Omeprazole Sun

Package leaflet: Information for the patient

Omeprazolo Sun 10 mg gastro-resistant hard capsules, 20 mg gastro-resistant hard capsules

Generic medicine
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 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, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Omeprazolo Sun 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 Sun is used to treat the following conditions:

In adults:

• 'Gastro-oesophageal reflux disease' (GORD). 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 associated with infection by 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 Sun may also be used to prevent ulcers from developing if you are taking NSAIDs.
• Excessive acid production due to a growth of tissue in the pancreas (Zollinger-Ellison syndrome).

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

• 'Gastro-oesophageal reflux disease' (GORD). 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, vomiting, and poor weight gain.

Children aged over 4 years and adolescents

• Ulcers associated with infection by a bacterium called ‘Helicobacter pylori’. If the 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 Omeprazole Sun

Do not take Omeprazole Sun:

• 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 (for example pantoprazole, lansoprazole, rabeprazole, esomeprazole).
• If you are taking a medicine containing nelfinavir (used for HIV infections).

Do not take Omeprazole Sun if any of the above apply to you. If you are in doubt, consult your
doctor or pharmacist before taking Omeprazole Sun.
Warnings and precautions
Talk to your doctor or pharmacist before taking Omeprazole Sun:

• If you are due to have a specific blood test (chromogranin A).
• If you have ever had a skin reaction after treatment with a medicine similar to Omeprazole Sun that reduces stomach acidity. 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 stop treatment with Omeprazole Sun. Remember to also report any other side effects such as joint pain.

Omeprazole Sun may mask symptoms of other diseases. Therefore, if you experience any of the
following symptoms before or while taking Omeprazole Sun, contact your doctor immediately:

• Unexplained weight loss and difficulty swallowing.
• Stomach pain or indigestion.
• Vomiting food or blood.
• Black stools (indicating presence of blood in stools).
• Severe or persistent diarrhoea, as omeprazole has been associated with a slight increase in the risk of infectious diarrhoea.
• Severe liver problems.

If you take a proton pump inhibitor such as Omeprazole Sun, especially for more 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 take Omeprazole Sun for a long time (more than 1 year), your doctor will prescribe regular
check-ups. Report any new or unusual symptoms or circumstances to your doctor.
Children
Some children with chronic conditions may require long-term treatment, even though it is not
recommended.
Do not give this medicine to children under 1 year of age or with body weight less than 10 kg.
Other medicines and Omeprazole Sun
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicines. This is important because Omeprazole Sun may affect how some medicines work, and
conversely, some medicines may affect the action of Omeprazole Sun.
Do not take Omeprazole Sun if you are taking a medicine containing nelfinavir (used to treat HIV
infections).
Inform your doctor or pharmacist if you are taking any of the following medicines:

• Ketoconazole, itraconazole, posaconazole 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 Omeprazole Sun
• 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 Omeprazole Sun.
• 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 to treat cancer). If you are taking high doses of methotrexate, your doctor may temporarily discontinue your treatment with Omeprazole Sun.

If your doctor has prescribed the antibiotics amoxicillin and clarithromycin together with Omeprazole Sun
for the treatment of ulcers caused by Helicobacter pylori infection, it is very important that you
inform your doctor if you are taking any other medicines.
Omeprazole Sun with food and drink
This medicine should preferably be taken on an empty stomach.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become
pregnant, consult your doctor or pharmacist before taking this medicine.
Your doctor will decide whether you can take Omeprazole Sun during this period.
Omeprazole is excreted in breast milk, but is unlikely to affect the infant when used at therapeutic
doses. Your doctor will decide whether you can take Omeprazole Sun while breastfeeding.
Driving and using machines
It is unlikely that Omeprazole Sun will affect your ability to drive or use tools or machines. However,
side effects such as dizziness and visual disturbances may occur (see section 4). If you experience
these, do not drive or operate machinery.
Omeprazole Sun contains lactose
If your doctor has told you that you have an intolerance to certain sugars, contact your doctor before
taking this medicine.

3. How to take Omeprazolo Sun

Always 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 doses are listed below.

Adults:

For the treatment of symptoms of gastroesophageal reflux disease (GERD), such as heartburn and acid regurgitation:

• If your doctor has found 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.
• Once the esophagus has healed, the recommended dose is 10 mg once daily.
• If the esophagus is not damaged, the recommended 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 Helicobacter pylori infection and prevention of their recurrence:

• The recommended dose is 20 mg of Omeprazolo Sun 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 treatment.

Use in children

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

• Omeprazolo Sun 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:

• Omeprazolo Sun 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 should preferably be taken on an empty stomach.
• The capsules must be swallowed whole with half a glass of water. The capsules must not be chewed or crushed. This is because the capsules contain coated granules that prevent the medicine from dissolving in the acid of the stomach. It is important not to damage the granules.

What to do if you or your child has difficulty swallowing the capsules

• If you or your 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), fruit juice (e.g., apple, orange, or pineapple), or 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. The solid particles contain the medicine. Do not chew or crush them.

If you take more Omeprazolo Sun than you should
If you take more Omeprazolo Sun than prescribed by your doctor, contact your doctor or pharmacist immediately.

If you forget to take Omeprazolo Sun
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 Sun
Do not stop taking Omeprazolo Sun without first talking to your doctor or pharmacist.
If you have any doubts about how to use 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
Omeprazolo Sun and contact your doctor immediately:

• Sudden breathlessness, swelling of the lips, tongue, throat or body, skin rash, fainting or difficulty swallowing (severe allergic reaction).
• Reddening 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".
• Yellowing of the skin, dark urine and tiredness, which may 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 pain, constipation, gas in the intestine (flatulence).
• Feeling unwell (nausea) or sickness (vomiting).
• Benign polyps in the stomach.

Uncommon side effects (may affect up to 1 in 100 people):

• Swelling of the feet and ankles.
• Sleep disturbances (insomnia).
• Dizziness, tingling, drowsiness.
• Sensation of spinning (vertigo).
• Changes in blood tests related to liver function.
• Skin rash, hives and itching.
• General feeling of being unwell and lack of energy.
• Fracture of the hip, wrist or spine (see section 2 “Warnings and precautions”).
• Rare side effects (may affect up to 1 in 1,000 people):
• Blood disorders, such as reduced numbers of white blood cells or platelets. This may cause weakness, bruising, or may make infections more likely.
• Allergic reactions, sometimes very severe, including swelling of the lips, tongue and throat, fever, breathlessness.
• Low levels of sodium in the blood. This may cause weakness, sickness (vomiting) and cramps.
• Feeling restless, confused or depressed.
• Altered taste.
• Vision problems, such as blurred vision.
• Sudden breathlessness or shortness of breath (bronchospasm).
• Dry mouth.
• Inflammation inside the mouth.
• A fungal infection called “candidiasis” which may affect the intestine.
• 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 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, hearing or feeling things that do not exist (hallucinations).
• Severe liver problems leading to liver failure and brain inflammation.
• Sudden onset of severe skin rash, blisters or 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, Omeprazolo Sun 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 a local infection such as neck, throat or mouth
pain, or difficulty urinating, you should consult your doctor as soon as possible so that a blood
test can exclude a lack of white blood cells (agranulocytosis). It is important that you inform your
doctor about the medicine you are taking.
Side effects with unknown frequency (frequency cannot be estimated from the available data):

• Inflammation of the intestine (which may lead to diarrhoea).
• If you take Omeprazolo Sun for more than three months, your blood magnesium levels may decrease. Low magnesium levels may cause fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, or increased heart rate. If you experience any of these symptoms, contact your doctor immediately. Low magnesium levels may also lead to reduced levels of potassium or calcium in the blood. Your doctor may decide to monitor your blood magnesium levels periodically.
• Erythema, possible 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 experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
Side effects can also be reported directly via the national reporting system at
http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Omeprazole Sun

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the packaging after Exp. The expiry date refers to the last day of that month.
• Blister: store at a temperature not exceeding 25°C in the original packaging to protect the medicine from moisture.
• Bottle: store at a temperature not exceeding 25°C, in a tightly closed container to protect the medicine from moisture. Omeprazole Sun must be used within 100 days after first opening the bottle.
• 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 Omeprazolo Sun contains

• The active substance is omeprazole. Omeprazolo Sun 10 mg gastro-resistant hard capsules contain 10 mg of omeprazole.
• The active substance is omeprazole. Omeprazolo Sun 20 mg gastro-resistant hard capsules contain 20 mg of omeprazole.
• The other components are: mannitol, anhydrous lactose, microcrystalline cellulose, hydroxypropylcellulose, disodium hydrogen phosphate dihydrate, sodium lauryl sulfate, hypromellose, methacrylic acid/ethyl acrylate copolymer, macrogol, magnesium stearate, gelatin, red iron oxide (E172), black iron oxide (E172) (only in 20 mg), yellow iron oxide (E172) (only in 20 mg), titanium dioxide (E171), printing ink (shellac, propylene glycol, black iron oxide, potassium hydroxide).

Description of the appearance of Omeprazolo Sun and package contents
Omeprazolo Sun 10 mg: capsule with pink body and cap, printed with 10/O.
Omeprazolo Sun 20 mg: capsule with pink body and brown cap, printed with 20/O.

Pack sizes:
10 mg:
HDPE bottles containing 14, 15, 28, 30, 50, 60, 90, 100 capsules. The bottle contains two sachets of silica gel desiccant. DO NOT SWALLOW the contents of the sachets.
Blister packs containing 14, 15, 28, 30, 50, 60, 90, 100 capsules.

20 mg:
HDPE bottles containing 7, 10, 14, 15, 20, 28, 30, 50, 56, 60, 90, 98, 100 capsules. The bottle contains two sachets of silica gel desiccant. DO NOT SWALLOW the contents of the sachets.
Blister packs containing 7, 10, 14, 15, 20, 28, 30, 50, 56, 60, 90, 98, 100 capsules.

Not all pack sizes may be marketed.

Marketing Authorisation Holder
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH Hoofddorp
The Netherlands

Responsible manufacturers for batch release
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH Hoofddorp - The Netherlands
Terapia SA
124 Fabricii Str.
400 632 Cluj-Napoca - Romania

This medicinal product has been authorised in the European Economic Area Member States under the following names:
Germany: OMEPRAZOL BASICS 10 mg/20 mg/40 mg magensaftresistente Hartkapseln
Spain: Omeprazol Mundogen 20 mg cápsulas duras gastrorresistentes EFG
France: OMEPRAZOLE RANBAXY 10 mg/20 mg, gélule gastro-résistante
Italy: Omeprazolo Sun 10 mg/20 mg capsule rigide gastroresistenti
Poland: Nozer, 20 mg/40 mg, kapsułki dojelitowe, twarde

This leaflet was last approved on: