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NALTREXONE HYDROCHLORIDE 50 MG FILM-COATED TABLETS
Active substance(s): NALTREXONE HYDROCHLORIDE / NALTREXONE HYDROCHLORIDE / NALTREXONE HYDROCHLORIDE
PATIENT INFORMATION LEAFLET
Read all of this leaflet carefully before you start taking this medicine
because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if their signs of illness are the same as
- If you get any side effects, talk to your doctor or pharmacist. This includes
any possible side effects not listed in this leaflet. See section 4.
This medicine is available using the above name but will be referred to as
Naltrexone Hydrochloride film-coated tablets throughout the following leaflet.
What is in this leaflet:
1. What Naltrexone Hydrochloride film-coated tablets is and what it is used
2. What you need to know before you take Naltrexone Hydrochloride filmcoated tablets
3. How to take Naltrexone Hydrochloride film-coated tablets
4. Possible side effects
5. How to store Naltrexone Hydrochloride film-coated tablets
6. Contents of the pack and other information
1. WHAT NALTREXONE HYDROCHLORIDE FILM-COATED TABLETS IS
AND WHAT IT IS USED FOR
The active ingredient, naltrexone hydrochloride, belongs to a group of
medicines other nervous system drugs; drugs used in addictive disorders
What is Naltrexone Hydrochloride film-coated tablets used for
Naltrexone hydrochloride is used in combination with other medicines or
therapy to help those who are dependent on drugs such as heroin (opioids),
overcome their addiction.
It is indicated as supportive therapy in maintaining abstinence (self denial) in
alcohol-dependent patients. Naltrexone acts by blocking receptors in the
brain to block the action of opioids. Individuals will no longer experience the
euphoria previously experienced after taking opioids.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE NALTREXONE
HYDROCHLORIDE FILM-COATED TABLETS
Do not take Naltrexone Hydrochloride film-coated tablets
- if you are allergic to naltrexone hydrochloride or any of the other
ingredients of this medicine (listed in section 6).
- if you are dependent on opiates or are undergoing treatment involving
abstinence (self denial), since abstinence syndrome or an exacerbation of
abstinence syndrome can occur.
- if you are continuously using a medicinal product containing an opioid, for
example certain cough medicines, medicines to treat diarrhoea (such as
kaolin and morphine) and analgesics (pain killers). Note: Naltrexone
hydrochloride does not have a blocking effect on analgesics which do not
contain any opioids (such as ibuprofen, paracetamol and acetylsalicylic
- if you have an acute liver infection or if your liver function is poor.
- if patients have withdrawal symptoms after naloxone hydrochloride
- if you take methadone.
If you think any of these apply to you, do not take the tablets. Talk to your
doctor first and follow his advice.
Warnings and precautions
Talk to your doctor or pharmacist before taking Naltrexone Hydrochloride
- If you have liver or kidney diseases. Patients who have used Naltrexone
Hydrochloride film-coated tablets can still have hypersensitivity reactions
when taking medicines containing opiates, even in the period after use.
- Before starting the treatment. Your doctor may carry out a blood test.
Blood tests are also necessary during treatment, because Naltrexone
Hydrochloride film-coated tablets is processed by the liver and these tests
show how well your liver is working.
- If patient needs opioid treatment e.g. opioid analgesic or anaesthesia in
emergency situation, opioid dose is higher to achieve the therapeutic
effect. In these cases respiratory depression and circulatory effect will be
more profound and longer lasting.
- Naltrexone treatment must begin only when the opioid has been
discontinued for a sufficiently long period (about 5 to 7 days for heroin and
at least 10 days for methadone).
- Liver function test abnormalities have been reported in obese and elderly
patients taking naltrexone who have no history of drug abuse.
- It is important to stop taking Naltrexone Hydrochloride film-coated tablets
immediately and to tell your doctor in the event of the following symptoms:
persistent abdominal pain, white stools, dark urine or if your eyes and/or
skin turn yellow.
