TRIENTINE WAYMADE 200 mg HARD CAPSULES

Introduction

Patient Information Leaflet

Trientine Waymade 200 mg hard capsules EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.

• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Trientine Waymade and what is it used for
2. What you need to know before you take Trientine Waymade
3. How to take Trientine Waymade
4. Possible side effects
5. Storage of Trientine Waymade
6. Contents of the pack and further information

1. What is Trientine Waymade and what is it used for

This medicine is called Trientine Waymade 200 mg hard capsules. In this leaflet, it will be referred to as Trientine Waymade or trientine.

Trientine is indicated for the treatment of Wilson's disease in adults, adolescents, and children aged 5 years and older. It is used in patients who cannot take another medicine, D-penicillamine, due to side effects.

This medicine contains the active substance trientine, a copper-chelating agent used to remove excess copper from the body. Trientine binds to copper, which is then excreted from the body.

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

Do not take Trientine Waymade

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, among others, skin rash, itching, swelling of the face, fainting, and breathing difficulties.

Warnings and precautions

Your doctor will need to regularly check your symptoms of the disease and your copper levels in blood and urine. Regular monitoring is especially important at the start of treatment or when changing the dose, in growing children, and in pregnant women, to ensure that copper levels are maintained at an adequate level. Your doctor may need to increase or decrease the dose of trientine.

Problems in the nervous system (such as tremors, lack of coordination, difficulty speaking, muscle stiffness, and worsening of muscle spasms) may occur, especially in patients who have just started treatment with trientine. If you notice any of these while taking this medicine, you should inform your doctor immediately.

Pseudolupus reactions (symptoms could include persistent skin rash, fever, joint pain, and fatigue) have been described in some patients who have switched to trientine after taking penicillamine. However, it has not been possible to determine whether the reaction was due to trientine or previous treatment with penicillamine.

Other medicines and Trientine Waymade

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 neutralize stomach acid, leave at least 2 hours before or after taking trientine, as they may reduce its effect. It is recommended to take trientine at least 1 hour before or after any other medicine.

Taking Trientine Waymade with food and drinks

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, 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 that you continue treatment to maintain normal copper levels during pregnancy. You should discuss the possible benefits of treatment with your doctor, taking into account any potential risks. Your doctor will advise you on the best treatment and dose for your situation. If you become pregnant while taking trientine, talk to your doctor.

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

The limited information available indicates that trientine is not excreted in breast milk, but it is not certain that the baby is risk-free. It is important that you inform your doctor if you are breastfeeding or plan to breastfeed. Your doctor will help you decide whether to stop breastfeeding or stop taking trientine, considering the benefit of breastfeeding for the child and the benefit of trientine for the mother. Your doctor will advise you on the best treatment and dose for your situation.

Driving and using machines

Trientine is unlikely to affect your ability to drive or use tools or machines.

3. How to take Trientine Waymade

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are unsure, ask your doctor or pharmacist again.

Adults (including elderly patients)

The usual dose is between 4 and 8 capsules per day, taken orally.

Use in children and adolescents (from 5 to 17 years)

The dose in children and adolescents 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 may be divided into 2 to 4 smaller doses, as indicated by your doctor. Swallow the capsules whole with water, on an empty stomach, at least 1 hour before or 2 hours after meals.

Patients who have difficulty swallowing should contact their doctor.

DO NOT ingest the desiccant.

If you take more Trientine Waymade than you should

If you take more medicine than you should, you may experience nausea, vomiting, and dizziness. You should contact your doctor or another healthcare professional immediately.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20.

If you forget to take Trientine Waymade

If you forget to take a dose, take the next dose at the usual scheduled time.

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

If you stop taking Trientine Waymade

This medicine is intended for long-term use because Wilson's disease is a lifelong condition. Do not stop or change treatment without discussing it 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.

Sometimes (frequency not known; cannot be estimated from the available data) treatment with this medicine may cause inflammation of the small intestine or colon. If you experience any of the following side effects, contact your doctor immediately:

• Severe stomach pain
• Persistent diarrhea
• Nervous system problems (such as tremors, lack of coordination, difficulty speaking, muscle stiffness, and 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
• Anemia (you may feel unusually tired)

Reporting of side effects

If you experience 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 through the Spanish Medicines Monitoring System: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Trientine Waymade

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

Do not use this medicine after the expiry date which is stated on the bottle and carton after EXP. The expiry date is the last day of the month shown.

Use within 3 months of first opening the bottle.

Store below 30°C.

Store in the original package. Keep the bottle tightly closed and keep the silica gel desiccant in the bottle to protect it from moisture.

DO NOT ingest the desiccant.

Medicines should not be disposed of via wastewater or household waste. Return the containers and any unused medicines to the pharmacy. If you are unsure, ask your pharmacist how to dispose of the containers and any unused medicines. This will help protect the environment.

6. Contents of the pack and further information

Composition of Trientine Waymade

• The active substance is trientine. Each hard capsule contains 300 mg of trientine dihydrochloride, equivalent to 200 mg of trientine.
• The other ingredients are

Capsule content: Stearic acid

Capsule shell: Gelatin, Titanium dioxide (E171)

Printing ink: Lacquer, Iron oxide black (E172), potassium hydroxide

Appearance and packaging

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

White, high-density polyethylene (HDPE) round bottles, containing a silica gel desiccant and closed with a white polypropylene screw cap with an induction seal coating.

Pack size: 1 bottle of 100 hard capsules.

Marketing authorisation holder

Waymade B.V.

Herikerbergweg 88,

1101CM Amsterdam, Netherlands.

Local representative

Biojam España, S.L.

Avda. De las Águilas 2B, 5º 6ª

28044 Madrid, Spain

Manufacturer

Drehm Pharma GmbH

Grünbergstraße 15/3/3,

1120, Vienna, Austria

or

Waymade B.V.

Herikerbergweg 88,

1101CM Amsterdam, Netherlands.

Date of last revision of this leaflet: August 2024

Other sources of information

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).