Prenome

Package leaflet: Information for the user

Prenome, enteric hard capsules, 20 mg
Prenome, enteric hard capsules, 40 mg
Omeprazole
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. Do not pass it on to others. It may harm them even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Contents of the leaflet

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

Prenome contains the active substance called 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.
Prenome is used to treat the following conditions:

In adults:

• Gastro-oesophageal reflux disease (GERD). This is when acid from the stomach flows back into the oesophagus (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 in the stomach (gastric ulcers).
• Ulcers infected with bacteria called "Helicobacter pylori". In such cases, your doctor may also prescribe antibiotics to eliminate the infection and allow the ulcers to heal.
• Ulcers caused by non-steroidal anti-inflammatory drugs (NSAIDs). Prenome may also be used to prevent ulcers from developing during NSAID treatment.
• Excess acid in the stomach due to a growth in the pancreas (Zollinger-Ellison syndrome).

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

• Gastro-oesophageal reflux disease (GORD). This is when acid from the stomach flows back into the oesophagus, causing pain, inflammation and heartburn. In children, symptoms may include regurgitation of stomach contents into the mouth (spitting up, vomiting), vomiting, and poor weight gain.

Children and adolescents above 4 years of age

• Ulcers infected with bacteria called "Helicobacter pylori". If your child has this condition, 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 had an allergic reaction 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 Prenome if any of the above apply to the patient.
If in doubt, speak to your doctor or pharmacist before starting treatment with Prenome.
Warnings and precautions
Talk to your doctor or pharmacist before taking Prenome.
Severe skin reactions have been reported with Prenome treatment, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), and acute generalized exanthematous pustulosis (AGEP).
If you notice any symptoms related to these severe skin reactions described in section 4, stop taking Prenome immediately and seek medical help without delay.

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

• Unexplained weight loss and difficulty swallowing.
• Stomach pain or indigestion.
• Vomiting food or blood.
• Passing black stools (blood in the stool).
• Severe or persistent diarrhoea, as use of omeprazole is associated with a small increased risk of infectious diarrhoea.
• Severe liver problems.
• If the patient has ever had a skin reaction while taking a medicine similar to Prenome that reduces stomach acid secretion.
• Regarding a planned specific blood test (chromogranin A levels).

If Prenome is taken long-term (for more than 1 year), the patient will likely require regular medical monitoring. Report any new or unusual symptoms or circumstances during visits to your doctor.
Taking a proton pump inhibitor such as Prenome, especially for over a year, may slightly increase the risk of fractures of the hip, wrist, or spine. Inform your doctor if you have osteoporosis or if you are taking corticosteroids (which may increase the risk of osteoporosis).
Kidney inflammation may occur during omeprazole treatment. Symptoms may include reduced urine volume or blood in the urine and/or allergic reactions such as fever, rash, and joint stiffness. Patients should report such symptoms to their doctor.
This medicine may affect vitamin B\textsubscript{12} absorption, particularly if taken for a long time. Contact your doctor if any of the following symptoms occur, which may indicate low vitamin B\textsubscript{12} levels:

• extreme tiredness or lack of energy;
• tingling and numbness;
• sore or red tongue, mouth ulcers;
• muscle weakness;
• vision disturbances;
• memory problems, confusion, depression.

If a skin rash develops, especially in areas exposed to sunlight, inform your doctor as soon as possible, as discontinuation of Prenome may be necessary. Also report any other adverse effects such as joint pain.
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 with body weight < 10 kg.
Prenome and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take. This includes medicines available without a prescription. This is important because Prenome may affect how some other medicines work, and some other medicines may affect how Prenome works.
Do not take Prenome if you are taking a medicine containing nelfinavir (used in the treatment of HIV infection).
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 disorders).
• Diazepam (used to treat anxiety, reduce muscle tension, or 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 after 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 in the treatment of malignant tumours.
• Methotrexate (a chemotherapy medicine used in high doses to treat cancer) – if high-dose methotrexate is being taken, the doctor may temporarily discontinue treatment with Prenome.

