Naltrexone Accord - Naltrexone hydrochloride uses, dose and side effects

The active substance, naltrexone hydrochloride, belongs to a group of medicines acting on the nervous system which are used in the treatment of addiction.

What Naltrexone Accord is used for

Naltrexone hydrochloride is used in combination with other medicines or treatments to help those who are addicted to drugs such as heroin ( opioids ) get out of their addiction.

It is used as a supportive adjunctive therapy in alcoholic patients to counteract withdrawal symptoms.

Naltrexone works by blocking receptors in the brain that block the effects of opioids. You will no longer feel the elation you once experienced after taking opioids.

Naltrexone hydrochloride contained in Naltrexone Accord may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professionals if you have any further questions, and always follow their instructions.

What you need to know before using Naltrexone Accord

Do not use Naltrexone Accord

if you are allergic to naltrexone hydrochloride or any of the other ingredients of this medicine (listed in section 6).
if you are addicted to opioids or undergoing detoxification treatment, as withdrawal syndrome or an exacerbation of withdrawal syndrome may occur.
if you are taking opioid-containing medicines, such as certain cough medicines, medicines to treat diarrhea (such as kaolin and morphine) and painkillers.
Note that naltrexone hydrochloride has no blocking effect on non- opioid analgesics (eg ibuprofen , paracetamol and acetylsalicylic acid ).
if you have an acute liver infection or if your liver function is impaired.
if you have withdrawal symptoms after administration of naloxone hydrochloride.
if you are taking methadone .

If you think any of these apply to you, do not take the tablets. Talk to your doctor first and follow your doctor’s advice.

Warnings and cautions

Talk to your doctor or pharmacist before taking Naltrexone Accord:

If you have any liver or kidney disease. Patients taking Naltrexone Accord may still experience hypersensitivity reactions when taking opiate-containing medicines, even after use.
Before starting treatment, your doctor may take a blood sample. Blood tests are also necessary during treatment, as Naltrexone Accord is metabolised by the liver and these tests show how well your liver is working.
If a patient needs to be treated with opioids , e.g. painkillers or anesthesia during surgery in an emergency, a higher dose of opioid is required to achieve the treatment effect. In these cases, respiratory depression and circulatory effects will be deeper and longer lasting.
Treatment with naltrexone should be started only when the opioid has not been used for a sufficiently long time (about 5 to 7 days for heroin and at least 10 days for methadone ).
Abnormal results from liver function tests have been reported in obese and elderly patients taking naltrexone and who have no previous drug abuse.
It is important to stop taking Naltrexone Accord immediately and tell your doctor if you get the following symptoms: persistent stomach pain, white stools, dark urine or if your eyes and / or skin turn yellow.

Consult a physician if any of the above warnings apply or have previously applied to you.

Older

There are insufficient data on the safety and efficacy of naltrexone in elderly patients.

Children and young people

Naltrexone should not be used in children and adolescents below 18 years of age due to a lack of clinical data in this age group. Safe use in children has not been ensured.

Other medicines and Naltrexone Accord

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Concomitant use of Naltrexone Accord and opiate-containing drugs must be avoided. If you try to overcome the blocking effect of Naltrexone Accord with large amounts of opioids , you can get serious problems, which can lead to difficulty breathing, coma and even death.
Concomitant use of Naltrexone Accord and thioridazine may cause drowsiness. No other adverse effects between Naltrexone Accord and other medicines are known.
Drugs can affect or be affected by each other.

Naltrexone Accord with food and drink

Taking food and drink has no effect on your treatment with Naltrexone Accord.

Pregnancy and breastfeeding

The safety of Naltrexone Accord during pregnancy has not been established.

It is not known whether naltrexone is excreted in human milk. As the safety of naltrexone in neonates and infants has not been established, breastfeeding is discouraged when using Naltrexone Accord.

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Naltrexone may impair the mental and/or physical ability required to perform potentially dangerous tasks such as driving or using machines.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Naltrexone Accord contains lactose monohydrate

This medicine contains 192.85 mg of lactose. According to the dose recommendations, each dose contains up to 192.85 mg of lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

How to use Naltrexone Accord

Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

The recommended dose is 1 tablet daily unless your doctor prescribes another dose.

Naltrexone Accord is taken by mouth with a small amount of liquid.
Before you start taking Naltrexone Accord, you must not have taken any other opioids for at least 7-10 days. Before starting treatment, your doctor may use a test to determine if you are free of these drugs. Treatment is usually started with a dose of half a tablet daily (25 mg), which is later increased to 1 tablet daily (50 mg).
Naltrexone Accord should only be used for the condition prescribed by your doctor.
It is important to carefully follow the dosage one prescribed by your doctor.
It is important that you take Naltrexone Accord for as long as your doctor prescribes it. The treatment period is usually three months, but can last longer. Your doctor will decide how long you should be treated. Naltrexone Accord should be combined with other treatments.

If you notice that the effect of Naltrexone Accord is too strong or not strong enough, you should consult your doctor or pharmacist.

If you use more Naltrexone Accord than you should

If you have ingested too much medicine or if e.g. a child inadvertently ingested the medicine immediately contact a doctor or hospital for risk assessment and advice.

If you forget to use Naltrexone Accord

You can still take Naltrexone Accord when you remember.

Do not take a double dose to make up for a forgotten dose.

If you stop using Naltrexone Accord

If you are considering stopping before the end of the agreed treatment period, always discuss this with your doctor.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Naltrexone Accord may affect your liver function. Your doctor may take a blood sample before you start treatment and then at different times during treatment to check your liver function.

Stop taking Naltrexone Accord and contact your doctor immediately if you notice any of the following:

abdominal pain lasting more than a few days
white stools
dark urine
yellowing of the eyes

as this may be a sign that your liver is not working well

If you notice any of the following, contact your doctor immediately:

swelling of the face, lips or tongue
rash
breathing difficulties

as this may be a sign of an allergic reaction.

Very common (may affect more than 1 user in 10)

difficulty sleeping
anxiety or nervousness
abdominal cramps and abdominal pain
malaise and / or nausea
lack of energy or strength
joint and / or muscle pain
headache
fast or irregular heartbeat
restlessness

Common (may affect up to 1 in 10 people)

irritation
Mood swings
increased energy
Depression
dizziness
frostbite
increased or profuse sweating
dizziness
increased tear production
fast pulse
palpitation
ECG changes
chest pain
diarrhea
constipation
rash
difficulty urinating ( urinary retention )
delayed ejaculation
difficulty getting an erection
lack of appetite
thirst
feeling of increased energy
overindulge

Uncommon (may affect up to 1 in 100 people)

some infections (eg cold sores, tinea pedis )
swollen / enlarged lymph nodes
hallucinations
confusion
Depression
paranoia
disorientation
nightmares
indignation
decreased sexual desire
abnormal dreams
tremors
drowsiness
dimsyn
eye irritation
hypersensitivity to light
swelling of the eyes
pain in the eyes
strained eyes
ear problems
pain in the ears
ringing in the ears
dizziness
blood pressure variations
hot flashes
nasal congestion and discomfort
sneezing
increased saliva volume
sinus problems
voice problems
shortness of breath / difficulty breathing
cough
yawn
Runny nose
gas in the stomach
hemorrhoids
gastric ulcer
dry mouth
liver disease (including hepatitis)
elevated liver enzymes
oily skin
itching
acne
hair loss
groin pain
increased urine output
inflammation of the bladder
increased appetite
weight loss
weight gain
fever
pain
cold hands and feet
feeling of warmth

Rare (may affect up to 1 in 1,000 people)

suicidal thoughts
suicide attempt
bleeding disorder
speech disorders

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

euphoria (feeling of elation)
rash
skeletal muscle injury

How to store Naltrexone Accord

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after “EXP”. and on the blister after “EXP”. The expiration date is the last day of the specified month.
There are no special storage instructions for this medicine.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Contents of the pack and other information

Content declaration

The active substance is naltrexone hydrochloride.

One film-coated tablet contains 50 mg of naltrexone hydrochloride.

Other ingredients are:

Tablet core: lactose monohydrate, microcrystalline cellulose, crospovidone, colloidal anhydrous silica, magnesium stearate

Film coating: hypromellose (E464), macrogol 400, polysorbate 80 (E433), yellow iron oxide (E172), red iron oxide (E172), titanium dioxide (E171)

What the medicine looks like and contents of the pack

Naltrexone Accord is yellow, oval, biconvex, film-coated tablets with a scoreline on one side and flat on the other.

The tablet can be divided into two equal doses.

Naltrexone Accord is available in white, opaque PVC / PE / Aclar-Alu blister and Alu-Alu blister packs containing 7, 14, 28, 30, 50, and 56 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Accord Healthcare BV

Winthontlaan 200

3526 kV Utrecht

Netherlands

Manufacturer

Accord Healthcare Polska Sp.z oo,

ul. Lutomierska 50,95-200 Pabianice, Poland