NALOREX 50MG FILM-COATED TABLETS

Active substance: NALTREXONE HYDROCHLORIDE

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4180

(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.

Phone contact: +39 0692708387
e-mail contact: artwork@grafimed.it
www.grafimed.it

Live Text:
Country:

S

Product Name:

NALOREX TAB 50MG

Product Code:
Barcode Type:
Format/Dimension:
Tech. Drawing No.:

1264748A2
2/5: 4180
130 x 280 (130 x 38) mm

Min. Font Size Text:
Proof No.: 1


9 pt
08.04.2014

UK

Yes /

£

No

Production Site:
CTM:

Anagni
Parisi

Printing Colours:

Black

Technical Colours:

Diecut

Castaldo
Pag 1/2

4180
4180

4180

NALOREX®
50mg Film Coated Tablets

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 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

1264748A2

Package leaflet: Information for the
patient

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 fast 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
• Restlessness
• Confusion
• Nightmares
• Blurred /burning eyes
• Light sensitive eyes
• Swollen/aching/strained eyes
• clogged/aching ears
• Ringing in the ears
• Drowsiness
Very rare side effects of Nalorex (affecting
less than 1 user in 10,000) are:
• Breakdown of injured skeletal muscle
tissue
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.
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 UB8 1DH,
England.
Tel: 0800 7311736
Manufacturer
Bristol-Myers Squibb, S.r.l.
Contrada Fontana del Ceraso
03012 Anagni (FR)
Italy
or
Aesica Queenborough Limited
North Road, Queenborough,
Kent, MEL11 5EL
UNITED KINGDOM
This leaflet was revised in April 2014

1264748A2

Phone contact: +39 0692708387
e-mail contact: artwork@grafimed.it
www.grafimed.it

Live Text:
Country:

S

Product Name:

NALOREX TAB 50MG

Product Code:
Barcode Type:
Format/Dimension:
Tech. Drawing No.:

1264748A2
2/5: 4180
130 x 280 (130 x 38) mm

Min. Font Size Text:
Proof No.: 1


9 pt
08.04.2014

UK

Yes /

£

No

Production Site:
CTM:

Anagni
Parisi

Printing Colours:

Black

Technical Colours:

Diecut

Castaldo
Pag 2/2

Expand view ⇕

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.

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