Prenome

Leaflet accompanying the packaging: information for the user

Prenome, hard gastro-resistant capsules, 20 mg

Prenome, hard gastro-resistant capsules, 40 mg

Omeprazole

It is essential to carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• The leaflet should be kept, so that it can be re-read if necessary.
• In case of any doubts, the patient should consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Prenome and what is it used for

Prenome 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.

Prenome is used to treat the following diseases and disorders:

In adults:

• Gastro-esophageal reflux disease (GERD). This is when stomach acid flows back into the esophagus (the tube connecting the throat to the stomach), causing pain, inflammation, and heartburn.
• Ulcers in the upper part of the small intestine (duodenal ulcers) or stomach (gastric ulcers).
• Ulcers infected with bacteria called "Helicobacter pylori". In such cases, the doctor may also prescribe antibiotics to cure the infection and allow the ulcers to heal.
• Ulcers caused by medicines called non-steroidal anti-inflammatory drugs (NSAIDs). Prenome can also be used to prevent the development of ulcers when taking NSAIDs.
• Excessive stomach acid due to a tumor in the pancreas (Zollinger-Ellison syndrome).

In children:

Children over 1 year of age and weighing 10 kg or more

• Gastro-esophageal reflux disease (GORD). This is when stomach acid flows back into the esophagus (the tube connecting the throat to the stomach), causing pain, inflammation, and heartburn. In children, symptoms of this disorder may include regurgitation of stomach contents into the mouth, vomiting, and poor weight gain.

Children and adolescents over 4 years of age

• Ulcers infected with bacteria called "Helicobacter pylori". If a child has this disease, the doctor may also prescribe antibiotics to cure the infection and allow the ulcers to heal.

2. Important information before taking Prenome

When not to take Prenome:

• If the patient is allergic to omeprazole or any of the other ingredients of this medicine (listed in section 6);
• If the patient has been diagnosed with 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 to treat HIV infection).

Prenome should not be taken if any of the above points apply to the patient. In case of any doubts before starting to take Prenome, the patient should consult a doctor or pharmacist.

Warnings and precautions

Before taking Prenome, the patient should consult a doctor or pharmacist.

During treatment with Prenome, 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 Prenome and seek medical help immediately.

Prenome may mask the symptoms of other diseases. Therefore, if the patient experiences any of the following conditions before or during treatment with Prenome, they should immediately inform their doctor:

• Unexplained weight loss and difficulty swallowing.
• Stomach pain or indigestion.
• Vomiting blood or black tarry stools.
• Severe or persistent diarrhea, as the use of omeprazole is associated with a slight increase in the frequency of infectious diarrhea.
• Severe liver problems.
• If the patient has ever had a skin reaction after taking a medicine that reduces stomach acid.
• About a planned specific blood test (chromogranin A levels).

In case of long-term use of Prenome (more than 1 year), the patient will most likely remain under close and regular medical supervision. During the visit to the doctor, the patient should report any new or unusual symptoms and circumstances.

Taking a proton pump inhibitor like Prenome, especially for a period longer than a year, may slightly increase the risk of hip, wrist, or spine fractures. The patient should inform their doctor if they have osteoporosis or are taking corticosteroids (which may increase the risk of osteoporosis).

During treatment with omeprazole, 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.

This medicine may affect the absorption of vitamin B12, especially if taken for a long time. The patient should contact their doctor if they experience any of the following symptoms, which may indicate a low level of vitamin B12:

• Severe fatigue or lack of energy;
• Numbness or tingling;
• Pain or redness of the tongue, mouth ulcers;
• Muscle weakness;
• Vision problems;
• Memory problems, disorientation, depression.

If the patient experiences a skin rash, especially in areas exposed to sunlight, they should inform their doctor as soon as possible, as it may be necessary to stop taking Prenome. The patient should also report any other side effects, such as joint pain.

Prenome 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 those they plan to take. This includes medicines available without a prescription. It is essential because Prenome may affect the way some other medicines work, and some other medicines may affect the way Prenome works.

The patient should not take Prenome if they are taking a medicine containing nelfinavir (used to treat HIV infection).

The patient should inform their doctor or pharmacist if they are taking any of the following medicines:

• Ketoconazole, itraconazole, posaconazole, or voriconazole (used to treat fungal infections).
• Digoxin (used to treat heart rhythm disorders).
• Diazepam (used to treat anxiety, to reduce muscle tension, or to treat epilepsy).
• Phenytoin (used to treat epilepsy). If the patient is taking phenytoin, their doctor will need to monitor their condition when starting or stopping Prenome.
• 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 or stopping Prenome.
• 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).
• Medicines used to treat cancer.
• Methotrexate (a chemotherapy medicine used to treat cancer) - if the patient is taking high doses of methotrexate, their doctor may temporarily stop Prenome treatment.

If the doctor has prescribed the patient antibiotics amoxicillin and clarithromycin and Prenome to treat ulcers caused by Helicobacter pylori infection, it is crucial for the patient to inform their doctor about any other medicines they are taking.

Prenome with food and drink

See section 3.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to become pregnant, they should consult their doctor or pharmacist before taking this medicine.

Omeprazole passes into breast milk, but its effect on the baby is unlikely if the medicine is used at therapeutic doses. The doctor will decide whether the breastfeeding patient can take Prenome.

Driving and using machines

Prenome is unlikely to affect the ability to drive or use machines. However, the patient may experience side effects such as dizziness or blurred vision (see section 4). If these occur, the patient should not drive or operate machinery.

Prenome contains sucrose and sodium

Prenome contains sucrose. If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking Prenome.

The medicine contains less than 1 mmol (23 mg) of sodium per capsule, which means it is essentially "sodium-free".

3. How to take Prenome

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. In case of doubts, the patient should consult their doctor or pharmacist.

The doctor will inform the patient how many capsules to take and for how long. This will depend on the patient's health and age.

For doses other than 20 mg and 40 mg, capsules of 10 mg of other omeprazole medicines are available.

Dosing recommendations are presented below.

Use in adults:

Treatment of GERD symptoms, such as heartburn and acid reflux:

• If the doctor has found that the patient's esophagus is slightly damaged, the recommended dose is 20 mg once daily for 4 to 8 weeks. The doctor may recommend that the patient take a dose of 40 mg for another 8 weeks if the esophagus has not yet 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.

Treatment of duodenal ulcers:

• The recommended dose is 20 mg once daily for 2 weeks. The doctor may recommend taking the same dose for another 2 weeks if the ulcers have not healed within this time.
• If the ulcer has not healed completely, the dose may be increased to 40 mg once daily for 4 weeks.

Treatment of gastric ulcers:

• The recommended dose is 20 mg once daily for 4 weeks. The doctor may recommend taking the same dose for another 4 weeks if the ulcers have not healed within this time.
• If the ulcer has not healed completely, the dose may be increased to 40 mg once daily for 8 weeks.

Prevention of duodenal and gastric ulcers:

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

Treatment of duodenal and gastric ulcers caused by NSAIDs:

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

Prevention of duodenal and gastric ulcers during NSAID use:

• The recommended dose is 20 mg once daily.

Treatment of ulcers caused by Helicobacter pylori infection and prevention of their recurrence:

• The recommended dose of Prenome is 20 mg twice daily for one week.
• The doctor will also prescribe two antibiotics: amoxicillin and clarithromycin.

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

• The recommended dose is 60 mg daily.
• The doctor will adjust the dose according to the individual needs of the patient and decide how long the treatment should last.

Use in children and adolescents

Treatment of GERD symptoms, such as heartburn and acid reflux:

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

Treatment of ulcers caused by Helicobacter pylori infection and prevention of their recurrence:

• Children over 4 years of age can take Prenome. The dose for children depends on their weight, and the appropriate dose will be recommended by the doctor.
• The doctor will also prescribe two antibiotics: amoxicillin and clarithromycin.

Method of administration

• It is recommended to take the capsules in the morning.
• The capsules can be taken with or without food.
• The capsules should be swallowed whole, with half a glass of water. The capsules should not be chewed or crushed, as they contain enteric-coated pellets, whose coating prevents the breakdown of the medicine by stomach acid. It is essential not to damage the pellets.

What to do in case of difficulty swallowing the capsules (in adults or children)

• If the patient has difficulty swallowing the capsules:
• Open the capsule and swallow the contents directly, with a glass of water, or pour the contents into a glass of non-carbonated water, any acidic fruit juice (e.g., apple, orange, or pineapple), or apple sauce.

Always mix the mixture immediately before drinking (the mixture will not be clear). Then, drink the mixture immediately after preparation or within 30 minutes.

• To ensure that the patient has taken the entire dose, the glass should be rinsed with half a glass of water and the rinse swallowed. The solid particles contain the medicine - they should not be chewed or crushed.

Taking a higher dose of Prenome than recommended

In case of taking a higher dose of Prenome than prescribed by the doctor, the patient should contact their doctor or pharmacist immediately.

Missing a dose of Prenome

In case of missing a dose due to forgetfulness, the patient should take the dose as soon as they remember. However, if it is almost time for the next dose, the missed dose should be skipped. The patient should not take a double dose to make up for the missed dose.

Stopping treatment with Prenome

The patient should not stop taking Prenome without consulting their doctor or pharmacist first.

In case of any further doubts about the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

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

In case of noticing any of the following rare (may affect up to 1 in 1000 people) or very rare (may affect up to 1 in 10,000 people) but serious side effects, the patient should stop taking Prenome and contact their doctor immediately:

• Sudden wheezing, swelling of the lips, tongue, or throat, or body, rash, fainting, or difficulty swallowing (severe allergic reaction). (rare)
• Redness of the skin with blistering or peeling. Large blisters and bleeding in the mouth, eyes, lips, nose, and genitals may also occur. This may be Stevens-Johnson syndrome or toxic epidermal necrolysis. (very rare)
• Widespread rash, high fever, and enlarged lymph nodes (DRESS or drug hypersensitivity syndrome). (rare)
• 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). (rare)
• Yellowing of the skin, dark urine, and fatigue, which may be signs of liver problems. (rare)

Other side effects include:

Common side effects (may affect up to 1 in 10 people)

• Headache.
• Effects on the stomach or intestines: diarrhea, stomach pain, constipation, gas (bloating).
• Feeling sick (nausea) or being sick (vomiting).
• Mild stomach polyps.

Uncommon side effects (may affect up to 1 in 100 people)

• Swelling of the feet and ankles.
• Sleep disorders (insomnia).
• Feeling of dizziness, tingling, or drowsiness.
• Feeling of spinning (vertigo).
• Changes in liver function test results.
• Skin rash, urticaria, and itching.
• General feeling of being unwell and lack of energy.

Rare side effects (may affect up to 1 in 1000 people):

• Blood problems, such as a decreased number of white blood cells or platelets. This may lead to weakness, easy bruising, or an increased risk of infection.
• Low sodium levels in the blood. This may lead to weakness, vomiting, and muscle cramps.
• Feeling agitated, confused, or depressed.
• Changes in taste.
• Vision problems, such as blurred vision.
• Sudden shortness of breath or wheezing (bronchospasm).
• Dry mouth.
• Mouth inflammation.
• Fungal infection, which can affect the intestines.
• Hair loss (alopecia).
• Skin rash when exposed to sunlight.
• Joint pain (arthralgia) or muscle pain (myalgia).
• Severe kidney problems (interstitial nephritis).
• Increased sweating.

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

• Changes in blood cell count, including agranulocytosis (lack of white blood cells).
• Aggression.
• Seeing, feeling, or hearing things that do not exist (hallucinations).
• Severe liver problems leading to liver failure and brain inflammation.
• Erythema multiforme.
• Muscle weakness.
• Breast enlargement in men.

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

• Colitis (leading to diarrhea).
• If Prenome 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, or 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 associated with joint pain.

In very rare cases, Prenome 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 severe deterioration of general well-being or fever with signs of local infection, such as pain in the neck, throat, or mouth, 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 inform their doctor or pharmacist about the medicine they are taking.

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should inform 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.

By reporting side effects, it is possible to gather more information on the safety of this medicine.

5. How to store Prenome

• The medicine should be stored out of sight and reach of children.
• Prenome should not be used after the expiry date stated on the carton after EXP. The expiry date refers to the last day of the month.
• For Al/Al blisters: Store in a temperature below 30°C. Store in the original packaging to protect from moisture.
• For PVC-PVDC/Al blisters: Store in a temperature below 25°C. Store in the original packaging to protect from moisture.
• For bottles: No special storage temperature instructions. Shelf life after first opening the bottle: 100 days. Store the bottle tightly closed to protect from moisture.
• 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 use. This will help protect the environment.

6. Contents of the pack and other information

What Prenome contains

• The active substance of Prenome is omeprazole. Prenome hard gastro-resistant capsules contain 20 mg or 40 mg of omeprazole.
• Other ingredients are sucrose spheres (sucrose and maize starch), hypromellose (E-464), talc (E-553b), titanium dioxide (E-171), disodium phosphate dihydrate (E-339 ii), sodium lauryl sulfate, polysorbate, methacrylic acid, and ethyl acrylate copolymer, triethyl citrate (E-1505). Capsule:gelatin, titanium dioxide (E-171), ink (iron oxide black (E-172), potassium hydroxide, and shellac). See section 2 Prenome contains sucrose.

What Prenome looks like and contents of the pack

Prenome 20 mg capsules are white, hard, and have "OM 20" printed on them, and contain spherical pellets.

Prenome 40 mg capsules are white, hard, and have "OM 40" printed on them, and contain spherical pellets.

A white HDPE bottle with a screw cap and a ring-pull seal, with a desiccant capsule: 14 and 28 capsules.

Al/Al blister: 14 and 28 capsules.

PVC-PVDC/Al blister: 14 and 28 capsules.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Mercapharm Sp. z o.o.

ul. Świętopełka 39

81-524 Gdynia, Poland

Manufacturer:

TOWA Pharmaceutical Europe, S.L.

C/ de Sant Martí, 75-97

Martorelles, 08107 Barcelona - Spain

This medicine has been approved in the EEA member states under the following names:

Belgium: Prenome 10, 20, 40 mg gastro-resistant capsule, hard

Spain: Omeprazol ABDrug 20, 40 mg capsule, hard, gastro-resistant

Netherlands: Prenome 10, 20, 40 mg gastro-resistant capsule, hard

Poland: Prenome

Romania: Prenome 10, 20, 40 mg gastro-resistant capsule

United Kingdom: Omeprazole 10, 20 & 40 mg gastro-resistant capsule, hard

Date of last revision of the leaflet: 03.2023