Special Warning : אזהרת שימוש

4.4 Special warnings and precautions for use

Patients experiencing difficulty in urination and/or enlargement of the prostate, or patients with thyroid disease who are receiving thyroid hormones should not take pseudoephedrine unless directed by a physician.
Caution should be exercised when using the product in the presence of severe hepatic impairment or moderate to severe renal impairment (particularly if accompanied by cardiovascular disease), or in occlusive vascular disease. The hazards of overdose are greater in those with non-cirrhotic alcoholic liver disease.
If any of the following occur, this product should be stopped:
• Hallucinations
• Restlessness
• Sleep disturbances
Severe Skin reactions: Severe skin reactions such as acute generalized exanthematous pustulosis (AGEP) may occur with pseudoephedrine-containing products. This acute pustular eruption may occur within the first 2 days of treatment, with fever, and numerous, small, mostly non-follicular pustules arising on a widespread oedematous erythema and mainly localized on the skin folds, trunk, and upper extremities. Patients should be carefully monitored. If signs and symptoms such as pyrexia, erythema, or many small pustules are observed, administration of this medicine should be discontinued, and appropriate measures taken if needed.
Ischaemic colitis: Some cases of ischaemic colitis have been reported with pseudoephedrine. Pseudoephedrine should be discontinued, and medical advice sought if sudden abdominal pain, rectal bleeding or other symptoms of ischaemic colitis develop.
Ischaemic optic neuropathy: Cases of ischaemic optic neuropathy have been reported with pseudoephedrine.
Pseudoephedrine should be discontinued if sudden loss of vision or decreased visual acuity such as scotoma occurs.
Posterior reversible encephalopathy syndrome (PRES) and reversable cerebral vasoconstriction syndrome (RCVS) Cases of PRES and RCVS have been reported with the use of pseudoephedrine containing products (see section 4.8). The risk is increased in patients with severe or uncontrolled hypertension, or with severe acute or chronic kidney disease/renal failure (see section 4.3).
Pseudoephedrine should be discontinued and immediate medical assistance sought if the following symptoms occur: sudden severe headache or thunderclap headache, nausea, vomiting, confusion, seizures and/or visual disturbances. Most reported cases of PRES and RCVS resolved following discontinuation and appropriate treatment

Taking this product with other paracetamol-containing products, could lead to overdose and should therefore be avoided.
Caution is advised if paracetamol is administered concomitantly with flucloxacillin due to increased risk of high anion gap metabolic acidosis (HAGMA), particularly in patients with severe renal impairment, sepsis, malnutrition and other sources of glutathione deficiency (e.g. chronic alcoholism), as well as those using maximum daily doses of paracetamol.
Close monitoring, including measurement of urinary 5-oxoproline, is recommended.
For Paracetamol
Paracetamol has been associated with a risk of rare but serious skin reactions. These skin reactions, known as Stevens- Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN), and acute generalized exanthematous pustulosis (AGEP), can be fatal. Reddening of the skin, rash, blisters, and detachment of the upper surface of the skin can occur with the use of drug products that contain paracetamol. These reactions can occur with first-time use of paracetamol or at any time while it is being taken.

Anyone who develops a skin rash or reaction while using paracetamol should stop the drug and seek medical attention right away. Anyone who has experienced a serious skin reaction with paracetamol should not take the drug again and should contact their health care professional to discuss alternative pain relievers/fever reducers.
Acamol Tsinun Liquigel Night SK 08.2024                                                                                            2/8 Health care professionals should be aware of this rare risk and consider paracetamol along with other drugs already known to have such an association, when assessing patients with potentially drug induced skin reactions.

Paracetamol can cause accidental poisoning in toddlers and infants. Paracetamol-containing products should be kept well out of reach of children.

Potentially fatal hepatotoxicity can result from paracetamol overdosage. However, in rare cases, hepatotoxicity has occurred in patients receiving high or excessive doses within therapeutic doses. Certain patients may be more susceptible to paracetamol hepatotoxicity, e.g., chronic alcoholics, patients with liver disease, or those who are malnourished or taking other drugs that induce hepatic enzymes.

Because of the risk of heptotoxicity, patients should be cautioned against the inadvertent administration of excessive doses of paracetamol by using multiple paracetamol-containing products at once, such as cough and cold remedies, analgesics or arthritic formulations, antipyretics or products for relief of menstrual symptoms or muscle spasm. Administration of paracetamol to children may be especially prone to error due to the many concentrations and strengths of products available.
To avoid dosing errors, all product labels should be checked carefully to ensure calculation of the amount of paracetamol to be given.

Chlorphenamine in common with other drugs having anticholinergic effects, should be used with caution in epilepsy,raised intra-ocular pressure including glaucoma, prostatic hypertrophy; severe hypertension or cardiovascular disease; bronchitis, bronchiectasis or asthma; hepatic impairment; renal impairment. Children and the elderly are more likely toexperience the neurological anticholinergic effects and paradoxical excitation (eg. increased energy, restlessness,nervousness). Avoid use in elderly patients with confusion.
The anticholinergic properties of chlorphenamine may cause drowsiness, dizziness, blurred vision and psychomotor impairment in some patients which may seriously affect ability to drive and use machinery.
Concurrent use with drugs which cause sedation such as anxiolytics and hypnotics may cause an increase in sedative effects, therefore medical advice should be sought before taking chlorphenamine concurrently with these medicines.
The effects of alcohol may be increased and therefore concurrent use should be avoided.
Should not be used with other antihistamine containing products, including antihistamine containing cough and cold medicines.

Risks of abuse
Pseudoephedrine carries the risk of abuse. Increased doses may ultimately produce toxicity. Continuous use can lead to tolerance resulting in an increased risk of overdosing. The recommended maximum dose and treatment duration should not be exceeded (see section 4.2).

Keep out of the sight and reach of children.
Do not exceed recommended dose.

Effects on Driving

4.7 Effects on ability to drive and use machines
This medicine can impair cognitive function and can affect a patient's ability to drive safely.
The anticholinergic properties of chlorphenamine may cause drowsiness, dizziness, blurred vision and psychomotor impairment which can seriously hamper the patient's ability to drive and use machinery 
When taking this medicine, patients should be told:

•         The medicine is likely to affect your ability to drive
•         Do not drive until you know how the medicine affects you