Losec

Package leaflet: Information for the patient

Warning! Keep this leaflet. The information on the immediate packaging is in a foreign language.
Losec (Mopral 20 mg), 20 mg gastro-resistant capsules, hard
Omeprazolum
Losec and Mopral 20 mg are different brand names for the same medicinal product.
Please read this leaflet carefully before using the medicine, as it contains important information for you.

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

Table of contents of the leaflet

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

1. What Losec is and what it is used for

Losec contains the active 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 of the upper part of the small intestine (duodenal ulcers) or stomach (gastric ulcers).
• Ulcers infected with bacteria called Helicobacter pylori. In such cases, your doctor may also prescribe antibiotics to eliminate the infection and allow ulcers to heal.
• Ulcers caused by non-steroidal anti-inflammatory drugs (NSAIDs). Losec may also be used to prevent the development of ulcers during NSAID treatment.
• Excessive acid production due to a tumour in the pancreas (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 condition may include regurgitation of stomach contents into the mouth (spitting up/food regurgitation), 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 ulcers to heal.

2. Important information before taking Losec

When not to take 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 to the patient. If in doubt, consult a doctor or pharmacist before starting treatment with Losec.

Warnings and precautions

Before taking Losec, speak to your doctor or pharmacist.

Severe skin reactions have been reported with treatment using Losec, 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, 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 (blood-stained faeces).
• Severe or persistent diarrhoea, as a slight increase in the frequency of infectious diarrhoea has been associated with omeprazole use.
• 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 tests (chromogranin A levels).

If Losec is taken for a long time (longer than 1 year), the patient will likely require careful and regular medical monitoring. During visits to the doctor, report any new or unusual symptoms and 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 osteoporosis has been diagnosed or if you are taking corticosteroids (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 discontinuation of Losec may be necessary. Also report any other adverse effects such as joint pain.

While taking omeprazole, inflammation of the kidneys may occur. Symptoms may include reduced urine volume or presence of blood in the urine and/or allergic reactions such as fever, rash, and joint stiffness. The patient should report such symptoms to their doctor.

This medicine may affect how the body absorbs vitamin B₁₂, especially 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
• Painful or red tongue, mouth ulcers
• Muscle weakness
• Vision disturbances
• Memory problems, confusion, depression

Children

Some children with chronic diseases may require long-term treatment, although this is not recommended. This medicine must not be given to children under 1 year of age or weighing less than 10 kg.

Losec with other medicines

Tell your doctor or pharmacist about all medicines currently used, recently taken, or planned for use, including those 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).

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 disorders)
• Diazepam (used to treat anxiety, reduce muscle tension, or treat epilepsy)
• 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 treatment with 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 treatment with Losec.
• Rifampicin (used to treat tuberculosis)
• Atazanavir (used to treat HIV infection)
• Tacrolimus (used in organ transplant patients)
• 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 treatment with Losec.

If your doctor has prescribed amoxicillin and clarithromycin antibiotics along with Losec to treat ulcers caused by Helicobacter pylori infection, it is very important that the patient informs the doctor about all other medicines being taken.

Losec with food and drink

See section 3.

Pregnancy, breastfeeding and fertility

If the patient is pregnant, suspects she may be pregnant, or plans to become pregnant, consult a 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. The decision whether a breastfeeding mother can take Losec will be made 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 mechanical equipment.

Losec capsules contain lactose and sodium

Losec capsules contain lactose. If the patient has been diagnosed with intolerance to certain sugars, consult a doctor before starting this medicine.

Losec capsules contain less than 1 mmol of sodium (23 mg) per capsule; hence, this medicine is considered "sodium-free".

3. How to take Losec

This medicine should always be taken as directed by your doctor or pharmacist. If you have any doubts,
you should 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.
Dosage recommendations are given below.

Use in adults:
Treatment of GERD symptoms such as heartburn and acid regurgitation:

• If your doctor has determined that your esophagus has been slightly damaged, 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 esophagus has not healed.
• The recommended dose after healing of the esophagus is 10 mg once daily.
• If the esophagus is not damaged, the usual dose is 10 mg once daily.

Treatment of duodenal ulcers (ulcers in the upper part of the small intestine):

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

Treatment of gastric ulcers (stomach 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 does not heal completely, 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 in the stomach caused by a pancreatic tumor (Zollinger-Ellison syndrome):

• The usual dose is 60 mg daily.
• 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 GERD symptoms such as heartburn and acid regurgitation:

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

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

• Children over 4 years of age may take Losec. The dose for children depends on body weight and is individually determined by the treating physician.
• 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.
• 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 capsules (in adults or children)

• If an adult or child 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 non-carbonated water, any acidic fruit juice (e.g., apple, orange, or pineapple juice), or with apple puree.
• Always mix the mixture immediately before drinking (the mixture will not be clear). Drink the mixture immediately after preparation or within 30 minutes.
• To ensure the patient receives the full dose, rinse the glass thoroughly with half a glass of water and drink this liquid as well. 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, 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 treatment with Losec
Do not stop taking Losec without first consulting your doctor or pharmacist.
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 gets 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 Losec immediately and contact your doctor without delay:

• Sudden wheezing, swelling of the lips, tongue or throat, skin rash, fainting or difficulty swallowing (severe allergic reaction). (rare)
• Redness of the skin with blistering 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 generalized exanthematous pustulosis). (rare)
• Yellowing of the skin, dark urine and fatigue, which may indicate liver function disorders. (rare)

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

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

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

• Swelling of 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 reactions (may affect up to 1 in 1,000 people)

• Blood-related problems 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 sensation of wheezing or breathlessness (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 upon 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 (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 males.

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

• Inflammation of the intestine (causing diarrhoea).
• If Losec has been taken for longer than three months, there may be a decrease in blood magnesium levels. Low magnesium levels may present as fatigue, involuntary muscle spasms, disorientation, seizures, dizziness, rapid heartbeat. If any of these symptoms occur, inform your doctor immediately. Low magnesium levels may lead to low potassium or calcium levels in the blood. Your doctor may recommend regular blood tests to monitor magnesium levels.
• Rash occurring with 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, seek medical advice as soon as possible
to rule out possible deficiency of white blood cells (agranulocytosis), based on blood test results.
It is important that the patient informs the doctor or pharmacist about the medication being taken in such a case.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions
can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the 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
By reporting adverse reactions, additional information on the safety of the medicine can be collected.

5. How to store the medicine Losec

This medicine should be stored out of the sight and reach 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 in use. Such measures help protect the environment.

6. Contents of the pack and other information

What Losec contains
The active substance in Losec is omeprazole. Each capsule (enteric hard capsules) contains
20 mg of omeprazole.
Excipients: disodium phosphate dihydrate, low-substituted hydroxypropylcellulose, hypromellose, lactose, magnesium stearate, mannitol, methacrylic acid and ethyl acrylate copolymer (1:1), 30% dispersion, microcrystalline cellulose, macrogol 400, sodium lauryl sulfate; capsule shell: iron oxide red (E 172), titanium dioxide (E 171), gelatin, magnesium stearate, sodium lauryl sulfate, printing ink (contains 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
Capsules with a pink body marked with the number "20" and a reddish-brown cap marked A/OM.
Pack size:
HDPE bottles with PP screw cap containing a desiccant, packed in a cardboard box, containing 14 capsules.

For more detailed information, please contact the responsible party or the parallel importer.

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

Manufacturer:
Saneca Pharmaceuticals a.s., Nitrianska 100, 920 27 Hlohovec, Slovakia
CHEPLAPHARM Arzneimittel GmbH, Ziegelhof 23-24, 17489 Greifswald, Germany

Parallel Importer:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland

Repackaged by:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland

Marketing Authorisation Number in France, country of export: 3400934081217
Parallel Import Authorisation Number: 159/24

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