SUMMARY CMI

TRIENTINE DR. REDDY'S

Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.

▼ This medicine is new or being used differently. Please report side effects. See the full CMI for further details.

1. Why am I using TRIENTINE DR. REDDY'S?

TRIENTINE DR. REDDY'S contains the active ingredient trientine dihydrochloride. TRIENTINE DR. REDDY'S is used to treat Wilson's disease in people who cannot take another medicine called penicillamine. For more information, see Section 1. Why am I using TRIENTINE DR. REDDY'S? in the full CMI.

2. What should I know before I use TRIENTINE DR. REDDY'S?

Do not use if you have ever had an allergic reaction to trientine dihydrochloride or any of the ingredients listed at the end of the CMI.

Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.

For more information, see Section 2. What should I know before I use TRIENTINE DR. REDDY'S? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with TRIENTINE DR. REDDY'S and affect how it works.

A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use TRIENTINE DR. REDDY'S?

• Your doctor will decide the dose and how often to take this medicine.
• The capsules are to be swallowed whole with a full glass of water. Do not chew, open or crush the capsules
• Take trientine on an empty stomach, at least 1 hour before or 2 hours after a meal. More instructions can be found in Section 4. How do I use TRIENTINE DR. REDDY'S? in the full CMI.

5. What should I know while using TRIENTINE DR. REDDY'S?

For more information, see Section 5. What should I know while using TRIENTINE DR. REDDY'S? in the full CMI.

6. Are there any side effects?

Common side effects include nausea, particularly when starting treatment. Less common side effects include skins rashes and anaemia, which may make you feel very tired.

There are some important serious side effects that you should tell your doctor about or get medical help right away. These include severe stomach pain or persistent diarrh oea, lack of co-ordination, slurred speech, muscle stiffness, worsening of muscle spasm

For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems

FULL CMI

TRIENTINE DR. REDDY'S

Active ingredient(s): trientine dihydrochloride

Consumer Medicine Information (CMI)

This leaflet provides important information about using TRIENTINE DR. REDDY'S. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using TRIENTINE DR. REDDY'S.

Where to find information in this leaflet:

1. Why am I using TRIENTINE DR REDDY'S?
2. What should I know before I use TRIENTINE DR. REDDY'S?
3. What if I am taking other medicines?
4. How do I use TRIENTINE DR. REDDY'S?
5. What should I know while using TRIENTINE DR. REDDY'S?
6. Are there any side effects?
7. Product details

1. Why am I using TRIENTINE DR. REDDY'S?

TRIENTINE DR. REDDY'S contains the active ingredient trientine dihydrochloride.

Trientine is a chelating (KEE-late-ing) agent that works by removing copper from the blood.

Wilson's disease is a genetic metabolic defect that causes excess copper to build up in the body.

Trientine dihydrochloride is used to treat this inherited condition in people who cannot take penicillamine.

2. What should I know before I use TRIENTINE DR. REDDY'S?

Warnings

Do not use TRIENTINE DR. REDDY'S if:

• you are allergic to trientine dihydrochloride, or any of the ingredients listed at the end of this leaflet.
  Always check the ingredients to make sure you can use this medicine.

Check with your doctor if you:

• have any other medical conditions
• take any medicines for any other condition
• have anaemia (low red blood cells)

Your doctor will need to regularly check for symptoms of your disease and copper levels in your blood and urine. Regular monitoring is especially important at the start of your treatment and when your dose is changed, in growing children and pregnant women to ensure that copper levels are maintained at a suitable level. The doctor may need to increase or decrease your dose of TRIENTINE DR. REDDY'S.

Regular monitoring is also important if you have liver or kidney problems.

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Check with your doctor if you are pregnant or intend to become pregnant. TRIENTINE DR.REDDY'S can be harmful to the unborn baby when taken by a woman during pregnancy so your doctor will discuss with you the benefits and risks of using it. If you are pregnant and taking TRIENTINE DR. REDDY'S you will be monitored throughout your pregnancy for any effect on the baby or changes in your copper levels.

Talk to your doctor if you are breastfeeding or intend to breastfeed. It is not known if TRIENTINE DR. REDDY'S passes in to your breastmilk.

3. What if I am taking other medicines?

Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.

Some medicines may interfere with TRIENTINE DR. REDDY'S and affect how it works.

• Mineral supplements may block the absorption of TRIENTINE DR. REDDY'S.
• If your doctor has advised you to take an iron supplement, separate the dose by at least two hours after your dose of TRIENTINE DR. REDDY'S
• If you are taking antacids containing calcium or magnesium, do not take them at the same time as TRIENTINE DR. REDDY'S.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect TRIENTINE DR. REDDY'S.

4. How do I use TRIENTINE DR. REDDY'S?

How much to take

• Your doctor will decide the correct dose for you.
• The usual dose for Children above 5 years is: 2 to 3 capsules given in divided doses two or three times daily.
• The usual dose for adults is: 3 to 5 capsules given in divided doses two, three or four times daily.
• Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts than prescribed by your doctor or for longer than recommended.
• The total dose can be divided in to 2 to 4 smaller doses as directed by your doctor
• Follow the instructions provided and use TRIENTINE DR. REDDY'S until your doctor tells you to stop.

When to take TRIENTINE DR. REDDY'S

• Take the capsules on an empty stomach, at least 1 hour before or 2 hours after a meal.
• The capsules should be swallowed whole with water

If you forget to take TRIENTINE DR. REDDY'S

Discuss with your Doctor or Pharmacist about what to do if you miss your dose. Do not exceed the daily dose prescribed by your Doctor.

TRIENTINE DR. REDDY'S should be used regularly at the same time each day. Take the missed dose as soon as you remember.

If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.

Do not take a double dose to make up for the dose you missed.

If you use too much TRIENTINE DR. REDDY'S

If you think that you have used too much TRIENTINE DR. REDDY'S, you may need urgent medical attention.

You should immediately:

• phone the Poisons Information Centre (by calling 13 11 26), or
• contact your doctor, or
• go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

5. What should I know while using TRIENTINE DR. REDDY'S?

Things you should do

• Your doctor may have you take extra iron while you are taking trientine. Take only the amount of iron that your doctor has prescribed.
• While using trientine, you may need frequent blood and urine tests. You should remain under the care of a doctor during treatment

Call your doctor straight away if you:

• Develop nervous system problems (for example, shaking, lack of co-ordination, slurred speech, muscle stiffness and worsening of muscle spasm, especially in patients just starting treatment with TRIENTINE DR. REDDY'S.
• Notice Lupus-like symptoms (symptoms of Lupus may include joint pain, stiffness and swelling; fatigue; fever; rash including on the face; and skin lesions from sun exposure). These symptoms have been reported in some patients switched to trientine medicine after penicillamine medicine. However it was not possible to determine if the reaction was due to trientine or to previous penicillamine treatment.

Remind any doctor, dentist or pharmacist you visit that you are using TRIENTINE DR. REDDY'S.

Things you should not do

• Do not drink milk, eat food, or take any other medications for at least 1 hour before or after you take trientine.
• Do not chew, break, or open a trientine capsule. Swallow it whole.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how TRIENTINE DR. REDDY'S affects you.

Looking after your medicine

• Store below 25­C.

Follow the instructions attached to the bottle on how to take care of your medicine properly.

Store it in a cool dry place away from moisture, heat or sunlight; for example, do not store it:

• in the bathroom or near a sink, or
• in the car or on window sills.

Keep it where young children cannot reach it.

Getting rid of any unwanted medicine

If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.

Do not use this medicine after the expiry date.

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary.

However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

Less serious side effects

Serious side effects

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

This medicine is only available with a doctor's prescription.

What TRIENTINE DR. REDDY'S contains

Do not take this medicine if you are allergic to any of these ingredients.

What TRIENTINE DR. REDDY'S looks like

TRIENTINE DR. REDDY'S is a yellow opaque, hard gelatin size “1” capsules imprinted with “RDY” on cap and “459” on body in black ink filled with white to pale yellow powder, in bottles of 100 capsules (Aust R 329316)

Who distributes TRIENTINE DR. REDDY'S

Dr Reddy's Laboratories (Australia) Pty Ltd
Melbourne, VIC, 3004, Australia
Phone: 1800 733 397

This leaflet was prepared in February 2021.

Published by MIMS August 2021

1 Name of Medicine

Trientine dihydrochloride.

2 Qualitative and Quantitative Composition

Capsules containing 250 mg of trientine dihydrochloride, equivalent to 167 mg trientine base. Capsules also contain gelatin. For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Trientine Dr. Reddy's, trientine dihydrochloride capsules, 250 mg, are yellow opaque, hard gelatin size "1" capsules imprinted with "RDY" on cap and "459" on body in black ink filled with white to pale yellow powder.

4 Clinical Particulars

4.1 Therapeutic Indications

Trientine dihydrochloride capsules are indicated for the treatment of patients with Wilson's disease who are intolerant of penicillamine.

4.2 Dose and Method of Administration

Systematic evaluation of dose and/or interval between dose has not been done. However, based on clinical experience, the recommended initial doses of trientine dihydrochloride capsules are given below.
The doses are expressed in terms of trientine dihydrochloride and the equivalent dose of trientine free base. It should be noted that a dose of 250 mg trientine dihydrochloride corresponds to a dose of 167 mg trientine free base. This should be considered if a patient is transferred from one trientine formulation to another.

Children > 5 years.

Adults.

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients listed (see Section 6.1 List of Excipients.)

4.4 Special Warnings and Precautions for Use

Patients receiving trientine dihydrochloride capsules should remain under regular medical supervision throughout the period of drug administration. Patients (especially women) should be closely monitored for evidence of iron deficiency anaemia.
Caution is advised when switching a patient from another trientine formulation. Different trientine salts are available which may have a different trientine content (base) and dose adjustment may be required (see Section 4.2 Dose and Method of Administration).
Trientine is a chelating agent that has been found to reduce serum iron levels. Iron supplementation may be necessary in some cases and concomitant oral iron should be administered at a different time than trientine (see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions).
The combination of trientine with zinc is not recommended.
There is no evidence that calcium and magnesium antacids alter the efficacy of trientine but it is recommended to separate their administration (see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions).
In patients who were previously treated with D-Penicillamine, lupus-like reactions have been reported during subsequent treatment with trientine, however it is not possible to determine if there is a causal relationship with trientine.
Unlike penicillamine, trientine hydrochloride capsules are not recommended in cystinuria or rheumatoid arthritis. The absence of a sulfhydryl moiety renders it incapable of binding cysteine and, therefore, it is of no use in cystinuria. In 15 patients with rheumatoid arthritis, trientine hydrochloride was reported not to be effective in improving any clinical or biochemical parameter after 12 weeks of treatment.
Trientine hydrochloride capsules are not indicated for treatment of biliary cirrhosis.

Monitoring.

Use in hepatic impairment.

Use in renal impairment.

Use in the elderly.

Paediatric use.

Effects on laboratory tests.

4.5 Interactions with Other Medicines and Other Forms of Interactions

No interaction studies have been performed.
Trientine has been found to reduce serum iron levels, possibly by reducing its absorption, and iron supplements may be required. Since iron and trientine may inhibit absorption of each other, iron supplements or other heavy metals should be taken after at least two hours have elapsed from the administration of trientine.
No specific food interaction studies in humans have been performed with trientine. However as trientine is poorly absorbed following oral intake, food may inhibit absorption. The principal mechanism of action of trientine requires its systemic exposure (see Section 5.1 Pharmacodynamic Properties) so it is recommended that trientine be taken at least 1 hour before meals or 2 hours after meals and at least one hour apart from any other medicinal product, food, or milk to allow for maximum absorption and reduce the likelihood of the formation of complexes by metal binding in the gastrointestinal tract (see Section 4.2 Dose and Method of Administration).
Although there is no evidence that calcium or magnesium antacids alter the efficacy of trientine, it is good practice to separate their administration.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

4.7 Effects on Ability to Drive and Use Machines

The effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration.

4.8 Adverse Effects (Undesirable Effects)

Nausea can commonly occur on initial treatment and occasionally skin rash can occur. Duodenitis and severe colitis have been reported; gastrointestinal disorders are possibly related to higher doses of trientine.
There have been reports of neurological deterioration at the start of treatment in Wilson's disease patients treated with copper chelators including trientine, with symptoms of dystonia, rigidity, tremor and dysarthria (see Section 4.4 Special Warnings and Precautions for Use).
No clinical studies have included a systematic evaluation of adverse effects of trientine, however clinical experience over many years supports that it is well tolerated in the treatment of patients with Wilson's Disease, with adverse events reported less frequently for trientine than for D-penicillamine therapy.
The table presented below is according to the MedDRA system organ classification (SOC and Preferred Term Level). Frequencies are defined as: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); not known (cannot be estimated from the available data). See Table 1.

Reporting suspected adverse effects.

4.9 Overdose

Occasional cases of trientine overdose have been reported. A large overdose of 40 g of trientine base resulted in self-limiting dizziness and vomiting with no other clinical sequelae or significant biochemical abnormalities reported (Hashim and Parnell, 2015).
There is no antidote for trientine acute overdose.
Chronic high dose trientine treatment can lead to copper deficiency and reversible sideroblastic anaemia. A patient who received 2500 mg trientine/day for about 10 years was reported to have copper depletion and the consequent decrease of copper-binding holo-ceruloplasmin induced anemia, iron deposition and liver function abnormality in the patient (Harada et al, 2011).
Overtreatment and excess copper removal can be monitored using values of urine copper excretion and of non-ceruloplasmin bound copper. Close monitoring is required to optimise the dose or to adapt treatment if necessary (see Section 4.4 Special Warnings and Precautions for Use).
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Clinical trials.

5.2 Pharmacokinetic Properties

Absorption.

Distribution.

Metabolism.

Excretion.

Linearity/non-linearity.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

Trientine Dr. Reddy's capsules contain colloidal silicon dioxide, ferric oxide yellow, gelatin, magnesium stearate, polyethylene glycol, titanium dioxide and purified water as inactive ingredients. The imprinting ink (TekPrint SW-9008 Black Ink) contains black iron oxide, potassium hydroxide, propylene glycol and shellac.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Keep container tightly closed. Store below 25°C.

6.5 Nature and Contents of Container

HDPE bottle with child-resistant screw cap, in packs of 100.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

6.7 Physicochemical Properties

Trientine dihydrochloride is N,N'-bis (2-aminoethyl)-1,2-ethanediamine dihydrochloride. It is a white to pale yellow powder. It is soluble in methanol and freely soluble in water.

Chemical structure.

CAS number.

References

Cho H-Y., Blum R.A., Sunderland T., et al. Journal of Clinical Pharmacology. 49 (8) (pp 916-928), 2009.
Kodama H., Meguro Y., Tsunakawa A., et al. Tohoku Journal of Experimental Medicine. 169 (1) (pp 59-66), 1993.
Harada M., Miyagawa K., Honma Y., et al. Internal Medicine. 50 (14) (pp 1461-1464), 2011.
Hashim A and Parnell N. Toxicology International. 22 (1) (pp 158-159), 2015.
Hedera P. Parkinsonism and Related Disorders. 59 (pp 140-145), 2019.
Lu J., Chan Y.-K., Gamble G.D., Poppitt S.D., et al. Drug Metabolism and Disposition. 35 (2) (pp 221-227), 2007.
Weiss K.H., Thurik F., Gotthardt D.N., et al. Clinical Gastroenterology and Hepatology. 11 (8) (pp 1028-1035), 2013.

7 Medicine Schedule (Poisons Standard)

Schedule 4 - Prescription Only Medicine.

Summary Table of Changes