Consult your doctor if one of the above warnings applies to you, or has done
so in the past.
Children and adolescents
Naltrexone should not be used in children and adolescents under 18 years
of age, since clinical data in this age- group are lacking. Safe use in children
has not been established.
Use in older people
There are insufficient data on the safety and efficacy of naltrexone for this
indication in elderly patients.
Other medicines and Naltrexone Hydrochloride film-coated tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.
- Simultaneous use of Naltrexone Hydrochloride film-coated tablets and
medicines containing opiates must be avoided. If you try to overcome the
blocking action of Naltrexone Hydrochloride film-coated tablets with large
quantities of opioids, you will find yourself in great difficulties. Such action
can lead to breathlessness, coma and can even be fatal.
- Simultaneous use of Naltrexone Hydrochloride film-coated tablets and
thioridazine can cause drowsiness. No other harmful affects due to
interaction between Naltrexone Hydrochloride film-coated tablets and
other medicines are known.
- Medicines can have a reciprocal effect on one another.
Naltrexone Hydrochloride film-coated tablets with food and drink
Taking food and drink has no influence on your treatment with Naltrexone
Hydrochloride film-coated tablets.
Pregnancy and breast-feeding
The safety of using Naltrexone Hydrochloride film-coated tablets during
pregnancy has not been demonstrated. It is not known whether naltrexone
is excreted in breast milk. Because the safety of using naltrexone in
neonates and children has not been demonstrated, breast-feeding is not
advised while using Naltrexone Hydrochloride film-coated tablets.
If you are pregnant or breast-feeding, 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 abilities required for
performance of potentially hazardous tasks such as driving a car or
Naltrexone Hydrochloride film-coated tablets contains lactose
This medicinal product contains 192.85 mg of lactose. According to dosage
recommendations each dose supplies 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 medicinal product.
3. HOW TO TAKE NALTREXONE HYDROCHLORIDE FILM-COATED
Always take this medicine exactly as your doctor or pharmacist has told you.
Check with your doctor or pharmacist if you are not sure.
The recommended dose is 1 tablet per day unless a different dose has been
prescribed by your doctor.
- Naltrexone Hydrochloride film-coated tablets taken orally with small
amount of liquid.
- Before starting to take Naltrexone Hydrochloride film-coated tablets, you
must not have used any other opiates for at least 7-10 days. Your doctor
can use a test to establish whether you are clear of these drugs before
you start the treatment. Generally speaking, treatment begins at a dose of
1/2 tablet per day (25 mg), later increased to 1 tablet per day (50 mg).
- Naltrexone Hydrochloride film-coated tablets must be used exclusively for
the disorder for which your doctor has prescribed this medicine.
- It is important to follow your doctor’s instructions closely with respect to
- It is important that you take Naltrexone Hydrochloride film-coated tablets
for the period of time prescribed by your doctor. The treatment can last for
three months or longer, according to the judgment of your doctor.
Naltrexone Hydrochloride film-coated tablets should be combined with
other forms of treatment.
If you notice that the effect of Naltrexone Hydrochloride film-coated tablets is
too strong or not strong enough, consult your doctor or pharmacist.
If you take more Naltrexone Hydrochloride film-coated tablets than you
If you have taken more than the prescribed number of tablets, you should
inform your doctor immediately.
If you forget to take Naltrexone Hydrochloride film-coated tablets
You can still take the Naltrexone Hydrochloride film-coated tablets when you
remember. Do not take a double dose to make up for a forgotten dose.
If you stop taking Naltrexone Hydrochloride film-coated tablets
If you consider stopping before the end of the agreed period of treatment,
always discuss this with your doctor.
If you have any further questions on the use of this medicine, ask your
doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not
everybody gets them. Naltrexone Hydrochloride film-coated tablets can
affect your liver function. Your doctor may carry out blood test before you
start treatment and at various times during treatment to monitor your liver
If you notice any of the following, stop taking Naltrexone Hydrochloride filmcoated tablets and contact your doctor immediately: - Abdominal pain lasting more than a few days
- White bowel movements
- Dark urine
- Yellowing of your eyes
As these may be signs that your liver isn’t working well.
If you notice any of the following, tell your doctor immediately:
- Swelling of the face, lips, or tongue
- Skin rash
- Difficulty breathing
As 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
- Feeling sick and/or being sick
- Lack of energy or strength
- Joint and/or muscle pain
- Fast or irregular heartbeat
Common (may affect up to 1 in 10 people)
- Mood swings
- Increased energy
- Increased or excessive sweating
- Increased lacrimation
- Increased heart beat
- Change in ECG readings
- Pain in the chest
- Urine retention
- Delayed ejaculation
- Erectile dysfunction
- Lack of appetite
- Energy increased
Uncommon (may affect up to 1 in 100 people)
- Some infections (e.g. Oral herpes, tinea pedis)
- Swollen/enlarged lymph nodes
- Confusional state
- Reduced libido
- Abnormal dreams
- Blurred vision
- Irritation in eye
- Abnormal intolerance to visual perception of light
- Swelling of eyes
- Eye pain - Strain in eye
- Ear discomfort
- Ear pain
- Ringing of ear
- Blood pressure fluctuation
- Nasal congestion & discomfort
- Sputum increased
- Sinus problems
- Voice disorders
- Shortness of breath/difficulty in breathing
- Runny nose
- Dry mouth
- Liver disorders (including inflammation of liver)
- Increase in liver enzymes
- Greasy skin
- Hair loss
- Groin pain
- Increased urination
- Inflammation of urinary bladder
- Increased appetite
- Weight loss
- Weight gain
- Coldness in hands or feet
- Feeling hot
Rare (may affect up to 1 in 1,000 people)
- Suicidal thoughts
- Attempt to suicide
- Bleeding disorder
- Speech disorder
Very rare (may affect up to 1 in 10,000 people)
- Skin rash/ eruptions
- Skeletal muscle damage
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This
includes any possible side effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard. By reporting side effects, you can help
provide more information on the safety of this medicine.
5. HOW TO STORE NALTREXONE HYDROCHLORIDE FILM-COATED
- 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 label
after ‘EXP’. The expiry date refers to the last day of that month.
- This medicinal product does not require any special storage conditions.
- If the tablets become discoloured or show signs of any deterioration, you
should seek the advice of your pharmacist who will advise you what to do.
- Medicines should not be disposed of via wastewater or household waste.
Ask you pharmacist how to dispose of medicine no longer required. These
measures will help to protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Naltrexone Hydrochloride film-coated tablets contains
The active substance is naltrexone hydrochloride.
Each film-coated tablet contains 50 mg naltrexone hydrochloride.
The other ingredients are:
Core Tablet: lactose monohydrate, microcrystalline cellulose, crospovidone,
colloidal anhydrous silica, magnesium stearate
Film-coating: hypromellose (E464), macrogol 400, polysorbate 80 (E433),
yellow iron oxide (E172), iron oxide red (E172), titanium dioxide (E171)
What Naltrexone Hydrochloride film-coated tablets looks like and
contents of the pack
Naltrexone Hydrochloride film-coated tablets are available as yellow
coloured, oval, biconvex, film coated tablets with breakline on one side and
plain on other side. The tablet can be divided into equal halves.
Naltrexone Hydrochloride film-coated tablets are available in white opaque
PVC/PE/aluminium blister packs containing 14 or 28 tablets.
Manufacturer and Product Licence holder
Manufactured by Accord Healthcare Limited, 319 Pinner Road, North
Harrow, Middlesex, HA1 4HF, United Kingdom.
Procured from within the EU by Product Licence holder:
Star Pharmaceuticals Ltd, 5 Sandridge Close, Harrow, Middlesex,
HA1 1XD. Repackaged by Servipharm Ltd.
Leaflet revision and issue date (Ref). 10.05.16
Source: Medicines and Healthcare Products Regulatory Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.