Ziz
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
ZIZ
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10 mg of the active substance Promethazine Hydrochloride Also contains 23.6 mg of lactose and 33.7 mg of sucrose.
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Sugar-coated tablet Blue sugar coated tablet
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
As symptomatic treatment for allergic conditions of the upper respiratory tract and skin including allergic rhinitis, urticaria and anaphylactic reactions to drugs and foreign proteins.
As an antiemetic.
For short term use:
- Treatment of insomnia in adults.
- As a paediatric sedative.
4.2 Posology and method of administration
Route of administration: Oral
Not for use in children under the age of 2 years (see section 4.3)
As an antihistamine in allergy:
|
Children 2-5 years |
The use of Promethazine liquid is recommended for this age group. |
|
Children 5-10 years |
Either 10 or 20 mg as a single dose*. Or 10 mg bd. Maximum daily dose 20 mg. |
|
Children over 10 years and |
Initially 10 mg bd. |
adults (including elderly)
Increasing to a maximum of 20 mg tds as required.
*Single doses are best taken at night.
As an antiemetic:
|
Children 2-5 years |
The use of Promethazine liquid is recommended for this age group. |
|
Children 5-10 years |
10 mg to be taken the night before the journey. To be repeated after 6-8 hours as required. |
|
Children over 10 years and adults (including elderly) |
20 mg to be taken the night before the journey. To be repeated after 6-8 hours as required. |
As a paediatric sedative for short term use and for short term treatment of insomnia in adults:
|
Children 2-5 years |
The use of a promethazine liquid is recommended for this age group. |
|
Children 5-10 years |
20 mg as a single dose at bedtime |
|
Children over 10 years and adults (including elderly) |
20 mg to be taken at bedtime, which may be increased up to 50 mg if necessary. |
4.3 Contraindications
Ziz should not be used in patients:
• in coma or;
• suffering from CNS depression of any cause or,
• with a known hypersensitivity to promethazine or other phenothiazines, or any of the inactive ingredients of the tablet.
Ziz is contraindicated for use in children less than two years old because of the potential for fatal respiratory depression. (This includes neonates and premature infants.)
Ziz should be avoided in patients taking monoamine oxidase inhibitors up to 14 days previously.
4.4 Special warnings and precautions for use
Promethazine hydrochloride should be used with caution in patients with hepatic disease.
Promethazine may thicken or dry lung secretions and impair expectoration. Therefore caution should be exercised in patients who might be at risk from the anti-cholinergic actions of the drug, including those with asthma, bronchitis or bronchiectasis.
Use with caution in patients with severe coronary artery disease, narrow angle glaucoma, epilepsy, urinary retention or hepatic and renal insufficiency (where dose reduction may be necessary).
Caution should be exercised in patients with prostatic hypertrophy and bladder neck or pyloro-duodenal obstruction.
There have been case reports of drug abuse with promethazine. The risk of abuse is greater in patients with a history of drug abuse.
As with neuroleptics, Neuroleptic Malignant Syndrome (NMS) characterized by hyperthermia, extrapyramidal disorders, muscle rigidity, altered mental status, autonomic nervous instability and elevated CPK, may occur. As this syndrome is potentially fatal, promethazine must be discontinued immediately and intensive clinical monitoring and symptomatic treatment should be initiated.
Promethazine may mask the warning signs of ototoxicity caused by ototoxic drugs e.g. salicylates. It may also delay the early diagnosis of intestinal obstruction or raised intracranial pressure through the suppression of vomiting.
Promethazine should be prescribed with caution in children and the elderly, as they are more susceptible to side effects.
The use of promethazine should be avoided in children and adolescents with signs and symptoms suggestive of Reye’s Syndrome.
Patients with rare hereditary problems of lactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Promethazine should not be used for more than 7 days without seeking medical advice.
4.5 Interaction with other medicinal products and other forms of interaction
Promethazine will enhance the action of any anti-cholinergic agent, tricyclic antidepressant, sedative, hypnotic. Alcohol should be avoided during treatment.
Promethazine may interfere with immunological urine pregnancy tests to produce false- positive or false-negative results.
Promethazine should be discontinued at least 72 hours before the start of skin tests as it may inhibit the cutaneous histamine response and thus produce false-negative results.
4.6 Fertility, pregnancy and lactation
Promethazine should not be used in pregnancy unless the physician considers it essential. The use of Promethazine is not recommended in the 2 weeks prior to delivery in view of the risk of irritability and excitement in the neonate.
Available evidence suggests that the amount of Promethazine excreted in breast milk is insignificant. However, there are risks of neonate irritability and excitement.
4.7 Effects on ability to drive and use machines
Because the duration of action may be up to 12 hours, patients should be advised that if they feel drowsy they should not drive or operate heavy machinery.
4.8 Undesirable effects
The following CIOMS frequency rating is used: Very common (>1/10); common (>1/100 to <1/10); uncommon (>1/1000 to <1/100); rare (>1/10 00 to <1/1000); very rare (<1/10 000), not known (cannot be estimated from the available data).
Side effects may be seen in a few patients: drowsiness, dizziness, restlessness, headaches, psychomotor impairment, nightmares, tiredness, and disorientation.
Anticholinergic side effects such as urinary retention, dry mouth, blurred vision, difficulty in lachrymation and gastrointestinal disturbances, like constipation occur occasionally. Retention of urine may exacerbate the symptoms of prostatism.
Infants are susceptible to the anticholinergic effects of promethazine, while other children may display paradoxical hyperexcitability.
The elderly are more prone to the anti-cholinergic effects and confusion due to promethazine.
Other side effects include urticaria, rashes, pruritus, anorexia, gastric irritation, palpitations, arrhythmias, hypotension, extrapyramidal effects, confusion, depression, sleep disturbances, tremor, convulsions, muscle spasms and tic-like movements of the head and face.
Anaphylaxis, jaundice, blood dyscrasias including haemolytic anaemia or liver dysfunction rarely occur.
Hypersensitivity reactions include bronchospasm, angioedema, skin reactions and photosensitivity reactions have been reported; strong sunlight should be avoided during treatment.
Not known (cannot be estimated from the available data): Neuroleptic Malignant Syndrome
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. Healthcare professionals are asked to report any suspected adverse reactions via Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
The following CIOMS frequency rating is used: Very common (>1/10); common (>1/100 to <1/10); uncommon (>1/1000 to <1/100); rare (>1/10 00 to <1/1000); very rare (<1/10 000), not known (cannot be estimated from the available data).
Side effects may be seen in a few patients: drowsiness, dizziness, restlessness, headaches, nightmares, tiredness, and disorientation.
Anticholinergic side effects such as urinary retention, dry mouth and blurred vision, occur occasionally.
Infants are susceptible to the anticholinergic effects of promethazine, while other children may display paradoxical hyperexcitability.
The elderly are more prone to the anti-cholinergic effects and confusion due to promethazine.
Other side effects include urticaria, rashes, pruritus, anorexia, gastric irritation, palpitations, arrhythmias, hypotension, extrapyramidal effects, muscle spasms and tic-like movements of the head and face.
Anaphylaxis, jaundice, blood dyscrasias including haemolytic anaemia rarely occur.
Photosensitivity reactions have been reported; strong sunlight should be avoided during treatment.
Not known (cannot be estimated from the available data): Neuroleptic Malignant Syndrome
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. Healthcare professionals are asked to report any suspected adverse reactions via Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
4.9 Overdose
The symptoms of severe overdose are variable. They are characterised in children by various combinations of excitation, ataxia, unco-ordination, athetosis and hallucinations, while adults may become drowsy and lapse into coma.
Convulsions may occur in both adults and children; coma or excitement may precede their occurrence. Cardiorespiratory depression is uncommon.
If the patient is seen soon enough after ingestion, it should be possible to induce vomiting with ipecacuanha despite the anti-emetic effect of Promethazine; alternatively, gastric lavage may be used.
Treatment is otherwise supportive with attention to maintenance of adequate respiratory and circulatory status. Convulsions should be treated with Diazepam or other suitable anticonvulsant.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Antihistamines for systemic use; Phenothiazine derivatives, ATC code: R06AD02
Potent, long acting, antihistamine with additional anti-emetic central sedative and anti-cholinergic properties.
5.2 Pharmacokinetic properties
Promethazine is distributed widely in the body. It enters the brain and crosses the placenta. Phenothiazines pass into the milk at low concentrations.
5.3 Preclinical safety data
No relevant information additional to that contained elsewhere in the SPC.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Core:
Lactose Maize Starch
Maize Starch, Pregelatinised Magnesium Stearate
Coating:
Bleached Shellac Talc
Titanium Dioxide Povidone
Opalux AS-80924-Blue (containing Sucrose, Brillant Blue FCF lake E133, Indigo carmine lake E132, Titanium dioxide E171, Povidone, Sodium Benzoate)
6.2 Incompatibilities
Promethazine Hydrochloride is incompatible with alkaline substances which precipitate Promethazine Base.
6.3 Shelf life
36 Months
6.4 Special precautions for storage
Do not store above 25°C. Store in the original packaging. Keep in the outer carton.
6.5 Nature and contents of container
Strips of 250 micron PVC and 20 micron aluminium foil, with 5/6 gsm heat-seal lacquer on the dull side and printed on the bright side.
6.6 Special precautions for disposal
No special precautions.
7 MARKETING AUTHORISATION HOLDER
Chelonia Healthcare Limited 11 Boumpoulinas Street,
3rd Floor, 1060 Nicosia Cyprus
8 MARKETING AUTHORISATION NUMBER(S)
PL 33414/0146
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
28/11/2006
10
DATE OF REVISION OF THE TEXT
03/10/2016