Skip to Content

The originating document has been archived. We cannot confirm the completeness, accuracy and currency of the content.

METHADONE MARTINDALE PHARMA 2MG/ML ORAL SOLUTION

PDF options:  View Fullscreen   Download PDF

PDF Transcript

PACKAGE LEAFLET: INFORMATION FOR THE USER

Methadone Martindale Pharma®
2 mg/ml oral solution
methadone hydrochloride

D0269600000

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.
In this leaflet:
1. What Methadone is and what it is used for
2. Before you take Methadone
3. How to take Methadone
4. Possible side effects
5. How to store Methadone
6. Content of the pack and other information
This leaflet contains a summary of the information available
for this medicine. You should ask your doctor or pharmacist if
you are unsure about any aspect of this medicine.

1. What Methadone is and what it is used for
Methadone is a synthetic opiate (a morphine-like drug) used
to treat opiate dependent patients. The treatment should
be given at the same time as medical and psychological
treatment and social rehabilitation.

2. What you need to know before you take
Methadone
Do not take Methadone:
• if you are allergic (hypersensitive) to methadone
hydrochloride or any of the other ingredients of this
medicine (listed in section 6 of this leaflet)
• if you use or have used monoamine oxidase inhibitors
(MAOI’s) within the last two weeks (medicinal products used
in the treatment of depression, Parkinson’s disease)
• if you suffer difficulty breathing
Methadone must NOT be given to children
Take special care with Methadone
Warning and precautions
Talk to your doctor before taking methadone if:
• you have acute asthma attacks
• you are suffering from lung disease or breathing difficulties
• you have liver or kidney problems (including kidney calculi
and gallstones)
• you suffer from heart problems
• you have an under-active thyroid gland or skin and tissues
disorders
• you have an enlarged prostate gland or narrowed urethra
• you have suffered a head injury and the pressure inside
your brain is higher than it should be (check this with your
doctor). You might be getting bad headaches
• you are being treated for drug addiction or opioid overdose
• you have difficulty in passing urine
• you have abdominal pain, diarrhoea or constipation
• you have low oxygen level or high carbon dioxide level in
the blood
• you are taking other opioid type (painkiller) drugs such as
morphine and pentazocine
• you are taking medicines that relax you and help you to
sleep (barbiturates and benzodiazepines)
If any of the conditions above apply to you, please consult your
doctor.
Methadone may affect the electrical signals which control your
heart contractions, particularly at high doses. Tell your doctor if
you have a history of heart problems.
Children
Children are more sensitive to methadone than adults,
that is why poisoning may occur at very low doses. To avoid
unintentional intake of methadone by children when it is taken
home, keep it in a safe place where children cannot reach it.
Other medicines and Methadone
Please tell your doctor or pharmacist if you are taking, have
recently taken or might use any other medicines, including
medicines obtained without a prescription.
Tell your doctor if you are taking any of the following:
• any medicines that have an effect on your mental state
(e.g. thioridazine, phentiazines, haloperidol and sertindole)

• medicines used to treat heart diseases (verapamil, quinidine)
• medicines used to treat depression known as monoamine
oxidase inhibitors (MAOI’s), particularly if you have taken
them within the last two weeks. Also tell your doctor if you
use other medicines to treat depression (e.g. imipramine,
desipramine, nefazodone, fluoxetine, fluvoxamine,
paroxetine and sertraline)
• anti-inflammatory and immunosuppressants (e.g.
dexamethasone and cyclosporine)
• antiviral drugs including some medicines used to treat HIV
e.g. nevirapine, zidovudine, efavirenz, nelfinavir, ritonavir,
abacavir, didanosine and stavudine
• macrolide antibiotics (medicines used to treat bacterial
infections) such as clarithromycin, telithromycin and
erythromycin
• cimetidine (a medicine used to treat stomach ulcers)
• antifungals (medicines used to treat fungal infections) such
as ketoconazole, itraconazole and fluconazole
• naloxone (a medicine used to treat difficulties with breathing)
• medicines used to treat addiction e.g. naltrexone and
buprenorphine
• rifampicin (a medicine used to treat tuberculosis or ‘TB’)
• drugs used to treat epilepsy (e.g. phenytoin, phenobarbital
and carbamazepine)
• vitamin tablets (containing vitamin C )
• medicines used to treat diarrhoea (loperamide, diphenoxylate)
• medicines that make urine more acidic e.g. ammonium
chloride
• diuretic medicines (spironolactone)
• medicines that make you feel sleepy
• herbal medicines containing St John´s Wort
Other medicines you may be taking can also affect the heart
(e.g. sotalol, amiodarone and flecainide).
You must tell your doctor about any other medicines that you
are taking as they may be dangerous if they are taken with
methadone. In these situations your doctor may decide that it
is necessary to monitor your heart with an electrocardiogram
(ECG) at the start of treatment to ensure that these effects do
not occur. Methadone can also affect some blood and urine
tests. Please tell your doctor if you are taking methadone
before any test is performed.
Methadone with food, drink and alcohol
You must not drink alcohol whilst you are taking Methadone
as this could cause serious side effects. Do not drink grapefruit
juice while you are taking Methadone, as it may alter the
effect of the medicinal product.
Pregnancy and breast-feeding
Methadone should not be taken during labour. If you are
pregnant or breast-feeding, think you may be pregnant or are
planning to have a baby, ask your doctor for advice before
taking this medicine.
Driving and using machines
Methadone affects the coordination of brain and body
movement so ability to drive or use machinery may be severely
affected until your medication has been stabilised at a certain
dose level. You should therefore not drive or use machinery
during the initial period of treatment. The time period before
you are capable of driving or use machinery varies from person
to person, and should be decided together with the doctor.
The medicine can affect your ability to drive as it may make you
sleepy or dizzy.
• Do not drive while taking this medicine until you know how
it affects you.
• It is an offence to drive if this medicine affects your ability to
drive.
• However, you would not be committing an offence if:
•  he medicine has been prescribed to treat a medical or
T
dental problem and
•  ou have taken it according to the instructions given by
Y
the prescriber or in the information provided with the
medicine and
• It was not affecting your ability to drive safely

