Sagalix

Package leaflet: Information for the patient

Sagalix, 10 mg, hard enteric-coated capsules
Sagalix, 20 mg, hard enteric-coated capsules
Sagalix, 40 mg, hard enteric-coated capsules
Omeprazole
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.

• Keep this leaflet for future reference.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for you personally. Do not share it with others. This medicine may harm other people, even if their symptoms are the same as yours.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

1. What Sagalix is and what it is 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 pack and other information

1. What Sagalix is and what it is used for

Sagalix contains the active substance omeprazole. It belongs to a group of medicines called "proton pump inhibitors". These 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 oesophagus (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 in the stomach (gastric ulcer).
• Ulcers infected with bacteria called "Helicobacter pylori". In such cases, your doctor may also prescribe antibiotics to treat the infection and allow the ulcer to heal.
• Ulcers caused by medicines called NSAIDs (non-steroidal anti-inflammatory drugs). Sagalix may also be used to prevent ulcers if you are taking NSAIDs.
• Excess stomach acid caused by a pancreatic tumour (Zollinger-Ellison syndrome).

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

• "Gastro-esophageal reflux disease" (GERD). GERD causes stomach acid to flow back into the oesophagus (the tube connecting the throat to the stomach), causing pain, inflammation, and heartburn.
• In children, symptoms may include regurgitation of stomach contents into the mouth (spitting up, vomiting), nausea (vomiting), and poor weight gain.

Children and adolescents aged 4 years and older

• Ulcers infected with bacteria called "Helicobacter pylori". If your child has this condition, the doctor may prescribe antibiotics to treat the infection and allow the ulcers to heal.

2. Important information before using 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 in the treatment of HIV infection).

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

Warnings and precautions
Before taking Sagalix, consult a doctor or pharmacist.
Severe skin reactions have been reported with omeprazole 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, discontinue use of Sagalix immediately and seek urgent medical help.

Sagalix may mask 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 food or blood.
• Black stools (stool containing blood).
• Severe or persistent diarrhoea, as omeprazole use is associated with a slight increase in the risk of infectious diarrhoea.
• Severe liver function impairment.
• Previous skin reaction after treatment with a medicine similar to Sagalix that reduces stomach acid.
• A specific blood test (chromogranin A) is planned.

While taking omeprazole, kidney inflammation may occur. 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.

If Sagalix is taken for a prolonged period (longer than 1 year), regular medical check-ups will likely be necessary. During each visit, report any new or unusual symptoms or circumstances.

Taking a proton pump inhibitor such as Sagalix, particularly for more than 1 year, may slightly increase the risk of fractures of the hip, wrist, or spine. Inform the doctor if the patient has osteoporosis or is taking corticosteroids (which may increase the risk of osteoporosis).

If a skin rash develops, especially in areas exposed to sunlight, inform the doctor as soon as possible, as treatment with Sagalix may need to be discontinued. 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 to children weighing less than 10 kg.

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

Do not take Sagalix if the patient is taking medicines 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 relax muscles, or in epilepsy)
• Phenytoin (used in epilepsy). If the patient is taking phenytoin, medical monitoring will be necessary at the beginning or end of Sagalix treatment
• Medicines used to thin the blood, such as warfarin or other vitamin K antagonists. Medical monitoring may be necessary at the beginning or end of Sagalix treatment
• 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 (thrombosis))
• Erlotinib (used to treat cancer)
• Methotrexate (chemotherapy, a medicine used in high doses to treat cancer) – if the patient is taking a high dose of methotrexate, the doctor may temporarily discontinue Sagalix treatment

If the doctor has prescribed amoxicillin and clarithromycin antibiotics along with Sagalix for the treatment of ulcers caused by Helicobacter pylori infection, it is very important to inform the doctor about all medicines being taken.

Sagalix 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 is unlikely to affect the infant when used at therapeutic doses. The doctor will decide whether the patient may take Sagalix while breastfeeding.

Driving and operating machinery
Sagalix is unlikely to affect the ability to drive or operate tools or machinery. However, adverse effects such as dizziness and visual disturbances may occur (see section 4). In such cases, do not drive or operate machinery.

Sagalix contains sucrose and sodium
If the patient has previously been diagnosed with an intolerance to certain sugars, consult a doctor before taking this medicine.

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

3. How to take Sagalix

This medicine should always be taken as directed by your doctor or pharmacist. If you have any doubts,
consult your doctor or pharmacist.
Your doctor will inform you how many capsules to take and for how long. This will depend on your
health condition and age.
Recommended doses are given below.

Use in adults:
In the treatment of GERD symptoms such as heartburn and acid regurgitation:

• If your doctor determines that the oesophagus has been slightly damaged, the recommended dose is 20 mg once daily for 4–8 weeks. Your doctor may recommend continuing with 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.

In the treatment of ulcers in the upper intestine (duodenal ulcer):

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

In the treatment of gastric ulcers (stomach ulcers):

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

To prevent 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.

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

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

To prevent duodenal and gastric ulcers in patients taking NSAIDs:

• The recommended dose is 20 mg once daily.

For the treatment of ulcers caused by Helicobacter pylori infection and prevention of their recurrence:

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

In the treatment of excessive stomach acid caused by a pancreatic tumour (Zollinger-Ellison syndrome):

• The recommended dose is 60 mg per day.
• Your doctor will adjust the dose according to your needs and will decide how long you should continue taking the medicine.

