due to an increased risk of gastrointestinal complications. The increased risk will be assessed according to individual patient risk factors, such as age (65 years or older), history of gastric or duodenal ulcers, or gastrointestinal bleeding.
• If the patient has vitamin B12 deficiency or risk factors indicating possible reduced vitamin B12 levels and is undergoing long-term pantoprazole treatment. Like all medicines that reduce gastric acid absorption, pantoprazole may lead to reduced absorption of vitamin B12.
• If the patient is taking HIV protease inhibitors, such as atazanavir (used in HIV treatment), concurrently with pantoprazole, they should seek detailed advice from their doctor.
• Taking a proton pump inhibitor such as Noacid 20 mg, particularly for longer than one 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 that they are at risk of developing osteoporosis (e.g., if the patient is taking steroid medications).
• If the patient takes Noacid 20 mg for longer than 3 months, magnesium levels in the blood may decrease. Low magnesium levels may manifest as fatigue, involuntary muscle contractions, disorientation, muscle spasms, seizures, dizziness, or rapid heartbeat. If any of these symptoms occur, inform your doctor immediately. Low magnesium levels may also lead to reduced potassium or calcium levels in the blood. Your doctor may decide to perform regular blood tests to monitor magnesium levels.
• If the patient has ever experienced a skin reaction due to taking a medicine similar to Noacid 20 mg that reduces gastric acid secretion.
• If the patient develops a skin rash, especially in areas exposed to sunlight, they should inform their doctor as soon as possible, as discontinuation of Noacid 20 mg may be necessary. Also report any other adverse reactions, such as joint pain. Contact your doctor immediately before starting or during treatment if any of the following symptoms occur, as they may indicate other, more serious conditions:
• Unintended weight loss;
• Vomiting, especially recurrent;
• Bloody vomit, which may look like dark coffee grounds;
• Blood in stool, black or tarry stools;
• Difficulty swallowing or pain during swallowing;
• Pallor and weakness (anaemia);
• Chest pain;
• Abdominal pain;
• Severe and/or persistent diarrhoea, as treatment with Noacid 20 mg is associated with a small increased risk of infectious diarrhoea. The treating doctor may decide to perform further tests to rule out an underlying tumour, as treatment with pantoprazole may alleviate symptoms of tumour disease and delay diagnosis. If symptoms persist despite treatment, further investigations should be considered.

If Noacid 20 mg is taken for a prolonged period (over 1 year), the patient will likely be under continuous medical supervision. In such cases, report any new or unexpected symptoms and the circumstances of their occurrence during every visit to the doctor.

Children and adolescents
Noacid 20 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 20 mg and other medicines
Inform your doctor about all medicines currently or recently taken, as well as any medicines the patient plans to take, because Noacid 20 mg may affect the effectiveness of other medicines. Therefore, inform your doctor if the patient is taking:

• Medicines such as ketoconazole, itraconazole, and posaconazole (used to treat fungal infections) or erlotinib (used in certain types of cancer), as Noacid 20 mg may inhibit the proper action of these and other medicines;
• Warfarin and phenprocoumon (medicines used to prevent blood clotting and thrombosis). Additional tests may be required;
• Medicines used in the treatment of HIV infection, such as atazanavir;
• Methotrexate (used in the treatment of rheumatoid arthritis, psoriasis, and cancer) – if the patient is taking methotrexate, the doctor may temporarily discontinue Noacid treatment, 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.

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 become pregnant, 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 risks 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 or operate mechanical equipment if the patient experiences adverse effects such as dizziness or visual disturbances.

Noacid 20 mg contains deoiled soy lecithin, maltitol, and sodium
Do not use this medicine if the patient is hypersensitive to peanuts or soy.
If a doctor has previously informed the patient about 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 20 mg
Always use this medicine exactly as prescribed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

When and how to take Noacid 20 mg
Take tablets one hour before a meal, without chewing or dividing the tablet. Swallow whole with water.

