United Kingdom - English - eMC (Electronic Medicines Compendium)
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Pharma code 836
How to take Dihydrocodeine
Always take Dihydrocodeine exactly as your doctor has told you.
You should check with your doctor or pharmacist if you are not
Your prescriber should have discussed with you, how long the
course of tablets will last.
They will arrange a plan for stopping treatment. This will outline
how to gradually reduce the dose and stop taking the medicine.
The tablets should be swallowed preferably with a glass of water
and are best taken after food.
The recommended dose is:
One tablet (30 mg) every 4 to 6 hours. However, your doctor may
recommend a dosage individual to you.
A reduced adult dose is recommended; your doctor will advise
Use in children and adolescents
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
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
Do not suddenly stop taking this medicine. If you want to stop
taking this medicine, discuss this with your prescriber first. They
will tell you how to do this, usually by reducing the dose gradually
so that any unpleasant withdrawal effects are kept to a minimum.
Withdrawal symptoms such as restlessness, difficulty sleeping,
irritability, agitation, anxiety, feeling your heartbeat (palpitations),
increased blood pressure, feeling or being sick, diarrhoea,
shaking, shivering or sweating may occur if you suddenly stop
taking this medicine.
If you have any further questions on the use of this product, ask
your doctor or pharmacist.
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
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: may affect up to 1 in 10 people
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: may affect up to 1 in 100 people
Diarrhoea, a condition where the bowel does not work
properly (paralytic ileus)
Headache, confusion, a feeling of unusual weakness
A feeling of dizziness or 'spinning', seizures, fits or
Tingling or numbness
Low blood pressure
Decreased sexual drive
Difficulty in passing urine
suffer with low blood pressure or are in shock
suffer from convulsions (fits)
have constipation or obstructive bowel disorders (symptoms
may include constipation, diarrhoea, abdominal pain or
have inflammation of the pancreas (which causes severe pain
in the abdomen and back)
have problems with your gall bladder (urethral stricture)
have a severe heart problem after long-term lung disease
(severe cor pulmonale)
are or have ever been addicted to drugs
have adrenocortical insufficiency (symptoms include low
blood pressure, weakness, nausea, vomiting, dizziness, skin
discolouration, weight loss).
Other medicines and Dihydrocodeine
Tell your doctor or pharmacist if you are taking, have recently
taken or might take any other medicines.
Talk to your doctor if you are taking any of the following:
medicines for allergies (antihistamines)
any sedatives, such as temazepam or diazepam
MAOI’s (monoamine oxidase inhibitors) such as phenelzine for
depression, or have taken any of these tablets within the last 14
cyclizine, metoclopramide or domperidone, to prevent nausea
ciprofloxacin, an antibacterial used to treat infections of the
chest, intestine and urinary tract
antipsychotic drugs e.g. phenothiazines, chlorpromazine or
mexiletine, used to treat certain heart conditions
ritonavir, used to treat HIV
cimetidine, used to treat stomach ulcers
tricyclic antidepressants e.g. amitriptyline
anaesthetics (important if you have recently or about to receive
treatment where an anaesthetic may be used)
medicines used for treating anxiety (anxiolytics).
Concomitant use of Dihydrocodeine and sedative medicines such
as benzodiazepines or related drugs increases the risk of
drowsiness, difficulties in breathing (respiratory depression),
coma and may be life-threatening. Because of this, concomitant
use should only be considered when other treatment options are
However if your doctor does prescribe Dihydrocodeine together
with sedative medicines the dose and duration of concomitant
treatment should be limited by your doctor.
Please tell your doctor about all sedative medicines you are
taking, and follow your doctor’s dose recommendation closely. It
could be helpful to inform friends or relatives to be aware of the
signs and symptoms stated above. Contact your doctor when
experiencing such symptoms.
Taking Dihydrocodeine with alcohol
Drinking alcohol during your treatment with these tablets may
make you sleepy or enhance hypotensive effect and respiratory
depression. If you are affected you should avoid drinking alcohol.
Pregnancy and breast-feeding
Do not take Dihydrocodeine if you are pregnant or think you might
be pregnant unless you have discussed this with your prescriber
and the benefits of treatment are considered to outweigh the
potential harm to the baby.
If you use Dihydrocodeine during pregnancy, your baby may
become dependent and experience withdrawal symptoms after
the birth which may need to be treated.
