SAGALIX 10 mg Capsules

Contents of the leaflet

1. Leaflet accompanying the packaging: patient information
2. Sagalix, 10 mg, gastro-resistant hard capsules
3. Sagalix, 20 mg, gastro-resistant hard capsules
4. Sagalix, 40 mg, gastro-resistant hard capsules
   1. You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
5. What is Sagalix and what is it used for
6. Important information before taking Sagalix
   1. When not to take Sagalix
   2. Warnings and precautions
   3. Children
   4. Sagalix and other medicines
   5. Sagalix with food and drink
   6. Pregnancy, breastfeeding, and fertility
   7. Driving and using machines
   8. Sagalix contains sucrose and sodium
7. How to take Sagalix
   1. Use in adults:
   2. Use in children and adolescents
   3. Taking this medicine
   4. What to do if an adult or child has difficulty swallowing the capsules
   5. Taking more Sagalix than prescribed
   6. Missing a dose of Sagalix
   7. Stopping Sagalix treatment
8. Possible side effects
   1. 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 Sagalix 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 1000 people)
   5. Very rare side effects (may affect up to 1 in 10,000 people)
   6. Side effects with unknown frequency (frequency cannot be estimated from available data)
   7. Reporting side effects
9. How to store Sagalix
10. Contents of the packaging and other information
    1. What Sagalix contains
    2. What Sagalix looks like and contents of the pack
    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. Ireland
    7. Romania
    8. Poland
    9. Portugal
    10. Date of last revision of the leaflet:

Leaflet accompanying the packaging: patient information

Sagalix, 10 mg, gastro-resistant hard capsules

Sagalix, 20 mg, gastro-resistant hard capsules

Sagalix, 40 mg, gastro-resistant hard capsules

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 Sagalix and what is it used for
• 2. Important information before taking Sagalix
• 3. How to take Sagalix
• 4. Possible side effects
• 5. How to store Sagalix
• 6. Contents of the packaging and other information

1. What is Sagalix and what is it used for

Sagalix contains the active substance omeprazole. It belongs to a group of medicines called "proton pump inhibitors". They reduce the amount of acid produced by the stomach.

Sagalix is used to treat the following conditions:

In adults:

• "Gastro-esophageal reflux disease" (GERD). GERD causes stomach acid to flow 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 ulcer) or stomach (gastric ulcer).
• Ulcers infected with bacteria called "Helicobacter pylori". In such cases, the doctor may also prescribe antibiotics to cure the infection and allow the ulcer to heal.
• Ulcers caused by medicines called non-steroidal anti-inflammatory drugs (NSAIDs). Sagalix may also be used to prevent ulcers from forming if the patient is taking NSAIDs.
• Excessive stomach acid caused by a tumor in the pancreas (Zollinger-Ellison syndrome).

In children:

Children over 1 year of age and weighing 10 kg or more

• "Gastro-esophageal reflux disease" (GERD). GERD causes stomach acid to flow back into the esophagus (the tube connecting the throat to the stomach), causing pain, inflammation, and heartburn.
• In children, symptoms of this condition may include reflux of stomach contents into the mouth (regurgitation), nausea (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 prescribe antibiotics to cure the infection and allow the ulcers to heal.

2. Important information before taking Sagalix

When not to take Sagalix

• 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 medicines containing nelfinavir (used to treat HIV infection).

Do not take Sagalix if any of the above statements apply to you. If in doubt, consult a doctor or pharmacist before taking Sagalix.

Warnings and precautions

Before taking Sagalix, consult a doctor or pharmacist.

Omeprazole has been associated with severe skin reactions, 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 severe skin reactions, as described in section 4, stop taking Sagalix and seek medical help immediately.

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

• Unexplained significant weight loss and difficulty swallowing.
• Abdominal pain or indigestion.
• Vomiting blood or food.
• Black stools (stool with blood).
• Severe or persistent diarrhea, as omeprazole use is associated with a slight increase in the frequency of infectious diarrhea.
• The patient has severe liver dysfunction.
• A skin reaction has occurred after treatment with a medicine that reduces stomach acid.
• A specific blood test (chromogranin A) is planned.

