Leaflet: information for the user

Tranalex 50 mg film-coated tablets EFG

Naltrexone hydrochloride

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

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

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

• This medicine has been prescribed for you only and should not be given to others, even if they have the same symptoms, as it may harm them.

• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet.

1. What is Tranalex and what it is used for

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

3. How to take Tranalex

4. Possible side effects

5. Storage of Tranalex

6. Contents of the pack and additional information

The active ingredient, hydrochloride of naltrexone, belongs to the group of medications “other

medications that act on the nervous system; medications used in addictive disorders”.

What is Tranalex used for

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

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

It is also indicated as a supporting treatment to maintain abstinence (self-denial) of patients dependent on alcohol.

Tranalex does not cause dependence.

Do not take Tranalex

• if you are allergic to naltrexone hydrochloride or any of the other ingredients in this

medication (listed in section 6).

• if you have severe kidney problems.

• if you have severe liver problems.

• if you have an acute liver infection.

• if you are dependent on opioids.

• if you are taking a medication that contains an opioid, for example, certain

medications for cough, medications to treat diarrhea (such as kaolin or morphine) and

analgesics (to relieve pain). Note: Tranalex does not block the effects of non-opioid analgesics (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

Consult your doctor or pharmacist before starting to take Tranalex.

• Do not take opioids while taking Tranalex. Although Tranalex will normally block some of the effects (i.e., the high), if you take high doses of opioids, you may experience respiratory difficulties and circulatory problems (opioid overdose).

• 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 who treat you that you are taking Tranalex. Non-opioid anesthetics should be used if you need an anesthetic in an emergency. If you need to use anesthetics that contain opioids, you may need higher doses than usual. You may also be more sensitive to side effects (respiratory difficulties and circulatory problems).

• Do not attempt to overcome the blocking effect of Tranalex with high doses of opioids. There is a risk that the opioids will still be present in your body after the effects of Tranalex have worn off. If this happens, you could experience an involuntary overdose with severe consequences.

• Naltrexone is eliminated from the body through 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 if they did in the past.

Children and adolescents

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

Use in elderly patients

There is insufficient data on the safety and efficacy of Tranalex for this

indication in elderly patients.

Other medications and Tranalex

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

Some common medications contain opioids and may not work when you are taking Tranalex. You must inform your doctor if you need medications for cough or medications against diarrhea or pain, as they may contain opioids.

If, despite the contraindication of concurrent use, in emergency situations you need medications that contain opioids, the appropriate dose to relieve pain may be higher than usual. It is absolutely necessary for the doctor to exercise close monitoring because the depression of respiration and other symptoms that occur 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 may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using any medication.

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

It is unknown whether 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 operating machinery

Naltrexone may decrease the physical and/or mental abilities necessary to perform 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 certain sugars, consult your doctor before takingthis medication.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in 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 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. Generally, treatment begins 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 medication.

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

• It is essential that you take Tranalex for the prescribed period of time. Treatment may last 3 months or more, as determined by your doctor. 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 compensate for the missed dose.

If you interrupt treatment with Tranalex

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

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

Like all medications, Tranalex may cause side effects, although not everyone will experience them.

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

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

- Abdominal pain that lasts more than a few days

- White stools

- Dark urine

- Yellow eyes

Since these may be signs that your liver is not functioning correctly.

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

- Swelling of the face, lips, or tongue

- Skin rash

- Difficulty breathing

Since these may be signs of an allergic reaction.

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

- Difficulty sleeping

- Anxiety or nervousness

- Muscle cramps and abdominal pain

- Feeling nauseous or having nausea

- Weakness

- Muscle and/or joint pain

- Headache

- Irregular or rapid heart rhythm

- Restlessness

Common (may affect up to 1 in 10 people)

- Irritability

- Mood changes

- Fatigue

- Dizziness

- Chills

- Increased sweating

- Dizziness

- Increased tear production

- Increased heart rate

- Palpitations

- Changes in the 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)

- 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 visual perception of light

- Swelling of the eyes

- Eye pain

- Eye pressure

- Ear discomfort

- Ear pain

- Tinnitus

- Dizziness

- Fluctuations in blood pressure

- Redness

- Nasal congestion and discomfort

- Sneezing

- Increased sputum

- Sinus problems

- Voice disorders

- Difficulty or insufficient breathing

- Coughing

- Yawning

- Nasal discharge

- Flatulence

- Hemorrhoids

- Ulcer

- Dry mouth

- Liver disorders (including liver inflammation)

- Increased liver enzymes

- Greasy skin

- Itching

- Acne

- Hair loss

- Pain in the groin

- Increased urination frequency

- Urinary tract inflammation

- Increased appetite

- Weight loss

- Weight gain

- Fever

- Pain

- Cold hands or feet

- Feeling hot

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

- Suicidal thoughts

- Suicide attempts

- Hemorrhagic disorder

- Speech disorder

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

- Euphoria

- Skin rash or exanthema

- Muscle and skeletal muscle damage

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 that does not appear in this prospectus. You can also report them directly through the Spanish System for the Vigilance of Medicines for Human Use: https://www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

• Keep out of sight and reach of children.
• Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.
• No special storage conditions are required.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medicines at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medicines. By doing so, you will help protect the environment.

Composition of Tranalex

The active ingredient is naltrexone hydrochloride.

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

The other components are:

Core tablet:monohydrate lactose, 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 contents of the package

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

The tablets can be divided into equal halves.

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

Only some package sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Accord Healthcare, S.L.U.

World Trade Center,

Moll de Barcelona, s/n,

Edifici Est, 6th floor,

08039 Barcelona

Spain

Responsible 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 medicinal product is authorized in the member states of the European Economic Area with the following names

Last review date of this leaflet: June 2024

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