Naltex

Package leaflet: Information for the user

Warning! Keep the leaflet – the packaging information in a foreign language!
Naltex ( Tranalex 50 mg )
50 mg, coated tablets
Naltrexoni hydrochloridum
Naltex and Tranalex 50 mg are different trade names for the same medicinal product.
Please read the entire leaflet carefully before taking this medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if necessary.
• If you have any doubts, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm someone else, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any possible adverse reactions not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet

1. What Naltex is and what it is 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 Naltex is and what it is 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 Naltex is used for
Naltrexone hydrochloride is used in combination with other medicines or other treatment methods to help patients addicted to narcotics such as heroin (opioids) overcome their addiction. It is also indicated as a supportive medicine to maintain abstinence in the treatment of alcohol dependence. Naltrexone blocks receptors in the brain, thereby blocking the effects of opioids. Patients no longer experience the euphoric state they previously felt after taking opioids.

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 is opioid-dependent or undergoing abstinence maintenance treatment, as withdrawal syndrome or its exacerbation may occur,
• if the patient is regularly taking a medicinal product containing an opioid, 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 has acute hepatitis or impaired liver function,
• if the patient has experienced withdrawal syndrome after administration of naltrexone hydrochloride,
• if the patient is taking methadone.

If any of the above situations apply, Naltex 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 the following with your doctor or pharmacist:

• If the patient has liver or kidney disease. In patients who have taken naltrexone, hypersensitivity reactions to opioid-containing drugs may still occur, even after completion of treatment.
• Before starting treatment, the doctor may perform a blood count test. Blood tests are also necessary during treatment, as Naltex is metabolized by the liver. Blood tests help assess liver function.
• If opioid treatment becomes necessary, e.g. for pain relief or anesthesia in emergencies, higher opioid doses will be required to achieve therapeutic effect. In such cases, respiratory depression and circulatory effects will be stronger and last longer.
• Naltrexone treatment should only be initiated after an appropriate period has elapsed since discontinuation of opioid use (5–7 days in the case of heroin, and at least 10 days after stopping methadone).
• Abnormal liver function test results have been reported in obese patients and elderly patients taking naltrexone who were not opioid-dependent.
• Immediately stop taking Naltex and contact your doctor if any of the following symptoms occur: severe abdominal pain, pale stools, dark urine, or yellowing of the eyes and/or skin (jaundice).

If any of the above conditions are present or have occurred in the past, 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 the medicine in children has not been established.

Use in elderly patients

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

Naltex and other medicines

Inform 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.

• Concomitant use of Naltex with opioid-containing medicines should be avoided. Attempts to overcome the blocking effect of Naltex by using large amounts of opioids may lead to serious complications: respiratory distress, coma, and even death.
• Concomitant use of Naltex with thioridazine may cause drowsiness. No other harmful interactions between Naltex and other medicines are known.
• Medicines may interact with each other.

Taking Naltex with food and drink

Food and drink do not affect treatment with Naltex.

Pregnancy and breastfeeding

The safety of Naltex during pregnancy has not been established.

It is unknown whether naltrexone passes into breast milk. Because the safety of naltrexone in infants and children has not been established, breastfeeding is not recommended during treatment with Naltex.

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to have a child, she should consult her doctor or pharmacist before using this medicine.

Driving and operating machinery

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

Naltex contains monohydrate lactose

The medicinal product contains lactose. Each dose contains 192.85 mg of lactose. If the patient has been diagnosed with intolerance to certain sugars, the patient should consult their doctor before taking this medicine.

3. How to take Naltex

This medicine should always be taken according to the instructions of your doctor or pharmacist.
If in doubt, consult your doctor or pharmacist again.
The recommended dose is 1 tablet per day, unless your doctor prescribes otherwise.

• 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, your doctor may perform a test to determine whether any of these drugs remain in your body. Treatment is usually started 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 your doctor prescribed it.
• It is important to take and dose the medicine strictly according to your doctor's instructions.
• It is important to continue taking Naltex for the duration 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 the effect of Naltex appears too strong or too weak, consult your doctor or pharmacist for advice.

Taking more Naltex than recommended
If you take more tablets than recommended, inform your doctor immediately.
Missing a dose of Naltex
If you forget to take a dose, take Naltex as soon as you remember. Do not take a double dose to make up for a missed dose.
Stopping Naltex
If you are considering stopping the medicine before the prescribed treatment period ends, you must always discuss this with your doctor.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine may cause adverse reactions, although not everybody experiences 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, 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.

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 people):

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

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

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

Uncommon (may occur in 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,
• visual fatigue,
• ear discomfort,
• ear pain,
• tinnitus,
• dizziness,
• blood pressure fluctuations,
• flushing (redness),
• nasal mucosal congestion and discomfort,
• sneezing,
• increased mucus production in the bronchi,
• sinus problems,
• voice disturbances,
• shortness of breath, difficulty breathing,
• 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 1 in 1,000 patients):

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

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

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

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department for Monitoring Adverse Reactions of Medicinal Products at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Naltex

Keep the 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 conditions 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 packaging 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, round, biconvex, film-coated tablets with a score 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-Al blisters containing 14, 28, or 56 film-coated tablets per cardboard box.
For further information, please contact the Marketing Authorisation Holder or the Parallel Importer.

Marketing Authorisation Holder in Spain, the country of export:
Accord Healthcare, S.L.U.
World Trade Center
Moll de Barcelona, s/n
Edifici Est, 6th floor
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:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland

Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland
SHIRAZ PRODUCTIONS Sp. z o.o.
ul. Tymiankowa 24/28
95-054 Ksawerów
Poland

Marketing Authorisation numbers in Spain, the country of export: 679763.1, 679764.8
Parallel Import Authorisation number: 247/23

This medicinal product is authorised in the European Economic Area (EEA) Member States under the following trade names:

| Member State | Trade 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 |