Prenome

Leaflet accompanying the packaging: information for the user

Prenome, gastro-resistant hard capsules, 10 mg

Prenome, gastro-resistant hard capsules, 20 mg

Prenome, gastro-resistant hard 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 in case it needs to be read again.
• In case of any doubts, the doctor or pharmacist should be consulted.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness 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 packaging 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 drugs 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).

Children over 1 year of age and with a body weight of 10 kg or more

• 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.

In children, symptoms of this disorder may include: regurgitation of stomach contents into the mouth (regurgitation), 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 has been diagnosed with an allergy (hypersensitivity) to omeprazole or any of the other ingredients of Prenome (listed in section 6);
• if the patient has been diagnosed with an allergy to drugs containing other proton pump inhibitors (e.g., pantoprazole, lansoprazole, rabeprazole, esomeprazole);
• if the patient is taking a drug containing nelfinavir (used to treat HIV infection).

Before starting to take Prenome, the doctor or pharmacist should be consulted.

Warnings and precautions

Prenome may mask the symptoms of other diseases. Therefore, if any of the following conditions occur before or during treatment with Prenome, the doctor should be contacted immediately:

• Unexplained weight loss and difficulty swallowing.
• Stomach pain or indigestion.
• Vomiting blood or food.
• Passing black stools (stool discolored with blood).
• Severe or persistent diarrhea, as omeprazole use 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.

If a skin rash appears, especially in areas exposed to sunlight, the doctor should be informed as soon as possible, as it may be necessary to stop taking Prenome. Any other side effects, such as joint pain, should also be reported.
Before taking the medicine, the doctor should be informed about any planned specific blood test (chromogranin A level).
In the case of long-term use of Prenome (longer than 1 year), the patient will most likely remain under close and regular medical supervision. During the visit to the doctor, any new and unusual symptoms and circumstances should be reported.
Taking a proton pump inhibitor, such as Prenome, especially for a period longer than a year, may slightly increase the risk of hip, wrist, or spine fractures. The doctor should be informed if osteoporosis is present or if corticosteroids are being taken (which may increase the risk of osteoporosis).

Prenome and other medicines

The doctor or pharmacist should be informed about all medicines currently being taken by the patient, including those that can be obtained without a prescription. This is important because Prenome may affect the way some other medicines work, and some other medicines may affect the way Prenome works.
Prenome should not be taken if a medicine containing nelfinavir (used to treat HIV infection) is being taken.
The doctor or pharmacist should be informed if any of the following medicines are being taken:

• Ketoconazole, itraconazole, 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, the doctor will need to monitor the patient's 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 in high doses) - if high doses of methotrexate are taken, the 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 very important for the patient to inform the doctor about any other medicines being taken.

Taking Prenome with food and drink

The capsules can be taken with or without food. THEY SHOULD NOT BE CHEWED OR CRUSHED. They should be swallowed whole, washed down with a glass of water.

Pregnancy and breastfeeding

During pregnancy and breastfeeding, or if pregnancy is suspected or planned, the doctor or pharmacist should be consulted before taking this medicine.
Omeprazole is excreted into breast milk, but the likelihood of affecting the baby after taking therapeutic doses is low. The decision to take Prenome during breastfeeding is made by the doctor.

Driving and using machines

Prenome should not affect the ability to drive or use tools and machines. However, side effects such as dizziness and vision disturbances (see section 4) may occur. If they occur, the patient should not drive or operate machinery.

Prenome contains sucrose

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

3. How to take Prenome

This medicine should always be taken as directed by the doctor. In case of doubts, the doctor or pharmacist should be consulted.
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.
The recommended dose is:

• Treatment of GERD symptoms, such as heartburn and acid reflux:
• If the doctor has found that the patient's esophagus has been slightly damaged, the recommended dose is 20 mg once a day 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 a day.
• If the esophagus has not been damaged, the recommended dose is 10 mg once a day.

Treatment of duodenal ulcers (duodenal ulcers):

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

Treatment of gastric ulcers (gastric ulcers):

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

Prevention of duodenal and gastric ulcers:

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

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

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

Prevention of duodenal and gastric ulcers during NSAID use:

• The recommended dose is 20 mg once a day.

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

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

Treatment of excessive stomach acid production due to a tumor in the pancreas (Zollinger-Ellison syndrome):

• The recommended dose is 60 mg per day. 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

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

• Children over 1 year of age and with a body weight greater than 10 kg can take Prenome. The dose for children depends on the child's body weight, and the appropriate dose for the child will be recommended 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 the child's body weight, and the appropriate dose for the child will be recommended by the doctor.
• The doctor will also prescribe two antibiotics: amoxicillin and clarithromycin.

Taking the medicine

• 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, washed down with half a glass of water. DO NOT CHEW OR CRUSH THE CAPSULES. This is important because the capsules contain enteric-coated pellets that prevent 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, washed down with a glass of water, or pour the contents into a glass of still water, any acidic fruit juice (e.g., apple, orange, or pineapple), or applesauce.
• 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 of the medicine, the glass should be rinsed with half a glass of water and the liquid drunk. The solid particles contain the medicine - DO NOT CHEW OR CRUSH THEM.

Taking a higher dose of Prenome than recommended

In case of taking a higher dose of Prenome than prescribed by the doctor, the doctor or pharmacist should be contacted immediately.

Missing a dose of Prenome

In case of missing a dose due to forgetfulness, the dose should be taken as soon as remembered. However, if it is almost time for the next dose, the missed dose should be skipped. A double dose should not be taken to make up for the missed dose.

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 but serious side effects, the patient should stop taking Prenome 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. Large blisters and bleeding in the area of the lips, eyes, mouth, nose, and genitals may also occur. This may be Stevens-Johnson syndrome or toxic epidermal necrolysis.
• Yellowing of the skin, dark urine, and fatigue, which may be symptoms of liver problems.

Other side effects include:

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

• Headache.
• Affecting the stomach or intestines: diarrhea, stomach pain, constipation, gas (bloating).
• Feeling unwell (nausea) or sickness (vomiting).
• Mild stomach polyps.

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

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

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

• Blood problems, such as a reduced number of white blood cells or platelets. This may lead to weakness, easier bruising, or an increased risk of infection.
• Allergic reactions, sometimes very severe, including swelling of the lips, tongue, and throat, fever, wheezing.
• Low sodium levels in the blood. This may lead to weakness, vomiting, and muscle cramps.
• Feeling agitated, confused, or depressed.
• Change in taste.
• Vision problems, such as blurred vision.
• Sudden feeling of wheezing or shortness of breath (bronchospasm).
• Dry mouth.
• Mouth inflammation.
• Fungal infection, which can affect the intestines and is caused by fungi.
• Liver problems, including jaundice, which can cause yellowing of the skin, dark urine, and fatigue.
• 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 morphology, 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.
• Sudden onset of severe rash or blistering of the skin or peeling. This may be accompanied by high fever and joint pain (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Muscle weakness.
• Breast enlargement in men.

Unknown frequency (cannot be estimated from the available data)

• Enteritis (leading to diarrhea).
• If Prenome is used for more than three months, a decrease in magnesium levels in the blood may occur. Low magnesium levels may cause fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, or an increased heart rate. If any of these symptoms occur, the doctor should be contacted immediately. Low magnesium levels may also lead to low 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, 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 a significant worsening of general well-being 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) detected in a blood test. The patient should not worry about the list of side effects mentioned above.

Reporting side effects

If any side effects occur, including those not listed in the leaflet, the doctor or pharmacist should be informed. 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, e-mail: ndl@urpl.gov.pl.
Side effects can also be reported to the marketing authorization holder.
Reporting side effects can help gather more information on the safety of the medicine.

5. How to store Prenome

• The medicine should be stored out of sight and reach of children.
• The medicine should not be used after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month stated.
• 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 30°C.
Store in the original packaging to protect from moisture.

• For bottles:

No special storage precautions are required.
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 pharmacist should be asked how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Prenome contains

• The active substance of Prenome is omeprazole. Prenome gastro-resistant hard capsules contain 10 mg, 20 mg, or 40 mg of omeprazole.
• Other ingredients are sugar spheres (sugar and cornstarch), 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), printing 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 10 mg capsules are white, hard, and have "OM 10" printed on them, and contain spherical pellets.
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:
Esteve Pharmaceuticals, S.A.
C/ San Martí, 75-97
Martorelles, 08107 Barcelona - Spain

This medicine has been approved in the EEA countries 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 10, 20, 40 mg gastro-resistant hard capsule
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:05.2019