Do not take Dihydrocodeine while you are breastfeeding as
Dihydrocodeine passes into breast milk and will affect your baby.
Driving and using machines
These tablets may cause a number of side effects such as
drowsiness which could affect your ability to drive or use
machinery (see section 4 for a full list of side effects). These are
usually most noticeable when you first start taking the tablets or
when changing to a higher dose. If you are affected you should
NOT drive or use machinery.
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
It is an offence to drive if this medicine affects your ability to
However, you would not be committing an offence if:
The medicine has been prescribed to treat a medical or dental
You have taken it according to the instructions given by the
prescriber or in the information provided with the medicine
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
Dihydrocodeine contains lactose and sodium
Patients who are intolerant to lactose should note that
Dihydrocodeine tablets contain a small amount of lactose. If you
have been told by your doctor that you have an intolerance to
some sugars, contact your doctor before taking this medicinal
This medicine contains less than 1 mmol sodium (23 mg) per
dose, that is to say essentially ‘sodium-free’.
Flushing of the skin
Rash or itchy skin
Shortness of breath
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.
Not known: frequency cannot be estimated from the available
Slower heart rate
Faster heart rate
A fall in blood pressure on standing up which causes
dizziness, light-headedness or fainting
Contraction of the pupil of the eye
Low body temperature
Breathing difficulty in infants born to mothers who have
received this medicine during pregnancy
Dependence and addiction (see section “How do I know if I
When you stop taking Dihydrocodeine, you may experience drug
withdrawal symptoms, which include restlessness, difficulty
sleeping, irritability, agitation, anxiety, feeling your heartbeat
(palpitations), increased blood pressure, feeling or being sick,
diarrhoea, shaking, shivering or sweating.
How do I know if I am addicted?
If you notice any of the following signs whilst taking
Dihydrocodeine, it could be a sign that you have become
You need to take the medicine for longer than advised by your
You feel you need to use more than the recommended dose
You are using the medicine for reasons other than prescribed
When you stop taking the medicine you feel unwell, and you
feel better once taking the medicine again
If you notice any of these signs, it is important you talk to your
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 or search for MHRA Yellow Card in
the Google Play or Apple App Store.
By reporting side effects you can help provide more information
on the safety of this medicine.
How to store Dihydrocodeine
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on
the outer packaging. The expiry date refers to the last day of that
These tablets should be stored in a dry place below 25°C and
protected from light, in the package or container supplied.
Do not throw away any medicines via wastewater or household
waste. Ask your pharmacist how to throw away medicines you no
longer use. These measures will help protect the environment.
Contents of the pack and other information
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 sizes 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.
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: 02/2020
This medicine contains dihydrocodeine tartrate which is an
opioid, which can cause addiction. You can get withdrawal
symptoms if you stop taking it suddenly.
Read all of this leaflet carefully before you start taking this
medicine because it contains important information for you.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or
This medicine has been prescribed for you only. Do not pass it
on to others. It may harm them, even if their signs of illness
are the same as yours.
If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this leaflet.
See section 4.
1. What Dihydrocodeine is and what it is used for
2. What you need to know before you take Dihydrocodeine
3. How to take Dihydrocodeine
4. Possible side effects
5. How to store Dihydrocodeine
6. Contents of the pack and other information
What Dihydrocodeine is and what it is used for
This medicine has been prescribed for you for the relief of
moderate to severe pain. It contains dihydrocodeine tartrate
which belongs to a class of medicines called opioids, which are
This medicine has been prescribed to you and should not be
given to anyone else. Opioids can cause addiction and you may
get withdrawal symptoms if you stop taking it suddenly. Your
prescriber should have explained how long you will be taking it
for and when it is appropriate to stop, and how to do this safely.
What you need to know before you take
Do not take Dihydrocodeine if you:
are allergic (hypersensitive) to dihydrocodeine, or any of the
other ingredients of this medicine
suffer from problems with your breathing
suffer from alcoholism
have suffered a significant head injury
are at risk of paralytic ileus (an inactive bowel) which may
cause a blockage of the gut
are having an asthma attack
have an intolerance to some sugars
have a severe headache or feel sick due to a head injury or
increased pressure in your skull (for instance due to brain
disease). This is because the tablets may make these
symptoms worse or hide the extent of a head injury.