Unless otherwise directed by the doctor, the recommended dose is:
Adults and adolescents aged 12 years and older:
For treatment of symptoms (e.g., heartburn, acid regurgitation, pain during swallowing) associated with gastroesophageal reflux disease caused by reflux of acidic stomach contents:
The recommended dose is one tablet daily. This dose usually provides relief within 2–4 weeks of treatment – at the latest within the following 4 weeks. The doctor will decide how long the medicine should be taken. Recurrent symptoms can be managed by taking one tablet daily as needed.

For long-term treatment and prevention of recurrence of reflux esophagitis (inflammation of the oesophagus associated with regurgitation of acidic stomach contents):
The recommended dose is one tablet daily. If symptoms recur, the doctor may recommend doubling the dose. In this case, one tablet of Noacid 40 mg daily may be used. After symptoms resolve, the dose may be reduced again to one tablet of 20 mg daily.

Adults:
For prevention of gastric and duodenal ulcers in patients who must continuously take NSAIDs:
The recommended dose is one tablet daily.

Special patient groups:
Patients with impaired liver function
If the patient has severe liver function impairment, do not take more than one 20 mg tablet daily.

Use in children and adolescents
Noacid 20 mg is not recommended for use in children under 12 years of age.

Taking more Noacid 20 mg than recommended
Consult your doctor or pharmacist. Symptoms of overdose are not known.

If you miss a dose of Noacid 20 mg
Do not take a double dose to make up for the missed dose. Take the next dose at the usual time.

Stopping Noacid 20 mg
Do not stop taking the tablets 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 reactions occur, you should
immediately inform your doctor or contact 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, urticaria (rash resembling nettle burn), breathing difficulties, angioedema of the face (Quincke's edema/angioedema), 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 - formation of blisters on the skin and sudden deterioration in 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, which may lead 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, erythema, skin eruptions (caused by infection), itching of the skin, 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 in males.
• Very rare (may affect up to 1 in 10,000 patients): Disorientation.
• Frequency unknown (frequency cannot be estimated from available data): Hallucinations, confusional state (particularly in patients who have previously experienced such symptoms), sensation of tingling, pricking and numbness, burning or anaesthetic sensation, rash sometimes with joint pain. Colitis, which causes persistent watery diarrhoea.

Adverse reactions identified 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 concentration, 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 cause more frequent bleeding and bruising,

decreased white blood cell count, which may predispose to more frequent infections, simultaneous
abnormal decrease in red blood cells, white blood cells and platelets.

• 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 symptoms occur, including any adverse symptoms not listed
in this leaflet, you should 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.: + 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.
By reporting adverse reactions, more information on the safety of the medicine can be collected.

5. How to store Noacid 20 mg

Keep the medicine out of sight and reach of children.
No special storage conditions are required for this medicinal product.
Tablets packed in plastic bottles: Noacid 20 mg can be used for 3 months after opening the packaging.
Do not use this medicine after the expiry date stated on the blister and carton following the term “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 should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Noacid 20 mg contains
The active substance is pantoprazole.
Each enteric-coated tablet contains 20 mg of pantoprazole (as sodium pantoprazole
sesquihydrate).
The other ingredients are:
Tablet core:
Maltitol (E 965), crospovidone type B, sodium carboxymethylcellulose, anhydrous sodium
carbonate (E 500), calcium 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), copolymer of methacrylic
acid and ethyl acrylate (1:1), triethyl citrate (E 1505).
What Noacid 20 mg looks like and contents of the pack
Noacid 20 mg tablets are yellow, oval enteric-coated tablets, 8.2 mm in length and 4.4 mm in
diameter.
Noacid 20 mg is available in packs containing 7, 14, 28 tablets in blisters and in bottles containing
7, 14, 28 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation 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 authorised in the Member States of the European Economic Area under
the following names:
Hungary (RMS): Noacid 20 mg gyomornedv-ellenálló tabletta
Bulgaria: Ноацид 20 mg стомашно-устойчиви таблетки
Noacid 20 mg gastro-resistant tablets
Poland: Noacid
Romania: Noacid 20 mg comprimate gastro-rezistente