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. The patient should report such symptoms to their doctor.

With long-term use of Sagalix (more than 1 year), regular medical check-ups are likely to be necessary. During each visit to the doctor, the patient should report any new or unusual symptoms and circumstances.

Taking a proton pump inhibitor like Sagalix, especially for a period longer than 1 year, may slightly increase the risk of hip, wrist, or spine fractures. The patient should inform their doctor if they have osteoporosis or are taking corticosteroids (which may increase the risk of osteoporosis).

If the patient experiences a skin rash, especially in areas exposed to sunlight, they should inform their doctor as soon as possible, as it may be necessary to stop Sagalix treatment. The patient 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. Do not give this medicine to children under 1 year of age or weighing less than 10 kg.

Sagalix and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take, including those that can be obtained without a prescription. This is important because Sagalix may affect the way some other medicines work, and some other medicines may affect the way Sagalix works.

Do not take Sagalix if you are taking medicines containing nelfinavir (used to treat HIV infection).

Tell 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 relax muscles, or in epilepsy)
• Phenytoin (used in epilepsy). If you are taking phenytoin, medical monitoring may be necessary at the start or end of Sagalix treatment
• Blood-thinning medicines, such as warfarin or other vitamin K antagonists. Medical monitoring may be necessary at the start or end of Sagalix treatment
• Rifampicin (used to treat tuberculosis)
• Atazanavir (used to treat HIV infection)
• Tacrolimus (used in organ transplants)
• 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 (chemotherapy, used in high doses to treat cancer) - if you are taking high doses of methotrexate, your doctor may temporarily stop Sagalix treatment

If your doctor has prescribed antibiotics amoxicillin and clarithromycin, and Sagalix to treat ulcers caused by Helicobacter pyloriinfection, it is very important to tell your doctor about all the medicines you are taking.

Sagalix 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 it is unlikely to affect the baby at therapeutic doses. The doctor will decide whether you can take Sagalix if you are breastfeeding.

Driving and using machines

Sagalix is unlikely to affect your ability to drive or use tools or machines. Side effects such as dizziness and blurred vision (see section 4) may occur. In such cases, do not drive or use machines.

Sagalix contains sucrose and sodium

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

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

3. How to take Sagalix

This medicine should always be taken as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.

Your doctor will tell you how many capsules to take and for how long. This will depend on your condition and age.

Recommended doses are given below.

Use in adults:

For the treatment of GERD symptoms, such as heartburn and acid reflux:

• If the doctor finds that the esophagus is slightly damaged, the recommended dose is 20 mg once daily for 4-8 weeks. The doctor may recommend taking a dose of 40 mg for another 8 weeks if the esophagus has not yet healed.
• The recommended dose after esophageal healing is 10 mg once daily.
• If the esophagus is not damaged, the usual dose is 10 mg once daily.

For the treatment of duodenal ulcers:

• The recommended dose is 20 mg once daily for 2 weeks. The doctor may recommend taking the same dose for another 2 weeks if the ulcer has not yet healed.
• If the ulcers do not heal completely, the dose may be increased to 40 mg once daily for 4 weeks.

For the treatment of gastric ulcers:

• The recommended dose is 20 mg once daily for 4 weeks. The doctor may recommend taking the same dose for another 4 weeks if the ulcers have not yet healed.
• If the ulcers do not heal completely, the dose may be increased to 40 mg once daily for 8 weeks.

To prevent duodenal and gastric ulcers:

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

For the treatment of ulcers caused by NSAIDs:

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

To prevent duodenal and gastric ulcersif you are taking NSAIDs:

• The recommended dose is 20 mg once daily.

For the treatment of ulcers caused by Helicobacter pylori infection:

• The recommended dose is 20 mg of Sagalix twice daily for 1 week.
• The doctor will also prescribe two antibiotics: amoxicillin and (or) clarithromycin and (or) metronidazole.

For the treatment of excessive stomach acid caused by a tumor in the pancreas (Zollinger-Ellison syndrome):

• The recommended dose is 60 mg daily.
• The doctor will adjust the dose according to needs and decide how long to take the medicine.

