Gerdin 20 mg

Leaflet attached to the packaging: patient information

Gerdin 20 mg, 20 mg, enteric-coated tablets
Pantoprazole

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not give it to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

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

Gerdin 20 mg is a selective "proton pump inhibitor", a medicine that reduces stomach acid production. It is used to treat stomach and intestinal diseases associated with acid production.

Gerdin 20 mg is used to treat:

Adults and adolescents aged 12 and over:

• 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 accompanied by acid reflux) and prevention of its recurrence.

Adults:

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

2. Important information before taking Gerdin 20 mg

When not to take Gerdin 20 mg

• If the patient has been diagnosed with an allergy (hypersensitivity) to pantoprazole or any of the other ingredients of Gerdin 20 mg (see section 6).
• If the patient has been diagnosed with an allergy to medicines containing other proton pump inhibitors.

Warnings and precautions

Before starting to take Gerdin 20 mg, discuss it with your doctor or pharmacist.

When to be particularly careful when taking Gerdin 20 mg

• If there are severe liver function disorders. Inform your doctor if you have ever had liver function disorders. Your doctor may order more frequent monitoring of liver enzyme activity, especially if you are taking long-term treatment with Gerdin 20 mg. If liver enzyme activity increases, the use of the medicine should be discontinued.
• If the patient must continuously take NSAIDs and take Gerdin 20 mg at the same time, due to the increased risk of stomach or intestinal complications. The increased risk will be assessed according to the patient's risk factors, such as age (65 or older), stomach or duodenal ulcers in the medical history, or stomach or intestinal bleeding.
• If the patient has a vitamin B deficiency or risk factors indicating a possible decrease in vitamin B levels, and the patient is being treated long-term with pantoprazole. Like all medicines that reduce gastric acid secretion, pantoprazole may lead to reduced vitamin B absorption.
• If the patient is taking a medicine containing atazanavir (used to treat HIV infection) at the same time as pantoprazole, they should ask their doctor for detailed advice.
• Inform your doctor about planned specific blood tests (chromogranin A levels). If the following symptoms occur, inform your doctor immediately:
• unintentional weight loss;
• recurring vomiting;
• difficulty swallowing;
• bloody vomiting;
• pallor and weakness (anemia);
• blood in the stool;
• chest pain;
• abdominal pain;
• severe and (or) persistent diarrhea, as taking Gerdin 20 mg is associated with a slight increase in the risk of infectious diarrhea.

Your doctor may decide to perform tests to rule out a malignant underlying disease, as treatment with pantoprazole may alleviate the symptoms of the disease and delay its diagnosis. If symptoms persist despite treatment, further tests should be considered.
In the case of taking Gerdin 20 mg for a longer period (over 1 year), the patient will likely be under constant medical supervision. In such a case, during each visit to the doctor, all new and unexpected symptoms and the circumstances of their occurrence should be reported.

Children and adolescents

There is no experience with the use of Gerdin 20 mg in children. Therefore, Gerdin 20 mg should not be used in children under 12 years of age.

Gerdin 20 mg and other medicines

Gerdin 20 mg may affect the effectiveness of other medicines, so 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 Gerdin 20 mg may inhibit the proper functioning of these and other medicines;
• warfarin and phenprocoumon, which affect blood density. Further tests may be necessary;
• atazanavir (used to treat HIV infection);
• methotrexate (used to treat rheumatoid arthritis, psoriasis, and cancer) - in the case of taking methotrexate, the doctor may temporarily discontinue the use of Gerdin 20 mg, as pantoprazole may increase the level of methotrexate in the blood.

Tell your doctor about all the medicines you are currently taking or have recently taken, as well as any medicines you plan to take.

Gerdin 20 mg with food and drink

Take the medicine 1 hour before a meal, without chewing or breaking the tablet. Swallow whole with water.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.
Experience with the use of Gerdin 20 mg in pregnant women is limited. It has been found that the active substance of the medicine passes into breast milk.
The medicine may be used in pregnant women or women who cannot rule out pregnancy or breastfeeding only if the doctor considers that the benefit of its use outweighs the potential risk to the unborn child or infant.
Before taking any medicine, consult your doctor or pharmacist.

Driving and using machines

Do not drive vehicles or operate machinery if you experience side effects such as dizziness or vision disturbances.

3. How to take Gerdin 20 mg

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, consult your doctor or pharmacist.
If your doctor has not prescribed a different dosage, the usual dose is:
Adults and adolescents aged 12 and over:

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

The usual dose is one tablet per day. This dose usually provides relief after 2-4 weeks of treatment - no later than 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

The usual dose is one tablet per day. If the symptoms of the disease return, your doctor may recommend doubling the dose. In this case, one tablet per day of Gerdin 40 mg can be used. After the symptoms have subsided, the dose can be reduced again to one tablet (20 mg) per day.
Adults:

In the prevention of duodenal and (or) gastric ulcers in patients who must continuously take NSAIDs

The usual dose is one tablet per day.

Special patient groups:

Patient with liver disease
In the case of severe liver disease, do not take more than one 20 mg tablet per day.
Children under 12 years of age
Tablets are not recommended for use in children under 12 years of age.

Taking a higher dose of Gerdin 20 mg than recommended

Consult your doctor or pharmacist. Symptoms of overdose are not known.

Missing a dose of Gerdin 20 mg

Do not take a double dose to make up for a missed dose. Take the next planned dose at the usual time.

