Prenome

Leaflet accompanying the packaging: information for the user

Prenome, gastro-resistant hard capsules, 20 mg

Prenome, gastro-resistant hard capsules, 40 mg

Omeprazole

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should 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 as yours.
• 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 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 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 the presence of a tumor in the pancreas (Zollinger-Ellison syndrome).

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

• 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 (regurgitation, vomiting), 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:

Do not take Prenome if any of the above points apply to you.
In case of any doubts before starting to take Prenome, you should talk to your doctor or pharmacist.

Warnings and precautions

Before taking Prenome, you should talk to your 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 you notice any symptoms related to these serious skin reactions described in section 4, you should stop taking Prenome and seek medical help immediately.
Prenome may mask the symptoms of other diseases. For this reason, if you experience any of the following conditions before or during treatment with Prenome, you should immediately inform your 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 similar to Prenome, which reduces stomach acid.
• About a planned specific blood test (chromogranin A levels).

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, you should report any new and unusual symptoms and circumstances.
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. You should inform your doctor if you have osteoporosis or if you 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. Such symptoms should be reported to the attending physician.
This medicine may affect the absorption of vitamin B, especially if the medicine is taken for a long time. You should contact your doctor if you experience any of the following symptoms that may indicate low vitamin B levels:

• Very severe fatigue or lack of energy;
• Numbness and tingling;
• Pain or redness of the tongue, mouth ulcers;
• Muscle weakness;
• Visual disturbances;
• Memory problems, disorientation, depression.

If you experience a skin rash, especially in areas exposed to sunlight, you should tell your doctor as soon as possible, as it may be necessary to stop taking Prenome. You should also report any other side effects, such as joint pain.
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.

Prenome and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as those you plan to take. This includes medicines available 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.
Do not take Prenome if you are taking a medicine containing nelfinavir (used to treat HIV infection).
You should inform your doctor or pharmacist if you 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 you are taking phenytoin, your doctor will need to monitor your condition when starting and stopping Prenome.
• Medicines used to reduce blood clotting, such as warfarin or other vitamin K antagonists. Your doctor will need to monitor your condition when starting and 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, your doctor may temporarily stop Prenome treatment.

If your doctor has prescribed you antibiotics amoxicillin and clarithromycin and Prenome to treat ulcers caused by Helicobacter pylori infection, it is very important that you inform your doctor about any other medicines you are taking.

Prenome with food and drink

See section 3.

Pregnancy, breastfeeding, and fertility

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.
Omeprazole passes into breast milk, but its effect on the baby is unlikely if the medicine is used at therapeutic doses. Whether a breastfeeding woman can take Prenome will be decided by the doctor.

Driving and using machines

Prenome should not affect your ability to drive or use machines. However, side effects such as dizziness and blurred vision (see section 4) may occur. If they do, you should not drive or operate machinery.

Prenome contains sucrose and sodium

Prenome contains sucrose. If you have been diagnosed with intolerance to some sugars, you should consult your doctor before taking the medicine.
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 directed by your doctor or pharmacist. If you are unsure, you should consult your doctor or pharmacist.
Your doctor will tell you how many capsules to take and for how long. This will depend on your health and age.
For doses other than 20 mg and 40 mg, capsules of 10 mg of other medicines containing omeprazole are available.
Dosing instructions are presented below.

Use in adults:

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

• If your doctor has found that your esophagus is slightly damaged, the recommended dose is 20 mg once a day for 4 to 8 weeks. Your doctor may recommend that you take a dose of 40 mg for another 8 weeks if your esophagus has not yet healed.
• The recommended dose after healing of the esophagus is 10 mg once a day.
• If your esophagus is not damaged, the usual 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. Your doctor may recommend that you take 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 a day for 4 weeks.

Treatment of gastric ulcers(gastric ulcers):

• The recommended dose is 20 mg once a day for 4 weeks. Your doctor may recommend that you take 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 a day for 8 weeks.

Prevention of duodenal and gastric ulcers:

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

Treatment of 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 ulcerswhen taking NSAIDs (non-steroidal anti-inflammatory drugs):

• The recommended dose is 20 mg once a day.

Treatment of ulcers caused by Helicobacter pylori infectionand prevention of their recurrence:

• The recommended dose of Prenome is 20 mg twice a day for one week.
• Your doctor will also prescribe you 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 per day.
• Your doctor will adjust the dose according to individual needs and decide how long you need to take the medicine.

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 will be determined individually by the doctor.

Treatment of ulcers caused by Helicobacter pylori infectionand prevention of their recurrence:

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

How to take the medicine

• It is recommended to take the capsules in the morning.
• The capsules can be taken with or without food.
• You should swallow the capsules whole, with half a glass of water. Do not chew or crush the capsules, as they contain enteric-coated pellets, whose coating prevents the medicine from being broken down by stomach acid. It is essential that the pellets are not damaged.

What to do if you have difficulty swallowing the capsules (in adults or children)

• If you have 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 applesauce.

Always mix the mixture just before drinking (the mixture will not be clear). Then drink the mixture immediately after preparation or within 30 minutes.
To ensure that you have taken the entire dose of the medicine, you should rinse the glass with half a glass of water and drink the liquid. The solid particles contain the medicine - do not chew or crush them.

Taking a higher dose of Prenome than recommended

If you have taken a higher dose of Prenome than prescribed by your doctor, you should contact your doctor or pharmacist immediately.

Missing a dose of Prenome

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

Stopping treatment with Prenome

You should not stop taking Prenome without consulting your doctor or pharmacist first.
If you have any further doubts about the use of this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

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

If you notice 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, stop taking Prenome and contact a 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 could 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 can be symptoms 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 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 disturbances (insomnia).
• Feeling dizzy, 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 1000 people):

• Blood problems, such as a reduced number of white blood cells or platelets. This can lead to weakness, easy bruising, or an increased risk of infection.
• Low sodium levels in the blood. This can lead to weakness, vomiting, and muscle cramps.
• Feeling agitated, confused, or depressed.
• Changes in taste.
• Vision problems, such as blurred vision.
• Sudden wheezing or shortness of breath (bronchospasm).
• Dry mouth.
• Mouth inflammation.
• Fungal infection, which can affect the intestines.
• Hair loss (alopecia).
• Skin rash in response 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 counts, 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.
• Multi-form erythema.
• Muscle weakness.
• Enlargement of the breasts in men.

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

• Colitis (leading to diarrhea).
• If you have taken Prenome for more than three months, there is a possibility of reduced magnesium levels in the blood. Low magnesium levels can cause fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, or rapid heartbeat. If you experience any of these symptoms, you should inform your doctor immediately. Low magnesium levels can lead to low potassium or calcium levels in the blood. Your doctor may recommend regular blood tests to monitor magnesium levels.
• Skin 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 you experience an infection with symptoms such as fever with severe deterioration of general well-being or fever with symptoms of local infection, such as pain in the neck, throat, or mouth, or difficulty urinating, you should consult your doctor as soon as possible to rule out a possible lack of white blood cells (agranulocytosis) based on blood test results. It is essential that you inform your doctor or pharmacist about the medicine you are taking.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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 Prenome

• The medicine should be stored out of the sight and reach of children.
• Do not use this medicine 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 package to protect from moisture.
• For PVC-PVDC/Al blisters: Store in a temperature below 25°C. Store in the original package to protect from moisture.
• For bottles: No special storage precautions are required. Shelf-life after first opening of the bottle: 100 days. Store the bottle tightly closed to protect from moisture.
• 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 Prenome contains

• The active substance of Prenome is omeprazole. Prenome gastro-resistant hard capsules contain 20 mg or 40 mg of omeprazole.
• Other ingredients are sucrose spheres (sucrose 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), 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 opaque, made of white hard gelatin, with the inscription "OM 20" and contain spherical pellets.
Prenome 40 mg capsules are opaque, made of white hard gelatin, with the inscription "OM 40" and contain spherical pellets.
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 authorized 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