Omeprazole Azevedos

PACKAGE LEAFLET: INFORMATION FOR THE USER

Omeprazole SOS 40 mg powder for solution for infusion

Equivalent medicine
Please read all of this leaflet carefully before you start using 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, pharmacist, or nurse.
• If you experience any side effects, including those not listed in this leaflet, please tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

1. What Omeprazole SOS is and what it is used for
2. What you need to know before using Omeprazole SOS
3. How to use Omeprazole SOS
4. Possible side effects
5. How to store Omeprazole SOS
6. Contents of the pack and other information

1. WHAT OMEPRAZOLE SOS IS AND WHAT IT IS USED FOR

Omeprazole SOS contains the active substance omeprazole. It belongs to a group of medicines called "proton pump inhibitors". These work by reducing the amount of acid produced by the stomach.
Omeprazole SOS can be used as an alternative to oral therapy.

2. WHAT YOU SHOULD KNOW BEFORE TAKING OMEPRAZOLE SOS

Do not use Omeprazole SOS

• 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 other proton pump inhibitors (e.g. pantoprazole, lansoprazole, rabeprazole, esomeprazole).
• if you are taking a medicine containing nelfinavir (used for HIV infections).

Do not use Omeprazole SOS if any of the above conditions apply to you. If you have any doubts, consult your
doctor, nurse or pharmacist before taking this medicine.
Consult your doctor, pharmacist or nurse before taking this medicine
Warnings and precautions
Omeprazole SOS may mask symptoms of other diseases. Therefore, if any of the following conditions occur
before or after taking Omeprazole SOS, 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 the stool).
• Severe or persistent diarrhoea, as omeprazole has been associated with a slight increase in infectious diarrhoea.
• Severe liver problems.
• If you have previously had a skin reaction after treatment with a medicine similar to Omeprazole SOS that reduces stomach acidity.
• If you need to undergo a specific blood test (Chromogranin A).

If you develop a skin rash, especially in areas exposed to sunlight, contact your doctor as soon as possible,
as treatment with Omeprazole SOS may need to be discontinued. Also remember to report other adverse
effects such as joint pain.
Taking a proton pump inhibitor such as Omeprazole SOS, 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 Omeprazole SOS
Inform your doctor or pharmacist if you are taking, have recently taken or might take any other medicines,
including those not requiring a prescription. This is because Omeprazole SOS may affect how some
medicines work, and some medicines may affect Omeprazole SOS.
Do not take Omeprazole SOS 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 SOS
• Medicines used to thin the blood, such as warfarin and other vitamin K antagonists. Your doctor will monitor you closely at the beginning and end of treatment with Omeprazole SOS
• Rifampicin (used to treat tuberculosis)
• Atazanavir (used to treat HIV infections)
• 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 (chemotherapeutic agent used at high doses for cancer treatment) – if you are taking high doses of methotrexate, your doctor may temporarily discontinue treatment with Omeprazole SOS.

If your doctor has prescribed the antibiotics amoxicillin and clarithromycin together with Omeprazole SOS 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.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Your doctor will decide whether you can take Omeprazole SOS while breastfeeding.
Driving and using machines
It is unlikely that Omeprazole SOS will affect your ability to drive or operate machinery. However, side effects
such as dizziness and visual disturbances may occur (see section 4). If you experience these, do not drive or operate machinery.

3. HOW TO TAKE OMEPRAZOLE SOS

• Omeprazole SOS can be taken by adults, including the elderly.
• There is limited experience with Omeprazole SOS for intravenous use in children.

Administration of Omeprazole SOS

• Omeprazole SOS will be administered to you by a doctor, who will decide the dose you require.
• The medicine will be given to you as an infusion into one of your veins.

If you take more Omeprazole SOS than you should
If you think you have taken too much Omeprazole SOS, contact your doctor immediately.

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 SOS and contact your doctor immediately.

• Sudden wheezing, swelling of the lips, tongue, throat or body, rash, fainting or difficulty swallowing (severe allergic reaction).
• Skin redness with blistering or peeling. There may also be severe blister formation and bleeding of the lips, eyes, mouth, nose and genitals. This may be "Stevens-Johnson syndrome" or "toxic epidermal necrolysis".
• Yellowing of the skin, dark urine and fatigue, which may be symptoms of liver problems.

Side effects may occur with a certain frequency, as defined below:

Common side effects (may affect up to 1 in 10 patients)

• Headache.
• Stomach or intestinal problems: diarrhoea, stomach ache, constipation, passing wind (flatulence).
• Feeling unwell (nausea) or being unwell (vomiting).
• Benign stomach polyps.

Uncommon side effects (may affect up to 1 in 100 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 skin swelling (urticaria), and itching.
• General feeling of being unwell and lack of energy.

Rare side effects (may affect up to 1 in 1,000 patients)

• Changes in blood composition such as reduced number of white blood cells or platelets. This may cause weakness, 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 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 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 (may affect up to 1 in 10,000 patients)

• Changes in blood cell count 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 appearance of a severe skin rash, blisters or peeling of the skin. This 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 available data)

• Inflammation in the intestine (up to diarrhoea).

• If you have been taking Omeprazole SOS 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 side effects, 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 carry out regular blood tests to monitor your magnesium levels.

• Rash, possibly with joint pain.

Irreversible visual impairment has been reported in isolated cases involving critically ill patients treated with omeprazole by intravenous injection, especially at high doses, but no causal relationship has been established.
In very rare cases, Omeprazole SOS 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 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) through a blood test. It is important that in this case 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. If you do experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse.
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.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE OMEPRAZOLE SOS

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 following "Exp".
The expiry date refers to the last day of that month.
Keep the vial in the outer packaging to protect the medicine from light.
Validity period after reconstitution: The reconstituted infusion solution with sodium chloride 9 mg/ml (0.9%)
must be used within 12 hours of preparation. The reconstituted infusion solution with glucose 50 mg/ml (5%)
must be used within 6 hours of preparation. From a microbiological standpoint, the product should be used
immediately, unless reconstitution occurred under controlled and validated aseptic conditions.
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. PACK CONTENTS AND OTHER INFORMATION

What Omeprazolo SOS contains

• The active substance is omeprazole. Each vial of powder for infusion contains sodium omeprazole equivalent to 40 mg of omeprazole.
• The other components are disodium edetate and sodium hydroxide.

Description of the appearance of Omeprazolo SOS and contents of the pack
Omeprazolo SOS (powder for infusion) is contained in a vial.
Omeprazolo SOS is available in packs of 1, 5 or 10 vials.
Not all pack sizes may be marketed.
The dry powder in the vial is dissolved in a solution before administration.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
So.Se.PHARM S.r.l.
Via dei Castelli Romani, 22
00071 Pomezia (Rome), Italy
Manufacturer:
Sofarimex Indústria Química e Farmacêutica, S.A.
Av. das Indústrias - Alto do Colaride-Agualva
2735-213-Cacém
Portugal

This medicinal product is authorised in the European Economic Area countries under the following names:
Italy: Omeprazolo SOS
Portugal: Omeprazol SOS 40 mg Pó para solução para perfusão
United Kingdom: Omeprazole 40 mg powder for solution for infusion

This leaflet was last approved on

The following information is intended exclusively for healthcare professionals:
The entire contents of each vial must be dissolved in approximately 5 ml and then immediately diluted to 100 ml. Either a 9 mg/ml (0.9%) sodium chloride infusion solution or a 50 mg/ml (5%) glucose infusion solution must be used. The stability of omeprazole is influenced by the pH of the infusion solution, which is why no other solvent or volume should be used for dilution.

Preparation

1. Withdraw 5 ml of infusion solution from a 100 ml infusion bag or bottle using a syringe.
2. Add this amount to the vial containing lyophilised omeprazole and shake well to ensure that the omeprazole is completely dissolved.
3. Aspirate the omeprazole solution back into the syringe.
4. Transfer the solution into the infusion bag or bottle.
5. Repeat steps 1 to 4 to ensure that all omeprazole has been transferred from the vial into the infusion bag or bottle.

Alternative preparation method for infusions in flexible containers

1. Use a double-ended transfer needle and connect it to the injection port of the infusion bag. Attach the other end of the needle to the vial containing lyophilised omeprazole.
2. Dissolve the omeprazole by pumping the infusion solution back and forth between the infusion bag and the vial.
3. Ensure that the omeprazole is completely dissolved.

The infusion solution must be administered via intravenous infusion over 20–30 minutes.