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The product code(s) for this leaflet is: PL 21344/0002 .
Naltrexone hydrochloride 50 mg film-coated tablets
Naltrexone hydrochloride 50 mg film-coated tablets
(Naltrexone hydrochloride)
1. What Naltrexone hydrochloride is and what it is used for
2. What you need to know before you take Naltrexone hydrochloride
3. How to take Naltrexone hydrochloride
4. Possible side effects
5. How to store Naltrexone hydrochloride
6. Contents of the pack and other information
Naltrexone hydrochloride is used as part of a treatment programme to help you stop taking opiates and remain off of them.
Naltrexone belongs to a group of medicines called opiate antagonists. It blocks the euphoric feelings (highs) that you may experience after taking opiates. In treatment for withdrawal from opiates it will reduce the craving.
Naltrexone tablets do not cause dependency.
Your treatment should be started by a physician experienced in treatment of addictions.
Tell your doctor if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
Some common medicines contain opiates and these may not work when you are taking Naltrexone hydrochloride. You should inform your doctor if you need cough-mixtures or medicines against diarrhoea or pain since these may contain opiates.
If, despite the contraindication to use in conjunction, opioid containing drugs are needed in emergency cases the suitable dose for pain relief can be higher as usual. Close monitoring through the doctor is absolutely necessary because occurring respiratory depression and other symptoms may be stronger and longer-lasting.
Food and drink do not interfere with the effects of Naltrexone.
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.
Naltrexone hydrochloride should only be used in pregnancy if the benefit to the mother is greater than the possible risk.
Breastfeeding is not recommended if you are taking Naltrexone hydrochloride.
Ask your doctor or pharmacist for advice before taking any medicine.
Naltrexone hydrochloride may make you feel less alert or drowsy. You should not drive or operate machines if you are affected.
Naltrexone hydrochloride contains lactose (a kind of sugar). If you have ever been told that you have intolerance to some sugars, contact your doctor before taking this medicine.
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
The initial dose of Naltrexone hydrochloride is half a tablet (25 mg) on the first day of treatment. After that the usual dose is one tablet per day (50 mg). Your doctor may prescribe a different dosage depending on your individual needs.
The amount of time you should take Naltrexone hydrochloride for will be decided by your doctor. The usual length of treatment is three months. However, in certain cases, a longer period of treatment may be beneficial.
Naltrexone hydrochloride should not be used in children and adolescents under 18 years.
There are insufficient data on the safety and efficacy for this indication in elderly patients.
If you take more Naltrexone hydrochloride than you should, tell your Doctor or Pharmacist or contact your nearest hospital emergency department immediately.
Do not take a double dose to make up for a forgotten dose. Never take more than your prescribed dose at one time.
After stopping treatment with Naltrexone hydrochloride you may be more sensitive to the effects of opiates. You could unintentionally overdose, even if you take the same dose as you previously used. This is because you build up tolerance whilst taking opiates and once you stop, this tolerance is lost. If you take a high dose, this could have severe consequences or in extreme cases may even be fatal.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The most serious side effects occurring in people taking Naltrexone hydrochloride include feeling depressed, feeling suicidal, attempted suicide and hallucinations. Although these effects are rare or uncommon, if you do experience any of these, then you must contact you Doctor or Pharmacist immediately for help and support.
The following side effects to Naltrexone hydrochloride are sorted according to their frequency:
Very common (may affect more than 1 in 10 patients)
Anxiety, sleeplessness, headache, restlessness, nervousness, abdominal pain, nausea, vomiting, joint and muscle pain, weakness
Common (may affect up to 1 in 10 patients)
Decreased appetite, heart palpitations, increased heart rate, anomalies in ECG, libido disorders, thirst, dizziness, increased tear secretion, chest pains, diarrhoea, constipation, rash, delayed ejaculation, erectile dysfunction, increased energy, irritability, increased sweating, affective disorders
Uncommon (may affect up to 1 in 100 patients)
Oral herpes, athlete’s foot, enlarged lymph nodes, hallucination, confusion, depression, paranoia, disorientation, nightmares, agitation, abnormal dreams, shaking, drowsiness, vision disorders, irritation and swelling of the eye, photophobia, eye pain or tiredness, eye strain, blood pressure changes, hot flushes, nasal congestion, nasal discomfort, rhinorrhoea (runny nose), sneezing, disorders of the mouth and throat, increased sputum, sinus disorders, disorders of the voice, coughing, breathlessness, yawning, flatulence, haemorrhoids, ulcer, mouth dryness, hepatic disorders, increased bilirubin levels, hepatitis, seborrhea (mild dermatitis), acne, hair loss, itching, groin pain, abnormally frequent urination, painful urination, tinnitus, vertigo, ear pain, ear discomfort, increased appetite, weight loss, weight gain, fever, pain, sensation of cold in extremities
Rare (may affect up to 1 in 1,000 patients)
Decreased number of blood platelets, thoughts of suicide, attempted suicide
Very rare (may affect up to 1 in 10,000 patients)
Breakdown of skeletal muscle tissue
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via
or search for MHRA Yellow Card in the Google Play or Apple App Store
By reporting side effects you can help provide more information on the safety of this medicine.
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 and blister after “Exp”. The expiry date refers to the last day of that month.
Do not store above 25 °C. Store in the original package in order to protect from moisture.
If you notice any defects in the tablets such as chipped or broken tablets, ask your pharmacist for advice before taking them.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
Each tablet contains 50 mg of the active substance naltrexone hydrochloride.
The other ingredients are:
Lactose monohydrate, powdered cellulose, microcrystalline cellulose, silica colloidal anhydrous, crospovidone, magnesium stearate, hypromellose, titanium dioxide (E 171), macrogol 4000, black ferric oxide (E172), red ferric oxide (E 172), yellow ferric oxide (E 172).
Naltrexone hydrochloride film-coated tablets are beige and capsule-shaped, with a break-line across the middle. The film-coated tablet can be divided in to equal halves.
Naltrexone hydrochloride is available in packs of 7, 14, 28, 30 and 56 tablets.
Not all pack sizes may be marketed.
This medicinal product is authorised in the Member States of the EEA under the following names:
Czech Republic Naltrexone AOP 50 mg potahované tablety
Denmark Naltrexon AOP filmovertrukne tabletter
Germany Naltrexon HCl aop 50 mg Filmtabletten
Hungary Naltrexone aop 50 mg filmtabletta
Ireland Naltrexone 50 mg film-coated tablets
Netherlands Naltrexon HCl aop 50 mg, filmomhulde tabletten
Slovenia Naltrekson aop 50 mg filmsko obložene tablet
United Kingdom Naltrexone hydrochloride 50 mg film-coated tablet
The leaflet was last revised in December 2021.