Naltex

Package leaflet: Information for the patient

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.
Naltex (Naltrexona Accord)
50 mg, film-coated tablets
Naltrexoni hydrochloridum
Naltex and Naltrexona Accord are different trade names for the same medicine.
Please read the entire leaflet carefully before taking this medicine, as it contains important information for the patient.

• Keep this leaflet to be able to read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform 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 acting on the
nervous system – medicines used in the treatment of addictions.
What is Naltex used for?
Naltrexone hydrochloride is used in combination with other medicines or other treatment methods
to help opioid-dependent patients overcome their addiction.
Naltrexone blocks receptors in the brain and thereby blocks the effects of opioids. Patients no
longer experience the euphoric state they previously felt after taking opioids.
Naltrexone hydrochloride is used as part of a comprehensive treatment program to help
alcohol-dependent individuals maintain abstinence (self-restraint).
Naltex does not cause dependence.

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 medicine (listed in section 6),
• if the patient has severe kidney disorders,
• if the patient has severe liver disorders,
• if the patient has acute hepatitis,
• if the patient is opioid-dependent,
• if the urine test for opioids is positive,
• if the patient has withdrawal syndrome following naloxone injection,
• if the patient is taking a medicinal product containing opioids, such as certain antitussive, antidiarrheal (e.g. kaolin and morphine), or analgesic drugs. Note: naltrexone hydrochloride does not block the effects of non-opioid analgesics (e.g. ibuprofen, paracetamol, and acetylsalicylic acid),
• if the patient is taking methadone.

If any of the above situations apply, tablets should not be taken. Before taking the medicine, inform your doctor and follow their advice.

Warnings and precautions

Before starting treatment with Naltex, discuss this with your doctor or pharmacist:

• Do not take opioids while using Naltex. Although Naltex usually blocks certain effects (i.e. euphoria), taking large doses of opioids may still cause breathing difficulties and circulatory problems (opioid poisoning).
• Do not use Naltex if the patient is still opioid-dependent, as Naltex will trigger severe withdrawal symptoms.
• Inform all treating physicians that the patient is taking Naltex. In an emergency requiring anesthesia, non-opioid anesthetics should be used. If opioid-containing anesthetics are required, higher than usual doses may be needed. The patient may also be more susceptible to adverse effects (breathing difficulties and circulatory problems).
• Do not attempt to overcome the blocking effect of Naltex by taking large doses of opioids. There is a risk that opioids may still remain in the body after the effect of Naltex has worn off. In such a case, unintentional overdose may occur, which could have serious consequences.
• Naltrexone is eliminated from the body by the liver and kidneys. Liver problems are common in opioid-dependent individuals. Your doctor will perform liver function tests before and during treatment.

If the patient has or has previously had any of the conditions listed above, inform the 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 the medicine in children has not been established.

Use in elderly patients

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

Naltex with other medicines

Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines planned for future use.

Some commonly used medicines contain opioids that may not work while taking Naltex. If the patient needs cough, antidiarrheal, or pain-relief medicines, inform the doctor, as these may contain opioids.

Despite contraindications regarding concomitant use of opioid-containing medicines, in emergency situations it may be necessary to administer a pain-relieving drug in a higher than usual dose. Strict medical supervision is absolutely essential, as respiratory depression and other symptoms may be more severe and prolonged.

Taking Naltex with food and drink

Food and drink do not affect treatment with Naltex.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.

The safety of using Naltex during pregnancy has not been established.

It is not known whether naltrexone passes into breast milk. Because the safety of naltrexone use in infants and young children has not been established, breastfeeding should not be undertaken during treatment with Naltex.

Driving and operating machinery

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

Naltex contains monohydrate lactose

If the patient has been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

3. How to take Naltex

This medicine should always be taken as directed by the physician or pharmacist.
If in doubt, consult your doctor or pharmacist again.
The recommended dose is 1 tablet per day, unless otherwise prescribed by the doctor.

• Naltex should be taken orally, with a small amount of liquid.
• Before starting treatment with Naltex, no other opioids should be used for a period of 7–10 days. Prior to initiating therapy, the doctor may perform a test to confirm the absence of these drugs in the patient's system. Treatment usually begins with a dose of half a tablet per day (25 mg), which is then increased to one tablet per day (50 mg).
• Naltex should be used only for the treatment of the condition for which the doctor has prescribed it.
• It is important to take and dose the medicine strictly according to the doctor's instructions.
• It is important to continue taking Naltex for the duration specified 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 effect of Naltex appears too strong or too weak, consult your doctor or pharmacist for advice.

