Gactazel Injection

GACTAZEL contains a medicine called esomeprazole, it belongs to a group of medicines called ‘Proton Pump Inhibitors’. They are used to reduce the amount of acid that your stomach produces. It is used for the short-term treatment (up to 10 days), when you are not able to take your treatment by mouth. It used for the following conditions:

• Gastro-oesophageal reflux disease (GORD). This is where acid from the stomach escapes into the gullet (the tube which connects your throat to your stomach) causing pain, inflammation and heartburn.
• Prevention of rebleeding following therapeutic endoscopy for acute bleeding gastric or duodenal ulcers.

GACTAZEL should not be administered to you:

• If you are hypersensitive (allergic) to esomeprazole, substituted benzimidazoles or any of the other ingredients of GACTAZEL (listed in section 6).
• If you are taking medicines containing nelfinavir (used to treat HIV infection) and atazanavir (used to treat and prevent HIV/AIDS).

Warnings and precautions

Tell your doctor or health care provider before being given the injection:

• If you are suddenly losing weight.
• If you are vomiting regularly.
• If you experience heartburn.
• If you are vomiting blood.
• If you have blood in your stools (faeces).
• If you suspect that you have a stomach ulcer.
• If you have a vitamin deficiency (especially a vitamin B12 deficiency).
• If you develop hypomagnesaemia (fatigue, convulsions, dizziness, abnormal rapid heart rhythms) or if you are taking medicines that can cause hypomagnesaemia (diuretics).
• If you have ever had a skin reaction after treatment with a medicine similar to GACTAZEL that reduces stomach acid. If you get a rash on your skin, especially in areas exposed to the sun, tell your doctor as soon as possible, as you may need to stop your treatment with GACTAZEL.
• If you are due to have a specific blood test (Chromogranin A). You should stop receiving GACTAZEL at least 5 days before this blood test.

Using a proton pump inhibitor like GACTAZEL, especially over a period of more than one year, increases your risk of fracture of 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).

Children and adolescents

GACTAZEL should not be used in children.

Other medicines and GACTAZEL

Always tell your healthcare provider if you are taking any other medicine. (This includes complementary or traditional medicines). GACTAZEL can affect the way some medicines work and some medicines can have an effect on GACTAZEL.

• You must not be given GACTAZEL if you are taking a medicine containing nelfinavir (used to treat HIV infection) and atazanavir (used to treat and prevent HIV/AIDS).
• Ketoconazole, itraconazole or voriconazole (used to treat fungal infections).
• Phenytoin (used to treat epilepsy (fits/seizures)).
• Warfarin (used in the prevention of blood clotting formation).
• Diazepam (used to treat anxiety, relax muscles or in epilepsy).
• Citalopram, imipramine or clomipramine (used to treat depression).
• Cilostazol (used to treat intermittent claudication – a pain in your legs when you walk which is caused by an insufficient blood supply).
• Erlotinib (used to treat cancer).
• Digoxin (used for heart problems).
• Methotrexate (a chemotherapy medicine used in high doses to treat cancer). If you are taking a high dose of methotrexate, your doctor may temporarily stop your GACTAZEL treatment.
• Clopidogrel (used to prevent blood clots).
• Tacrolimus (used to prevent rejection after organ transplantation).
• Rifampicin (used for treatment of tuberculosis).
• St. John’s wort (Hypericum perforatum) (used to treat depression).

You will not be expected to give yourself GACTAZEL. It will be given to you by a person who is qualified to do so. GACTAZEL will be administered to you into a vein (intravenous) or with a drip (infusion) in the hospital. This will last for up to 30 minutes.

Use in adults

• GACTAZEL will be given to you by your doctor who will decide how much you need.
• The recommended dose is 20 mg or 40 mg once a day.
• If you have severe liver problems, the maximum dose is 20 mg a day (GORD).
• The recommended dose for prevention of re-bleeding of gastric or duodenal ulcer, is 80 mg administered as intravenous infusion over 30 minutes followed by a continuous infusion of 8 mg/hr given over 3 days. If you have severe liver problems, a continuous infusion of 4 mg/hr given over 3 days may be sufficient.

If you take more GACTAZEL than you should

Since a healthcare provider will administer GACTAZEL, he/she will control the dosage. However, in the event of overdosage your doctor will manage the overdosage.

If you forget to take GACTAZEL

Since a health care provider will administer GACTAZEL, it is unlikely that the dose will be missed.

GACTAZEL can have side effects. Not all side effects reported for GACTAZEL are included in this leaflet. Should your general health worsen or if you experience any untoward effects while receiving GACTAZEL, please consult your healthcare provider for advice.

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

• Swelling of your hands, feet, ankles, face, lips, mouth or throat, which may cause difficulty in swallowing or breathing.
• Rash or itching.
• Fainting.

These are all very serious side effects. If you have them, you may have had a serious allergic reaction to GACTAZEL. You may need urgent medical attention or hospitalisation.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

Less frequently occurring:

• Suddenly feeling wheezy or short of breath (bronchospasm).
• Changes in blood tests that check how your liver is working.
• Yellowing of your skin or eyes, dark urine (also called jaundice).
• Severe liver problems leading to liver failure and inflammation of the brain.
• Sudden onset of a severe rash or blistering or peeling skin. This may be associated with a high fever and joint pains (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, bullous eruption).
• Blood problems such as a reduced number of white blood cells, red blood cells or platelets (this can cause weakness, dizziness, rapid heart rate, shortness of breath, pale skin, bruising or make infections more likely).
• Interstitial nephritis (a kidney disorder in which the spaces between the kidney tubules become swollen (inflamed), causing problems with your kidney function).
• Urinary problems (such as changes in the amount of urine).
• Inflammation of pancreas (nausea, vomiting, fever, pain of your stomach area that radiates to your back, increased heart rate).

Frequency unknown:

• Chest pain, changes in the way your heart beats (faster or slower).
• Low levels of magnesium (hypomagnesaemia) causing problems such as fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, increased heart rate. Low levels of magnesium can also lead to a reduction in potassium or calcium levels in the blood.

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

Tell your doctor as soon as possible if you notice any of the following:

Frequently occurring:

• Headache.
• Stomach pain, diarrhoea, flatulence, nausea (feeling sick), vomiting (being sick), constipation.
• Pain at the injection site.

Less frequently occurring:

• Low levels of sodium in the blood. This may cause weakness, being sick (vomiting) and cramps.
• Disturbed sleep (insomnia).
• Feeling agitated, confused, depressed, aggressive or having hallucinations (seeing or hearing things that do not exist).
• Dizziness, tingling feelings such as “pins and needles”, feeling sleepy, feeling tired.
• Taste changes.
• Blurred vision, eye problems.
• Spinning feeling (vertigo), tinnitus (ringing in your ears).
• Dry mouth, inflammation of the inside of the mouth, an infection called “thrush” which can affect the gut and is caused by a fungus.
• Hair loss (temporary).
• Skin rash on exposure to sunshine (photosensitivity).
• Joint pains (arthralgia) or muscle pains (myalgia), back pain.
• Hip, wrist or spine fractures.
• Breast enlargement (in men).
• Inability to develop or maintain an erection during sexual activity (impotence).
• Coughing.

Frequency unknown:

• Unusual weakness or tiredness.
• Increased sweating.
• Severe rash and peeling, similar to psoriasis, mainly in sun-exposed areas such as the neck and forearms (subacute cutaneous lupus erythematosus).
• Inflammation of the colon, or large intestine (watery diarrhoea, cramping).

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 or pharmacist or nurse. You can also report side effects to SAHPRA via “6.04 Adverse Drug Reactions Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/publications/Index/8 or to the Holder of certificate of registration through the mail: [email protected]. By reporting side effects, you can help provide more information on the safety of GACTAZEL.

• Before reconstitution: Store at or below 25 °C. Protect from light.
• Keep vial in outer carton until required for use.
• After reconstitution: The reconstituted solution should be stored at or below 25 °C and administered within 12 hours after reconstitution with either 0,9 % sodium chloride injection or Ringer's lactate solution. Administer within 6 hours if 5 % dextrose is used for reconstitution.
• No refrigeration is required.
• Discard any unused solution.
• STORE ALL MEDICINES OUT OF REACH OF CHILDREN.
• Do not use after the expiry date printed on the label or carton.
• Discard any unused portions.
• Return all unused medicine to your pharmacist.
• Do not dispose of unused medicine in drains and sewerage systems (e.g., toilets).