Skip to Content

METHADONE HYDROCHLORIDE SUGAR FREE 1 MG/ML ORAL SOLUTION

Active substance(s): METHADONE HYDROCHLORIDE

View full screen / Print PDF » Download PDF ⇩
Transcript
METHADONE HYDROCHLORIDE
SUGAR FREE 1 mg/ml
ORAL SOLUTION
PACKAGE LEAFLET: INFORMATION
FOR THE USER

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

1 WHAT METHADONE

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 Hydrochloride 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
Hydrochloride 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.



METHADONE HYDROCHLORIDE
SUGAR FREE 1 mg/ml ORAL

SOLUTION

420

Do NOT take Methadone Hydrochloride
1 mg/ml Oral Solution

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 Hydrochloride 1 mg/ml Oral
Solution.

BAR CODE

Take special care with Methadone
Hydrochloride 1 mg/ml Oral Solution
Before you take this medicine, tell your
doctor if you:
• have liver or kidney problems
• have epilepsy
• are addicted to alcohol
• have or have recently had a head
injury
• have low thyroid function
(hypothyroid)
• have problems with your adrenal
glands. These are linked to your
kidneys
• have an enlarged prostate gland
• have low blood pressure
• are in shock
• have a muscle weakness disease
called myasthenia gravis
• have bowel problems
• have a history of irregular heart beat
• have a history of heart disease
• have a family history of people dying
suddenly without cause
• have low potassium, sodium or
magnesium levels
• are pregnant or breast-feeding
• are extremely ill or an older person.
You may be more sensitive to the
medicine.










Common (these side effects may affect
1 to 10 users in 100):
• Weight increase
• Water retention
Important information about some of
• Constipation
the ingredients of Methadone
• Feeling high (euphoria), seeing or
Hydrochloride 1 mg/ml Oral Solution
hearing things that are not real
(hallucinations), feeling sleepy
This medicine contains:
• Feeling of dizziness or spinning
• Methyl and propyl
• Blurred vision, pin point pupils
parahydroxybenzoates, which may
cause an allergic reaction. This allergy • Skin rash, sweating
may happen some time after starting • Feeling tired.
the medicine
• Liquid maltitol. If you have been told Uncommon (these side effects may
affect 1 to 10 users in 1,000):
by your doctor that you have an
• Loss of appetite
intolerance to some sugars, contact
• Breathing difficulty (including with
your doctor before taking this
cough)
medicinal product.
• Dry mouth, inflammation of the
tongue
3 HOW TO TAKE METHADONE
HYDROCHLORIDE SUGAR FREE • Feeling down (dysphoria), agitation,
confusion, difficulty sleeping
1 mg/ml ORAL SOLUTION
• Reduction of sex drive
• Headache
Always take Methadone Hydrochloride
• Fainting, low blood pressure, swelling
1 mg/ml Oral Solution exactly as your
of the legs, facial flush
doctor has told you. You should check
• Itching, hives, rash
with your doctor or pharmacist if you
• Weakness.
are not sure.
• Urine retention, difficulty in passing
urine
Take this medicine by mouth.
• Bile duct spasm (abdominal pain)
• Difficulty achieving or maintaining an
Adults
erection
The starting dose is 10 mg to 20 mg
• Disturbances of menstruation.
(10 ml to 20 ml) each day.
The doctor can increase this to 60 mg to
Blood potassium or magnesium
100 mg (60 ml to 100 ml) each day.
deficiency or lower levels of platelets in
blood may also occur, although the
Older people and very ill people
frequency of these side effects is not
If you have to have repeated doses of
known.
this medicine, the doctor may want to
monitor you more closely.
If any of the side effects get serious, or if
you notice any side effects not listed in
Children
this leaflet, please tell your doctor.
This medicine is not suitable for
children.

If you forget to take Methadone
Hydrochloride 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
Hydrochloride 1 mg/ml Oral Solution

Taking Methadone Hydrochloride
1 mg/ml Oral Solution with food and
drink

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.

Do not drink alcohol whilst taking
Methadone Hydrochloride 1 mg/ml Oral
Solution. This is because Methadone
Hydrochloride 1 mg/ml Oral Solution
can make you feel sleepy and drinking
alcohol will make you even more sleepy.

5 HOW TO STORE METHADONE

HYDROCHLORIDE SUGAR FREE
1 mg/ml ORAL SOLUTION

• Keep out of the reach and sight of
children.
• Do not use Methadone Hydrochloride
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.

6 FURTHER INFORMATION
What Methadone Hydrochloride
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.

If you have any further questions on the What Methadone Hydrochloride
1 mg/ml Oral Solution looks like and
use of this product, ask your doctor or
contents of the pack
pharmacist.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for
advice before taking any medicine.

Very common (these side effects may
affect more than 1 user in 10 patients):
• Feeling or being sick.

If you take too much Methadone
Hydrochloride 1 mg/ml Oral Solution,
you can experience the following:
• difficulty breathing
• extreme sleepiness, fainting or coma
• pinpoint 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 any of the above apply to you, talk to
your doctor before taking Methadone
Hydrochloride 1 mg/ml Oral Solution.

• Talk to your doctor before taking
Methadone Hydrochloride 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 Hydrochloride 1 mg/ml
Oral Solution. Talk to your doctor
before starting breast-feeding.

Methadone Hydrochloride 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.

4 POSSIBLE SIDE EFFECTS
Like all medicines, Methadone
Hydrochloride 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.

• Methadone Hydrochloride 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.
Marketing Authorisation Holder:
Teva UK Limited, Eastbourne,
BN22 9AG.
Manufacturer:
TEVA Czech Industries s.r.o, Ostravská,
č.p. 305, 747 70 Opava-Komárov.
This leaflet was last revised in May 2011
PL 00289/1343
13278-A

BAR CODE

This medicine is not suitable for
children.



Other possible side effects include:

If you take more Methadone
Hydrochloride 1 mg/ml Oral Solution
than you should

BAR CODE

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.



BAR CODE

2 BEFORE YOU TAKE

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.

BAR CODE

This medicine contains methadone
hydrochloride, which belongs to a group
of medicines called narcotic analgesics.
It is used to treat opioid drug addiction.

420

BAR CODE

HYDROCHLORIDE SUGAR FREE
Tell your doctor if you are taking any of
1 mg/ml ORAL SOLUTION IS
the following medicines:
AND WHAT IT IS USED FOR
• medicines that dull your senses such

Driving and using machines

BAR CODE

IN THIS LEAFLET:

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.

BAR CODE

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.

If you are not sure if any of the above
apply to you, talk to your doctor or
pharmacist before taking Methadone
Hydrochloride 1 mg/ml Oral Solution.

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.

Hide