Special Warning : אזהרת שימוש

   4.4 Special warnings and precautions for use
Dexchlorpheniramine maleate
• Dexchlorpheniramine maleate may cause drowsiness and may add to the effects of alcohol.
Drowsiness may continue the following day. Those affected should not drive or operate machinery; alcohol should be avoided.

• Dexchlorpheniramine maleate should be used with caution in patients with:  narrow-angle glaucoma
 stenosing peptic ulcer
 prostatic hypertrophy
 bladder neck obstruction
 pyloroduodenal obstruction
 cardiovascular disease including hypertension
 increased intraocular pressure
 hyperthyroidism
 use with caution in patients with renal or hepatic impairment
 seizures

Dexchlorpheniramine maleate may cause photosensitivity in some patients.

Pediatric Use
Dexchlorpheniramine maleate is contraindicated in children under 6 years of age.
Children may experience paradoxical excitation with dexchlorpheniramine maleate. In children this may cause excitability.

Use in the Elderly
The elderly may experience paradoxical excitation with dexchlorpheniramine maleate. In patients over 60 years of age, antihistamines may cause dizziness, sedation and hypotension.
Also they are more likely to have central nervous system (CNS) depressive side effects, including confusion.

Effect on laboratory tests
Antihistamines should be discontinued approximately 48 hours prior to skin testing procedures since these medicines may prevent or diminish otherwise positive reactions to dermal reactivity indicators.

Pseudoephedrine

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 reversible 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.

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).

Sodium
Nussidex contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium- free’.

Lactose
Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucosegalactose malabsorption should not take this medicine.

4.5 Interaction with other medicinal products and other forms of interactions

Effects on Driving

4.7 Effects on ability to drive and use machines
May cause drowsiness and may add to the effects of alcohol. Drowsiness may continue the following day. Those affected should not drive or operate machinery; alcohol should be avoided.
Patients should be cautioned about engaging in activities such as driving a car or operating machinery, until they have established their own response to the drug.