Package leaflet: Information for the patient

Gerdin 40 mg, 40 mg, enteric-coated tablets
Pantoprazole
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

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

Contents of the leaflet:

What Gerdin 40 mg is and what it is used for
What you need to know before taking Gerdin 40 mg
How to take Gerdin 40 mg
Possible side effects
How to store Gerdin 40 mg
Contents of the pack and other information

1. What Gerdin 40 mg is and what it is used for
Gerdin 40 mg is a selective "proton pump inhibitor", a medicine that reduces acid secretion in the stomach. It is used in the treatment of stomach and intestinal disorders associated with hydrochloric acid secretion.
Gerdin 40 mg is used to treat:
Adults and adolescents aged 12 years and above:

Gastro-oesophageal reflux disease (GORD). This is inflammation of the oesophagus (the tube connecting the throat to the stomach), accompanied by backflow of hydrochloric acid from the stomach.

Adults:

Helicobacter pylori infection in patients with gastric or duodenal ulcer, in combination with two antibiotics (eradication therapy), to eliminate the bacteria and prevent recurrence of ulcers.
Gastric and/or duodenal ulcer disease.
Zollinger-Ellison syndrome and other conditions associated with excessive hydrochloric acid secretion in the stomach.

2. What you need to know before taking Gerdin 40 mg

When not to take Gerdin 40 mg

If you are allergic (hypersensitive) to pantoprazole or to 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 starting treatment with Gerdin 40 mg, discuss this with your doctor or pharmacist.
When to be cautious when taking Gerdin 40 mg

If you have severe liver function impairment. Inform your doctor if you have ever had liver problems. Your doctor may recommend more frequent monitoring of liver enzyme activity, especially during long-term treatment with Gerdin 40 mg. If liver enzyme activity increases, treatment should be discontinued.
If you have vitamin B12 deficiency or risk factors indicating possible reduced vitamin B12 levels, and you are receiving long-term pantoprazole therapy. Like all medicines that reduce (inhibit) gastric acid secretion, pantoprazole may lead to reduced absorption of vitamin B12.
If you are taking a medicine containing atazanavir (used in the treatment of HIV infection) at the same time as pantoprazole, you should ask your doctor for detailed advice.
Inform your doctor if you are scheduled for a specific blood test (chromogranin A levels).

You should contact your doctor immediately if you experience any of the following symptoms:

Unintentional weight loss;
Recurrent vomiting;
Difficulty swallowing;
Vomiting blood;
Pallor and weakness (anaemia);
Blood in the stool;
Chest pain;
Abdominal pain;
Severe and/or persistent diarrhoea, as treatment with Gerdin 40 mg is associated with a slightly increased risk of infectious diarrhoea.

Your doctor may decide that further investigations are necessary to exclude an underlying tumour, as treatment with pantoprazole may relieve symptoms of tumour disease and delay diagnosis. If symptoms persist despite treatment, further investigations should be considered.
If you are taking Gerdin 40 mg for a prolonged period (over 1 year), you will likely be under regular medical supervision. In such cases, you should report any new or unexpected symptoms and the circumstances of their occurrence during each visit to your doctor.
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 in certain types of cancer), because Gerdin 40 mg may interfere with 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 cancer). When methotrexate is used, your doctor may temporarily discontinue Gerdin 40 mg, as pantoprazole may increase methotrexate blood levels.

Tell your doctor about all medicines you are currently taking, have recently taken, or plan to take.
Gerdin 40 mg with food and drink
Take the medicine 1 hour before a meal. Do not chew or divide the tablet. Swallow whole with water.
Pregnancy and breastfeeding
If you are pregnant, breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before taking this medicine.
Experience with use in pregnant women is limited. It has been shown that the active substance passes into breast milk.
Gerdin 40 mg may be used in pregnant women, women in whom pregnancy cannot be excluded, or breastfeeding women only if your doctor considers that the benefit 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 or operate machinery if you experience side effects such as dizziness or visual disturbances.

