OMASEPT 10 mg Kapsułka Twarda Powlekana

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1. OMASEPT 10 mg hard gastro-resistant capsules, 20 mg hard gastro-resistant capsules, 40 mg hard gastro-resistant capsules
   1. What is OMASEPT and what it is used for
   2. What you need to know before taking OMASEPT
   3. How to take OMASEPT
   4. Possible side effects
   5. How to store OMASEPT
   6. Contents of the pack and other information

OMASEPT 10 mg hard gastro-resistant capsules, 20 mg hard gastro-resistant capsules, 40 mg hard gastro-resistant capsules

omeprazole
Generic medicine

Read this leaflet carefully before you start taking this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What OMASEPT is and what it is used for
• 2. What you need to know before you take OMASEPT
• 3. How to take OMASEPT
• 4. Possible side effects
• 5. How to store OMASEPT
• 6. Contents of the pack and other information

1. What is OMASEPT and what it is used for

OMASEPT contains the active ingredient omeprazole. It belongs to a group of medicines called
‘proton pump inhibitors’, which work by reducing the amount of acid produced by the stomach.
OMASEPT is used for the treatment of the following conditions:
In adults:

• Treatment of ‘Gastro-oesophageal Reflux Disease’ (GERD). This disease occurs when acid leaks from the stomach into the oesophagus (the tube that connects the throat to the stomach) causing pain, inflammation and heartburn.
• Reflux oesophagitis with scarring.
• Treatment and prevention of recurrence of ulcers in the upper part of the intestine (duodenal ulcer) or of the stomach (gastric ulcer).
• Ulcers infected by a bacterium called ‘ Helicobacter pylori’. If you suffer from this disease, 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). OMASEPT can also be used to prevent the formation of ulcers if you are taking NSAIDs.
• Excessive acid production in the stomach caused by an increase in tissue in the pancreas (Zollinger-Ellison syndrome).

In children:

Children over 1 year of age and with a body weight of 10 kg or more

• Treatment of ‘Gastro-oesophageal Reflux Disease’ (GERD). This disease occurs when acid leaks from the stomach into the oesophagus (the tube that connects the throat to the stomach) causing pain, inflammation and heartburn.

In children, the symptoms of this disease also include the return of stomach contents into the mouth (regurgitation), discomfort (vomiting) and poor weight gain.

• Treatment of heartburn and acid regurgitation in gastro-oesophageal reflux disease.

Children over 4 years of age and adolescents

• Ulcers infected by a bacterium called ‘ Helicobacter pylori’. If the child suffers from this disease, the doctor may also prescribe antibiotics to treat the infection and allow the ulcer to heal.

2. What you need to know before taking OMASEPT

Do not take OMASEPT

• 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 for HIV infections).

Do not take OMASEPT if you fall into any of the above categories. If you have any doubts, ask your doctor or pharmacist before taking OMASEPT.

Warnings and precautions
Talk to your doctor or pharmacist before taking OMASEPT:

• if you have ever had a skin reaction after treatment with a medicine similar to OMASEPT that reduces stomach acid.
• If you are going to undergo a specific blood test (Chromogranin A).

If you notice the appearance of a skin rash, especially in areas exposed to sunlight, contact your doctor as soon as possible, as you may need to stop treatment with OMASEPT.
Also remember to report any other undesirable effects such as joint pain.
OMASEPT can mask the symptoms of other diseases. Therefore, if you experience the symptoms described below before taking OMASEPT or while taking it, contact your doctor immediately:

• Unexplained weight loss and difficulty swallowing.
• Vomiting of food or blood.
• Dark-colored stools (presence of blood in the stool).
• Stomach pain or indigestion.
• Severe or persistent diarrhea, because omeprazole has been associated with a slight increase in infectious diarrhea.
• Serious liver problems.

If you take OMASEPT for a long time (more than 1 year) your doctor will prescribe regular check-ups. Inform your doctor if you notice the appearance of new and particular symptoms.
If you take a proton pump inhibitor such as OMASEPT, especially for a period longer than one year, there may be a slight increase in the risk of fractures of the hip, wrist or spine.
If you suffer from osteoporosis or are taking corticosteroids (which can increase the risk of osteoporosis) consult your doctor.
During treatment with omeprazole, inflammation of your kidneys may occur. Signs and symptoms may include reduced urine volume or the presence of blood in the urine and/or hypersensitivity reactions such as fever, skin rashes and joint stiffness. Report these signs to your doctor.