If your doctor has prescribed amoxicillin and clarithromycin together with 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, breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before taking this medicine.
Omeprazole passes into breast milk, but its effect on the infant is unlikely when used at therapeutic doses. Whether a breastfeeding woman can take Prenome will be decided by the doctor.
Driving and using machines
Prenome is unlikely to affect the ability to drive or operate machinery. However, adverse effects such as dizziness and visual disturbances may occur (see section 4). If these occur, do not drive or operate mechanical equipment.
Prenome contains sucrose and sodium
Prenome contains sucrose. If the patient has been previously diagnosed with an intolerance to certain sugars, consult your doctor before taking this medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per capsule, meaning the medicine is considered "sodium-free".

3. How to take Prenome

This medicine should always be taken as directed by your doctor or pharmacist. If in
doubt, consult your doctor or pharmacist.
Your doctor will inform you how many capsules to take and for how long. This will
depend on your medical condition and age.
For doses other than 20 mg and 40 mg, 10 mg capsules of other medicines containing
omeprazole are available.
Dosage recommendations are provided below.

Use in adults:
Treatment of symptoms of GORD, such as heartburn and acid regurgitation:

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

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

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

Treatment of gastric ulcers (ulcers in the stomach):

• The recommended dose is 20 mg once daily for 4 weeks. Your doctor may recommend continuing the same dose for another 4 weeks if the ulcers have not healed by then.
• If the ulcer does not heal completely, the dose may be increased to 40 mg once daily for 8 weeks.

Prevention of recurrence of duodenal and gastric ulcers:

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

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

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

Prevention of recurrence of duodenal and gastric ulcers during treatment with NSAIDs (non-steroidal anti-inflammatory drugs):

• The recommended dose is 20 mg once daily.

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

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

Treatment of excessive acid secretion in the stomach caused by pancreatic tumour (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 the treatment should continue.

Use in children and adolescents
Treatment of symptoms of GORD, such as heartburn and acid regurgitation:

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

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

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

Instructions for taking the medicine

• It is recommended to take the capsules in the morning.
• The capsules may be taken with food or on an empty stomach.
• Swallow the capsules whole with half a glass of water. Do not chew or crush the capsules, as they contain coated pellets designed to protect the medicine from breakdown by stomach acid. It is important that the pellets remain intact.

What to do 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 a glass of water, or mix the contents into a glass of non-carbonated water, any acidic fruit juice (e.g. apple, orange, or pineapple juice), or apple puree.
• Always mix the preparation immediately before drinking (the mixture will not be clear). Drink the mixture immediately after preparation or within 30 minutes.
• To ensure the patient receives the full dose, thoroughly rinse the glass with half a glass of water and drink this liquid. The solid particles contain the medicine – do not chew or crush them.

If you take more Prenome than prescribed
If you take more Prenome than prescribed by your doctor, contact your doctor or pharmacist immediately.

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

Stopping Prenome treatment
Do not stop taking Prenome without first consulting your doctor or pharmacist.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If you notice any of the following rare (may affect up to 1 in
1,000 people) or very rare (may affect up to 1 in 10,000 people) but serious side effects,
discontinue taking Prenome immediately and contact your doctor without delay:

• Sudden wheezing, swelling of the lips, tongue or throat, or body, rash, fainting or difficulty swallowing (severe allergic reaction). (rare)
• Skin redness with blister formation or peeling. Large blisters and bleeding around the lips, eyes, mouth, nose and genital organs may also occur. This may be Stevens-Johnson syndrome or toxic epidermal necrolysis. (very rare)
• Widespread rash, high fever and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome). (rare)
• Red, scaly, widespread rash with subcutaneous nodules 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 adverse reactions include:
Common adverse reactions (may affect up to 1 in 10 people)

• Headache.
• Effects on stomach or intestines: diarrhoea, stomach pain, constipation, gas (bloating).
• Nausea or vomiting.
• Benign gastric polyps.

