NALOREX 50MG FILM-COATED TABLETS

Active substance: NALTREXONE HYDROCHLORIDE

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PATIENT INFORMATION LEAFLET

NALOREX®

50mg Film Coated Tablets
(Naltrexone Hydrochloride)
Please read this leaflet carefully before you start taking your medicine.
• This leaflet provides a summary of the information available on your medicine.
• This medicine has been prescribed for you. Do not pass it on to others.
• It may harm them, even if their symptoms are the same as yours.
• If you want to know more or are not sure ask your doctor or pharmacist.
In this Leaflet:
1. What Nalorex is and what it is used for
2. Before taking your medicine
3. How to take your medicine
4. Possible Side Effects
5. How to store your medicine
6. Further 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. Before TAKING YOUR MEDICINE
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 (cold turkey)
– Have liver failure, hepatitis or severe renal failure
– Are currently taking any medicines which contain any opioids which include certain
cough medicines, (e.g. mixtures containing dextromethorphan like Benylin), analgesic
pain killers (e.g. morphine, codeine) and some medicines used to treat diarrhoea (e.g.
kaolin).
Attempts to overcome the blockade with high doses of opioid may result in acute opioid
intoxication, which may be life threatening.
You must tell your doctor if you:
- Have any liver or kidney problems
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.
Pregnancy and Breast-feeding
If you are pregnant, think you may be pregnant, or if you are breast-feeding, tell your doctor
who will advise whether Nalorex is suitable for you.
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.
Do not stop taking Nalorex without consulting your doctor. You may need to take it for as
long as three months, or for as long as your doctor prescribes.
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.

CODICE INTERNO GRAFIMED / GRAFIMED Internal Code :

180694/13

CLIENTE / Customer :

BRISTOL

BOZZA DEL / Proof date :

25-06-2013

PRODOTTO / Product :

NALOREX 50 MG

DESCRIZIONE MATERIALE / Material description :

INSERT

DESTINAZIONE COMMERCIALE / Presentation :
MERCATO / Market :

GB

CODICE ITEM / Code :

9103A1

CODICE LAETUS / Laetus code :
FORMATO POSA STESA / Flat size :

130X280 mm

FORMATO POSA PIEGATA / Folded size :

130X38 mm

NUMERO FACCIATE / Sides number :

2

CARTA / Paper :
COLORI / Colors :

black

FORNITORE / Supplier :
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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 test before you start
treatment and at various times during treatment to monitor your liver function.
If you notice any of the following, stop taking Nalorex 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 side effects of Nalorex (affecting more than 10% of patients) are:
– Difficulty sleeping
– Anxiety or nervousness
– Abdominal cramps and pain
– Feeling sick and/or being sick
– Lack of energy
– Joint and muscle pain
– Headaches
– Fast or irregular heartbeat
Other side effects of Nalorex 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
If any of the side effects gets serious, or you notice any side effect not listed on the leaflet,
please contact your doctor.
5. How to store your medicine
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. Further 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
UK
Ireland
Bristol-Myers Squibb Pharmaceuticals Ltd.,
Bristol-Myers Squibb Pharmaceuticals Ltd.,
Uxbridge Business Park,
Swords,
Sanderson Road,
County Dublin,
Uxbridge,
Ireland
Middlesex UB8 1DH,
Tel: 1 800 749 749
England.
Tel: 0800 7311736
Manufacturer
Bristol-Myers Squibb, S.r.l.
Contrada Fontana del Ceraso
03012 Anagni (FR) - Italy
9103A1

Date of Preparation: May 2013

CODICE INTERNO GRAFIMED / GRAFIMED Internal Code :

180694/13

CLIENTE / Customer :

BRISTOL

BOZZA DEL / Proof date :

25-06-2013

PRODOTTO / Product :

NALOREX 50 MG

DESCRIZIONE MATERIALE / Material description :

INSERT

DESTINAZIONE COMMERCIALE / Presentation :
MERCATO / Market :

GB

CODICE ITEM / Code :

9103A1

CODICE LAETUS / Laetus code :
FORMATO POSA STESA / Flat size :

130X280 mm

FORMATO POSA PIEGATA / Folded size :

130X38 mm

NUMERO FACCIATE / Sides number :

2

CARTA / Paper :
COLORI / Colors :

black

FORNITORE / Supplier :
FONT - FONT SIZE / Font - Font Size :

9/9

NOTE / Notes :

X

2nd draft
Date

1st draft
Date 25-06-13

Operator Mariani

Operator

8th draft
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Operator

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Operator

9th draft
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Operator

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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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