OMOLIN 10 mg Kapsułki O Działaniu Gastroopornym

Treść ulotki

1. OMOLIN
   1. What is OMOLIN and what it is used for
   2. What you need to know before taking OMOLIN
   3. How to take OMOLIN
   4. Possible side effects
   5. How to store OMOLIN
   6. Package contents and other information

OMOLIN

10 mg hard gastro-resistant capsules
20 mg hard gastro-resistant capsules
Omeprazole
Generic medicine

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 their symptoms are the same as yours, as it could 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 OMOLIN is and what it is used for
• 2. What you need to know before you take OMOLIN
• 3. How to take OMOLIN
• 4. Possible side effects
• 5. How to store OMOLIN
• 6. Contents of the pack and other information

1. What is OMOLIN and what it is used for

Omolin 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.
Omolin 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). Omolin 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
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• ‘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 may 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 OMOLIN

Do not take OMOLIN

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

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

Warnings and precautions
Talk to your doctor or pharmacist before taking Omolin.
Omolin can mask the symptoms of other diseases. Therefore, if you experience the symptoms described below before taking Omolin or while you are 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 diarrhoea, because omeprazole has been associated with a slight increase in infectious diarrhoea.
• Serious liver problems.
• If you take a proton pump inhibitor such as omeprazole, 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 you have ever had a skin reaction after treatment with a medicine similar to Omolin that reduces stomach acid.
• If you are to undergo a specific blood test (Chromogranin A).

If you take Omolin for a long time (more than 1 year), your doctor will probably prescribe you regular check-ups. Every time you see your doctor, report any new or exceptional symptoms and circumstances.
Taking a proton pump inhibitor such as Omolin, particularly for a period longer than one year, may slightly increase your risk of fractures of the hip, wrist or spine. Tell your doctor if you have osteoporosis or are taking corticosteroids (which can increase the risk of osteoporosis).
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If you notice the appearance of a skin rash, especially in areas exposed to sunlight, contact your doctor as soon as possible, as you may need to stop treatment with Omolin.
Also remember to report any other undesirable effects 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 one year of age or weighing < 10 kg.

Other medicines and OMOLIN
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is important because Omolin can influence the way some medicines work and, in turn, some medicines can affect the action of Omolin.
Do not take Omolin 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 Omolin.
• 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 Omolin.
• 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 at high doses for the treatment of cancer) - if you are taking high doses of methotrexate, your doctor may temporarily suspend treatment with omeprazole

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

OMOLIN 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 to have effects on the baby when used at therapeutic doses. If you are breastfeeding, your doctor will decide whether you can take Omolin.

Driving and using machines
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It is unlikely that Omolin 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 section 4). If you suffer from these, you should not drive vehicles or use machinery.

Omolin contains sucrose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

3. How to take OMOLIN

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 dose is:
Adults:
For the treatment of symptoms of GERD, 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. The doctor may increase the dose to 40 mg for another 8 weeks if the esophagus is not yet completely 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. The doctor may extend the intake of this dose for another 2 weeks if the ulcer has not yet healed.
• If the ulcer is not completely 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. The doctor may extend the intake of this dose for another 4 weeks if the ulcer has not yet healed.
• If the ulcer is not completely 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. 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 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.

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For the treatment of ulcers causedby infection byHelicobacter pyloriand prevention of their
recurrence :

• The usual dose is 20 mg of Omolin twice a day for one week.
• The doctor will tell you to also take two antibiotics among 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 should take the medicine.

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

• Omolin 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 by
Helicobacter pylori:

• Omolin 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 or without food.
• 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 present 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 OMOLIN than you should
If you take an amount of Omolin greater than that prescribed by your doctor, contact
your doctor or pharmacist immediately.

If you forget to take OMOLIN
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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 Omolin
Do not stop taking Omolin 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 but serious side effects, stop taking Omolin
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 formation of blisters with bleeding of the lips, eyes, mouth, nose and genitals may also appear. This could be “Stevens-Johnson syndrome” or “toxic epidermal necrolysis”.
• Yellowing of the skin, dark urine and fatigue may be symptoms of liver problems.

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 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.
• Fracture of the wrist, hip or spine.

Rare side effects (may affect up to 1 in 1000 people):

• Changes in the composition of the blood, 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. Page 6of 9
• 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” 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 (may affect up to 1 in 10000 people):

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

In very rare cases OMOLIN can affect white blood cells leading to immunodeficiency. If
you develop an infection with symptoms such as fever with a severedeterioration of general 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 that in
this case you inform the doctor about the medicine you are taking.

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

• Inflammation of the intestine (leading to diarrhea)
• If you have been treated with Omolin for more than 3 months, the levels of magnesium in the blood may decrease. Low levels of magnesium are visible in the form of fatigue, involuntary contractions, disorientation, convulsions, dizziness, increased heart rate. If you experience any of these symptoms, tell your doctor immediately. Low levels of magnesium can also lead to a decrease in potassium or calcium levels in the blood. The doctor may decide to perform regular blood tests to monitor your magnesium levels.
• Skin rash, possibly with joint pain.

Do not be worried by this list of possible side effects. You may not experience any of them.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist.
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You can also report side effects directly through the national reporting system at 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 OMOLIN

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging, blister or
bottle after Exp. The expiry date refers to the last day of the month.
Store at a temperature below 25°C.
OPA-Al-PVC/Al blister pack: Keep the blister in the original packaging to
protect the medicine from moisture.
HPDE bottle: Keep the bottle tightly closed 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 OMOLIN contains

• The active ingredient is omeprazole. OMOLIN capsules contain 10 mg or 20 mg of omeprazole.
• The other ingredients are: Capsule content:sugar spheres (consisting of corn starch and sucrose), sodium lauryl sulfate, anhydrous dibasic sodium phosphate, mannitol, hypromellose 6 cP, macrogol 6000, talc, polysorbate 80, titanium dioxide (E 171) and ethyl acrylate-methacrylic acid copolymer (1:1). Capsule shell:gelatin. The 10 and 20 mg capsules also contain quinoline yellow dye (E 104) and titanium dioxide (E 171).

Description of the appearance of OMOLIN and package contents

• OMOLIN 10 mg: opaque yellow capsule containing spherical microgranules ranging in color from whitish to cream.
• OMOLIN 20 mg: opaque yellow capsule containing spherical microgranules ranging in color from whitish to cream. The capsules are in blisters of 7, 14, 15, 28, 30, 50, 56, 60, 90, 100, 140, 280 and 500 capsules, and in HDPE bottles containing 5, 7, 14, 28, 30, 56, 60, 90 and 500 capsules.

Not all pack sizes may be marketed

Marketing Authorisation Holder

Marketing Authorisation Holder
S.F. GROUP Srl
Via Tiburtina 1143
00156 Rome
Italy

Manufacturer
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LABORATORIOS LICONSA S.A.
Avda. Miralcampo, 7 Poligono Industrial Miralcampo, 19200
Azuqueca da Henares
(Guadalajara) Spain

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
Estonia: Omolin
Netherlands: Omolin 10 / 20 / 40 mg, gastro-resistant capsules, hard
Hungary: Ludea 10 / 20 / 40 mggyomornedvnek ellenálló, kemény kapszula
Italy: Omolin 10 / 20 mg gastro-resistant hard capsules
Lithuania: Omolin 10 / 20 / 40 mg skrandyje neirios kietos kapsulės
Latvia: Omolin 10 / 20 / 40 mg zarnas skistosas cietas kapsulas
Poland: Agastin 10 / 20 / 40
Slovenia: Omolin 10 / 20 / 40 mg gastro-resistant capsule, hard
Slovakia: Asilar 10 / 20 / 40 mg tvrdá gastrorezistentná kapsula
Spain: Omeprazol Stada 40 mg cápsulas duras gastrorresistentes
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