Package leaflet: Information for the patient 1000009204

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.

-    Keep this leaflet. You may need to read it again.

-    If you have any further questions, ask your doctor or pharmacist or nurse.

-    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 yours.

-    If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

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:

•    Are allergic (hypersensitive) to naltrexone hydrochloride or any of the other ingredients of Nalorex

•    Are currently dependent on opiate drugs or going through withdrawal

•    If your urine tests are positive for opiates

•    Have liver failure or hepatitis (inflammation of the liver),

•    If you have kidney failure

•    Are currently taking any medicines which contain any opioids which include certain cough medicines (e.g. mixtures containing dextromethorphan), analgesic pain killers (e.g. morphine, codeine) and some medicines used to treat diarrhoea (e.g. kaolin)

•    Attempts to overcome the effects of Nalorex with high doses of opioids may result in acute opioid intoxication, which may be life threatening

Warnings and precautions

Talk to your doctor or pharmacist or nurse before taking Nalorex:

•    If you have any liver or kidney problems

•    If you are still addicted to opiates as Nalorex will cause severe withdrawal symptoms in this situation 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:

•    Medicines used to treat pain (analgesics)

•    Medicines to treat coughs (antitussives)

•    Medicines to manage mental illness (neuroleptics)

•    Sedative medicines e.g. barbiturates, benzodiazepines, hypnotics

•    Medicines to relieve anxiety (i.e meprobamate)

•    Sedative antidepressants (amitiptyline, doxepin, mianserin, trimipramine)

•    Sedative antihistamines

•    Medicines to treat high blood pressure

•    Baclofen or thalidomide

•    Acamprosate

•    Thioridazine

Pregnancy and Breast-feeding

If you are pregnant, think you may be pregnant, tell your doctor who will advise whether Nalorex is suitable tor 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:

•    Difficulty sleeping

•    Anxiety or nervousness

•    Abdominal cramps and pain

•    Nausea and /or vomiting

•    Feeling sick and/or being sick

•    Lack of energy

•    Joint and muscle pain

•    Headaches

•    Restlessness

Common side effects of Nalorex (affecting more than 1 in 100) are:

•    Loss of appetite

•    Diarrhoea or constipation

•    Increased thirst

•    Increased energy

•    Feeling down or tired

•    Irritability

•    Dizziness

•    Skin rash

•    Delayed ejaculation, reduced libido

•    Chills

•    Chest pain

•    Increased sweating and increased flow of tears

•    Bruising/bleeding

•    Abnormal heart beats (too last or too slow)

Uncommon side effects of Nalorex (affecting more than 1 in 1,000) are:

•    Nasal congestion

•    Itching

•    Runny nose

•    Sneezing

•    Sore throat

•    Excess mucus

•    Trouble with sinus

•    Heavy breathing

•    Abnormal changes in voice

•    Coughing

•    Shortness of breath

•    Yawning

•    Excessive gas production

•    Dry mouth

•    Painful shoulders, legs or knees

•    Piles

•    Ulcer

•    Twitching

•    Shaking of the body

•    Groin pain

•    Increased frequency of or discomfort during urination

•    Oily Skin

•    Spots

•    Cold scores

•    Athletes foot

•    Loss of hair

•    Depression

•    Paranoia

•    Confusion

•    Nightmares

•    Blurred /burning eyes

•    Light sensitive eyes

•    Swollen/aching/strained eyes

•    clogged/aching ears

•    Ringing in the ears

•    Drowsiness

•    Changes in blood pressure

•    Flushing

•    Agitation

•    Reduced libido

Very rare side effects of Nalorex (affecting less than 1 user in 10,000) are:

•    Breakdown of injured skeletal muscle tissue

•    Suicidal thoughfs/feelings 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

Bristol-Myers Squibb Pharmaceuticals Ltd Uxbridge Business Park,

Sanderson Road, Uxbridge,

Middlesex UB81DH,

England.

Tel: 0800 7311736 Manufacturer

Bristol-Myers Squibb, S.r.l.

Contrada Fontana del Ceraso 03012Anagni (FR)

Italy

This leaflet was revised in August 2015

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1000009204