Omeprazole Liconsa

Package leaflet: Information for the user

Omeprazolo Liconsa 10 mg gastro-resistant hard capsules, 20 mg gastro-resistant hard capsules, 40 mg gastro-resistant hard capsules

Omeprazole
Please read this leaflet carefully before 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 they have the same symptoms as yours, because it may be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Omeprazolo Liconsa is and what it is used for

Omeprazolo Liconsa 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 by the
stomach.
Omeprazolo Liconsa is used to treat the following conditions:

In adults:

• Treatment of 'gastro-oesophageal reflux disease' (GERD). This condition occurs when acid leaks from the stomach 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). Omeprazolo Liconsa can also be used to prevent the formation of ulcers if you are taking NSAIDs.
• Excess stomach acid caused by a growth of tissue in the pancreas (Zollinger-Ellison syndrome).

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

• Treatment of 'gastro-oesophageal reflux disease' (GERD). This condition occurs when acid leaks from the stomach 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 into the mouth, discomfort (vomiting), and poor weight gain.

Children over 4 years of age and adolescents

• Ulcers infected with a bacterium called Helicobacter pylori. If your child has this condition, the doctor may also prescribe antibiotics to treat the infection and allow the ulcer to heal.

2. What you need to know before taking Omeprazolo Liconsa

Do not take Omeprazolo Liconsa

• 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, rabeprazolo, esomeprazole).
• If you are taking a medicine containing nelfinavir (used for HIV infections).

Do not take Omeprazolo Liconsa if any of the above apply to you. If you are unsure, consult your doctor or pharmacist before taking Omeprazolo Liconsa.
Warnings and precautions
Talk to your doctor or pharmacist before taking Omeprazolo Liconsa:

• If you are due to have a specific blood test (Chromogranin A).

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 omeprazole treatment. Stop taking omeprazole and contact a doctor immediately if you notice any symptoms related to these severe skin reactions described in section 4.
Omeprazolo Liconsa may mask symptoms of other diseases. Therefore, if you experience any of the following symptoms before or while taking Omeprazolo Liconsa, contact your doctor immediately:

• Unexplained 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, as omeprazole has been associated with a slight increase in risk of infectious diarrhea.
• Severe liver problems.
• Skin reaction after treatment with a medicine similar to Omeprazolo Liconsa that reduces stomach acid.

During treatment with omeprazole, 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 take Omeprazolo Liconsa long-term (more than 1 year), your doctor will likely monitor you regularly. You should report any new or unusual symptoms or circumstances at each doctor's visit.
If you take a proton pump inhibitor such as Omeprazolo Liconsa, 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 can increase the risk of osteoporosis), consult your doctor.
If a skin rash develops, especially in sun-exposed areas, inform your doctor as soon as possible, as it may be necessary to discontinue treatment with Omeprazolo Liconsa. Remember to report any other adverse effects, such as joint pain.
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 Omeprazolo Liconsa
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription. This is important because Omeprazolo Liconsa can affect how some medicines work, and conversely, some medicines can affect the action of Omeprazolo Liconsa.
Do not take Omeprazolo Liconsa 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 at the beginning and end of treatment with Omeprazolo Liconsa.
• 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 Omeprazolo Liconsa.
• 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 agent used in high doses to treat cancer) – if you are taking high-dose methotrexate, your doctor may temporarily discontinue your treatment with Omeprazolo Liconsa.

If your doctor has prescribed the antibiotics amoxicillin and clarithromycin together with Omeprazolo Liconsa for the treatment of ulcers caused by Helicobacter pylori infection, it is very important that you report if you are taking any other medicines.
Omeprazolo Liconsa with food and drink
See section 3.
Pregnancy, breastfeeding, and fertility
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
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 Omeprazolo Liconsa during breastfeeding.
Driving and using machines
It is unlikely that Omeprazolo Liconsa will affect your ability to drive or use tools or machines. Adverse drug reactions such as dizziness and visual disturbances may occur (see section 4). If you experience these, do not drive or operate machinery.
Omeprazolo Liconsa contains sucrose.
Omeprazolo Liconsa contains sucrose. If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.
Omeprazolo Liconsa contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e. essentially "sodium-free".

3. How to take Omeprazolo Liconsa

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 age.
The recommended doses are:
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 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 esophagus has not yet fully healed.
• The recommended 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 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 taking NSAIDs:

• The recommended dose is 20 mg once daily.

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

• The recommended dose is 20 mg of Omeprazolo Liconsa 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 pancreatic tissue overgrowth (Zollinger-Ellison syndrome):

• The recommended dose is 60 mg daily.
• 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:

• Omeprazolo Liconsa 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 Helycobacter pylori infection:

• Omeprazolo Liconsa 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. Do not chew or crush the capsules, as they contain coated granules designed to protect 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 mix the contents in a glass of water (non-carbonated), in acidic fruit juice (e.g., apple, orange, or pineapple), or in apple puree.
• 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 full dose, rinse the glass thoroughly with half a glass of water and drink the rinse water. The solid particles contain the medicine; do not chew or crush them.

If you take more Omeprazolo Liconsa than you should
If you take more Omeprazolo Liconsa than prescribed by your doctor, contact your doctor or pharmacist immediately.
If you forget to take Omeprazolo Liconsa
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 Omeprazolo Liconsa
Do not stop taking Omeprazolo Liconsa without first talking to your doctor or pharmacist. If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, 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 side effects, stop taking Omeprazolo Liconsa and contact your doctor immediately:

• Sudden wheezing, swelling of the lips, tongue, throat or body, rash, fainting or difficulty swallowing (severe allergic reaction) (rare).
• Redness of the skin with blistering or peeling. There may also be severe blistering with bleeding of the lips, eyes, mouth, nose and genitals. 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).
• Widespread red, scaly rash with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis) (rare).
• Yellowing of the skin, dark urine and tiredness could be symptoms of liver problems (rare).

Other side effects include:
Common side effects (may affect up to 1 in 10 people)

• Headache
• Stomach or intestinal problems: diarrhoea, stomach pain, 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
• Disturbed sleep (insomnia)
• Dizziness, tingling, drowsiness
• Sensation of spinning (vertigo)
• Changes in blood tests related to liver function
• Rash, rash with skin swelling (urticaria) and itching of the skin
• General feeling of being unwell and lack of energy

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

• 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.
• Low levels of sodium in the blood. This may cause weakness, feeling unwell (vomiting) and cramps.
• Feeling restless, confusion or depression.
• Changes in taste.
• Vision problems, such as blurred vision.
• Sudden wheezing or shortness of breath (bronchospasm).
• Dry mouth.
• Inflammation inside the mouth.
• Infection called “candidiasis” which may affect the intestine and is caused by a fungus.
• Hair loss (alopecia).
• 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).
• 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 rashes or blisters and skin peeling. 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.

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

• Inflammation of the intestine (resulting in diarrhoea).
• If you take Omeprazolo Liconsa 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 levels of potassium or calcium in the blood. Your doctor should decide whether to periodically monitor your blood magnesium levels.
• Rash, possibly with joint pain.

In very rare cases, Omeprazolo Liconsa may affect white blood cells, leading to immunodeficiency.
If you develop an infection with symptoms such as fever with a severe deterioration in your general health, or fever with symptoms of a 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 this case 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 national reporting system at the following website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Omeprazolo Liconsa

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 packaging after Exp. The expiry
date refers to the last day of that month.
Store below 25°C.
Keep in the original packaging to protect the medicine from moisture.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.

6. Pack contents and other information

What Omeprazolo Liconsa contains

• The active substance is omeprazole. Omeprazolo Liconsa hard gastro-resistant capsules (gastro-resistant capsules) contain 10 mg, 20 mg or 40 mg of omeprazole.
• The other ingredients are sugar spheres (composed of maize starch and sucrose), magnesium hydroxide, maize starch, disodium phosphate, hypromellose, sodium lauryl sulphate, mannitol (E421), sodium starch glycolate, talc, titanium dioxide (E171), macrogol, polysorbate 80 and methacrylic acid-ethyl acrylate copolymer (1:1).
• The 10 mg gelatin capsules contain: Brilliant Blue FCF (E133), yellow iron oxide (E172), titanium dioxide (E171) and gelatin.
• The 20 mg gelatin capsules contain: indigotine (E132), titanium dioxide (E171) and gelatin.
• The 40 mg gelatin capsules contain: black iron oxide (E172), titanium dioxide (E171) and gelatin.

Description of the appearance of Omeprazolo Liconsa and pack contents
Omeprazolo Liconsa 10 mg capsules: approximately 15 mm capsule with a green cap and white body, containing spherical granules ranging in colour from white to off-white or cream-white.
Omeprazolo Liconsa 20 mg capsules: approximately 15 mm capsule with a blue cap and white body, containing spherical granules ranging in colour from white to off-white or cream-white.
Omeprazolo Liconsa 40 mg capsules: approximately 16 mm capsule with a white cap and grey body, containing spherical granules ranging in colour from white to off-white or cream-white.

Pack sizes:
Omeprazolo Liconsa 10 mg is available in PVC/PE/PVdC//Alu blisters containing 7, 14, 15, 28, 30, 56 and 100 hard gastro-resistant capsules.
Omeprazolo Liconsa 20 mg is available in PVC/PE/PVdC//Alu blisters containing 7, 14, 15, 28, 30, 56 and 100 hard gastro-resistant capsules.
Omeprazolo Liconsa 40 mg is available in PVC/PE/PVdC//Alu blisters containing 7, 14, 15, 28, 30, 56 and 100 hard gastro-resistant capsules.
Not all pack sizes may be marketed.

Marketing Authorization Holder
LABORATORIOS LICONSA, S.A.
C/Dulcinea s/n
Alcalá de Henares, Madrid
Spain

Manufacturer
Laboratorios Liconsa S.A.
Avenida De Miralcampo 7
Poligono Industrial Miralcampo
Azuqueca De Henares, Guadalajara 19200
Spain

This medicinal product is authorized in the European Economic Area countries under the following names:
Sweden Omeprazole Liconsa 10/20/40 mg hard enteric capsule
Belgium Omeprazole Liconsa 10/20/40 mg gastro-resistant capsules
France Omeprazole Liconsa 10/20/40 mg gastro-resistant capsule
Greece Omeprazole Liconsa (10/20/40 mg)
Italy Omeprazolo Liconsa (10/20/40 mg)