Tylex 30mg/500mg effervescent tablets

Land: Bretland

Tungumál: enska

Heimild: MHRA (Medicines & Healthcare Products Regulatory Agency)

Virkt innihaldsefni:

Codeine phosphate; Paracetamol

Fáanlegur frá:

UCB Pharma Ltd

ATC númer:

N02AJ06

INN (Alþjóðlegt nafn):

Codeine phosphate; Paracetamol

Skammtar:

30mg ; 500mg

Lyfjaform:

Effervescent tablet

Stjórnsýsluleið:

Oral

Tegund:

Schedule 5 (CD Inv)

Gerð lyfseðils:

Valid as a prescribable product

Vörulýsing:

BNF: 04070100; GTIN: 5015366000767

Upplýsingar fylgiseðill

TYLEX
®
PATIENT INFORMATION LEAFLET
Codeine Phosphate Hemihydrate 30 mg
Paracetamol 500 mg
EFFERVESCENT TABLETS
30 MG / 500 MG
other ingredients in Tylex (see section 6)
• You are taking other Paracetamol containing medicines
• You are pregnant without first talking to your doctor
• You are a child under 12 years old
If any of the above applies to you talk to your doctor.
WARNINGS AND PRECAUTIONS
Codeine is transformed to morphine in the liver by an enzyme. Morphine
is the
substance that produces pain relief. Some people have a variation of
this enzyme
and this can affect people in different ways. In some people, morphine
is not
produced or produced in very small quantities, and it will not provide
enough pain
relief. Other people are more likely to get serious side effects
because a very high
amount of morphine is produced. If you notice any of the following
side effects, you
must stop taking this medicine and seek immediate medical advice: slow
or shallow
breathing, confusion, sleepiness, small pupils, feeling or being sick,
constipation, lack
of appetite.
CHILDREN AND ADOLESCENTS
USE IN CHILDREN AND ADOLESCENTS AFTER SURGERY
Codeine should not be used for pain relief in children and adolescents
after removal
of their tonsils or adenoids due to Obstructive Sleep Apnoea Syndrome.
USE IN CHILDREN WITH BREATHING PROBLEMS
Codeine is not recommended in children with breathing problems, since
the
symptoms of morphine toxicity may be worse in these children.
CHECK WITH YOUR DOCTOR BEFORE TAKING TYLEX IF:
• You have had a serious head injury or raised pressure on the brain
• You have any condition that affects your breathing
• You have liver or kidney disease
• You have an under-active thyroid gland
• You suffer from urinary problems (e.g. difficulty in passing
water) including those
associated with an enlarged prostate gland
• You have a disease of the Adrenal gland called Addison’s disease
• You have decreased brain functioning
• You have inflammatory or obstructive bowel disorders
• You ha

Vara einkenni

OBJECT 1
TYLEX EFFERVESCENT
Summary of Product Characteristics Updated 03-Sep-2015 | UCB Pharma
Limited
1. Name of the medicinal product
Tylex 30 mg / 500 mg effervescent tablets
Medocodene 30 mg / 500 mg effervescent tablets
2. Qualitative and quantitative composition
Each effervescent tablet contains 500 mg of paracetamol and 30 mg of
codeine phosphate hemihydrate.
Excipients:
Sodium: 326.6 mg per tablet
Aspartame (E951): 25 mg per tablet
For a full list of excipients, see section 6.1
3. Pharmaceutical form
Effervescent tablet.
Round, white or off white tablets.
4. Clinical particulars
4.1 Therapeutic indications
Tylex is indicated in patients older than 12 years of age for the
treatment of acute moderate pain which is
not considered to be relieved by other analgesics such as paracetamol
or ibuprofen (alone).
4.2 Posology and method of administration
Codeine should be used at the lowest effective dose for the shortest
period of time.
The duration of treatment should be limited to 3 days and if no
effective pain relief is achieved the
patients/carers should be advised to seek the views of a physician.
ADULTS
The tablets are given orally and should be dissolved in at least half
a tumblerful of water before taking.
The usual dose is one or two tablets up to 4 times a day at intervals
of not less than 6 hours. Maximum
daily dose should not exceed 240 mg of codeine phosphate (i.e., not
more than eight tablets per 24 hours
should be taken)
ELDERLY
A reduced dose may be required.
PAEDIATRIC POPULATION
Children aged 12 years to 18 years
The recommended codeine dose for children 12 years and older should be
30 to 60 mg every 6 hours
when necessary up to a maximum dose of 240 mg daily. The dose is based
on the body weight (0.5-
1mg/kg).
Children aged less than 12 years
Codeine should not be used in children below the age of 12 years
because of the risk of opioid toxicity
due to the variable and unpredictable metabolism of codeine to
morphine (see sections 4.3 and 4.4).
Dosage should be adjusted according to the severity