Gerdin Max

Package Leaflet: Information for the Patient

Gerdin Max, 20 mg, gastro-resistant tablets
Pantoprazole

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

This medicine should always be taken exactly as described in the package leaflet or as directed by your doctor or pharmacist.

• You should keep this leaflet, you may need to read it again.
• If you have any further questions, ask your pharmacist.
• If you experience any side effects, talk to your doctor or pharmacist. See section 4.
• If after 14 days you do not feel better or if you feel worse, you should contact your doctor.

Table of Contents of the Package Leaflet:

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

1. What is Gerdin Max and what is it used for

Gerdin Max 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 intestinal diseases associated with excessive acid production.
Gerdin Max is used for short-term treatment of symptoms of gastroesophageal reflux disease (such as heartburn and acid regurgitation) in adults.
Reflux occurs when stomach acid flows back into the esophagus, which can lead to inflammation of the esophagus and cause pain. Symptoms such as painful burning in the chest extending to the throat (heartburn), sour taste in the mouth (acid regurgitation) may also appear.
Gerdin Max can relieve symptoms of reflux disease (such as heartburn, acid regurgitation) as early as the first day of use, but it is not a medicine intended for immediate relief of symptoms.
In order to achieve complete relief of symptoms, it may be necessary to take the tablets for 2-3 consecutive days.
If after 2 weeks there is no improvement or the patient feels worse, they should consult a doctor.

2. Important information before taking Gerdin Max

When not to take Gerdin Max

• If the patient has been diagnosed with an allergy (hypersensitivity) to pantoprazole or any of the other ingredients of Gerdin Max (see section 6).
• If the patient has been diagnosed with an allergy to medicines containing other proton pump inhibitors.
• If the patient is taking a medicine containing atazanavir (for HIV infection treatment). See "Gerdin Max and other medicines".

Warnings and precautions

Before starting to take Gerdin Max, the patient should discuss it with their doctor or pharmacist.

When to exercise special caution when taking Gerdin Max

Before starting to take Gerdin Max, the patient should discuss it with their doctor or pharmacist:

• if the patient has been treated for heartburn or indigestion continuously for 4 or more weeks;
• if the patient is over 55 years old and takes over-the-counter indigestion medicines every day;
• if the patient is over 55 years old and has noticed any new worrying symptoms or a change in the nature of existing symptoms of reflux disease;
• if the patient has had stomach ulcers or stomach surgery;
• if the patient has liver problems or jaundice (yellowing of the skin and eyes);
• if the patient is under regular medical supervision due to other serious illnesses or conditions;
• if the patient is going to have an endoscopy or urea breath test
• the patient should inform their doctor about a planned specific blood test (chromogranin A concentration).

The patient should immediately inform their doctorbefore or after taking this medicine if they notice the occurrence of the following symptoms, which may be a sign of other, more serious diseases:

• unintentional weight loss (not related to diet or exercise);
• vomiting, especially recurring;
• bloody vomiting, which may look like dark coffee grounds;
• blood in the 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 the use of this medicine is associated with a slight increase in the risk of infectious diarrhea).

It is possible that the patient may experience relief of reflux and heartburn symptoms as early as the first day of taking Gerdin Max. However, this is not a medicine intended for immediate relief of symptoms.
It should not be used as a preventive measure.
If the patient has been experiencing recurring heartburn or indigestion for some time, they should remain under regular medical supervision.

Children and adolescents

Gerdin Max should not be used in children and adolescents under 18 years of age due to the lack of data on the safety of use of this medicine in this age group.

Gerdin Max and other medicines

Gerdin Max may affect the effectiveness of other medicines, so the patient should tell their doctor if they 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 Max 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 case of methotrexate use, the doctor may temporarily discontinue the use of Gerdin Max, as pantoprazole may increase the concentration of methotrexate in the blood.

Gerdin Max should not be used with medicines that reduce the amount of acid produced in the stomach, such as other proton pump inhibitors (omeprazole, lansoprazole, or rabeprazole) or H2 antagonists (e.g., ranitidine, famotidine).
Gerdin Max can be used if necessary with antacids (e.g., magaldrate, alginic acid, sodium bicarbonate, aluminum hydroxide, magnesium carbonate, or their combinations).
The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

Gerdin Max with food and drink

The medicine should be taken 1 hour before a meal, without chewing or breaking the tablet. Swallow whole with water.

Pregnancy, breastfeeding, and fertility

The use of this medicine is contraindicated if the patient is pregnant or breastfeeding.
If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.

Driving and using machines

The patient should not drive vehicles or operate machinery if they experience side effects such as dizziness or vision disturbances.

3. How to take Gerdin Max

This medicine should always be taken exactly as directed by the doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist.
The recommended dose is 1 tablet per day. The daily dose should not exceed 20 mg.
The medicine should be taken for at least 2-3 consecutive days. The patient should stop taking Gerdin Max after complete relief of symptoms. It is possible to experience relief of reflux and heartburn symptoms as early as the first day of taking Gerdin Max, but the patient should remember that this medicine is not intended for immediate relief of symptoms.
The patient should consult their doctor if, after taking this medicine for 2 weeks, the symptoms do not disappear.
The patient should not take Gerdin Max for more than 4 weeks without consulting their doctor.

Taking a higher dose of Gerdin Max than recommended

The patient should immediately inform their doctor or pharmacist if they have taken a higher dose of Gerdin Max than recommended. If possible, they should bring the medicine and the package leaflet with them.

Missing a dose of Gerdin Max

The patient should not take a double dose to make up for a missed dose. They should take the next scheduled dose at the usual time.
In case of doubts about taking the medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Gerdin Max can cause side effects, although not everybody gets them.

In case of the following side effects, the patient should immediately inform their doctor or contact the nearest hospital where emergency services are available.

The patient should stop taking this medicine and bring the package leaflet and/or tablets with them.

• Severe allergic reactions (rare - may occur in less than 1 in 1000 people):swelling of the tongue and/or throat, difficulty swallowing, hives (urticaria), 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):blistering of the skin and severe deterioration of general condition, ulcers (with slight bleeding) of the eyes, nose, mouth/throat, 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 with accompanying fever (severe kidney inflammation).

Other side effects that may occur:

• Common(from 1 to 10 in 100 treated patients): mild stomach polyps.
• Uncommon(from 1 to 10 in 1000 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, increased activity of liver enzymes. 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. The patient should tell their doctor if they have osteoporosis or if they are taking corticosteroids (which may increase the risk of osteoporosis).
• Rare(from 1 to 10 in 10,000 treated patients): 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): disturbances of orientation.
• Frequency not known(cannot be estimated from the available data): hallucinations, confusion (especially in patients who have experienced such symptoms before), decreased sodium concentration in the blood, colitis (which can cause persistent watery diarrhea).

In case the patient takes pantoprazole for a period longer than three months, they may experience a decrease in magnesium concentration in the blood, which can cause fatigue, weakness, confusion, seizures, dizziness, and cardiac arrhythmias. If the patient experiences any of these symptoms, they should inform their doctor. Low magnesium concentration in the blood can also cause a decrease in potassium and calcium concentration in the blood. The doctor may decide to periodically check the magnesium concentration in the patient's blood.

Side effects detected by blood tests:

• Uncommon(from 1 to 10 in 1000 treated patients): increased activity of liver enzymes.
• Rare(from 1 to 10 in 10,000 treated patients): increased bilirubin concentration; increased concentration of fats 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 the patient experiences any side effects, including those not listed in the package leaflet, they should inform their doctor or pharmacist.
Side effects can be reported directly to the Department of Post-Marketing Surveillance 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].
By reporting side effects, it is possible to gather more information on the safety of the medicine.

5. How to store Gerdin Max

The medicine should be stored in a place inaccessible and invisible to children.
The medicine should not be used after the expiry date stated on the carton after the term "EXP".
The expiry date refers to the last day of the given month.
There are no special precautions for the storage of the medicinal product.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Other information

What Gerdin Max 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, hydroxypropylcellulose (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 Max looks like and contents of the pack

Gerdin Max is a yellow, oval, biconvex gastro-resistant tablet.
The medicine is packaged in a PA/Aluminum/PVC/Aluminum blister pack in a cardboard box.
Gerdin Max is available in packs containing 7 or 14 gastro-resistant 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 package leaflet: 02/2023