Children
Some children with chronic illnesses 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.

Other medicines and OMASEPT
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is important because OMASEPT can affect how some medicines work and, in turn, some medicines can affect the action of OMASEPT.
Do not take OMASEPT if you are taking a medicine containing nelfinavir(used for the treatment of HIV infections).
Tell your doctor or pharmacist if you are taking one or more of the following medicines:

• Posaconazole, Ketoconazole, Itraconazole or Voriconazole (used to treat fungal infections).
• Digoxin (used for the treatment of heart problems).
• Diazepam (used for the treatment of anxiety, to relax muscles or for epilepsy).
• Phenytoin (used for epilepsy). If you are taking phenytoin, your doctor will monitor you at the beginning and end of treatment with OMASEPT.
• Medicines used to thin the blood, such as warfarin or other vitamin K antagonists. Your doctor will monitor you at the beginning and end of treatment with OMASEPT.
• Rifampicin (used for the treatment of tuberculosis).
• Atazanavir (used for the treatment of HIV infection).
• Tacrolimus (used in organ transplantation).
• St. John's Wort ( Hypericum perforatum) (used for the treatment of mild depression).
• Cilostazol (used for the treatment of intermittent claudication).
• Erlotinib (used for the treatment of cancer).
• Saquinavir (used for the treatment of HIV infection).
• Clopidogrel (used to prevent blood clots (thrombi)).
• Methotrexate (a chemotherapeutic medicine used in high doses for the treatment of cancer) - if you are taking methotrexate in high doses, your doctor may temporarily interrupt your treatment with OMASEPT.

If your doctor has prescribed you the antibiotics amoxicillin and clarithromycin together with OMASEPT for the treatment of ulcers caused by Helicobacter pyloriinfections, it is very important that you tell them if you are taking any other medicines.

OMASEPT with food and drink
The capsules can be taken with or without food.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine. The doctor will decide whether you can take OMASEPT during pregnancy or if you are breastfeeding.
Omeprazole is excreted in breast milk but it is unlikely to have an effect on the baby when used at therapeutic doses.
The doctor will decide if you can take OMASEPT during breastfeeding.

Driving and using machines
It is unlikely that OMASEPT can affect your ability to drive vehicles or use tools or machinery. Adverse reactions such as dizziness and visual disturbances may occur (see section 4). If you suffer from these, you should not drive vehicles or use machinery.

OMASEPT contains sucrose
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

OMASEPT contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per hard gastro-resistant capsule, i.e. essentially sodium-free.

3. How to take OMASEPT

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
doubts consult your doctor or pharmacist. The doctor will tell you how many capsules to take and for how long.
This will depend on your condition and age. The recommended doses are:

• If your doctor has told you that your esophagus is slightly damaged, the recommended dose is 20 mg once a day for 4-8 weeks. The doctor may increase the dose to 40 mg for another 8 weeks if the esophagus is not yet completely healed.
• The recommended dose once the esophagus has healed is 10 mg once a day.
• If the esophagus is not damaged, the usual dose is 10 mg once a day.

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

• The recommended dose is 20 mg once a day for 2 weeks. The doctor may extend the intake of this dose for another 2 weeks if the ulcer has not yet healed.
• If the ulcer is not completely healed, the dose may be increased to 40 mg once a day for 4 weeks.

For the treatment of stomach ulcers(gastric ulcer):

• The recommended dose is 20 mg once a day for 4 weeks. The doctor may extend the intake of this dose for another 4 weeks if the ulcer has not yet healed.
• If the ulcer is not completely healed, the dose may be increased to 40 mg once a day for 8 weeks.

To preventthe recurrence of duodenal and gastric ulcers:

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

For the treatment of duodenal and gastric ulcers caused by taking NSAIDs(Non-Steroidal
Anti-inflammatory Drugs):

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

To prevent the formation of duodenal and gastric ulcersif you are using NSAIDs:

• The recommended dose is 20 mg once a day.

For the treatment of ulcers causedby infection byHelicobacter pyloriand prevention of their
recurrence:

• The recommended dose is 20 mg (or 40 mg) of OMASEPT twice a day for one week.
• The doctor will tell you to also take two antibiotics such as amoxicillin, clarithromycin and metronidazole.

For the treatment of excessive acid in the stomach caused by an increase in tissue in the
pancreas (Zollinger-Ellison syndrome):

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

Use in children and adolescents
For the treatment of symptoms of GERD, such as heartburn and acid reflux:

• OMASEPT can be taken by children over 1 year of age and weighing more than 10 kg. The dose for children is based on the child's weight and the exact dose will be decided by the doctor.

For the treatment and prevention of the recurrence of ulcers causedby infection byHelicobacter pylori:

• OMASEPT can be taken by children over 4 years of age. The dose for children is based on the child's weight and the exact dose will be decided by the doctor.
• The doctor will also prescribe two antibiotics called amoxicillin and clarithromycin to your child.

Taking this medicine

• It is recommended to take the capsules in the morning.
• The capsules can be taken with food or on an empty stomach.
• The capsules should be swallowed whole with half a glass of water. The capsules must not be chewed or crushed, as they contain granules coated in such a way as to prevent the medicine from being broken down by the acid in the stomach. It is important not to damage the granules.

What to do if you or the child has difficulty swallowing the capsules

• If you or the child has difficulty swallowing the capsules:
• Open the capsules and swallow the contents directly with half a glass of water or pour the contents into a glass of water (non-carbonated), fruit juice (e.g. apple, orange or pineapple) or applesauce.
• Always shake the contents before drinking (the mixture will not be clear), then drink the preparation immediately or within 30 minutes.
• To be sure you have taken all the medicine, rinse the glass very well with half a glass of water and drink the contents. The solid particles contain the medicine - do not chew or crush them.

Special populations:

• If you are an elderly patient and/or if your kidneys do not function as they should, you can take OMASEPT at the recommended doses.
• If the function of your liver is impaired, it is recommended to take a dose of 10-20 mg per day.

If you take more OMASEPT than you should
If you take an amount of OMASEPT greater than that prescribed by your doctor, contact your
doctor or pharmacist immediately.
Nausea, vomiting, dizziness, abdominal pain, diarrhea and headache have been reported. In isolated cases, apathy, depression and confusion have also been observed. The symptoms are transient and no serious consequences have been reported.

If you forget to take OMASEPT
If you forget to take a dose, take it as soon as you remember. However, if it is almost time to
take the next dose, skip the missed dose. Do not take a double dose to make up for the
forgotten dose.

If you stop taking OMASEPT
Do not stop taking OMASEPT without first talking to your doctor or pharmacist.
If you have any doubts about the use of this medicine, contact your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
manifest.

If you notice any of the following rare but serious side effects, stop taking OMASEPT and
contact your doctor immediately:

• Sudden wheezing, swelling of the lips, tongue and throat or body, rash, fainting or difficulty swallowing (severe allergic reaction).
• Redness of the skin with the appearance of blisters or peeling. A severe formation of blisters with bleeding of the lips, eyes, mouth, nose and genitals may also appear. This could be “Stevens-Johnson syndrome” or “toxic epidermal necrolysis”.
• Yellowing of the skin, dark urine and fatigue may be symptoms of liver problems.

The side effects are listed below in order of frequency:

Common (affects 1 to 10 patients in 100)

• Headache.
• Effects on the stomach or intestines: diarrhea, stomach pain, constipation, passing gas (flatulence).
• Feeling unwell (nausea) or feeling sick (vomiting).
• Benign polyps in the stomach.

Uncommon (affects 1 to 10 patients in 1000)

• Swelling of the feet and ankles (peripheral edema).
• Disturbed sleep (insomnia).
• Dizziness, tingling, feeling sleepy.
• Feeling of spinning (vertigo).
• Changes in blood tests related to liver function.
• Dermatitis, rash, rash with swelling of the skin (urticaria) and itching on the skin.
• General feeling of discomfort and lack of energy.
• If you are taking a proton pump inhibitor such as OMASEPT, especially for a period longer than one year, there may be a slight increase in the risk of fractures of the hip, wrist or spine. If you suffer from osteoporosis or are taking corticosteroids (which can increase the risk of osteoporosis) consult your doctor.

