Tylex Effervescent

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 31/10/19

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Summary of Product Characteristics last updated on medicines.ie: 1/11/2019

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UCB (Pharma) Ireland Limited

UCB (Pharma) Ireland Limited

Company Products

Medicine NameActive Ingredients
Medicine Name Briviact 10 mg/ml solution for injection/infusion Active Ingredients Brivaracetam
Medicine Name Briviact 10mg/ml oral solution Active Ingredients Brivaracetam
Medicine Name Briviact film-coated tablets Active Ingredients Brivaracetam
Medicine Name Cimzia 200 mg solution for injection in pre-filled pen Active Ingredients Certolizumab Pegol
Medicine Name Cimzia 200 mg solution for injection in pre-filled syringe Active Ingredients Certolizumab Pegol
Medicine Name Keppra 100 mg/ml oral solution Active Ingredients Levetiracetam
Medicine Name Keppra 1000 mg film-coated tablets Active Ingredients Levetiracetam
Medicine Name Keppra 100mg/ml concentrate for solution for infusion Active Ingredients Levetiracetam
Medicine Name Keppra 250 mg film-coated tablets Active Ingredients Levetiracetam
Medicine Name Keppra 500 mg film-coated tablets Active Ingredients Levetiracetam
Medicine Name Keppra 750 mg film-coated tablets Active Ingredients Levetiracetam
Medicine Name Neupro 1mg/24hr and 3 mg/24 hTransdermal Patch Active Ingredients Rotigotine
Medicine Name Neupro 2mg/24hr Transdermal Patch Active Ingredients Rotigotine
Medicine Name Neupro 4 mg/24hr, 6 mg/24hr, 8 mg/24hr Transdermal Patch Active Ingredients Rotigotine
Medicine Name Tylex 30mg/500mg Hard Capsules Active Ingredients Codeine Phosphate Hemihydrate, Paracetamol
Medicine Name Tylex Effervescent Active Ingredients Codeine Phosphate Hemihydrate, Paracetamol
Medicine Name Vimpat 10 mg/ml solution for infusion Active Ingredients lacosamide
Medicine Name Vimpat 10 mg/ml syrup Active Ingredients lacosamide
Medicine Name Vimpat 50 mg, 100 mg, 150 mg, 200 mg film-coated tablets Active Ingredients lacosamide
Medicine Name Xyrem 500mg/ml oral solution Active Ingredients Sodium oxybate
Medicine Name Xyzal 0.5mg/ml oral solution Active Ingredients Levocetirizine dihydrochloride
Medicine Name Xyzal 5mg Tablets Active Ingredients Levocetirizine dihydrochloride
Medicine Name Xyzal 5mg/ml Oral Drops, Solution Active Ingredients Levocetirizine dihydrochloride
Medicine Name Zirtek Oral Solution Active Ingredients Cetirizine Dihydrochloride
Medicine Name Zirtek Plus Decongestant 5mg/120mg Prolonged Release Tablets Active Ingredients Cetirizine Dihydrochloride, Pseudoephedrine Hydrochloride
1 - 0 of 27 items.Total: Infinity pages

When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 1 November 2019 SmPC

Reasons for updating

  • Change to improve clarity and readability

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 31 October 2019 SmPC

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 4.8 – Undesirable effects - how to report a side effect
  • 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.

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 PIL

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

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, Website: www.hpra.ie.

By reporting side effects you can help provide more information on the safety of this medicine.

6. Further information

Manufacturer

UCB Pharma Limited, 208 Bath Road, Slough, Berkshire, SL1 3WE, UK.

This leaflet was last revised in October 2019.

Updated on 11 October 2019 PIL

Reasons for updating

  • Change to section 2 - what you need to know - contraindications

Updated on 11 October 2019 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Changes in Section 4.4, 4.5, 4.6

Updated on 24 July 2019 PIL

Reasons for updating

  • Change to section 2 - use in children and adolescents

Updated on 4 February 2019 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 6 - date of revision

Updated on 3 February 2019 SmPC

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 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

- update in section 4.4 and 4.5 in what concerns Interaction of benzodiazepines and opioids

- update in the date revision of the text

Updated on 15 August 2018 SmPC

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 of text colour.

Updated on 14 August 2018 SmPC

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

uUpdate to section 4.4 and 4.5 with interaction reagrding Tylex with Benzodiazepine.

Updated on 21 November 2017 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 21 November 2017 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • 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 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 PIL

Reasons for updating

  • New PIL for new product

Updated on 15 November 2017 PIL

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 - date of revision

Updated on 7 July 2015 PIL

Reasons for updating

  • Addition of information on reporting a side effect.

Updated on 7 July 2015 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Addition of Adverse Event Reporting information:

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

Updated on 25 July 2014 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to dosage and administration

Updated on 9 January 2014 SmPC

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


4.1 Therapeutic Indications
Tylex Effervescent Tablets 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 Effervescent Tablets are given orally. The usual dose is one or two Effervescent 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 hemihydrate (i.e. not more than eight tablets 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 Effervescent Tablets 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 Effervescent Tablets is not recommended during pregnancy since safety in pregnant women has not been established.
Tylex Effervescent Tablets 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 7 November 2011 PIL

Reasons for updating

  • Change to information about pregnancy or lactation

Updated on 20 May 2011 SmPC

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 is not recommended during pregnancy since safety in pregnant women has not been established.

 

 

At normal therapeutic doses codeine and its active metabolites may be present in breast milk at very low doses and are unlikely to adversely affect the breast fed infant.

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 22 September 2010 SmPC

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 6.1 - List of excipients
  • Change to section 6.5 - Nature and contents of container
  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 2 & 4.1: sodium content changed to 326.6mg
Section 6.1: removal of blackcurrent flavour
Section 6.5: Addition of 8 (correction) and 100
Section 7: Change to UCB Pharma Ireland Ltd
Section 8: New PA number PA 891/14/2

Updated on 22 September 2010 PIL

Reasons for updating

  • Change to further information section
  • Change to marketing authorisation holder

Updated on 24 February 2010 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to drug interactions
  • Change to date of revision
  • Change due to user-testing of patient information

Updated on 1 February 2010 SmPC

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 4.6 - Pregnancy and lactation
  • 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

Section 4.4: addition of (i) a number of conditions in which Tylex can be used with caution; (ii) a warning concerning the abrupt withdrawal of opioids; (iii) a warning concerning the long-term use of high doses of combined codieen-paracetamol with deafness.

Section 4.5: updated to include information on possible interactions with quinidine and centrally acting muscle relaxants, in addition to a warning concerning plasma-paracetamol concentrations during antidote treatment in patients receiving enzyme-inducing drugs.

Section 4.6: inclusion of statements concerning the use of codeine-containing medictation during pregnancy may result in neonatal withdrawal symptoms and that paracetamol is known to pass into breast milk.

Section 4.8: inclusion of reports of deafness, anaphylaxis, angiodema, toxic epidermal necrolysis and drug-induced pancreatitis associated with paracetamol; and pancreatitis associated with codeine.

Section 4.9: hypokalaemia included as a reported symptom of paracetamol overdose.

Section 10: updated to reflect approval of the above changes.

Updated on 22 January 2010 SmPC

Reasons for updating

  • Correction of spelling/typing errors

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 6.5 amended to include a missing non-marketed pack size (8).

Updated on 22 September 2008 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 19 September 2008 SmPC

Reasons for updating

  • Change to section 4.3 - Contraindications
  • Change to section 4.6 - Pregnancy and lactation

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Sections 4.3 and 4.6 updated with additional warning statements relation to nursing mothers and potential codeine toxicity in baby/mother.

Updated on 19 June 2007 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.8 - Text revised into Medra format

Updated on 1 September 2006 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • 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 4.4 - The sentence ' Prolonged regular use, except under medical supervision, may lead to physical and psychological dependence (addiction) and result in withdrawal symptoms, such as restlessness and irritability once the drug is stopped.' has been added.
 
Section 10 - May 2006 has been removed, August 2006 has been added.

Updated on 30 August 2006 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 7 (change of address) - the old Marketing Authorisation Holder address has been removed:
SCHWARZ PHARMA Limited
East Street
Chesham
Buckinghamshire, HP5 1DG
England 
 
It has been replaced by the new address for the Marketing Authorisation Holder which is:
SCHWARZ PHARMA Limited
5 Hercules Way
Leavesden Park
Watford
WD25 7GS
United Kingdom

Updated on 21 April 2006 SmPC

Reasons for updating

  • 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)

Updated on 13 October 2005 SmPC

Reasons for updating

  • Correction of spelling/typing errors

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 26 September 2005 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 2 June 2005 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • 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)

Updated on 5 January 2004 SmPC

Reasons for updating

  • Change to section 6.4 - Special precautions for storage

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 20 June 2003 SmPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Product subject to medical prescription which may be renewed (B)