SYNDOL FILM -COATED

Posology Treatment goals and discontinuation Before initiating treatment with Syndol, treatment duration and treatment goals should be agreed together with the patient, in accordance with pain management guidelines. Duration of treatment 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.

Do not take continuously for more than 3 days without consulting your doctor. The duration of treatment should be as short as possible, and if no effective pain relief is achieved the patients/carers should be advised to seek the views of a healthcare professional.

Adults One or two tablets every four to six hours as needed for relief. Total dosage over a 24 hour period should not normally exceed eight tablets. Elderly and debilitated Codeine should be used with caution in the elderly and debilitated patients as they may be more susceptible to the respiratory depressant effects.

4). Children aged 16 years to 18 years One to two tablets every 6 hours when necessary up to a maximum of 8 tablets in 24 hours. Children aged 12 years to 15 years One tablet every six hours when necessary to a maximum of 4 tablets in 24 hours Method of administration Oral use.

Adverse effects of doxylamine succinate:

Common side effects: CNS effects: Drowsiness (usually diminishes within a few days), paradoxical stimulation, headaches, psychomotor impairment.

Antimuscarinic effects:

Urinary retention, dry mouth, blurred vision, gastrointestinal disturbances, thickened respiratory tract secretions.

Rare side effects:

Hypotension, extrapyramidal effects, dizziness, confusion, depression, sleep disturbances, tremor, convulsions, palpitation, arrhythmia hypersensitivity reactions, blood disorders and liver dysfunction.

Adverse effects of paracetamol:

Blood and lymphatic system disorders Very rare: thrombocytopenia, neutropenia, leukopenia. Not known: agranulocytosis, haemolytic anaemia in particular in patients with underlying glucose 6-phosphate-dehydrogenase deficiency. Immune system disorders Hypersensitivity including skin rash may occur.

Not known:

Anaphylactic shock, angioedema. Skin and subcutaneous tissue disorders Very rare cases of serious skin reactions have been reported. Very rare: erythema, urticaria, rash. Not known: toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome (SJS), acute generalized exanthematous pustulosis, fixed drug eruption.

Hepatobiliary disorders Not known: cytolytic hepatitis, which may lead to acute hepatic failure.

Respiratory, thoracic and mediastinal disorders Not known:

Bronchospasm Metabolism and nutrition disorders High anion gap metabolic acidosis, frequency – not known. 4). Pyroglutamic acidosis may occur as a consequence of low glutathione levels in these patients.

Adverse effects of Codeine:

The most frequent undesirable effects of codeine are constipation and drowsiness. Less frequent effects are nausea, vomiting, sweating, facial flushing, dry mouth, blurred or double vision, dizziness, orthostatic hypotension, malaise, tiredness, headache, anorexia, vertigo, bradycardia, palpitations, respiratory depression, dyspnoea, allergic reactions (itch, skin rash, facial oedema) and difficulties in micturition (dysuria, increased frequency, decrease in amount).

Side effects, which occur rarely, include convulsions, hallucinations, nightmares, uncontrolled muscle movements, muscle rigidity, mental depression and stomach cramps. Very rare cases of pancreatitis have been reported. Immune system disorders Not Known: hypersensitivity.

Psychiatric disorders Not Known: confusional state, dysphoria, euphoria. Long-term use also entails the risk of drug dependence. Nervous system disorders Not Known: seizure, headache, somnolence, dizziness, sedation. Eye disorders Not Known: miosis.

Not Known: visuomotor coordination and visual acuity may be adversely affected in a dose-dependent manner at higher doses or in particularly sensitive patients. Ear and labyrinth disorders Not Known: tinnitus. Skin and subcutaneous tissue disorders Not Known: pruritus.

Renal and urinary disorders Not Known: urinary retention.

Vascular disorders Not Known:

Hypotension. Hepatobiliary disorders Not known: sphincter of Oddi dysfunction Regular prolonged use of codeine is known to lead to addiction and symptoms of restlessness and irritability may result when treatment is stopped. Prolonged use of a painkiller for headaches can make them worse.

Drug dependence Repeated use of Syndol can lead to drug dependence, even at therapeutic doses. 4).

Adverse effects of Caffeine:

Psychiatric disorders Not known: anxiety, insomnia, restlessness and tremor. Gastrointestinal disorders Not known: gastric disorders. Cardiac disorders Not known: heart rate increased. 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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Paediatric population Not recommended for children under 12 years of age. CY2D6 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. 3). All children received doses of codeine that were within the appropriate dose range; however there was evidence that these children were either ultra-rapid 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. Codeine is not recommended in children 12 to 18 years of age with risk factors that may increase their sensitivity to the respiratory depressant effects of codeine. Risk factors include conditions associated with hypoventilation, such as obstructive sleep apnea, obesity, and pulmonary disease.

Do not exceed the stated dose. Do not take concurrently with any other paracetamol or codeine containing compounds. This product may cause drowsiness. Tolerance and opioid use disorder (abuse and dependence) Tolerance, physical and psychological dependence, and opioid use disorder (OUD) may develop upon repeated administration of opioids such as Syndol.

Repeated use of Syndol can lead to OUD. A higher dose and longer duration of opioid treatment can increase the risk of developing OUD. Abuse or intentional misuse of Syndol may result in overdose and/or death. g. major depression, anxiety and personality disorders).

The patient should be made aware of the risks and signs of OUD as set out in the package leaflet. If these signs occur, patients should contact their physician. For patients who experience signs and symptoms of OUD, and/or exibit drug seeking behaviours, review of concomitant opioids and psycho-active drugs (like benzodiazepines) and consultation with an addiction specialist may be required.

Administration must be discontinued gradually after prolonged treatments. There have been reports of drug abuse with codeine, including cases in children and adolescents. Caution is particularly recommended for use in children, adolescents, young adults, and in patients with a history of drug and/or alcohol abuse.

g. coffee, tea, foods, other drugs and beverages) should be avoided while taking this product. Keep out of the reach and sight of children. g. peptic ulcer), recent gastrointestinal surgery, gallstones, myasthenia gravis, a history of cardiac arrhythmias or convulsions, and in patients with a history of drug abuse or emotional instability.

Hepatotoxicity may occur with paracetamol even at therapeutic doses, after short treatment duration and in patients without pre-existing liver dysfunction. Severe cutaneous adverse reactions (SCARs) Life-threatening cutaneous reactions Stevens-Johnson syndrome (SJS), and Toxic epidermal necrolysis (TEN) have been reported with the use of Syndol.

Patients should be advised of the signs and symptoms and monitored closely for skin reactions. g. progressive skin rash often with blisters or mucosal lesions) occur, patients should immediately stop Syndol treatment and seek medical advice.

Patients who have had a cholecystectomy should be treated with caution. The contraction of the sphincter of Oddi can cause symptoms resembling those of myocardial infarction or intensify the symptoms in patients with pancreatitis. Hepatobiliary disorders Codeine may cause dysfunction and spasm of the sphincter of Oddi, thus increasing the risk of biliary tract symptoms and pancreatitis.

Therefore, codeine/paracetamol has to be administered with caution in patients with pancreatitis and diseases of the biliary tract. Codeine may induce faecal impaction, producing incontinence, spurious diarrhoea, abdominal pain and […]

Hypersensitivity to paracetamol, codeine or other opioid analgesics, doxylamine succinate, caffeine, or any of the other constituents. 5). 4). In patients for whom it is known that they are CYP2D6 ultra-rapid metabolisers. Severe hepatocellular insufficiency.