Omolin

Package leaflet: Information for the patient

OMOLIN

10 mg gastro-resistant hard capsules
20 mg gastro-resistant hard capsules
Omeprazole
Equivalent medicine
Please read all of 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. Never give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact 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 taking 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 OMOLIN is and what it is used for

Omolin 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.

Omolin is used to treat the following conditions:

In adults:

• 'Gastro-oesophageal reflux disease' (GERD). This condition occurs when acid leaks out of 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). Omolin may also be used to prevent ulcers from developing if you are taking NSAIDs.
• Excessive acid production due to overgrowth of tissue in the pancreas (Zollinger-Ellison syndrome).

In children:
Children over 1 year of age and weighing more than or equal to 10 kg

• 'Gastro-oesophageal reflux disease' (GERD). This condition occurs when acid leaks out of 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 back 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.

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2. What you need to know before taking OMOLIN

Do not take OMOLIN

• If you are allergic to omeprazole or to 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, consult your doctor or pharmacist before taking Omolin.
Warnings and precautions
Talk to your doctor or pharmacist before taking Omolin.
Omolin may mask symptoms of other diseases. Therefore, if you experience any of the following symptoms before or while taking Omolin, contact your doctor immediately:

• Unintentional weight loss and difficulty swallowing.
• Stomach pain or indigestion.
• Vomiting of food or blood.
• Dark-coloured stools (indicating presence of blood in stools).
• Severe or persistent diarrhoea, as omeprazole has been associated with a slight increase in risk of infectious diarrhoea.
• Severe liver problems.
• If you take a proton pump inhibitor such as omeprazole, particularly 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.
• If you have ever had a skin reaction after treatment with a medicine similar to Omolin that reduces stomach acid.
• If you are scheduled for a specific blood test (Chromogranin A).

If you have been taking Omolin for a long time (more than 1 year), your doctor will likely prescribe regular check-ups. Each time you see your doctor, report any new or unusual symptoms or circumstances.
Taking a proton pump inhibitor such as Omolin, particularly for longer than one year, may slightly increase your risk of fractures of the hip, wrist, or spine. Inform your doctor if you have osteoporosis or if you are taking corticosteroids (which may increase the risk of osteoporosis).
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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 Omolin.
Remember to also report any other adverse effects such as joint pain.
Children
Some children with chronic diseases 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
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is important because Omolin can affect how some medicines work, and some medicines can affect how Omolin works.
Do not take Omolin 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:

• 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 closely 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 closely at the beginning and end of treatment with Omolin.
• 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 agent used at high doses for cancer treatment) – if you are taking high doses of methotrexate, your doctor may temporarily suspend treatment with omeprazole

If your doctor has prescribed the antibiotics amoxicillin and clarithromycin together with Omolin for the treatment of ulcers caused by Helicobacter pylori infection, it is very important that you inform them if you are taking any other medicines.
OMOLIN with food and drinks
See section 3.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you might be pregnant, planning to become pregnant, or breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Omeprazole is excreted in breast milk but is unlikely to affect the breastfed infant 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 will affect your ability to drive or operate machinery. However, adverse drug reactions such as dizziness and visual disturbances may occur (see section 4). If you experience these, do not drive or operate machinery.
Omolin contains sucrose
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3. How to take OMOLIN

Take this medicine exactly as instructed 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 dose is:

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.
• Once the esophagus has healed, the usual dose 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 when you are using NSAIDs:

• The usual dose is 20 mg once daily.

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

• The usual dose is 20 mg of Omolin 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 per day.
• 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:

• Omolin 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:

• Omolin 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. The capsules must not be chewed or crushed, as they contain coated granules designed 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 juice), or apple puree.
• Always shake the mixture before drinking (the mixture will not be clear), and drink the preparation immediately or within 30 minutes.
• To ensure the full dose is taken, 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 OMOLIN than you should
If you take more Omolin than 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 for your next dose, skip the missed dose. Do not take a double dose to make up for the missed one.
If you stop taking Omolin
Do not stop taking Omolin without first talking to your doctor or pharmacist.
If you have any questions about using this medicine, consult 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, rash, fainting or difficulty swallowing (severe allergic reaction).
• Reddening of the skin with blistering 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”.
• Yellowing of the skin, dark urine and tiredness could be symptoms of liver problems.

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

• Headache.
• Stomach or intestinal problems: diarrhoea, stomach ache, 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.
• Feeling of spinning (vertigo).
• Changes in blood tests related to liver function.
• Rash, skin rash with skin swelling (urticaria) and itching of the skin.
• General feeling of being unwell and lack of energy.
• Fracture of the wrist, hip or spine.

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.
• Allergic reactions, sometimes very severe, including swelling of the lips, tongue and throat, fever, wheezing.
• Low levels of sodium in the blood. This may cause weakness, feeling unwell (vomiting) and cramps.
• Feeling restless, confused or depressed. Page 6 of 9
• Changes in taste.
• Vision problems, such as blurred vision.
• Sudden wheezing or shortness of breath (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).
• 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 count, including agranulocytosis (lack of white blood cells).
• Aggression.
• Seeing, feeling or hearing events that are not real (hallucinations).
• Severe liver problems up to liver failure and brain inflammation.
• Sudden onset of severe rash 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.

In very rare cases, OMOLIN 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 local infection such as neck, throat or mouth pain, or difficulty urinating, you must consult 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.
Not known (frequency cannot be estimated from the available data)

• Inflammation of the intestine (leading to diarrhoea).
• If you have been treated with Omolin for more than 3 months, magnesium levels in your blood may decrease. Low magnesium levels may present as fatigue, involuntary contractions, disorientation, seizures, dizziness, increased heart rate. If you experience any of these symptoms, inform your doctor immediately. Low magnesium levels may also lead to reduced levels of potassium or calcium in the blood. Your doctor may decide to perform regular blood tests to monitor your magnesium levels.
• Rash, possibly with joint pain.

Do not be alarmed by this list of possible side effects. You may not experience any of them.
Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist.
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You can also report side effects directly via 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 the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging, blister or bottle after Exp. The expiry date refers to the last day of the month.
Store 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 via 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 substance is omeprazole. OMOLIN capsules contain 10 mg or 20 mg of omeprazole.
• The other ingredients are: Capsule contents: sugar spheres (composed of maize starch and sucrose), sodium lauryl sulfate, anhydrous dibasic sodium phosphate, mannitol, hypromellose 6 cP, macrogol 6000, talc, polysorbate 80, titanium dioxide (E 171), and methacrylic acid-ethyl acrylate copolymer (1:1). Capsule shell: gelatin. The 10 mg and 20 mg capsules also contain the colouring agents quinoline yellow (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 of whitish to cream colour.
• OMOLIN 20 mg: opaque yellow capsule containing spherical microgranules of whitish to cream colour. Capsules are available 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 Authorization Holder
Marketing Authorization 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 de Henares
(Guadalajara) Spain
This medicinal product is authorized in the European Economic Area countries under the
following names:
Estonia: Omolin
Netherlands: Omolin 10 / 20 / 40 mg, maagsapresistente capsules, hard
Hungary: Ludea 10 / 20 / 40 mg gyomornedvnek ellenálló, kemény kapszula
Italy: Omolin 10 / 20 mg capsule rigide gastroresistenti
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 gastrorezistentna kapsula, trda
Slovakia: Asilar 10 / 20 / 40 mg tvrdá gastrorezistentná kapsula
Spain: Omeprazol Stada 40 mg cápsulas duras gastrorresistentes
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