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DIHYDROCODEINE 30MG TABLETS

Active substance(s): DIHYDROCODEINE TARTRATE

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231-30-63457-X LEA DIHYDROCODEINE 30mg TAB TUK

REG0061761

Version 4.4

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• are or have ever been addicted to drugs
• have adrenocortical insufficiency (symptoms include
low blood pressure, weakness, nausea, vomiting,
dizziness, skin discolouration, weight loss).
PACKAGE LEAFLET: INFORMATION
Taking other medicines
FOR THE USER
Talk to your doctor if you are taking any of the following:
Read all of this leaflet carefully before you start taking
• medicines for allergies (antihistamines)
this medicine.
• any sedatives, such as temazepam or diazepam
• Keep this leaflet. You may need to read it again.
• MAOI’s (monoamine oxidase inhibitors) such as
• If you have any further questions, ask your doctor or
phenelzine for depression, or have taken any of these
pharmacist.
tablets within the last 14 days
• This medicine has been prescribed for you. Do not
• cyclizine, metoclopramide or domperidone, to prevent
pass it on to others. It may harm them, even if their
nausea or vomiting
symptoms are the same as yours.
• ciprofloxacin, an antibacterial used to treat infections
• If you get any side effects, talk to your doctor or
of the chest, intestine and urinary tract
pharmacist. This includes any possible side effects not • antipsychotic drugs e.g. phenothiazines,
listed in this leaflet. See section 4.
chlorpromazine or haloperidol
• mexiletine, used to treat certain heart conditions
IN THIS LEAFLET:
• ritonavir, used to treat HIV
• cimetidine, used to treat stomach ulcers
1. What Dihydrocodeine is and what it is used for
• tricyclic antidepressants e.g. amitriptyline
2. Before you take Dihydrocodeine
3. How to take Dihydrocodeine
• anaesthetics (important if you have recently or about to
4. Possible side effects
receive treatment where an anaesthetic may be used)
5. How to store Dihydrocodeine
• medicines used for treating anxiety (anxiolytics).
6. Further information
Please tell your doctor or pharmacist if you are taking or
have recently taken any other medicines, including
WHAT DIHYDROCODEINE IS AND WHAT IT IS
medicines obtained without a prescription.
USED FOR
Taking Dihydrocodeine with food and drink
• Dihydrocodeine is a painkiller
Drinking alcohol during your treatment with these tablets
• Dihydrocodeine is used for the relief of moderate to
may make you sleepy or enhance hypotensive effect and
severe pain.
respiratory depression. If you are affected you should
avoid drinking alcohol.
BEFORE YOU TAKE DIHYDROCODEINE
Pregnancy and breast-feeding
Do not take these tablets if you are pregnant or likely to
Do NOT take Dihydrocodeine if you:
• are allergic (hypersensitive) to dihydrocodeine, or any become pregnant. If you are breast-feeding do not take
these tablets until you have spoken to your doctor.
of the other ingredients of this medicine
• suffer from problems with your breathing
If you are pregnant, planning to become pregnant or
• suffer from alcoholism
breast-feeding, ask your doctor for advice before taking
• have suffered a significant head injury
any medicine.
• are at risk of paralytic ileus (an inactive bowel) which
Driving and using machines
may cause a blockage of the gut
These tablets may cause a number of side effects such as
• are having an asthma attack
drowsiness which could affect your ability to drive or use
• have an intolerance to some sugars
machinery (see section 4 for a full list of side effects).
• have a severe headache or feel sick due to a head
These are usually most noticeable when you first start
injury or increased pressure in your skull (for instance taking the tablets or when changing to a higher dose. If
due to brain disease). This is because the tablets may
you are affected you should NOT drive or use machinery.
make these symptoms worse or hide the extent of a
The medicine can affect your ability to drive as it may
head injury.
make you sleepy or dizzy.
Take special care with Dihydrocodeine
• Do not drive while taking this medicine until you know
Do NOT take Dihydrocodeine:
how it affects you
• for longer than directed by your prescriber
• It is an offence to drive if this medicine affects your
• regularly for a long time as it can lead to addiction,
ability to drive.
which may cause you to feel restless and irritable
However, you would not be committing an offence if:
when you stop the tablets
• The medicine has been prescribed to treat a medical
• as a painkiller for headaches too often or for too long
or dental problem and
as it can make them worse.
• You have taken it according to the instructions given
Tell your doctor before you start to take this medicine if
by the prescriber or in the information provided with
you:
the medicine and
• suffer from liver or kidney problems
• It was not affecting your ability to drive safely.
• are asthmatic, as dihydrocodeine should be given with Talk to your doctor or pharmacist if you are not sure
care to persons liable to attacks and should not be
whether it is safe for you to drive while taking this
given during an attack
medicine.
• suffer from hypothyroidism (an underactive thyroid
Important information about some of the ingredients of
gland)
Dihydrocodeine
• suffer with prostatic hypertrophy (a problem with the
Patients who are intolerant to lactose should note that
prostate gland)
Dihydrocodeine tablets contain a small amount of
• are elderly or debilitated as the dosage should be
lactose. If you have been told by your doctor that you
reduced
have an intolerance to some sugars, contact your doctor
• suffer with low blood pressure or are in shock
before taking this medicinal product.
• suffer from convulsions (fits)
HOW TO TAKE DIHYDROCODEINE
• have constipation or obstructive bowel disorders
(symptoms may include constipation, diarrhoea,
Always take Dihydrocodeine exactly as your doctor has
abdominal pain or discomfort)
told you. You should check with your doctor or
• have inflammation of the pancreas (which causes
pharmacist if you are not sure.
severe pain in the abdomen and back)
• have problems with your gall bladder (urethral stricture) The tablets should be swallowed preferably with a glass
• have a severe heart problem after long-term lung
of water and are best taken after food.
disease (severe cor pulmonale)

DIHYDROCODEINE
30 mg TABLETS

PAGE 1: FRONT FACE (INSIDE OF REEL)

TEVA UK Ref:

Top of page cut-off to middle of registration mark: 96 mm.

ApprovedPharma code 475

Page 1 of 3

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29 May 2015

POSSIBLE SIDE EFFECTS
Like all medicines, Dihydrocodeine can cause side
effects, although not everybody gets them.
If the following happens, stop taking the tablets and tell
your doctor immediately or go to the casualty
department at your nearest hospital:
• an allergic reaction (swelling of the lips, face or neck
leading to severe difficulty in breathing; skin rash or
hives).
This is a very serious but rare side effect. You may need
urgent medical attention or hospitalisation.
The most serious side effect is a condition where you
breathe more slowly or weakly than expected
(respiratory depression).
As with all strong painkillers, there is a risk you may
become addicted or reliant on these tablets. Symptoms
of restlessness and irritability may result when treatment
is then stopped.
Taking a painkiller for headaches too often or for too long
can make your headaches worse.
Common side effects: affects 1 to 10 users in 100
• Constipation (your doctor can prescribe a laxative to
overcome this problem)
• Feeling or being sick (this should normally wear off
after a few days, however your doctor can prescribe
an anti-sickness medicine if it continues to be a
problem)
• Drowsiness (this is most likely when you start taking
your tablets or when your dose is increased, but it
should wear off after a few days)
• Dry mouth, abdominal pain or discomfort.
Uncommon side effects: affects 1 to 10 users in 1,000
• Diarrhoea, a condition where the bowel does not work
properly (paralytic ileus)
• Mood changes
• Headache, confusion, a feeling of unusual weakness
• Hallucinations
• Blurred vision

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The usual dose is:
Adults
One tablet (30 mg) every 4 to 6 hours. However, your
doctor may recommend a dosage individual to you.
The Elderly
A reduced adult dose is recommended; your doctor will
advise you.
Children from 4 to 12 years of age
Your doctor will calculate the appropriate dose of
Dihydrocodeine for your child based on the child’s body
weight. The dose should be taken every 4-6 hours.
Children under the age of 4 years
Dihydrocodeine is not recommended for use in children
under 4 years of age.
If you take more Dihydrocodeine than you should
If you (or someone else) swallow a lot of the tablets all
together, or if you think a child has swallowed any of the
tablets, contact your nearest hospital casualty
department or your doctor immediately. An overdose is
likely to cause difficulty in breathing, nausea, vomiting,
fast heart rate, low blood pressure causing dizziness and
a reduction in the size of the eye pupil which can all be
exacerbated by also taking alcohol or other sedatives.
Please take this leaflet, any remaining tablets and the
container with you to the hospital or doctor so that they
know which tablets were consumed.
If you forget to take Dihydrocodeine
If you forget to take a tablet, take one as soon as you
remember, unless it is nearly time to take the next one. Do
not take a double dose to make up for a forgotten dose.
If you stop taking Dihydrocodeine
You should continue to take these tablets for as long as
your doctor tells you to. When you stop taking your
tablets, you may feel anxious, depressed and restless,
and have difficulty sleeping. If this happens, ask your
doctor for advice.
If you have any further questions on the use of this
product, ask your doctor or pharmacist.

PAGE 2: REAR FACE (OUTSIDE OF REEL)

Version:

HOW TO STORE DIHYDROCODEINE

FURTHER INFORMATION

63457-X
160 x 237

What Dihydrocodeine tablets contain:
The active ingredient is dihydrocodeine tartrate. The
other ingredients are maize starch, lactose monohydrate,
povidone (E1201), sodium starch glycolate (Type A),
magnesium stearate (E572) and colloidal silicon dioxide.
What Dihydrocodeine tablets look like and contents of
the pack:
• Dihydrocodeine are white, flat, bevel edged tablets
engraved 5B4 with a breakline
• The product is available in pack sizes1 of 7, 10, 14, 21,
25, 28, 30, 50, 56, 60, 84, 90, 100, 110, 112, 120, 150,
160, 168, 250, 500 and 1000 tablets.
See outer packaging or the pharmacy label for contents
i.e. the number of tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation holder and company
responsible for manufacture: TEVA UK Limited,
Eastbourne, BN22 9AG.
This leaflet was last revised: 05/2015
PL 00289/0228

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Keep out of the reach and sight of children.
These tablets should be stored in a dry place below 20°C
and protected from light, in the package or container
supplied. Do not use Dihydrocodeine after the expiry
date that is stated on the outer packaging. 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.

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• A feeling of dizziness or 'spinning', seizures, fits or
convulsions
• Tingling or numbness
• Low blood pressure
• Decreased sexual drive
• Difficulty in passing urine
• Flushing of the skin
• Rash or itchy skin
• Shortness of breath
• Sweating
• A need to take increasingly higher doses to obtain the
same level of pain relief (tolerance)
• A worsening in liver function tests (seen in a blood
test)
• Constant acute abdominal pain.
Side effects with frequency not known: frequency cannot
be estimated from the available data
• Facial redness
• Slower heart rate
• Faster heart rate
• Palpitation
• A fall in blood pressure on standing up which causes
dizziness, light-headedness or fainting
• Bowel spasm
• Depressed mood
• Contraction of the pupil of the eye
• Low body temperature
• Breathing difficulty in infants born to mothers who
have received this medicine during pregnancy
• Swelling (oedema)
• Muscle rigidity.
Reporting of side effects
If you get any side effects, talk to your doctor or
pharmacist. 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.

+ 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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