Tylex 30mg/500mg Hard Capsules
*Company:
UCB (Pharma) Ireland LimitedStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may be renewed (B)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 30 August 2022
File name
ie-pil-tylex-hardcap.pdf
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
Updated on 30 August 2022
File name
ie-spc-tylex-hardcap.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 18 August 2022
File name
ie-pil-tylex-hardcap.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - pregnancy, breast feeding and fertility
Updated on 18 August 2022
File name
ie-spc-tylex-hardcap.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.9 - Overdose
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 08 August 2022
File name
ie-pil-tylex-hardcap.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - pregnancy, breast feeding and fertility
Updated on 08 August 2022
File name
ie-spc-tylex-hardcap.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.9 - Overdose
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 23 December 2020
File name
ie-pil-tylex-caps-clean.pdf
Reasons for updating
- Change to section 2 - excipient warnings
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Miosis (section 4.9 ) + Gap Analysis (sections 4.4 , 4.5 & 4.8) + Excipients
Updated on 23 December 2020
File name
ie-spc-caps-clean.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Miosis (section 4.9 ) + Gap Analysis (sections 4.4 , 4.5 & 4.8) + Excipients
Updated on 28 August 2020
File name
ie-pil-tylex-hardcap-en-clean.pdf
Reasons for updating
- Change to section 6 - manufacturer
Free text change information supplied by the pharmaceutical company
Manufacturer
Lusomedicamenta Sociedade Técnica Farmacêutica, S.A, Estrada Consiglieri Pedroso, 66,no. 69-B, Queluz de Baixo, 2730-055 Barcarena, Portugal.
Updated on 15 November 2019
File name
ie-spc-tylex-hardcap-clean.pdf
Reasons for updating
- Change to section 5.3 - Preclinical safety data
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Update to section 5.3 Preclinical safety data.
5.3 Preclinical safety data
None stated.Conventional studies using the currently accepted standards for the evaluation of paracetamol toxicity to reproduction and development are not available.
Updated on 31 October 2019
File name
20191029-ie-spc-approved tylex.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
4.4 Special warnings and precautions for use
These capsules should be used with caution in patients sensitive to the effects of opioids, e.g. the elderly (who may be sensitive to their central and gastro-intestinal effects) and debilitated patients, patients with CNS depression, hypothyroidism, Addison's disease and prostatic hypertrophy or urethral stricture, myasthenia gravis, reduced blood volume, seizures, shock, inflammatory or obstructive bowel disorders. Care should also be observed if prolonged therapy is contemplated.
Opioid analgesics should be avoided in patients with pancreatobiliary tract disorders.
Care is advised in the administration of paracetamol to patients with severe renal or severe hepatic impairment. The hazard of overdose is greater in those with alcoholic liver disease.
4.5 Interaction with other medicinal products and other forms of interaction
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. [MD1]
Cases of serotonin syndrome, a potentially life-threatening condition, have been reported during concomitant use of opioids with serotonergic drugs (including selective serotonin reuptake inhibitor, serotonin-norepinephrine reuptake inhibitors, tricyclic antidepressants, and monoamine oxidase inhibitors). Similar cases have also been reported with codeine. This may occur within the recommended dose.
Therefore, caution is advised when paracetamol/codeine is coadministered with medicinal products that affect the serotonergic neurotransmitter systems. Patients should be monitored for the sign and symptoms suggestive of serotonin syndrome in case of coadministration of these drugs. If serotonin syndrome is suspected, treatment with paracetamol/codeine should be discontinued.
Concurrent use of MAO inhibitors or tricyclic antidepressants with codeine may increase the effect of either the antidepressant or codeine. Concurrent use of anticholinergics and codeine may produce paralytic ileus.
4.8 Undesirable effects
|
System organ class |
Frequency |
Adverse reactions |
|
Immune system disorders |
Rare |
Hypersensitivity including skin rash may occur |
|
Not known |
Anaphylactic shock, angioedema |
|
|
Blood and lymphatic system disorders |
Rare |
Agranulocytosis, thrombocytopenia |
|
Very Rare |
Neutropenia, leucopenia |
|
|
Psychiatric disorders |
Common |
Dysphoria, euphoria |
|
Unknown |
Hallucination |
|
|
Nervous system disorders |
Common |
Dizziness, light-headedness, sedation |
|
Respiratory, thoracic and mediastinal disorders |
Common |
Shortness of breath, asthma |
|
Not known |
Bronchospasm |
|
|
Gastrointestinal disorders |
Common |
Nausea & vomiting, constipation, abdominal pain |
|
Rare |
Pancreatitis |
|
|
Skin and subcutaneous tissue disorders |
Common |
Pruritus, rash, urticaria |
|
Very rare |
Very rare cases of serious skin reactions 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 HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: medsafety@hpra.ie.
