Relumo

Package leaflet: Information for the patient

Relumo, 20 mg, enteric hard capsules
Omeprazolum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.
This medicine should always be taken exactly as described in this patient leaflet or as directed by
the doctor or pharmacist.

• Keep this leaflet so that it can be read again if necessary.
• If advice or further information is needed, please contact the pharmacist.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform the doctor or pharmacist. See section 4.
• If there is no improvement after 14 days, or if the patient feels worse, contact the doctor.

Table of contents of the leaflet

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

1. What Relumo is and what it is used for

Relumo contains the active substance omeprazole. It belongs to a group of medicines called "proton pump inhibitors". These medicines work by reducing the amount of hydrochloric acid produced in the stomach.
Relumo is used in adults for the short-term treatment of symptoms of gastro-oesophageal reflux disease (e.g. heartburn, regurgitation of acidic stomach contents).
Reflux refers to the backflow of acid from the stomach into the oesophagus (the tube connecting the throat to the stomach), which may become inflamed and painful. This may cause symptoms such as a burning pain in the chest rising up towards the throat (heartburn) and a sour taste in the mouth (due to regurgitation of acidic contents).
For symptom relief, it may be necessary to take the capsules for 2-3 consecutive days.

2. Important information before using Relumo

When not to use Relumo

• If the patient is allergic to omeprazole or any of the other ingredients of this medicine (listed in section 6).
• If the patient is allergic 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).

Relumo should not be taken if any of the above situations apply. If in doubt, discuss this with a doctor or pharmacist before taking Relumo.

Warnings and precautions

Before starting treatment with Relumo, consult a doctor or pharmacist.

Severe skin reactions have been reported with Relumo treatment, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), and acute generalized exanthematous pustulosis (AGEP). If any symptoms related to these severe skin reactions described in section 4 occur, treatment with Relumo should be discontinued immediately and medical help should be sought without delay.

Do not take Relumo for longer than 14 days without consulting a doctor. If there is no improvement in symptoms, or if symptoms worsen, consult a doctor.

Relumo may mask symptoms of other diseases. Therefore, if any of the following conditions occur before or during treatment with Relumo, contact a doctor immediately:

• Unexplained weight loss and difficulty swallowing.
• Stomach pain or indigestion.
• Vomiting food or blood.
• Passing black stools (stools discolored by blood).
• Severe or persistent diarrhoea, as use of omeprazole is associated with a small increased risk of infectious diarrhoea.
• Previous history of gastric ulcer or gastrointestinal surgery.
• Continuous symptomatic treatment of indigestion or heartburn for 4 or more weeks.
• Ongoing indigestion or heartburn lasting 4 or more weeks.
• Age over 55 years and new onset of symptoms or recent change in existing symptoms.
• Development of jaundice or severe liver function impairment.
• Previous skin reaction due to use of a medicine similar to Relumo that reduces gastric acid secretion.
• Prior to a specific blood test (chromogranin A levels).

Patients should not take omeprazole preventively.

If a skin rash develops, especially in areas exposed to sunlight, the patient should inform the doctor as soon as possible, as treatment with Relumo may need to be discontinued. Inform the doctor about any other adverse reactions, such as joint pain.

Interstitial nephritis (inflammation of the kidneys) 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.

Relumo with other medicines

Tell the doctor or pharmacist about all medicines currently or recently taken, as well as any medicines the patient plans to take. This includes medicines available without a prescription. This is important because Relumo may affect the action of certain other medicines, and some other medicines may affect the action of Relumo.

Do not take Relumo if the patient is taking a medicine containing nelfinavir (used in the treatment of HIV infection).

Inform the doctor or pharmacist if the patient is 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, to reduce muscle tension, or in epilepsy treatment)
• Phenytoin (used in epilepsy treatment). If the patient is taking phenytoin, the doctor will need to monitor the patient’s condition when starting or stopping Relumo.
• 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 Relumo.
• 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 in the treatment of cancer)
• Methotrexate (a chemotherapeutic agent used in high doses for cancer treatment) – if the patient is taking high doses of methotrexate, the doctor may temporarily discontinue treatment with Relumo.

Relumo with food and drink

See section 3.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a 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 decision on whether a breastfeeding woman can take Relumo will be made by the doctor.

Driving and using machines

Relumo has no influence on the ability to drive or use tools and machines. However, adverse reactions such as dizziness and visual disturbances may occur (see section 4). If these occur, the patient should not drive or operate machinery.

Relumo contains sucrose

If the patient has been previously diagnosed with an intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

Relumo contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. the medicine is considered "sodium-free".

3. How to use Relumo

This medicine should always be taken exactly as described in this patient information leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
The recommended dose is one 20 mg capsule once daily for 14 days. If symptoms do not resolve after this time, contact your doctor.
To relieve symptoms, it may be necessary to take capsules for an additional 2–3 consecutive days.

