LIMNOS 20 mg Enteric-Coated Hard Capsule

Содержание инструкции

1. LIMNOS 20 mg hard gastro-resistant capsules
   1. WHAT LIMNOS IS AND WHAT IT IS USED FOR
   2. WHAT YOU NEED TO KNOW BEFORE TAKING LIMNOS
   3. HOW TO TAKE LIMNOS
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE LIMNOS
   6. OTHER INFORMATION

LIMNOS 20 mg hard gastro-resistant capsules

Omeprazole
Read this leaflet carefully before taking this medicine.

• 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 personally. Never give it to others. In fact, this medicine may be dangerous for other individuals, even if their symptoms are the same as yours.
• If any of the side effects worsen, or if you notice any side effect not listed in this leaflet, tell your doctor or pharmacist.

Contents of this leaflet:

• 1. What LIMNOS is and what it is used for
• 2. What you need to know before you take LIMNOS
• 3. How to take LIMNOS
• 4. Possible side effects
• 5. How to store LIMNOS
• 6. Further information

1. WHAT LIMNOS IS AND WHAT IT IS USED FOR

LIMNOS 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.
LIMNOS is used for the treatment of the following conditions:
In adults:

• ‘Gastro-oesophageal reflux disease’ (GERD). This disease occurs when acid leaks from the stomach and passes into the oesophagus (the tube that connects the throat to the stomach) causing pain, inflammation and heartburn.
• 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). LIMNOS can also be used to prevent the formation of ulcers if you are taking NSAIDs.
• Excessive acid in the stomach caused by an increase of tissue in the pancreas (Zollinger-Ellison syndrome).

In children:

Children aged over 1 year and with a body weight greater than or equal to 10 kg

• ‘Gastro-oesophageal reflux disease’ (GERD). This disease occurs when acid leaks from the stomach and passes 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.

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 LIMNOS

Do not take LIMNOS

• If you are allergic (hypersensitive) to omeprazole or any of the excipients of LIMNOS.
• 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).

If you have any doubts, ask your doctor or pharmacist before taking LIMNOS.

Warnings and precautions
Tell your doctor before taking this medicine:

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

During treatment with omeprazole, inflammation of your kidneys may occur. Signs and
symptoms may include a 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.
If you notice the appearance of a skin rash, especially in areas exposed to sunlight, contact
your doctor as soon as possible, as it may be necessary to stop therapy with
LIMNOS. Remember to also report any other undesirable effects such as joint
pain.

Pay particular attention with LIMNOS
LIMNOS may mask the symptoms of other diseases. Therefore, if you experience the symptoms described below before taking LIMNOS or while taking it, contact your doctor
immediately:

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

If you take LIMNOS for a long time (more than 1 year) your doctor will prescribe regular check-ups.
Tell your doctor if you notice the appearance of new and particular symptoms.
If you are taking a proton pump inhibitor such as LIMNOS, 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.

Taking LIMNOS with other medicines
Tell your doctor or pharmacist if you are taking or have recently taken any other
medicines, including those available without a prescription. This is important because LIMNOS can
affect the way some medicines work and, in turn, some medicines can have
effects on the action of LIMNOS.
Do not take LIMNOS 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:

• 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 LIMNOS
• 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 LIMNOS
• 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)
• Saquinavir (used for the treatment of HIV infection)
• Clopidogrel (used to prevent blood clots (thrombi))
• Erlotinib (used for the treatment of cancer)
• 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 LIMNOS.

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

Taking LIMNOS with food and drink
The capsules can be taken with food or on an empty stomach.

Pregnancy and breastfeeding
Before taking LIMNOS tell your doctor if you are pregnant or if you wish to become
pregnant. The doctor will decide if you can take LIMNOS during this period.
The doctor will decide if you can take LIMNOS during breastfeeding.

Driving and operating machinery
It is unlikely that LIMNOS can affect your ability to drive vehicles or use tools or
machinery. Adverse reactions to the medicine such as dizziness and visual disturbances may occur (see
paragraph 4). If you suffer from these, do not drive vehicles or use machinery.

3. HOW TO TAKE LIMNOS

Always take LIMNOS exactly as your doctor has instructed. 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 age.
The usual doses are given below.

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

• If your doctor has told you that your esophagus is slightly damaged, the usual dose is 20 mg once a day for 4-8 weeks. Your doctor may increase the dose to 40 mg for another 8 weeks if the esophagus is not yet fully healed.
• The usual 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 usual dose is 20 mg once a day for 2 weeks. Your doctor may extend the intake of this dose for another 2 weeks if the ulcer has not yet healed.
• If the ulcer has not fully healed, the dose may be increased to 40 mg once a day for 4 weeks.

For the treatment of stomach ulcers(gastric ulcer):

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

To preventthe recurrence of duodenal and gastric ulcers:

• The usual dose is 10 mg or 20 mg once a day. Your 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 usual 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 usual dose is 20 mg once a day.

For the treatment of ulcers caused by infection with Helicobacter pyloriand prevention of their
recurrence:

• The usual dose is 20 mg of LIMNOS twice a day for one week.
• Your doctor will also tell you to take two antibiotics, such as amoxicillin, clarithromycin and metronidazole.

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

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

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

• LIMNOS 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 with
Helicobacter pylori:

• LIMNOS 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.
• Your 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), acidic 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.

If you take more LIMNOS than you should
If you take an amount of LIMNOS greater than that prescribed by your doctor, contact
your doctor or pharmacist immediately.

If you forget to take LIMNOS
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 missed dose.

4. POSSIBLE SIDE EFFECTS

Like all medicines, LIMNOS can cause side effects, although not everybody gets them.
manifest.

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

• Sudden wheezing, swelling of the lips, tongue and throat or body, skin rash, fainting or difficulty swallowing (severe allergic reaction).
• Redness of the skin with the appearance of blisters or peeling. A severe blistering may also appear with bleeding of the lips, eyes, mouth, nose and genitals. This could be "Stevens-Johnson syndrome" or "toxic epidermal necrolysis".
• Yellowing of the skin, dark urine and fatigue may be symptoms of liver problems. Side effects can occur with a certain frequency, as defined below:

Other side effects include:

Common side effects

• 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 side effects

• Swelling of the feet and ankles.
• Disturbed sleep (insomnia).
• Dizziness, tingling, feeling sleepy.
• Feeling of spinning (vertigo).
• Changes in blood tests related to liver function.
• Skin rash, skin rash with swelling of the skin (urticaria) and itching on the skin.
• General feeling of unwellness and lack of energy.
• If you are taking a proton pump inhibitor such as LIMNOS, 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 side effects

• Changes in blood composition, 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).
• Skin rash during exposure to sunlight.
• Joint pain (arthralgia) or muscle pain (myalgia).
• Serious kidney problems (interstitial nephritis).
• Increased sweating.

Very rare side effects

• Changes in blood cell counts, including agranulocytosis (lack of white blood cells)
• Aggression.
• Seeing, feeling or hearing things that are not real (hallucinations).
• Serious liver problems up to liver failure and brain inflammation.
• Sudden onset of 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

• Inflammation of the intestine (resulting in diarrhea).
• Erythema, possible joint pains.
• If you take LIMNOS 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 check magnesium levels in the blood periodically.
• Decreased levels of calcium in the blood (hypocalcemia). Decreased levels of calcium in the blood may result from very low levels of magnesium.

In very rare cases LIMNOS can affect white blood cells leading to immunodeficiency. If
you should develop an infection with symptoms such as fever with a seriousdeterioration in
general health or fever with symptoms of local infection such as sore throat, sore throat or
difficulty urinating, you should consult a doctor as soon as possible, so as to rule out
a lack of white blood cells (agranulocytosis) by performing a blood test. It is important that
in this case you inform the doctor about the medicine you are taking.
Do not worry about the list of possible side effects. You may not experience any of them.
If any of the side effects gets worse, or if you notice any side effect

Reporting of side effects
If 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 national reporting system at
http://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 LIMNOS

• Keep LIMNOS out of the reach and sight of children.
• Do not use LIMNOS after the expiry date stated on the packaging after Exp. The expiry date refers to the last day of the month.
• Do not store at a temperature above 30°C.
• Keep the blister in the original packaging.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. OTHER INFORMATION

What LIMNOS contains

• The active ingredient is omeprazole. LIMNOS capsules contain 20 mg of omeprazole.
• The excipients are: core: microcrystalline cellulose, low-substituted hydroxypropylcellulose, mannitol, sodium croscarmellose, polysorbate 80, povidone K-30, arginine, sodium lauryl sulfate, glycine, light magnesium carbonate. Coating: hypromellose, methacrylic acid-ethyl acrylate copolymer, triethyl citrate, sodium hydroxide, titanium dioxide, talc. Capsule: gelatin, indigo carmine (E-132), titanium dioxide, water.

Description of the appearance of LIMNOS and contents of the pack
LIMNOS 20 mg capsules have a light blue body and cap.
Packs:
Blisters containing 14 capsules
Blisters containing 28 capsules

MARKETING AUTHORISATION HOLDER
Laboratorio Farmaceutico C.T. S.r.l. – Via Dante Alighieri, 71 – 18038 Sanremo (IM)

MANUFACTURER AND FINAL CONTROL
Special Product’s Line SpA - Via Fratta Rotonda Vado Largo, 1 - 03012 Anagni (FR)

OF THE MEDICINAL PRODUCT: