Omeprazole Doc Generici

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

OMEPRAZOLE DOC Generics 10 mg gastro-resistant hard capsules, 20 mg gastro-resistant hard capsules

Generic medicine
Please 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. Never give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What OMEPRAZOLO DOC Generici is and what it is used for

OMEPRAZOLO DOC Generici contains the active substance omeprazole. It belongs to a
group of medicines known as "proton pump inhibitors". These work by reducing the
amount of acid produced by the stomach.
OMEPRAZOLO DOC Generici 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). OMEPRAZOLO DOC Generici may also be used to prevent ulcers from forming if you are taking NSAIDs.
• Excess stomach acid caused by a growth of tissue in the pancreas (Zollinger-Ellison syndrome).

In children:
Children aged over 1 year 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 aged over 4 years 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 DOC Generici

Do not take OMEPRAZOLO DOC Generici

• 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, rabeprazole, esomeprazole)
• if you are taking a medicine containing nelfinavir (used to treat HIV infections)

Warnings and precautions
Talk to your doctor or pharmacist before taking OMEPRAZOLO DOC Generici.
OMEPRAZOLO DOC Generici may mask symptoms of other diseases. Therefore, if you
experience any of the following symptoms before or while taking OMEPRAZOLO DOC
Generici, contact your doctor immediately:

• Unintentional weight loss and difficulty swallowing.
• Stomach pain or indigestion.
• Vomiting 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 infectious diarrhoea.
• Severe liver problems.
• If you take a proton pump inhibitor such as omeprazole, 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 may increase the risk of osteoporosis), consult your doctor.
• If you have ever had a skin reaction after treatment with a medicine similar to OMEPRAZOLO DOC Generici that reduces stomach acidity.
• If you are scheduled to have a specific blood test (chromogranin A)

If you have been taking OMEPRAZOLO DOC Generici for a long time (more than 1 year), your
doctor will likely recommend regular check-ups. Inform your doctor if you notice any new or
unusual symptoms or circumstances.
If you take a proton pump inhibitor such as OMEPRAZOLO DOC Generici,
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 may increase the risk of osteoporosis), consult your doctor.
If you develop a skin rash, especially in areas exposed to sunlight, contact your doctor as soon as possible, as treatment with OMEPRAZOLO DOC Generici may need to be discontinued. 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. This medicine must not be given to children under 1 year of age or with body weight <10 kg.
Other medicines and OMEPRAZOLO DOC Generici
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
This is important because OMEPRAZOLO DOC Generici may affect how some medicines work, and some medicines may affect the action of OMEPRAZOLO DOC Generici.
Do not take OMEPRAZOLO DOC Generici 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 OMEPRAZOLO DOC Generici.
• 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 OMEPRAZOLO DOC Generici.
• 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 infections)
• 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 a high dose of methotrexate, your doctor may temporarily discontinue treatment with OMEPRAZOLO DOC Generici

If your doctor has prescribed the antibiotics amoxicillin and clarithromycin together with
OMEPRAZOLO DOC Generici 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.
OMEPRAZOLO DOC Generici with food and drink
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 passes into breast milk, but it is unlikely to affect the infant when used at therapeutic doses.
Your doctor will decide whether you can take OMEPRAZOLO DOC Generici during breastfeeding.
Driving and using machines
It is unlikely that OMEPRAZOLO DOC Generici will affect your ability to drive or use tools or machines. However, adverse reactions such as dizziness and visual disturbances may occur (see section 4). If you experience these, do not drive or operate machinery.
OMEPRAZOLO DOC Generici contains sucrose.
If your doctor has told you that you have an intolerance to certain sugars, contact them before taking this medicine.

3. How to take OMEPRAZOLO DOC Generici

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

• If your doctor has told 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.

To prevent the formation of duodenal and gastric ulcers if you are taking NSAIDs:

• The usual dose is 20 mg once daily.

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

• The usual dose is 20 mg of OMEPRAZOLO DOC Generici 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 a growth of tissue in the pancreas (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 take the medicine.

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

• OMEPRAZOLO DOC Generici 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 DOC Generici 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 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:
• Break open the capsule and mix its contents in a spoonful of water (non-carbonated), acidic fruit juice (such as apple, orange, or pineapple juice), or applesauce.
• Always stir the mixture before drinking (the mixture will not be clear), then drink the preparation immediately or within 30 minutes.
• To ensure you have taken the full dose, thoroughly rinse the glass 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 DOC Generici than you should
If you take more OMEPRAZOLO DOC Generici than prescribed by your
doctor, contact your doctor or pharmacist immediately.
If you forget to take OMEPRAZOLO DOC Generici
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 a forgotten dose.
If you stop taking OMEPRAZOLO DOC Generici
Do not stop treatment with OMEPRAZOLO DOC Generici without first talking to your
doctor or pharmacist.
If you have any questions 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 everyone experiences them.
If you notice any of the following rare but serious side effects, stop taking
OMEPRAZOLE DOC Generics and contact your doctor immediately:

• Sudden wheezing, 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. 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.
• Sensation of spinning (vertigo).
• Changes in blood tests related to liver function.
• Skin rash, skin rash with swelling of the skin (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 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.
• 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 can 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).
• Skin rash after 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 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.
• Enlargement of the breasts in men.

In very rare cases, OMEPRAZOLE DOC Generics may affect white blood cells, leading to
immunodeficiency. If you develop an infection with symptoms such as fever with a
severe worsening of general health, or fever with symptoms of local infection such as
neck, throat or mouth pain, or difficulty urinating, you should consult your
doctor as soon as possible, so that a lack of white blood cells
(agranulocytosis) can be ruled out by 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 (which may lead to diarrhoea).
• If you take OMEPRAZOLE DOC Generics 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 blood levels of potassium or calcium. Your doctor should decide whether periodic monitoring of magnesium levels in the blood is necessary.
• 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. 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 OMEPRAZOLE DOC Generici

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton, bottle,
label or blister after “EXP:”. The expiry date refers to the last day of
that month.
Do not store above 25 °C.
OPA-Al-PVC/Al blisters: store in the original container to protect the medicine
from moisture.
HDPE bottle: keep the bottle tightly closed to protect the medicine from moisture.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What OMEPRAZOLO DOC Generici contains:

• The active substance is omeprazole: each capsule contains 10 mg or 20 mg of omeprazole.
• The other components are: Capsule contents: sugar spheres (consisting of maize starch and sucrose), sodium lauryl sulfate, anhydrous disodium phosphate, mannitol, hypromellose 6 cP, macrogol 6000, talc, polysorbate 80, titanium dioxide (E171), and methacrylic acid-ethyl acrylate copolymer (1:1). Capsule components: gelatin. The 10 mg and 20 mg capsules also contain the colouring agents quinoline yellow and titanium dioxide.

Description of the appearance of OMEPRAZOLO DOC Generici and pack sizes:
OMEPRAZOLO DOC Generici 10 mg: opaque yellow capsule containing spherical microgranules of whitish to cream-white colour.
OMEPRAZOLO DOC Generici 20 mg: opaque yellow capsule containing spherical microgranules of whitish to cream-white colour.
The capsules are packaged in blisters of 7, 14, 15, 28, 30, 50, 56, 60, 90, 98, 100, 140, 280 and 500 capsules; and in HDPE bottles of 5, 7, 14, 15, 28, 30, 50, 56, 60, 90, 100 and 500 capsules.
Not all pack sizes may be marketed.

Marketing Authorization Holder
DOC Generici Srl – Via Turati 40 - 20121 Milano
Manufacturer
LABORATORIOS LICONSA, S.A.
Av. Miralcampo, Nº 7, Polígono Industrial Miralcampo
19200 Azuqueca de Henares (Guadalajara)
Spain