Dihydrocodeine 30mg tablets

מדינה: הממלכה המאוחדת

שפה: אנגלית

מקור: MHRA (Medicines & Healthcare Products Regulatory Agency)

מרכיב פעיל:

Dihydrocodeine tartrate

זמין מ:

Actavis UK Ltd

קוד ATC:

N02AA08

INN (שם בינלאומי):

Dihydrocodeine tartrate

כמות:

30mg

טופס פרצבטיות:

Oral tablet

מסלול נתינה (של תרופות):

Oral

סיווג:

Schedule 5 (CD Inv)

סוג מרשם:

Valid as a prescribable product

leaflet_short:

BNF: 04070200; GTIN: 5012617010155 5012617010216 5012617015341

עלון מידע

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.
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
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.
POSSIBLE SIDE EFFECTS
Li

מאפייני מוצר

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Dihydrocodeine 30mg Tablets BP.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains dihydrocodeine tartrate 30 mg
Also contains Lactose monohydrate 155 mg
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Tablet
White, flat, circular, bevel edged plain tablet with breakline.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Dihydrocodeine 30mg Tablets BP (as an analgesic) are indicated for the
relief
of moderate to severe pain. Dihydrocodeine 30mg Tablets BP are
indicated in
all painful conditions where an alert patient is desired, e.g.
sciatica, osteo-
arthritis, chronic rheumatoid arthritis, arthritis of the spine,
peripheral vascular
disease,
post-herpetic
neuralgia,
Paget’s
disease,
malignant
disease,
post-
operative pain.
Because
Dihydrocodeine,
in
the
recommended
doses,
causes
little
or
no
respiratory depression, its use in the treatment of post-operative
pain may
reduce the risk of chest complications.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_ _
_POSOLOGY: _
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.
ADULTS AND CHILDREN OVER 12 YEARS: One tablet (30 mg) every 4 – 6
hours or at the
discretion of the practitioner. Maximum dose in 24 hours 180mg (6
tablets)
PAEDIATRIC POPULATION: A more suitable dosage form is recommended for
children
under 12 years (e.g. elixir)
ELDERLY: Dosage should be reduced in the elderly
Prior to starting treatment with opioids, a discussion should be held
with patients to
put in place a strategy for ending treatment with Dihydrocodeine in
order to minimise
the risk of addiction and drug withdrawal syndrome (see section 4.4).
4.3
CONTRAINDICATIONS
•
Hypersensitivity to dihydrocodeine or other opioid analgesics or to
any of the
excipients listed in section 6.1.
•
Respiratory depression
•
Obstructive airways disease
•