Noacid

Leaflet attached to the packaging: patient information

Noacid, 20 mg, gastro-resistant tablets

Pantoprazole

Please read carefully the contents of the leaflet before taking the medicine, as it contains important information for the patient.

Please keep this leaflet, so you can read it again if you need to.

• In case of any doubts, you should consult a doctor, pharmacist, or nurse.
• 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, please inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Noacid 20 mg and what is it used for
• 2. Important information 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 packaging and other information

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

Noacid 20 mg gastro-resistant tablets contain the active substance pantoprazole. 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 gut conditions related to acid production.

Noacid 20 mg is used in:

Adults and adolescents aged 12 years and older:

• Treatment of symptoms (e.g., heartburn, acid reflux, pain when swallowing) associated with gastroesophageal reflux disease caused by acid reflux from the stomach.
• Long-term treatment of reflux esophagitis (inflammation of the esophagus caused by acid reflux) and prevention of its recurrence.

Adults:

• Prevention of duodenal and stomach ulcers caused by non-steroidal anti-inflammatory drugs (NSAIDs, e.g., ibuprofen) in patients at risk who need to continuously take NSAIDs.

2. Important information before taking Noacid 20 mg

When not to take Noacid 20 mg

• If you are allergic to pantoprazole, soybeans, or soybean oil, or any of the other ingredients of this medicine (listed in section 6).
• If you are allergic to medicines containing other proton pump inhibitors.

Warnings and precautions

Before taking Noacid 20 mg, you should discuss it with your doctor or pharmacist.

• If you are scheduled for a specific blood test (chromogranin A levels).
• If you have severe liver problems. You should inform your doctor if you have ever had liver problems. Your doctor may decide to monitor your liver enzymes more frequently, especially if you are taking Noacid 20 mg for a long time. If your liver enzymes increase, your doctor may decide to stop the treatment.
• If you need to take NSAIDs continuously and also take Noacid 20 mg, as this may increase the risk of stomach or gut problems. The increased risk will be assessed based on your individual risk factors, such as age (65 years or older), history of stomach or duodenal ulcers, or bleeding from the stomach or gut.
• If you have a vitamin B12 deficiency or risk factors for vitamin B12 deficiency, and you are taking pantoprazole long-term. Like all medicines that reduce acid production in the stomach, pantoprazole may lead to reduced vitamin B12 absorption.
• If you are taking HIV protease inhibitors, such as atazanavir (used to treat HIV infection), you should consult your doctor for specific advice.
• Taking a proton pump inhibitor like Noacid 20 mg, especially for a period longer than one year, may slightly increase the risk of hip, wrist, or spine fractures. You should tell your doctor if you have osteoporosis (reduced bone density) or if your doctor has told you that you are at risk of osteoporosis (e.g., if you are taking steroid medicines).
• If you take Noacid 20 mg for more than 3 months, it may lead to reduced magnesium levels in the blood. Low magnesium levels may cause fatigue, involuntary muscle contractions, disorientation, muscle cramps, seizures, dizziness, or rapid heartbeat. If you experience any of these symptoms, please tell your doctor immediately. Low magnesium levels may also lead to reduced potassium or calcium levels in the blood. Your doctor may decide to regularly perform blood tests to monitor magnesium levels.
• If you have ever had a skin reaction after taking a medicine that reduces acid production in the stomach.
• If you experience a skin rash, especially in areas exposed to sunlight, you should tell your doctor immediately, as it may be necessary to stop taking Noacid 20 mg. You should also tell your doctor about any other side effects, such as joint pain.

You should immediately inform your doctor before or during treatment if you experience any of the following symptoms, which may be signs of more serious conditions:

• - Unintentional weight loss;
• - Vomiting, especially if it is recurring;
• Bloody vomiting, which may look like coffee grounds;
• Blood in the stool, black or tarry stools;
• - Difficulty swallowing or pain when swallowing;
• Pale skin and weakness (anemia);
• Chest pain;
• Abdominal pain;
• Severe and/or persistent diarrhea, as taking Noacid 20 mg is associated with a slight increase in the risk of infectious diarrhea. Your doctor may decide to perform tests to rule out an underlying malignant condition, as pantoprazole treatment may alleviate the symptoms of the malignant condition and delay its diagnosis. If symptoms persist despite treatment, further tests should be considered.

If you take Noacid 20 mg for a long period (more than 1 year), you will probably be under regular medical supervision. In this case, you should report any new or unexpected symptoms and their circumstances during each visit to your doctor.

Children and adolescents

Noacid 20 mg is not recommended for use in children under 12 years of age due to limited data on the safety and efficacy of the medicine in this age group.

Noacid 20 mg and other medicines

You should tell your doctor about all the medicines you are taking or have recently taken, as well as any medicines you plan to take, as Noacid 20 mg may affect the efficacy of other medicines. Therefore, you should 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 Noacid 20 mg may inhibit the proper functioning of these and other medicines,
• Warfarin and phenprocoumon (medicines used to prevent blood clotting) and prevent thrombosis. Further tests may be necessary,
• Medicines used to treat HIV infection, such as atazanavir,
• Methotrexate (used to treat rheumatoid arthritis, psoriasis, and cancer) - if you are taking methotrexate, your doctor may temporarily stop Noacid treatment, as pantoprazole may increase methotrexate levels in the blood,
• Fluvoxamine (used to treat depression and other mental health conditions) - 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.

Pregnancy, breastfeeding, and fertility

There are no adequate data on the use of pantoprazole in pregnant women. It has been found that the active substance of the medicine passes into breast milk.
If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, you should consult your doctor or pharmacist before taking this medicine.
The medicine may only be used if your doctor considers that the benefits of taking the medicine for you outweigh the potential risk to the unborn child or baby.

Driving and using machines

Pantoprazole has no or negligible influence on the ability to drive and use machines.
You should not drive vehicles or operate machinery if you experience side effects such as dizziness or vision disturbances.

Noacid 20 mg contains soybean lecithin, maltitol, and sodium

You should not take this medicine if you are allergic to peanuts or soybeans.
If your doctor has told you that you have an intolerance to some sugars, you should consult your doctor before taking this medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially "sodium-free".

3. How to take Noacid 20 mg

This medicine should always be taken exactly as advised by your doctor or pharmacist. In case of doubt, you should consult your doctor or pharmacist.

When and how to take Noacid 20 mg

Take the tablets 1 hour before a meal, without chewing or breaking the tablet. Swallow the tablet whole with water.
If your doctor has not prescribed a different dosage, the recommended dose is:
Adults and adolescents aged 12 years and older:

In the treatment of symptoms (e.g., heartburn, acid reflux, pain when swallowing) associated with gastroesophageal reflux disease caused by acid reflux from the stomach:

The recommended dose is one tablet per day. This dose usually provides relief after 2-4 weeks of treatment - at the latest within the next 4 weeks. Your doctor will decide how long you should take the medicine. Recurring symptoms can be controlled by taking one tablet per day as needed.

In the long-term treatment and prevention of recurrence of reflux esophagitis (inflammation of the esophagus caused by acid reflux):

The recommended dose is one tablet per day. If symptoms of the disease return, your doctor may recommend doubling the dose. In this case, you can take one tablet per day of Noacid 40 mg.
After the symptoms have subsided, you can reduce the dose to one tablet of 20 mg per day.
Adults:

In the prevention of duodenal and stomach ulcers in patients who need to continuously take NSAIDs.

The recommended dose is one tablet per day.

Special patient groups:

Patient with liver problems
If you have severe liver problems, you should not take more than one 20 mg tablet per day.

Use in children and adolescents

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

What to do if you take more Noacid 20 mg than you should

You should consult your doctor or pharmacist. Symptoms of overdose are not known.

What to do if you forget to take Noacid 20 mg

You should not take a double dose to make up for a forgotten dose. You should take the next dose at the usual time.

What to do if you stop taking Noacid 20 mg

You should not stop taking the tablets without consulting your doctor or pharmacist first.
In case of any further doubts about the use of this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Noacid 20 mg can cause side effects, although not everybody gets them.

If you experience any of the following side effects, you should immediately inform your doctor or contact the nearest hospital where emergency services are available:

• - Severe allergic reactions (rare – may affect up to 1 in 1,000 people):swelling of the tongue and/or throat, difficulty swallowing, hives (nettle rash), difficulty breathing, allergic swelling of the face (Quincke's edema/angioedema), severe dizziness with rapid heartbeat and excessive sweating.
• Severe skin reactions (frequency not known - frequency cannot be estimated from the available data):the patient may notice one or more of the following symptoms -blistering of the skin and rapid deterioration of the general condition, erosive lesions of the eyes, nose, mouth/ lips, or genitals, or rash, especially on sun-exposed areas. 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 some white blood cells or liver enzymes (Stevens-Johnson syndrome, Lyell's syndrome, polymorphic erythema, acute cutaneous lupus erythematosus, drug rash with eosinophilia and systemic symptoms (DRESS), hypersensitivity to light).
• - Other severe reactions (frequency not known):yellowing of the skin and eyes (severe liver cell damage, jaundice) or fever, rash, and kidney problems, which may lead to kidney failure. Other side effects:
• Frequent(may affect up to 1 in 10 people) Mild gastric polyps.
• - Infrequent(may affect up to 1 in 100 people) Headache, dizziness, diarrhea, nausea, vomiting, feeling of fullness in the stomach and bloating with gas (gas), constipation, dry mouth, abdominal pain and discomfort, skin rash, redness, skin eruptions (caused by infection), itching, weakness, fatigue, or general feeling of being unwell, sleep disturbances, hip, wrist, or spine fractures.
• - Rare(may affect up to 1 in 1,000 people) Disturbances of taste or complete loss of taste, vision disturbances, such as blurred vision, hives, joint pain, muscle pain, changes in body weight, elevated body temperature, swelling of the limbs (peripheral edema), allergic reactions, depression, breast enlargement in men.
• Very rare(may affect up to 1 in 10,000 people) Disorientation.
• - Frequency not known(frequency cannot be estimated from the available data) Hallucinations, confusion (especially in patients who have experienced such symptoms before), feeling of tingling, prickling, or numbness, feeling of burning or tingling, rash sometimes with joint pain. Colitis, which causes persistent watery diarrhea.

Side effects detected by blood tests:

• - Infrequent(may affect up to 1 in 100 people) Increased liver enzyme activity.
• - Rare(may affect up to 1 in 1,000 people) Increased bilirubin levels, increased fat levels in the blood, sudden decrease in the number of granulocytes with high fever.
• Very rare(may affect up to 1 in 10,000 people) Decreased platelet count, which may cause more frequent bleeding and bruising,

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

• 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, you should inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 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 Noacid 20 mg

The medicine should be stored out of the sight and reach of children.
The medicinal product does not require special storage conditions.
Tablets packaged 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 pack and carton after "Expiry date (EXP)". The expiry date refers to the last day of the month stated.
Do not use this medicine if you notice visible signs of deterioration.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Noacid 20 mg contains

The active substance of the medicine is pantoprazole.
Each gastro-resistant tablet contains 20 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), 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), methacrylic acid-ethyl acrylate copolymer (1:1), triethyl citrate (E 1505).

What Noacid 20 mg looks like and contents of the pack

Noacid 20 mg tablets are yellow, oval, gastro-resistant tablets, 8.2 mm long and 4.4 mm in diameter.
Noacid 20 mg is available in packs containing 7, 14, 28 tablets in blisters and in packs containing 7, 14, 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 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

Date of last revision of the leaflet: 18.11.2021