RELUMO 20 mg Capsules

Contents of the leaflet

1. Leaflet accompanying the packaging: patient information
2. Relumo, 20 mg, gastro-resistant hard capsules
   1. Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
3. What is Relumo and what is it used for
4. Important information before taking Relumo
   1. When not to take Relumo
   2. Warnings and precautions
   3. Relumo with other medicines
   4. Relumo with food and drink
   5. Pregnancy, breastfeeding, and fertility
   6. Driving and using machines
   7. Relumo contains sucrose
   8. Relumo contains sodium
5. How to take Relumo
   1. How to take this medicine
   2. What to do if you have difficulty swallowing the capsules
   3. What to do if you take more Relumo than you should
   4. What to do if you forget to take Relumo
6. Possible side effects
   1. If you experience any of the following rare or very rare but serious side effects, stop taking Relumo and contact your doctor immediately:
   2. Common side effects (may affect up to 1 in 10 people)
   3. Uncommon side effects (may affect up to 1 in 100 people)
   4. Rare side effects (may affect up to 1 in 1,000 people)
   5. Very rare side effects (may affect up to 1 in 10,000 people)
   6. Frequency not known (frequency cannot be estimated from the available data)
   7. Reporting side effects
7. How to store Relumo
8. Contents of the pack and other information
   1. What Relumo contains:
   2. Marketing authorization holder and manufacturer
   3. Marketing authorization holder:
   4. Manufacturer:
   5. This medicine is authorized in the Member States of the European Economic Area under the following names:
   6. Date of last revision of the leaflet: 09/2024

Leaflet accompanying the packaging: patient information

Relumo, 20 mg, gastro-resistant hard capsules

Omeprazole

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in this patient leaflet or as directed by your doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or further information, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• If after 14 days there is no improvement or you feel worse, you should consult your doctor.

Table of contents of the leaflet

• 1. What is Relumo and what is it 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 is Relumo and what is it used for

Relumo 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. Relumo is used in adults for short-term treatment of symptoms of gastroesophageal reflux disease (e.g., heartburn, acid reflux). Reflux occurs when stomach acid flows back into the esophagus (the tube connecting the throat to the stomach), which can become inflamed and painful. This can cause symptoms such as a burning pain in the chest rising to the throat (heartburn) and a sour taste in the mouth (due to acid reflux). To relieve symptoms, it may be necessary to take capsules for 2-3 consecutive days.

2. Important information before taking Relumo

When not to take Relumo

• If you are allergic to omeprazole or any of the other ingredients of this medicine (listed in section 6).
• If you are allergic to medicines containing other proton pump inhibitors (e.g., pantoprazole, lansoprazole, rabeprazole, esomeprazole).
• If you are taking a medicine containing nelfinavir (used to treat HIV infection).

Do not take Relumo if any of the above situations apply to you. If in doubt, consult your doctor or pharmacist before taking Relumo.

Warnings and precautions

Before starting treatment with Relumo, consult your doctor or pharmacist. Serious skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug rash with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP) have been reported with Relumo treatment. If you notice any symptoms related to these serious skin reactions described in section 4, stop taking Relumo and seek medical help immediately. Do not take Relumo for more than 14 days without consulting your doctor. If there is no improvement and if symptoms worsen, consult your doctor. Relumo may mask the symptoms of other diseases. Therefore, if you experience any of the following conditions before or during treatment with Relumo, consult your doctor immediately:

• Unexplained weight loss and difficulty swallowing.
• Stomach pain or indigestion.
• Vomiting blood or black tarry stools.
• Severe or persistent diarrhea, as omeprazole is associated with a slight increase in the frequency of infectious diarrhea.
• Prior presence of stomach ulcers or gastrointestinal surgery.
• Continuous symptomatic treatment of indigestion or heartburn for 4 or more weeks.
• Persistent indigestion or heartburn for 4 or more weeks.
• Age over 55 and new or recently changed symptoms.
• Jaundice or severe liver dysfunction.
• Previous skin reaction after taking a medicine that reduces stomach acid.
• Before a specific blood test (chromogranin A levels).