3. How to use Gerdin 40 mg

This medicine should always be taken as advised by your doctor or pharmacist. If you have any
doubts, consult your doctor or pharmacist. Unless otherwise directed by your doctor, the usual
dose is:
Adults and adolescents aged 12 years and above:
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 from 4 to 8 weeks.
Your doctor will decide how long you should take the medicine.
Adults:
For the treatment of infection with a bacterium called Helicobacter pylori , in patients with duodenal
and (or) gastric ulcers, in combination with two antibiotics (eradication therapy)
One tablet twice daily plus two antibiotic tablets: amoxicillin, clarithromycin or
metronidazole (or tinidazole), each taken twice daily together with a pantoprazole tablet.
The first pantoprazole tablet should be taken 1 hour before breakfast, and the second pantoprazole
tablet 1 hour before dinner. Follow the instructions provided by your doctor and
read the patient leaflets included in the antibiotic packaging. Treatment is usually continued
for 1 to 2 weeks.
For the treatment of gastric and (or) duodenal ulcers
The usual dose is one tablet per day. After consultation with your doctor, the dose may be
doubled. Your doctor will decide how long you should take the medicine. The treatment period
for gastric ulcers usually lasts from 4 to 8 weeks. The treatment period for duodenal ulcers
usually lasts from 2 to 4 weeks.
For long-term treatment of Zollinger-Ellison syndrome and other medical conditions
associated with excessive hydrochloric acid secretion in the stomach
The recommended initial dose is usually two tablets per day.
Both tablets should be taken 1 hour before a meal. Later, the dosage may be adjusted appropriately
by your doctor, depending on the amount of hydrochloric acid secreted in the stomach.
If more than two tablets per day are prescribed, they should be taken twice daily.
If your doctor prescribes a daily dose greater than four tablets, you will be specifically informed
when to stop taking the medicine.
Special patient groups:
Patients with kidney or liver disease
In patients with renal problems or moderate to severe liver impairment, do not take Gerdin 40 mg
for Helicobacter pylori eradication.
In severe liver disease, do not take more than one 20 mg pantoprazole tablet per day (tablets
containing 20 mg pantoprazole are available for this purpose).
Children under 12 years of age
The tablets are not recommended for use in children under 12 years of age.
Taking more than the recommended dose of Gerdin 40 mg
Consult 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 missed dose. Take the next scheduled dose at the
usual time.
Stopping the medicine
Do not stop taking the tablets without first consulting your doctor or pharmacist.
If you have any doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, Gerdin 40 mg may cause adverse reactions, although not everyone experiences them.
The frequency of adverse reactions is defined as follows:

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

If any of the following adverse reactions occur, contact your doctor immediately or go to the nearest hospital emergency department.

Severe allergic reactions (rare): swelling of the tongue and/or throat, difficulty swallowing, hives (rash similar to nettle rash), breathing difficulties, allergic facial swelling (Quincke's edema / angioedema), severe dizziness with rapid heartbeat and excessive sweating.
Severe skin reactions (frequency not known): formation of skin blisters and sudden deterioration in general condition, erosions (with slight bleeding) of the eyes, nose, oral cavity/mouth or genital organs (Stevens-Johnson syndrome, Lyell's syndrome, erythema multiforme), and photosensitivity.
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 swelling, sometimes with pain during urination and pain in the lower back (severe kidney inflammation).

Other adverse reactions occurring:

Common (1 to 10 in 100 patients treated): mild gastric polyps.
Uncommon (1 to 10 in 1,000 patients treated): 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, exhaustion or general malaise, sleep disturbances. 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. Inform your doctor if the patient has osteoporosis or is taking corticosteroids (which may increase the risk of osteoporosis).
Rare (1 to 10 in 10,000 patients treated): 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 (breast enlargement in males).
Very rare (less than 1 in 10,000 patients treated): disorientation.
Frequency not known (cannot be estimated from available data): hallucinations, confusion (particularly in patients who have previously experienced such symptoms), decreased sodium levels in blood, inflammation of the large intestine causing persistent watery diarrhoea.

If a patient takes pantoprazole for longer than three months, magnesium levels in the blood may decrease, which may lead to fatigue, tetany, delirium, seizures, dizziness, and ventricular arrhythmias. If any of these symptoms occur, inform the doctor. Low magnesium levels in blood may also lead to decreased potassium and calcium levels in blood. The doctor may decide to perform periodic blood magnesium level tests.

Adverse reactions identified through blood tests occurring:

Uncommon (1 to 10 in 1,000 patients treated): increased liver enzyme activity.
Rare (1 to 10 in 10,000 patients treated): 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 patients treated): 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 decrease in red blood cells, white blood cells, and platelets.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist.
Adverse reactions can be reported directly to the Department of 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].
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of the 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 stated on the carton after EXP.
The expiry date refers to the last day of that month.
No special storage precautions are required for this medicinal product.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. These measures 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 sodium pantoprazole sesquihydrate).
The other ingredients are:
mannitol, crospovidone (type B), sodium carbonate, hypromellose (low viscosity), magnesium stearate.
Ingredients of the coating:
hypromellose (3 cP), iron oxide yellow (E172), methacrylic acid and ethyl acrylate copolymer (1:1) dispersion 30%, triethyl citrate.

What Gerdin 40 mg looks like and contents of the pack
Gerdin 40 mg is yellow, oval, biconvex enteric-coated tablets.
The medicine is packed in PA/Aluminium/PVC/Aluminium blisters in a cardboard box.
Gerdin 40 mg is available in pack sizes containing: 14, 28, 56, and 90 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