Progastim

PATIENT INFORMATION LEAFLET

Leaflet accompanying the packaging: patient information

Progastim, 20 mg, gastro-resistant capsules

Omeprazole

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

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Progastim and what is it used for

Progastim contains the active substance omeprazole. It belongs to a group of medicines called "proton pump inhibitors". Their action is to reduce the amount of acid produced in the stomach.
Progastim is indicated for use in the following cases:
In adults:

• Treatment of gastro-esophageal reflux disease (GERD). This is when stomach acid flows back into the esophagus (the tube connecting the throat and stomach) causing pain, inflammation, and heartburn.
• Treatment of ulcers in the upper part of the small intestine (duodenal ulcers) and stomach (gastric ulcers).
• Treatment of ulcers caused by infection with a bacterium called Helicobacter pylori. If the patient has a Helicobacter pyloriinfection, the doctor will also prescribe appropriate antibiotics to cure the infection and allow the ulcers to heal.
• Treatment of ulcers caused by the use of non-steroidal anti-inflammatory drugs (NSAIDs). Progastim can also be used to prevent the formation of ulcers when taking NSAIDs.
• Excessive acid production in the stomach caused by a tumor in the pancreas (Zollinger-Ellison syndrome).

In children:
Children over 1 year of age and weighing ≥ 10 kg:

• Treatment of gastro-esophageal reflux disease (GERD). This is when stomach acid flows back into the esophagus (the tube connecting the throat and stomach) causing pain, inflammation, and heartburn. Symptoms of the disease in children may include: regurgitation of stomach contents into the mouth, vomiting, and poor weight gain.

Children over 4 years of age and adolescents:

• Treatment of ulcers caused by infection with a bacterium called Helicobacter pylori. If the child has a Helicobacter pyloriinfection, the doctor will also prescribe appropriate antibiotics to cure the infection and allow the ulcers to heal.

2. Important information before taking Progastim

When not to take Progastim:

• If the patient is allergic to the active substance or any of the other ingredients of this medicine (listed in section 6).
• If the patient is allergic to medicines containing other proton pump inhibitors (e.g., pantoprazole, lansoprazole, rabeprazole, esomeprazole).
• If the patient is taking a medicine containing nelfinavir (used to treat HIV infection).

Do not take Progastim if any of the above points apply to the patient. In case of doubts, consult a doctor or pharmacist before starting to take Progastim.
Before starting to take Progastim, the patient should discuss it with their doctor or pharmacist.
With the use of Progastim, serious skin reactions have been reported, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug rash with eosinophilia and systemic symptoms (DRESS) and acute generalized exanthematous pustulosis (AGEP). If the patient notices any symptoms related to these serious skin reactions described in section 4, they should stop taking Progastim and seek medical help immediately.
Progastim may mask the symptoms of other diseases. Therefore, before starting or during treatment with Progastim, the patient should immediately inform their doctor if they experience any of the following symptoms:

• Unexplained weight loss and swallowing problems.
• Stomach pain or indigestion.
• Vomiting blood or food.
• Black stools (bloody stools).
• Sudden or persistent diarrhea, as omeprazole use is associated with a slight increase in the risk of infectious diarrhea.
• Severe liver dysfunction.
• If the patient has ever had a skin reaction after taking a medicine similar to Progastim that reduces stomach acid. The patient should also inform their doctor about a planned specific blood test (chromogranin A levels).

In the case of long-term use of Progastim (more than 1 year), the patient will most likely remain under close and regular medical supervision. During visits to the doctor, the patient should report any new or unusual symptoms and circumstances.
When taking proton pump inhibitors like Progastim, especially for a period longer than one year, the risk of hip, wrist, or spine fractures may increase slightly. The patient should inform their doctor if they have been diagnosed with osteoporosis or are taking corticosteroids (which may increase the risk of osteoporosis).
If the patient experiences a skin rash, especially in areas exposed to sunlight, they should tell their doctor as soon as possible, as it may be necessary to stop taking Progastim. The patient should also report any other side effects, such as joint pain.
During omeprazole treatment, kidney inflammation may occur. Symptoms may include: decreased urine output or blood in the urine and (or) hypersensitivity reactions, such as fever, rash, and joint stiffness. The patient should report such symptoms to their doctor.

