Losec

Package leaflet: Information for the patient

Warning! Keep the leaflet, information on the immediate packaging in a foreign language!
Losec (Mopral 20 mg)
20 mg enteric hard capsules
Omeprazolum
Losec and Mopral 20 mg are different brand names for the same medicine.
Please read the entire leaflet carefully before taking this medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any doubts, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, please inform your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

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

1. What is Losec and for what is it used

Losec contains a substance called omeprazole. It belongs to a group of medicines known as
"proton pump inhibitors". These medicines work by reducing the amount of acid produced in
the stomach.
Losec is used to treat the following conditions:

In adults:

• Gastro-esophageal reflux disease (GERD). This condition occurs 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 eradicate the infection and allow the ulcers to heal.
• Ulcers caused by non-steroidal anti-inflammatory drugs (NSAIDs). Losec may also be used to prevent ulcers from developing during NSAID treatment.
• Excessive acid production due to a pancreatic tumour (Zollinger-Ellison syndrome).

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

• Gastro-esophageal reflux disease (GERD). This condition occurs when acid from the stomach flows back into the oesophagus, causing pain, inflammation, and heartburn.

In children, symptoms of this disorder may include regurgitation of stomach contents into the mouth (spitting up), vomiting, and poor weight gain.

Children and adolescents aged above 4 years

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

2. Important information before using Losec

When not to use Losec:

• 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).

Do not take Losec if any of the above apply. If in doubt, speak to your doctor or pharmacist before starting treatment with Losec.
Warnings and precautions
Talk to your doctor or pharmacist before taking Losec.
Severe skin reactions have been reported with treatment with Losec, 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 Losec immediately and seek urgent medical help.
Losec may mask symptoms of other diseases. Therefore, if any of the following conditions occur before or during treatment with Losec, inform your doctor immediately:

• Unexplained weight loss and difficulty swallowing.
• Stomach pain or indigestion.
• Vomiting food or blood.
• Passing black stools (stools discoloured by blood).
• 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 to a medicine similar to Losec that reduces stomach acid secretion.
• Regarding planned specific blood test (chromogranin A level).

If Losec is taken for a long time (more than 1 year), the patient will likely require regular medical monitoring. During visits to the doctor, report any new or unusual symptoms or circumstances.
Taking proton pump inhibitors such as Losec, especially for more than one year, may slightly increase the risk of fractures of the hip, wrist, or spine. Inform your doctor if you have been diagnosed with osteoporosis or are taking corticosteroid medicines (which may increase the risk of osteoporosis).
If the patient develops a rash, especially in areas exposed to sunlight, inform the doctor as soon as possible, as this may require discontinuation of Losec. Also report any other adverse effects such as joint pain.
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. The patient should report such symptoms to the treating doctor.
This medicine may affect how the body absorbs vitamin B12, particularly if taken for a long time. Contact your doctor if you notice any of the following symptoms, which may indicate low vitamin B12 levels:

• Extreme tiredness or lack of energy
• Tingling and numbness
• Sore or red tongue, mouth ulcers
• Muscle weakness
• Vision disturbances
• Memory problems, confusion, depression

Children
Some children with chronic diseases may require long-term treatment, even though this is not recommended. This medicine must not be given to children under 1 year of age or with body weight < 10 kg.
Losec with other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or might take in the future. This includes medicines available without a prescription. This is important because Losec may affect how some other medicines work, and some other medicines may affect how Losec works.
Do not take Losec if you are taking a medicine containing nelfinavir (used in the treatment of 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 disorders).
• Diazepam (used to treat anxiety, to reduce muscle tension, or in epilepsy treatment).
• Phenytoin (used to treat epilepsy). If the patient is taking phenytoin, the doctor will need to monitor the patient’s condition when starting and stopping Losec.
• 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 and stopping Losec.
• Rifampicin (used to treat tuberculosis).
• Atazanavir (used to treat HIV infection).
• Tacrolimus (used following 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 chemotherapeutic agent used in high doses to treat cancer) – if the patient is taking high doses of methotrexate, the doctor may temporarily discontinue Losec.

If your doctor has prescribed the antibiotics amoxicillin and clarithromycin, together with Losec, to treat ulcers caused by Helicobacter pylori infection, it is very important that you inform your doctor about any other medicines you are taking.
Losec with food and drink
See section 3.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before starting 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 Losec will be decided by the doctor.
Driving and using machines
Losec does not affect the ability to drive or operate tools and machines.
However, adverse effects such as dizziness and visual disturbances may occur (see section 4 of this leaflet). If these occur, do not drive or operate machinery.
Losec capsules contain lactose and sodium
Losec capsules contain lactose. If the patient has been diagnosed with intolerance to certain sugars, consult your doctor before starting this medicine.
Losec capsules contain less than 1 mmol sodium (23 mg) per capsule, i.e. the medicine is considered “sodium-free”.

3. How to take Losec

This medicine should always be taken exactly as your doctor or pharmacist has advised. If you are unsure,
you should 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 your age.
Dosage recommendations are given below.

Use in adults:
Treatment of symptoms of GERD, such as heartburn and regurgitation of acidic stomach contents:

• If your doctor has diagnosed mild damage to your oesophagus, the recommended dose is 20 mg once daily for 4 to 8 weeks. Your doctor may recommend taking 40 mg for an additional 8 weeks if the oesophagus has not 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 ulcers in the upper part of the small intestine (duodenal ulcers):

• 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 has not completely healed, the dose may be increased to 40 mg once daily for 4 weeks.

Treatment of stomach ulcers (gastric ulcers):

• 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 has not completely healed, 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 Losec 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 caused by a tumour in the pancreas (Zollinger-Ellison syndrome):

• The usual dose is 60 mg per day.
• Your doctor will adjust the dose according to individual needs and will decide how long treatment with Losec should continue.

Use in children and adolescents
Treatment of symptoms of GERD, such as heartburn and regurgitation of acidic stomach contents:

• Children aged over 1 year and weighing more than 10 kg may take Losec. The dose depends on body weight and is individually determined by the treating doctor.

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

• Children aged over 4 years may take Losec. The dose for children depends on body weight and is individually determined by the treating doctor.
• Your doctor will also prescribe two antibiotics for the child: amoxicillin and clarithromycin.

How to take Losec capsules

• 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 being broken down by stomach acid. It is important that the pellets remain intact.

What to do if you have difficulty swallowing the capsules (in adults or children)

• If an adult or child has difficulty swallowing the 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 sauce.
• Always mix the mixture immediately before drinking (the mixture will not be clear). Then 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 Losec than you should
If you take more Losec than prescribed by your doctor, contact your doctor or pharmacist immediately.

If you forget to take Losec
If you forget to take a dose, take it as soon as you remember.
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.

Stopping Losec
Do not stop taking Losec without first consulting your doctor or pharmacist.
If you have any further questions about how to use this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
If you notice any of the following rare (may affect 1 in 1,000 people) or very rare (may affect 1 in 10,000 people), but serious adverse effects, stop taking Losec and contact your doctor immediately:

• 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 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 occur at the beginning of treatment (acute generalised exanthematous pustulosis). (rare)
• Yellowing of the skin, dark urine and fatigue, which may indicate liver dysfunction. (rare)

Other adverse effects include:
Common adverse effects (may affect 1 in 10 people)

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

Uncommon adverse effects (may affect 1 in 100 people)

• Swelling of the feet and ankles.
• Sleep disturbance (insomnia).
• Dizziness, tingling or pricking sensation, 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 effects (may affect 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 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.
• 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 effects (may affect 1 in 10,000 people)

• Changes in blood count including agranulocytosis (absence of white blood cells).
• Aggression.
• Seeing, feeling or hearing things that are not real (hallucinations).
• Severe liver dysfunction 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 intestine (causing diarrhoea).
• If you have been taking Losec for longer than three months, there is a possibility of decreased magnesium levels in the blood. Low magnesium levels may manifest as fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, rapid heartbeat. If any of these symptoms occur, inform your doctor immediately. Low magnesium levels may lead to decreased potassium or calcium levels in the blood. Your doctor may recommend regular blood tests to monitor magnesium levels.
• Rash which may be accompanied by joint pain.

In very rare cases, Losec 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 signs of local infection such as pain in the neck, throat or mouth, or difficulty urinating, consult a doctor as soon as possible to rule out possible deficiency of white blood cells (agranulocytosis), based on blood test results. It is important that, in such a situation, the patient informs the doctor, pharmacist or nurse about the medicine being taken.
Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. Adverse effects 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, PL-02 222 Warsaw, tel.: + 48 22 49 21 301, fax: + 48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Reporting adverse effects helps to provide more information on the safety of this medicine.

5. How to store the medicine Losec

This medicine should be stored in a place inaccessible and out of sight of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Do not store above 30°C.
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. Such measures help protect the environment.

6. Contents of the packaging and other information

What Losec contains

• The active substance in Losec is omeprazole. Each capsule (enteric hard capsule) contains 20 mg of omeprazole.
• Excipients: disodium phosphate dihydrate, low-substituted hydroxypropyl cellulose, hypromellose, lactose, magnesium stearate, mannitol, methacrylic acid and ethyl acrylate copolymer (1:1), 30% dispersion, microcrystalline cellulose, polyethylene glycol 400, sodium lauryl sulfate; Capsule shell: iron oxide red (E 172), titanium dioxide (E 171), gelatin, sodium lauryl sulfate, magnesium stearate, printing ink (containing shellac, ammonium hydroxide, potassium hydroxide, iron oxide black (E 172)), colloidal anhydrous silica, and liquid paraffin. (See section 2: "Losec capsules contain lactose").

What Losec looks like and contents of the pack
Losec 20 mg: pink-bodied capsules marked with the number "20" and a red-brown cap marked A/OM.
Pack sizes:
HDPE bottles containing 14 capsules, in a cardboard box.
For more detailed information, please contact the marketing authorization holder or parallel importer.

Marketing Authorization Holder in France, the country of export:
CHEPLAPHARM Arzneimittel GmbH
Ziegelhof 24
17489 Greifswald
Germany

Manufacturer:
Saneca Pharmaceuticals a.s.
Nitrianska 100
Hlohovec 92027
Slovakia
CHEPLAPHARM Arzneimittel GmbH
Ziegelhof 23-24
17489 Greifswald
Germany

Parallel Importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland

Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland

Marketing Authorization Number in France, the country of export: 34009 340 812 1 7
340 812-1

Parallel Import Authorization Number: 235/25

This medicinal product is authorized for sale in the European Economic Area countries and in the United Kingdom (Northern Ireland) under the following names: