Omasept

Italy
Brand name Omasept
Form capsules, hard gelatin, gastro-resistant
Active substance / Dosage
OMEPRAZOLE
Prescription type Prescription only
ATC code
A02BC01
Registration number 042666
Manufacturer PHARMACARE S.R.L.

Table of Contents

Package leaflet: Information for the user

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

Omeprazole
Generic medicine
Please read all of this leaflet carefully before you start taking this medicine because 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 give it to other people, even if their symptoms are the same as yours, as it may be harmful.
  • If you experience any adverse reaction, including those not listed in this leaflet, contact 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 taking 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 OMASEPT is and what it is used for

OMASEPT contains the active substance omeprazole. It belongs to a group of medicines known as proton pump inhibitors, which work by reducing the amount of acid produced in the stomach.
OMASEPT is used to treat the following conditions:

In adults:

  • Treatment of gastro-oesophageal reflux disease (GERD). This condition occurs when acid leaks out of the stomach into the oesophagus (the tube connecting the throat to the stomach), causing pain, inflammation, and heartburn.
  • Healing of reflux oesophagitis.
  • Treatment and prevention of relapses of ulcers in the upper part of the intestine (duodenal ulcer) or in the stomach (gastric ulcer).
  • Ulcers caused by a bacterium called Helicobacter pylori. If you suffer from this condition, your doctor may also prescribe antibiotics to treat the infection and allow the ulcer to heal.
  • Ulcers caused by non-steroidal anti-inflammatory drugs (NSAIDs). OMASEPT can also be used to prevent the formation of ulcers if you are taking NSAIDs.
  • Excessive stomach acid caused by a growth of tissue in the pancreas (Zollinger-Ellison syndrome).

In children:
Children aged over 1 year and weighing more than or equal to 10 kg

  • Treatment of gastro-oesophageal reflux disease (GERD). This condition occurs when acid leaks out of the stomach into the oesophagus (the tube connecting the throat to the stomach), causing pain, inflammation, and heartburn.

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

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

Children aged over 4 years and adolescents

  • Ulcers caused by a bacterium called Helicobacter pylori. If the child suffers from this condition, the doctor may 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 to 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 any of the above apply to you. If you are unsure, consult your doctor or pharmacist before taking OMASEPT.

Warnings and precautions

Talk to your doctor or pharmacist before taking OMASEPT.

Severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP), have been reported in association with treatment with OMASEPT. Stop using OMASEPT and contact a doctor immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.

If you develop a skin rash, especially in areas exposed to sunlight, consult your doctor as soon as possible, as it may be necessary to discontinue treatment with OMASEPT.

Remember to also report any other adverse effects such as joint pain.

OMASEPT may mask symptoms of other diseases. Therefore, if you experience any of the following symptoms before or while taking OMASEPT, contact your doctor immediately:

  • Unintentional weight loss and difficulty swallowing.
  • Vomiting food or blood.
  • Dark-coloured stools (indicating presence of blood in the stool).
  • Stomach pain or indigestion.
  • Severe or persistent diarrhoea, as omeprazole has been associated with a slight increase in infectious diarrhoea.
  • Severe liver problems.
  • If you have ever had a skin reaction after treatment with a medicine similar to OMASEPT that reduces gastric acidity.
  • If you are scheduled for a specific blood test (Chromogranin A).

If you have been taking OMASEPT for a long time (more than 1 year), your doctor will prescribe regular check-ups. Inform your doctor if you notice any new or unusual symptoms.

If you take a proton pump inhibitor such as OMASEPT, especially for more than one year, there may be a slight increase in the risk of fractures of the hip, wrist, or spine. If you have osteoporosis or are taking corticosteroids (which can increase the risk of osteoporosis), consult your doctor.

During treatment with omeprazole, inflammation of the kidneys may occur. Signs and symptoms may include reduced urine volume and/or presence of blood in the urine and/or hypersensitivity reactions such as fever, skin rash, and joint stiffness. Report such signs to your doctor.

Children

Some children with chronic conditions 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 may affect how some medicines work, and conversely, some medicines may affect the action of OMASEPT.

Do not take OMASEPT if you are taking a medicine containing nelfinavir (used to treat HIV infections).

Inform 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 to treat heart problems).
  • Diazepam (used to treat anxiety, to relax muscles, or for epilepsy).
  • Phenytoin (used for epilepsy). If you are taking phenytoin, your doctor will monitor you closely 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 closely at the beginning and end of treatment with OMASEPT.
  • 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).
  • Erlotinib (used to treat cancer).
  • Saquinavir (used to treat HIV infection).
  • Clopidogrel (used to prevent blood clots (thrombi)).
  • Methotrexate (a chemotherapeutic agent used in high doses for cancer treatment) – if you are taking high-dose methotrexate, your doctor may temporarily interrupt your treatment with OMASEPT.

If your doctor has prescribed the antibiotics amoxicillin and clarithromycin together with OMASEPT for the treatment of ulcers caused by Helicobacter pylori infection, it is very important that you inform your doctor 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, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine. Your doctor will decide whether you can take OMASEPT during pregnancy or while breastfeeding.

Omeprazole is excreted in breast milk, but it is unlikely to affect the infant when used at therapeutic doses. Your doctor will decide whether you can take OMASEPT while breastfeeding.

Driving and using machines

It is unlikely that OMASEPT will affect your ability to drive or use tools or machines. However, adverse drug reactions such as dizziness and visual disturbances may occur (see section 4). If you experience these, do not drive or operate machinery.

OMASEPT contains sucrose

If your doctor has diagnosed you with an intolerance to certain sugars, consult them before taking this medicine.

OMASEPT contains sodium

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

3. How to take OMASEPT

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, 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. The recommended doses are:

Adults

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

  • If your doctor has told you that your oesophagus is slightly damaged, the recommended dose is 20 mg once daily for 4–8 weeks. Your doctor may increase the dose to 40 mg for an additional 8 weeks if the oesophagus has not yet fully healed.
  • The recommended dose once the oesophagus has healed is 10 mg once daily.
  • If the oesophagus is not damaged, the usual dose is 10 mg once daily.

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

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

For the treatment of stomach ulcers (gastric ulcer):

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

For preventing the 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.

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

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

For preventing the formation of duodenal and gastric ulcers if you are using 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 (or 40 mg) of OMASEPT twice daily for one week.
  • Your doctor will also instruct you to take two antibiotics, chosen from amoxicillin, clarithromycin, and metronidazole.

For the treatment of excessive stomach acid caused by pancreatic tissue overgrowth (Zollinger-Ellison syndrome):

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

Use in children and adolescents

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

  • OMASEPT may be taken by children over 1 year of age and weighing more than 10 kg. The dose for children is based on body weight, and the exact dose will be determined by the doctor.

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

  • OMASEPT may be taken by children over 4 years of age. The dose for children is based on body weight, and the exact dose will be determined by the doctor.
  • Your doctor will also prescribe two antibiotics called amoxicillin and clarithromycin for your child.

How to take this medicine

  • 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. 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 stomach acid. 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 capsule and take the contents directly with half a glass of water, or pour the contents into a glass of water (non-carbonated), acidic fruit juice (e.g. apple, orange or pineapple), or apple puree.
    • Always shake the mixture before drinking (the mixture will not be clear), then drink it immediately or within 30 minutes.
    • To ensure that the entire dose is taken, rinse the glass thoroughly with half a glass of water and drink the rinse. The solid particles contain the medicine – do not chew or crush them.

Special populations:

  • If you are elderly and/or have impaired kidney function, you may take OMASEPT at the recommended doses.
  • If you have impaired liver function, a daily dose of 10–20 mg is recommended.

If you take more OMASEPT than you should
If you take more OMASEPT than prescribed by your doctor, contact your doctor or pharmacist immediately.
Symptoms reported include nausea, vomiting, dizziness, abdominal pain, diarrhoea, and headache. In isolated cases, apathy, depression, and confusion have also been observed. 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 for your 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 questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone 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 side effects, stop taking OMASEPT and contact your doctor immediately:

  • Sudden wheezing, swelling of the lips, tongue, throat or body, skin rash, fainting or difficulty swallowing (severe allergic reaction). (Rare)
  • Skin redness with blistering or peeling. Severe blistering with bleeding of the lips, eyes, mouth, nose or genitals may also occur. This could be “Stevens-Johnson syndrome” or “toxic epidermal necrolysis”. (Very rare)
  • Widespread rash, high temperature and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome). (Rare)
  • A widespread red, scaly rash with bumps under the skin and blisters accompanied by fever. Symptoms usually appear early in treatment (acute generalised exanthematous pustulosis). (Rare)
  • Yellowing of the skin, dark urine and fatigue could be symptoms of liver problems. (Rare)

The side effects are listed below in order of frequency:
Common side effects (may affect up to 1 in 10 people)

  • Headache
  • Stomach or intestinal problems: diarrhoea, stomach ache, constipation, passing wind (flatulence)
  • Feeling unwell (nausea) or being unwell (vomiting)
  • Benign polyps in the stomach

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

  • Swelling of the feet and ankles (peripheral oedema)
  • Disturbed sleep (insomnia)
  • Dizziness, tingling, drowsiness
  • Sensation of dizziness (vertigo)
  • Abnormalities in blood tests relating to liver function
  • Dermatitis, skin rash, skin rash with skin swelling (urticaria) and itching of the skin
  • General feeling of being unwell and lack of energy
  • If you take a proton pump inhibitor such as OMASEPT, especially for longer than one year, there may be a slight increase in the risk of fractures of the hip, wrist or spine. If you have osteoporosis or are taking corticosteroids (which may increase the risk of osteoporosis), consult your doctor.

Rare side effects (may affect up to 1 in 1,000 people)

  • Changes in blood composition, such as reduced numbers of white blood cells or platelets. This may cause weakness and easy bruising, or may make infections more likely.
  • Low levels of sodium in the blood. This may cause weakness, feeling unwell (vomiting) and cramps.
  • Feeling restless, confused or depressed.
  • Taste disturbances.
  • Vision problems, such as blurred vision.
  • Sudden wheezing or breathlessness (bronchospasm).
  • Dry mouth.
  • Inflammation inside the mouth.
  • A fungal infection called “candidiasis” which may affect the intestine.
  • Hair loss (alopecia).
  • Skin rash during 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 cell counts, including agranulocytosis (lack of white blood cells).
  • Aggressiveness.
  • Seeing, feeling or hearing things that are not real (hallucinations).
  • Severe liver problems up to liver failure and inflammation of the brain.
  • Erythema multiforme.
  • Muscle weakness.
  • Breast enlargement in men.

Not known (frequency cannot be estimated from the available data)

  • If you take OMASEPT for more than three months, your blood magnesium levels may decrease. Low magnesium levels may present as fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, increased heart rate. If you experience any of these symptoms, consult your doctor immediately. Low magnesium levels may also lead to reduced blood levels of potassium or calcium. Your doctor should decide whether periodic monitoring of blood magnesium levels is necessary.
  • Erythema, possible joint pain.
  • Reduced levels of calcium in the blood (hypocalcaemia). Reduced calcium levels may result from very low magnesium levels.
  • Reduced levels of potassium in the blood (hypokalaemia).
  • Inflammation of the intestine (resulting in diarrhoea).

In very rare cases, OMASEPT may affect white blood cells, leading to immunodeficiency. If you develop an infection with symptoms such as fever accompanied by a severe deterioration in your general health, or fever with signs of local infection such as neck, throat or mouth pain or difficulty urinating, you should contact your doctor as soon as possible to rule out a lack of white blood cells (agranulocytosis) by means of a blood test. It is important that in such cases you inform your doctor about the medicine you are taking.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via 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 below 30°C. Keep in the original packaging to protect the medicine from moisture.

Bottle:
Store below 30°C. Keep the bottle tightly closed to protect the medicine from moisture.
The shelf life after first opening is 30 days.

Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What OMASEPT contains

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

Capsule core: sugar spheres (sucrose and maize starch), sodium carboxymethyl starch (Type A), sodium lauryl sulfate, povidone, trisodium phosphate dodecahydrate, hypromellose, methacrylic acid–ethyl acrylate copolymer (1:1), triethyl citrate, titanium dioxide (E171), talc, sodium hydroxide.
Capsule cap: red iron oxide (E172) (only 10 mg), erythrosine (E127), indigo carmine (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” is printed in white ink on the cap and the number “10” on the body. The capsules are filled with pelletized microgranules ranging in color from white to beige.
Blister packs containing 14 and 28 capsules; bottle 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” is printed in white ink on the cap and the number “20” on the body. The capsules are filled with pelletized microgranules ranging in color from white to beige.
Blister packs containing 14 and 28 capsules; bottle 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” is printed in white ink on the cap and the number “40” on the body. The capsules are filled with pelletized microgranules ranging in color from white to beige.
Blister pack or bottle containing 14 capsules.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Pharmacare S.r.l.
Via Marghera, 29 - 20149 Milano
Italy

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