Uncommon adverse reactions (may affect up to 1 in 100 people)

• Swelling of feet and ankles.
• Sleep disturbance (insomnia).
• Dizziness, tingling and pricking sensation, drowsiness.
• Sensation of spinning (dizziness).
• Changes in liver function test results.
• Skin rash, nodular rash (urticaria), and skin itching.
• General malaise and lack of energy.

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

• Blood disorders such as reduced number of white blood cells or platelets. This may lead to weakness, easier bruising or increased likelihood of infection.
• Low blood sodium levels. This may lead to weakness, vomiting and muscle cramps.
• Feeling of restlessness, confusion or depression.
• Altered sense of taste.
• Vision problems such as blurred vision.
• Sudden sensation of wheezing or shortness of breath (bronchospasm).
• Dryness of the mouth.
• Inflammation of the mucous membrane of the mouth.
• Fungal infection known as "thrush", which may affect the intestines and is caused by fungi.
• Hair loss (alopecia).
• Skin rash occurring during exposure to sunlight.
• Joint pain (arthralgia) or muscle pain (myalgia).
• Severe kidney problems (interstitial nephritis).
• Increased sweating.

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

• Blood count abnormalities 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.
• Erythema multiforme.
• Muscle weakness.
• Breast enlargement in men.

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

• Inflammation of the intestines (leading to diarrhoea).
• If Prenome has been taken for longer than three months, there may be a decrease in blood magnesium levels. Low magnesium levels may present as fatigue, involuntary muscle contractions, disorientation, seizures, dizziness or rapid heartbeat. If any of these symptoms occur, inform your doctor immediately. Low magnesium levels may lead to reduced potassium or calcium levels in the blood. Your doctor may recommend regular blood tests to monitor magnesium levels.
• Rash possibly accompanied by joint pain.

In very rare cases, Prenome may affect the number of white blood cells in the blood, leading to immunodeficiency. If a patient develops an infection with symptoms such as fever accompanied by severe deterioration in general condition or fever with local infection signs such as neck, throat or mouth pain or difficulty urinating, medical advice should be sought 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.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the 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.
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Prenome

• Keep this medicine 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 stated month.
• For Al/Al blisters: Store below 30°C. Keep in the original packaging to protect from moisture.
• For PVC-PVDC/Al blisters: Store below 25°C. Keep in the original packaging to protect from moisture.
• For bottles: No special storage temperature requirements. Shelf life after first opening of the bottle: 100 days. Keep the bottle tightly closed to protect from moisture.
• Medicines must 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 package and other information

What Prenome contains

• The active substance is omeprazole. Prenome enteric capsules, hard, containing 20 mg or 40 mg of omeprazole.
• Other ingredients are sucrose pellets (sucrose and corn 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 shell: gelatin, titanium dioxide (E-171), printing ink (black iron oxide (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,
printed with "OM 20" and contain spherical granules.
Prenome 40 mg capsules are opaque, made of white hard gelatin,
printed with "OM 40" and contain spherical granules.
White HDPE bottle with cap and tamper-evident ring closure,
with a moisture-absorbing insert: 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 Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Mercapharm Sp. z o.o.
Świętopełka 39
81-524 Gdynia, Poland
Manufacturer:
TOWA Pharmaceutical Europe, S.L.
C/ de Sant Martí, 75-97
Martorelles, 08107 Barcelona - Spain

This medicinal product has been authorised in EEA countries under the following names:
Belgium: Prenome 10, 20, 40 mg gastro-resistant capsule
Spain: Omeprazol ABDrug 20, 40 mg hard gastro-resistant capsule
Netherlands: Prenome 10, 20, 40 mg hard gastro-resistant capsule
Poland: Prenome
Romania: Prenome 10, 20, 40 mg gastro-resistant capsule
United Kingdom: Omeprazole 10, 20 & 40 mg hard gastro-resistant capsule