Taking more Naltex than recommended
If more tablets than recommended have been taken, contact your doctor immediately.
Missing a dose of Naltex
Naltex may be taken as soon as the missed dose is remembered.
Do not take a double dose to make up for a missed dose.
Stopping Naltex treatment
If a patient is considering stopping the medicine before the end of the prescribed treatment period, they must always consult their doctor.
If there are any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Naltex may affect liver function. Your doctor may carry out a blood test before starting treatment and during treatment to monitor liver function.
If any of the following symptoms occur, you must stop taking the medicine and contact your doctor immediately:

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

You should contact your doctor immediately if any of the following symptoms occur:

• swelling of the face, lips or tongue,
• skin rash,
• difficulty breathing. These may be symptoms of an allergic reaction.

Very common (may occur in more than 1 in 10 patients):

• difficulty sleeping,
• anxiety or nervousness,
• abdominal cramps and pain,
• nausea and/or vomiting,
• weakness,
• joint and/or muscle pain,
• headache,
• fast or irregular heartbeat,
• restlessness.

Common (may occur in less than 1 in 10 patients):

• irritability,
• mood changes,
• feeling of increased energy,
• depression,
• dizziness,
• chills,
• excessive sweating,
• vertigo,
• increased tearing,
• rapid heartbeat,
• palpitations,
• changes in ECG recording,
• chest pain,
• diarrhoea,
• constipation,
• rash,
• urinary retention,
• delayed ejaculation,
• erectile dysfunction,
• loss of appetite,
• thirst.

Uncommon (may occur in less than 1 in 100 patients):

• certain infections (e.g. cold sores, athlete's foot),
• swelling, enlarged lymph nodes,
• hallucinations,
• confusion,
• depression,
• paranoia,
• disorientation,
• nightmares,
• agitation,
• decreased libido,
• unusual dreams,
• tremor,
• drowsiness,
• blurred vision,
• eye irritation,
• photophobia,
• eye swelling,
• eye pain,
• eye strain,
• ear discomfort,
• ear pain,
• tinnitus,
• dizziness,
• blood pressure fluctuations,
• flushing (erythema),
• nasal mucosa congestion and discomfort,
• sneezing,
• increased mucus production in the bronchi,
• sinus problems,
• voice disturbances,
• shortness of breath, breathing difficulties,
• cough,
• yawning,
• runny nose,
• bloating,
• haemorrhoids,
• ulcers,
• dry mouth,
• liver function disorders (including hepatitis),
• increased liver enzyme activity,
• oily skin,
• itching,
• acne,
• hair loss,
• groin pain,
• increased frequency of urination,
• cystitis,
• increased appetite,
• weight loss,
• weight gain,
• fever,
• pain,
• cold hands or feet,
• feeling of warmth.

Rare (may occur in less than 1 in 1,000 patients):

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

Very rare (may occur in less than 1 in 10,000 patients):

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

Reporting of adverse effects
If any adverse effects occur, including any possible adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can also be reported directly to the Department of Monitoring Adverse Drug Reactions, 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.
Reporting adverse effects helps provide more information on the safety of this medicine.

5. How to store the medicine Naltex

Keep this medicine 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 stated month.
No special storage instructions apply.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Naltex contains

• The active substance is naltrexone hydrochloride. Each coated tablet contains 50 mg of naltrexone hydrochloride.
• Other ingredients are:
  Tablet core: Monohydrate lactose, 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-shaped, biconvex, film-coated tablets with a division line on one side and no marking on the other side.
The tablet can be divided into two equal doses.
Naltex tablets are packed in PVC/PE/Aclar-Aluminium blisters containing 14, 28 or 56 film-coated tablets, in a cardboard carton.
For further information, please contact the responsible party or the parallel importer.

Marketing Authorisation Holder in Portugal, 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
The Netherlands

Parallel Importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw

Marketing Authorisation Number in Portugal, country of export: 5328919
Parallel Import Authorisation Number: 39/25
This medicinal product is authorised for sale in the European Economic Area and the United Kingdom (Northern Ireland) under the following names: