Progastim

Package leaflet: Information for the patient

Progastim, 20 mg, enteric-coated capsules
Omeprazolum
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet, as 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. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Progastim is and what it is used for
2. What you need to know 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 Progastim is and what it is used for

Progastim contains as the active substance omeprazole. It belongs to a group of medicines known as "proton pump inhibitors". These work by reducing the amount of acid produced in the stomach.

Progastim is indicated for use in the following conditions:

In adults:

• Treatment of gastro-oesophageal reflux disease (GERD). This condition occurs when acid from the stomach flows back into the oesophagus (the tube connecting the throat and the stomach), causing pain, inflammation, and heartburn.
• Treatment of peptic ulcers in the upper part of the small intestine (duodenal ulcers) and in the stomach (gastric ulcers).
• Treatment of ulcers caused by infection with a bacterium called Helicobacter pylori. If you have a Helicobacter pylori infection, your doctor will also prescribe appropriate antibiotics to eradicate the infection and allow the ulcers to heal.
• Treatment of ulcers induced by the use of non-steroidal anti-inflammatory drugs (NSAIDs). Progastim may also be used to prevent the formation of ulcers during NSAID therapy.
• Excessive acid production in the stomach due to a proliferative lesion in the pancreas (Zollinger-Ellison syndrome).

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

• Treatment of gastro-oesophageal reflux disease (GERD). This condition occurs when acid from the stomach flows back into the oesophagus, causing pain, inflammation, and heartburn. Symptoms in children may include regurgitation of gastric contents into the mouth (spitting up/vomiting), vomiting, and poor weight gain.

Children aged over 4 years and adolescents:

• Treatment of ulcers caused by infection with a bacterium called Helicobacter pylori. If your child has a Helicobacter pylori infection, the doctor will also prescribe appropriate antibiotics to eradicate 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 to any of the other ingredients of this medicine (listed in section 6).
• If the patient has an allergy to medicines containing other proton pump inhibitors (e.g. pantoprazole, lansoprazole, rabeprazole, esomeprazole).
• If the patient is taking a medicine containing nelfinavir (used in the treatment of HIV infection).

Do not take Progastim if any of the above apply.
If in doubt, consult a doctor or pharmacist before starting to take Progastim.
Warnings and precautions
Talk to your doctor or pharmacist before taking Progastim.
Severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), and acute generalized exanthematous pustulosis (AGEP), have been reported during treatment with Progastim. If you notice any symptoms related to these severe skin reactions described in section 4, stop taking Progastim immediately and seek urgent medical advice.

Progastim may mask symptoms of other diseases. Therefore, inform your doctor immediately if any of the following symptoms occur before or during treatment with Progastim:

• Unexplained weight loss and difficulty swallowing.
• Stomach pain or indigestion.
• Vomiting of food or blood.
• Black stools (bloody stools).
• Severe or persistent diarrhoea, as the use of omeprazole is associated with a slight increase in the risk of infectious diarrhoea.
• Severe liver function disorders.
• If the patient has ever had a skin reaction due to treatment with a medicine similar to Progastim that reduces gastric acid secretion. The patient should also inform the doctor about a planned specific blood test (chromogranin A levels).

If Progastim is taken for a prolonged period (over 1 year), the patient will likely be under close and regular medical supervision. During visits to the doctor, report any new or unusual symptoms and circumstances.

Taking proton pump inhibitors such as Progastim, especially for longer than one year, may slightly increase the risk of fractures of the hip, wrist, or spine. Inform your doctor if osteoporosis has been diagnosed or if the patient is taking glucocorticosteroids (which may increase the risk of osteoporosis).

If a skin rash develops, especially in areas exposed to sunlight, inform the doctor as soon as possible, as discontinuation of Progastim may be necessary. Also report any other adverse effects such as joint pain.

During treatment with omeprazole, kidney inflammation may occur. Symptoms may include reduced urine volume or presence of blood in the urine and/or hypersensitivity reactions such as fever, rash, and joint stiffness. Such symptoms should be reported to the treating physician.

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

Progastim with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take. This includes medicines available without a prescription. This is important because Progastim may affect the action of certain medicines and some medicines may affect the action of Progastim.

Do not take Progastim together with medicines containing nelfinavir (used in the treatment of HIV infection).

Inform your doctor or pharmacist if the patient is taking any of the following medicines:

• ketoconazole, itraconazole, or voriconazole (used to treat fungal infections),
• digoxin (used to treat heart disorders),
• diazepam (used to treat anxiety, to relax muscles, or in the treatment of epilepsy),
• phenytoin (used to treat epilepsy). If the patient is taking phenytoin, the doctor will monitor the patient’s condition when starting and stopping Progastim,
• medicines used to reduce blood clotting, such as warfarin or other vitamin K antagonists. 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 cancers),
• methotrexate (a chemotherapeutic agent used in high doses to treat cancers) – if the patient is taking high doses of methotrexate, the doctor may temporarily discontinue Progastim.

If the doctor has prescribed antibiotics—amoxicillin and clarithromycin—along with Progastim to treat a peptic ulcer caused by Helicobacter pylori infection, it is very important that the patient informs the doctor about all medicines being taken.

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, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.

Omeprazole passes into breast milk, but its effect on the infant is unlikely when used at therapeutic doses. The doctor will decide whether the patient may take Progastim while breastfeeding.

Driving and operating machinery
Progastim does not affect the ability to drive or operate machinery. However, adverse effects such as dizziness and visual disturbances may occur (see section 4). If such adverse effects occur, do not drive or operate machinery.

Progastim contains sucrose
If the patient has been previously diagnosed with an intolerance to certain sugars, the patient should consult a doctor before starting to take this medicine.

3. How to take Progastim

This medicine should always be taken exactly as directed by your doctor. If you have any doubts, consult your doctor.

Your doctor will inform you how many capsules you should take and for how long. This depends on your health condition and age.

The usual recommended doses are given below.

Use in adults:

In the treatment of symptoms of gastroesophageal reflux disease (GERD), such as heartburn and regurgitation of acidic stomach contents:

• If your doctor has determined that your esophagus has been slightly damaged, the recommended dose is 20 mg once daily for 4 to 8 weeks. Your doctor may recommend taking 40 mg once daily for an additional 8 weeks if the esophagus has not healed.
• The recommended dose after healing of the esophagus is 10 mg once daily.
• If the esophagus is not damaged, the usual dose is 10 mg once daily.

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

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

In the treatment of gastric ulcers (stomach ulcers):

• The usual dose is 20 mg once daily for 4 weeks. Your doctor may recommend continuing the same dose for another 4 weeks if the ulcer has not completely healed.
• If the ulcer has not completely healed, the dose may be increased to 40 mg once daily for 8 weeks.

Prevention of recurrence of duodenal and gastric ulcers:

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

In the treatment of duodenal and gastric ulcers caused by non-steroidal anti-inflammatory drugs (NSAIDs):

• The usual dose is 20 mg once daily for 4 to 8 weeks.

Prevention of duodenal and gastric ulcers during NSAID treatment:

• The usual dose is 20 mg once daily.

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

• The usual dose is 20 mg twice daily for 1 week.
• Your doctor will also prescribe two antibiotics, such as amoxicillin, clarithromycin, or metronidazole.

In the treatment of excessive gastric acid production caused by a hyperplastic change in the pancreas ( Zollinger-Ellison syndrome ):

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

Use in children and adolescents:

In the treatment of symptoms of gastroesophageal reflux disease (GERD), such as heartburn and regurgitation of acidic stomach contents:

• Children over 1 year of age and weighing more than 10 kg may take Progastim. The dose for children depends on body weight and is individually determined by the treating physician.

In the treatment of ulcers caused by Helicobacter pylori infection and prevention of recurrence:

• Children over 4 years of age may take Progastim. The dose for children depends on body weight and is individually determined by the treating physician.
• Your doctor will also prescribe two antibiotics—amoxicillin and clarithromycin.

How to take Progastim

• It is recommended to take the capsules in the morning.
• Capsules may be taken with or without food.
• Swallow the capsules whole with half a glass of water. Do not chew or crush the capsules, as they contain pellets that protect the medicine from being broken down by stomach acid. It is important not to damage the pellets.

Instructions if you have difficulty swallowing capsules (in adults or children)

If an adult or child has difficulty swallowing capsules:

• Open the capsule and swallow the contents directly with half a glass of water, or pour the contents into a glass of non-carbonated water, acidic fruit juice (e.g., apple, orange, or pineapple juice), or apple puree.
• Always mix the suspension thoroughly just before drinking (the suspension will not be clear). The prepared suspension should be consumed immediately or within 30 minutes of preparation.
• To ensure the full dose is taken, it is recommended to thoroughly rinse the glass with half a glass of water and drink the rinse water. The hard pellets contain the medicine—do not chew or crush them.

If you take more Progastim than you should

If you take more than the prescribed dose, contact your doctor or pharmacist immediately.

If you forget to take Progastim

If you miss a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose. Do not take a double dose to make up for a forgotten dose.

If you have any further questions about the use of this medicine, consult your doctor.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
If the patient notices any of the following rare but serious severe adverse effects, administration of Progastim should be discontinued immediately and the patient should contact a doctor without delay:

• Sudden wheezing, swelling of the lips, tongue or throat, skin rash, fainting or difficulty swallowing (severe allergic reaction).
• Skin redness with blister formation or skin peeling. A severe blistering reaction and bleeding from the lips, eyes, mouth, nose and genitals may also occur. This may be Stevens-Johnson syndrome or toxic epidermal necrolysis.
• Widespread rash, high body temperature and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).
• Red, scaly, widespread rash with subcutaneous nodules and blisters, accompanied by fever. Symptoms usually occur at the beginning of treatment (acute generalised exanthematous pustulosis).
• Yellowing of the skin, dark urine and fatigue, which may be symptoms of liver problems.

Other possible adverse effects are listed below, grouped according to their frequency of occurrence. The patient should inform their doctor or pharmacist if any of the adverse effects worsen.
Common (may occur in up to 1 in 10 patients)

• Headache.
• Gastrointestinal disorders: diarrhoea, abdominal pain, constipation, flatulence (wind).
• Nausea or vomiting.
• Benign gastric polyps.

Uncommon (may occur in up to 1 in 100 patients)

• Swelling of feet and ankles.
• Sleep disturbances (insomnia).
• Dizziness, paraesthesia (tingling or numbness sensation), drowsiness.
• Sensation of spinning (vertigo).
• Changes in blood test results related to liver function.
• Skin rash, nodular rash (urticaria) and skin itching.
• General malaise and lack of energy.

Rare (may occur in up to 1 in 1,000 patients)

• Blood disorders, such as reduced number of white blood cells or platelets. This may cause weakness, easy bruising or more 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.
• Restlessness, confusion or depression.
• Taste disturbances.
• Vision disorders, such as blurred vision.
• Sudden wheezing or shortness of breath (bronchospasm).
• Dryness of the mouth.
• Inflammation of the oral mucosa.
• Fungal infection known as "thrush", which may affect the gastrointestinal tract and is caused by a fungal infection.
• Liver function disorders, including jaundice, which may cause yellowing of the skin, dark urine and fatigue.
• Hair loss (alopecia).
• Skin rash occurring during exposure to sunlight.
• Joint pain or muscle pain.
• Severe kidney function disorders (interstitial nephritis).
• Increased sweating.

Very rare (may occur in up to 1 in 10,000 patients)

• Changes in blood cell counts, including agranulocytosis (lack of white blood cells).
• Aggression.
• Seeing, feeling or hearing things that are not real (hallucinations).
• Severe liver disorders leading to liver failure and encephalopathy.
• Sudden severe rash, blisters or skin peeling. This may be associated with 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 available data)

• Intestinal inflammation (causing diarrhoea).
• If Progastim has been taken for longer than three months, there may be a decrease in blood magnesium levels. Low magnesium levels may manifest as fatigue, involuntary muscle cramps, disorientation, seizures, dizziness, rapid heartbeat. If any of these symptoms are observed, the doctor should be informed immediately. Low magnesium levels may lead to reduced potassium or calcium levels in the blood. The doctor may recommend regular blood tests to monitor magnesium levels.
• Rash accompanied by joint pain.

In very rare cases, Progastim may affect the number of white blood cells in the blood, leading to immunodeficiency. If the patient develops an infection with symptoms such as fever accompanied by severe deterioration in general condition, or fever with signs of local infection such as neck, throat or oral pain, or difficulty urinating, the patient should consult a doctor as soon as possible to rule out possible white blood cell deficiency (agranulocytosis) based on blood test results. It is important that, in such a situation, the patient informs the doctor or pharmacist about the medicine being taken.
Patients should not be alarmed by the above-mentioned adverse effects. None of them may occur in the patient.
If any adverse symptoms occur, including any possible adverse effects not listed in this leaflet, the patient should consult a doctor or pharmacist.
Reporting of adverse effects
If any adverse symptoms occur, including any adverse effects not listed in this leaflet, the patient should inform their 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.: +48 22 4921301, Fax: +48 22 4921309, website: https://smz.ezdrowie.gov.pl
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 Progastim

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the outer carton, bottle, or
blister after "EXP". The expiry date refers to the last day of the stated month.
Store below 30°C.
Medicines must not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. Such practices help protect the environment.

6. Contents of the pack and other information

What Progastim contains

• The active substance is omeprazole. One enteric capsule of Progastim contains 20 mg of omeprazole.
• The other ingredients are: sugar spheres (sucrose, maize starch), sodium carboxymethyl starch (type A), sodium lauryl sulphate, povidone, trisodium phosphate, dodecahydrate, hypromellose, methacrylic acid and ethyl acrylate copolymer (1:1), sodium hydroxide, triethyl citrate, titanium dioxide (E 171), talc. Composition of the gelatin capsule: capsule cap: gelatin, titanium dioxide (E 171), indigotine (E 132), erythrosine (E 127), water; capsule body: erythrosine (E 127), quinoline yellow (E 104), titanium dioxide (E 171), water, gelatin. Composition of ink TekPrint SB-0007P White Ink: shellac, propylene glycol, povidone, sodium hydroxide, titanium dioxide (E 171).

What Progastim looks like and contents of the pack
Hard gelatin capsules, size 2, with an opaque blue cap and an opaque orange body. The capsules are marked with the letter "O" on the cap and the number "20" on the body, printed in white ink. The capsules are filled with white to beige micropelettes of omeprazole.
Packaged in a cylindrical white bottle made of high-density polyethylene (HDPE) with a polypropylene screw cap containing a desiccant gel, or in a PA/Aluminium/PVC/Aluminium blister pack in a cardboard box.
Each pack contains 14 or 28 enteric capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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

For more detailed information, please contact the local representative of the Marketing Authorisation Holder:
Recordati Polska sp. z o.o.
al. Armii Ludowej 26
00-609 Warsaw
tel: +48 22 206 84 50