Limnos

PACKAGE LEAFLET: INFORMATION FOR THE USER

LIMNOS 20 mg gastro-resistant hard 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. It may be harmful to other people, even if their symptoms are the same as yours.
• If any of the side effects worsens, or if you notice any side effects not listed in this leaflet, inform 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 taking 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 substance omeprazole. It belongs to a group of medicines called
'proton pump inhibitors', which work by reducing the amount of acid produced in the
stomach.
LIMNOS is used to treat the following conditions:

In adults:

• 'Gastro-oesophageal reflux disease' (GERD). This condition occurs when acid leaks out of the stomach and passes into the oesophagus (the tube connecting the throat to the stomach), causing pain, inflammation, and heartburn.
• Ulcers in the upper part of the intestine (duodenal ulcer) or in the stomach (gastric ulcer).
• Ulcers infected with a bacterium called 'Helicobacter pylori'. If you have this condition, 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 may also be used to prevent ulcers from forming if you are taking NSAIDs.
• Excess stomach acid caused by a growth of tissue in the pancreas (Zollinger-Ellison syndrome).

In children:
Children above 1 year of age and with body weight greater than or equal to 10 kg

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

In children, symptoms of this condition may also include regurgitation of stomach contents back into the mouth, discomfort (vomiting), and poor weight gain.
Children above 4 years of age and adolescents
Ulcers infected with a bacterium called 'Helicobacter pylori'. If your child has this
condition, the doctor may prescribe antibiotics to treat the infection and allow the ulcer to heal.

2. WHAT YOU SHOULD KNOW BEFORE TAKING LIMNOS

Do not take LIMNOS

• If you are allergic (hypersensitive) to omeprazole or to 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, consult 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 gastric acidity
• if you need to undergo a specific blood test (chromogranin A).

During treatment with omeprazolo, inflammation of the kidneys may occur. Signs and
symptoms may include reduced urine volume 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.
If you notice the appearance of 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
LIMNOS. Remember to also report any other adverse effects such as joint pain.
Exercise special caution with LIMNOS
LIMNOS may mask symptoms of other diseases. Therefore, if you experience any of the
following symptoms before or while taking LIMNOS, contact your doctor
immediately:

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

If you have been taking LIMNOS for a long time (more than 1 year), your doctor will prescribe regular check-ups.
Inform your doctor if you notice the onset of new or unusual symptoms.
If you are taking a proton pump inhibitor such as LIMNOS, 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 suffer from osteoporosis or are taking corticosteroids (which may 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 without a prescription. This is important because LIMNOS may
affect how some medicines work, and conversely, some medicines may affect the action of LIMNOS.
Do not take LIMNOS if you are taking a medicine containing nelfinavir (used for the
treatment of HIV infections).
Inform 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 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 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 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)
• Saquinavir (used to treat HIV infection)
• Clopidogrel (used to prevent blood clots (thrombi))
• Erlotinib (used to treat cancer)
• Methotrexate (a chemotherapeutic medicine used in high doses to treat cancer) - if you are taking high-dose methotrexate, your doctor may temporarily discontinue treatment with LIMNOS.

If your doctor has prescribed the antibiotics amoxicillin and clarithromycin together with LIMNOS for the
treatment of ulcers caused by Helicobacter pylori infection, it is very important that
you report whether you are taking any other medicines.
Taking LIMNOS with food and drinks
The capsules can be taken with food or on an empty stomach.
Pregnancy and breastfeeding
Before taking LIMNOS, inform your doctor if you are pregnant or intend to become pregnant. Your doctor will decide whether you can take LIMNOS during this period.
Your doctor will decide whether you can take LIMNOS during breastfeeding.
Driving and using machines
It is unlikely that LIMNOS will affect your ability to drive or use tools or machinery. Adverse drug reactions such as dizziness and visual disturbances may occur (see section 4). If you experience these, do not drive or use machinery.

3. HOW TO TAKE LIMNOS

Always take LIMNOS exactly as directed by your doctor. 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 listed below.

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

• If your doctor has informed you that your esophagus is slightly damaged, the usual 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 esophagus has not yet fully healed.
• The usual dose once the esophagus has healed is 10 mg once daily.
• If the esophagus 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 usual 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 usual 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 usual 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 usual 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 usual dose is 20 mg once daily.

