Package leaflet: Information for the patient

Gerdin 20 mg, 20 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. You may need to read it again.
If you have any further questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents:

What Gerdin 20 mg is and what it is used for
Important information before taking Gerdin 20 mg
How to take Gerdin 20 mg
Possible side effects
How to store Gerdin 20 mg
Contents of the pack and other information

1. What Gerdin 20 mg is and what it is used for
Gerdin 20 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 related to hydrochloric acid secretion.
Gerdin 20 mg is used to treat:
Adults and adolescents aged 12 years and older:

Treatment of symptoms (e.g. heartburn, acid regurgitation, pain on swallowing) associated with gastroesophageal reflux disease (GERD) caused by backflow of hydrochloric acid from the stomach.
Long-term treatment of reflux esophagitis (inflammation of the oesophagus accompanied by backflow of gastric acid) 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 require continuous NSAID therapy.

2. Important information before taking Gerdin 20 mg

When not to take Gerdin 20 mg

If you are allergic (hypersensitive) to pantoprazole or to any of the other ingredients of Gerdin 20 mg (see section 6).
If you are allergic to medicines containing other proton pump inhibitors.

Warnings and precautions
Before starting treatment with Gerdin 20 mg, please discuss it with your doctor or pharmacist.
When to exercise special caution when taking Gerdin 20 mg

If you have severe liver function disorders. Inform your doctor if you have ever had liver problems. Your doctor may recommend more frequent monitoring of liver enzyme activity, especially if long-term treatment with Gerdin 20 mg is required. If liver enzyme activity increases, treatment should be discontinued.
If you need to take NSAIDs continuously while also taking Gerdin 20 mg, due to an increased risk of gastrointestinal complications. This increased risk will be assessed according to patient-specific risk factors such as age (65 years or older), history of gastric or duodenal ulcers, or gastrointestinal bleeding.
If you have vitamin B\12 deficiency or risk factors indicating possible reduced vitamin B\12 levels, and are being treated long-term with pantoprazole. Like all medicines that reduce (inhibit) gastric hydrochloric acid secretion, pantoprazole may lead to reduced absorption of vitamin B\12.
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 about planned specific blood tests (chromogranin A levels). If any of the following symptoms occur, inform your doctor immediately:
- Unintentional weight loss;
- Recurrent vomiting;
- Difficulty swallowing;
- Vomiting blood;
- Pallor and weakness (anaemia);
- Blood in stool;
- Chest pain;
- Abdominal pain;
- Severe and/or persistent diarrhoea, as treatment with Gerdin 20 mg is associated with a slightly increased risk of infectious diarrhoea.

Your doctor may decide that investigations are necessary to exclude an underlying tumour, as treatment with pantoprazole may alleviate symptoms of tumour disease and delay diagnosis. If symptoms persist despite treatment, further investigations should be considered.
If you are taking Gerdin 20 mg for a prolonged period (over 1 year), you will likely be under continuous medical supervision. In such cases, report any new or unexpected symptoms and circumstances of their occurrence during every visit to your doctor.
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, therefore 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 20 mg may inhibit the proper action of these and other medicines;
Warfarin and phenprocoumon, which affect blood clotting. Further testing may be required;
Atazanavir (used in the treatment of HIV infection);
Methotrexate (used in the treatment of rheumatoid arthritis, psoriasis and cancer diseases). When methotrexate is used, your doctor may temporarily discontinue Gerdin 20 mg, because pantoprazole may increase methotrexate blood levels.

Tell your doctor about all 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 dividing 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 using this medicine.
Experience with use in pregnant women is limited. It has been shown that the active substance passes into breast milk.
Gerdin 20 mg may be used in pregnant women, women in whom pregnancy cannot be excluded, or women who are breastfeeding only if your doctor considers that the benefit of treatment 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 20 mg

This medicine should always be taken as directed by a doctor or pharmacist. If in
doubt, consult a doctor or pharmacist.
If the doctor has not advised otherwise, the usual dose is:
Adults and adolescents aged 12 years and above:
For treatment of symptoms (e.g. heartburn, acid regurgitation, pain when swallowing) associated with gastro-oesophageal reflux disease
The usual dose is one tablet per day. This dose usually provides relief within 2–4
weeks of treatment – at the latest within the following 4 weeks. The doctor will decide how long the medicine should be taken.
Recurrent symptoms may be managed by taking one tablet per day as needed.
For long-term treatment and prevention of relapse of reflux oesophagitis
The usual dose is one tablet per day. If symptoms return, the doctor may
recommend doubling the dose. In this case, one tablet per day of Gerdin 40 mg may be used.
After symptoms have resolved, the dose may be reduced again to one tablet ( 20 mg) per day.
Adults:
For 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:
Patients with liver disease
In case of severe liver disease, no more than one 20 mg tablet per day should be taken.
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 20 mg
Consult a 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 scheduled dose at the usual time.
Stopping the medicine
Do not stop taking the tablets without first consulting a doctor or pharmacist.
If in doubt about the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Gerdin 20 mg may cause adverse effects, although not everyone experiences them.
The occurrence of adverse effects is defined according to the following frequency categories:

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

If any of the following adverse effects 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, urticaria (rash resembling nettle burns), breathing difficulties, angioedema (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, mouth/oral cavity 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 kidney enlargement, sometimes with pain during urination and pain in the lower back (severe kidney inflammation).

Other adverse effects occurring:

Common (affects 1 to 10 in 100 patients): benign gastric polyps.
Uncommon (affects 1 to 10 in 1,000 patients): headache, dizziness, diarrhoea, nausea, vomiting, abdominal fullness 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. 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 (affects 1 to 10 in 10,000 patients): disturbances or complete loss of taste, visual disturbances such as blurred vision, urticaria, joint pain, muscle pain, weight changes, elevated body temperature, high fever, limb swelling (peripheral oedema), allergic reactions, depression, gynaecomastia (breast enlargement in males).
Very rare (affects less than 1 in 10,000 patients): disturbances in orientation.
Frequency not known (cannot be estimated from the available data): hallucinations, confusion (particularly in patients who have previously experienced such symptoms), decreased sodium levels in blood, colitis causing persistent watery diarrhoea. If the patient takes pantoprazole for longer than three months, magnesium levels in blood may decrease, which may subsequently lead to fatigue, tetany, hallucinations, 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 effects detected by blood tests occurring:

Uncommon (affects 1 to 10 in 1,000 patients): increased liver enzyme activity.
Rare (affects 1 to 10 in 10,000 patients): increased bilirubin levels; increased blood lipid levels associated with high fever, sudden decrease in circulating granulocytes – white blood cells.
Very rare (affects less than 1 in 10,000 patients): decreased platelet count, which may lead to increased 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 effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist.
Adverse effects 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 effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Gerdin 20 mg medicine

Keep this 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.
No special precautions for storage of the medicinal product.
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 20 mg 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 (3 cP), yellow iron oxide (E 172), methacrylic acid and ethyl acrylate copolymer (1:1) dispersion 30%, triethyl citrate.
What Gerdin 20 mg looks like and contents of the pack
Gerdin 20 mg is a light yellow, oval, biconvex enteric-coated tablet.
The medicine is packed in PA/Aluminum/PVC/Aluminum blisters in a cardboard carton.
Gerdin 20 mg is available in packages containing: 28, 56, 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