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METHADONE 1MG/ML ORAL SOLUTION BP-SUGAR FREE

Active substance(s): METHADONE HYDROCHLORIDE

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PATIENT INFORMATION LEAFLET

Methadone 1mg/ml Oral Solution B.P. Sugar Free
(Methadone Hydrochloride 1mg/ml)

Dimensions

210mm x 297mm flat (105mm x 148mm folded)

Proof No.

1

Date

29.02.2016

Times New Roman

Talk to your doctor or pharmacist if you are not sure whether it is safe
for you to drive while taking this medicine.

Turn over

22908108

29.02.2016
Date

1

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:
◦ The medicine has been prescribed to treat a medical or dental
problem and
◦ You have taken it according to the instructions given by the
prescriber or in the information provided with the medicine and
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◦ It was not affecting your ability to drive safely.

210mm x 297mm flat (105mm x 148mm folded)

This medicine may make you drowsy. If affected do not drive or
operate machinery. People are affected differently so your doctor will
advise you when it is safe to drive again.

Dimensions

Driving and using machinery

Proof No.

Children should not take this medicine as they may be at greater risk
from its effects.

22908108

• Heart disease or other heart problems such as angina.
• Liver disease, including Hepatitis C.
• Kidney disease.
• Problems with your thyroid gland.
• Enlargement of your prostate gland.
• Hormonal problems.
• A family history of sudden death.
• Low levels of potassium or magnesium in your blood.

Asthma.
MHRA
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• Or if you are elderly, or extremely ill, as these people can react
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1mg/ml Oral Solution B.P.
Product
differently to Methadone
this medicine.
Title
Sugar
Free
• Epilepsy.
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• Low blood pressure.
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• Component
Shock.
• Pack
Problems
your adrenal glands.
Size with500ml
• Bowel problems.
Code
22908108
• IGMuscle
weakness
problems called myasthenia gravis.

Use by children (Age 12 and below)

IG Code

Talk to your doctor or pharmacist if you have any of the
following:

When pregnant it is especially important that you follow the instruction
for treatment given by your doctor or clinic. Do not use this medicine
whilst in labour. Talk to your doctor before breast feeding.

Keyline (non-printing)

Children must not be given this medicine.

Pregnancy and breast feeding

500ml

• Are also taking heroin and/or other illegal substances.
• Are dependent on any other non opioid drugs.
• Are allergic to any of the ingredients listed under ‘further
information’.
• Have shallow breathing or other breathing difficulties. Do not use
during an asthma attack.
• Have taken antidepressants known as Monoamine Oxidase Inhibitors
(MAOIs) including moclobenide within the past two weeks.
• Have or have recently had a head injury.
• Are at risk of a type of blocked bowel called paralytic ileus
following abdominal surgery.
• Are addicted to alcohol.
• Are in labour.
Ask your doctor for advice if any of these apply to you.

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Do not take the medicine if you:

Pack Size

2. Before you take the medicine

• Other Methadone products or buprenorphine.
• Cimetidine for stomach ulcers or heartburn.
• Drugs for the treatment of HIV infection (known as CYP 3A4
inhibitors).
• The antibiotic medicine Ciprofloxacin.
• Medicines for fungal infections.
• Drugs which make the urine more alkaline, including potassium
citrate.
• Fluvoxamine, a medicine used to treat depression.
Ask your doctor if you are unsure if any of these apply.

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The product works to prevent withdrawal symptoms in people who are
addicted to opioid drugs such as heroin. It is important that it is taken
regularly to reduce the risk of withdrawal symptoms occurring.

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What is it for?

The doctor may need to reduce the dose of Methadone if
taking these medicines:

Component

The name of your medicine is Methadone 1mg/ml Oral Solution B.P.
Sugar Free. It is a solution to be swallowed and is intended for adult
use only.

• Rifampicin for tuberculosis.
• Phenytoin, Phenobarbital or Carbamazepine for epilepsy.
• Some drugs used for the treatment of HIV infection including
Nevirapine, efavirenz and abacavir.
• Drugs which make the urine more acid, including ammonium
chloride.

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1. What is the medicine and
what does it do?

The doctor may need to increase the dose of Methadone if
taking these medicines:

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1. What is the medicine and what does it do?
2. Before you take the medicine
3. How to take the medicine
4. Possible side effects
5. How to store the medicine
6. Further information

Methadone 1mg/ml Oral Solution B.P.
Sugar Free

In this leaflet

• Alcohol on a regular basis, including binge drinking (See Section 3).
• Any drugs which affect the heart.
• Drugs which affect the salt levels in your body.
• Desipramine or other drugs for depression.
• Medicine for mental illness.
• Painkillers (other than Methadone).
• Sleeping tablets/mixtures or any other tranquillisers.
• Naloxone or naltrexone for drug or alcohol addiction.
• Metoclopramide or domperidone to stop feeling or being sick.
• Zidovudine, didanosine or stavudine for the treatment of HIV
infections.

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• This medicine has been prescribed for you personally and you
should not pass it on to others. It may harm them, even if their
symptoms are the same as yours.
• Keep this leaflet. You may need to read it again.
• If you have further questions, please ask your doctor or pharmacist.
• If any of the side effects become serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or pharmacist.

Also talk to your doctor or pharmacist if you are already
taking any of the following:
These medicines may have a different effect when taking
Methadone.

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Read all this leaflet carefully before you
start taking this medicine.

Important information about some of the
ingredients of this medicine

Reporting of side effects

This medicine contains small amounts of ethanol (alcohol), less than
100mg per 5ml. It contains colouring agent (E110) which may cause
allergic reactions. It also contains sorbitol. If you have been told by
your doctor that you have an intolerance to some sugars, contact your
doctor before taking this medicine.

If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side effects not listed in this leaflet.
You can also report side effects directly via the Yellow Card Scheme
at: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the
safety of this medicine.

3. How to take the medicine

5. How to store the medicine

Dose: Always take your medicine as prescribed by your doctor. The
usual starting dose is 2 to 4 x 5ml spoonfuls by mouth daily, but doctors
sometimes prescribe different doses to this. Follow the doctor’s
instructions carefully. The dose should be taken all at once and
preferably at the same time every day.

Do not use the medicine after any expiry date which may appear on the
label. Medicines should not be disposed of via wastewater or household
waste. Return any unused medicine to your pharmacist. These measures
will help protect the environment.

This medicine has been prescribed for you personally. Do not pass
it on to others as it may harm them.

If you take too much see a doctor straight away.

Effects when taken with alcohol or illegal substances

The risk of overdose and serious harm is greatly increased if taken with
alcohol, heroin and/or other illegal substances. Do not mix these with
your Methadone.

Effects when treatment is stopped

Stopping this medication abruptly will cause side effects, possibly
severe. Follow the doctor’s instructions carefully for coming off this
medicine gradually.

Do not store above 25°C.
Keep out of the sight and reach of children.
Keep the medicine in a locked cupboard if possible.

6. Further information
What the medicine contains

The active substance is methadone hydrochloride 1mg per ml.
The other ingredients are benzoic acid solution (E210, propylene
glycol), sorbitol solution (70% non-crystallising), saccharin sodium,
quinoline yellow (E104), green S dye (E142), sunset yellow dye (E110),
and purified water.

What the medicine looks like

The medicine is a green coloured liquid.

Marketing Authorisation Holder and Manufacturer

4. Possible side effects

Like all medicines, Methadone 1mg/ml can have side effects although
not everybody gets them.

Thornton and Ross Ltd., Huddersfield, HD7 5QH, England.

This leaflet was last revised in March 2016

Important side effects:

• Shallow breathing. This may lead to unconsciousness and death.
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An allergic reaction which may include:
•  Swelling of your face, lips, tongue or throat or difficulty breathing or
swallowing.
• Severe itching of your skin with raised lumps or rash.

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If you think you have the following serious side effects or symptoms,
stop taking this medicine immediately and see a doctor straight away.

Date

29.02.2016

29.02.2016
Date

1
Proof No.

210mm x 297mm flat (105mm x 148mm folded)

Keyline (non-printing)

Process Black

Dimensions

1

22908108

Proof No.

22908108

IG Code

210mm x 297mm flat (105mm x 148mm folded)

500ml

Dimensions

Leaflet

22908108

Pack Size

IG Code

Times New Roman

Component

Process Black

IfComponent
any of the side effects gets serious or you notice any side effect not
Leaflet
Keyline (non-printing)
included above, please tell your doctor or pharmacist straight away.
Pack
Size
500ml
They will tell you what to do.

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Methadone 1mg/ml Oral Solution B.P.
Sugar Free

Sugar Free

Product
Title

Title

MHRA Header Box

• Pinpoint pupils.
• Low blood pressure on standing up, facial flushing.
• Worsening of existing asthma.
• Nausea, vomiting, constipation and dry mouth.
• Hallucinations, confusion, mood changes, anxiety, depression, lower
sexual urge or desire.
• Increase in pressure within the head, particularly if pressure is
already raised for other reasons, dizziness/vertigo, headache and
drowsiness.
• Difficulty in passing water (urine), passing less water (urine) than
usual.
• Reduction in the body’s normal production of adrenal hormones.
• Low body heat (hypothermia).
• Abnormal rapid, slow, or irregular heartbeat.
• Pain in the lower back and abdomen caused by muscle spasms.
• When taken for a long period of time, it is possible that you may
become dependent on Methadone Solution. Long term use may cause
excessive sweating and irregularities in the make-up of the blood
MHRA
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Box of white blood cells, increased protein or antibody
(increased
levels). Erectile function, ejaculate volume and testosterone levels
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Methadone 1mg/ml Oral Solution B.P.
Product
may be reduced in men.

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Other possible side effects:

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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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