TRANALEX 50 mg FILM-COATED TABLETS

2. What you need to know before you take Tranalex

Do not take Tranalex

• if you are allergic to naltrexone hydrochloride or any of the other ingredients of this medicine (listed in section 6).

if you have severe kidney problems.

• if you have severe liver problems.
• if you have an acute infection in the liver.
• if you are dependent on opiates.
• if you are taking a medicine that contains an opiate, for example, certain cough medicines, anti-diarrheal medicines (such as kaolin or morphine) and painkillers (to relieve pain). Note: Tranalex does not block the effects of painkillers that do not contain opiates (such as ibuprofen, paracetamol, and acetylsalicylic acid).

If any of these situations apply to you, do not take the tablets. Consult your doctor first and follow their instructions.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Tranalex.

• Do not take opiates while taking Tranalex. Although Tranalex will normally block some of the effects (i.e., the elevated effects), if you take high doses of opiates, you may experience breathing difficulties and circulatory problems (opiate intoxication).
• You must not use Tranalex if you are still addicted to opiates, as Tranalex will cause severe withdrawal symptoms in this situation.
• You should inform all doctors who treat you that you are taking Tranalex. Non-opiate anesthetics should be used if you need an anesthetic in an emergency situation. If you have to use anesthetics that contain opiates, you may need higher doses than usual. You may also be more sensitive to side effects (breathing difficulties and circulatory problems).
• You should not try to overcome the blocking effect of Tranalex with high doses of opiates. There is a risk that the opiates will still be in your body after the effects of Tranalex have passed. If this happens, you could suffer an unintentional overdose with serious consequences.
• Naltrexone is eliminated from the body through the liver and kidneys. Liver problems are common in people dependent on opiates. Your doctor will perform liver function tests before and during treatment.

Tell your doctor if any of the above warnings are applicable to you, or if they were in the past.

Children and adolescents

Tranalex is not recommended for use in children and adolescents under 18 years of age, due to the lack of clinical data in this age group. Its safe use in children has not been established.

Use in elderly patients

There is not enough data on the safety and efficacy of Tranalex for this indication in elderly patients.

Other medicines and Tranalex

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

Some common medicines contain opiates and may not work when you are taking Tranalex. You should tell your doctor if you need medicines for coughs or medicines for diarrhea or pain, as they may contain opiates.

If, despite the contraindication of combined use, in cases of emergency, medicines that contain opioids are needed, the dose suitable for pain relief may be higher than usual. It is absolutely necessary to have close medical supervision because the respiratory depression and other symptoms that occur may be stronger and more lasting.

Taking Tranalex with food and drinks

The intake of food or drinks does not affect your treatment with Tranalex.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using any medicine.

The safety of using Tranalex during pregnancy has not been demonstrated.

It is not known if Tranalex is excreted in breast milk. Since the safety of Tranalex in neonates and children has not been demonstrated, breastfeeding is not recommended while taking Tranalex.

Driving and using machines

Naltrexone may decrease the physical and/or mental abilities necessary for performing potentially hazardous activities such as driving a car or operating machinery.

Tranalex contains lactose

If your doctor has told you that you have an intolerance to some sugars, consult your doctor before taking this medicine.

3. How to take Tranalex

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is 1 tablet per day, unless your doctor has prescribed a different dose.

• Tranalex is taken orally with a small amount of liquid.
• Before starting to take Tranalex, you must have been without taking any other type of opiates for a period of at least 7-10 days. Your doctor may perform a test to rule out the presence of these substances in your body before starting treatment. In general, treatment starts with a dose of half a tablet per day (25 mg), and then increases to 1 tablet per day (50 mg).

Tranalex must be used exclusively for the disorder for which your doctor has prescribed this medicine.

• It is important that you carefully follow your doctor's instructions regarding the administration schedule.

It is important that you take Tranalex for the period of time prescribed by your doctor. Treatment may last 3 months or more, depending on your doctor's judgment. Tranalex should be combined with other treatment modalities.

• If you think the effect of Tranalex is too strong or not strong enough, consult your doctor or pharmacist.

If you take more Tranalex than you should

If you have taken more tablets than prescribed, inform your doctor immediately.

If you forget to take Tranalex

You can take Tranalex when you remember.

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

If you stop taking Tranalex

If you intend to stop treatment before the end of the agreed period, always consult your doctor before doing so.

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

4. Possible side effects

Like all medicines, Tranalex can cause side effects, although not everybody gets them.

Tranalex may affect liver function. Your doctor will perform liver function tests before and several times during treatment to monitor liver function.

If you notice any of the following symptoms, stop takingTranalex and consult your doctor immediately:

• Abdominal pain that lasts more than a few days
• White stools
• Dark urine
• Yellow eyes

As these may be signs that your liver is not working properly.

If you notice any of the following symptoms, consult your doctor immediately:

• Swelling of the face, lips, or tongue
• Skin rash
• Breathing difficulties

As these may be signs of an allergic reaction.

Very common (may affect more than 1 in 10 people)

• Difficulty sleeping
• Anxiety or nervousness
• Abdominal cramps and pain
• Feeling sick and/or being sick
• Weakness
• Muscle and/or joint pain
• Headache
• Irregular or rapid heartbeat
• Restlessness

Common (may affect up to 1 in 10 people)

• Irritability
• Mood changes
• Depression
• Dizziness
• Chills
• Increased sweating
• Dizziness
• Increased tear production
• Increased heart rate
• Palpitations
• Changes in electrocardiogram (ECG)
• Chest pain
• Diarrhea
• Constipation
• Skin rash
• Urinary retention
• Delayed ejaculation
• Erectile dysfunction
• Loss of appetite
• Thirst
• Increased energy
• Feeling cold

Uncommon (may affect up to 1 in 100 people)

• Some infections (e.g., oral herpes, athlete's foot)
• Swollen lymph nodes
• Hallucinations
• Confusion
• Depression
• Paranoia
• Disorientation
• Nightmares
• Agitation
• Reduced libido
• Abnormal dreams
• Tremors
• Blurred vision
• Drowsiness
• Eye irritation
• Abnormal intolerance to light perception
• Eye swelling
• Eye pain
• Pressure in the eye
• Ear discomfort
• Ear pain
• Ringing in the ear
• Dizziness
• Fluctuations in blood pressure
• Redness
• Nasal congestion and discomfort
• Sneezing
• Increased sputum
• Sinus problems
• Voice disorders
• Breathing difficulties or insufficiency
• Cough
• Runny nose
• Flatulence
• Hemorrhoids
• Ulcer
• Dry mouth
• Liver disorders (including liver inflammation)
• Increased liver enzymes
• Oily skin
• Itching
• Acne
• Hair loss
• Groin pain
• Increased urination frequency
• Urinary bladder inflammation
• Increased appetite
• Weight loss
• Weight gain
• Fever
• Pain
• Coldness in hands or feet
• Feeling hot

Rare (may affect up to 1 in 1,000 people)

• Suicidal thoughts
• Suicide attempts
• Bleeding disorders
• Speech disorders

Very rare (may affect up to 1 in 10,000 people)

• Euphoria
• Skin rash or exanthema
• Muscle damage

Reporting of side effects:

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Tranalex

• Keep out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of the month shown.
• No special storage conditions are required.

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 protect the environment.

6. Contents of the pack and other information

Composition of Tranalex

The active substance is naltrexone hydrochloride.

Each film-coated tablet contains 50 mg of naltrexone hydrochloride.

The other ingredients are:

Core of the tablet: lactose monohydrate, microcrystalline cellulose, crospovidone, anhydrous colloidal silica, and magnesium stearate.

Coating: hypromellose (E464), macrogol 400, polysorbate 80 (E433), yellow iron oxide (E172), red iron oxide (E172), and titanium dioxide (E171).

Appearance of the product and pack contents

Tranalex are film-coated tablets, yellow, biconvex, oval, with a score line on one face and smooth on the other.

The tablets can be divided into two equal halves.

Tranalex is packaged in white opaque PVC/PE/Aclar-Aluminum and Aluminum-Aluminum blisters containing 7, 14, 28, 30, 50, and 56 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Accord Healthcare, S.L.U.

World Trade Center,

Moll de Barcelona, s/n,

Edifici Est, 6ª planta,

08039 Barcelona

Spain

Manufacturer

Accord Healthcare Polska Sp.z o.o.,

ul. Lutomierska 50, 95-200 Pabianice,

Poland

or

Accord Healthcare B.V.,

Winthontlaan 200,

3526 KV Utrecht,

Netherlands

or

Accord Healthcare Single Member S.A.

64th Km National Road Athens, Lamia, 32009

Greece

This medicine is authorized in the Member States of the European Economic Area under the following names

Date of last revision of this leaflet: June 2024

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