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

• The usual dose is 20 mg of LIMNOS twice daily for one week.
• Your doctor will also instruct you to take two antibiotics among amoxicillin, clarithromycin, and metronidazole.

For the treatment of excessive stomach acid caused by an overgrowth of 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 will also decide how long you should take the medicine.

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

• LIMNOS 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:

• LIMNOS 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 for your child: amoxicillin and clarithromycin.

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 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 applesauce.
  • Always shake the mixture before drinking (the mixture will not be clear), and drink it immediately or within 30 minutes.
  • To ensure you have taken the entire dose, 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.

If you take more LIMNOS than you should
If you take more LIMNOS than 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 for your next dose, skip the missed dose. Do not take a double dose to make up for the forgotten dose.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, LIMNOS can cause adverse reactions, although not everyone experiences them.
If you notice any of the following rare but serious adverse reactions, stop taking
LIMNOS and contact your doctor immediately:

• Sudden wheezing, swelling of the lips, tongue, throat or body, rash, fainting or difficulty swallowing (severe allergic reaction).
• Skin redness with blistering or peeling. Severe blistering may also occur, 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 could be symptoms of liver problems. Adverse reactions may occur with a certain frequency, as defined below:

Other adverse effects include:
Common adverse effects

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

Uncommon adverse effects

• Swelling of the feet and ankles.
• Disturbed sleep (insomnia).
• Dizziness, tingling, drowsiness.
• Sensation of spinning (vertigo).
• Changes in blood tests related to liver function.
• Skin rash, skin rash with swelling of the skin (urticaria), and itching of the skin.
• General feeling of being unwell and lack of energy.
• If you take a proton pump inhibitor such as LIMNOS, 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 adverse effects

• Changes in blood composition, such as reduced number of white blood cells or platelets. This may cause weakness and easy bruising, or may make infections more likely.
• Allergic reactions, sometimes very severe, including swelling of the lips, tongue and throat, fever, shortness of breath.
• Low levels of sodium in the blood. This may cause weakness, feeling unwell (vomiting) and cramps.
• Feeling restless, confused or depressed.
• Changes in taste.
• Vision problems, such as blurred vision.
• Sudden shortness of breath or wheezing (bronchospasm).
• Dry mouth.
• Inflammation inside the mouth.
• An infection called "candidiasis" which may affect the intestine and is caused by a fungus.
• Liver problems, including jaundice, which may cause yellowing of the skin, dark urine and tiredness.
• 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

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

Frequency not known

• Inflammation of the intestine (resulting in diarrhoea).
• Erythema, possible joint pain.
• If you take LIMNOS for more than three months, your blood magnesium levels may decrease. Low magnesium levels may present as fatigue, involuntary muscle contractions, disorientation, seizures, vertigo, and increased heart rate. If you experience any of these symptoms, consult your doctor immediately so that a lack of white blood cells (agranulocytosis) can be ruled out with a blood test. It is important that in this case you inform your doctor about the medicine you are taking.
• Decreased calcium levels in the blood (hypocalcemia). Reduced calcium levels in the blood may result from very low magnesium levels.

In very rare cases, LIMNOS 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 symptoms of local infection such as neck, throat or mouth pain, or difficulty urinating, you must consult your doctor as soon as possible so that a lack of white blood cells (agranulocytosis) can be excluded by a blood test. It is important that in this case you inform your doctor about the medicine you are taking.
Do not be alarmed by this list of possible adverse effects. You may not experience any of them.
If any of the adverse effects worsen, or if you notice any adverse effect not listed in this leaflet, inform your doctor or pharmacist.
Reporting of adverse effects
If you experience any adverse effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report adverse effects directly via the national reporting system at the website
http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting adverse 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 above 30°C.
• Store the blister pack in the original packaging.
• Medicines must 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 substance is omeprazole. LIMNOS capsule contains 20 mg of omeprazole.
• The excipients are: core: microcrystalline cellulose, low-substituted hydroxypropylcellulose, mannitol, croscarmellose sodium, 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 shell: gelatin, indigo carmine (E-132), titanium dioxide, water.

Description of the appearance of LIMNOS and the contents of the pack
LIMNOS 20 mg capsules have a blue body and cap.
Pack sizes:
Blister packs containing 14 capsules
Blister packs containing 28 capsules

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

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

REVISION OF THE PACKAGE LEAFLET BY THE ITALIAN MEDICINES AGENCY: