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Document: spc-doc_PL 33414-0147 change

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• spc-doc_PL 33414-0147

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SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

ZIZ Extra Strength

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains 25 mg of the active substance Promethazine Hydrochloride Also contains 35.44 mg of lactose.

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 of allergic conditions of the upper respiratory tract and skin: including allergic rhinitis, urticaria and anaphylactic reactions to drugs or 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 because the safety of such use has not been established.

As an antihistamine in allergy:

Children 2-5 years	The use of Promethazine liquid is recommended for this age group.
Children 5-10 years	25 mg as a single dose*. Maximum daily dose 25 mg.
Children over 10 years and adults (including elderly)	25 mg as a single dose*. Increasing to a maximum of 25 mg twice a day as

4.3 Contraindications

Ziz Extra Strength 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 Extra Strength 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 Extra Strength 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 disease, narrow angle glaucoma, epilepsy, urinary retention or hepatic and renal insufficiency.

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 and cause 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 producing 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 include drowsiness, dizziness, restlessness, headaches, psychomotor impairment, nightmares, tiredness, and disorientation.

Anticholinergic side effects such as urinary retention, dry mouth and 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

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.

5.1    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 crossed 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 Blue AS-F-4321G (contains Indigo Carmine E132, Patent Blue E131, Titanium Dioxide E171 and Sodium Benzoate E211)

Sucrose Beeswax Carnauba Wax

6.2 Incompatibilities

Promethazine Hydrochloride is incompatible with alkaline substances which precipitate Promethazine Base.

6.3    Shelf life

Polystyrene/polypropylene containers - 36 months PVC/Aluminium strips - 24 months

6.4    Special precautions for storage

Containers: Do not store above 25°C. Keep the container tightly closed. Store in the original container.

Strips: Do not store above 25°C. Store in the original package. Keep container in the outer carton.

6.5 Nature and contents of container

High density polystyrene with polythene lids and/or polypropylene containers with polypropylene or polythene lids and polyurethane/polythene inserts.

Packs of 100, 500 and 1000 tablets.

PVC/Aluminium foil strips.

Packs of 10, 30 and 56 tablets.

6.6 Special precautions for disposal

No special precautions.

7    MARKETING AUTHORISATION HOLDER

Chelonia Healthcare Limited 11 Boumpoulinas Street,

3^rd Floor, 1060 Nicosia Cyprus

8    MARKETING AUTHORISATION NUMBER(S)

PL 33414/0147

DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

28/11/2006

DATE OF REVISION OF THE TEXT

27/05/2016