Aspepraz 40 mg Injection

ASPEPRAZ 40 mg INJECTION is used for a condition known as Gastro - oesophageal Reflux Disease (GORD).

Gastro - oesophageal reflux disease:

• Treatment of inflammation of the oesophagus which is caused by acid reflux.
• Long - term management of patients who have healed from inflammation of the oesophagus and to prevent relapse in such patients.
• Treatment of severe symptoms of acid reflux disease.

ASPEPRAZ 40 mg INJECTION is also used for the prevention of rebleeding in patients who have undergone therapeutic endoscopy (a procedure used to look inside the stomach using an endoscope). Your doctor will prescribe ASPEPRAZ 40 mg INJECTION for the shortest possible time.

ASPEPRAZ 40 mg INJECTION should not be administered to you:

• If you are hypersensitive (allergic) to esomeprazole or to any of the other ingredients of ASPEPRAZ 40 mg INJECTION (see section 6).
• If you are allergic to substituted benzimidazoles.
• If you are pregnant or breastfeeding.
• If you take nelfinavir or atazanavir, used to treat HIV infection.
• If you take clopidogrel, used to prevent blood clots.

ASPEPRAZ 40 mg INJECTION is contraindicated in children.

Warnings and precautions

Take special care with ASPEPRAZ 40 mg INJECTION:

• Seek immediate care if you experience unintentional loss of weight, repeated vomiting, difficulty swallowing, vomiting of blood, if you look pale or and feel weak (anaemia) or if you notice blood in your stool or your stool appears black. Your doctor may decide that you need some tests to rule out malignant disease because ASPEPRAZ 40 mg INJECTION also alleviates the symptoms of cancer and could cause delay in diagnosing it. If your symptoms continue in spite of your treatment, further investigations will be considered.
• Using ASPEPRAZ 40 mg INJECTION may increase your risk of fracture in the hip, wrist or spine. Tell your doctor if you have osteoporosis or if you are taking corticosteroids (which can increase the risk of osteoporosis).
• If you develop lesions (deterioration of tissue due to injury or disease) especially in sun - exposed areas of the skin, and if accompanied by severe joint pains consult your healthcare provider as this could be signs of a diseases called subacute cutaneous lupus erythematosus.
• The following should be considered:
• ASPEPRAZ 40 mg INJECTION, as with all acid - blocking medicines, may reduce the absorption of vitamin B 12 (cyanocobalamin). This should be considered in patients with reduced body stores or risk factors for reduced vitamin B 12 absorption on long - term therapy.
• If you are on ASPEPRAZ 40 mg INJECTION for more than three months it is possible that the levels of magnesium in your blood may fall. Low levels of magnesium can be seen as fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness or increased heart rate. If you get any of these symptoms, please tell your doctor promptly. Low levels of magnesium can also lead to a reduction in potassium or calcium levels in the blood. Your doctor may decide to perform regular blood tests to monitor your levels of magnesium.
• You should seek immediate help from a healthcare professional if you experience watery stools, abdominal pain and fever whilst ASPEPRAZ 40 mg INJECTION is being administered to you.
• Proton pump inhibitors, such as ASPEPRAZ 40 mg INJECTION, especially if used in high doses and over long durations (> 1 year), may increase the risk of hip, wrist and spine fracture, predominantly in the elderly or in presence of other recognised risk factors. If you are at risk of osteoporosis, you should speak to your doctor.
• ASPEPRAZ 40 mg INJECTION can cause an increased risk of kidney disease leading to kidney failure. This is called tubulointerstitial nephritis and you may have increased urine output, blood in your urine or dark urine, changes in mental status, such as drowsiness or confusion, swelling of any area of your body.

Do not share medicines prescribed for you with any other person. ASPEPRAZ 40 mg INJECTION will be administered to you in a hospital setting and your healthcare professional will prescribe a specific dose according to your condition. The usual dose is 20 mg to 40 mg of ASPEPRAZ 40 mg injection. Your healthcare professional will tell you how long your treatment with ASPEPRAZ 40 mg INJECTION will last.

If you have the impression that the effect of ASPEPRAZ 40 mg INJECTION is too strong or too weak, tell your doctor or pharmacist.

If you receive more ASPEPRAZ 40 mg INJECTION than you should

If your healthcare professional gives you more ASPEPRAZ 40 mg INJECTION than they should:

• You may experience drowsiness, headaches and an increase in the rate of your heart beat.

Since a healthcare professional will administer ASPEPRAZ 40 mg INJECTION, he/she will control the dosage. However, in the event of overdosage your doctor will manage the overdosage. Since a healthcare provider will administer ASPEPRAZ 40 mg INJECTION, it is unlikely that the dose will be missed.

ASPEPRAZ 40 mg INJECTION can have side effects. Not all side effects reported for ASPEPRAZ 40 mg INJECTION are included in this leaflet. Should your general health worsen or if you experience any untoward effects while ASPEPRAZ 40 mg INJECTION is being administered to you, please consult your doctor, pharmacist or other healthcare professional for advice.

If any of the following happens, stop receiving ASPEPRAZ 40 mg INJECTION and tell your doctor immediately or go to the casualty department at your nearest hospital:

• swelling of the hands, feet, ankles, face, lips, mouth or throat, which may cause difficulty in swallowing or breathing,
• rash or itching,
• blistering of the skin, mouth, eyes and genitals as these may be due to a serious allergic reaction known as Stevens - Johnson Syndrome (SJS) or toxic epidermal necrolysis (TEN) and Subacute cutaneous lupus erythematosus (SCLE). These are all very serious side effects. If you have them, you may have had a serious allergic reaction to ASPEPRAZ 40 mg INJECTION. You may need urgent medical attention or hospitalisation.

Tell your doctor immediately if you notice any of the following:

• Severe pain in the chest (usually pain arising from the heart), faster heart beat; increased rate of heart beat or abnormally slow pulse rate; slower heartbeat.
• If you lose a lot of weight for no reason and have problems swallowing.
• If you get stomach pain or indigestion.
• If you begin to vomit food or blood.
• If you pass black stools (blood - stained faeces).
• Fracture of the hip, wrists or spine.
• Fatigue, confusion, convulsions, dizziness and abnormal heart rhythm.
• Yellowing of the skin and eyes, dark urine and tiredness as these may be symptoms of liver problems.
• Painful urination and low back pain as these may be symptoms of kidney problems.
• Inflammation of the pancreas which causes severe pain in the abdomen and back.
• Changes in blood count including agranulocytosis (lack of white blood cells),
• low levels of sodium, calcium and potassium in the blood.

These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

Frequent side effects:

• Headache,
• excessive stomach or intestinal gas,
• constipation.

Less frequent side effects:

• Swelling of the hands and feet due to water retention,
• difficulty to sleep, agitation, depression, aggression and hallucination (senses created by the mind but that are not real),
• tingling feelings such as pins and needles,
• feeling sleepy,
• taste disturbance,
• suddenly feeling wheezy or shortness of breath,
• inflammation of the inside of the mouth,
• blurred vision, eye disorders,
• ringing in the ears,
• joint and muscle pains,
• muscle weakness,
• increased sweating,
• enlarged breasts in men,
• generally feeling unwell and lacking energy,
• rash, hair loss, skin rash on exposure to sunshine,
• changes in blood tests that check how the liver is working,
• loss of male sexual ability,
• tiredness,
• injection site reaction.

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects

If you get side effects, talk to your doctor, pharmacist or nurse. You can also report side effects to SAHPRA via the Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who - umc.org) found on SAHPRA website.

Aspen Pharmacare: E - mail: [email protected] Tel: 0800 118 088 By reporting side effects, you can help provide more information on the safety of ASPEPRAZ 40 mg INJECTION.

Store all medicines out of reach of children.

Store at or below 25 °C. Protect from light and moisture.

For reconstituted and diluted solution: Physical and chemical stability for the reconstituted solution has been proven for 12 hours at 25 °C. From a microbiological point of view, the product should be used immediately. If not used immediately, in - use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 °C to 8 °C, unless reconstitution/dilution has taken place in controlled and validated aseptic conditions.

For single use only. Discard any unused portion. Keep in original packaging until required for use. Do not store in a bathroom. Do not use after the expiry date stated on the label. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).