Active ingredient
- naltrexone hydrochloride
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original can be viewed in PDF format using the link above.
The text only version may be available from RNIB in large print, Braille or audio CD. For further information call RNIB Medicine Leaflet Line on 0800 198 5000. The product code(s) for this leaflet is: PL 11184/0104.
Nalorex
Package leaflet: Information for the patient
NALOREX®
50mg Film Coated Tablets
(Naltrexone Hydrochloride)
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
What is in this leaflet
1. What Nalorex is and what it is used for
2. What you need to know before you take Nalorex
3. How to take Nalorex
4. Possible side effects
5. How to store Nalorex
6. Contents of the pack and other information
1. What Nalorex is and what it is used for
The name of your medicine is Nalorex. Nalorex contains the active ingredient naltrexone hydrochloride. Naltrexone hydrochloride belongs to a group of medicines called opioid antagonists.
NALOREX is used together with your other forms of treatment such as counselling to help you to remain free from your dependence on heroin, methadone and other similar opiate drugs of addiction.
2. What you need to know before you take Nalorex
Do not take Nalorex if you:
Warnings and precautions
Talk to your doctor or pharmacist or nurse before taking Nalorex:
Nalorex is removed from the body by the liver and kidney. Liver problems are common in opiate dependant individuals. Your doctor will carry out liver function tests both before and during treatment.
People dependent on opioids or other substances of addiction have an increased risk of depression, suicidal thoughts and attempted suicide. Please tell your doctor if you affected.
Children and adolescent
Nalorex is not recommended in patients below 18 years old.
Taking with other medicines
Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Some common medicines contain opiates and these may not work when you are taking Nalorex. You should inform your doctor if you need medicines to relieve a cough, cold, pain or diarrhoea since these may contain opiates.
If you use opiate containing anaesthetics in an emergency situation, you may need higher doses than usual. You may also be more sensitive to the side effects (breathing difficulties and circulatory problems).
Please tell you doctor if you are taking:
Pregnancy and Breast-feeding
If you are pregnant, think you may be pregnant, tell your doctor who will advise whether Nalorex is suitable for you.
Breastfeeding is not recommended during naltrexone treatment.
Driving and operating machinery
Nalorex may make you feel tired or dizzy. Do not drive or operate machinery until you know how this medicine affects you.
Important information about some of the ingredients of Nalorex
This medicine contains lactose. If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicine.
3. How to take NALOREX
Always take Nalorex exactly as your doctor has told you. You should check with your doctor if you are not sure.
You must have stopped taking any opiate drugs for at least 7-10 days before starting Nalorex.
Your doctor may carry out a test which will show that you are free from these drugs before starting your treatment.
The initial dose is usually half a tablet (25mg) once a day.
This will be increased to the usual dose of one tablet (50mg) once a day.
The tablets should be swallowed with a glass of water.
If you take more Nalorex than you should
If you take too many tablets go to your nearest hospital emergency department or contact your doctor immediately.
If you miss a dose of Nalorex
If you forget to take a tablet, do not worry. Miss out this dose completely and take the next dose as usual. Do not take a double dose to make up for the forgotten dose.
4. Possible side effects
Like all medicines, Nalorex can cause side effects although not everybody gets them. Nalorex can affect your liver function. Your doctor may carry out blood tests before you start treatment and at various times during treatment to monitor your liver function.
Tell your doctor immediately if you or your family notice any symptoms listed below:
Allergic reaction may include swelling of the face, lips and tongue; skin rash; difficulty breathing
Liver symptoms may include white bowel movements; dark urine; yellowing of the eyes.
Very common side effects of Nalorex (affecting more than 1 in 10 users) are:
Common side effects of Nalorex (affecting more than 1 in 100) are:
Uncommon side effects of Nalorex (affecting more than 1 in 1,000) are:
Very rare side effects of Nalorex (affecting less than 1 user in 10,000) are:
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 NALOREX
Please check the expiry date of the product, shown on the outer packaging of Nalorex tablets. Do not use after the month stated.
Do not store your tablets above 25°C. They should not get too hot or damp; so do not leave your tablets near a radiator, on a window sill or in the bathroom.
Store in the original packaging.
Keep your medicines out of the reach and sight of children.
If you are told to stop taking this medicine, return any unused tablets to your pharmacist.
6. Contents of the pack and other information
What Nalorex tablets contain
Each Nalorex tablet contains 50mg of the active ingredient naltrexone hydrochloride. The other ingredients are: lactose monohydrate, microcrystalline cellulose, crospovidone, silica, colloidal anhydrous, magnesium stearate; pale yellow opadry YS-1-6378-G (hypromellose, macrogol, polysorbate 80 and colouring agents titanium dioxide (E171), and yellow and red iron oxide (E172).
What Nalorex tablets look like and contents of the pack
Nalorex tablets are pale yellow, capsule-shaped tablets marked on one side with 'R11' and on the other side with '50'.
Nalorex tablets are available in a blister pack of 28 tablets.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Manufacturer
or
This leaflet was revised in September 2015
Bristol-Myers Squibb House, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex, UB8 1DH, UK
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