Patient should not take omeprazole as a preventive measure. If a skin rash appears, especially in areas exposed to sunlight, tell your doctor as soon as possible, as it may be necessary to interrupt treatment with Relumo. Also, inform your doctor about any other side effects, such as joint pain. During omeprazole treatment, 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 doctor.

Relumo with other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, including those obtained without a prescription. This is important because Relumo may affect the way some other medicines work, and some other medicines may affect the way Relumo works. Do not take Relumo if you are taking a medicine containing nelfinavir (used to treat 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 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 or stopping Relumo.
• Medicines used to reduce blood clotting, such as warfarin or other vitamin K antagonists. Your doctor will need to monitor your 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 to treat cancer)
• Methotrexate (a chemotherapy medicine used to treat cancer) - if you are taking high doses of methotrexate, your doctor may temporarily stop Relumo treatment.

Relumo 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 when the medicine is used at therapeutic doses. Whether a breastfeeding woman can take Relumo will be decided by the doctor.

Driving and using machines

Relumo does not affect the ability to drive or use machines. However, side effects such as dizziness and blurred vision (see section 4) may occur. If they do, do not drive or use machines.

Relumo contains sucrose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Relumo contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per dose, which means it is essentially 'sodium-free'.

3. How to take Relumo

This medicine should always be taken exactly as described in this patient leaflet or as directed by your doctor or pharmacist. If you are in doubt, consult your doctor or pharmacist. The recommended dose is one 20 mg capsule per day for 14 days. If symptoms do not improve after this time, consult your doctor. To relieve symptoms, it may be necessary to take capsules for 2-3 consecutive days.

How to take this 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 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 important that the pellets are not damaged.

What to do if you have difficulty swallowing the capsules

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 take the entire dose, 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.

What to do if you take more Relumo than you should

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

What to do if you forget to take Relumo

If you forget to take 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 forgotten dose. If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

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

If you experience any of the following rare or very rare but serious side effects, stop taking Relumo and contact your 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. Blisters or bleeding in the area of the lips, eyes, mouth, nose, and genitals may also appear. 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 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).
• Nausea or vomiting.
• Mild stomach polyps.

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

• Swelling of the feet and ankles.
• Sleep disorders (insomnia).
• Dizziness, tingling, or numbness, feeling sleepy.
• Feeling of spinning (dizziness).
• 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 can lead to weakness, bruising, or 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 can lead to weakness, vomiting, and 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.
• A fungal infection called "thrush" that 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.
• Acute generalized exanthematous pustulosis (AGEP), drug rash with eosinophilia and systemic symptoms (DRESS).
• 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 are not there (hallucinations).
• Severe liver problems leading to liver failure and brain disease.
• Sudden onset of a severe rash or blistering of the skin, or peeling of the skin. 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 the available data)

• -Inflammation of the intestines (causing diarrhea).
• -Low magnesium levels in the blood.
• Rash that may be associated with joint pain.

In very rare cases, Relumo 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 a serious deterioration in general health or fever with local infection symptoms, such as sore throat, or mouth and throat ulcers, consult your doctor as soon as possible to rule out a lack of white blood cells (agranulocytosis) based on blood test results. It is important that you inform your doctor or pharmacist that you are taking Relumo.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, 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, you can help provide more information on the safety of this medicine.

5. How to store Relumo

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

6. Contents of the pack and other information

What Relumo contains:

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

Relumo looks like a hard gelatin capsule, size "4" (about 14.3 mm ± 0.3 mm), with a blue cap and a white body, containing white to off-white or cream-colored spherical pellets. The gastro-resistant hard capsules are supplied in blisters of PVC/PE/PVDC/Aluminum containing 7 and 14 capsules; and in HDPE bottles containing 7 and 14 capsules, in a cardboard box. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Medreg s.r.o.
Na Florenci 2116/15
Nové Město
110 00 Praga 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 medicine is authorized in the Member States of the European Economic Area under the following names:

Czech Republic:
Relumo
Poland:
Relumo

Date of last revision of the leaflet: 09/2024