Paracetamol Galpharm 1 g Tablett

Sverige - svenska - Läkemedelsverket (Medical Products Agency)

Bipacksedel Bipacksedel (PIL)

22-04-2018

Produktens egenskaper Produktens egenskaper (SPC)

22-04-2018

Aktiva substanser:
paracetamol
Tillgänglig från:
Galpharm Healthcare Limited,
ATC-kod:
N02BE01
INN (International namn):
paracetamol
Dos:
1 g
Läkemedelsform:
Tablett
Sammansättning:
paracetamol 1 g Aktiv substans
Receptbelagda typ:
Receptbelagt
Bemyndigande status:
Avregistrerad
Godkännandenummer:
52859
Tillstånd datum:
2016-12-22

Dokument på andra språk

Bipacksedel Bipacksedel - engelska

13-10-2016

Produktens egenskaper Produktens egenskaper - engelska

13-10-2016

Offentlig bedömningsrapport Offentlig bedömningsrapport - engelska

23-12-2016

Läs hela dokumentet

Version 7

Patient

leaflet:

Information for the user

Paracetamol Galpharm 500mg tablets

paracetamol

[For medicines available only on prescription:]

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, pharmacist or nurse. This includes any possible

side effects not listed in this leaflet. See section 4.

[For medicines available without prescription:]

Read all of this leaflet carefully before you start taking this medicine because it contains

important information for you.

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told

you.

Keep this leaflet. You may need to read it again.

Ask your pharmacist if you need more information or advice.

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.

You must talk to a doctor if you do not feel better or if you feel worse after 3 days with fever

and 5 days with pain.

What is in this leaflet

What Paracetamol Galpharm is and what it is used for

What you need to know before you take Paracetamol Galpharm

How to take Paracetamol Galpharm

Possible side effects

How to store Paracetamol Galpharm

Contents of the pack and other information

1.

What Paracetamol Galpharm is and what it is used for

Paracetamol Galpharm contains paracetamol which belongs to the group of medicines

called analgesics and antipyretics.

Paracetamol Galpharm is used to relieve mild to moderate pain and/or fever.

2.

What you need to know before you take Paracetamol Galpharm

Do not take Paracetamol Galpharm

If you are allergic to paracetamol or any of the other ingredients of this

medicine listed in the section 6

If you have severe liver insufficiency.

Warnings and precautions

Version 7

Talk to your doctor or pharmacist or nurse before taking Paracetamol Galpharm

If you have liver problems

If you have asthma and at the same time are sensitive to acetylsalicylic acid

If you have Gilbert’s syndrome (mild jaundice)

If you are suffering from kidney problems

suffering

from

glucose-6-phosphatedehydrogenase

deficiency

(enzyme deficiency)

If you have haemolytic anaemia (abnormal breakdown of red blood cells)

If you use any other medicines affecting live function (see section other

medicines and Paracetamol Galpharm).

If you are malnourished or dehydrated.

Do not

use Paracetamol Galpharm without prescription if you have alcohol-related

problems or liver damage and do not use Paracetamol Galpharm together with

alcohol.

Do not

take any other paracetamol containing products.

Do not

take more Paracetamol Galpharm than the dose recommended in section 3 or

that your doctor has prescribed.

Higher doses than the recommended doses

do not

provide better pain relief but

instead increase the risk of very severe liver damage. Symptoms of liver damage will

normally occur after a few days. Therefore it is important that you contact your doctor

as soon as possible if you have taken more than the recommended dose.

Other medicines and Paracetamol Galpharm

Tell your doctor or pharmacist if you are taking or have recently taken or might take

any other medicines.

