Transalex 50 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Tranalex 50 mg film-coated tablets EFG

Naltrexone hydrochloride

Read the entire 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if the side effects are not listed in this leaflet.

Contents of the leaflet:

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

1. What Tranalex is and what it is used for

The active substance, naltrexone hydrochloride, belongs to the group of medicines called "other
medicines acting on the nervous system; medicines used in addictive disorders".

What Tranalex is used for

Tranalex is used in combination with other medicines or treatments to help people dependent on opioid drugs overcome their addiction.

Tranalex works by blocking receptors in the brain to neutralize the action of opioids. Patients will no longer experience the euphoria they previously felt after taking opioids.

It is also indicated as supportive treatment to maintain abstinence (self-denial) in patients dependent on alcohol.

Tranalex does not cause dependence.

2. What you need to know before starting to take Tranalex

Do not take Tranalex

• if you are allergic to naltrexone hydrochloride or to 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 acute liver infection.
• if you are dependent on opioids.
• if you are taking a medicine containing an opioid, for example, certain
  cough medicines, medicines to treat diarrhoea (such as kaolin or morphine), and
  analgesics (to relieve pain). Note: Tranalex does not block the effects of analgesics that do not contain opioids (such as ibuprofen, paracetamol, and acetylsalicylic acid).
• If you are taking methadone.

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

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Tranalex.

• Do not take opioids while taking Tranalex. Although Tranalex normally blocks some of the effects (i.e., the euphoric effects), if you take high doses of opioids, you may experience breathing difficulties and circulatory problems (opioid poisoning).
• You must not use Tranalex if you are still addicted to opioids, as Tranalex will cause severe withdrawal symptoms in this situation.
• You must inform all doctors treating you that you are taking Tranalex. Non-opioid anaesthetics should be used if you require anaesthesia in an emergency. If opioid-containing anaesthetics must be used, you may need higher-than-usual doses. You may also be more sensitive to their side effects (breathing difficulties and circulatory problems).
• You must not attempt to overcome the blocking effect of Tranalex by taking high doses of opioids. There is a risk that opioids may still remain in your body after the effects of Tranalex have worn off. If this happens, you could suffer an unintentional overdose with serious consequences.
• Naltrexone is eliminated from the body via the liver and kidneys. Liver problems are common in people dependent on opioids. Your doctor will perform liver function tests before and during treatment.

Inform your doctor if any of the above warnings apply to you, or have applied to you 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 safety and use have not been established in children.

Use in elderly patients

There are insufficient data on the safety and efficacy of Tranalex for this indication in elderly patients.

Other medicines and Tranalex

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

Some common medicines contain opioids and may not work while you are taking Tranalex. You should inform your doctor if you need cough medicines, anti-diarrhoeal medicines, or painkillers, as they may contain opioids.

If, despite the contraindication for concomitant use, opioid-containing medicines are required in emergency situations, the appropriate dose to relieve pain may be higher than usual. Close medical supervision is absolutely necessary, as respiratory depression and other symptoms may be more severe and prolonged.

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 might be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using any medicine.

The safety of Tranalex during pregnancy has not been established.

It is unknown whether Tranalex is excreted in breast milk. Since the safety of Tranalex in neonates and children has not been established, breastfeeding is not recommended while taking Tranalex.

Driving and use of machines

Naltrexone may reduce the physical and/or mental abilities required to perform potentially dangerous activities such as driving a car or operating machinery.

Tranalex contains lactose

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

3. How to take Tranalex

Follow exactly the instructions for use of this medicine provided by your doctor or pharmacist. If you are unsure, 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 abstained from taking any other type of opioid 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 begins with a dose of half a tablet per day (25 mg), and then is increased to 1 tablet per day (50 mg).

• Tranalex should be used exclusively for the condition for which your doctor has prescribed it.

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

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

If you think that 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 may take Tranalex as soon as you remember.

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

If you stop taking Tranalex

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

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

4. Possible adverse effects

Like all medicines, Tranalex may cause adverse effects, although not everyone experiences them.

Tranalex may affect the functioning of your liver. Your doctor must carry out tests before starting treatment and several times during treatment to monitor your liver function.

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

• Abdominal pain lasting longer than a few days
• Pale stools
• Dark urine
• Yellowing of the 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
• Difficulty breathing

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 and/or having nausea
• Weakness
• Muscle and/or joint pain
• Headache
• Irregular or rapid heartbeat
• Restlessness

Common (may affect up to 1 in 10 people)

• Irritability
• Mood changes
• Lethargy
• Dizziness
• Chills
• Increased sweating
• Dizziness
• Increased tearing
• 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 level
• Feeling cold

Uncommon (may affect up to 1 in 100 people)

• Certain 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 visual perception of light
• Swelling of the eyes
• Eye pain
• Pressure in the eye
• Ear discomfort
• Ear pain
• Tinnitus
• Vertigo
• Fluctuations in blood pressure
• Flushing
• Nasal congestion and discomfort
• Sneezing
• Increased sputum
• Sinus problems
• Voice disorders
• Breathing difficulty or respiratory insufficiency
• Cough
• Yawning
• Runny nose
• Flatulence
• Hemorrhoids
• Ulcer
• Dry mouth
• Liver disorders (including liver inflammation)
• Increased liver enzymes
• Oily skin
• Itching
• Acne
• Hair loss
• Groin pain
• Increased frequency of urination
• Inflammation of the urinary bladder
• 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 disorder
• Speech disorder

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

• Euphoria
• Skin rash or exanthema
• Damage to skeletal muscles

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaRAM.es. By reporting adverse 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 stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.
• No special storage conditions are required.

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 you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This 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 components are:

Tablet core: monohydrate lactose, microcrystalline cellulose, crospovidone, colloidal anhydrous 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 contents of the pack

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

The tablets can be divided into equal halves.

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

Only certain 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, 6th floor,

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,

The Netherlands

or

Accord Healthcare Single Member S.A.

64th Km National Road Athens, Lamia, 32009

Greece

This medicinal product is authorized in the European Economic Area member states under the following names

Date of the most recent review of this leaflet: June 2024

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.