Children

Some children with chronic diseases may require long-term treatment, although this is not recommended. This medicine should not be given to children under 1 year of age or weighing less than 10 kg.

Progastim and other medicines

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. This includes medicines available without a prescription. This is important because Progastim may affect the action of some medicines, and some medicines may affect the action of Progastim.
Do not take Progastim at the same time as medicines containing nelfinavir(used to treat HIV infection).
The patient should inform their doctor or pharmacist if they are taking any of the following medicines:

• ketokonazole, itraconazole, or voriconazole (used to treat fungal infections),
• digoxin (used to treat heart disorders),
• diazepam (used to treat anxiety, to relax muscles, or to treat epilepsy),
• phenytoin (used to treat epilepsy). If the patient is taking phenytoin, the doctor will monitor their condition when starting and stopping Progastim,
• medicines used to reduce blood clotting, such as warfarin or other medicines that inhibit the action of vitamin K. The doctor will need to monitor the patient's condition when starting and stopping Progastim,
• rifampicin (used to treat tuberculosis).
• atazanavir (used to treat HIV infection),
• tacrolimus (used in organ transplantation),
• St. John's Wort (Hypericum perforatum) (used to treat mild depression),
• cilostazol (used to treat intermittent claudication),
• saquinavir (used to treat HIV infection),
• clopidogrel (used to prevent blood clots),
• erlotinib (used to treat cancer).
• methotrexate (a chemotherapeutic agent used in high doses to treat cancer) - if the patient is taking high doses of methotrexate, the doctor may temporarily stop Progastim.

If the doctor has prescribed the patient antibiotics - amoxicillin and clarithromycin - and Progastim to treat ulcers caused by Helicobacter pyloriinfection, it is very important for the patient to inform their doctor about all the medicines they are taking.

Progastim with food and drink

Progastim can be taken with food or on an empty stomach.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine.
Omeprazole passes into breast milk, but its effect on the baby is unlikely when the medicine is used at therapeutic doses. The doctor will decide whether the patient can take Progastim while breastfeeding.

Driving and using machines

Progastim does not affect the ability to drive or use machines. However, side effects such as dizziness and visual disturbances (see section 4) may occur. If the patient experiences any of these side effects, they should not drive or use machines.

Progastim contains sucrose

If the patient has been diagnosed with intolerance to some sugars, they should consult their doctor before taking this medicine.

3. How to take Progastim

This medicine should always be taken as directed by the doctor. In case of doubts, consult a doctor.
The doctor will inform the patient how many capsules to take and for how long. This depends on the patient's health and age.
The usual dosing is given below.
Use in adults:
In the treatment of symptoms of gastro-esophageal reflux disease (GERD), such as heartburn and acid reflux
into the stomach:

• If the doctor has found that the patient's esophagus is slightly damaged, the recommended dose is 20 mg once a day for 4-8 weeks. The doctor may recommend that the patient take a dose of 40 mg for another 8 weeks if the esophagus does not heal.
• The recommended dose after healing of the esophagus is 10 mg once a day.
• If the esophagus is not damaged, the usual dose is 10 mg once a day.

In the treatment of ulcers in the upper part of the small intestine(duodenal ulcers):

• The usual dose is 20 mg once a day for 2 weeks. The doctor may recommend taking the same dose for another 2 weeks if the ulcer has not healed completely. If the ulcer does not heal completely, the dose can be increased to 40 mg once a day for 4 weeks.

In the treatment of stomach ulcers(gastric ulcers):

• The usual dose is 20 mg once a day for 4 weeks. The doctor may recommend taking the same dose for another 4 weeks if the ulcer has not healed completely.
• If the ulcer does not heal completely, the dose can be increased to 40 mg once a day for 8 weeks.

Prevention of duodenal and stomach ulcers:

• The usual dose is 10 mg or 20 mg once a day. The doctor may increase the dose to 40 mg once a day.

In the treatment of ulcers in the upper part of the small intestine and stomach caused by non-steroidal anti-inflammatory drugs
(NSAIDs):

• The usual dose is 20 mg once a day for 4-8 weeks.

Prevention of ulcers in the upper part of the small intestine and stomachwhen taking NSAIDs:

• The usual dose is 20 mg once a day.

In the treatment of ulcers caused by Helicobacter pylori infectionand prevention of their recurrence:

• The usual dose is 20 mg twice a day for 1 week.
• The doctor will also recommend taking two antibiotics, such as amoxicillin and clarithromycin.

In the treatment of excessive acid production in the stomach caused by a tumor in the pancreas (Zollinger-Ellison syndrome):

• The usual dose is 60 mg per day.
• The doctor will adjust the dose according to the individual needs of the patient and decide how long Progastim should be taken.

Use in children and adolescents:
In the treatment of symptoms of gastro-esophageal reflux disease (GERD), such as heartburn and acid reflux
into the stomach:

• Children over 1 year of age and weighing more than 10 kg can take Progastim. The dose in children depends on the child's weight and is determined individually by the doctor.

In the treatment of ulcers caused by Helicobacter pylori infectionand prevention of their recurrence:

• Children over 4 years of age can take Progastim. The dose in children depends on the child's weight and is determined individually by the doctor.
• The doctor will also recommend taking two antibiotics - amoxicillin and clarithromycin.

How to take Progastim

• It is recommended to take the capsules in the morning.
• The capsules can be taken with food or on an empty stomach.
• The capsules should be swallowed whole with half a glass of water. Do not chew or crush the capsules, as they contain pellets that prevent the breakdown of the medicine by stomach acid. It is essential not to damage the pellets.

What to do if the patient has difficulty swallowing the capsules (in adults or children)

If the patient has difficulty swallowing the capsules:

• Open the capsule and swallow its contents directly with half a glass of water or pour the contents of the capsule into a glass of non-carbonated water, acidic fruit juice (e.g., apple, orange, or pineapple), or apple sauce.
• The suspension should always be mixed just before drinking (the suspension will not be clear), and the prepared suspension should be drunk immediately or within 30 minutes of preparation.
• To ensure that the entire medicine is taken, it is recommended to rinse the glass with half a glass of water and drink the contents. The hard pellets contain the medicine - they should not be chewed or crushed.

What to do if the patient takes more Progastim than they should

In case of taking a higher dose than recommended, the patient should immediately inform their doctor or pharmacist.

What to do if the patient forgets to take Progastim

If the patient misses a dose, they should take it as soon as they remember. However, if it is almost time for the next dose, they should skip the missed dose. The patient should not take a double dose to make up for the missed dose.
In case of any further doubts about taking this medicine, the patient should consult their doctor.

4. Possible side effects

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

If the patient notices any of the following serious side effects, they should stop taking Progastim and contact their doctor immediately:

• Sudden wheezing, swelling of the lips, tongue, and throat, or body, rash, fainting, or difficulty swallowing (severe allergic reaction).
• Redness of the skin with blistering or peeling. It may also be accompanied by a severe blistering rash and bleeding in the lips, eyes, mouth, nose, and genitals. This may be Stevens-Johnson syndrome or toxic epidermal necrolysis.
• Widespread rash, high fever, and swollen lymph nodes (DRESS or drug hypersensitivity syndrome).
• Red, scaly, widespread rash with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis).
• Yellowing of the skin, dark urine, and fatigue, which may be signs of liver problems.

Other side effects that may occur are listed below, grouped by frequency:

Common (may affect up to 1 in 10 people)

• Headache.
• Gastrointestinal disorders: diarrhea, stomach pain, constipation, flatulence (bloating).
• Nausea or vomiting.
• Mild stomach polyps.

Uncommon (may affect up to 1 in 100 people)

• Swelling of the feet and ankles.
• Sleep disorders (insomnia).
• Dizziness, paresthesia (tingling and numbness), drowsiness.
• Feeling of spinning (vertigo).
• Changes in liver function test results.
• Skin rash, urticaria (hives), and itching.
• General malaise and lack of energy.

