Dihydrocodeine 30mg tablets

United Kingdom - English - eMC (Electronic Medicines Compendium)

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Active ingredient:
Dihydrocodeine tartrate
Available from:
M & A Pharmachem Ltd
ATC code:
N02AA08
INN (International Name):
Dihydrocodeine tartrate
Dosage:
30mg
Pharmaceutical form:
Tablet
Administration route:
Oral
Class:
Schedule 5 (CD Inv)
Prescription type:
Valid as a prescribable product
Product summary:
BNF: 04070200; GTIN: 5056205100200 5056205100217
Authorization number:
; PL 04077/0183

PAGE 1: FRONT FACE (INSIDE OF REEL)

PAGE 2: REAR FACE (OUTSIDE OF REEL)

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

sure.

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:

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.

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

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

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

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: 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)

Mood changes

Headache, confusion, a feeling of unusual weakness

Hallucinations

Blurred vision

A feeling of dizziness or 'spinning', seizures, fits or

convulsions

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

discomfort)

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

days

cyclizine, metoclopramide or domperidone, to prevent nausea

or vomiting

ciprofloxacin, an antibacterial used to treat infections of the

chest, intestine and urinary tract

antipsychotic drugs e.g. phenothiazines, chlorpromazine or

haloperidol

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

not possible.

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

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

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.

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

product.

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

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.

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

Dependence and addiction (see section “How do I know if I

am addicted?”).

Drug Withdrawal

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

addicted.

You need to take the medicine for longer than advised by your

prescriber

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

prescriber

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

month.

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

PL 00289/0228

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

pharmacist.

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

‘pain relievers’.

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

Dihydrocodeine

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

reliever.

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

death.

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

an attack

suffer from hypothyroidism (an underactive thyroid gland)

suffer with prostatic hypertrophy (a problem with the

prostate gland)

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

EAS1834c

63457-AA

200 x 323

3

2

1

4

5

6

BLACK

PANTONE® GREEN C

Template

ZINC Ref:

EAS1834c LEA DIHYDROCODEINE 30MG TAB TUK

20 February 2020

Version:

2

Colours Used:

Length:

Width:

Depth:

323 mm

200 mm

-

UK & Ireland Artwork Department

Version

REG0061761

Approved

Page 1 of 2

T

HIS IS A REPRESENTATION OF AN ELECTRONIC RECORD THAT WAS SIGNED ELECTRONICALLY AND THIS

PAGE IS THE MANIFESTATION OF THE ELECTRONIC SIGNATURE

A

PPROVALS

Signed by

Meaning of Signature

Server Date

Teva Pharmaceuticals Europe B.V

1.3.2 mockup-pil-uk-pl-00289-0228-dihydrocodeine-30mg-tablets

Annette Huggett

Regulatory Affairs Approval

24-Feb-2020 09:47:45 AM

Version

REG0061761

Approved

Page 2 of 2

SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT

Dihydrocodeine Tablets BP 30mg

2.

Qualitative and Quantitative Composition

Each tablet contains 30mg Dihydrocodeine Tartrate

3.

Pharmaceutical Form

Tablet

4

CLINICAL PARTICULARS

4.1

Therapeutic indications

Dihydrocodeine tablets are indicated for the relief of moderate to severe pain.

4.2

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).

Elderly

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

4.3

Contraindications

Hypersensitivity to dihydrocodeine or any of the excipients

Respiratory depression

Obstructive airways disease

Acute alcoholism

Risk of paralytic ileus

Head injuries or conditions in which intracranial pressure is raised.

4.4

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

asthma attack.

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

palliative care.

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

related drugs:

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

as possible.

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

prescriber.

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

them worse.

The label will state (to be displayed prominently on outer pack – not

boxed):

Do not take for longer than directed by your prescriber as taking DHC

regularly for a long time can lead to addiction

4.5

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

depression

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

MAOI discontinuation.

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

and domperidone.

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).

4.6

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.

4.7

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

operating machinery.

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

defence’) 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 and in the information provided with the medicine and

- It was not affecting your ability to drive safely

4.8

Undesirable effects

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

pain, constipation.

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

ureteric spasm.

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

stopped.

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.

4.9

Overdose

The effects in overdosage will be potentiated by simultaneous ingestion of

alcohol and psychotropic drugs.

Symptoms

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.

Management

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.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties

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.

5.2

Pharmacokinetic properties

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.

5.3

Preclinical safety data

Not applicable.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients

The tablet contains Maize Starch, Lactose Monohydrate,

Polyvinylpyrrolidone, Sodium Starch Glycollate (Type A), Magnesium

Stearate and Colloidal Silicon Dioxide.

6.2.

Incompatibilities

None stated

6.3.

Shelf Life

36 months

6.4.

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.

6.5.

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

tablets.

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.

6.6.

Instruction for Use/Handling

Not applicable

Administrative Data

7

MARKETING AUTHORISATION HOLDER

M & A Pharmachem Ltd

Wigan Road

Westhoughton

Bolton BL5 2AL

United Kingdom

8.

Marketing Authorization Number

PL 04077/0183

9

Date of the first authorisation or renewal

27/09/2005

10

DATE OF REVISION OF THE TEXT

22/03/2019

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