Naltex

Package Leaflet: Information for the User

Warning! Keep the leaflet, the information on the immediate packaging is in a foreign language!

Naltex(Tranalex 50 mg)

50 mg, coated tablets

Naltrexone hydrochloride
Naltex and Tranalex 50 mg are different trade names for the same medicine.

You should read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any side effects, including any possible side effects not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1. What is Naltex and what is it used for

The active substance, naltrexone hydrochloride, belongs to a group of medicines that act on the nervous system - medicines used to treat addictions.

What is Naltex used for

Naltrexone hydrochloride is used in combination with other medicines or other treatment methods to help patients addicted to drugs, such as heroin (opioids), overcome their addiction. It is also indicated as a supportive treatment for maintaining abstinence in the treatment of alcohol dependence. Naltrexone blocks receptors in the brain, thereby blocking the action of opioids. Patients no longer experience the state of euphoria they experienced after taking opioids.

2. Important information before taking Naltex

When not to take Naltex

• if you are allergic to naltrexone hydrochloride or any of the other ingredients of the medicine (listed in section 6),
• if you are addicted to opioids or are undergoing treatment with maintenance therapy (abstinence), as withdrawal syndrome or its exacerbation may occur,
• if you are constantly taking a medicinal product containing an opioid, such as some cough medicines, anti-diarrheal medicines (such as kaolin and morphine) and painkillers, Note: naltrexone hydrochloride has no blocking effect on painkillers that do not contain opioids (e.g. ibuprofen, paracetamol and acetylsalicylic acid),
• if you have acute liver inflammation or if liver function is impaired,
• if you have a withdrawal syndrome after taking naltrexone hydrochloride,
• if you are taking methadone.

If any of the above situations occur, you should not take the tablets. Before taking the medicine, you should inform your doctor and then follow their instructions.

Warnings and precautions

Before starting treatment with Naltex, you should discuss it with your doctor or pharmacist:

• If you have liver or kidney disease. In patients who have taken naltrexone, hypersensitivity reactions to opioid-containing medicines may still occur, even after treatment has ended,
• Before starting treatment, your doctor may perform a blood test. Blood tests are also necessary during treatment, as Naltex is metabolized by the liver. Blood tests allow for the assessment of liver function.
• If it is necessary to treat you with opioids, e.g. for pain relief or anesthesia in emergency situations, a higher dose of opioids should be used to achieve a therapeutic effect. In such cases, respiratory depression and effects on circulation will be stronger and longer-lasting.
• Treatment with naltrexone can only be started when a sufficient period of time has passed since the last use of opioids (5-7 days in the case of heroin and at least 10 days since the last use of methadone),
• There have been reports of abnormal liver function test results in obese patients and elderly patients taking naltrexone who were not addicted to drugs,
• You should stop taking Naltex immediately and inform your doctor if you experience any of the following symptoms: severe abdominal pain, white stools, dark urine, or if the whites of your eyes and/or skin turn yellow.

If you have or have had any of the above circumstances, you should inform your doctor.

Children and adolescents

Naltrexone should not be given to children and adolescents under 18 years of age, due to insufficient clinical data in this age group. The safety of using the medicine in children has not been established.

Use in the elderly

There is a lack of sufficient data on the safety and efficacy of using naltrexone in the treatment of this indication in elderly patients.

Naltex and other medicines

You should tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.

• You should avoid taking Naltex with medicines containing opioids. Attempting to overcome the blocking effect of Naltex by using large amounts of opioids can lead to serious complications: respiratory depression, coma, and even death.
• Taking Naltex with thioridazine may cause drowsiness. No other harmful effects of interactions between Naltex and other medicines are known.
• Medicines can interact with each other.

Taking Naltex with food and drink

Taking food and drink has no effect on treatment with Naltex.

Pregnancy and breastfeeding

The safety of using Naltex during pregnancy has not been established.
It is not known whether naltrexone passes into breast milk. Due to the lack of safety data for the use of naltrexone in children and infants, breastfeeding is not recommended during treatment with Naltex.
If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before taking this medicine.

Driving and using machines

Naltrexone may affect your mental and/or physical ability to perform potentially hazardous activities such as driving or operating machinery.

Naltex contains lactose monohydrate

The medicinal product contains lactose. Each dose of the medicine contains 192.85 mg of lactose. If you have been diagnosed with an intolerance to some sugars, you should contact your doctor before taking the medicine.

3. How to take Naltex

This medicine should always be taken according to the instructions of your doctor or pharmacist.
If you have any doubts, you should consult your doctor or pharmacist again.
The recommended dose is one tablet per day, unless your doctor prescribes otherwise.

• Naltex should be taken orally, with a small amount of liquid.
• Before starting treatment with Naltex, you should not take any other opioids for 7-10 days. Before starting treatment, your doctor may perform a test to determine if there are any residues of these medicines in your body. Usually, treatment starts with a dose of half a tablet per day (25 mg), which is then increased to one tablet per day (50 mg).
• Naltex should only be used for the treatment of the disorder for which your doctor prescribed the medicine.
• It is important to take the medicine and dose it strictly according to your doctor's instructions.
• It is important to continue taking Naltex for the period prescribed by your doctor. Treatment may last for three months or longer, depending on your doctor's decision. Naltex should be used in combination with other treatment methods. If you notice too strong or too weak an effect of Naltex, you should ask your doctor or pharmacist for advice.

Taking a higher dose of Naltex than recommended

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

Missing a dose of Naltex

Naltex can be taken as soon as you remember. You should not take a double dose to make up for the missed dose.

Stopping treatment with Naltex

If you are considering stopping the medicine before the scheduled end of treatment, you should always discuss it with your doctor.
If you have any further doubts about the use of this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Naltex can cause side effects, although not everybody gets them.
Naltex may affect liver function. Your doctor may perform a blood test before starting treatment and during treatment to monitor liver function.
If you experience any of the following symptoms, you should stop taking the medicine and immediately consult your doctor:

• abdominal pain lasting more than a few days,
• white stools,
• dark urine,
• yellowing of the whites of the eyes. These may be signs of liver failure.

You should immediately consult your doctor if you experience any of the following symptoms:

• swelling of the face, lips, or tongue,
• skin rash,
• difficulty breathing. 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,
• nausea and/or vomiting
• weakness,
• joint and/or muscle pain,
• headache,
• rapid or irregular heartbeat
• restlessness.

Common (may affect up to 1 in 10 people):

• irritability,
• mood changes,
• energy surge,
• depression,
• dizziness,
• chills,
• increased sweating,
• vertigo of labyrinthine origin,
• increased tear production,
• rapid heartbeat,
• palpitations,
• changes in ECG recording,
• chest pain,
• diarrhea,
• constipation,
• rash,
• urinary retention,
• delayed ejaculation,
• erectile dysfunction,
• loss of appetite,
• thirst.

Uncommon (may affect up to 1 in 100 people):

• certain infections (e.g. herpes, foot fungus),
• edema, lymph node enlargement,
• hallucinations,
• confusion,
• depression,
• paranoia,
• disorientation,
• nightmares,
• agitation,
• decreased libido,
• unusual dreams,
• tremors,
• fatigue,
• blurred vision,
• eye irritation,
• photophobia,
• eye swelling,
• eye pain,
• eye strain,
• ear problems,
• ear pain,
• tinnitus,
• vertigo,
• blood pressure fluctuations,
• flushing,
• nasal congestion and discomfort,
• sneezing,
• increased mucus production in the bronchi,
• sinus problems,
• voice disorders,
• shortness of breath, difficulty breathing,
• cough,
• yawning,
• runny nose,
• bloating,
• hemorrhoids,
• ulcers,
• dry mouth,
• liver function disorders (including hepatitis),
• increased liver enzyme activity,
• oily skin,
• itching,
• acne,
• hair loss,
• groin pain,
• increased urination,
• urinary tract infection,
• increased appetite,
• weight loss,
• weight gain,
• fever,
• pain,
• cold hands or feet,
• feeling of heat.

Rare (may affect up to 1 in 1000 people):

• suicidal thoughts,
• suicide attempts,
• blood clotting disorders,
• speech disorders.

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

• euphoria,
• skin rash/eruptions,
• skeletal muscle damage.

Reporting side effects

If you experience any side effects, including any possible side effects not listed in the leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products Al. Jerozolimskie 181C 02-222 Warsaw tel: +48 22 49 21 301 fax: +48 22 49 21 309 website: https://smz.ezdrowie.gov.pl By reporting side effects, you can help provide more information on the safety of the medicine.

5. How to store Naltex

Store in a place out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
There are no special precautions for storage.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Naltex contains

• The active substance of the medicine is naltrexone hydrochloride. Each coated tablet contains 50 mg of naltrexone hydrochloride.
• The medicine also contains: Tablet core: lactose monohydrate, microcrystalline cellulose, crospovidone, colloidal silica anhydrous, magnesium stearate. Coating: hypromellose (E 464), macrogol 400, polysorbate 80 (E 433), yellow iron oxide (E 172), red iron oxide (E 172), titanium dioxide (E 171).

What Naltex looks like and contents of the pack

Naltex tablets are yellow, round, biconvex, and coated, with a dividing line on one side and no marking on the other side.
The tablet can be divided into two equal doses.
Naltex tablets are packaged in PVC/PE/Aclar-Al blisters containing 14, 28, and 56 coated tablets in a cardboard box.
For more detailed information, you should contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Spain, the country of export:

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
Accord Healthcare B.V.
Winthontlaan 200, 3526 KV Utrecht
Netherlands

Parallel importer:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź

Repackaged by:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
SHIRAZ PRODUCTIONS Sp. z o.o.
ul. Tymiankowa 24/28
95-054 Ksawerów
Marketing authorization number in Spain, the country of export:

• 679763.1
• 679764.8

Parallel import authorization number: 247/23

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Member State
Medicinal product name
Austria
Naltrexone Accord 50 mg Filmtabletten
Belgium
Naltrexone Accord 50 mg comprimes pellicules/ filmomhulde tabletten/ Filmtabletten
Bulgaria
Naltrexone Акорд 50 мг филмирани таблетки
Cyprus
Naltrexone Accord 50 mg Film-coated Tablets
Denmark
Naltrexone Accord 50 mg filmovertrukne tabletter
Estonia
Naltrexone Accord 50 mg õhukese polümeerikattega tabletid
Finland
Naltrexone Accord 50 mg kalvopäällysteinen tabletti/ filmdragerade tabletter

Date of leaflet approval: 30.10.2023

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