Stopping treatment with Gerdin 20 mg

Do not stop taking the tablets without consulting your doctor or pharmacist first.
If you have any doubts about taking the medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Gerdin 20 mg can cause side effects, although not everybody gets them.
The occurrence of side effects is defined based on the frequency of their occurrence:

• very common (more than 1 in 10 treated patients);
• common (between 1 in 100 and 1 in 10 treated patients);
• uncommon (between 1 in 1,000 and 1 in 100 treated patients);
• rare (between 1 in 10,000 and 1 in 1,000 treated patients);
• very rare (less than 1 in 10,000 treated patients);
• frequency not known (cannot be estimated from available data).

In the event of any of the following side effects, inform your doctor or contact the nearest hospital where emergency services are provided.

• -Severe allergic reactions (rare):swelling of the tongue and (or) throat, difficulty swallowing, hives (rash like after nettle sting), difficulty breathing, allergic swelling of the face (Quincke's edema / angioedema), severe dizziness with rapid heartbeat and profuse sweating.
• -Severe skin reactions (frequency not known):blistering of the skin and severe deterioration of the general condition, erosion (with slight bleeding) of the eyes, nose, mouth/ lips or genitals (Stevens-Johnson syndrome, Lyell's syndrome, erythema multiforme) and 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 manifested by their enlargement, sometimes with pain when urinating and pain in the lower back (severe kidney inflammation).

Other side effects that occur:

• Common(between 1 in 100 and 1 in 10 treated patients): mild stomach polyps.
• Uncommon(between 1 in 1,000 and 1 in 100 treated patients): headache, dizziness, diarrhea, nausea, vomiting, feeling of fullness in the abdominal cavity and bloating with gas (gas), constipation, dry mouth, abdominal pain and discomfort, skin rash, redness, skin eruptions, itching, weakness, fatigue, or general malaise, sleep disturbances. The use of proton pump inhibitors, especially for a period of more than 1 year, may slightly increase the risk of hip, wrist, or spine fractures. Tell your doctor if you have osteoporosis or if you are taking corticosteroids (which may increase the risk of osteoporosis).
• Rare(between 1 in 10,000 and 1 in 1,000 treated patients): taste disturbances or complete loss of taste, vision disturbances, such as blurred vision, hives, joint pain, muscle pain, changes in body weight, elevated body temperature, high fever, swelling of the limbs (peripheral edema), allergic reactions, depression, breast enlargement in men.
• Very rare(less than 1 in 10,000 treated patients): disorientation.
• Frequency not known(cannot be estimated from available data): hallucinations, confusion (especially in patients who have had such symptoms before), decreased sodium levels in the blood, colitis (which causes persistent watery diarrhea). If you take pantoprazole for more than three months, you may experience a decrease in magnesium levels in the blood, which can cause fatigue, cramps, confusion, seizures, dizziness, and ventricular arrhythmias. If you experience any of these symptoms, inform your doctor. Low magnesium levels in the blood can also cause decreased potassium and calcium levels in the blood. Your doctor may decide to periodically check your magnesium levels in the blood.

Side effects detected by blood tests that occur:

• Uncommon(between 1 in 1,000 and 1 in 100 treated patients): increased liver enzyme activity.
• Rare(between 1 in 10,000 and 1 in 1,000 treated patients): increased bilirubin levels; increased fat levels in the blood, associated with high fever, sudden decrease in the number of circulating granulocytes - white blood cells.
• Very rare(less than 1 in 10,000 treated patients): decreased platelet count, which can cause more frequent bleeding and bruising, decreased white blood cell count, which can lead to more frequent infections, concurrent, abnormal decrease in the number of red and white blood cells, as well as platelets.

Reporting side effects

If you experience any side effects, including any side effects not listed in the leaflet, tell your doctor or pharmacist.
Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.:

• (22) 49 21 301, fax: (22) 49 21 309, e-mail: ndl@urpl.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 the medicine.

5. How to store Gerdin 20 mg

Keep the medicine out of the reach and sight of children.
Do not use this medicine after the expiry date stated on the carton after EXP.
The expiry date refers to the last day of that month.
There are no special precautions for storing the medicinal product.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Other information

What Gerdin 20 mg contains

The active substance of the medicine is pantoprazole.
Each tablet contains 20 mg of pantoprazole (in the form of pantoprazole sodium sesquihydrate).
The other ingredients are:
mannitol, crospovidone (type B), sodium carbonate, hydroxypropyl cellulose (low viscosity), calcium stearate.
Coating ingredients:
hypromellose (3cP), yellow iron oxide (E 172), methacrylic acid and ethyl acrylate copolymer (1:1) dispersion 30%, triethyl citrate.

What Gerdin 20 mg looks like and what the pack contains

Gerdin 20 mg is a light yellow, oval, biconvex enteric-coated tablet.
The medicine is packaged in a PA/Aluminum/PVC/Aluminum blister pack in a cardboard box.
Gerdin 20 mg is available in packs containing: 28, 56, 90 enteric-coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and importer

Marketing authorization holder:
S-LAB Sp. z o.o.
ul. Kiełczowska 2
55-095 Mirków
Tel.: 71 330 50 80
Importer:
APL Swift Services (Malta) Limited
HF 26, Hal Far Industrial Estate, Hal Far
BBG 3000 Birzebbugia
Malta

Date of last revision of the leaflet: 02/2023