Gerdin 40 mg

Package Leaflet: Information for the Patient

Gerdin 40 mg, 40 mg, enteric-coated tablets
Pantoprazole

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

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

Table of Contents of the Leaflet:

• 1. What is Gerdin 40 mg and what is it used for
• 2. Important information before taking Gerdin 40 mg
• 3. How to take Gerdin 40 mg
• 4. Possible side effects
• 5. How to store Gerdin 40 mg
• 6. Contents of the pack and other information

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

Gerdin 40 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 40 mg is used to treat:

Adults and adolescents aged 12 and over:

• Reflux esophagitis. This is an inflammatory condition of the esophagus (the tube that connects the throat to the stomach) in which stomach acid flows back up into the esophagus.

Adults:

• Infections with the bacterium Helicobacter pyloriin patients with stomach and/or duodenal ulcers, in combination with 2 antibiotics (eradication therapy), to eliminate the bacteria and prevent recurrence of ulcers.
• Stomach and/or duodenal ulcers.
• Zollinger-Ellison syndrome and other conditions associated with excessive acid production in the stomach.

2. Important information before taking Gerdin 40 mg

When not to take Gerdin 40 mg

• If you are allergic (hypersensitive) to pantoprazole or any of the other ingredients of Gerdin 40 mg (see section 6).
• If you are allergic to medicines containing other proton pump inhibitors.

Warnings and precautions

Before taking Gerdin 40 mg, discuss it with your doctor or pharmacist.

When to be particularly cautious when taking Gerdin 40 mg

• 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 enzyme activity more frequently, especially if you are taking Gerdin 40 mg for a long time. If your liver enzyme activity increases, you should stop taking the medicine.
• If you have a vitamin B12 deficiency or risk factors for a vitamin B12 deficiency, and you are taking pantoprazole long-term. Like all medicines that reduce stomach acid, pantoprazole may lead to reduced absorption of vitamin B12.
• If you are taking a medicine containing atazanavir (used to treat HIV infection) at the same time as pantoprazole, you should ask your doctor for specific advice.
• You should inform your doctor about a planned specific blood test (chromogranin A levels).

If you experience any of the following symptoms, you should immediately inform your doctor:

• 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 40 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 disease, as treatment with pantoprazole may alleviate the symptoms of the malignant disease and delay its diagnosis. If symptoms persist despite treatment, further tests should be considered.
If you are taking Gerdin 40 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 and unexpected symptoms and their circumstances to your doctor during each visit.

Children and adolescents

There is no experience with the use of Gerdin 40 mg in children. Therefore, Gerdin 40 mg should not be used in children under 12 years of age.

Gerdin 40 mg and other medicines

Gerdin 40 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 40 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) - if you are taking methotrexate, your doctor may temporarily stop taking Gerdin 40 mg, as pantoprazole may increase methotrexate levels in the blood.

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

Gerdin 40 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, ask your doctor or pharmacist for advice before taking this medicine.
Experience with the use of Gerdin 40 mg in pregnant women is limited. The active substance of the medicine has been shown to pass into breast milk.
Gerdin 40 mg may be used in pregnant or breastfeeding women, or women who cannot rule out pregnancy, only if the doctor considers that the benefits of its use outweigh the potential risks to the unborn child or infant.
Before taking any medicine, ask your doctor or pharmacist for advice.

Driving and using machines

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

3. How to take Gerdin 40 mg

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist. If your doctor has not prescribed a different dosage, the usual dose is:

For the treatment of reflux esophagitis

The usual dose is one tablet per day. Your doctor may recommend increasing the dose to 2 tablets per day. The treatment period for reflux esophagitis usually lasts 4 to 8 weeks. Your doctor will decide how long you should take the medicine.
Adults
For the treatment of Helicobacter pylori infection, in patients with duodenal and/or stomach ulcers, in combination with 2 antibiotics (eradication therapy)

One tablet twice a day plus two antibiotic tablets: amoxicillin, clarithromycin, or metronidazole (or tinidazole) taken twice a day with a pantoprazole tablet.
The first pantoprazole tablet should be taken 1 hour before breakfast, and the second pantoprazole tablet 1 hour before dinner. You should follow the instructions given by your doctor and read the patient information leaflets in the antibiotic packages. The treatment usually lasts for 1 to 2 weeks.

For the treatment of stomach and/or duodenal ulcers

The usual dose is one tablet per day. After consulting your doctor, the dose can be doubled. Your doctor will decide how long you should take the medicine. The treatment period for stomach ulcers usually lasts 4 to 8 weeks. The treatment period for duodenal ulcers usually lasts 2 to 4 weeks.

For long-term treatment of Zollinger-Ellison syndrome and other conditions associated with excessive acid production in the stomach

The recommended initial dose is usually 2 tablets per day.
Both tablets should be taken 1 hour before a meal. Later, the dosage may be adjusted by your doctor, depending on the amount of acid produced in the stomach. If your doctor prescribes more than 2 tablets per day, you should take them twice a day.
If your doctor prescribes a daily dose greater than 4 tablets per day, he will inform you exactly when to stop taking the medicine.

Special patient groups:

Patient with kidney and liver disease
In case of kidney problems, moderate or severe liver damage do not takeGerdin 40 mg for Helicobacter pylorieradication.
In severe liver disease, do not take more than one 20 mg pantoprazole tablet per day (20 mg pantoprazole tablets are available for this purpose).
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 40 mg than recommended

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

Missing a dose of Gerdin 40 mg

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

Stopping treatment with Gerdin 40 mg

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

4. Possible side effects

Like all medicines, Gerdin 40 mg can cause side effects, although not everybody gets them.
The frequency of side effects is defined as follows:

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

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

• -Severe allergic reactions (rare):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):blistering of the skin and severe deterioration of general condition, erosion (with slight bleeding) of the eyes, nose, mouth/ lips, or genitals (Stevens-Johnson syndrome, Lyell syndrome, polymorphic erythema) 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, which may be associated with kidney enlargement, sometimes with pain when urinating and pain in the lower back (severe kidney inflammation).

Other side effects that may occur:

• -Common(between 1 and 10 in 100 patients treated): mild stomach polyps.
• -Uncommon(between 1 and 10 in 1,000 patients treated): 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. Long-term use of proton pump inhibitors, especially for more than 1 year, may slightly increase the risk of hip, wrist, or spine fractures. You should tell your doctor if you have osteoporosis or if you are taking corticosteroids (which may increase the risk of osteoporosis).
• -Rare(between 1 and 10 in 10,000 patients treated): 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 patients treated): disorientation.
• -Frequency not known(cannot be estimated from the available data): hallucinations, confusion (especially in patients who have had such symptoms before), decreased sodium levels in the blood, colitis (which can cause persistent watery diarrhea).

If you take pantoprazole for a period longer than 3 months, you may experience a decrease in magnesium levels in the blood, which can cause fatigue, convulsions, confusion, seizures, dizziness, and ventricular arrhythmias. If you experience any of these symptoms, inform your doctor. Low magnesium levels in the blood may also cause low 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:

• -Uncommon(between 1 and 10 in 1,000 patients treated): increased liver enzyme activity.
• -Rare(between 1 and 10 in 10,000 patients treated): 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 patients treated): 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 not listed in this leaflet, please inform 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: [email protected].
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 Gerdin 40 mg

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

6. Other information

What Gerdin 40 mg contains

The active substance is pantoprazole.
Each tablet contains 40 mg of pantoprazole (as pantoprazole sodium sesquihydrate).
The other ingredients are:
mannitol, crospovidone (type B), sodium carbonate, hydroxypropylcellulose (low viscosity), calcium stearate.
Coating ingredients:
hypromellose (3cP), yellow iron oxide (E172), methacrylic acid - ethyl acrylate copolymer (1:1) dispersion 30%, triethyl citrate.

What Gerdin 40 mg looks like and contents of the pack

Gerdin 40 mg is a yellow, oval, biconvex tablet.
The medicine is packaged in a PA/Aluminum/PVC/Aluminum blister pack in a cardboard box.
Gerdin 40 mg is available in packs containing: 14, 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