Trientina Waymade 200 mg hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Trientina Waymade 200 mg hard capsules EFG

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.

• If you have any questions, ask your doctor, pharmacist or nurse.

• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.

  • If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if these are effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

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

Trientina 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 taking Trientina Waymade

Do not take Trientina Waymade

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

Signs of an allergic reaction include, among others, skin rash, itching, facial swelling, fainting, and breathing difficulties.

Warnings and precautions

Your doctor will need to regularly monitor your disease symptoms and your copper levels in blood and urine. Regular monitoring is especially important at the beginning of treatment or when the dose is changed, in growing children and pregnant women, to ensure that copper levels remain at an appropriate level. Your doctor may need to increase or decrease your dose of trientine.

Neurological problems (for example, tremor, lack of coordination, difficulty speaking, muscle rigidity, and worsening of muscle spasms) may occur, particularly in patients who have recently started treatment with trientine. If you notice any of these symptoms while taking this medicine, you must inform your doctor immediately.

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

Other medicines and Trientina Waymade

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

If you are taking iron tablets or medicines that neutralize stomach acid, ensure at least 2 hours pass before or after taking trientine, as they could reduce its effect. It is recommended to take trientine at least one hour before or after any other medicine.

Taking Trientina Waymade with food and drinks

Take this medicine with water only. Do not take it with other beverages, milk, or food, as they could reduce the medicine's effect. 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 might be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine. It is very important that you continue treatment to maintain normal copper levels during pregnancy. You should discuss thoroughly with your doctor the potential benefits of treatment, while also considering any possible risks. Your doctor will advise you on the most appropriate treatment and dosage for your situation. If you become pregnant while taking trientine, speak with 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 available information indicates that trientine is not excreted in breast milk, but it cannot be certain that the baby is free of risk. It is important that you inform your doctor if you are breastfeeding or intend to breastfeed. Your doctor will help you decide whether it is better to discontinue breastfeeding or to stop taking trientine, taking into account the benefits of breastfeeding for the child and the benefits of trientine for the mother. Your doctor will advise you on the most appropriate treatment and dosage for your situation.

Driving and using machines

It is unlikely that trientine will affect your ability to drive or operate tools or machinery.

3. How to take Trientina Waymade

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult 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 of age)

The dose for children and adolescents depends on age and body weight, and will be adjusted by the doctor. At the beginning of treatment, the dose ranges 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 directed 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 Trientina Waymade than you should

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

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

If you forget to take Trientina Waymade

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

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

If you stop taking Trientina Waymade

This medicine is intended for long-term use because Wilson's disease is a lifelong condition. Do not stop or change your treatment without consulting your doctor, even if you feel better.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everybody gets them.

Sometimes (frequency not known; cannot be estimated from 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 diarrhoea
• Problems with the nervous system (for example, tremor, lack of coordination, difficulty speaking, muscle rigidity, worsening of muscle spasms)

Other possible side effects include:

Frequent (may affect up to 1 in 10 patients)

• Nausea (especially when starting treatment)

Uncommon (may affect up to 1 in 100 patients)

• Skin rashes
• Anaemia (you may feel unusually tired)

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Trientina Waymade

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

Do not use this medicine after the expiry date stated on the bottle and carton following EXP. The expiry date refers to the last day of the month indicated.

Use within 3 months after first opening the bottle.

Store below 30°C.

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

DO NOT SWALLOW the desiccant.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the container and other information

Composition of Trientina Waymade

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

Capsule contents: Stearic acid

Capsule shell: Gelatin, Titanium dioxide (E171)

Printing ink: Lacquer, Black iron oxide (E172), potassium hydroxide

Appearance of the product and contents of the container

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

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

Pack size: 1 bottle containing 100 hard capsules.

Marketing Authorization Holder

Waymade B.V.

Herikerbergweg 88,

1101CM Amsterdam, The 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, The Netherlands.

Date of the most recent revision of this leaflet: August 2024

Other sources of information

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).