ОМЕПРАЗОЛО 10 MG Enteric-coated hard capsule

Содержание инструкции

1. Omeprazolo Liconsa 10 mg hard gastro-resistant capsules, 20 mg hard gastro-resistant capsules, 40 mg hard gastro-resistant capsules
   1. What is Omeprazolo Liconsa and what is it 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. Package Contents and Other Information

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

Omeprazolo
Read this leaflet carefully before 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 Omeprazolo Liconsa is and what it is used for
• 2. What you need to know before you take 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 is Omeprazolo Liconsa and what is it used for

Omeprazolo Liconsa 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.
Omeprazolo Liconsa 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 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 ‘Helycobacter 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). Omeprazolo Liconsa can also be used to prevent the formation of ulcers if you are taking NSAIDs.
• Excessive acid 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 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 ‘ Helycobacter 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 Omeprazolo Liconsa

Do not take Omeprazolo Liconsa

• 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 Omeprazolo Liconsa if you fall into any of the above categories. If you have any doubts, ask your
doctor or pharmacist before taking Omeprazolo Liconsa.

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

• If you are going to undergo 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 treatment with omeprazole. Stop
using omeprazole and contact a doctor immediately if you notice any of the symptoms related
to these severe skin reactions described in section 4.
Omeprazolo Liconsa can mask the symptoms of other diseases. Therefore, if you experience the
symptoms described below before taking Omeprazolo Liconsa 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 stool (presence of blood in the stool).
• Severe or persistent diarrhea, because omeprazole has been associated with a slight increase in infectious diarrhea.
• Serious liver problems.
• Skin reaction after treatment with a medicine similar to Omeprazolo Liconsa that reduces stomach acid.

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.
If you take Omeprazolo Liconsa for a long time (more than 1 year), your doctor will probably keep you under
regular surveillance. You should report any new and unusual symptoms every time you
see your doctor.
If you take a proton pump inhibitor such as Omeprazolo Liconsa, 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.
If a rash appears, especially in areas exposed to the sun, tell your doctor as soon as
possible, as it may be necessary to stop treatment with Omeprazolo Liconsa. Remember to report any other adverse effects as well, such as joint pain.

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 Omeprazolo Liconsa
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 Omeprazolo Liconsa can
affect how some medicines work and, in turn, some medicines can have
effects on the action of Omeprazolo Liconsa.
Do not take Omeprazolo Liconsa 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 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 blockers. 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 transplantation).
• 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 at high doses to treat cancer) - if you are taking methotrexate at high doses, your doctor may temporarily interrupt treatment with Omeprazolo Liconsa.

If your doctor has prescribed you the antibiotics amoxicillin and clarithromycin together with Omeprazolo Liconsa
for the treatment of ulcers caused by Helycobacter pyloriinfections, 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, suspect you may be pregnant or are planning to become pregnant, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Omeprazole is excreted in breast milk but it is unlikely that when used at therapeutic doses it will have
an effect on the baby. The doctor will decide whether you can take Omeprazolo Liconsa during breastfeeding.

Driving and operating machinery
It is unlikely that Omeprazolo Liconsa will affect your ability to drive vehicles or use
tools or machinery. Adverse reactions to the drug such as dizziness and visual disturbances may occur
(see section 4). If you suffer from these, you should not drive vehicles or operate machinery.

Omeprazolo Liconsa contains sucrose.
Omeprazolo Liconsa contains sucrose. If your doctor has diagnosed you with an intolerance to some
sugars, contact him 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 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:

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 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 does not heal completely, 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 does not heal completely, 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 byHelycobacter pyloriand prevention of their
recurrence:

• The recommended dose is 20 mg of Omeprazolo Liconsa twice a day for one week.
• The doctor will tell you to also take two antibiotics from 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 will need to take the medicine.

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

• Omeprazolo Liconsa 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 byHelycobacter
pylori:

• Omeprazolo Liconsa 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), 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 Omeprazolo Liconsa than you should
If you take an amount of Omeprazolo Liconsa greater than that 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 to
take the next dose, skip the missed dose. Do not take a double dose to make up for the
missed 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 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 everybody gets them.

If you notice any of the following rare (may affect up to 1 in 1,000) or very rare (may affect up to 1 in 10,000) but serious side effects, stop taking
Omeprazolo Liconsa 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) (rare).
• Reddening of the skin with the appearance of blisters or peeling. Severe blistering with bleeding of the lips, eyes, mouth, nose and genitals may also occur. This could be “Stevens-Johnson syndrome” or “toxic epidermal necrolysis” (very rare).
• Widespread skin rash, high temperature and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome) (rare).
• Red, scaly and widespread skin 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 fatigue may be symptoms of liver problems (rare).

Other side effects include:

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

• 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 (may affect up to 1 in 100 people)

• Swelling of the feet and ankles.
• Disturbed sleep (insomnia).
• Dizziness, tingling, feeling sleepy.
• Feeling lightheaded (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 discomfort and lack of energy.

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

• Changes in blood cell 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.
• Low levels of sodium in the blood. This can cause weakness, feeling unwell (vomiting) and cramps.
• Feeling agitated, confused or depressed.
• Changes in taste.
• Eye problems, such as blurred vision.
• Sudden wheezing or shortness of breath (bronchospasm).
• Dry mouth.
• Inflammation inside the mouth.
• Infection called “candidiasis” that can affect the intestines and is caused by a fungus.
• Hair loss (alopecia).
• Skin rash during exposure to the sun.
• Joint pain (arthralgia) or muscle pain (myalgia).
• Serious kidney problems (interstitial nephritis).
• Increased sweating.

Very rare side effects (may affect up to 1 in 10,000)

• Changes in the blood cell count, 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 skin rashes 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)

• Inflammation of the intestine (resulting in diarrhea).
• If you take Omeprazolo Liconsa for more than three months, it is possible that your blood magnesium levels 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.
• Skin rash, possibly with joint pain.

In very rare cases Omeprazolo Liconsa may affect white blood cells leading to an immuno-deficiency.
If you should develop an infection with symptoms such as fever with a serious deterioration of the general
state of health, or fever with symptoms of local infection such as sore throat, sore throat or
mouth or difficulty urinating, you should consult a doctor as soon as possible, in order to rule out a
lack of white blood cells (agranulocytosis) by performing a blood test. It is important in
this case to inform the doctor about the medicine you are taking.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. You can also report side effects directly through the national reporting system at: 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 Omeprazolo Liconsa

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date that is stated on the pack after Exp. The expiry date
refers to the last day of that month.
Store at a temperature below 25°C.
Store in the original packaging, to protect the medicine from moisture.
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. Package Contents and Other Information

What Omeprazolo Liconsa contains

• The active ingredient is omeprazole. The gastroresistant hard capsules of Omeprazolo Liconsa (gastroresistant capsules) contain 10 mg, 20 mg or 40 mg of omeprazole.
• The other ingredients are sugar spheres (composed of corn starch and sucrose), magnesium hydroxide, corn starch, disodium phosphate, hypromellose, sodium lauryl sulfate, 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 package contents
Omeprazolo Liconsa 10 mg capsules: capsule of approximately 15 mm, with a green cap and white body, containing
spherical granules of colour from white to off-white or cream-white.
Omeprazolo Liconsa 20 mg capsules: capsule of approximately 15 mm, with a blue cap and white body, containing
spherical granules of colour from white to off-white or cream-white.
Omeprazolo Liconsa 40 mg capsules: capsule of approximately 16 mm, with a white cap and grey body, containing
spherical granules of colour from white to off-white or cream-white.
Package sizes:
Omeprazolo Liconsa 10 mg is available in PVC/PE/PVdC//Alu blisters of 7, 14, 15, 28, 30, 56 and 100
gastroresistant hard capsules.
Omeprazolo Liconsa 20 mg is available in PVC/PE/PVdC//Alu blisters of 7, 14, 15, 28, 30, 56 and 100
gastroresistant hard capsules.
Omeprazolo Liconsa 40 mg is available in PVC/PE/PVdC//Alu blisters of 7, 14, 15, 28, 30, 56 and 100
gastroresistant hard capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
LABORATORIOS LICONSA, S.A.
C/Dulcinea s/n
Alcalá de Henares, Madrid
28805
Spain

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

This medicinal product is authorised in the Member States of the European Economic Area with the following
names:
Sweden Omeprazole Liconsa 10/20/40 mg hard gastroresistant capsule
Belgium Omeprazole Liconsa 10/20/40 mg gastroresistant 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)