Paracetamol Galpharm can affect or be affected by other medicinal products. Tell

your doctor or pharmacist if you are taking:

Metoclopramide (used to treat nausea and vomiting)

Warfarin (used to thin the blood). There is a risk that the effect of warfarin

will be increased

Probenecid (used for gout)

Phenytoin, phenobarbital, or carbamazepine (used to treat epilepsy)

Rifampicin (used to treat tuberculosis)

Cholestyramine (used to treat dyslipidemia). This medicine should be taken at

least one hour before or after taking paracetamol

Chloramphenicol for injection (used to treat bacterial infections). However,

chloramphenicol used to treat infections of the eye and Paracetamol Galpharm

can be used together

Zidovudine (a medicine used to treat HIV infection)

St John’s Wort extract (included in some herbal remedies)

Laboratory Tests

Version 7

These tablets may affect the results of laboratory blood uric acid test and blood sugar

level tests. Check with your doctor before the tests.

Paracetamol Galpharm with food and alcohol

Do not drink alcohol while you are taking Paracetamol Galpharm.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to

have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Paracetamol Galpharm can be used in pregnancy. However you should use the lowest

effective dose for the shortest possible duration.

Paracetamol Galpharm passes into breast milk, but is unlikely to affect breast-fed

babies. However consult your doctor or pharmacist if you are taking paracetamol for a

long period while breast-feeding.

Driving and using machines

Paracetamol Galpharm does not affect your ability to drive or use machines.

3.

How to take Paracetamol Galpharm

For medicines available only on prescription:

Always take this medicine exactly as your doctor or pharmacist has told you. Check

with your doctor or pharmacist if you are not sure.

For medicines available without prescription:

Always take this medicine exactly as described in this leaflet or as your doctor or

pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The recommended dose is:

Adults and adolescents over 40 kg (over 12 years): 1-2 tablets (500 mg-1 g) every 4-6

hours, maximum 8 tablets (4 g) in 24 hours.

Children:

Paediatric dosage should be based on body weight and suitable dosage form used.

Information on the age of the children within each weight group given below is for

guidance only.

Children between 17 – 25 kg (4-7 years): ½ tablet (250 mg) every 4-6 hours,

maximum 2 tablets (1 g) in 24 hours.

Children between 25- 40 kg (7 – 12 years): ½ to 1 tablet (250 mg – 500 mg) every 4-6

hours, maximum 4 tablets (2 g) in 24 hours.

[For medicines available without prescription:]You must talk to a doctor if you do not

feel better or if you feel worse after 3 days with fever and 5 days with pain.

Version 7

The dose interval should always be at least 4 hours.

Maximum daily dose should not be exceeded due to risk of serious liver damage.

Do not use Paracetamol Galpharm in children less than 12 years for more than 48

hours, unless prescribed by a doctor.

If you have severe kidney or liver problems, the dose should be reduced or the

interval between doses should be prolonged. Ask your doctor for advice.

If you take more Paracetamol Galpharm than you should

Talk to a doctor at once if you take too much of this medicine, even if you feel well.

This is because too much Paracetamol Galpharm can cause delayed, serious liver

damage.

If you forget to take Paracetamol Galpharm

Do not take a double dose to make up for a forgotten dose.

If you have any questions on use of this medicine, ask your doctor or pharmacist.

4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets

them.

Stop taking Paracetamol Galpharm and contact a doctor or go to nearest

hospital immediately if you experience any of these serious side effects:

swollen face, tongue or throat, difficulty swallowing, hives and difficulty in

breathing (angioedema) (rare side effect)

severe allergic reaction or hypersensitivity reaction with fever, rash, swelling

and sometimes fall in blood pressure (very rare side effect)

serious

skin

reactions

(toxic

epidermal

necrolysis

Stevens-Johnson’s

syndrome) (Frequency cannot be estimated from the available data)

in rare cases Paracetamol Galpharm may affect the white blood cells to the

detriment of the immune system. If you develop an infection with symptoms

such as fever coupled with a severely deteriorated general state of health or a

fever with local infection symptoms such as sore throat/mouth or difficulty

urinating, you are to contact a doctor immediately so blood samples can be

used to rule out a lack of white blood cells (agranulocytosis). It is important

that

connection

with

this

inform

medical

personnel

about

your

medication.

Other possible side effects

Rare (may affect up to 1 in 1,000 people):

oedema (abnormal accumulation of fluid under the skin)

depression, confusion, hallucination, abnormal vision

headache, tremor

abdominal pain, diarrhoea, stomach or intestinal bleeding, nausea, vomiting

abnormal liver function, liver failure, hepatic necrosis(death of liver cells),

jaundice

Version 7

reduction of certain blood cells (red blood cells, platelets, and neutrophils),

clotting disorders, stem cell disorders (disorders of the blood-forming cell in

the bone marrow), haemolytic anaemia (abnormal breakdown of red blood

cells)

fever, sedation and sweating.

Very rare (may affect up to 1 in 10,000 people):

serious breathing difficulties with shortness of breath

liver damage

low blood sugar levels

cloudy urine, kidney disorders

serious skin reactions

dizziness (excluding vertigo), malaise.

Not known (frequency cannot be estimated from the available data):

erythema multiforme

(allergic reaction or infection of skin)

accumulation of fluid on the larynx (voice box)

anaemia (decrease in amount of red blood cells)

kidney disorders (severe renal impairment, interstitial nephritis, blood in urine,

inability to urinate)

liver disorders and infection of the liver (hepatitis)

vertigo.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist or nurse. This includes

any possible side effects not listed in this leaflet. You can also report side effects

directly via <to be completed nationally>. By reporting side effects you can help

provide more information on the safety of this medicine.

5.

How to store Paracetamol Galpharm

Keep this medicine out of the sight and reach of children and adolescents.

Do not use this medicine after the expiry date which is stated on the carton, bottle and

blister after Exp. The expiry date refers to the last day of that month.

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.

6.

Contents of the pack and other information

What Paracetamol Galpharm contains

The active ingredient is paracetamol. Each tablet contains 500 mg paracetamol.

The other ingredients are pre-gelatinised starch and magnesium stearate.

What Paracetamol Galpharm looks like and contents of the pack

Version 7

Paracetamol Galpharm are white capsule shaped tablets, 16.5 x 8.2 mm, with a break

line on the one side and plain on the other side. The tablet can be divided in to equal

doses.

Pack sizes:

Blister: 20 and 50 tablets

Bottle: 100 and 300 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder:

To be completed nationally.

Manufacturer:

Galpharm International Limited, Elmhirst Park, Middle Field Road, Barnsley, South

Yorkshire, S75 4LS, United Kingdom.

For any information about this medicine, please contact the local representative

of the Marketing Authorization Holder:

This leaflet was last revised in:

2016-10-13

Läs hela dokumentet

S

UMMARY OF

P

RODUCT

C

HARACTERISTICS

1

N

AME OF THE

M

EDICINAL

P

RODUCT

Paracetamol Galpharm 500mg tablets

2

Q

UALITATIVE AND

Q

UANTITATIVE

C

OMPOSITION

1 tablet contains 500 mg of paracetamol.

For the full list of excipients, see section 6.1

3

P

HARMACEUTICAL

F

ORM

Tablet

White, 16.5 x 8.2 mm, oblong tablet with score line on one side.

The tablet can be divided into equal doses.

4

C

LINICAL

P

ARTICULARS

4.1

Therapeutic indications

Symptomatic treatment of mild to moderate pain and/or fever.

4.2

Posology and method of administration

Posology

Adults (including elderly) and children 12 years and older (minimum 40kg):

Tablets 500 mg: 1-2 tablets every 4-6 hours,,

The maximum daily dose is 4g (8 tablets per 24 hours).

Paediatric population:

Paediatric dosage should be based on body weight and suitable dosage form used.

Information on the age of children within each weight group given below is for guidance only.

50 mg /kg/day divided into 3 to 4 doses.

Maximum treatment time without consulting a doctor is 3 days for fever and 5 days for pain.

