Naltex

Leaflet attached to the packaging: patient information

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Naltex (Naltrexone Accord)

50 mg, coated tablets

Naltrexone hydrochloride
Naltex and Naltrexone Accord are different trade names for the same medicine.

You should read the contents of the leaflet 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 packaging 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 opioids overcome their addiction.
Naltrexone blocks receptors in the brain, and in this way, blocks the action of opioids. Patients no longer experience a state of euphoria that they experienced after taking opioids.
Naltrexone hydrochloride is used as part of a comprehensive treatment program to help people addicted to alcohol maintain abstinence (self-restraint).
Naltex does not cause addiction.

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 have severe kidney problems,
• if you have severe liver problems,
• if you have acute hepatitis,
• if you are addicted to opioids,
• if the result of the opioid test in your urine is positive,
• if you have withdrawal syndrome after naloxone injection,
• if you are 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 does not have a blocking effect on painkillers that do not contain opioids (e.g. ibuprofen, paracetamol and acetylsalicylic acid),
• 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:

• Do nottake opioids while taking Naltex. Although Naltex usually blocks some symptoms (i.e. highs), taking large doses of opioids can cause breathing difficulties and circulation problems (opioid poisoning).
• Do not take Naltex if you are still addicted to opioids, as it can cause severe withdrawal symptoms.
• You should inform every doctor treating you that you are taking Naltex. If you need anesthesia in an emergency, you should use anesthetics other than opioids. If opioid anesthetics are required, you may need to take larger doses than usual. You may also be more sensitive to side effects (breathing difficulties and circulation problems).
• Do not try to overcome the blocking effect of Naltex with large doses of opioids. There is a risk that opioids may still be present in your body after the effect of Naltex has stopped. In this case, you may experience unintended overdose, which can have serious consequences.
• Naltrexone is eliminated from the body by the liver and kidneys. People addicted to opioids often have liver problems. Your doctor will perform liver function tests before and during treatment.

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 naltrexone in children has not been established.

Use in the elderly

There is a lack of sufficient data on the safety and efficacy of 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.
Some commonly used medicines contain opioids that may not work while taking Naltex. If you need cough medicines or anti-diarrheal medicines or painkillers, you should inform your doctor, as these medicines may contain opioids.
Despite the contraindications for concomitant use of opioid-containing medicines, in emergency situations, it may be necessary to administer a painkiller in a dose larger than usual. Absolute medical supervision is necessary, as the occurring respiratory depression and other symptoms may be stronger and longer-lasting.

Taking Naltex with food and drink

Taking food and drink has no effect on Naltex therapy.

Pregnancy and breastfeeding

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.
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 established safety of using naltrexone in children and infants, you should not breastfeed while taking Naltex.

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

If you have been told that you have 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 exactly as your doctor or pharmacist has told you.
If you are unsure, 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. Treatment usually 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 to treat the condition for which your doctor has prescribed it.
• It is important to take the medicine and dose it exactly as your doctor has told you.
• It is important to continue taking Naltex for the period your doctor has prescribed. 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

You can take Naltex as soon as you remember.
You should not take a double dose to make up for a forgotten dose.

Stopping treatment with Naltex

If you are considering stopping treatment before the scheduled end date, you should always consult your doctor.
If you have any further doubts about using 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 stoptaking Naltex and immediately consultyour 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,
• change 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 simplex, foot fungus),
• edema, lymph node enlargement,
• hallucinations,
• confusion,
• depression,
• paranoia,
• disorientation,
• nightmares,
• agitation,
• decreased libido,
• unusual dreams,
• tremors,
• drowsiness,
• 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, breathing difficulties,
• 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 1,000 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 this 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, 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 this medicine.

5. How to store Naltex

The medicine should be stored 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 packaging 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 anhydrous silica, 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, oval, biconvex and coated, with a dividing line on one side and no marking on the other.
The tablet can be divided into two equal doses.
Naltex tablets are packaged in PVC/PE/Aclar-Aluminium 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 Portugal, 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:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorization number in Portugal, the country of export:5328919

Parallel import authorization number: 39/25

This medicine is authorized in the Member States of the European Economic Area and the United Kingdom (Northern Ireland) under the following names:

Date of approval of the leaflet: 29.01.2025

[Information about the trademark]