Warnings and precautions
Talk to your prescriber before taking this medicine if you:
are or have ever been addicted to opioids, alcohol,
prescription medicines, or illegal drugs.
have previously suffered from withdrawal symptoms such as
agitation, anxiety, shaking or sweating, when you have
stopped taking alcohol or drugs.
feel you need to take more of Dihydrocodeine to get the same
level of pain relief, this may mean
you are becoming tolerant
to the effects of this medicine or are becoming addicted to it.
Speak to your prescriber who will discuss your treatment and
may change your dose or switch you to an alternative pain
Taking this medicine regularly, particularly for a long time, can
lead to addiction. Your prescriber should have explained how
long you will be taking it for and when it is appropriate to stop,
how to do this safely.
Rarely, increasing the dose of this medicine can make you more
sensitive to pain. If this happens, you need to speak to your
prescriber about your treatment.
Addiction can cause withdrawal symptoms when you stop taking
this medicine. Withdrawal symptoms can include restlessness,
difficulty sleeping, irritability, agitation, anxiety, feeling your
heartbeat (palpitations), increased blood pressure, feeling or
being sick, diarrhoea, loss of appetite, shaking, shivering or
sweating. Your prescriber will discuss with you how to gradually
reduce your dose before stopping the medicine. It is important
that you do not stop taking the medicine suddenly as you will be
more likely to experience withdrawal symptoms.
Opioids should only be used by those they are prescribed for. Do
not give your medicine to anyone else. Taking higher doses or
more frequent doses of opioid, may increase the risk of
addiction. Overuse and misuse can lead to overdose and/or
Tell your doctor before you start to take this medicine if you:
suffer from liver or kidney problems
are asthmatic, as dihydrocodeine should be given with care
to persons liable to attacks and should not be given during
suffer from hypothyroidism (an underactive thyroid gland)
suffer with prostatic hypertrophy (a problem with the
are elderly or debilitated as the dosage should be reduced
Package leaflet: Information for the user
DIHYDROCODEINE 30 mg TABLETS
What is in this leaflet
200 x 323
PANTONE® GREEN C
EAS1834c LEA DIHYDROCODEINE 30MG TAB TUK
20 February 2020
UK & Ireland Artwork Department
Page 1 of 2
HIS IS A REPRESENTATION OF AN ELECTRONIC RECORD THAT WAS SIGNED ELECTRONICALLY AND THIS
PAGE IS THE MANIFESTATION OF THE ELECTRONIC SIGNATURE
Meaning of Signature
Teva Pharmaceuticals Europe B.V
Regulatory Affairs Approval
24-Feb-2020 09:47:45 AM
Page 2 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
NAME OF THE MEDICINAL PRODUCT
Dihydrocodeine Tablets BP 30mg
Qualitative and Quantitative Composition
Each tablet contains 30mg Dihydrocodeine Tartrate
Dihydrocodeine tablets are indicated for the relief of moderate to severe pain.
Posology and method of administration
For oral administration
The analgesic effect is not materially enhanced by increasing the dose above
that recommended below; in severe cases the interval between doses should be
reduced to obtain the requisite analgesic cover.
Dihydrocodeine tablets are best taken with or after food.
Adults and children over 12 years: 1 tablet every four to six hours or at the
discretion of the practitioner. Maximum dose in 24 hours 180mg (6 tablets).
A reduced adult dose is recommended, at the advice of the physician.
Children 4 to 12 years of age
0.5 to 1 mg/kg body weight, every 4 to 6 hours.
Children under 4 years of age
Dihydrocodeine is not recommended
Hypersensitivity to dihydrocodeine or any of the excipients
Obstructive airways disease
Risk of paralytic ileus
Head injuries or conditions in which intracranial pressure is raised.
Special warnings and precautions for use
Dihydrocodeine should be given in reduced doses or with caution to patients
with asthma and decreased respiratory reserve. Avoid use during an acute
Dihydrocodeine should be avoided, or the dose reduced in patients with
hepatic or renal impairment.
Dihydrocodeine should be given in reduced doses or with caution to;
debilitated patients, adrenocortical insufficiency, prostatic hyperplasia,
urethral stricture, hypotension, shock, inflammatory or obstructive bowel
disorders, hypothyroidism or convulsive disorders.
However, these conditions should not necessarily be a deterrent to use in
Use in caution in those with a history of drug abuse.