Talk to your doctor or pharmacist if you are not sure whether it
is safe for you to drive while taking this medicine.
Important information about some of the ingredients of
Methadone
Methadone contains Sunset Yellow (E110), which may
cause allergic reactions and blood orange flavour (including
propylene glycol) which may cause alcohol-like symptoms.

may cause serious and permanent damage to your body with
possibly fatal consequences.
Your doctor will tell you how much Methadone you need to
take, and how often you need to take it. It is important that
you do not take more than the dose agreed with your doctor.
Adults:
The recommended dose is 10-30 mg a day. The dose will be
slowly increased until you show no signs of withdrawal or
intoxication. The usual dose is 60-120 mg/day. Your doctor will
decide what dose you need and when to reduce the dose.
Elderly or ill:
Caution must be exercised if you are elderly, ill or have liver or
kidney problems.
Use in Children:
Methadone must NOT be given to children. There is a serious
risk of poisoning. Remember to keep this medicine safely
where children cannot get it.
If you take more Methadone than you should
If you take too much Methadone, you may 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
During a course of treatment it is important that, should you
miss a dose, you take the dose as soon as you remember.
However, if it is almost time for you to take your next dose, miss
the dose and wait until the next scheduled dose. DO NOT TAKE
A DOUBLE DOSE TO MAKE UP FOR A FORGOTTEN DOSE.

4. Possible side effects
Like all medicines, Methadone can cause side effects, although
not everybody gets them.
Side effects which may occur include:
Very common
side effects:
These may affect
more than 1 in 10
people treated
with Methadone

• feeling sick or being sick

Common side
effects: These
may affect up to
1 in 100 people
treated with
Methadone

• weight increase
• water retention
• constipation
• feeling high (euphoria)
• seeing or hearing things that are not
real (hallucinations)
• feeling of dizziness or spinning
• blurred vision
• pin point pupils
• feeling sleepy
• skin rash
• sweating
• feeling tired

Uncommon side
effects:
These may affect
up to 1 in 1000
people treated
with Methadone

Rare side effects:
These may affect
up to 1 in 10,000
people treated
with Methadone

• heart problems
• slower heart beat
• feeling your heart beat (palpitations)

Unknown side
effects:
Frequency of
these side effects
is not known yet.

• deficiency of potassium or
magnesium in blood
• lower levels of platelets in blood

If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this leaflet.

5. How to store Methadone
Keep out of the reach and sight of children.
Keep the bottle in the outer carton in order to protect from light.
Dispose of this medicine one month after first opening.
Do not use this medicine after the expiry date which is stated
on the label. This will have been checked by your pharmacist
or doctor. If you have a product that has passed the given
expiry date, return it to your pharmacist or doctor for safe
disposal.

6. Contents of the pack and other information
What Methadone contains
The active substance is methadone hydrochloride. Each 1ml of
solution contains 2 mg methadone hydrochloride.
The other ingredients are sodium benzoate (E211), sodium
cyclamate, saccharin sodium, povidone, Sunset Yellow
(E110), blood orange flavouring (including propylene glycol),
hydrochloric acid and purified water.
What Methadone looks like and contents of the pack
Methadone is a clear yellow to orange solution with a scent
of orange supplied in a brown glass bottle in cardboard
carton. Each pack contains 5, 10, 15, 20, 25, 30, 35, 40, 45,
50, 55, 60, 65, 70, 75 or 500 ml of the liquid. It is supplied in
packs containing one bottle as a unit pack or in multipacks
comprising 7 or 24 packs, each containing 1 bottle. Not all
pack sizes may be marketed.
Marketing Authorisation Holder:
Martindale Pharmaceuticals Ltd.
Bampton Road, Harold Hill
Romford, RM3 8UG
United Kingdom.
Manufacturer:
Macarthys Laboratories Ltd. T/A Martindale Pharmaceuticals
Bampton Road, Harold Hill
Romford, RM3 8UG
United Kingdom
This leaflet was last revised in January 2014
Product licence number:
PL 00156/0316

• loss of appetite
• breathing difficulty (including with
cough)
• dry mouth
• inflammation of tongue
• feeling down (dysphoria)
• agitation
• difficulty sleeping
• confusion
• reduction of sex drive
• headache
• fainting
• low blood pressure
• itching
• hives
• rash
• swelling of legs
• weakness
• water retention
• bile duct spasm (abdominal pain)
• facial flush
• difficulty in passing urine
• difficulty achieving or maintaining an
erection
• disturbances in menstruation

3. How to take Methadone
Always take Methadone exactly as your doctor has told you.
You should check with your doctor or pharmacist if you are
not sure.
You must only take Methadone by mouth. Under no
circumstances should you inject this product as injection
Continued overleaf

D0269600000

2696-D

100mm Measurement Verification Bar

DEVELOPMENT ARTWORK
Component Code: D02696
Paper size: 170 x 296mm
Version Control Date

By

Version A Created 15/01/14 HM
Version B

31/03/14 HM

Version C

02/04/14 HM

Version D

03/04/14 HM

Version E
Version F
Version G
Version H
Version I
Version J
Version K
Version L
Version M
Version N
Grand Fromage Creative Ltd
Amherst House, 22 London Road
Sevenoaks, Kent TN13 2BT
t:+44 (0)1732 456 187
e:alan@grand-fromage.co.uk
www.grand-fromage.co.uk

+ 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.

Hide