Solpadeine Soluble Tablets

Lactation

Codeine should not be used during breastfeeding (see section 4.3).

 

At normal therapeutic doses codeine and its active metabolite may be present in breast milk at very low doses and is

unlikely to adversely affect the breast fed infant.

 

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.

 

Paracetamol and caffeine are excreted in breast milk but not in a clinically significant amount.

Although significant caffeine toxicity has not been observed in breastfed infants, caffeine may have a stimulating

effect on the infant.

Update the SPC revision date to reflect the variation approval date

• 4.1 - re-worded to  include "indicated in patients older than 12 years," minor typographical changes.
• 4.2 - typographical changes and explanation of posology on paediatric population and duration of treatment.
• 4.3 - addition of 3 contraindications on lactation, CYP2D6 metabolisers and paediatric patients (0-18 years) who undergo tonsillectomy and/or adenoidectomy for obstructive sleep apnoea syndrome.
• 4.4 - addition of information on CYP2D6 metabolism and post-operative use in children
• 4.6 - amended to contraindicate use in lactation
• 5.1 - amended information on codeine pharmacodynamics

Section 7 MAH Holder address changed from GSK Ireland to:

Chefaro Ireland Limited First Floor

Block A

The Crescent Building Northwood Office Park

Dublin 9

Ireland

Section 8 Marketing Authoriation Number to:

PA 1186/011/001

Section 10 Revision date to January 2013

In section 4.3: Contraindication removed.
In section 4.4: Information about CYP2D6 and ultra-rapid metabolisers added.
In section 4.6: Information about the use of Solpadeine Soluble Tablets in breatfeedimg changed.

In section 4.2 (Posology and method of administration)

The text” and children aged 12 years and over” was added to the heading “Adults (including the elderly)”. The text underneath this was changed to, “the usual dose is two tablets three to four times in a 24 hour period as required.”

The text “under 12” was added to the heading “Children”. Underneath this the text detailing dosing for those aged 7-12 was removed and replaced by “Not recommended in children under 12 years of age”.

Warning text was also added, advising the maximum number of tablets to be taken in 24hours, how often doses should be repeated and for how long the tablets should be taken without consulting a doctor. Warning on not to take with other paracetamol or codeine containing products was also added as was advice for those with renal and/or hepatic impairment.

In section 4.4 (Special warnings and precautions for use)

The first sentence advising care in those with severe renal or hepatic impairment was removed and replaced by text advising patients with such impairments to seek medical advice before use. A sentence was also added stating the increased risk of paracetamol-related liver damage in those with underlying liver disease.

In the next paragraph the final part of the last sentence was removed (i.e. “and those with inflammatory or obstructive bowel disorders.”)

In the next paragraph the advice that excessive intake of tea or coffee should be avoided was replaced with “Excessive intake of caffeine (e.g. tea, coffee and some canned drinks) should be avoided while taking this product.”

Two paragraphs were added after this precaution. The first detailed that those with inflammatory or obstructive bowel disorders or acute abdominal condition should consult a doctor before use. The second details that patients with a history of cholecystectomy should consult a doctor before use due to the risk of acute pancreatitis.

Another paragraph was added detailing how prolonged use of painkillers for headaches may make them worse. Information was given on what should be done if this is suspected or experienced and also advice on how to diagnose this “medication over headache”.

Near the end of section 4.4 the following warning statements were added:

“This product should be used only when clearly necessary.”

“Do not take for more than 3 days without consulting a doctor.”

“Immediate medical advice should be sought in the event of overdosage because of the risk of irreversible liver damage.”

The phrase “Do not take with other paracetamol containing medicines.” was replaced with “Do not take with other paracetamol or codeine containing products”

The text “Contains Carmoisine (E122). May cause allergic reactions.” was added.

The warning for people with renal problems, hypertension or oedema was changed to:“Each effervescent tablet contains 427 mg of sodium. The product should be used with caution in patients with hypertension, oedema or renal insufficiency because of the sodium content.”

 

In section 4.6 (Pregnancy and Lactation)

The opening paragraph detailing safety evidence in pregnancy was removed. Section 4.6 is now split by two subheadings (Pregnancy and Lactation). Underneath the Pregnancy subheading two paragraphs have been added detailing that use of this product should be avoided during pregnancy unless advised by a physician. Details on the fact that safety during pregnancy for paracetamol-caffeine-codeine has not been established relative to the possible adverse events is given and also details of the increased risk of spontaneous abortion due to caffeine consumption is given.

Underneath the second subheading, Lactation, all of the information previously listed in the SPC remains with the addition of the line “Although significant caffeine toxicity has not been observed in breastfed infants, caffeine may have a stimulating effect on the infant.”

In section 4.8 (Undesirable effects)

The text present at the moment has been deleted and replaced by information on classification of undesirable effects, including very common, common, uncommon, rare, very rare and not known. Information for undesirable effects for Paracetamol, Caffeine and Codeine was then tabulated by blood system, undesirable effect and frequency. Text has also been added under neat the tabulated undesirable effects of caffeine detailing the increase in risk for caffeine related adverse events when the product is combined with dietary caffeine.

In section 4.9 (Overdose)

The text present has been erased or reworded or broken up into different sections.

Now the text has been put into subheadings for Paracetamol, Codeine and Caffeine each of which is further broken up into two subheadings:

1.      Symptoms and signs

2.      Treatment.

For Paracetamol the Symptoms and signs now contains two paragraphs the first of which opens with the new text “Paracetamol overdose may cause liver failure.” Following on from this the text which was previously in the first paragraph of the old SPC beginning with “Ingestion of more than 12g paracetamol “and detailing what quantities of paracetamol can cause liver damage and what biochemical evidence may be present is given after this new opening sentence.

The second paragraph details all of the symptoms associated with paracetamol overdose, and how this paracetamol toxicity occurs.

In the Treatment subheading for paracetamol two paragraphs are given detailing that immediate medical attention should be sought. Advice is given on the appropriate treatments and timelines for which they may be effective (i.e. advice on N-acetylcysteine, oral methionine and activated charcoal).

For Codeine an opening sentence detailing that the effects of overdose would be subsumed by the effects of paracetamol overdose is given. In the Symptoms and Signs subheading what signs and symptoms to be expected are listed and in the Treatment section the appropriate treatments to be given are stated.

For Caffeine in the Symptoms and Signs subheading what signs and symptoms to be expected are listed and in the Treatment section details that no specific antidote for caffeine overdose is given but states that supportive measures such as beta adrenoreceptors should be used.

 

The following was also added:

“Sodium bicarbonate

High doses of sodium bicarbonate would be expected to induce gastrointestinal symptoms including belching and nausea. In addition, high doses of sodium bicarbonate may cause hypernatraemia, electrolytes should be monitored and patients managed accordingly.”

 

In section 10 (date of revision) the date was changed to July 2010.

 

 

 

 

Section 3- Addition of "The tablet can be divided into equal halves."
Section 10-Date of revision of text updated.

Section 4.3

The following text has been  added:

 

Use of codeine containing products is contraindicated in mothers who are breastfeeding unless prescribed by a doctor.

 

Section 4.6

The following text has been deleted:

 

Insignificant levels of codeine also pass into breast milk. Available published data do not contraindicate breast feeding.

 

The following text has been  added:

 

In nursing mothers, who are ultra-rapid metabolisers of codeine, higher than expected serum and breast milk morphine levels can occur. Morphine toxicity in babies can cause excessive somnolence, hypotonia, miosis and difficulty breastfeeding or breathing. In severe cases respiratory depression and death can occur. In severe cases, naloxone may be appropriate to reverse the effects. The lowest effective dose should be used, for the shortest possible time.

 

Nursing mothers should be informed about carefully monitoring the infant during treatment for any signs and/or symptoms of morphine toxicity such as increased drowsiness or sedation, difficulty breastfeeding, breathing difficulties, miosis and decreased tone, and seeking immediate medical care if such symptoms or signs are noticed. The nursing mother should be informed about monitoring for signs and symptoms of maternal opioid toxicity as well. Should such signs/symptoms be noted in mother or baby, the mother should immediately stop taking all codeine-containing medicines and seek medical advice.

 

Codeine-containing products must not be used while breastfeeding unless prescribed by a docto

Sections 1, 2, 4.4, 5.1, 6.1, 6.4, 6.5, 9 and 10 are updated.