Rare (affects 1 to 10 patients in 10,000)

• Changes in the composition of the blood, such as a decrease in the number of white blood cells or platelets. This can cause weakness and easy bruising, or may make you more likely to get infections.
• Allergic reactions, sometimes very serious, including swelling of the lips, tongue and throat, fever, wheezing.
• Low levels of sodium in the blood. This can cause weakness, feeling unwell (vomiting) and cramps.
• Feeling agitated, confused or depressed.
• Changes in taste.
• Problems with vision, such as blurred vision.
• Sudden wheezing or shortness of breath (bronchospasm).
• Dry mouth.
• Inflammation inside the mouth.
• An infection called “candidiasis” that can affect the intestines and is caused by a fungus.
• Liver problems, including jaundice, which can cause yellowing of the skin, dark urine and fatigue.
• Hair loss (alopecia).
• Rash during exposure to the sun.
• Joint pain (arthralgia) or muscle pain (myalgia).
• Serious kidney problems (interstitial nephritis).
• Increased sweating.

Very rare (affects less than 1 patient in 10,000)

• Changes in blood cell counts, including agranulocytosis (lack of white blood cells).
• Aggression.
• Seeing, feeling or hearing events that are not real (hallucinations).
• Serious liver problems up to liver failure and brain inflammation.
• Sudden appearance of a severe rash or blisters and peeling of the skin. These effects may be associated with high fever and joint pain (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Muscle weakness.
• Enlargement of the breasts in men.

Not known (frequency cannot be estimated from available data)

• If you take OMASEPT for more than three months, it is possible that blood levels of magnesium may decrease. Low levels of magnesium can manifest with fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, increased heart rate. If you have any of these symptoms, consult your doctor immediately. Low levels of magnesium can also lead to a decrease in blood levels of potassium or calcium. The doctor should decide whether to periodically check magnesium levels in the blood
• Erythema, possible joint pain.
• Reduced levels of calcium in the blood (hypocalcemia). The reduction in calcium levels in the blood may result from very low levels of magnesium.
• Reduced levels of potassium in the blood (hypokalaemia). Inflammation of the intestine (resulting in diarrhea). Reporting of side effectsIf you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store OMASEPT

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack after Exp. The expiry date
refers to the last day of that month.
Blister:
Store at a temperature below 30°C. Store in the original package to protect the
medicine from moisture.
Bottle:
Store at a temperature below 30°C. Keep the bottle tightly closed to protect the medicine
from moisture.
The validity after first opening is 30 days.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What OMASEPT contains

• The active ingredient is omeprazole. Each capsule contains 10 mg, 20 mg or 40 mg of omeprazole as gastro-resistant granules.
• The other ingredients are:

Capsule core:sugar spheres (sucrose and corn starch), sodium carboxymethylcellulose (Type
A), sodium lauryl sulfate, povidone, trisodium phosphate dodecahydrate, hypromellose, ethyl
acrylate – methacrylic acid copolymer (1:1), triethyl citrate, titanium dioxide (E171), talc, sodium hydroxide.

Capsule cap:red iron oxide (E172) (only 10 mg), erythrosine (E127), indigotine
(E132) (only 20 mg and 40 mg) titanium dioxide (E171), water, gelatin.

Capsule body:Quinoline Yellow (E104), erythrosine (E127), titanium dioxide (E171), water,
gelatin.

Printing ink:shellac, povidone, propylene glycol, sodium hydroxide, titanium dioxide
(E171).

Description of the appearance of OMASEPT and contents of the pack
OMASEPT 10 mg:
Hard gelatin capsules, size 3, with an opaque red cap and an opaque orange body. The letter “O” has been
printed on the cap and the number “10” on the body with white ink. The capsules are filled with pelleted
microgranules ranging in color from white to beige.
Blister packs containing 14 and 28 capsules, bottles containing 14 capsules.
Not all pack sizes may be marketed.
OMASEPT 20 mg:
Hard gelatin capsules, size 2, with an opaque blue cap and an opaque orange body. The letter “O” has been
printed on the cap and the number “20” on the body with white ink. The capsules are filled with pelleted
microgranules ranging in color from white to beige.
Blister packs containing 14 and 28 capsules, bottles containing 14 capsules.
Not all pack sizes may be marketed.
OMASEPT 40 mg:
Hard gelatin capsules, size 0, with an opaque blue cap and an opaque orange body. The letter “O” has been
printed on the cap and the number “40” on the body with white ink. The capsules are filled with pelleted
microgranules ranging in color from white to beige.
Blister packs or bottles containing 14 capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Pharmacare S.r.l.
Via Marghera, 29 - 20149 Milan
Italy

Manufacturer
TEVA Pharma S.L.U.
Poligono Industrial Malpica, calle C., number 4, 50016 Zaragoza
Spain