Tablets 500 mg:

Weight

Dose

17-25 kg

4 - 7 years

½ tablet every 4-6 hours, max. 4 times per 24 hours.

25-40 kg

7-12 years

½-1 tablet every 4-6 hours, max. 4 times per 24 hours.

>40 kg

>12 years

1-2 tablets every 4-6 hours, max. 8 tablets per 24 hours.

The dose interval should always be at least 4 hours.

Maximum daily dose should not be execeeded due to risk of serious hepatic damage (see

sections 4.4 and 4.9)

Method of administration

For oral administration.

Special groups of patients:

Impaired liver function:

In patients with impaired hepatic function or Gilbert’s syndrome, the dose must be reduced or

the dosing interval prolonged.

Impaired kidney function:

In patients with renal insufficiency, the dose should be reduced:

Glomerular filtration rate

Dose

10–50 ml/min

500 mg every 6 hours

< 10 ml/min

500 mg every 8 hours

Elderly patients:

Dose adjustment is not required in the elderly.

4.3

Contraindications

Hypersensitivity to the active substance or any of the excipients listed in section 6.1.

Sever liver insufficiency.

4.4

Special warnings and precautions for use

Caution is advised in the administration of paracetamol to patients with moderate and severe

renal

insufficiency,

mild

moderate

hepatocellular

insufficiency

(including

Gilbert’s

syndrome), severe hepatic insufficiency (Child-Pugh > 9), acute hepatitis, concomitant treatment

with

medicinal

products

affecting

hepatic

functions,

glucose-6-phosphatedehydrogenase

deficiency, haemolytic anaemia, dehydration, alcohol abuse and chronic malnutrition.

Do not combine with other analgesics containing paracetamol (e.g. combination medications).

Higher doses than recommended lead to a risk of very severe liver damage.

Clinical signs of liver damage generally only start after a few days and climax after 4-6 days as a

rule. An antidote should be administered as soon as possible. See also under 4.9 Overdose.

In the event of high fever, signs of secondary infection or if symptoms last longer than 3 days,

treatment must be reassessed.

Caution should be exercised in patients with asthma who are sensitive to acetylsalicylic acid, as

mild

reactions

bronchospasm

have

been

reported

with

paracetamol

(cross-reaction).

The risks of overdose are greater in those with non-cirrhotic alcoholic liver disease due to

alcohol intake. Caution should be exercised in patients with chronic alcoholism. In such cases,

the dose should not exceed 2 g daily. Alcohol should not be used during treatment with

paracetamol.

4.5

Interaction with other medicinal products and other forms of interaction

Pharmacodynamic interactions

Studies have shown that the effect of

warfarin

may be enhanced in treatment with paracetamol.

The effect appears to increase with the dose of paracetamol but can occur at doses of just 1.5-2.0

g paracetamol a day for at least 5-7 days. Single doses of paracetamol at normal dosage are not

deemed to have any effect.

Pharmacokinetic interactions

Effects of other medicinal products on the pharmacokinetics of paracetamol

In pharmacokinetic studies, enzyme-inducing medicinal products such as certain anti-epileptic

drugs (

phenytoin, phenobarbital, carbamazepine

) have been shown to reduce the plasma AUC of

paracetamol to approx. 60%. Other substances with enzyme-inducing properties, e.g. rifampicin

and St. John's wort (hypericum) are also suspected of producing lower concentrations of

paracetamol. In addition, there may be a greater risk of liver damage from treatment with the

maximum recommended dose of paracetamol in patients who are on enzyme-inducing medicinal

products.

Probenecid

immediately halves clearance of paracetamol by inhibiting its conjugation with

glucuronic acid. This should mean that the dose of paracetamol can be halved in simultaneous

treatment with probenecid.

The absorption rate of paracetamol may be increased by

metoclopramide

, but the substances can

be given together. The absorption of paracetamol is reduced by

cholestyramine

. Cholestyramine

should not be given within an hour if the maximum analgesic effect is to be achieved.

Zidovudine

may affect paracetamol metabolism and vice versa, which may add to the toxicity of

both.

Effects of <

to be completed nationally > on the pharmacokinetics of other medicinal products

Paracetamol

affect

pharmacokinetics

chloramphenicol

Analysis

plasma

chloramphenicol is therefore recommended with combination therapy.

Effect on laboratory tests

Paracetamol may affect uric acid tests in serum through the phosphotungstic acid and blood

sugar tests by glucose-oxidase-peroxidase.

4.6

Fertility, pregnancy and lactation

Pregnancy

A large amount of data on pregnant women indicates neither malformative, nor feto/neonatal

toxicity. Paracetamol can be used during pregnancy if clinically needed however it should be

used at the lowest effective dose for the shortest possible time and at the lowest possible

frequency.

Breastfeeding

Low levels of paracetamol are excreted in human milk. No undesirable effects on breastfed

infants have been reported. Paracetamol can be used during breast-feeding as long as the

recommended dosage is not exceeded. In case of long-term use, caution should be exercised.

Fertility

There are no concerns about effects on fertility due to paracetamol treatment.

4.7

Effects on ability to drive and use machines

No effects have been observed.

4.8

Adverse effects

Side effects caused by <product name> are generally rare. The most common side effects are

skin reactions and elevated liver transaminase.

Adverse reactions frequency is specified as follows:

Very common (≥ 1/10)

Common (≥1/100 to <1/10)

Uncommon (≥1/1,000 to <1/100)

Rare (≥1/10,000 to <1/1,000)

Very rare (<1/10,000

Not known (cannot be estimated from the available data)

Blood and lymphatic system disorders

Rare: Platelet disorders, stem cell disorders, agranulocytosis, thrombocytopenia, neutropenia,

leukopenia, haemolytic anaemia, pancytopenia

Immune system disorders

Rare: Allergies (excluding angioedema)

Very rare: Anaphylactic shock, hypersensitivity reaction (requiring discontinuation of treatment)

Metabolism and nutrition disorders

Very rare: Hypoglycaemia

Psychiatric disorders:

Rare: Depression, confusion, hallucination

Nervous system disorders:

Rare: Tremor, headache

Eye disorders

Rare: Abnormal vision

Respiratory, thoracic and mediastinal disorders

Very rare: Bronchospasm

Gastrointestinal disorders:

Rare: Haemorrhage, abdominal pain, diarrhoea, nausea, vomiting

Hepatobiliary disorders

Rare: Elevated liver transaminase, abnormal hepatic function, hepatic failure, hepatic necrosis,

jaundice

Very rare: liver damage

Skin and subcutaneous tissue disorders

Rare: Rash, urticaria, angioedema, Allergic dermatitis

Very rare cases of serious skin reactions have been reported.

Not known: Stevens-Johnson syndrome, toxic epidermal necrolysis

Renal and urinary system

Very rare: Sterile pyuria (cloudy urine), renal side effects

Liver damage with paracetamol has occurred in conjunction with alcohol abuse. The risk of

kidney damage cannot be entirely ruled out with long-term use.

Interstitial nephritis has been reported incidentally after prolonged use of high doses. Some cases

erythema multiforme

, oedema of the larynx, anaemia, liver alteration and hepatitis, renal

alteration (severe renal impairment, haematuria, anuresis) and vertigo have been reported.

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 national reporting

system <to be completed nationally>.

4.9

Overdose

At excess doses the conjugation capacity in the liver may be reduced after which a large part of

dose

metabolised

oxidation.

stores

glutathione

depleted

reactive

intermediate metabolites bind irreversibly to liver macromolecules. Clinical symptoms of liver

damage generally only appear after a few days. It is therefore crucial to start treatment with an

antidote as soon as possible in order to prevent or minimise liver damage after toxic doses.

Toxicity:

See below under Treatment for information on toxic plasma concentrations. 5 g over 24 hours

for up to 3½ year-olds, 15-20 g for adults, 10 g to an alcoholic produced lethal intoxication. A

toxic dose for adults is generally 140 mg/kg and a toxic dose for children approx. 175 mg/kg.

Starvation, dehydration, medication with enzyme-inducing agents (antiepileptic’s, promethazine

etc.) and chronic high alcohol consumption are risk factors and can cause pronounced liver

damage

even

small

doses.

Even

sub-acute

"therapeutic"

overdose

serious

intoxication with doses varying from 6 g/day for a week, 20 g for 2 or 3 days, etc.

Symptoms:

For a few hours following ingestion and for the first 1-2 days there may be abdominal pains,

nausea

vomiting.

After

days

there

signs

liver

damage

with

elevated

transaminase levels, falling prothrombin values, coagulopathy, icterus, malaise, hypoglycaemia,

hypokaliemia,

hypophosphataemia,

metabolic

acidosis,

disseminated

intravasal

coagulation.

Manifest liver failure and hepatic coma. Liver damage generally peaks after 4-6 days. Kidney

damage may be secondary to liver damage or as the sole or main toxic manifestation within 24-

72 hours of the overdose. Pancreatitis and toxic myocardial damage with arrhythmia and heart

failure have been reported.

At extremely high concentrations there have been reports of loss of

consciousness combined with acidosis and hyperglycaemia. Pancytopaenia.

Treatment:

If necessary, gastric irrigation and activated charcoal. Plasma paracetamol concentration should

be measured at 4 hours or later after ingestion. Acute response. False lows may be measured if

acetylcysteine has already been administered. If an antidiarrhoeal has been taken a new sample

should

taken

hours

after

first

(delayed

peak

concentration).

Treatment

with

acetylcysteine initiated within 8-10 hours provides complete protection from liver damage, after

which the effect diminishes. Acetylcysteine is used if the paracetamol concentration is above the

following levels at respective points: 1000 micromol/l at 4 hours, 700 micromol/l at 6 hours and

450 micromol/l at 9 hours after exposure. In cases of concomitant alcoholism, starvation,

dehydration, impaired liver function or medication with enzyme-inducing drugs there may be

grounds for setting the threshold for antidote therapy at about ¾ the listed levels. The method of

administration is adapted to the circumstances (level of consciousness, tendency to vomiting

etc.). However, intravenously administered acetylcysteine is deemed more effective and safer.

Dosage of acetylcysteine:

Intravenously

initially 150 mg/kg in 200-300 ml isotonic infusion

solution over 15 minutes, then 50 mg/kg in 500 ml 50 mg/ml glucose over 4 hours and then 6.25

mg/kg/hour over 16 hours (75 mg/kg dissolved in 500 ml isotonic glucose solution and

administered over 12 hours). Fluid volumes can be reduced, if necessary. Contact the National

(local) Poisons Information Centre for information.) for a specific schedule. (In exceptional

circumstances,

acetylcysteine

administered

orally

intravenous

route

available.

Contact

National

(local)

Poisons

Information

Centre

information.

Acetylcysteine may provide some protection even after 10 hours, but in such cases prolonged

treatment should be administered. Acetylcysteine also reduces mortality in the event of manifest

paracetamol-induced liver failure (please discuss with the Poisons Information Centre). Close

monitoring of hepatic and renal function, coagulation status, fluid and electrolyte status. Liver

and kidney failure therapy is often required in cases where the deadline for effective antidote

treatment has passed and there are toxic concentrations present. Haemoperfusion may be

indicated in special circumstances. In extreme cases a liver transplant may be required.

5

P

HARMACOLOGICAL

P

ROPERTIES

5.1

Pharmacodynamic properties

Pharmacotherapeutic group: Analgesic, antipyretic, ATC code: N02BE01

Paracetamol is an aniline derivative with analgesic and antipyretic actions similar to those of

acetylsalicylic acid but paracetamol does not cause gastrointestinal irritation and is also well

tolerated by patients with ulcers. Paracetamol does not affect thrombocyte aggregation or

bleeding time. Paracetamol is generally well tolerated by patients who are hypersensitive to

acetylsalicylic acid.

The antipyretic effect is achieved through action on the hypothalamic heat-regulation centre,

whereby heat dissipation is increased.

The latency period for the analgesic effect is approx. ½ hour. The peak effect is achieved within

1-2 hours and lasts for 4-5 hours. The course of the antipyretic effect is somewhat slower. Thus

the latency period is approx. ½-1 hour, maximum reduction in fever is recorded after 2-3 hours

and the effect lasts for about 8 hours.

5.2

Pharmacokinetic properties

Absorption

Paracetamol

absorbed

well

when

administered

orally.

Peak

plasma

concentration

paracetamol is achieved within ½-1 hour.

Distribution

Paracetamol is distributed rapidly into all tissues. Blood, plasma and saliva concentrations are

comparable. Protien binding is low with recommended doses.

Biotransformation

The plasma half-life is approx. 2 hours. Paracetamol is primarily metabolised in the liver by

conjugation to glucuronide and sulphate. A small amount (about 3-10% of a therapeutic dose) is

metabolised by oxidation by cytochrome P450 and the reactive intermediate metabolite thus

formed is bound preferentially to the liver glutathione and excreted as cysteine and mercapturic

acid conjugates.

Elimination

Excretion occurs via the kidneys. Approx. 2-3% of a therapeutic dose is excreted unchanged,

approx. 80-90% as glucuronide and sulphate and a smaller amount as cysteine and mercapturic

acid derivatives.

Renal insufficiency

In patients with severe renal insufficiency (creatinine clearance < 10 ml/min), elimination of

paracetamol and its metabolites is delayed.

Elderly patients

Conjugation is unchanged in this patient group.

Paediatric population

In neonates and children < 12 years sulphate conjugation is the main elimination route and

glucuronidation is lower than in adults. Total elimination in children is comparable to that in

adults, due to an increased capacity for sulphate conjugation. In children the formation of the

toxic intermediate product is reduced compared with adults. Additionally, neonates have an

increased

ability

replete

liver

glutathione.

Therefore,

severe

liver

damage

caused

paracetamol would seem to be rarer in children than in adults. The elimination half-life of

paracetamol is 2–2.5 hours in children.

5.3

Preclinical safety data

There is no pre-clinical data of relevance to the safety assessment beyond what has already been

covered in the Summary of Product Characteristics.

6

P

HARMACEUTICAL

P

ARTICULARS

6.1

List of excipients

Pre-gelatinised starch

Magnesium stearate

6.2

Incompatibilities

Not applicable.

6.3

Shelf life

Blister strip: 3 years

HDPE plastic bottle: 3 years

6.4

Special precautions for storage

This medicinal product does not require any special storage conditions.

6.5

Nature and contents of container

Blister made from white opaque PVC with an aluminium /PVC lidding foil.

Package Size: 20, 50 tablets.

HDPE bottles with HDPE closures.

Package size: 100, 300 tablets.

Not all pack sizes may be marketed.

6.6

Special precautions for disposal and other handling

No special requirements

7

M

ARKETING

A

UTHORISATION

H

OLDER

<To be completed nationally>

8

M

ARKETING

A

UTHORISATION

N

UMBER

(

S

)

<To be completed nationally>

9

D

ATE OF

F

IRST

A

UTHORISATION

/R

ENEWAL OF

A

UTHORISATION

Date of first authorisation: <To be completed nationally>

10

D

ATE OF

R

EVISION OF THE

T

EXT

2016-10-13

Liknande Produkter

Sök varningar relaterade till denna produkt

Visa dokumenthistorik

Dela den här informationen