Omeprazole Mylan Generics Italia
Italy
Table of Contents
Package leaflet: Information for the user
Omeprazolo Mylan Generics Italia
40 mg powder for solution for infusion
Generic Medicine
Read all of this leaflet carefully before you are given 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, pharmacist, or nurse.
- This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, 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:
- What Omeprazolo Mylan Generics Italia is and what it is used for
- What you need to know before you are given Omeprazolo Mylan Generics Italia
- How Omeprazolo Mylan Generics Italia will be given to you
- Possible side effects
- How to store Omeprazolo Mylan Generics Italia
- Contents of the pack and other information
1. What Omeprazolo Mylan Generics Italia is and what it is used for
Omeprazolo Mylan Generics Italia contains the active substance omeprazolo. This medicine belongs to a class of drugs called "proton pump inhibitors". These medicines reduce the amount of acid produced by the stomach.
Omeprazolo Mylan Generics Italia powder for solution for infusion can be used as an alternative to oral therapy.
2. What you need to know before you are given Omeprazolo Mylan Generics Italia
Do not take Omeprazolo Mylan Generics Italia
- If you are allergic to omeprazole or to any of the excipients of this medicine (listed in section 6)
- If you are allergic to other proton pump inhibitor medicines (e.g. pantoprazole, lansoprazole, rabeprazolo, esomeprazolo)
- If you are taking a medicine containing nelfinavir (used to treat HIV infections).
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before you are given Omeprazolo Mylan Generics Italia if:
- You have ever had a skin reaction after treatment with a medicine similar to Omeprazolo Mylan Generics Italia that reduces stomach acidity.
- You need to undergo a specific blood test (chromogranin A).
Omeprazolo Mylan Generics Italia may mask symptoms of other diseases. Therefore, if any of the following conditions apply to you, contact your doctor immediately before or after taking Omeprazolo Mylan Generics Italia:
- Significant and unintentional weight loss and difficulty swallowing
- Stomach pain or indigestion
- Vomiting of food or blood
- Black stools (blood-stained stools)
- Severe or persistent diarrhoea, as omeprazole has been associated with a slight increase in diarrhoea due to infections
- Severe liver problems.
If you notice the appearance of a skin rash, especially in areas exposed to sunlight, contact your doctor as soon as possible, as treatment with Omeprazolo Mylan Generics Italia may need to be discontinued. Remember to also report any other adverse effects such as joint pain.
Monitoring tests
If you take Omeprazolo Mylan Generics Italia for a long time (more than 1 year), your doctor may want to monitor you regularly. Inform your doctor of any new or unusual symptoms or circumstances.
Taking a proton pump inhibitor such as omeprazole, particularly for a period longer than one year, may slightly increase the risk of fractures of the hip, wrist, or spine. Contact your doctor if you have osteoporosis or if you are taking corticosteroids (which can increase the risk of osteoporosis).
Other medicines and Omeprazolo Mylan Generics Italia
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
This is important because Omeprazolo Mylan Generics Italia can affect how some medicines work, and some medicines can affect how Omeprazolo Mylan Generics Italia works.
Do not take Omeprazolo Mylan Generics Italia 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, 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 Omeprazolo Mylan Generics Italia.
- 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 Generics Italia.
- Rifampicin (used to treat tuberculosis)
- Atazanavir (used to treat HIV infection)
- Tacrolimus (used in organ transplants)
- 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 medicine used at high doses to treat cancer) – If you are taking high doses of methotrexate, your doctor may temporarily discontinue treatment with Omeprazolo Mylan Generics Italia.
If your doctor has prescribed the antibiotics amoxicillin and clarithromycin together with Omeprazolo Mylan Generics Italia to treat ulcers caused by Helicobacter pylori infection, it is very important that you inform them if you are taking any other medicines.
If you are going to hospital for any other tests, talk to your doctor, as you may need to stop taking this medicine temporarily.
Pregnancy and breastfeeding
Pregnancy
Before you are given Omeprazolo Mylan Generics Italia, inform your doctor if you are pregnant or planning to become pregnant. Your doctor will decide whether you can take Omeprazolo Mylan Generics Italia during this time.
Breastfeeding
Omeprazole is excreted in breast milk, but it is unlikely to affect your baby when administered at therapeutic doses.
Your doctor will decide whether you can take Omeprazolo Mylan Generics Italia while breastfeeding.
Driving and using machines
It is unlikely that Omeprazolo Mylan Generics Italia 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, you must not drive or operate machinery.
Important information about some excipients of Omeprazolo Mylan Generics Italia
This medicine contains less than 1 mmol of sodium per dose (23 mg), therefore it is essentially “sodium-free”.
3. How Omeprazolo Mylan Generics Italia will be administered to you
Omeprazolo Mylan Generics Italia can be administered to adults and elderly patients.
There is limited experience with Omeprazolo Mylan Generics Italia for intravenous use in children.
How Omeprazolo Mylan Generics Italia will be administered to you
Omeprazolo Mylan Generics Italia will be administered by a doctor, who will decide the amount of
medication you require.
The medicine will be given to you through an intravenous infusion into one of your veins.
If you have been given more Omeprazolo Mylan Generics Italia than you should have
If you think you have been given too much Omeprazolo Mylan Generics Italia, contact your doctor immediately.
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 Omeprazole Mylan Generics Italia and contact your doctor immediately:
- Sudden breathlessness, swelling of the lips, tongue, throat or body, rash, fainting or difficulty swallowing (severe allergic reaction).
- Skin redness with blistering or peeling. Severe blistering and 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 may be symptoms of liver problems.
Other side effects include:
Common side effects (may affect up to 1 in 10 people)
- Headache
- Stomach or bowel problems: diarrhoea, stomach pain, constipation, passing wind (flatulence), benign stomach polyps
- Nausea or vomiting.
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
- Rash, skin rash with swelling of the skin (urticaria) and itching of the skin
- General feeling of being unwell and lack of energy
- Fractures of the hip, wrist or spine.
Rare side effects (may affect up to 1 in 1,000 people)
- Changes in blood composition, such as reduced numbers 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, breathlessness
- Low levels of sodium in the blood. This may cause weakness, vomiting and cramps
- Feeling restless, confused or depressed
- Changes in taste
- Vision problems, such as blurred vision
- Sudden wheezing or breathlessness (bronchospasm)
- Dry mouth
- Inflammation inside the mouth
- Infection called “candidiasis” which may affect the bowel 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 occurring during exposure to sunlight
- Joint pain (arthralgia) or muscle pain (myalgia)
- Serious kidney problems (interstitial nephritis)
- Increased sweating
- Inflammation of the bowel (causing diarrhoea).
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 rash or 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
- Enlargement of the breasts in men.
Frequency not known (cannot be estimated from the available data)
- Erythema, possible joint pain
- If you take Omeprazole Mylan Generics Italia 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 levels of potassium or calcium in the blood. Your doctor may decide to periodically monitor your blood magnesium levels. In isolated cases, irreversible visual impairment has been reported in critically ill patients who received intravenous Omeprazole Mylan Generics Italia, especially at high doses, although a causal relationship has not been established.
In very rare cases, Omeprazole Mylan Generics Italia 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 signs of 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 such cases you inform your doctor about the medicine you are taking.
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, pharmacist or nurse. 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 Omeprazolo Mylan Generics Italia
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the vial and outer packaging.
The expiry date refers to the last day of that month.
Before opening:
Store in the original packaging to protect from light. This medicine does not require any special
storage temperature conditions.
After reconstitution:
Physical and chemical stability during use has been demonstrated for 12 hours after reconstitution in 0.9% sodium chloride solution and for 6 hours after reconstitution in 5% glucose solution at 25°C.
However, from a microbiological standpoint, the medicine should be used immediately after reconstitution.
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 Generics Italia contains
The active substance is omeprazole.
Each vial of powder contains 42.5 mg of omeprazole sodium equivalent to 40 mg of omeprazole.
The other ingredients are: disodium edetate, sodium hydroxide.
Description of the appearance of Omeprazolo Mylan Generics Italia and package contents
This medicine is available as a powder for solution for infusion in 6 ml vials. A carton contains 5 vials.
Marketing Authorization Holder and Manufacturer
Mylan S.p.A., Via Vittor Pisani 20, 20124 Milano
Manufacturers
SIRTON PHARMACEUTICALS S.p.A., Piazza XX Settembre 2, 22079 Villa Guardia (CO) – Italy
MYLAN S.A.S., 117 Allée des parcs, 69800 Saint-Priest, France
More detailed information on this medicinal product is available on the website of the Italian Medicines Agency (Agenzia Italiana del Farmaco).
The following information is intended exclusively for healthcare professionals
Infusion preparation
The entire contents of each vial must be dissolved in approximately 5 ml and then immediately diluted to 100 ml. Only sodium chloride 9 mg/ml (0.9%) infusion solution or glucose 50 mg/ml (5%) infusion solution should be used.
The stability of omeprazole is influenced by the pH of the infusion solution; therefore, no other solvent or different volumes should be used for dilution.
Preparation
- Draw up 5 ml of infusion solution from a 100 ml infusion bottle or bag using a syringe.
- Add the solution to the vial containing the omeprazole lyophilisate and mix until the omeprazole is completely dissolved.
- Draw the omeprazole solution back into the syringe.
- Transfer this solution into the infusion bottle or bag.
- Repeat steps 1 to 4 to ensure that all the omeprazole has been transferred from the vial into the infusion bottle or bag.
Alternative preparation for infusions in flexible containers
- Using a transfer device, connect one end to the injection port of the infusion bag and connect the other outlet to the vial containing the omeprazole lyophilisate.
- Dissolve the omeprazole by pumping the infusion solution back and forth between the infusion bag and the vial.
- Ensure that the omeprazole is completely dissolved. The infusion solution must be administered by intravenous infusion over 20–30 minutes.
Unused medicine and waste material derived from the medicine must be disposed of in accordance with local regulations.