PA Transfer from McNeil Healthcare (Ireland) Ltd to Johnson & Johnson (Ireland) Ltd. Change in PA number. Note the address and contact details remain the same.

The following has been added:

Do not use to make a child sleepy.

Excitability may occur.

Do not use with any other product containing diphenydramine, even one used on skin.

Diphenhydramine may enhance the sedative effects of central nervous system depressants including alcohol, sedatives, and tranquilizers. While taking this product, avoid alcoholic beverages and consult a healthcare professional prior to taking with central nervous system depressants.

Patients with the following conditions should be advised to consult a physician before using diphenhydramine and menthol:

·         A respiratory condition such as emphysema, chronic bronchitis, or acute or chronic bronchial asthma.

·         Glaucoma

Patients with rare hereditary problems of fructose intolerance should not take this medicine.

This medicinal product contains 5 vol % ethanol (alcohol), i.e. up to 200mg per 5ml equivalent to 5ml beer, 2ml wine per 5ml. This can be harmful for those suffering from alcoholism. The ethanol content should be taken into account in pregnant or breast-feeding women, children and high-risk groups such as patients with liver or kidney disease or epilepsy.

This medicinal product contains 16.47 mg sodium per 5ml. This should be taken into consideration by those on a controlled sodium diet.

Section 4.6:

'Fertility' added to title.

'or lactation' added to sentence as follows:

This product should not be used during pregnancy or lactation unless considered essential by the physician.

Section 4.8:

Completley re-written, many additionl side effects added plus frequency etc.

Adverse drug reactions (ADRs) identified during Post marketing experience with diphenhydramine and menthol are included in Table 1.

The frequencies are provided according to the following convention:

Very common ≥1/10

Common ≥1/100 and < 1/10

Uncommon ≥1/1,000 and <1/100

Rare ≥1/10,000 and <1/1,000

Very rare <1/10,000, including isolated reports

Not known (cannot be estimated from the available data)

Table 1 Adverse Drug Reactions Identified During Post-Marketing Experience with Diphenhydramine/ Menthol Frequency Category Estimated from Clinical Trials or Epidemiology Studies*

(*) Frequency category based on clinical trials with single-ingredient diphenhydramine.

Section 4.9:

Symtoms section re-written with more detail and split out with seprate infomration for each active ingredient. Treatment section not changed.

Diphenhydramine

Mild to Moderate Symptoms: Somnolence, anticholinergic syndrome (hyperexia, mydriasis, flushing, fever, tachycardia, dry mouth, urinary retention, decreased bowel sounds, agitation confusion and hallucinations), mild hypertension, nausea and vomiting are common after overdose. Cerebral stimulation in children and occasionally in adults, insomnia, nervousness, tremors, epileptiform convulsions may occur.

Severe Symptoms: Effects may include delirium, psychosis, seizures, coma, hypotension, QRS widening, and ventricular dysrhythmias (including torsades de pointe), but are generally only reported in adults after large ingestions. Rhabdomyolysis and renal failure may rarely develop in patients with prolonged agitation, coma, or seizures. Death may occur as a result of respiratory failure or circulatory collapse.

Menthol

Excessive use of menthol may lead to abdominal pain, vomiting, flushed face, dizziness, weakness, tachycardia, stupor, and ataxia.

Sectiosn 5.1, 5.2 and 5.3:

More detail added.

Section 4.2:

Removal of indication for use in children under 6 years of age.
Addition of maximum daily dose information
Addition of extra warnings:

Use only when simple measures have failed to provide adequate relief.

Use for more than 5 consecutive days is not recommended

Section 4.3

CI in children under 6.


Section 4.4

Children 2 to 6 years: Not more than 3 doses should be given in any 24 hours. 

changed to:

Children 6 to 12 years: Not more than 3 doses should be given in any 24 hours. 

Consult a pharmacist or other healthcare professional before use in children under 6 years.
changed to:

Consult a pharmacist or other healthcare professional before use in children under 12 years.