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DIHYDROCODEINE ELIXIR BP 10MG IN 5ML

Active substance(s): DIHYDROCODEINE TARTRATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Dihydrocodeine Elixir BP 10mg/5ml
Dihydrocodeine Tartrate

D0269300000

Read all of this leaflet carefully before you use
Dihydrocodeine Elixir.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your doctor
or pharmacist.
• This medicine has been prescribed for you personally and
you must not pass it onto others. It may harm them, even
if their symptoms are the same as yours.
• 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.

• suffer with bowel problems
• suffer from problems with your pancreas
• have been told you suffer from a severe heart problem
known as cor pulmonale
• have a cough that is producing mucus
Taking other medicines
Please tell your doctor if you are taking or have recently
taken any other medicines, including those obtained without
prescription.
Dihydrocodeine Elixir must not be used with drugs used to
treat severe depression, such as phenelzine or moclobemide,
or if you are within 2 weeks of discontinuing them. These
drugs are known as Monoamine Oxidase Inhibitors (MAOI’s).

Other medicines which may interact with with
Dihydrocodeine Elixir include:
• medicines for sleeping problems and anxiety, such as
In this leaflet:
chloral, diazepam, and barbiturates.
• CNS depressants (drugs that act on the brain and make
1. What Dihydrocodeine Elixir is and what it is used for
you feel drowsy or faint). These include sleeping pills, anti2. Before you take Dihydrocodeine Elixir
histamines (medicines used to treat allergies) that make you
3. How to take Dihydrocodeine Elixir
drowsy, medicines used to treat certain mental disorders,
4. Possible side effects
other pain killers or a general anaesthetic.
5. Storing Dihydrocodeine Elixir
• alcohol
6. Further information
Taking Dihydrocodeine Elixir with food and drink
1. What Dihydrocodeine Elixir is and what it is
Dihydrocodeine Elixir should be taken with or after food.
used for
You are advised not to drink alcohol while being treated with
Dihydrocodeine.
Dihydrocodeine is a drug with powerful pain relieving
properties. This medicine is used for the relief of moderate to
Pregnancy and breast-feeding
severe pain. It can also be used to treat a cough.
Dihydrocodeine Elixir should not be used during pregnancy
and whilst breastfeeding, unless prescribed by your doctor.
2. Before you take Dihydrocodeine Elixir
Dihydrocodeine is likely to cross the placenta and be present
You should not take Dihydrocodeine Elixir if you:
in breast milk and it may cause breathing problems in
• are allergic (hypersensitive) to Dihydrocodeine or any of the newborn babies.
ingredients of this medicine (listed in section 6 & ‘Important Effects on the ability to drive and use machines
information about some of the ingredients, column 2).
This medicine can affect your ability to drive and operate
• suffer from breathing difficulties or are having an asthma
machinery. Do not drive or operate machinery if you feel
attack
drowsy or cannot think clearly.
• have a lung infection
This medicine can affect your ability to drive as it may make
• are taking any Monoamine Oxidase Inhibitors (MAOIs)
you sleepy or dizzy.
(a type of drug used to treat severe depression) or if you
• Do not drive while taking this medicine until you know how
stopped taking them within the last two weeks
it affects you.
• are suffering from severe headaches or have suffered a head
• It is an offence to drive if this medicine affects your ability to
injury
drive.
• have difficulty opening your bowel
• However, you would not be committing an offence if:
• have a tumour of the adrenal gland known as
• The medicine has been prescribed to treat a medical or
phaeochromocytoma
dental problem and
• have liver, kidney or stomach problems
• You have taken it according to the instructions given
This medicine should not be given to children under 4 years
by the prescriber or in the information provided with the
of age.
medicine and
Take special care with Dihydrocodeine Elixir
• It was not affecting your ability to drive safely
Tell your doctor if you:
Talk to your doctor or pharmacist if you are not sure whether it
• are elderly or suffer from an under active or over active
is safe for you to drive while taking this medicine
thyroid, liver or kidney problems, as the dose may need to
Important information about some of the ingredients
be reduced
• If you have been told by your doctor that you have an
• have any breathing or lung problems
intolerance to some sugars (fructose, glucose, sucrose),
• have any prostate problems
contact your doctor before taking this medicine.
• suffer from a convulsive disorder (fits) such as epilepsy
• This medicine contains 9.4% vol ethanol (alcohol), i.e. up to
• are suffering from a problem that could cause paralysis of
380mg per 5ml dose, equivalent to 9.4ml beer, 3.9ml wine
the small intestine (paralytic ileus)
per dose. It is harmful for those suffering from alcoholism
• suffer from problems related to your adrenal gland,
and has to be taken into account in pregnant or breastincluding Addison’s disease
feeding women, children and high-risk groups such as
• suffer from under-active thyroid gland
patients with liver disease, or epilepsy.
• suffer from muscle wasting disease known as myasthenia
Continued overleaf
gravis

• Dihydrocodeine Elixir contains ethyl hydroxybenzoate
(E214), propyl hydroxybenzoate (E216) and methyl
hydroxybenzoate (E218) which may cause an allergic
(hypersensitive) reaction which could be delayed. Although
rare, you may have difficulty breathing.

3. How to take Dihydrocodeine Elixir
Your doctor will decide on the dose and duration of your
therapy.
Always follow the instructions of your doctor or pharmacist.
Dihydrocodeine Elixir is for oral use and should be taken
with or after food.
Moderate to severe pain:
Adults
One to three 5ml spoonfuls (10 - 30mg) every 4 - 6 hours
Elderly
A reduced dose is recommended
Children aged 4 to 12 years
0.5 to 1mg per kg of body weight every 4 - 6 hours
Children under 4 years
Not recommended
Cough:
Adults
One 5ml spoonful (10mg) every 4 - 6 hours
Children aged 4 to 12 years
0.2 mg per kg of bodyweight every 4 - 6 hours
Children under 4 years
Not recommended
If you forget to take Dihydrocodeine Elixir
If you have missed a dose take it as soon as you remember
unless it is nearly time for your next dose. Then continue your
normal dose times. Do not take a double dose.
If you take more Dihydrocodeine Elixir than you should
If you take too much of your medicine seek immediate
medical advice from your doctor or your nearest hospital.
If you stop taking Dihydrocodeine Elixir
You should not stop taking Dihydrocodeine Elixir until advised
to do so by your doctor. If you stop treatment too suddenly
you may experience symptoms of withdrawal such as stomach
pains, feeling sick and feeling anxious. Your doctor will advise
you how to stop your treatment with Dihydrocodeine Elixir.

4. Possible side effects
Like all medicines, Dihydrocodeine Elixir can cause side effects,
although not everybody gets them.
Repeated use of Dihydrocodeine can result in tolerance and
addiction.
If any of the following symptoms occur contact your doctor or
nearest accident and emergency department immediately.
These are symptoms of a serious allergic reaction.
• sudden wheeziness and tightness of chest
• swelling of eyelids, face or lips
• skin lumps or hives
• skin rash (red spots), itchiness, fever
• collapse

• hallucinations (seeing or hearing things that aren’t real)
• changes in mood
• pin-point pupils
• sweating
• feeling faint when getting up from a seated position
• facial flushing
• constipation
• feeling sick (nausea)
• being sick (vomiting)
• skin reactions or itchy rashes
• difficulty passing urine
• stomach pain
• tingling, pricking or numbness of the skin (‘pins and
needles’)
• restlessness
• dry mouth
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.

5. Storing Dihydrocodeine Elixir
Keep out of the reach and sight of children.
Do not use Dihydrocodeine Elixir after the expiry date which
is stated on the label and carton. The expiry date refers to the
last day of that month.
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 Dihydocodeine Elixir contains:
Active ingredient: Dihydrocodeine Tartrate BP 10mg in each
5ml of the flavoured base
Other ingredients: glycerol, sugar syrup (sucrose), citric acid
monohydrate, alcohol, oxymel, sodium chloride, essence of
limes soluble, essence of bitter orange soluble, strong tincture
of ginger, E150 caramel, ethyl hydroxybenzoate (E214), propyl
hydroxybenzoate (E216), methyl hydroxybenzoate (E218),
purified water.
Each 5 ml dose of this elixir contains 0.38g of alcohol and 2.4g
of sugar.
What Dihydrocodeine Elixir looks like and contents of the
pack:
Dihydrocodeine Elixir is a thick brown liquid that smells of
limes and ginger and is supplied in a 150ml amber glass
bottle.
Marketing Authorisation Holder and Manufacturer:
Martindale Pharmaceuticals Ltd
Bampton Road, Harold Hill, Romford, Essex,
RM3 8UG, UK
Product licence number: PL 0156/0092
Date of approval: January 2014

Other side effects that may occur include:
• drowsiness
• headaches
• a feeling of dizziness or spinning
• feeling of being unwell
D0269300000

2693-D

100mm Measurement Verification Bar

DEVELOPMENT ARTWORK
Component Code: D02693
Paper size: 170 x 220mm
Version Control Date

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Version A Created 15/01/14 HM
Version B

07/02/14 AC

Version C

10/02/14 AC

Version D

17/02/14 AC

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www.grand-fromage.co.uk

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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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