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METHADONE HYDROCHLORIDE SUGAR FREE 1 MG/ML ORAL SOLUTION

Active substance(s): METHADONE HYDROCHLORIDE / METHADONE HYDROCHLORIDE / METHADONE HYDROCHLORIDE

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METHADONE TEVA
1 mg/ml ORAL SOLUTION

Last amend:

IN THIS LEAFLET:

1. What Methadone Teva 1 mg/ml Oral
solution is and what it is used for
2. Before you take Methadone Teva
1 mg/ml Oral solution
3. How to take Methadone Teva
1 mg/ml Oral solution
4. Possible side effects
5. How to store Methadone Teva
1 mg/ml Oral solution
6. Further information

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WHAT METHADONE TEVA
1 mg/ml ORAL SOLUTION IS
AND WHAT IT IS USED FOR
This medicine contains methadone
hydrochloride, which belongs to a
group of medicines called narcotic
analgesics. It is used to treat opioid
drug addiction.

BEFORE YOU TAKE
METHADONE TEVA
1 mg/ml ORAL SOLUTION
Do NOT take Methadone Teva 1 mg/ml
Oral solution
Do not take this medicine and tell your
doctor if
• you are allergic (hypersensitive) to
methadone or any other ingredients
in this liquid (see section 6 below).
An allergic reaction can include a
rash, itching or shortness of breath.
• you have severe breathing problems.
• you are taking monoamine oxidase
inhibitors (MAOIs) used to treat
depression or if you have taken a
MAOI medicine in the past two
weeks (see ‘Taking other medicines’).
• you are not dependent on opioid
drugs.
• you are in labour.
This medicine is not suitable for
children.
Do not take this medicine if any of the
above apply to you. If you are not sure,
talk to your doctor before taking
Methadone Teva 1 mg/ml Oral solution.
Take special care with Methadone Teva
1 mg/ml Oral solution
Before you take this medicine, tell your
doctor if:
• you have liver or kidney problems.
• you have epilepsy.
• you are addicted to alcohol.
• you have or have recently had a
head injury.
• you have low thyroid function
(hypothyroid).
• you have problems with your
adrenal glands. These are linked to
your kidneys.
• you have an enlarged prostate gland.
• you have low blood pressure.
• you are in shock.
• you have a muscle weakness disease
called myasthenia gravis.
• you have bowel problems.
• you have a history of irregular heart
beat.
• you have a history of heart disease.
• you have a family history of people
dying suddenly without cause.
• you have low potassium, sodium or
magnesium levels.
• you are pregnant or breast-feeding.
• you are extremely ill or an older
person. You may be more sensitive
to the medicine.
If you are not sure if any of the above
apply to you, talk to your doctor or
pharmacist before taking Methadone
Teva 1 mg/ml Oral solution.

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Leaflet

26-3-13
KA

x
27915

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 get serious,
or if you notice any side effects not
listed in this leaflet, please tell your
doctor or pharmacist.

Signed

• Subject to Reg. Agency approval
• Approved by Reg. Dept. for print

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Signed

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Methadone Teva 1mg/ml Oral
Sol. All (bottle) TEI V2 (Opava)

PRODUCT:

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PACKAGE LEAFLET:
INFORMATION FOR THE USER