Use in children and adolescents

For the treatment of GERD symptoms, such as heartburn and acid reflux:

• Children over 1 year of age and weighing more than 10 kg can take Sagalix. The dose for children depends on the child's weight, and the doctor will decide on the appropriate dose.

For the treatment of ulcers caused by Helicobacter pylori infection:

• Children over 4 years of age can take Sagalix. The dose for children depends on the child's weight, and the doctor will decide on the appropriate dose.
• The doctor will also prescribe two antibiotics: amoxicillin and clarithromycin.

Taking this medicine

• It is recommended to take the capsules in the morning.
• The capsules can be taken with or without food.
• Swallow the capsules whole with half a glass of water. Do not chew or crush the capsules. This is because the capsules contain enteric-coated pellets that prevent the medicine from being broken down by stomach acid. It is important not to damage the pellets.

What to do if an adult or child has difficulty swallowing the capsules

If an adult or child has difficulty swallowing the capsules:

• Open the capsules and swallow the contents directly, washing it down with half a glass of water, or pour the contents into a glass of non-carbonated water, any acidic fruit juice (e.g., apple, orange, or grapefruit), or apple sauce.
• Always mix the mixture just before drinking (the mixture will not be clear). Then drink the mixture immediately or within 30 minutes of preparation.
• To ensure that all the medicine is taken, rinse the glass with half a glass of water and drink. The solid particles contain the medicine - do not chew or crush them.

Taking more Sagalix than prescribed

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

Missing a dose of Sagalix

If you miss a dose, take it as soon as possible. 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 dose.

Stopping Sagalix treatment

Do not stop taking Sagalix without consulting your doctor or pharmacist first. If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Sagalix 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 Sagalix and contact your doctor immediately:

contact your doctor immediately:

• Sudden wheezing, swelling of the lips, tongue, and throat or body, rash, fainting, or difficulty swallowing (severe allergic reaction). (rare)
• Redness of the skin with blisters or peeling. Large blisters and bleeding in the lips, eyes, mouth, nose, and genitals may also occur. These could be symptoms of Stevens-Johnson syndrome or toxic epidermal necrolysis. (very rare)
• Widespread rash, high temperature, and enlarged lymph nodes (DRESS or drug hypersensitivity syndrome). (rare)
• Red, lumpy, widespread rash with blisters under the skin and fever, which usually appears in the first few days of treatment (acute generalized exanthematous pustulosis). (rare)
• Yellow skin, dark urine, and tiredness, 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, bloating with gas.
• Nausea (nausea) or vomiting.
• Mild stomach polyps.

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

• Swelling of the feet and ankles.
• Sleep disturbances (insomnia).
• Dizziness, tingling, numbness, drowsiness.
• Feeling of spinning (dizziness).
• Changes in blood tests that check liver function.
• Skin rash, lumpy rash (hives), and itchy skin.
• Feeling unwell and lacking energy.

Rare side effects (may affect up to 1 in 1000 people)

• Blood disorders, such as a reduced number of white blood cells or platelets. This can cause weakness, bruising, or increase the risk of infection.
• Low sodium levels in the blood. This can cause 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.
• A fungal infection called "thrush", which can affect the intestines and is caused by fungi.
• Hair loss (alopecia).
• Skin rash after exposure 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 tests, 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.
• Multi-form erythema.
• Muscle weakness.
• Enlarged breasts in men.

Side effects with unknown frequency (frequency cannot be estimated from available data)

• Intestinal inflammation (leading to diarrhea).
• If you take Sagalix for more than three months, it is possible that the level of magnesium in your blood may decrease. Low magnesium levels can cause fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, or increased heart rate. If you experience any of these symptoms, inform your doctor immediately. Low magnesium levels can also lead to low potassium or calcium levels in the blood. Your doctor may decide to perform regular blood tests to monitor magnesium levels.
• A rash that may be accompanied by joint pain.

Omeprazole can very rarely affect the number of white blood cells, leading to a lack of immunity. If you experience an infection with symptoms such as fever with a severely deteriorated general condition or fever with local infection symptoms, such as neck, throat, or mouth pain, or difficulty urinating, consult your doctor as soon as possible to rule out a lack of white blood cells (agranulocytosis) with a blood test.

