Trustan ® 20 mg Tablets

TRUSTAN contains a medicine called esomeprazole. This belongs to a group of medicine called proton pump inhibitors (medicines used to treat ulcers). It reduces the production of acid in your stomach.

TRUSTAN is used for treating the following conditions:

• Gastro - oesophageal reflux disease (GORD). Treatment and prevention of Gastro - oesophageal Reflux Disease (GORD). This is where fluid (acid) from the stomach escapes into the food pipe causing pain, inflammation (swelling) and heartburn.
• Prevention of ulcers caused by a medicine used for pain and inflammation (Non - steroidal anti - inflammatory drug treatment).
• Infection with bacteria called Helicobacter pylori that cause ulcers in the stomach with appropriate antibiotics.
• Hypersecretory conditions including hormone producing tumours causing excess acid in the stomach (Zollinger - Ellison syndrome).

Do not take TRUSTAN:

• if you are hypersensitive (allergic) to esomeprazole, other “proton pump inhibitors” or any of the other ingredients of TRUSTAN (listed in section 6).
• if you are taking medication for HIV treatment (atazanavir or nelfinavir)

Warnings and precautions

Take special care with TRUSTAN:

• if you notice any of the following:
• if you feel that you are losing weight without trying to lose it.
• you begin to vomit blood or food
• you pass black (blood - stained) stool. You should contact your doctor immediately.
• You get stomach pain or indigestion.

TRUSTAN 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.

if you have severe liver problems. You should discuss this with your doctor, as he/she may wish to reduce the dose.

if you have severe kidney problems. You should discuss this with your doctor.

if you have severe, debilitating diarrhoea (known as Clostridium Difficile - associated diarrhoea), that does not improve. Symptoms may include watery stools, stomach pain and fever.

if you are due to have a specific blood test (Chromogranin A).

Taking a proton pump inhibitor like TRUSTAN, especially over a period of more than one year, may slightly 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 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 TRUSTAN. Remember to also mention any other ill - effects like pain in your joints.

TRUSTAN, as all acid - blocking medicines, may reduce the absorption of vitamin B12 (cyanocobalamin) due to hypo - or achlorhydria. This should be considered in patients with reduced body stores or risk factors for reduced vitamin B12 absorption on long - term therapy.

if you are on TRUSTAN 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.

Children and adolescents

There is no experience with TRUSTAN in children younger than 12 years.

Do not share medicines prescribed for you with any other person. Always take TRUSTAN exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are unsure.

Adults

To treat gastroesophageal reflux disease (GORD):

• for treatment of erosive reflux oesophagitis. The usual dose is 40 mg once daily for 4 weeks. An additional 4 weeks treatment will be prescribed by your doctor when you have not healed, or who have persistent symptoms.
• long - term management of patients with healed oesophagitis to prevent relapse. The usual dose is 20 mg once daily.
• symptomatic treatment of gastro - oesophageal reflux disease (GORD). The usual dose is 20 mg once daily in patients without oesophagitis. If symptom control has not been achieved after 4 weeks, your doctor will need to do investigate further. Once the condition has been controlled, your doctor may tell you to take your medicine as and when you need it, up to a maximum of one TRUSTAN 20 mg tablet each day.

Patients requiring continued NSAID therapy:

• prevention of gastric and duodenal ulcers associated with NSAID therapy in patients at risk. The usual dose is 20 mg or 40 mg once daily.
• In combination with appropriate antibacterial therapeutic regimens for the eradication of Helicobacter pylori and healing of Helicobacter pylori associated duodenal ulcer.
• prevention of relapse of peptic ulcers in patients with Helicobacter pylori associated ulcer disease. The usual dose is 20 mg TRUSTAN with 1 g amoxicillin and 500 mg clarithromycin, all twice daily for 7 days.

To treat too much acid in the stomach caused by a growth in the pancreas (Zollinger - Ellison syndrome). The usual initial dosage is TRUSTAN 40 mg twice daily. The dosage should then be individually adjusted, and treatment continued as long as clinically indicated. Doses up to 120 mg twice daily have been administered.

Adolescents 12 - 18 years:

Gastro - oesophageal Reflux Disease (GORD):

• treatment of erosive reflux oesophagitis, the usual dose is 40 mg once daily for 4 weeks. An additional 4 weeks treatment is recommended for patients in whom oesophagitis has not healed, or who have persistent symptoms.
• long - term management of patients with healed oesophagitis to prevent relapse, the usual dose is 20 mg once daily.
• symptomatic treatment of gastro - oesophageal reflux disease (GORD), the usual dose is 20 mg once daily in patients without oesophagitis. If symptom control has not been achieved after 4 weeks, your doctor will need to do investigate further. Once symptoms have resolved, subsequent symptom control can be achieved using 20 mg once daily under medical supervision.

Children TRUSTAN is not recommended for children less than 12 years old.

Swallow your tablets whole with a drink of water. Do not chew or crush the tablets. If you have trouble swallowing the tablets:

• Disperse the tablets in half a glass of non - carbonated water. Do not use any other liquids.
• Stir until the tablet/s disintegrate and be sure to swallow all the tiny pellets that come out of the tablet without chewing them.
• Do not let the pellets sit in the water for more than 30 minutes before drinking.
• After drinking, rinse the glass with water and drink this as well.

Try to take your medicine at the same time each day. TRUSTAN should not be used in children younger than 12 years. TRUSTAN can be used in the elderly.

Your doctor will tell you how long your treatment with TRUSTAN will last. If you have the impression that the effect of TRUSTAN is too strong or too weak, tell your doctor or pharmacist.

If you take more TRUSTAN than you should In the event of an overdosage, immediately consult your doctor or pharmacist. If neither is available, seek help at the nearest hospital or poison control centre.

If you forget to take TRUSTAN Do not take a double dose to make up for forgotten individual doses. If you have missed a dose of TRUSTAN, take the dose that you have missed as soon as you remember. However, if it is nearly time for the next dose, skip the missed dose. If you have forgotten to take several doses, contact your doctor without delay.

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

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

• Sudden wheezing, swelling of the hands, feet, ankles, face, lips and mouth or throat, which may cause difficulty in swallowing or breathing.
• rash or itching,
• fainting
• blistering of the skin, mouth, eyes and genitals as these may be due to a serious allergic reaction known as Stevens - Johnson Syndrome (SJS).

These are all very serious side effects. If you have them, you may have had a serious reaction to TRUSTAN. 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:

• tightness of chest,
• suddenly feeling wheezy or short of breath (bronchospasm),
• fracture of the hip, wrists or spine,
• blood disorders (reduced number of cells in the blood i.e. leukopenia and thrombocytopenia),
• changes in blood count including agranulocytosis (lack of white blood cells) (agranulocytosis and pancytopenia),
• liver problems, including inflammation of the liver (with or without jaundice which can cause yellow skin, dark urine, and tiredness),

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, diarrhoea, wind (flatulence),
• feeling sick (nausea) / being sick (vomiting)
• constipation

Less frequent side effects

• dizziness,
• sensation of burning/prickling/numbness,
• feeling sleepy,
• dry mouth,
• skin reactions (rash, dermatitis, itching, hives),
• peripheral swelling,
• difficulty sleeping (insomnia),
• spinning feeling (vertigo)
• Taste changes,
• blurred vision,
• inflammation in the mouth,
• gastrointestinal fungal infection,
• gastrointestinal infection,
• hair loss (alopecia),
• skin rash due to sensitivity to sunlight,
• depression, nervousness, confusion,
• low blood sodium,
• muscular pain (myalgia), sore joints (arthralgia),
• feeling ill and increased sweating may occur,
• aggression,
• seeing, feeling or hearing things that are not there (hallucination),
• decreased consciousness,
• muscular weakness,
• inflammation of the kidney,
• development of breasts in males have been reported.
• low blood magnesium (which may result in low blood calcium and/or low blood potassium),
• inflammation of the gut (leading to diarrhoea).

The following side effect may also occur with TRUSTAN. This would only be seen when a blood test is taken; increase in the amount of liver enzymes. If you notice any side - effects not mentioned in this leaflet, please inform your doctor, pharmacist or other health care professional.

Reporting of side effects

If you get side effects, talk to your doctor, pharmacist or nurse. You can also report side effects to: SAHPRA: https://www.sahpra.org.za/health-products-vigilance/

Acino Pharma (Pty) Ltd E - mail: [email protected] Tel: 060 998 7896 By reporting side effects, you can help provide more information on the safety of TRUSTAN.

Store all medicines out of reach of children.

• Do not store in a bathroom. Keep your medicine stored at or below 30 °C in a dry place.
• Keep your tablets in the container they came in and keep the container tightly closed.
• Keep the blisters in the carton until required for use.
• 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).