Alcohol should be avoided whilst under treatment with these tablets.
Risk from concomitant use of sedative medicines such as benzodiazepines or
Concomitant use of Dihydrocodeine and sedative medicines such as
benzodiazepines or related drugs may result in sedation, respiratory
depression, coma and death. Because of these risks, concomitant prescribing
with these sedative medicines should be reserved for patients for whom
alternative treatment options are not possible. If a decision is made to
prescribe Dihydrocodeine concomitantly with sedative medicines, the lowest
effective dose should be used, and the duration of treatment should be as short
The patients should be followed closely for signs and symptoms of respiratory
depression and sedation. In this respect, it is strongly recommended to inform
patients and their caregivers to be aware of these symptoms (see section 4.5).
Contains lactose monohydrate. Patients with rare hereditary problems of
galactose intolerance, the Lapp lactose deficiency or glucose-galactose
malabsorption should not take this medicine.
The risk-benefit of continued use should be assessed regularly by the
The leaflet will state in a prominent position in the ‘before taking’ section:
Do not take for longer than directed by your prescriber
Taking dihydrocodeine (DHC) regularly for a long time can lead to
addiction, which might cause you to feel restless and irritable when
you stop the tablets
Taking a painkiller for headaches too often or for too long can make
The label will state (to be displayed prominently on outer pack – not
Do not take for longer than directed by your prescriber as taking DHC
regularly for a long time can lead to addiction
Interaction with other medicinal products and other forms of interaction
Dihydrocodeine may cause the release of histamine; hence this product should
not be administered during an asthmatic attack and should be administered
with caution in patients with allergic disorders.
The depressant effects of opioid analgesics are enhanced by other CNS
depressants such as:
Alcohol-enhanced hypotensive, sedative effect and respiratory
Anaesthetics - may increase anaesthetic and sedative effect
Sedating antihistamines - may enhance the CNS depressive effects
when taken with opioids.
Anxiolytics or Hypnotics - may enhance CNS depressive effects when
taken with opioids
Tricyclic antidepressants - may enhance CNS depressive effects when
taken with opioids
Antipsychotics - enhanced hypotensive, sedative effect
MAOIs taken with pethidine have been associated with severe CNS
excitation or depression. Although this has not been documented with
dihydrocodeine, it is possible that a similar interaction may occur with
other opioid analgesics. Therefore, the use of dihydrocodeine should
be avoided while the patient is taking MAOIs and for 2 weeks after
When dihydrocodeine is taken concomitantly with antipsychotics
there may be an increased sedative and hypotensive effect.
Concomitant use of dihydrocodeine and ritonavir should be avoided
due to the risk of toxicity.
Dihydrocodeine may antagonise the gastrointestinal effects metoclopramide
Cyclizine may counteract the haemodynamic benefits of opioids.
Dihydrocodeine may delay absorption of mexiletine.
Cimetidine may inhibit the metabolism of opioids
Sedative medicines such as benzodiazepines or related drugs: The concomitant
use of opioids with sedative medicines such as benzodiazepines or related
drugs increases the risk of sedation, respiratory depression, coma and death
because of additive CNS depressant effect. The dose and duration of
concomitant use should be limited (see section 4.4).
Pregnancy and lactation
Whilst there is no adequate evidence of safety in human pregnancy,
dihydrocodeine has been widely used without apparent ill-effect for many
years and studies in animals have not yet demonstrated any hazard. The
administration of opioid analgesics during labour may cause respiratory
depression in the new-born infant, therefore administration should be avoided
during the later stages of pregnancy.
Babies born to opioid-dependant mothers may suffer withdrawal symptoms.
Dihydrocodeine passes into breast milk in very small amounts which are
probably insignificant, however, it is recommended that administration should
be avoided if the mother is breast feeding.
Effects on ability to drive and use machines
Dihydrocodeine may impair the mental and/or physical abilities required for
the performance of potentially hazardous tasks such as driving a car or
Effects such as paraesthesia, dizziness, vertigo, muscle rigidity, visual
disturbances, drowsiness, confusion and hallucinations may occur. Do not
drive or operate machinery if affected.
This medicine can impair cognitive function and can affect a patient’s ability
to drive safely. This class of medicine is in the list of drugs included in
regulations under 5a of the Road Traffic Act 1988. When prescribing this
medicine, patients should be told:
The medicine is likely to affect your ability to drive
Do not drive until you know how the medicine affects you
It is an offence to drive while under the influence of this medicine
However, you would not be committing an offence (called ‘statutory
- The medicine has been prescribed to treat a medical or dental
- You have taken it according to the instructions given by the
prescriber and in the information provided with the medicine and
- It was not affecting your ability to drive safely
Skin disorders; rash, urticaria, pruritus, sweating.
Central and peripheral nervous system disorders; paraesthesia, dizziness,
headache, vertigo, respiratory depression. Muscle rigidity has been reported
after high doses.
Vision disorders; visual disturbances, miosis.
Psychiatric disorders; drowsiness, changes of mood, confusion, sexual
dysfunction, hallucinations, euphoria.
Gastro-intestinal system disorders; dry mouth, nausea, vomiting, abdominal
Liver and biliary system disorders; biliary spasm which may be associated
with alterations in liver enzyme values.
Cardiovascular disorders general; hypotension, syncope
Heart rate and rhythm disorders; bradycardia, tachycardia, palpitations.
Vascular (extracardiac) disorders; facial flushing.
Urinary systems disorders; Micturition may be difficult and there may be
Body as a whole, general; oedema.
Regular prolonged use of DHC is known to lead to addiction and tolerance.
Symptoms of restlessness and irritability may result when treatment is then
Prolonged use of a painkiller for headaches can make them worse.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal
product is important. It allows continued monitoring of the benefit/risk balance
of the medicinal product. Healthcare professionals are asked to report any
suspected adverse reactions via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the
Google Play or Apple App Store.
The effects in overdosage will be potentiated by simultaneous ingestion of
alcohol and psychotropic drugs.
Central nervous system depression, including respiratory depression, may
develop but is unlikely to be severe unless other sedative agents have been co-
ingested, including alcohol, or the overdose is very large. The pupils may be
pin-point in size; nausea and vomiting are common. Hypotension and
tachycardia are possible but unlikely.
This should include general symptomatic and supportive measures including a
clear airway and monitoring of vital signs until stable. Consider activated
charcoal if an adult presents within one hour of ingestion of more than 350 mg
or a child more than 5 mg/kg.
Give naloxone if coma or respiratory depression is present. Naloxone is a
competitive antagonist and has a short half-life so large and repeated doses
may be required in a seriously poisoned patient. Observe for at least four hours
after ingestion, or eight hours if a sustained release preparation has been taken.
ATC code N02A A08
Dihydrocodeine tartrate is an analgesic with uses similar to those of morphine
but it is much less potent as an analgesic and has only mild sedative effects.
Dihydrocodeine is well absorbed after oral administration. Peak plasma levels
occur 1.6 - 1.8 hours after ingestion. Plasma half-life has been reported to be
34 hours after oral ingestion.
Dihydrocodeine is metabolised in the liver by 0- and N- demethylation.
After oral administration the bioavailability of the drug is approximately 20%,
indicating that the pre-systemic metabolism plays a substantial role in
reducing the bioavailability of dihydrocodeine.
Dihydrocodeine is excreted in the urine as unchanged drug and metabolites.
The mean elimination half life ranges between 3.5 – 5 hours.
Preclinical safety data
List of excipients
The tablet contains Maize Starch, Lactose Monohydrate,
Polyvinylpyrrolidone, Sodium Starch Glycollate (Type A), Magnesium
Stearate and Colloidal Silicon Dioxide.
Special Precautions for Storage
Do not store above 25°C. For containers, keep tightly closed, store in the
original container. For strip packaging, store in the original package, keep in
the outer carton.
Nature and Contents of Container
HDPE containers with LDPE lids or polypropylene containers with
polyethylene lids (Securitainers) in packs of 25, 50, 100, 250, 500 and 1000
PVDC coated PVC film with hard temper aluminium foil (strips) in packs of 7,
10, 14, 21, 28, 30, 56, 60, 84, 90, 100, 110, 112, 120, 150, 160 and 168 tablets.
Instruction for Use/Handling
MARKETING AUTHORISATION HOLDER
M & A Pharmachem Ltd
Bolton BL5 2AL
Marketing Authorization Number
Date of the first authorisation or renewal
DATE OF REVISION OF THE TEXT