It is essential to inform your doctor that you are taking Sagalix in such cases.

Reporting side effects

If you experience any side effects, including any side effects 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 Sagalix

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the carton, blister, and bottle label after "EXP". The expiry date refers to the last day of the month stated.

Blister pack (PVC/PE/PVDC/Aluminum): Store below 25°C; store in the original packaging to protect from moisture.

HDPE bottles: No special storage precautions for the medicinal product; 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 that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Sagalix contains

• The active substance of Sagalix is omeprazole. The gastro-resistant hard capsules of Sagalix contain 10 mg, 20 mg, or 40 mg of omeprazole.
• The other ingredients are sucrose, pellets (consisting of cornstarch, sucrose, and purified water), magnesium hydroxide, cornstarch, disodium phosphate, hypromellose 2910 6cP, sodium lauryl sulfate, mannitol, carboxymethylcellulose sodium, type A, talc, titanium dioxide (E171), macrogol 6000, polysorbate 80, and methacrylic acid and ethyl acrylate copolymer (1:1).
• The 10 mg hard gastro-resistant capsules contain:brilliant blue FCF (E133), yellow iron oxide (E172), titanium dioxide (E171), and gelatin.
• The 20 mg hard gastro-resistant capsules contain:indigo carmine (E132), titanium dioxide (E171), and gelatin.
• The 40 mg hard gastro-resistant capsules contain:titanium dioxide (E171), black iron oxide (E172), and gelatin.

What Sagalix looks like and contents of the pack

Gastro-resistant hard capsules, 10 mg: Hard gelatin capsule, approximately 14.3 mm long, with a green cap and white body, containing white to off-white or cream-colored spherical pellets.

Gastro-resistant hard capsules, 20 mg: Hard gelatin capsule, approximately 14.3 mm long, with a blue cap and white body, containing white to off-white or cream-colored spherical pellets.

Gastro-resistant hard capsules, 40 mg: Hard gelatin capsule, approximately 15.9 mm long, with a white cap and gray body, containing white to off-white or cream-colored spherical pellets.

Pack sizes:

Sagalix, 10 mg is available in blister packs of 7, 14, 15, 28, 30, 35, 42, 50, 56, 60, 90, and 100 gastro-resistant hard capsules; and in HDPE bottles of 7, 14, 15, 28, 30, 50, 56, 60, 90, 98, 100, 105, 120, and 250 gastro-resistant hard capsules.

Sagalix, 20 mg is available in blister packs of 7, 14, 15, 28, 30, 35, 42, 50, 56, 60, 90, and 100 gastro-resistant hard capsules; and in HDPE bottles of 7, 14, 15, 28, 30, 50, 56, 60, 90, 98, 100, 105, 120, and 250 gastro-resistant hard capsules.

Sagalix, 40 mg is available in blister packs of 7, 14, 15, 28, 30, 35, 42, 50, 56, 60, 90, and 100 gastro-resistant hard capsules; and in HDPE bottles of 7, 14, 15, 28, 30, 50, 56, 60, 90, 98, 100, 105, and 120 gastro-resistant hard capsules.

Not all pack sizes may be marketed.

Marketing authorization holder

Medical Valley Invest AB

Brädgårdsvägen 28

236 32 Höllviken

Sweden

email: [email protected]

Manufacturer

Laboratorios Liconsa S.A.

Avda. Miralcampo, No7, Poligono Industrial Miralcampo

19200 Azuqueca De Henares (Guadalajara)

Spain

This medicine is authorized in the Member States of the European Economic Area under the following names:

Ireland

Licomep 10 mg hard gastro-resistant capsules

Licomep 20 mg hard gastro-resistant capsules

Licomep 40 mg hard gastro-resistant capsules

Romania

Sagalix 10 mg gastro-resistant capsules

Sagalix 20 mg gastro-resistant capsules

Sagalix 40 mg gastro-resistant capsules

Poland

Sagalix

Portugal

Laumart

Date of last revision of the leaflet: