Patient Information Leaflet

Gerdin Max, 20 mg, enteric-coated tablets
Pantoprazole
Please read all of this leaflet carefully before taking this medicine, as it contains important information for you.
This medicine should always be taken exactly as described in this patient leaflet or as directed by your doctor or pharmacist.

Keep this leaflet, as you may need to read it again.
If you need advice or further information, please consult your pharmacist.
If you experience any adverse effects, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement after 14 days, or if you feel worse, consult your doctor.

Table of contents:

What Gerdin Max is and what it is used for
Important information before taking Gerdin Max
How to take Gerdin Max
Possible side effects
How to store Gerdin Max
Contents of the pack and other information

1. What Gerdin Max is and what it is used for
Gerdin Max is a selective "proton pump inhibitor," a medicine that reduces the secretion of hydrochloric acid in the stomach. It is used to treat stomach and intestinal disorders associated with excessive hydrochloric acid secretion.
Gerdin Max is indicated for short-term treatment of symptoms of gastroesophageal reflux disease (such as heartburn, acid regurgitation) in adults.
Reflux refers to the backflow of acid from the stomach into the oesophagus, which may lead to inflammation of the oesophagus and cause pain. Other symptoms may include: painful burning sensation in the chest rising up to the throat (heartburn), sour taste in the mouth (acid regurgitation).
Gerdin Max may relieve symptoms associated with reflux disease (such as heartburn, acid regurgitation) as early as the first day of treatment, but it is not a medicine intended for immediate symptom relief.
To achieve full symptom relief, it may be necessary to take the tablets for 2–3 consecutive days.
If there is no improvement after 2 weeks, or if you feel worse, consult your doctor.

2. Important information before taking Gerdin Max

When not to take Gerdin Max

If you are allergic (hypersensitive) to pantoprazole or to any of the other ingredients of Gerdin Max (see section 6).
If you are allergic to medicines containing other proton pump inhibitors.
If you are taking a medicine containing atazanavir (used in the treatment of HIV infection). See "Gerdin Max and other medicines".

Warnings and precautions
Before starting treatment with Gerdin Max, discuss this with your doctor or pharmacist.
When to exercise special caution when taking Gerdin Max
Before starting treatment with Gerdin Max, discuss this with your doctor or pharmacist:

if you have been treated for heartburn or indigestion continuously for 4 or more weeks;
if you are over 55 years old and take over-the-counter antacids daily;
if you are over 55 years old and have noticed any new or concerning symptoms, or if the nature of your reflux symptoms has changed;
if you have had a peptic ulcer or undergone stomach surgery;
if you have liver problems or jaundice (yellowing of the skin and eyes);
if you are under ongoing medical supervision for other serious conditions or diseases;
if you are scheduled for an endoscopic examination or urease test;
inform your doctor about a planned specific blood test (chromogranin A levels).

Immediately inform your doctor before or after taking this medicine if you notice the following symptoms, which may indicate other, more serious conditions:

unintentional weight loss (not related to diet or exercise);
vomiting, especially recurrent;
vomiting blood, which may look like dark coffee grounds;
blood in stools, black or tarry stools;
difficulty swallowing or pain during swallowing;
paleness and weakness (anaemia);
chest pain;
abdominal pain;
severe and/or persistent diarrhoea (because use of this medicine is associated with a small increased risk of infectious diarrhoea).

You may notice improvement in reflux and heartburn symptoms as early as one day after starting Gerdin Max. However, this medicine is not intended for immediate symptom relief.
Do not use it preventively.
If you have recurrent heartburn or indigestion symptoms over time, you 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 lack of safety data in this age group.
Gerdin Max and other medicines
Gerdin Max may affect the effectiveness of other medicines. Therefore, inform your doctor if you are taking:

medicines such as ketoconazole, itraconazole, posaconazole (used to treat fungal infections) or erlotinib (used in certain types of cancer), because Gerdin Max may impair the proper action of these and other medicines;
warfarin and phenprocoumon, which affect blood clotting. Additional monitoring may be required;
atazanavir (used in the treatment of HIV infection);
methotrexate (used in the treatment of rheumatoid arthritis, psoriasis, and cancerous diseases). In case of methotrexate use, your doctor may temporarily discontinue Gerdin Max, as pantoprazole may increase methotrexate blood levels.

Do not take Gerdin Max together with medicines that reduce stomach acid production, such as other proton pump inhibitors (e.g. omeprazole, lansoprazole, rabeprazole) or H2 antagonists (e.g. ranitidine, famotidine).
Gerdin Max may be used as needed together with antacids (e.g. magaldrate, alginic acid, sodium bicarbonate, aluminium hydroxide, magnesium carbonate, or their combinations).
Inform your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Gerdin Max with food and drink
Take the medicine 1 hour before a meal, without chewing or dividing the tablet. Swallow whole with water.
Pregnancy, breastfeeding, and effects on fertility
This medicine should not be used if you are pregnant or breastfeeding.
If you are pregnant or breastfeeding, suspect you may be pregnant, or are planning to have a child, consult your doctor or pharmacist before taking this medicine.
Driving and operating machinery
Do not drive or operate machinery if you experience adverse effects such as dizziness or visual disturbances.

