Truloc IV 40 mg Solution

The active ingredient in TRULOC IV 40 mg is esomeprazole. Each vial contains esomeprazole sodium, equivalent to esomeprazole 40 mg and disodium edetate (EDTA) as a chelating agent. TRULOC IV 40 mg belongs to a class of medicines called proton pump inhibitors. They work by reducing the amount of acid that your stomach produces. TRULOC IV 40 mg is given when oral treatment cannot be used and for the shortest possible time. It is used for treatment of:

• gastro-oesophageal reflux disease (GORD), where acid from the stomach escapes into the oesophagus causing pain, inflammation and heartburn
• to treat and prevent recurrence of bleeding ulcers of the stomach or gut

TRULOC IV 40 mg should not be administered to you: Tell your doctor or healthcare professional before being given the injection if:

• if you are hypersensitive (allergic) to esomeprazole, substituted benzimidazoles or any of the other ingredients of TRULOC IV 40 mg (see section 6)
• if you are allergic to other proton pump inhibitors
• if you are also taking nelfinavir or atazanavir, for the treatment of HIV infections.

Warnings and precautions

Tell your doctor or healthcare professional before being given the injection: Special care should be taken with TRULOC IV 40 mg:

• if you present any alarm symptoms such as repeated vomiting, significant weight loss, vomiting of blood, difficulty in swallowing and black tarry faeces
• TRULOC IV 40 mg may affect the kidneys (interstitial nephritis). Inform your doctor if you experience any pain while urinating or lower back pain
• if you have liver problems, because your healthcare professional may need to adjust the dosage (see section 3)
• if you use medicines such as nelfinavir and atazanavir for HIV infection. (see section 2 – before TRULOC IV 40 mg is administered to you and Using other medicines with TRULOC IV 40 mg)
• if you are taking warfarin for blood thinning, because you will need frequent monitoring
• if you are known to have reduced ability to absorb vitamin B 12 from your gut
• if you are at risk of osteoporosis, special care should be taken when receiving TRULOC IV 40 mg in high doses and long-term. TRULOC IV 40 mg can increase the risk of hip, wrist and spine fractures, especially in elderly patients
• if you are due to have a specific blood test (Chromogranin A)

Since TRULOC IV 40 mg suppresses the secretion of stomach acid, you may be more prone to develop infections involving the stomach or gut. Please report to your doctor immediately if you develop large volumes of loose stools, vomiting and stomach cramps, especially in the presence of fever or chills.

When receiving long-term therapy with TRULOC IV 40 mg your healthcare professional may consider monitoring your magnesium levels. With a decrease in magnesium levels you may develop symptoms such as tiredness, confusion, involuntary contraction of muscles, dizziness, convulsions and abnormal heart rhythm.

If you get a rash on your skin, especially in areas exposed to the sun tell your doctor as soon as you can, as you may need to stop your treatment with TRULOC IV 40 mg.

Remember to also mention any other ill-effects like pain in your joints. TRULOC IV 40 mg will be reconstituted by your healthcare professional.

Children

TRULOC IV 40 mg should not be used in children since no data are available

Other medicines and TRULOC IV 40 mg

Always tell your healthcare provider if you are taking any other medicine. (This includes complementary or traditional medicines.)

If you are taking any of the following medicines, please inform your doctor before you receive TRULOC IV 40 mg:

• ketoconazole, itraconazole and voriconazole for fungal infections
• digoxin for heart problems, you will require monitoring of your digoxin therapy
• phenytoin for epilepsy (convulsions)
• blood thinners, such as warfarin, since you will require more frequent monitoring of your International Normalised Ratio (INR)
• clopidogrel, used to treat blood clots
• methotrexate to suppress the immune system. Your doctor may consider temporarily stopping your TRULOC IV 40 mg treatment
• tacrolimus to suppress the immune function
• cilostazol used to treat intermittent claudication – a pain in your legs when you walk which is caused by an insufficient blood supply
• cisapride for indigestion and heartburn
• nelfinavir, atazanavir, tipranavir and saquinavir for treatment of HIV infection
• clarithromycin, an antibiotic
• rifampicin for treatment of tuberculosis
• St. John’s Wort used to treat depression
• erlotinib, used in cancer treatment
• citalopram, imipramine or clomipramine (used to treat depression)
• diazepam (used to treat anxiety, relax muscles or in epilepsy)

Do not share medicines prescribed for you with any other person. TRULOC IV 40 mg is a powder for solution for injection and infusion that will be given into one of your veins over a period of time. It is administered to patients who cannot take oral medicines. Your doctor will determine your dosage based on your diagnosis. You will not be expected to give yourself TRULOC IV 40 mg. It will be administered to you by a person who is qualified to do so. Treatment with TRULOC IV 40 mg usually lasts up to 7 days, after which you may be given oral medicine. The total duration of treatment is dependent on your diagnosis and whether you are able to take oral medicines.

Use of TRULOC IV 40 mg in patients with kidney problems

Dose adjustment is not necessary in patients with weakened kidney function.

Use of TRULOC IV 40 mg in patients with liver problem

If you have severe impairment of liver function, your doctor may decide to adjust your dosage. If you have the impression that the effect of TRULOC IV 40 mg is too strong or too weak, tell your doctor or pharmacist.

If you are administered more TRULOC IV 40 mg than you should

Since a healthcare professional will administer TRULOC IV 40 mg, he/she will control the dosage. However, in the event of overdosage your doctor will manage the overdose.

If you miss a dose of TRULOC IV 40 mg

Do not receive a double dose to make up for forgotten individual doses. Since a healthcare professional will administer TRULOC IV 40 mg, it is unlikely that the dose will be missed.

TRULOC IV 40 mg can have side effects. Not all side effects reported for TRULOC IV 40 mg are included in this leaflet. Should your general health worsen, or if you experience any untoward effects while using TRULOC IV 40 mg, please consult your doctor, pharmacist or other healthcare professional for advice. If any of the following happens, stop using TRULOC IV 40 mg 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
• fainting

These are all very serious side effects. If you have them, you may have had a serious allergic reaction to TRULOC IV 40 mg. 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:

• yellow discolouration of the skin or whites of the eyes accompanied by loss of appetite, nausea, pain over the liver area and fever, with or without alteration in consciousness, as this may indicate inflammation of the liver
• seeing or hearing things that are not real (hallucinations)
• any skin rash with blister formation, reddening of the skin with blisters or peeling (there may also be severe blisters and bleeding in the lips, eyes, mouth, nose and genitals), symptoms of Stevens-Johnson syndrome, toxic epidermal necrolysis or drug reaction with eosinophilia and systemic symptoms
• cloudy, dark or discoloured urine, reduced frequency of urination, difficulty passing urine, pain over the bladder or kidneys and swelling of the feet, legs or hands
• pain in the wrist, back, or hip and groin area, with the inability to put weight on the affected limb, as this may be due to a fracture
• heart disease including tightness or chest pains, slower or increased heart rate

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
• stomach pain, loose stools, bloating and gas (flatulence), nausea, vomiting and constipation, benign polyps (non-cancerous tumours) in the stomach
• pain and burning at the injection site

Less frequent side effects:

• thrush
• bruising of the skin, unusual bleeding, pinpoint red spots on the skin, bleeding from the gums, pale skin, shortness of breath upon exertion, unusual tiredness or weakness, fever and chills, as these symptoms may be due to abnormal blood cell and platelet counts
• a combination of nausea and vomiting, headache, confusion, loss of energy, fatigue, muscle weakness, and muscle spasms or cramps, since this may be due to low blood sodium levels
• sleeplessness, agitation, confusion, depression, aggression
• dizziness, feeling sleepy or drowsy, taste changes, pins and needles
• blurred vision
• the feeling that your environment is moving or spinning, ringing in the ears
• wheezing or tightness of the chest (bronchospasm), coughing
• dry mouth, ulcers or sores inside the mouth, or on the lips, diarrhoea (loose stools); however, if you have severe, foul-smelling diarrhoea, you need to report to your doctor urgently
• rash on your skin, especially in areas exposed to the sun, hair loss
• joint pain (arthralgia), muscle pain (myalgia)
• enlargement of breast tissue in men, impotence (erectile dysfunction)
• feeling of general discomfort or uneasiness (malaise), excessive sweating (hyperhidrosis), swelling of the feet or hands
• tiredness and fever

The following side effects have been reported but the frequency for them to occur is not known:

• severe stomach pain accompanied by nausea and vomiting, distension of the stomach and fever or chills
• muscle weakness, shortness of breath, slow breathing, tiredness, mood changes and irregular heartbeat, as this may be due to low blood levels of potassium
• tiredness, involuntary muscle contractions, disorientation, irritability, convulsions, muscle spasms or cramps, dizziness or increased heart rate, as this may be due to low blood levels of magnesium or calcium
• loss of coordination (ataxia), anxiety with panic attacks, episodic night terrors, attention deficit
• muscle weakness

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. By reporting side effects, you can help provide more information on the safety of TRULOC IV 40 mg. You can also send an email directly to the company, [email protected], to ensure safety of the product.

Store all medicines out of reach of children. Store at or below 30 °C. Store in the outer container to protect the vials from light. Vials can be stored exposed to normal indoor light, for up to 24 hours outside the box. The reconstituted solution should be used immediately however it may be stored for up to 12 hours in 0,9 % sodium chloride solution for intravenous use. The reconstituted solution can be kept in normal indoor light at up to 30 °C. Do not use after the expiry date stated on the carton. Return all unused medicine to your pharmacist.

Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).