Patient leaflet - Trientine 200 mg hard capsules

1. What Trientine capsules are and what they are used for

Your medicine is called Trientine 200 mg hard capsules. In this leaflet, it will be referred to as Trientine capsules.

Trientine capsules are a medicine used for the treatment of Wilson’s disease in adults, adolescents and children aged 5 years or older. It is for use by patients who cannot take another medicine, D-Penicillamine, because of side effects.

Trientine capsules contain the active substance trientine, a copper-chelating agent that is used to remove excess of copper from the body. Trientine attaches to the copper, which is then passed from the body.

2. What you need to know before you take Trientine capsules

Do not take Trientine capsules:

If you are allergic to trientine or any of the other ingredients of this medicine (listed in section 6).

Signs of an allergic reaction include rash, itching, swelling of the face, fainting and breathing problems.

Warnings and precautions

Your doctor will need to check regularly for symptoms of the disease and copper levels in your blood and urine. Regular monitoring is especially important at the start of your treatment or 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 capsules.

Nervous system problems can occur (for example, shaking, lack of coordination, slurred speech, muscle stiffness and worsening of muscle spasms), especially in patients just starting treatment with Trientine capsules. If you notice these whilst taking Trientine capsules, you must tell your doctor immediately.

Lupus-like reactions (symptoms may include persistent rash, fever, joint pain, and tiredness) 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.

Other medicines and Trientine capsules

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

If you are taking iron tablets or medicines that neutralise the acid in your stomach, leave at least 2 hours before or after you have taken Trientine capsules because they may reduce the effect of trientine.

It is recommended that trientine is taken at least one hour apart from any other medicinal product.

Trientine capsules with food and drink

Take this medicine with water only. Do not take it with other drinks, milk or food because they may reduce the medicine’s effect. Avoid eating or drinking (except water) for 2 hours before, or 1 hour after taking Trientine capsules.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. It is very important to continue treatment to maintain normal copper levels during pregnancy. You and your doctor should fully discuss the potential benefits of treatment whilst considering any possible risks that there may be.

Your doctor will advise you which treatment and which dose is best in your situation. If you become pregnant whilst taking Trientine capsules, talk to your doctor.

If you are pregnant and taking Trientine capsules, you will be monitored throughout your pregnancy for any effects on the baby or changes in your copper levels.

The limited information available suggests that trientine does not pass into breast milk, but it is not certain that there is no risk to the baby. It is important to tell your doctor if you are breast-feeding or plan to do so. Your doctor will then help you decide whether to stop breast-feeding or to stop taking Trientine capsules, considering the benefit of breast-feeding to the baby and the benefit of Trientine capsules to the mother. Your doctor will decide which treatment and which dose is best in your situation.

Driving and using machines

Trientine is not likely to have an effect on your ability to drive or use machines.

3. How to take Trientine capsules

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Adults (including the elderly)

The usual dose is between 4 and 8 capsules per day, to be taken by mouth.

Use in children and adolescents (5 to 17 years)

In children and adolescents, the dose depends on age and body weight and will be adjusted by your doctor. At the start of treatment the dose varies between 2 and 5 capsules per day.

Method of administration

Your doctor will decide the correct dose for you.

The total daily dose can be divided into 2 to 4 smaller doses, as indicated by your doctor. Swallow the capsules whole with a drink of water on an empty stomach, at least 1 hour before or 2 hours after food.

Patients who have difficulties swallowing should contact their doctor.

DO NOT eat the desiccant.

UK 676-4237-01

If you take more Trientine capsules than you should

If you take more medicine than you should, you may get nausea, vomiting and dizziness. You must contact your doctor or another health care provider immediately.

If you forget to take Trientine capsules

If you forget to take a dose take your next dose at its usual scheduled time.

Do not take a double dose to make up for a forgotten dose.

If you stop taking Trientine capsules

This medicine is for long-term use because Wilson’s disease is a life-long condition. Do not stop or change your treatment without speaking with your doctor even if you feel better.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Occasionally (frequency unknown; cannot be estimated from available data), treatment with this medicine can cause inflammation of the small intestine or colon.

If you have any of the following side effects contact your doctor immediately:

Severe stomach pains
Persistent diarrhoea
Nervous system problems (for example shaking, lack of coordination, slurred speech, muscle stiffness, worsening of muscle spasms).

Other side effects may include:

Common (may affect up to 1 in 10 people)

Nausea (especially when starting treatment)

Uncommon (may affect up to 1 in 100 people)

Skin rashes
Anaemia (you may feel unusually tired)

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Trientine capsules

Keep this medicine out of the sight and reach of children.

Do not use after the expiry date which is stated on the bottle label and outer carton after EXP. The expiry date refers to the last day of the month.

Store below 30°C.

Store in the original container. Keep the bottle tightly closed and retain the silica gel desiccant in the bottle, in order to protect from moisture. DO NOT eat the desiccant.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the pack and other information

What Trientine capsules contain

The active substance is trientine.

Each hard capsule contains 300 mg trientine dihydrochloride, equivalent to 200 mg trientine.

The other ingredients are:

Capsule content:

Stearic acid

Capsule shell: Gelatin, titanium dioxide (E171)

Printing ink: Shellac (E904), black iron oxide (E172), potassium hydroxide (E525)

What Trientine capsules look like and contents of the pack

Each hard capsule is a cylindrical size “1” hard gelatin capsule with an opaque, white coloured-cap, printed with “NAV” in black ink and an opaque white coloured body, printed with “121” in black ink. The capsule is filled with white to off-white powder.

The capsules are packed in white, high density polyethylene (HDPE) round bottle with a silica gel desiccant in the bottle, and closed with a polypropylene closure.

Pack size: A bottle of 100 hard capsules in a carton.

Marketing Authorisation Holder

Waymade Plc

Sovereign House

Miles Gray Road

Basildon, Essex, SS14 3FR

United Kingdom.

Manufacturer