Use in children and adolescents
In the treatment of GERD symptoms such as heartburn and acid regurgitation:

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

For the treatment of ulcers caused by Helicobacter pylori infection and prevention of their recurrence:

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

How to take this medicine

• It is recommended to take the capsules in the morning.
• The capsules may be taken with or without food (on an empty stomach).
• Swallow the capsules whole with half a glass of water. Do not chew or crush the capsules. This is because the capsules contain 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 capsules
If an adult or child has difficulty swallowing capsules:

• Open the capsule and swallow the contents directly with half a glass of water, or mix the contents into a glass of still water, any acidic fruit juice (e.g. apple, orange or pineapple juice), or apple sauce.
• Always mix the mixture immediately before drinking (the mixture will not be clear). The mixture should then be drunk immediately or within 30 minutes of preparation.
• To ensure that all the medicine is taken, rinse the glass thoroughly with half a glass of water and drink it. The solid particles contain the medicine – do not chew or crush them.

Taking more Sagalix than recommended
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 the 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 first consulting your doctor or pharmacist. If you have any further doubts about using this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody 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 adverse reactions, stop taking Sagalix and contact your doctor immediately:

• Sudden wheezing, swelling of the lips, tongue or throat, skin rash, fainting or difficulty swallowing (severe allergic reaction). (rare)
• Reddening of the skin with blisters or peeling. Large blisters and bleeding of the lips, eyes, mouth, nose and genital organs may also occur. These may be symptoms of 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 occur at the beginning of treatment (acute generalized exanthematous pustulosis). (rare)
• Yellowing of the skin, dark urine and fatigue, which may be signs of liver dysfunction. (rare)

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

• Headache.
• Effects on the stomach or intestines: diarrhoea, stomach pain, constipation, bloating with gas.
• Nausea or vomiting.
• Benign polyps in the stomach.

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

• Swelling of the feet and ankles.
• Sleep disturbances (insomnia).
• Dizziness, tingling, pricking sensation, drowsiness.
• Sensation of spinning (dizziness).
• Changes in blood tests checking liver function.
• Skin rash, nodular rash (urticaria), and itchy skin.
• 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 cause weakness, bruising or increase the likelihood of infection.
• Low sodium levels in the blood. This may cause weakness, vomiting and muscle cramps.
• Feeling agitated, disoriented or depressed.
• Changes in taste.
• Vision problems such as blurred vision.
• Sudden wheezing or shortness of breath (bronchospasm).
• Dryness of the mouth.
• Inflammation of the mouth.
• A fungal infection called "thrush", which may affect the intestines.
• 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 adverse reactions (may affect up to 1 in 10,000 people)

• Changes in blood count, 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 encephalopathy.
• Erythema multiforme.
• Muscle weakness.
• Breast enlargement in men.

Adverse reactions of unknown frequency (frequency cannot be estimated from available data)

• Inflammation of the intestine (leading to diarrhoea).
• If the patient takes Sagalix for longer than three months, blood magnesium levels may decrease. Low magnesium levels may cause fatigue, involuntary muscle spasms, disorientation, seizures, dizziness or increased heart rate. If any of these symptoms occur, inform your doctor immediately. Low magnesium levels may also lead to low potassium or calcium levels in the blood. Your doctor may decide to perform regular blood tests to monitor magnesium levels.
• Rash associated with joint pain.

Omeprazole may, very rarely, affect the number of white blood cells, leading to immunodeficiency. If the patient develops an infection with symptoms such as fever with a significant deterioration in general condition, or fever with signs of local infection such as pain in the neck, throat or mouth, or difficulty urinating, medical advice should be sought immediately to rule out lack of white blood cells (agranulocytosis) by means of a blood test. It is important, in such a case, to inform the doctor about taking Sagalix.

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, 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 provide more information on the safety of the medicine.

5. How to store Sagalix

Keep this medicine out of 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 stated month.
Blister made of PVC/PE/PVDC/Aluminium: Store below 25°C; keep in the original packaging to protect from moisture.
HDPE bottles: No special storage temperature requirements; 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. This will help protect the environment.

6. Contents of the pack and other information

What Sagalix contains

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

What Sagalix looks like and contents of the pack
Enteric capsules, 10 mg: Hard gelatin capsule approximately 14.3 mm in length, with a green cap and white body, containing spherical granules white to off-white or cream in colour.
Enteric capsules, 20 mg: Hard gelatin capsule approximately 14.3 mm in length, with a blue cap and white body, containing spherical granules white to off-white or cream in colour.
Enteric capsules, 40 mg: Hard gelatin capsule approximately 15.9 mm in length, with a white cap and grey body, containing spherical granules white to off-white or cream in colour.

Pack sizes:
Sagalix 10 mg is available in PVC/PE/PVDC/Aluminium foil blisters containing 7, 14, 15, 28, 30, 35, 42, 50, 56, 60, 90 and 100 hard enteric capsules; and in HDPE bottles containing 7, 14, 15, 28, 30, 50, 56, 60, 90, 98, 100, 105, 120 and 250 hard enteric capsules.
Sagalix 20 mg is available in PVC/PE/PVDC/Aluminium foil blisters containing 7, 14, 15, 28, 30, 35, 42, 50, 56, 60, 90 and 100 hard enteric capsules; and in HDPE bottles containing 7, 14, 15, 28, 30, 50, 56, 60, 90, 98, 100, 105, 120 and 250 hard enteric capsules.
Sagalix 40 mg is available in PVC/PE/PVDC/Aluminium foil blisters containing 7, 14, 15, 28, 30, 35, 42, 50, 56, 60, 90 and 100 hard enteric capsules; and in HDPE bottles containing 7, 14, 15, 28, 30, 50, 56, 60, 90, 98, 100, 105 and 120 hard enteric capsules.
Not all pack sizes may be marketed.

Marketing Authorisation 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 medicinal product is authorised in 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 capsule gastrorezistente
Sagalix 20 mg capsule gastrorezistente
Sagalix 40 mg capsule gastrorezistente
Poland Sagalix
Portugal Laumart