TRIENTINE DR. REDDY’S

▼ 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

TRIENTINE DR. REDDY’S

Active ingredient(s): trientine dihydrochloride

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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

Less serious side effects	What to do
Stomach-related Nausea Blood-related Anaemia (feeling tired)	Speak to your doctor if you have any of these less serious side effects and they worry you.

Serious side effects

Serious side effects	What to do
Stomach-related Severe stomach pain Persistent diarrhoea Nervous system related Lack of co-ordination Muscle stiffness Worsening of muscle spasm Slurred speech Allergic reaction related Signs of Lupus–like symptoms Rash, itching, skin swelling Wheezing, trouble breathing or swallowing	Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these 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

Active ingredient (main ingredient)	Each capsule contains 250 mg of trientine dihydrochloride
Other ingredients (inactive ingredients)	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

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.