Omeprazole Mylan Pharma

Package leaflet: Information for the user

Omeprazolo Mylan Pharma 10 mg gastro-resistant hard capsules, 20 mg gastro-resistant hard capsules, 40 mg gastro-resistant hard capsules

Omeprazolo
Generic medicine
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. Do not give it to other people, even if they have the same symptoms as you, because 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 Mylan Pharma is and what it is used for
2. What you need to know before taking Omeprazolo Mylan Pharma
3. How to take Omeprazolo Mylan Pharma
4. Possible side effects
5. How to store Omeprazolo Mylan Pharma
6. Contents of the pack and other information

1. What Omeprazolo Mylan Pharma is and what it is used for

Omeprazolo Mylan Pharma 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 Mylan Pharma is used to treat the following conditions:

In adults:

• 'Gastro-oesophageal reflux disease' (GERD). 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 infected with a bacterium called 'Helicobacter pylori'. If you suffer from 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 Mylan Pharma may also be used to prevent the formation of ulcers if you are taking NSAIDs.
• Excessive production of stomach acid caused by a growth of tissue in the pancreas (Zollinger-Ellison syndrome).

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 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 over 4 years of age and adolescents:

• Ulcers infected with a bacterium called 'Helicobacter pylori'. If your child suffers from 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 Mylan Pharma

Do not take Omeprazolo Mylan Pharma

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

If you have any doubts, consult your doctor or pharmacist before taking Omeprazolo Mylan Pharma.
Warnings and precautions
Omeprazolo Mylan Pharma may mask symptoms of other diseases. Therefore, if you experience any of the following symptoms before or while taking Omeprazolo Mylan Pharma, 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 risk of infectious diarrhoea;
• Severe liver problems;
• If you have ever had a skin reaction after treatment with a medicine similar to Omeprazolo Mylan Pharma 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 discontinue treatment with Omeprazolo Mylan Pharma. Remember to also report any other adverse effects such as joint pain.
If you have been taking Omeprazolo Mylan Pharma for a long time (more than 1 year), your doctor will prescribe regular check-ups. Inform your doctor if you notice any new or unusual symptoms.
Taking a proton pump inhibitor such as Omeprazolo Mylan Pharma, particularly for more than one year, may slightly increase the 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).
Other medicines and Omeprazolo Mylan Pharma
Inform your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those without a prescription. This is important because Omeprazolo Mylan Pharma may affect how some medicines work, and some medicines may affect the action of Omeprazolo Mylan Pharma.
Do not take Omeprazolo Mylan Pharma if you are taking a medicine containing nelfinavir (used for the treatment of HIV infections).
Inform your doctor or pharmacist if you are taking one or more of the following medicines:

• Ketoconazole, posaconazole, 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 Mylan Pharma;
• 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 Mylan Pharma;
• 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 a high dose of methotrexate, your doctor may temporarily discontinue your treatment with Omeprazolo Mylan Pharma.

If your doctor has prescribed the antibiotics amoxicillin and clarithromycin together with Omeprazolo Mylan Pharma 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 Mylan Pharma with food and drink
Take the capsules preferably on an empty stomach. The capsules must NOT be chewed or crushed. They should be swallowed whole with a glass of water.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may 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 it is unlikely to affect the breastfed infant when administered at therapeutic doses. Your doctor will decide whether you can take Omeprazolo Mylan Pharma while breastfeeding.
Driving and using machines
Omeprazolo Mylan Pharma is unlikely to 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 Mylan Pharma contains sucrose and sodium
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e. essentially “sodium-free”.

3. How to take Omeprazolo Mylan Pharma

Take this medicine exactly as directed by your doctor. 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:

For the treatment of GERD symptoms, 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 ulcers have 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 ulcers have not completely healed, the dose may be increased to 40 mg once daily for 8 weeks.

For the prevention of 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 the prevention 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 Mylan Pharma 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 usual dose is 60 mg daily.
• Your doctor will adjust the dose according to your needs and decide how long you should continue treatment.

Use in children:

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

• Omeprazolo Mylan Pharma 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 Mylan Pharma may be used in 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 protect 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 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), acidic 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 Mylan Pharma than you should
If you take more Omeprazolo Mylan Pharma than prescribed by your doctor, contact your doctor or pharmacist immediately.

If you forget to take Omeprazolo Mylan Pharma
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 Mylan Pharma
Do not stop treatment with Omeprazolo Mylan Pharma without first talking to your doctor or pharmacist.

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
If you notice any of the following rare but serious side effects, stop taking
Omeprazole Mylan Pharma 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. 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-coloured urine and tiredness could be symptoms of liver problems.

Other side effects include:
Common side effects (occur in 1 to 10 out of 100 patients)

• Headache.
• Stomach or intestinal problems: diarrhoea, stomach pain, constipation, passing wind (flatulence).
• Feeling unwell (nausea) or sickness (vomiting).
• Benign polyps in the stomach.

Uncommon side effects (occur in 1 to 10 out of 1,000 patients)

• Swelling of the feet and ankles.
• Disturbed sleep (insomnia).
• Dizziness, tingling, drowsiness.
• Sensation of spinning (vertigo).
• Changes in blood tests relating to liver function.
• Skin rash, skin rash with swelling of the skin (urticaria) and itching.
• General feeling of being unwell and lack of energy.

Rare side effects (occur in 1 to 10 out of 10,000 patients)

• 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 and wheezing.
• Low levels of sodium in the blood. This may cause weakness, feeling unwell (vomiting) and cramps.
• Restlessness, confusion or depression.
• Changes in taste.
• Vision problems, such as blurred vision.
• Sudden wheezing or breathlessness (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-coloured urine and tiredness.
• Hair loss (alopecia).
• Skin rash during exposure to sunlight.
• Joint pain (arthralgia) or muscle pain (myalgia).
• Severe kidney problems (interstitial nephritis).
• Increased sweating.

Very rare side effects (occur in less than 1 out of 10,000 patients)

• 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 blistering 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.
• Breast enlargement in men.

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

• Inflammation of the intestine (leading to diarrhoea).

• If you have been taking Omeprazole Mylan Pharma for more than three months, your blood magnesium levels may decrease. Low magnesium levels may be indicated by tiredness, involuntary muscle contractions, confusion, seizures, dizziness or increased heart rate. If you develop 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 carry out regular blood tests to monitor your magnesium levels.

• Erythema, possible joint pain.

In very rare cases, Omeprazole Mylan Pharma may affect white blood cells, leading to immunodeficiency. If you develop an infection with symptoms such as fever with a severe deterioration in 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 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.
Reporting of side effects
If you get any side effects, including ones not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Omeprazole Mylan Pharma

• 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 the month.
• For Al/Al blisters:

Store below 30°C.
Keep the blister in the original packaging to protect the medicine from moisture.

• For PVC-PVDC/Al blisters: Store below 25°C. Keep the blister in the original packaging to protect the medicine from moisture.
• For bottles:

This medicine does not require any special storage temperature.
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 Omeprazolo Mylan Pharma contains

• The active substance is omeprazole. Omeprazolo Mylan Pharma gastro-resistant hard capsules contain 10 mg, 20 mg or 40 mg of omeprazole.
• The other components are sucrose, maize starch, hypromellose (E-464), talc (E-553b), titanium dioxide (E-171), disodium phosphate dihydrate (E-339 ii), sodium lauryl sulfate, polysorbate 80, methacrylic acid-ethyl acrylate copolymer, triethyl citrate (E-1505). Capsule: gelatin, titanium dioxide (E-171), printing ink (black iron oxide (E-172), potassium hydroxide, shellac). See section 2: Omeprazolo Mylan Pharma contains sucrose and sodium.

Description of the appearance of Omeprazolo Mylan Pharma and package contents
Omeprazolo Mylan Pharma 10 mg capsules are hard gelatin capsules with an opaque white body printed with “OM 10”, containing granules.
Omeprazolo Mylan Pharma 20 mg capsules are hard gelatin capsules with an opaque white body printed with “OM 20”, containing granules.
Omeprazolo Mylan Pharma 40 mg capsules are hard gelatin capsules with an opaque white body printed with “OM 40”, containing granules.
White HDPE bottles with hermetically sealed screw caps and desiccant cap: 14, 28, 90 and 100 capsules.
Al/Al blisters: 14 and 28 capsules.
PVC-PVDC/Al blisters: 14, 28, 30 and 100 capsules.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Mylan S.p.A.
Via Vittor Pisani, 20
20124 Milan, Italy

Responsible person for batch release
Laboratorios Dr. Esteve, S.A.
Sant Martí s/n, Polígon Industrial, Martorelles – Barcelona
08107 – Spain

This medicinal product is authorized in the European Economic Area countries under the following names:
IE: Omeprazole 10 mg/20 mg/40 mg gastro-resistant capsules, hard
IS: Omezyl
IT: Omeprazolo Mylan Pharma
PL: Heligen Neo
SK: Omemyl 20 mg tvrdé gastrorezistentné kapsuly
SE: Omezyl