Pantoprazole Genoptim

Package Leaflet: Information for the Patient

Pantoprazole Genoptim 40 mg, Gastro-Resistant Tablets

Pantoprazolum

Read the Package Leaflet Carefully Before Taking the Medication, 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 Package Leaflet:

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

1. What is Pantoprazole Genoptim and what is it used for

Pantoprazole Genoptim contains the active substance pantoprazole.
Pantoprazole Genoptim 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 gut conditions related to acid production.
Pantoprazole Genoptim is used in adults and adolescents aged 12 years and above for the treatment of:

• Reflux oesophagitis. This is a condition in which the acid in the stomach flows back into the oesophagus, causing pain and discomfort.

Pantoprazole Genoptim is used in adults for:

• Infection with a bacterium called Helicobacter pylori in patients with duodenal and/or gastric ulcers, in combination with two antibiotics (eradication therapy), to get rid of the bacteria and prevent recurrence of ulcers.
• Ulcers of the stomach and/or duodenum.
• Zollinger-Ellison syndrome and other conditions related to excessive acid production in the stomach.

2. Important information before taking Pantoprazole Genoptim

When not to take Pantoprazole Genoptim:

• If you are allergic to pantoprazole or any of the other ingredients of this medicine (listed in section 6).
• If you have previously been diagnosed with an allergy to other proton pump inhibitors.

Warnings and precautions

Before taking Pantoprazole Genoptim, inform your doctor, pharmacist or nurse:
If you have severe liver problems. Inform your doctor if you have ever had liver problems in the past. Your doctor may want to monitor your liver function more closely, especially if you are taking Pantoprazole Genoptim for a long time. If your liver function is impaired, your doctor may decide to stop the treatment with Pantoprazole Genoptim.

• If you have a deficiency of vitamin B12 or factors that may lead to a reduction in vitamin B12 absorption, and you are taking pantoprazole long-term. Like all medicines that reduce the production of stomach acid, pantoprazole may lead to a reduced absorption of vitamin B12.
• If you are taking HIV protease inhibitors such as atazanavir, you should ask your doctor for specific advice.
• Taking a proton pump inhibitor like pantoprazole, especially over a period of more than one year, may slightly increase the risk of hip, wrist, or spine fractures. Tell your doctor if you have osteoporosis or if your doctor has told you that you are at risk of osteoporosis (e.g. if you take corticosteroids, which can increase the risk of osteoporosis). If you take Pantoprazole Genoptim for more than three months, it may cause a reduction in magnesium levels in the blood, which may cause tiredness, muscle cramps, convulsions, dizziness, and an irregular heartbeat. If you experience any of these symptoms, inform your doctor. Low magnesium levels can also lead to a reduction in potassium and calcium levels in the blood. Your doctor may decide to monitor your magnesium levels regularly.
• If you have ever experienced a skin reaction after taking a medicine that reduces stomach acid, you should tell your doctor before taking Pantoprazole Genoptim.
• If you get a rash on your skin, especially in areas exposed to the sun, tell your doctor as soon as possible. You should also tell your doctor about any other side effects, such as joint pain.
• About a planned specific blood test (chromogranin A).

Tell your doctor immediatelybefore or during treatment with Pantoprazole Genoptim if you notice any of the following symptoms, which could be a sign of a more serious condition:

• Unintentional weight loss (not associated with dieting or exercise)
• Vomiting, especially when recurring
• Blood in your vomit, which may look like coffee grounds
• Blood in your stool, which may make it black or tarry
• Difficulty swallowing or pain when swallowing
• Pale skin and weakness (anaemia)
• Chest pain
• Severe stomach pain
• Severe and/or persistent diarrhoea, as the use of this medicine may be associated with a slightly increased risk of infectious diarrhoea.

Your doctor may decide to perform tests to exclude a malignant condition, as pantoprazole may mask the symptoms of the disease and delay its diagnosis. If the symptoms persist despite treatment, further investigations will be considered.
Pantoprazole Genoptim may affect the absorption of vitamin B12. If you experience any of the following symptoms, which could indicate a low level of vitamin B12, inform your doctor:

• Extreme tiredness or lack of energy
• Numbness or tingling
• Painful or red tongue, mouth ulcers
• Muscle weakness
• Visual disturbances
• Memory problems, confusion, depression.

If you take Pantoprazole Genoptim for a long period (more than 1 year), you will probably be under regular supervision of your doctor. In this case, you should report any new and unexpected symptoms to your doctor during each visit.

Children and adolescents

Pantoprazole Genoptim is not recommended for use in children under 12 years of age, as its use has not been studied in this age group.

Pantoprazole Genoptim and other medicines

Tell your doctor or pharmacist about all the medicines you are taking, have recently taken, or might take, including those obtained without a prescription.
Since Pantoprazole Genoptim may affect the efficacy of other medicines, inform 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 Pantoprazole Genoptim may inhibit the proper functioning of these and other medicines.
• Warfarin and phenprocoumon, which affect blood clotting. Further tests may be necessary.
• Medicines used to treat HIV infection, such as atazanavir.
• Methotrexate (used to treat rheumatoid arthritis, psoriasis, and cancer) - your doctor may temporarily stop the treatment with Pantoprazole Genoptim, as pantoprazole may increase the level of methotrexate in the blood.
• Fluvoxamine (used to treat depression and other mental disorders - if you are taking fluvoxamine, your doctor may reduce the dose).
• Rifampicin (used to treat infections).
• St. John's Wort (Hypericum perforatum) (used to treat mild depression).

Pregnancy, breastfeeding, and fertility

Experience with the use of pantoprazole in pregnant women is limited. It has been found that the active substance of the medicine passes into human milk.
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
The medicine should only be used if the doctor considers that the benefit to the mother outweighs the potential risk to the unborn child or baby.

Driving and using machines

Pantoprazole Genoptim has no or negligible influence on the ability to drive and use machines.
If you experience side effects such as dizziness or blurred vision, do not drive or operate machinery.

Pantoprazole Genoptim contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which is essentially sodium-free.

3. How to take Pantoprazole Genoptim

Take this medicine exactly as your doctor or pharmacist has told you.
If you are not sure, ask your doctor or pharmacist.
Recommended dose:
Adults and adolescents aged 12 years and above:

For the treatment of reflux oesophagitis

The recommended dose is one tablet per day. Your doctor may increase the dose to two tablets per day. The duration of treatment of reflux oesophagitis is usually 4 to 8 weeks. Your doctor will decide how long you need to take the medicine.
Adults:

For the treatment of Helicobacter pylori infection, in combination with two antibiotics (eradication therapy), in patients with duodenal and/or gastric ulcers

One tablet twice dailyplus two antibiotic tablets: amoxicillin, clarithromycin, or metronidazole (or tinidazole) taken twice daily 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 given by your doctor and read the patient information leaflets in the packs of the antibiotics. The recommended treatment duration is one or two weeks.

For the treatment of gastric and/or duodenal ulcers

The recommended dose is one tablet per day. After consulting your doctor, the dose can be doubled. Your doctor will decide how long you need to take the medicine. The treatment duration for gastric ulcers is usually 4 to 8 weeks. The treatment duration for duodenal ulcers is usually 2 to 4 weeks.

For long-term treatment of Zollinger-Ellison syndrome and other conditions related to excessive acid production 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 by your doctor, depending on the amount of acid produced in the stomach. If your doctor prescribes more than two tablets per day, take them twice daily.
If your doctor prescribes a daily dose greater than four tablets per day, he will inform you when to stop taking the medicine.

Patients with kidney problems

Do not take Pantoprazole Genoptim for the eradication of Helicobacter pylori if you have kidney problems.

Patients with liver problems

Do not take Pantoprazole Genoptim for the eradication of Helicobacter pylori if you have moderate or severe liver problems.

Use in children and adolescents

Tablets are not recommended for use in children under 12 years of age.

Method of administration

Take the medicine 1 hour before a meal, without chewing or breaking the tablet. Swallow the tablet whole with water.

Taking a higher dose of Pantoprazole Genoptim than recommended

Inform your doctor or pharmacist. The symptoms of overdose are unknown.

Missing a dose of Pantoprazole Genoptim

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

Stopping treatment with Pantoprazole Genoptim

Do not stop taking the medicine without consulting your doctor or pharmacist.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Pantoprazole Genoptim can cause side effects, although not everybody gets them.

If you experience any of the following side effects, stop taking the tablets and contact a doctor or go to the nearest hospital immediately:

• Severe allergic reactions (rare; less than 1 in 1000 people):swelling of the tongue and/or throat, difficulty swallowing, hives (nettle rash), difficulty breathing, allergic swelling of the face (Quincke's oedema/angioedema), severe dizziness with rapid heartbeat and excessive sweating.
• Severe skin reactions (frequency not known; frequency cannot be estimated from the available data):the patient may notice one or more of the following symptoms: blistering of the skin and rapid deterioration of the general condition, erosion (with slight bleeding) of the eyes, nose, mouth/ lips, or genitals, or rash, especially on areas of skin exposed to the sun. It may also cause joint pain or flu-like symptoms, fever, swelling of the lymph nodes (e.g. in the armpits), and changes in blood test results (Stevens-Johnson syndrome, Lyell syndrome, polymorphic erythema, acute cutaneous lupus erythematosus, drug rash with eosinophilia and systemic symptoms (DRESS) and hypersensitivity to light).
• Other severe reactions (frequency not known; frequency cannot be estimated from the available data):yellowing of the skin and eyes (severe liver damage, jaundice) or fever, rash, and kidney problems, which may lead to kidney failure.

Other side effects:

• - Common (less than 1 in 10 people):mild gastric polyps
• - Uncommon (less than 1 in 100 people):headache; dizziness; diarrhoea; nausea; vomiting; feeling of bloating and gas in the abdomen; constipation; dry mouth; abdominal pain and discomfort; skin rash, redness, skin eruptions; itching; weakness, fatigue, or general feeling of being unwell; sleep disturbances; fractures of the hip, wrist, or spine.
• - Rare (less than 1 in 1000 people):

disturbance or complete loss of taste; visual disturbances, such as blurred vision; hives; joint pain; muscle pain; changes in body weight; elevated body temperature; high fever; swelling of the limbs (peripheral oedema); allergic reactions; depression; breast enlargement in men.

• - Very rare (less than 1 in 10,000 people):disorientation.
• - Frequency not known (frequency cannot be estimated from the available data):hallucinations, confusion (especially in patients who have experienced these symptoms before), feeling of tingling, prickling, tingling, burning, or numbness, rash that may be accompanied by joint pain, colitis (inflammation of the large intestine) that may cause persistent watery diarrhoea.

Side effects identified through blood tests:

• - Uncommon (less than 1 in 100 people):increased liver enzyme activity.
• - Rare (less than 1 in 1000 people):increased bilirubin levels, increased levels of fats in the blood, sudden reduction in the number of circulating granulocytes - a type of white blood cell, associated with high fever.
• - Very rare (less than 1 in 10,000 people):reduction in the number of platelets, which may cause more frequent bleeding and bruising; reduction in the number of white blood cells, which may increase the risk of infection; concurrent, abnormal reduction in the number of red and white blood cells as well as platelets.
• - Frequency not known (frequency cannot be estimated from the available data):reduction in sodium, magnesium, calcium, or potassium levels in the blood (see section 2).

Reporting of side effects

If you experience any side effects, including any not listed in this leaflet, please inform your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorisation holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Pantoprazole Genoptim

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 and blister after EXP. The expiry date refers to the last day of that month.
Do not store above 25°C.
Medicines should 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. Contents of the pack and other information

What Pantoprazole Genoptim contains

• The active substance is pantoprazole. One tablet contains 40 mg of pantoprazole (as pantoprazole sodium sesquihydrate).
• The other ingredients are: Tablet core: mannitol (E 421), crospovidone type A (E 1202), sodium carbonate anhydrous, calcium stearate. Coating: hypromellose 5 cP (E 464), povidone K-25 (E 1201), propylene glycol (E 1520), titanium dioxide (E 171), yellow iron oxide (E 172), methacrylic acid copolymer (1:1), dispersion 30%, triethyl citrate (E 1505)

What Pantoprazole Genoptim 40 mg gastro-resistant tablets look like and contents of the pack

Yellow oval, biconvex, film-coated gastro-resistant tablets, smooth on both sides.
Pantoprazole Genoptim 40 mg gastro-resistant tablets are available in the following packs:
28, 56, 90, or 100 gastro-resistant tablets in blisters.
Not all pack sizes may be marketed.

Marketing authorisation holder

Synoptis Pharma Sp. z o.o.
ul. Krakowiaków 65
02-255 Warsaw
tel. 22 32 16 240

Manufacturer / Importer

IDIFARMA DESARROLLO FARMACÉUTICO, S.L.
Polígono Mocholí
C/Noain, n 1 Noain, 31110 Navarra
Spain
Synoptis Industrial Sp. z o.o.
ul. Rabowicka 15
62-020 Swarzędz
Macleods Pharma UK Limited
Wynyard Park House
Wynyard Avenue
Wynyard, Billingham
TS22 5TB, United Kingdom
Netpharmalab Consulting Services
Carretera de Fuencarral 22,
Alcobendas, Madrid, 28108,
Spain

Date of last revision of the package leaflet: 03.2023