How to take this medicine

• It is recommended to take the capsules in the morning.
• 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. The coating prevents the drug from being broken down by stomach acid. It is important that the pellets remain undamaged.

What to do if you have difficulty swallowing capsules
If a patient has difficulty swallowing capsules:

• Open the capsule and swallow the contents directly with a glass of water, or mix the contents with a glass of still water, any acidic fruit juice (e.g. apple, orange or pineapple juice), or with apple puree.
• Always mix the preparation immediately before taking (the mixture will not be clear). Then drink the mixture immediately after preparation or within 30 minutes.
• To ensure the patient has taken the full dose of medicine, rinse the glass thoroughly with half a glass of water and drink this liquid. The solid particles contain the active substance – do not chew or crush them.

Taking more Relumo than recommended
If you take more Relumo than recommended, contact your doctor or pharmacist immediately.

Missed dose of Relumo
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 missed one.

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 the patient experiences any of the following rare or very rare but serious adverse reactions,
treatment with Relumo must be discontinued immediately and medical advice must be sought
without delay:

• Sudden wheezing, swelling of the lips, tongue or throat, rash, fainting or difficulty swallowing (severe allergic reaction) (rare).
• Redness of the skin with blister formation or skin peeling. Large blisters and bleeding around the lips, eyes, mouth, nose or 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).
• Widespread, scaly, red 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 indicate liver problems (rare).

Other adverse reactions include:
Common adverse reactions (may affect up to 1 in 10 patients)

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

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

• Swelling of the feet and ankles.
• Sleep disturbances (insomnia).
• Dizziness, tingling or pricking sensations, drowsiness.
• Sensation of spinning (vertigo).
• Changes in liver function test results.
• Skin rash, nodular rash (urticaria) and itching.
• General malaise and lack of energy.

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

• Blood disorders such as reduced white blood cell or platelet counts. This may lead to weakness, bruising or increased risk of infections.
• Allergic reactions, sometimes severe, including swelling of the lips, tongue and throat, fever, wheezing.
• Low blood sodium levels. This may lead to weakness, vomiting and seizures.
• Feeling of restlessness, disorientation or depression.
• Altered sense of taste.
• Vision problems such as blurred vision.
• Sudden wheezing or shortness of breath (bronchospasm).
• Dry mouth.
• Inflammation of the mucous membrane of the mouth.
• Fungal infection known as "thrush", which may affect the intestines.
• 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.
• Acute generalized exanthematous pustulosis (AGEP), drug reaction with eosinophilia and systemic symptoms (DRESS syndrome).
• Joint pain (arthralgia) or muscle pain (myalgia).
• Severe kidney function disorders (interstitial nephritis).
• Increased sweating.

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

• Blood count abnormalities including agranulocytosis (absence 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 onset of severe rash, blistering or skin 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.

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

• Inflammation of the intestine (causing diarrhoea).
• Low blood magnesium levels.
• Rash that may be accompanied by joint pain.

In very rare cases, Relumo 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 a significant deterioration in general condition, or fever with local signs of infection such as pain in the neck, throat or mouth, or difficulty urinating, medical advice must be sought as soon as possible to rule out possible white blood cell deficiency (agranulocytosis), confirmed by blood tests. 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 adverse reactions not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at 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 authorisation holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Relumo

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton, bottle, or blister pack
after: EXP. The expiry date refers to the last day of the stated month.
Blister: Store below 25°C.
Keep in the original packaging to protect from moisture.
Bottle: No special storage temperature requirements.
Keep in the original packaging 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 package and other information

What Relumo contains:

• The active substance is omeprazole. Each 20 mg enteric hard capsule contains 20 mg of omeprazole.
• The other ingredients are sucrose, pellets (consisting of maize starch and sucrose), magnesium hydroxide (containing maize starch), disodium phosphate, hypromellose 2910, sodium lauryl sulfate, mannitol, sodium carboxymethyl starch (type A), talc, titanium dioxide (E 171), macrogol 6000, polysorbate 80, methacrylic acid and ethyl acrylate copolymer (1:1), 30% dispersion (solid substance), gelatin, indigo carmine (E 132).

What Relumo looks like and contents of the pack

Hard gelatin capsule size "4" (approximately 14.3 mm ± 0.3 mm), with a blue cap and a white body, containing white to off-white or cream-colored spherical pellets.

Enteric hard capsules (enteric capsules) are supplied in PVC/PE/PVDC/Aluminium foil blisters containing 7 and 14 capsules; and in HDPE bottles containing 7 and 14 capsules, packed in a cardboard box.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:
Medreg s.r.o.
Na Florenci 2116/15
Nové Město
110 00 Prague 1
Czech Republic
Tel.: (+420) 516 770 199

Manufacturer:
Medis International a.s.
Výrobní závod Bolatice
Průmyslová 961/16
747 23 Bolatice
Czech Republic

This medicinal product is authorised in the European Economic Area countries under the following names:
Czech Republic: Relumo
Poland: Relumo