Naltex

Package Leaflet: Information for the Patient

Naltex, 50 mg, Coated Tablets

Naltrexone Hydrochloride

Read the Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medication has been prescribed specifically for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should inform their 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 medications that affect the nervous system - medications used to treat addictions.

What is Naltex used for

Naltrexone hydrochloride is used in combination with other medications or treatment methods to help patients addicted to opioids overcome their addiction. Naltrexone blocks receptors in the brain, thereby blocking the effects of opioids. Patients no longer experience the state of euphoria they experienced after taking opioids. Naltrexone hydrochloride is used as part of a comprehensive treatment program to help individuals addicted to alcohol maintain abstinence (self-restraint). Naltex does not cause addiction.

2. Important information before taking Naltex

When not to take Naltex

• if the patient is allergic to naltrexone hydrochloride or any of the other ingredients of the medication (listed in section 6),
• if the patient has severe kidney problems,
• if the patient has severe liver problems,
• if the patient has acute hepatitis,
• if the patient is addicted to opioids,
• if the result of the opioid test in the urine is positive,
• if the patient experiences withdrawal symptoms after naloxone injection,
• if the patient is 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 (such as ibuprofen, paracetamol, and acetylsalicylic acid),

• if the patient is taking methadone.

If any of the above situations occur, do not take the tablets. Before taking the medication, inform your doctor and follow their instructions.

Warnings and precautions

Before starting Naltex, 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 lead to breathing difficulties and circulation problems (opioid poisoning).
• Do not use Naltex if the patient is still addicted to opioids, as Naltex can cause severe withdrawal symptoms in this situation.
• Inform every attending physician about taking Naltex. If anesthesia is needed in an emergency, use non-opioid anesthetics. If opioid anesthetics are required, higher doses than usual may be necessary. The patient 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 the body after the effect of Naltex has stopped. In this case, unintended overdose may occur, which can have serious consequences.
• Naltrexone is eliminated from the body by the liver and kidneys. In people addicted to opioids, liver problems often occur. The doctor will perform liver function tests before and during treatment.

If the patient has or has had any of the above circumstances, they should inform their 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 medication in children has not been established.

Use in the elderly

There is insufficient data on the safety and efficacy of naltrexone in the treatment of this indication in elderly patients.

Naltex and other medications

Tell your doctor or pharmacist about all medications the patient is currently taking or has recently taken, as well as medications the patient plans to take. Some commonly used medications contain opioids that may not work while taking Naltex. If the patient needs medications for cough or diarrhea or painkillers, they should inform their doctor, as these medications may contain opioids. Despite the contraindication for concomitant use of opioid-containing medications, in emergency situations, it may be necessary to administer a painkiller in a higher dose 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 the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medication. 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 naltrexone in children and infants, breastfeeding should be avoided while taking Naltex.

Driving and operating machinery

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

Naltex contains lactose monohydrate

If the patient has been diagnosed with intolerance to some sugars, they should contact their doctor before taking the medication.

3. How to take Naltex

This medication should always be taken according to the doctor's or pharmacist's instructions. In case of doubts, consult a doctor or pharmacist again. The recommended dose is one tablet per day, unless the doctor prescribes otherwise.

• Naltex should be taken orally, with a small amount of liquid.
• Before starting Naltex, the patient should not take any other opioids for 7-10 days. Before starting treatment, the doctor may perform a test to determine if there are any residues of these medications in the patient's 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 for the treatment of the disorder for which the doctor prescribed it.
• It is essential to take the medication and dose it strictly according to the doctor's instructions.
• It is essential to continue taking Naltex for the period prescribed by the doctor. Treatment may last for three months or longer, depending on the doctor's decision. Naltex should be used in combination with other treatment methods. If the patient observes too strong or too weak an effect of Naltex, they should ask their doctor or pharmacist for advice.

Taking a higher dose of Naltex than recommended

In case of taking a higher dose of tablets than recommended, the patient should immediately inform their doctor.

Missing a dose of Naltex

Naltex can be taken as soon as the patient remembers they missed a dose. Do not take a double dose to make up for the missed dose.

Stopping Naltex

If the patient is considering stopping the medication before the scheduled end of treatment, they should always consult their doctor. In case of any further doubts about the use of this medication, consult a doctor or pharmacist.

4. Possible side effects

Like all medications, Naltex can cause side effects, although not everybody gets them. Naltex may affect liver function. The doctor may perform a blood test before starting treatment and during its duration to monitor liver function. If any of the following symptoms occur, stoptaking the medication and immediately consult a doctor:

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

Immediately consult a doctor if any of the following symptoms occur:

• swelling of the face, lips, or tongue,
• skin rash,
• breathing difficulties. These may be symptoms 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,
• accelerated heart rate,
• 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 simplex, athlete's foot),
• 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, breathing difficulties,
• cough,
• yawning,
• runny nose,
• bloating,
• hemorrhoids,
• ulcers,
• dry mouth,
• liver function disorders (including hepatitis),
• increased liver enzyme activity,
• greasy 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
• muscle damage.

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the patient should inform their 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. Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be gathered on the safety of the medication.

5. How to store Naltex

Store in a place out of sight and reach of children. Do not use this medication after the expiry date stated on the blister and carton after "Expiry Date (EXP)": The expiry date refers to the last day of the month stated. There are no special precautions for storage. Medications should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medications they no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Naltex contains

• The active substance of the medication is naltrexone hydrochloride. Each coated tablet contains 50 mg of naltrexone hydrochloride.
• The medication also contains: Tablet core: lactose monohydrate, microcrystalline cellulose, crospovidone, colloidal anhydrous silica, magnesium stearate. Coating: hypromellose (E464), macrogol 400, polysorbate 80 (E433), yellow iron oxide (E172), red iron oxide (E172), titanium dioxide (E171)

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. The tablet can be divided into two equal doses. Naltex tablets are packaged in white, non-transparent PVC/PE/Aclar/Aluminum blisters and Aluminum/Aluminum blisters containing 7, 14, 28, 30, 50, and 56 tablets. Not all pack sizes may be marketed.

Marketing authorization holder

Accord Healthcare Polska Sp. z o.o., ul. Taśmowa 7, 02-677 Warsaw, Tel: +48 22 577 28 00

Manufacturer/Importer:

Accord Healthcare Polska Sp.z o.o., ul. Lutomierska 50, 95-200 Pabianice, Accord Healthcare B.V., Winthontlaan 200, 3526 KV Utrecht, Netherlands, Accord Healthcare Single Member S.A., 64th Km National Road Athens, 32009 Lamia, Greece

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

Country Name of the medicinal product

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

Spain Tranalex 50 mg comprimidos recubiertos con pelicula EFG

Netherlands Naltrexonhydrochloride Accord 50 mg filmomhulde tabletten

Ireland Naltrexone Hydrochloride 50 mg Film-coated Tablets

Lithuania Naltrexone Accord 50 mg plėvele dengtos tabletės

Latvia Naltrexone Accord 50 mg apvalkotās tabletes

Malta Naltrexone Hydrochloride 50 mg Film-coated Tablets

Germany Naltrexonhydrochlorid Accord 50 mg Filmtabletten

Norway Naltrexone Accord 50 mg Filmdrasjert tablett

Poland Naltex, 50 mg, tabletki powlekane

Portugal Naltrexona Accord 50 mg comprimidos revestidos por película

Sweden Naltrexone Accord 50 mg filmdragerad tablet

United Kingdom Naltrexone Hydrochloride 50 mg Film-coated Tablets

Italy Naltrexone Accord Healthcare 50 mg compresse rivestite con film

Date of last revision of the leaflet: December 2024