Rare (may affect up to 1 in 1,000 people)

• Blood disorders, such as decreased white blood cell or platelet count. This may cause weakness, bruising, or frequent infections.
• Allergic reactions, sometimes very severe, including swelling of the lips, tongue, and throat, fever, wheezing.
• Low sodium levels in the blood. This may cause weakness, vomiting, and muscle cramps.
• Agitation, confusion, or depression.
• Taste disorders.
• Visual disturbances, such as blurred vision.
• Sudden wheezing or shortness of breath (bronchospasm).
• Dry mouth.
• Oral thrush (a fungal infection of the mouth).
• Liver dysfunction, including jaundice, which may cause yellowing of the skin, dark urine, and fatigue.
• Hair loss (alopecia).
• Skin rash in response to sunlight.
• Joint or muscle pain.
• Severe kidney dysfunction (interstitial nephritis).
• Increased sweating.

Very rare (may affect up to 1 in 10,000 people)

• Changes in blood cell counts, including agranulocytosis (lack of white blood cells).
• Aggression.
• Seeing, feeling, or hearing things that are not there (hallucinations).
• Severe liver dysfunction leading to liver failure and encephalopathy.
• Sudden severe rash or blisters or peeling of the skin. This may be accompanied by high fever and joint pain (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Muscle weakness.
• Breast enlargement in men.

Frequency not known (frequency cannot be estimated from the available data)

• Colitis (causing diarrhea).
• If Progastim has been taken for more than three months, there is a possibility of decreased magnesium levels in the blood. Low magnesium levels may cause fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, and rapid heartbeat. If the patient experiences any of these symptoms, they should inform their doctor immediately. Low magnesium levels may lead to decreased potassium or calcium levels in the blood. The doctor may recommend regular blood tests to monitor magnesium levels.
• Rash that may be accompanied by joint pain.

In very rare cases, Progastim may affect the number of white blood cells in the blood, leading to a lack of immunity. If the patient experiences an infection with symptoms such as fever with a serious deterioration in general health or fever with signs of local infection, such as neck, throat, or mouth pain, or difficulty urinating, they should consult their doctor as soon as possible to rule out a possible lack of white blood cells (agranulocytosis) based on blood test results. It is essential for the patient to provide their doctor or pharmacist with information about the medicine they are taking.
Do not worry about the above side effects. None of them may occur in the patient.
If the patient experiences any side effects, including any side effects not listed in this leaflet, they should consult their doctor or pharmacist.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, 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 authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Progastim

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister or bottle after "EXP". The expiry date refers to the last day of the month.
Store in a temperature below 30°C.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer need. This will help protect the environment.

6. Contents of the pack and other information

What Progastim contains

• The active substance of Progastim is omeprazole. One gastro-resistant capsule of Progastim contains 20 mg of omeprazole.
• The other ingredients are: sucrose granules (sucrose, corn starch), carboxymethyl starch sodium (type A), sodium lauryl sulfate, povidone, trisodium phosphate dodecahydrate, hypromellose, methacrylic acid - ethyl acrylate copolymer (1:1), sodium hydroxide, triethyl citrate, titanium dioxide (E 171), talc. The composition of the capsule shell is: capsule cap: gelatin, titanium dioxide (E 171), indigo carmine (E 132), erythrosine (E 127), water; capsule body: erythrosine (E 127), quinoline yellow (E 104), titanium dioxide (E 171), water, gelatin. The composition of the TekPrint SB-0007P White Ink is: shellac, propylene glycol, povidone, sodium hydroxide, titanium dioxide (E 171).

What Progastim looks like and contents of the pack

Hard gastro-resistant capsules, size 2, with a non-transparent blue cap and a non-transparent orange body. The capsules have markings in the form of the letter "O" on the cap and the number "20" on the body, made with white ink. The capsules are filled with white to beige omeprazole micro-pellets.
A cylindrical white polyethylene (HDPE) bottle with a polypropylene cap and a desiccant gel, or a PA/Aluminum/PVC/Aluminum blister in a cardboard box.
Each pack contains 14 or 28 gastro-resistant capsules.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Recordati Ireland Ltd.
Raheens East
Ringaskiddy, Co. Cork
Ireland

Manufacturer:

TEVA PHARMA, S.L.U.
Poligono Industrial Malpica Calle C 4
50016 Zaragoza
Spain
To obtain more detailed information, the patient should contact the local representative of the marketing authorization holder:
Recordati Polska sp. z o.o.
al. Armii Ludowej 26
00-609 Warsaw
tel: +48 22 206 84 50

Date of last revision of the leaflet: