Package Insert: Information for the Patient

Trientina Waymade 200 mg Hard Capsules EFG

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.

- This medication has been prescribed only for you, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.

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

This medication is calledTrientina Waymade 200 mg hard capsules. In this leaflet, it will be referred to as Trientina Waymade or trientina.

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

This medication contains the active ingredient trientina, a copper chelating agent that is used to eliminate excess copper from the body. Trientina binds to copper, which is then expelled from the body.

Do not take Trientina Waymade

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

The signs of an allergic reaction include, among others, skin rash, itching, facial swelling, dizziness, and breathing difficulties.

Warnings and precautions

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

Problems in the nervous system (e.g., tremor, lack of coordination, difficulty speaking, muscle stiffness, and worsening muscle spasms) may occur, especially in patients who have just started taking trientine. If you notice any of these while taking this medication, inform your doctor immediately.

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

Other medications and Trientina Waymade

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

If you are taking iron tablets or medications that neutralize stomach acid, wait 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 medication.

Taking Trientina Waymade with food and drinks

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication. It is very important to continue treatment to maintain normal copper levels during pregnancy. Discuss the possible benefits of treatment with your doctor, taking into account the potential risks. Your doctor will advise you on the best treatment and dosage for your situation. If you become pregnant while taking trientine, talk to your doctor.

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

Available information indicates that trientineis not excreted in breast milk, but there is no certainty that the baby is at no risk. It is essential to inform your doctor if you are breastfeeding or plan to do so. Your doctor will help you decide whether to stop breastfeeding or stop taking trientineconsidering the benefits of breastfeeding for the baby and the benefits of trientinefor the mother. Your doctor will advise you on the best treatment and dosage for your situation.

Driving and operating machinery

It is unlikely that trientinewill affect your ability to drive or use tools or machines.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of 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 (5 to 17 years old)

The dose in children and adolescents depends on age and body weight, and will be adjusted by the doctor. Initially, the dose varies between 2 and 5 capsules per day.

Administration form

The doctor will decide what is the correct dose for you.

The total daily dose may be divided into 2 to 4 smaller doses, as indicated by the doctor. Swallow the capsules whole with water, with 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 medication 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 Trientina Waymade

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

Do not take a double dose to compensate for missed doses.

If you interrupt treatment with Trientina Waymade

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

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

Like all medications, this medication may produce adverse effects, although not all people may experience them.

At times (unknown frequency; cannot be estimated from available data) treatment with this medication may produce inflammation of the small intestine or colon. If you experience any of the following side effects, contact your doctorimmediately:

- Severe stomach pain

- Persistent diarrhea

- Neurological problems (e.g., tremor, lack of coordination, difficulty speaking, muscle rigidity, worsening muscle spasms)

Other side effects may be:

Frequent (may affect up to 1 in 10 patients)

- Nausea (especially when starting treatment)

Rare (may affect up to 1 in 100 patients)

- Skin eruptions

- Anemia (may feel unusually tired)

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor,pharmacist, or nurse, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

Do not use this medication after the expiration date that appears on the bottle and on the box after CAD. The expiration date is the last day of the month indicated.

Use within 3 months after the first opening of the bottle.

Store below 30°C.

Store in the original packaging. Keep the bottle perfectly closed and store the silica gel desiccant in the bottle, to protect it from moisture.

Do not ingest the desiccant.

Medications should not be disposed of through drains or in the trash.Deposit the containers and medications you no longer need at the SIGRE point of the pharmacy.Ask your pharmacist how to dispose of containers and medications you no longer need if you are unsure. By doing so, you will help protect the environment.

Composition of Trientina Waymade

- The active principle is trientina. Each hard capsule contains 300 mg of trientina dihydrochloride equivalent to 200 mg of trientina.

- The other components are

Contents of the capsule:Stearic acid

Capsule coating: Gelatin, Titanium dioxide (E171)

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

Appearance of the product and contents of the packaging

Each hard capsule is a hard gelatin cylindrical capsule of size "1" 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.

Round white high-density polyethylene (HDPE) bottles, which contain a silica gel desiccant and are closed with a white polypropylene screw cap with induction heat-seal coating.

Package size: a bottle of 100 hard capsules.

Marketing authorization 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

Responsible manufacturer

Drehm Pharma GmbH

Grünbergstraße 15/3/3,

1120, Vienna, Austria

or

Waymade B.V.

Herikerbergweg 88,

1101CM Amsterdam,Netherlands.

Last review date of this leaflet:August 2024

Other sources of information

The detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)} (http://www.aemps.gob.es/).