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Methadone hydrochloride

You should not use this medicine
during an asthma attack. If you give
this medicine to yourself
(self-administration), wait until the
asthma attack has passed and you are
fully recovered.
Taking other medicines
Please tell your doctor or pharmacist if
you are taking or have recently taken
any other medicines, including
medicines bought without a
prescription, and herbal medicines.
This is because Methadone Teva
1 mg/ml Oral solution can affect the
way some other medicines work. Also
some medicines can affect the way it
works.
You must not take Methadone Teva
1 mg/ml Oral solution:
• at the same time or within 2 weeks
of taking monoamine oxidase
inhibitors (MAOIs).
Some medicines can increase the risk
of heart problems when used with
methadone. Talk to your doctor before
taking methadone if you are taking:
• medicines for heart problems such
as verapamil and enalapril.
• medicines which affect electrolyte
balance such as diuretics (water
tablets) or lithium.
Tell your doctor if you are taking any of
the following medicines:
• medicines that dull your senses such
as medicine for depression (for
example, fluvoxamine, fluoxetine),
medicines to help you sleep
(including anaesthetics) and
medicines to calm you down called
tranquillisers.
• cimetidine, used to treat stomach
ulcers.
• rifampicin, used to treat tuberculosis
(TB).
• medicines used to treat epilepsy
such as phenytoin, carbamazepine,
phenobarbital and primidone.
• medicines that make your urine
acidic such as ascorbic acid
(vitamin C).
• narcotic painkillers such as codeine
and pentazocine.
• naloxone used to reverse the effects
of opioid drugs.
• medicines used to stop opioid drugs
working such as naltrexone and
buprenorphine.
• medicines used to treat HIV such as
nevirapine, efavirenz and nelfinavir.
The doctor may have to change the
amount of methadone you take
whilst on these medicines.
• antibiotics such as ciprofloxacin or
macrolide antibiotics for example
erythromycin.
• medicines used to treat fungal
infections such as ketoconazole or
fluconazole.
• St. John’s Wort - a herbal
preparation for depression.
If any of the above apply to you, talk to
your doctor before taking Methadone
Teva 1 mg/ml Oral solution.
Taking Methadone Teva 1 mg/ml Oral
solution with food and drink
Do not drink alcohol whilst taking
Methadone Teva 1 mg/ml Oral solution.
This is because Methadone Teva
1 mg/ml Oral solution can make you
feel sleepy and drinking alcohol will
make you even more sleepy.
Pregnancy and breast-feeding
• Talk to your doctor before taking
Methadone Teva 1 mg/ml Oral
solution if you are pregnant or likely
to become pregnant.
• Take care if you are taking a
pregnancy test as the methadone
may interfere with the results.
• You should not take this medicine
whilst you are in labour.
• Breast-feeding is possible if you are
taking 20 mg a day or less of
Methadone Teva 1 mg/ml Oral
solution. Talk to your doctor before
starting breast-feeding.
Ask your doctor or pharmacist for
advice before taking any medicine.
Driving and using machines
Methadone Teva 1 mg/ml Oral solution
will severely affect your ability to drive
or use machines, whilst taking it and
afterwards. You should only start doing
these activities again with the
permission of your doctor.
Important information about some of
the ingredients of Methadone Teva
1 mg/ml Oral solution
This medicine contains:

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HOW TO TAKE METHADONE
TEVA 1 mg/ml ORAL
SOLUTION

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POSSIBLE SIDE EFFECTS
Like all medicines, Methadone Teva
1 mg/ml Oral solution can cause side
effects, although not everybody gets
them.
Stop taking this medicine and see a
doctor straight away if you have any of
the following:
• Heart problems. The signs of this
may include changes in the way your
heart beats, such as it beating faster
or missed heart beats, breathing
difficulties and dizziness if your
breathing becomes slow and
shallow. These side effects are rare
and may affect 1 to 10 users in
10,000.
Other possible side effects include:
Very common (these side effects may
affect more than 1 user in 10 patients):
• Feeling or being sick.
Common (these side effects may affect
1 to 10 users in 100):
• Weight increase.
• Water retention.
• Constipation.
• Feeling high (euphoria), seeing or
hearing things that are not real
(hallucinations), feeling sleepy.
• Feeling of dizziness or spinning.
• Blurred vision, pin point pupils.
• Skin rash, sweating.
• Feeling tired.
Uncommon (these side effects may
affect 1 to 10 users in 1,000):
• Loss of appetite.
• Breathing difficulty (including with
cough).

HOW TO STORE METHADONE
TEVA 1 mg/ml ORAL
SOLUTION
Keep out of the reach and sight of
children.
Do not use Methadone Teva 1 mg/ml
Oral solution after the expiry date
which is stated on the bottle and carton
after ‘EXP’. The expiry date refers to the
last day of that month.
Keep the bottle tightly closed.
Use within 50 days after opening.
Do not freeze
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.