10. DATE OF REVISION OF THE TEXT
February 2019 October 2019
Updated on 31 October 2019
File name
20191024 ie-pl-hardcap SB.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
Free text change information supplied by the pharmaceutical company
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Seek immediate medical help if you have any of the following symptoms:
-
- Feeling faint
- Swelling of the hands, feet, ankles, face, lips or throat or blistering of the skin, mouth, eyes and genitals. You could also notice an itchy, lumpy rash (hives) or nettle rash. This may mean you are having an allergic reaction to this medicine
- Difficulty in breathing or wheezing, shortness of breath
- You get serious skin reactions. Very rare cases have been reported
Tell your doctor or pharmacist if you notice any of the following side effects get serious or last longer than a few days:
- Allergic reactions, including skin rash
- Feeling sick or being sick
- Light-headedness
- Confusion
- Dizziness
- Feeling sleepy
- Headache
- Mood changes
- Hallucination
- Difficulty in breathing, shortness of breath, wheezing, tightness in the chest (bronchospasm)
- Constipation
- Severe stomach pains (pancreatitis)
- Stomach pains after eating (hepatobiliary disorder)
- Stomach pains
- Itchy skin
- Deafness
- Difficulty in passing water (urine)
- Becoming dependent on codeine
- Problems with the blood (thrombocytopenia, agranulocytosis, neutropenia, leucopenia). This is usually shown by tiredness, weakness, or unexplained bruising or bleeding. This side effect is very rare.
Taking codeine regularly for a long time can lead to addiction. This might cause you to feel restless and irritable when you stop taking Tylex.
Taking a lot of Tylex for a long time can cause deafness.
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 HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. ; E-mail: medsafety@hpra.ie
By reporting side effects you can help provide more information on the safety of this medicine.
Updated on 11 October 2019
File name
master-pil-tylex-hardcap-ie (1).pdf
Reasons for updating
- Change to section 2 - what you need to know - contraindications
Updated on 11 October 2019
File name
master-SmPC-Tylex-hardcap-ie corrected.pdf
Reasons for updating
- Correction of spelling/typing errors
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 10 October 2019
File name
master-SmPC-Tylex-hardcap-ie (1).pdf
Reasons for updating
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Change to section 4.4, 4.5, 4.6
Updated on 24 July 2019
File name
ie-pl-caps-clean.pdf
Reasons for updating
- Change to section 2 - use in children and adolescents
Updated on 21 February 2019
File name
20190221-ie-spc-caps-approved-current.pdf
Reasons for updating
- Change to section 6.3 - Shelf life
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 21 December 2018
File name
pil.1402.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
Updated on 14 August 2018
File name
ie-spc-capscleanhardcapsule.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
change to section 4.4 and 4.5 regarding interaction with Benzodiazepine.
Updated on 14 August 2018
File name
ie-spc-capscleanhardcapsule.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Update to section 4.4 and 4.5 with interaction reagrding Tylex with Benzodiazepine.
Updated on 21 November 2017
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 21 November 2017
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 2: minor update to the wording.
Section 3: minor amendment to the product description, the word “opaque” has been added.
Section 4.1: minor update to the wording.
Section 4.2: the posology for paediatric population has been amended. There is a new posology for “Children aged 12 to 15 years”.
Section 4.3: Conditions where morphine and opioids are contraindicated have been included. “Monoamine oxidase inhibitor therapy, concurrent or within 14 days” has been added.
Section 4.4: Additional precautions have been added. Also additional precautionary wording in relation to use in paediatric population has been added.
Section 4.5: Chloramphenicol and oral contraceptives added. Also interaction with quinidine, fluoxetine, paroxetine or sertraline has been added.
Section 4.6: Updates to pregnancy (opioid analgesics may depress neonatal respiration and cause withdrawal effects in neonates of dependent mothers; avoided during the third trimester of pregnancy and during labor) and breastfeeding (codeine should not be used during breastfeeding).
Section 4.8: Major updates to undesirable effects.
Section 4.9: Major updates to the advice on paracetamol overdosage. Update to codeine overdose: “simultaneous ingestion of alcohol and psychotropic drugs will potentiate the effects of overdosage”.
Section 5.1: ATC code has been updated.
Section 10: date of revision has been amended to November 2017.