3. How to use Gerdin Max

This medicine should always be taken as directed by the doctor or pharmacist.
If in doubt, consult your 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. Treatment with Gerdin Max should be discontinued after symptoms have completely resolved. Relief of reflux and heartburn symptoms may occur as early as one day after starting Gerdin Max; however, bear in mind that this medicine is not intended for immediate relief of symptoms.
Consult your doctor if symptoms persist after taking this medicine for a full 2 weeks.
Do not take Gerdin Max for longer than 4 weeks without consulting a doctor.
Taking more Gerdin Max than recommended
Immediately inform your doctor or pharmacist if you have taken more than the recommended dose.
If possible, bring the medicine and its package leaflet with you.
If you miss a dose of Gerdin Max
Do not take a double dose to make up for a missed dose. Take the next scheduled dose at the usual time.
If you have any doubts about how to use the medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, Gerdin Max may cause adverse reactions, although not everyone experiences them.
If any of the following adverse reactions occur, contact your doctor immediately or go to the nearest hospital providing emergency care. You should also stop using this medicine, but bring the package leaflet and (or) tablets with you.

Severe allergic reactions (rare – may occur in no more than 1 in 1,000 people): swelling of the tongue and/or throat, difficulty swallowing, urticaria (rash similar to nettle rash), breathing difficulties, allergic facial swelling (Quincke's oedema / angioedema), severe dizziness with rapid heartbeat and excessive sweating.
Severe skin reactions (frequency unknown – frequency cannot be estimated from available data): formation of skin blisters and sudden deterioration in general condition, erosions (with slight bleeding) of the eyes, nose, mouth/oral cavity or genital organs (Stevens-Johnson syndrome, Lyell's syndrome, erythema multiforme) and 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 lower back pain accompanied by fever (severe kidney inflammation).

Other adverse reactions occurring:

Common (from 1 to 10 in 100 treated patients): benign gastric polyps.
Uncommon (from 1 to 10 in 1,000 treated 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, itching, weakness, fatigue or general malaise, sleep disturbances, increased liver enzyme activity. Use of proton pump inhibitors, especially for periods longer than 1 year, may slightly increase the risk of fractures of the hip, wrist or spine. You should inform your doctor if you have osteoporosis or if you 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 sensation, visual disturbances such as blurred vision, urticaria, joint pain, muscle pain, changes in body weight, elevated body temperature, high fever, limb swelling (peripheral oedema), allergic reactions, depression, gynaecomastia in men.
Very rare (less than 1 in 10,000 treated patients): disturbances in orientation.
Frequency not known (cannot be estimated from available data): hallucinations, confusion (particularly in patients who have previously experienced such symptoms), decreased sodium concentration in blood, colitis which causes persistent watery diarrhoea.

If a patient takes pantoprazole for longer than three months, they may develop low magnesium levels in the blood, which may subsequently lead to fatigue, tetany, hallucinations, seizures, dizziness and ventricular arrhythmias. If any of these symptoms occur, the patient should inform their doctor. Low magnesium levels in blood may also cause reduced potassium and calcium levels in blood. The doctor may decide that periodic monitoring of magnesium levels in the patient's blood is necessary.

Adverse reactions identified through blood tests occurring:

Uncommon (from 1 to 10 in 1,000 treated patients): increased liver enzyme activity.
Rare (from 1 to 10 in 10,000 treated patients): increased bilirubin levels; increased blood lipid levels associated with high fever, sudden decrease in circulating granulocytes – white blood cells.
Very rare (less than 1 in 10,000 treated patients): decreased platelet count, which may lead to more frequent bleeding and bruising, decreased white blood cell count, which may predispose to more frequent infections, concurrent abnormal reduction in red blood cells, white blood cells and platelets.

Reporting of adverse reactions
If any adverse symptoms occur, including any not listed in this leaflet, inform your doctor or pharmacist.
Adverse reactions can be reported directly to the Department for Monitoring Adverse Drug Reactions, Office for Registration 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].
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Gerdin Max

Keep this medicine out of the sight and reach 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 the stated month.
No special precautions for storage of the medicinal product are required.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist what to do with medicines no longer required. Such measures will help protect the environment.

6. Other information

What Gerdin Max contains
The active substance is pantoprazole.
Each tablet contains 20 mg of pantoprazole (as sodium pantoprazole 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 yellow, oval, biconvex enteric-coated tablets.
The medicine is packed in PA/Aluminium/PVC/Aluminium blisters in a cardboard box.
Gerdin Max is available in packs containing: 7 or 14 enteric-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Importer
Marketing Authorisation 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