TRUSTAN : Uses,Side Effects,Warnings,Precautions

TRUSTAN is a prescription medicine used to reduce excessive stomach acid. It contains esomeprazole, a type of medicine called a proton pump inhibitor (PPI). By lowering acid production, it helps to relieve heartburn and inflammation in the food pipe (oesophagus), treat and prevent certain ulcers (including those related to specific pain medicines), form part of treatment to clear Helicobacter pylori infection, and control conditions where the stomach makes too much acid.

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What it is and what it is used for

TRUSTAN contains esomeprazole, a proton pump inhibitor. PPIs are medicines that treat ulcers and acid-related problems by suppressing the stomach’s acid pumps.

Uses

• Gastro-oesophageal reflux disease (GORD):
  • Treatment of erosive reflux oesophagitis.
  • Long-term management after healing to prevent relapse.
  • Symptomatic treatment of GORD in patients without oesophagitis.
• Prevention of ulcers associated with ongoing NSAID (non-steroidal anti-inflammatory drug) therapy in at-risk patients.
• Eradication of Helicobacter pylori infection with appropriate antibiotics to:
  • Heal H. pylori-associated duodenal ulcer.
  • Prevent relapse of ulcers in patients with H. pylori-associated ulcer disease.
• Hypersecretory conditions such as Zollinger–Ellison syndrome (excess acid due to hormone-producing tumours).

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How it works

Your stomach contains tiny “pumps” that release acid to help digest food. In some conditions, too much acid is produced or acid flows back into the food pipe, causing pain and damage. Esomeprazole switches off many of these pumps by blocking the final step of acid production. With less acid, irritation, inflammation and ulcers can heal, and symptoms like heartburn usually improve.

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Who should NOT use this medicine

Do not take TRUSTAN if:

• You are allergic to esomeprazole, to any other proton pump inhibitors, or to any ingredients in TRUSTAN.
• You are taking HIV medicines atazanavir or nelfinavir.

Talk to your doctor or pharmacist before use if any of the following apply:

• You have unexplained weight loss, vomit blood or food, pass black/bloody stools, or develop new or worsening stomach pain/indigestion.
• You have or have had severe liver problems (a lower dose may be needed).
• You have severe kidney problems.
• You develop severe, persistent diarrhoea (possible Clostridium difficile–associated diarrhoea).
• You are scheduled for a Chromogranin A blood test.
• You have osteoporosis or use corticosteroids (long-term PPI use may slightly raise fracture risk of hip, wrist, or spine).
• You notice a rash in sun-exposed areas or joint pain.
• You have risk factors for vitamin B12 deficiency; acid suppression can reduce B12 absorption over time.
• You will be on TRUSTAN for more than three months (your doctor may check magnesium levels; low magnesium may cause fatigue, muscle cramps, confusion, seizures, dizziness, fast heartbeat and can also lower potassium or calcium).

Children
There is no experience with TRUSTAN in children under 12 years; it is not recommended for this age group.

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Warnings and precautions (Read before use)

• Kidneys: TRUSTAN can rarely cause tubulointerstitial nephritis (kidney inflammation). Seek medical help if you notice increased or dark urine, blood in urine, swelling, confusion or unusual drowsiness.
• Bones: Using a PPI beyond 1 year may slightly increase the risk of certain fractures.
• Infections: Severe, persistent diarrhoea may indicate a serious gut infection.
• Vitamin B12: Long-term acid reduction may lower B12 absorption; your doctor may monitor if you are at risk.
• Magnesium: Long-term use can lower magnesium; your doctor may arrange blood tests.
• Skin: Stop and tell your doctor if you develop a sun-sensitive rash; mention any joint pains.
• Driving and machinery: Some people may get dizziness or blurred vision. Do not drive or use machines until you know how TRUSTAN affects you.
• Sugar content: Tablets contain sucrose. If you have sugar intolerance, speak to your doctor before use.

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Pregnancy, planning pregnancy, and breastfeeding

Speak to your doctor or pharmacist before use.

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Interactions

Always tell your healthcare provider about all medicines you use (including traditional or complementary products). Interactions listed in the source include:

• Do not use together: Atazanavir or nelfinavir (HIV treatment).
• Antifungals: Itraconazole, ketoconazole, voriconazole.
• Certain anti-cancer medicines: e.g., erlotinib (and others from the same class).
• Epilepsy/anxiety/muscle-relaxant medicines: Diazepam; phenytoin, sodium valproate (monitoring may be needed when starting/stopping TRUSTAN).
• Blood thinners/antiplatelets: Warfarin, clopidogrel (doctor may monitor when starting/stopping TRUSTAN).
• Peripheral circulation medicine: Cilostazol.
• Transplant medicine: Tacrolimus.
• Indigestion/motility agent: Cisapride.
• Heart medicine: Digoxin.
• Cancer/rheumatoid arthritis: Methotrexate (high-dose use may require temporary stop of TRUSTAN).
• Tuberculosis treatment: Rifampicin.
• Antidepressants / herbal: Citalopram, imipramine, clomipramine, St John’s Wort.
• H. pylori treatment combination: If you are prescribed amoxicillin and clarithromycin with TRUSTAN, tell your doctor about all other medicines you take.

Food and drink
You may take TRUSTAN with food or on an empty stomach.

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How to take (Step-by-step)

Use exactly as your doctor or pharmacist has told you. Do not share your medicine with anyone else.

General instructions

1. Dose and duration: Follow your doctor’s directions for dose and length of treatment for your condition.
2. Swallow whole: Take the tablet whole with water. Do not crush or chew.
3. If you cannot swallow tablets:
   • Disperse the tablet in half a glass of non-carbonated water only.
   • Stir until the tablet disintegrates and swallow all the tiny pellets without chewing.
   • Do not let the mixture stand longer than 30 minutes.
   • Rinse the glass with more water and drink to take all the pellets.
4. Timing: Try to take it at the same time each day.
5. Elderly: TRUSTAN can be used in older adults.
6. Under 12 years: Do not use; not recommended.

Adult dosing

• GORD – erosive reflux oesophagitis (treatment):
  40 mg once daily for 4 weeks. Your doctor may prescribe another 4 weeks if not healed or if symptoms persist.
• GORD – long-term management after healing (to prevent relapse):
  20 mg once daily.
• GORD – symptomatic treatment without oesophagitis:
  20 mg once daily.
  If symptoms are not controlled after 4 weeks, your doctor may investigate further.
  Once controlled, your doctor may advise “as-needed” use up to one 20 mg tablet per day.
• Prevention of NSAID-associated gastric/duodenal ulcers (at-risk patients):
  20 mg or 40 mg once daily.
• H. pylori eradication to heal duodenal ulcer and prevent relapse:
  20 mg TRUSTAN twice daily plus amoxicillin 1 g twice daily and clarithromycin 500 mg twice daily for 7 days.
• Zollinger–Ellison syndrome (excess acid):
  Initial: 40 mg twice daily.
  The dosage is then individually adjusted and continued as long as clinically indicated.
  Doses up to 120 mg twice daily have been used.

Adolescents (12–18 years)

• GORD – erosive reflux oesophagitis (treatment):
  40 mg once daily for 4 weeks; an additional 4 weeks if not healed or symptoms persist.
• GORD – long-term management after healing:
  20 mg once daily.
• GORD – symptomatic treatment without oesophagitis:
  20 mg once daily.
  If not controlled after 4 weeks, further investigation may be needed.
  Once symptoms resolve, 20 mg once daily may maintain control under medical supervision.

Missed dose and overdose

• Missed a dose? Take it as soon as you remember.
  If it is almost time for your next dose, skip the missed dose.
  Do not double up.
  If you have missed several doses, contact your doctor.
• Overdose: Seek immediate medical help—doctor, pharmacist, nearest hospital, or poison control centre.

Practical tips for adherence

• Keep tablets in the original packaging so you remember the dose and to protect them.
• Set a daily reminder to take your dose at the same time each day.
• If you often struggle with tablets, ask your pharmacist to guide you through the dispersion in water method described above.

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Dosing table

Only follow doses prescribed for you by your doctor. This table is a quick reference of regimens described in the source leaflet.

Indication / Group	Dose	Frequency	Duration / Notes
Adults – GORD (erosive reflux oesophagitis) – treatment	40 mg	Once daily	4 weeks; may add 4 more weeks if not healed/persistent symptoms
Adults – GORD (post-healing maintenance)	20 mg	Once daily	Long-term to prevent relapse
Adults – GORD (symptomatic, no oesophagitis)	20 mg	Once daily	Reassess if not controlled after 4 weeks; once controlled, doctor may advise as-needed, max 20 mg once daily
Adults – Prevention of NSAID-associated ulcers	20 mg or 40 mg	Once daily	For at-risk patients requiring continued NSAIDs
Adults – H. pylori eradication	TRUSTAN 20 mg + amoxicillin 1 g + clarithromycin 500 mg	All twice daily	7 days
Adults – Zollinger–Ellison syndrome	40 mg (initial)	Twice daily	Adjust individually; up to 120 mg twice daily used; continue as indicated
Adolescents (12–18) – GORD (erosive) – treatment	40 mg	Once daily	4 weeks; consider additional 4 weeks if needed
Adolescents (12–18) – GORD (post-healing maintenance)	20 mg	Once daily	As directed to prevent relapse
Adolescents (12–18) – GORD (symptomatic, no oesophagitis)	20 mg	Once daily	Investigate if not controlled after 4 weeks; maintenance 20 mg once daily under supervision
Children <12 years	—	—	Not recommended

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Side effects

Serious—seek urgent medical help and stop taking TRUSTAN

• Severe allergic reactions: sudden wheezing; swelling of face, lips, mouth, throat, hands/feet/ankles; difficulty breathing or swallowing; rash or itching; fainting.
• Severe skin reactions including blistering of the skin, mouth, eyes or genitals (can indicate Stevens–Johnson syndrome).
• Breathing problems such as bronchospasm (sudden wheeze or shortness of breath).
• Fractures of hip, wrist, or spine.
• Blood disorders: lowered white cells or platelets (e.g., leukopenia, thrombocytopenia, agranulocytosis, pancytopenia).
• Liver problems, including inflammation (with or without jaundice) causing yellow skin, dark urine, and tiredness.

Warning: If you experience any of the above, stop the medicine and see a doctor immediately or go to the nearest casualty department.

Common side effects

• Headache
• Stomach pain, diarrhoea, wind (flatulence)
• Nausea or vomiting
• Constipation

Less common side effects

• Dizziness, sleepiness, insomnia, vertigo
• Pins and needles or numbness
• Dry mouth, inflammation in the mouth
• Taste changes, blurred vision
• Skin reactions: rash, dermatitis, itching, hives, sun-sensitivity rash
• Peripheral swelling
• Gastrointestinal infections, including fungal
• Hair loss (alopecia)
• Mood/neurological: depression, nervousness, confusion, aggression, hallucinations, reduced consciousness
• Electrolytes: low sodium, low magnesium (which may lead to low calcium and/or low potassium)
• Muscle/joint: muscle pain (myalgia), joint pain (arthralgia), muscle weakness
• Kidney inflammation
• Male breast development
• Inflammation of the gut (may lead to diarrhoea)
• Laboratory changes: raised liver enzymes seen on blood tests

What to do about side effects

Most side effects are mild and pass on their own. If they bother you, worsen, or you notice any unexpected symptom, speak to your doctor or pharmacist. For any severe reaction, seek urgent care.

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Storage and disposal

• Keep out of reach of children.
• Store at or below 30 °C in a dry place.
• Do not store in a bathroom.
• Keep tablets in the original container/blister with the carton until use; keep containers tightly closed.
• Do not use after the expiry date on the label.
• Return unused or expired medicine to your pharmacist.
• Do not dispose of medicines in drains or toilets.

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What the medicine contains

• Active ingredient:
  • TRUSTAN 20 mg: Esomeprazole 20 mg (as magnesium trihydrate)
  • TRUSTAN 40 mg: Esomeprazole 40 mg (as magnesium trihydrate)
• Key excipients (include): Crospovidone, glycerol monostearate, hypromellose, hydroxypropylcellulose, iron oxide, magnesium stearate, methacrylic acid–ethyl acrylate copolymer, microcrystalline cellulose, macrogol, polysorbate 80, synthetic paraffin, sugar spheres (sucrose and maize starch), sodium stearyl fumarate, talc, triethyl citrate, titanium dioxide.
• Sugar content:
  • 20 mg tablet: Sucrose 28 mg
  • 40 mg tablet: Sucrose 30 mg

Note: If you have been told you have an intolerance to some sugars, consult your doctor before taking TRUSTAN.

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Pack information and appearance

• TRUSTAN 20 mg: Light pink, oval, coated tablet; marked “20 mg” on one side and A / EH on the other.
• TRUSTAN 40 mg: Pink, oval, coated tablet; marked “40 mg” on one side and A / EI on the other.
• Packaging:
  • Blister strips in cartons: may contain 3, 7, 14, 15, 28, 30, 50, 56, 60, 98 or 100 tablets.
  • White plastic bottles (with or without child-resistant caps, tamper-evident ring) containing 2, 5, 7, 14, 15, 28, 30, 56, 60 or 100 tablets, packed in a carton.
• Holder of Certificate of Registration: Acino Pharma (Pty) Ltd

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Practical FAQs

Can I take TRUSTAN with food?
Yes. You can take the tablets with food or on an empty stomach.

I struggle to swallow tablets. What can I do?
You may disperse the tablet in half a glass of non-carbonated water, stir until it disintegrates, and swallow all the pellets without chewing. Do not let the mixture stand longer than 30 minutes. Rinse the glass with water and drink to take all pellets.

Can children use TRUSTAN?
There is no experience in children under 12 years; it is not recommended. It can be used in adolescents 12–18 years for GORD as directed.

Is it safe to drive while taking TRUSTAN?
TRUSTAN may cause dizziness and blurred vision in some people. Do not drive or use machines until you know how it affects you.

Does TRUSTAN contain sugar?
Yes. Each 20 mg tablet contains 28 mg sucrose; each 40 mg tablet contains 30 mg sucrose. If you have a sugar intolerance, speak to your doctor before using it.

What should I do if I miss a dose?
Take it as soon as you remember. If it is almost time for your next dose, skip the missed one. Do not take a double dose. If you have missed several doses, contact your doctor.

How long should I take TRUSTAN for GORD?
For erosive reflux oesophagitis, treatment is usually 4 weeks, and your doctor may add another 4 weeks if needed. For maintenance, 20 mg once daily is used to prevent relapse. Your doctor will advise based on your response.

Can TRUSTAN be used to prevent ulcers from pain medicines (NSAIDs)?
Yes, in at-risk patients who need ongoing NSAID therapy, 20 mg or 40 mg once daily may be used to prevent gastric or duodenal ulcers.

What if I am on many other medicines?
Tell your healthcare provider about all medicines you take. Some interactions require monitoring or avoidance (for example, atazanavir and nelfinavir must not be used with TRUSTAN).

Who should I contact about side effects?
Speak to your doctor, pharmacist or nurse. You can also report to SAHPRA or Acino Pharma (email/phone above).