Updated on 15 November 2017
File name
PIL_14655_174.pdf
Reasons for updating
- New PIL for new product
Updated on 15 November 2017
Reasons for updating
- Change to Section 1 - what the product is
- Change to section 1 - what the product is used for
- Change to section 2 - what you need to know - contraindications
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - use in children and adolescents
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 3 - use in children/adolescents
- Change to section 4 - possible side effects
- Change to section 5 - how to store or dispose
- Change to section 6 - what the product contains
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - date of revision
Updated on 07 September 2016
Reasons for updating
- Change to section 6.4 - Special precautions for storage
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
In section 6.4 (Special precautions for storage) the storage conditions have been amended:
From:
Do not store above 25°C.
Keep blister in the outer carton.
To:
Do not store above 25°C.
Store in the original package in order to protect from light and moisture.
In section 10, the date of revision of the text has been amended:
From:
December 2015
To:
June 2016
Updated on 06 September 2016
Reasons for updating
- Change to storage instructions
- Change to date of revision
Updated on 01 March 2016
Reasons for updating
- Change to section 6.1 - List of excipients
- Change to section 6.3 - Shelf life
- Change to section 6.5 - Nature and contents of container
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 6.1, the composition of the printing ink has changed to:
Shellac
Propylene glycol
Ammonium hydroxide
Iron oxide black (E172)
Section 6.3, the shelf life has been amended to 2 years.
Section 6.5, redundant packaging presentations have been deleted (high-density polyethylene containers).
Section 10, the date of revision has been amended to December 2015.
Updated on 24 February 2016
Reasons for updating
- Change of inactive ingredient
- Change of manufacturer
- Change to storage instructions
- Change to date of revision
- Deletion of a pack size
Updated on 14 October 2015
Reasons for updating
- Change to section 6.1 - List of excipients
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Aerosol OT B (Brand) deleted from excipient name
Updated on 13 October 2015
Reasons for updating
- Change of inactive ingredient
Updated on 07 July 2015
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.4 - Special warnings and precautions for use
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 6.1 - List of excipients
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Spelling of metabisul
Section 4.4:
Spelling of metabisul
Spelling of sul
Section 4.8
Addition of adverse event reporting:
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 HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: medsafety@hpra.ie
Section 5.2:
Spelling of sulphite to sulfite
Section 6.1
Spelling of metabisulphite to metabisulfite
Updated on 07 July 2015
Reasons for updating
- Change to warnings or special precautions for use
- Addition of information on reporting a side effect.
Updated on 21 October 2014
Reasons for updating
- Correction of spelling/typing errors
Updated on 25 July 2014
Reasons for updating
- Change to warnings or special precautions for use
- Change to dosage and administration
Updated on 13 January 2014
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.6 - Pregnancy and lactation
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Tylex Capsules 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
Adults: The capsules are given orally. The usual dose is one or two capsules 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 hemihydrate (i.e. not more than eight capsules per 24 hours should be taken).
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 240mg 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).
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.
4.3 Contraindications
Tylex Capsules are contraindicated:
- For children under the age of 12 years.
- In all paediatric patients (0-18 years of age) who undergo tonsillectomy and/or adenoidectomy for obstructive sleep apnoea syndrome due to an increased risk of developing serious and lifethreatening adverse reactions (see section 4.4)
- In women during breastfeeding (see section 4.6)
- In patients for whom it is known they are CYP2D6 ultra-rapid metabolisers.
4.4 Special Warnings and Precautions for Use
CYP2D6 metabolism
Codeine is metabolised by the liver enzyme CYP2D6 into morphine, its active metabolite. If a patient has a deficiency or is completely lacking this enzyme an adequate analgesic effect will not be obtained. Estimates indicate that up to 7% of the Caucasian population may have this deficiency. However, if the patient is an extensive or ultra-rapid metaboliser there is an increased risk of developing side effects of opioid toxicity even at commonly prescribed doses. These patients convert codeine into morphine rapidly resulting in higher than expected serum morphine levels. General symptoms of opioid toxicity include confusion, somnolence, shallow breathing, small pupils, nausea, vomiting, constipation and lack of appetite. In severe cases this may include symptoms of circulatory and respiratory depression, which may be life-threatening and very rarely fatal.
Estimates of prevalence of ultra-rapid metabolisers in different populations are summarized below:
Population Prevalence %
African/Ethiopian 29%
African American 3.4% to 6.5%
Asian 1.2% to 2%
Caucasian 3.6% to 6.5%
Greek 6.0%
Hungarian 1.9%
Northern European 1%-2%
Post-operative use in children
There have been reports in the published literature that codeine given post-operatively in children after tonsillectomy and/or adenoidectomy for obstructive sleep apnoea, led to rare, but life-threatening adverse events including death (see also section 4.3). All children received doses of codeine that were within the appropriate dose range; however there was evidence that these children were either ultrarapid or extensive metabolisers in their ability to metabolise codeine to morphine.
Children with compromised respiratory function
Codeine is not recommended for use in children in whom respiratory function might be compromised including neuromuscular disorders, severe cardiac or respiratory conditions, upper respiratory or lung infections, multiple trauma or extensive surgical procedures. These factors may worsen symptoms of morphine toxicity.
4.6 Fertility, pregnancy and Lactation
Tylex Capsules is not recommended during pregnancy since safety in pregnant women has not been established.
Tylex Capsules should not be used during breastfeeding (see section 4.3).
However, if the patient is an ultra-rapid metaboliser of CYP2D6, higher levels of the active metabolite, morphine, may be present in breast milk and on very rare occasions may result in symptoms of opioid toxicity in the infant, which may be fatal.
5.1 Pharmacodynamic Properties
Codeine is a centrally acting weak analgesic. Codeine exerts its effect through μ opioid receptors, although codeine has low affinity for these receptors, and its analgesic effect is due to its conversion to morphine. The major effect is on the CNS and the bowel. The effects are remarkably diverse and include analgesia, drowsiness, changes in mood, respiratory depression, decreased gastrointestinal motility, nausea, vomiting and alterations of the endocrine and autonomic nervous systems. The relief of pain is relatively selective, in that other sensory modalities, (touch, vibration, vision, hearing etc.) are not obtunded. Codeine, particularly in combination with other analgesics such as paracetamol, has been shown to be effective in acute nociceptive pain.
Updated on 28 September 2011
Reasons for updating
- Change to warnings or special precautions for use
- Change to information about pregnancy or lactation
Updated on 20 May 2011
Reasons for updating
- Change to section 4.3 - Contraindications
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
4.3 Contraindications
Deletion of the following:
Use of codeine containing products is contraindicated in mothers who are breastfeeding unless prescribed by a doctor
4.4 Special Warnings and Precautions for Use
The following additions:
Severe liver damage may occur if the maximal daily dose is exceeded, if Tylex is taken together with another paracetamol-containing product, or if Tylex is taken while consuming large amounts of alcohol.
Although paracetamol might logically be presumed to be the best alternative analgesic in patients with aspirin sensitivity, cross reactions have been reported.
Codeine is partially metabolised by CYP2D6. If a patient has a deficiency or is completely lacking this enzyme they will not obtain adequate analgesic effects. Estimates indicate that up to 7% of the Caucasian population may have this deficiency. However, if the patient is an ultra-rapid metaboliser there is an increased risk of developing side effects of opioid toxicity even at low doses. General symptoms of opioid toxicity include nausea, vomiting, constipation, lack of appetite and somnolence. In severe cases this may include symptoms of circulatory and respiratory depression. Estimates indicate that up to I to 2% of the Caucasian population may be ultra-rapid metabolisers.
Deletion of the following:
Chronic heavy alcohol abusers may be at increased risk of liver toxicity from excessive paracetamol use, although reports of this event are rare. Reports almost invariably involve cases of severe chronic alcoholics and the dosages of paracetamol most often exceed recommended doses and often involve substantial overdose. Professionals should alert their patients who regularly consume large amounts of alcohol not to exceed recommended doses of paracetamol.
4.6 Pregnancy and Lactation
Codeine warning amended as follows:
Tylex Capsules is not recommended during pregnancy since safety in pregnant women has not been established.
However, if the patient is an ultra-rapid metaboliser of CYP2D6, higher levels of the active metabolites may be present in breast milk and on very rare occasions may result in symptoms of opioid toxicity in the infant.
If symptoms of opioid toxicity develop in either the mother or the infant, then all codeine containing medicines should be stopped and alternative non-opioid analgesics prescribed. In severe cases consideration should be given to prescribing naloxone to reverse these effects.
4.8 Undesirable Effects
Addition of the following:
Respiratory: Asthma
4.9 Overdose
Addition of following for Paracetamol:
The following groups are at risk of liver damage from paracetamol doses above recommended dose:
§ patients on long-term treatment with drugs which induce liver enzymes (e.g. barbiturates, St John’s Wort)
§ people who drink excessive amounts of alcohol
§ patients with depleted glutathione levels (e.g. eating disorders, cystic fibrosis, HIV infection, starvation, cachexia)
§ Patients with pre-existing hepatitis C.
Symptoms of paracetamol overdose include:
Addition of anorexia and also in severe poisoning, hepatic failure may progress to encephalopathy, haemorrhage, hypoglycaemia, cerebral oedema and death.
Updated on 17 June 2010
Reasons for updating
- Change due to user-testing of patient information
Updated on 24 April 2010
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 19 April 2010
Reasons for updating
- New PIL for medicines.ie