FURTHER INFORMATION
What Methadone Teva 1 mg/ml Oral
solution contains
• The active ingredient is methadone
hydrochloride. Each millilitre of
solution contains 1 mg methadone
hydrochloride.
• The other ingredients are methyl
parahydroxybenzoate (E218), propyl
parahydroxybenzoate (E216),
propylene glycol (E1520), maltitol
liquid (E965), caramel colour (E150d),
patent blue 85 (E131) and purified
water.
What Methadone Teva 1 mg/ml Oral
solution looks like and contents of the
pack
• Methadone Teva 1 mg/ml Oral
solution is a clear green liquid.
• It is available in bottles of 30, 50, 100
and 500 ml. Not all bottle sizes may
be marketed.
• Brown precipitate may appear in the
bottle that does not affect quality of
the product. The precipitate
dissolves after shaking of the bottle.
Marketing Authorisation Holder
Teva Pharma B.V.
Computerweg 10
3542 DR Utrecht
The Netherlands
Manufacturer
TEVA UK Ltd, Brampton Road,
Hampden Park, Eastbourne, East
Sussex, BN22 9AG, England
TEVA Pharmaceutical Works Private
Limited Company, Pallagi út 13, 4042
Debrecen, Hungary
TEVA Czech Industries s.r.o., Ostravská
29, č.p. 305, 747 70 Opava –Komárov,
Czech Republic
This medicinal product is authorised in
the Member States under the following
names:
Ireland
Methadone Teva
1 mg/ml Oral
solution
Netherlands
Methadone HCl
1mg/ml Teva, drank
suikervrij
United Kingdom Methadone
Hydrochloride sugar
Free 1 mg/ml Oral
solution
This leaflet was last revised in March
2013

H27915

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Always take Methadone Teva 1 mg/ml
Oral solution exactly as your doctor has
told you. You should check with your
doctor or pharmacist if you are not
sure.
Take this medicine by mouth.
Adults
The starting dose is 10 mg to 20 mg
(10 ml to 20 ml) each day.
The doctor can increase this to 60 mg
to 100 mg (60 ml to 100 ml) each day.
Older people and very ill people
If you have to have repeated doses of
this medicine, the doctor may want to
monitor you more closely.
Children
This medicine is not suitable for
children.
If you take more Methadone Teva 1
mg/ml Oral solution than you should
If you take too much Methadone Teva
1 mg/ml Oral solution, you can
experience the following:
• difficulty breathing
• extreme sleepiness, fainting or coma
• pin-point pupils
• muscle weakness
• cold and clammy skin
• slow heartbeat, low blood pressure,
heart attack or shock
• in severe cases death may occur.
In the event of overdose you should
seek medical assistance immediately
even if you feel well as you may be
suffering from methadone poisoning.
If you forget to take Methadone Teva
1 mg/ml Oral solution
If you forget a dose do not take it. Wait
until the next dose is due and take only
that amount. Do not take a double dose
to make up for a forgotten dose.
If you stop taking Methadone Teva
1 mg/ml Oral solution
Do not stop taking this medicine unless
your doctor tells you to as you may
suffer withdrawal effects. Your doctor
will tell you how to lower the dose
gradually.
If you have any further questions on
the use of this product, ask your doctor
or pharmacist.

• Dry mouth, inflammation of the
tongue.
• Feeling down (dysphoria), agitation,
confusion, difficulty sleeping.
• Reduction of sex drive.
• Headache.
• Fainting, low blood pressure,
swelling of the legs, facial flush.
• Itching, hives, rash.
• Weakness.
• Urine retention, difficulty in passing
urine.
• Bile duct spasm (abdominal pain)
• Difficulty achieving or maintaining
an erection.
• Disturbances of menstruation.
Blood potassium or magnesium
deficiency or lower levels of platelets in
blood may also occur, although the
frequency of these side effects is not
known.
If any of the side effects get serious, or
if you notice any side effects not listed
in this leaflet, please tell your doctor.

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• Methyl and propyl
parahydroxybenzoates, which may
cause an allergic reaction. This
allergy may happen some time after
starting the medicine
• Liquid maltitol. If you have been told
by your doctor that your have an
intolerance to some sugars, contact
your doctor before taking this
medicinal product.

Expand Transcript

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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