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ADDNOK 2 MG SUBLINGUAL TABLETS

Active substance(s): BUPRENORPHINE HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Addnok 0.4, 2 and 8 mg
sublingual tablets
buprenorphine
Read all of this leaflet carefully before you start taking this
medicine.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- 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 any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or
pharmacist.
In this leaflet:
1. What Addnok is and what it is used for
2. Before you take Addnok
3. How to take Addnok
4. Possible side effects
5. How to store Addnok
6. Further information.

1. WHAT ADDNOK IS AND WHAT IT IS USED FOR
Addnok is used:
 if you are addicted to opioids, e. g. heroin or morphine, within a
framework of medical, social and psychological treatment.
The treatment is prescribed and monitored by doctors specialized
in treating drug addiction.

2. BEFORE YOU TAKE ADDNOK
Do not take Addnok if you:
 are allergic (hypersensitive) to buprenorphine or any of the other
ingredients of Addnok
 suffer from serious breathing difficulties
 suffer from a seriously reduced liver function
 suffer from alcoholism or delirium tremens.
Take special care with Addnok if you:
 have taken morphine or heroin (opioids) less than 6 hours ago,
as withdrawal symptoms can occur
 have taken methadone less than 24 hours ago, as withdrawal
symptoms can occur (if you use methadone your dose may have
to be adjusted before you take buprenorphine, see section 3)
 suffer from asthma or breathing difficulties
 suffer from reduced function of the kidneys or the liver. If you
suffer from serious liver insufficiency you must not take
buprenorphine
 suffer from low bloodpressure
 have difficulty passing urine (because of an enlarged prostate
gland or urethral stricture)
 suffer from a head injury and have an increased intracranial
pressure.
Observe that Addnok may:
cause dependence
cause a positive reaction to "anti doping tests"
cause your blood pressure to drop suddenly, causing you to feel
dizzy and unwell if you get up too quickly from sitting or lying down
 mask other diseases where pain is a symptom since
buprenorphine has a pain relieving effect.




Taking other medicines
Buprenorphine may influence the efffect of other medicines and
other medicines may influence the effect of buprenorphine.
It is therefore important you tell your doctor if you use any of the
following medicines:
 medicine used in the treatment of anxiety and disquiet and
sleeping difficulties (benzodiazepines and anxiolytics other
than benzodiazepines)
 medicine used in the treatment of skin infection in the scalp
(ketoconazole, itraconazole)
 medicine used in the treatment of certain infections (rifampicin)
 medicine used in the treatment of HIV (ritonavir, indinavir,
nelfinavir)
 some types of medicine used in the treatment of allergy
 some types of medicine used in the treatment of depression
 medicine used in the treatment of migraine, hot flushes and
abstinences as a result of medicine abuse (clonidine)
 cough medicine (dextromethorphan, noscapine)
 painkillers (morphine and morphine-like substances)
 medicine containing alcohol
 medicine used in the treatment of epilepsy (phenobarbital,
phenytoin, carbamazepine)
 medicine used in the treatment of psychosis (neuroleptics)
 medicine used as sedatives and to relieve convulsions
(barbiturates).
Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines, including medicines obtained
without a prescription.
Taking Addnok with food and drink
You can take Addnok independently of a meal.
Alcohol
Do not drink alcohol when you are treated with Addnok since
alcohol will increase the sedative effect of buprenorphine.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any
medicine.
Pregnancy
You should not use buprenorphine during your pregnancy. But if
your doctor finds it appropriate an exception can be made for the
first 3 months of your pregnancy.
Breast-feeding
Do not take buprenorphine if you are breast-feeding.
Driving and using machines
Addnok can be sedating, cause fainting and dizziness, and
therefore it can reduce the ability to drive and use machines.
Do not drive or use machines if you feel dizzy or drowsy. This
usually occurs at the beginning of treatment and when the dose is
increased.
Important information about some of the ingredients of
Addnok
Addnok contains lactose.
If you have been told by your doctor that you have an intolerance
to some sugars, contact your doctor before taking this medicinal
product

3. HOW TO TAKE ADDNOK
Always take Addnok exactly as your doctor has told you. You
should check with your doctor or pharmacist if you are not sure.

This is the way you take Addnok
A sublingual tablet is a tablet that is taken under your tongue. Keep
the tablet dose under your tongue until it dissolves - normally it
takes 5-10 minutes. Do not swallow, crush or chew the tablet.
Usual dose if you are/have:
Adults or elderly:
Your initial dose will be between 0.8 to 4 mg (one tablet once daily).
Your doctor will increase your dose according to your response to
the treatment until you have a stable dose, 16 mg daily is often
sufficient. The maximum daily dose is 24 mg. Your doctor will then
individually determine the length of your treatment and gradually
reduce your dose. Do not change the treatment in any way or stop
treatment without the agreement of the doctor who is treating you.
Children and adolescents (younger than 18 years):
Children and adolescents under the age of 18 must not use
Addnok.
Reduced kidney or liver function:
If you have problems with your kidneys or liver your dose may have
to be reduced. Talk to your doctor. If you suffer from serious liver
insufficiency you must not take buprenorphine.
Concomitant methadone treatment
Your dose of methadone has to be reduced to a maximum of 30 mg
daily before starting treatment with Addnok. Contact your doctor if
you experience withdrawal symptoms (sweating, disquiet or
restlessness).
If you take more Addnok than you should
In case of overdose of buprenorphine, you must go or be taken
immediately to an emergency centre or hospital for treatment.
Symptoms of an overdose is breathing difficulties, slowly breathing
or heart symptoms.
Toxic poisoning has been observed after misuse (overdose or
wrong administration) and in worst case it can result in stop of
breathing/heart failure and/or liver damage.
If you forget to take Addnok
Do not take a double dose to make up for a forgotten dose.
If you stop taking Addnok
Do not stop the treatment yourself, but ask your doctor how to end
the treatment. A sudden interruption can cause withdrawal
symptoms (sweating, disquiet and restlessness).
If you have any further questions on the use of this product, ask
your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Addnok can cause side effects, although not
everybody gets them.
You should stop taking Addnok and see your doctor
immediately if you experience symptoms of angioneurotic
oedema, such as:
 swollen face, tongue or pharynx
 difficulty to swallow
 hives and difficulties to breath
Addiction to Addnok
Please observe that Addnok may cause dependence.
Common side effects (occuring in more than 1 but less than 10 in
100 patients):
Headache, fainting, dizziness, obstipation, nausea, vomiting,
insomnia, drowsiness, feeling of weakness, drop in blood pressure
on changing position from sitting or lying down to standing, sweating.

In long term use of buprenorphine, the common undesirable
effects diminish successively. However constipation and sweating
often remain.
Rare side effects (occurring in more than 1 but less than 10 in
10,000 patients):
Hallucinations, respiratory depression, bronchial spasm, damage
of the liver, hepatitis, anafylatic shock, angioneurotic oedema,
urine retention.
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or
pharmacist

5. HOW TO STORE ADDNOK
Keep out of the reach and sight of children.
Do not use Addnok after the expiry date which is stated on the
carton and on the blister after Exp. The expiry date refers to the
last day of that month.
Does not require any special storage conditions.
Medicines should not be disposed of via wastewater or household
waste. Ask your pharmacist how to dispose of medicines no longer
required. These measures will help to protect the environment.

6. FURTHER INFORMATION
What Addnok contains
The active substance is buprenorphine as buprenorphine
hydrochloride. Each sublingual tablet contains 0.4 mg, 2 mg and 8
mg buprenorphine respectively.
The other ingredients are lactose monohydrate, mannitol (E421),
maize starch, citric acid (E330), sodium citrate (E331), povidone
(E1201), magnesium stearate (E470b).
The 0.4 mg sublingual tablets also contain: Talc (E553b) and
colloidal anhydrous silica.
What Addnok looks like and contents of the pack
Addnok 0.4 mg is a round, biconvex and white sublingual tablet.
Addnok 2 mg is an oval, biconvex and white sublingual tablet with
"2" embossed on one side.
Addnok 8 mg is an oval, biconvex and white sublingual tablet with
"8" embossed on one side.
Addnok is packed in blister packs of 7, 14 and 28 sublingual
tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder
Activase Pharmaceuticals Ltd., 11 Boumpoulinas St.,
1060 Nicosia, Cyprus
Manufacturer
Basic Pharma Manufacturing B.V., Burgemeester Lemmensstraat
352, 6163 JT Geleen, The Netherlands
DDSA Pharmaceuticals Ltd, 310 Old Brompton Road,
London SW5 9JQ, UK
L. Molteni & C. dei F.lli Alitti Società di Esercizio S.p.A.
Strada Statale 67, Fraz. Granatieri, 50018 Scandicci (Firenze),
Italy
This medicinal product is authorised in the Member States of
the EEA under the following names:
< To be completed nationally >
This leaflet was last approved in 03 June 2010.

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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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