- Approval Id
- b3f764d0fd2f2808
- Drug Approval Emc Name
- Hydroxyzine hydrochloride 25 mg film-coated tablets
- Drug Name
- Hydroxyzine hydrochloride 25 mg film-coated tablets
- Company Address
- Morningside House, Unit C Harcourt Way, Meridian Business Park, Leicester, LE19 1WP
- Company Website
- http://www.morningsidehealthcare.com
- Company Telephone
- +44 (0)116 204 5950
- Company Medical Info Direct Line
- +44 (0)116 478 0322
- Company Medical Info Email
- [email protected]
- Company Customer Care Direct Line
- +44 (0)116 204 5950
- Company Stock Availability
- +44 (0)1509 217 705
- Atc Code
- N05BB01
- Legal Category
- Prescription only medicine
- Authorisation Holder
- 7. Marketing authorisation holder Morningside Healthcare Ltd, Unit C, Harcourt Way Leicester, LE19 1WP, UK
- Authorisation Number
- 8. Marketing authorisation number(s) PL 20117/0318
- Authorisation Date
- 9. Date of first authorisation/renewal of the authorisation 27/08/2025
- Instruction Authorisation Holder
- 7. Marketing authorisation holder Morningside Healthcare Ltd, Unit C, Harcourt Way Leicester, LE19 1WP, UK
- Instruction Authorisation Number
- 8. Marketing authorisation number(s) PL 20117/0318
- Instruction Authorisation Date
- 9. Date of first authorisation/renewal of the authorisation 27/08/2025
- Instruction Composition
- 2. Qualitative and quantitative composition Each film-coated tablet contains Hydroxyzine hydrochloride 25mg. Excipient with known effect Each film-coated tablet contains 149mg lactose monohydrate. For the full list of excipients, see section 6.1.
- Instruction Dosage Form
- 3. Pharmaceutical form Film-coated tablets (tablets) White, circular, biconvex film-coated tablets with X25 debossed on one side having a diameter of 8.6 mm.
- Instruction Clinical Particulars
- 4. Clinical particulars 4.1 Therapeutic indications Hydroxyzine Tablets are indicated to assist in the management of anxiety in adults. Hydroxyzine Tablets are indicated for the management of pruritus associated with acute and chronic urticaria, including cholinergic and physical types, and atopic and contact dermatitis in adults and children. 4.2 Posology and method of administration Posology Hydroxyzine Tablets should be used at the lowest effective dose and for the shortest possible duration. In adults and children over 40 kg in weight, the maximum daily dose is 100mg per day. Anxiety Adults 50-100mg daily in divided doses Pruritis Adults Starting dose of 25mg at night increasing as necessary to 25mg three or four times daily. Elderly In the elderly, the maximum daily dose is 50 mg per day (see section 4.4). A reduced dose is advised. This is due to a possible increase in the volume of distribution, prolonged action and the possible effect of age-related changes on pharmacologic functions, including hepatic metabolism and renal excretion (see Section
- Instruction Pharmacology
- 5. Pharmacological properties 5.1 Pharmacodynamic properties Pharmacotherapeutic group: Anxiolytics ATC code: N05B B01 Hydroxyzine hydrochloride is unrelated chemically to benzodiazepines, phenothiazines, reserpine and meprobamate. Mechanism of Action Hydroxyzine is a first generation antihistamine, a piperazine derivative, with antimuscarinic and sedative properties. Antihistamines act as competitive antagonists of histamine at H1 histamine receptors, thus inhibiting H1 receptor-mediated reactions, such as vasodilation, flare and itch reactions and sneezing. First-generation H1 antagonists easily cross the blood-brain barrier, consequently producing well-documented sedative and anticholinergic effects. First-generation antihistamines also have affinity for 5-HT receptors, alphaadrenoreceptors, and muscarinic receptors. They also reduce cyclic GMP concentrations, increase atrioventricular nodal conduction, and inhibit activation of airway vagal afferent nerves. Pharmacodynamic effects Hydroxyzine has CNS depressant, anticholinergic, antispasmodic, and local anaesthetic activity, in addition to antihistaminic effects. The drug also has sedative, antiemetic and primary skeletal muscle relaxant activity. An onset of sedative action of hydroxyzine is usually noted within 15 to 30 minutes after oral administration. Sedative effects persist for 4-6 hours following administration of a single dose. Hydroxyzine suppresses the inflammatory response (wheal and flare reaction) and pruritus for up to 4 days after intradermal skin tests with allergens and histamine. The therapeutic range for plasma hydroxyzine concentrations and the relationship of plasma concentration to clinical response or toxicity have not been established. Hydroxyzine does not appear to increase gastric secretions or acidity, and usually has mild antisecretory effects. It induces a calming effect in anxious tense adults. It is not a cortical depressant, but its action may be due to a suppression of activity in certain key regions of the subcortical area of the central nervous system Clinical efficacy and safety Hydroxyzine Tablets has been shown clinically to be a rapid-acting anxiolytic with a wide margin of safety. Antihistamine effects have been demonstrated experimentally and confirmed clinically; it is highly effective in alleviating pruritus Paediatric population The pharmacokinetics and antipruritic effects of hydroxyzine were studied in 12 children (mean age
- Instruction Pharmaceutical Particulars
- 6. Pharmaceutical particulars 6.1 List of excipients Tablet Core: Lactose monohydrate; Microcrystalline cellulose; Croscarmellose sodium; Silica, colloidal anhydrous; Magnesium stearate. Tablet Coating: Opadry white Y-1-7000 which contains Hypromellose 2910, Titanium dioxide (E 171), Polyethylene glycol 400 (E 1520). 6.2 Incompatibilities Hydroxyzine hydrochloride has been reported to be incompatible with aminophylline, benzylpenicillin salts, chloramphenicol sodium succinate, dimenhydrinate, doxorubicin hydrochloride (in a liposomal formulation), thioridazine, and some soluble barbiturates. 6.3 Shelf life 3 years 6.4 Special precautions for storage This medicinal product does not require any special storage conditions. 6.5 Nature and contents of container PVC/Aclar-Alu blister pack containing packs of 7, 10, 14, 15, 20, 28, 30, 56, 60, 84, 90, 100, 112 and 120 tablets are available. Not all pack sizes may be marketed. 6.6 Special precautions for disposal and other handling No special requirements.
- Instruction Content
- ## Composition
2. Qualitative and quantitative composition Each film-coated tablet contains Hydroxyzine hydrochloride 25mg. Excipient with known effect Each film-coated tablet contains 149mg lactose monohydrate. For the full list of excipients, see section 6.1.
## Pharmaceutical Form
3. Pharmaceutical form Film-coated tablets (tablets) White, circular, biconvex film-coated tablets with X25 debossed on one side having a diameter of 8.6 mm.
## Clinical Particulars
4. Clinical particulars 4.1 Therapeutic indications Hydroxyzine Tablets are indicated to assist in the management of anxiety in adults. Hydroxyzine Tablets are indicated for the management of pruritus associated with acute and chronic urticaria, including cholinergic and physical types, and atopic and contact dermatitis in adults and children. 4.2 Posology and method of administration Posology Hydroxyzine Tablets should be used at the lowest effective dose and for the shortest possible duration. In adults and children over 40 kg in weight, the maximum daily dose is 100mg per day. Anxiety Adults 50-100mg daily in divided doses Pruritis Adults Starting dose of 25mg at night increasing as necessary to 25mg three or four times daily. Elderly In the elderly, the maximum daily dose is 50 mg per day (see section 4.4). A reduced dose is advised. This is due to a possible increase in the volume of distribution, prolonged action and the possible effect of age-related changes on pharmacologic functions, including hepatic metabolism and renal excretion (see Section
## Pharmacological Properties
5. Pharmacological properties 5.1 Pharmacodynamic properties Pharmacotherapeutic group: Anxiolytics ATC code: N05B B01 Hydroxyzine hydrochloride is unrelated chemically to benzodiazepines, phenothiazines, reserpine and meprobamate. Mechanism of Action Hydroxyzine is a first generation antihistamine, a piperazine derivative, with antimuscarinic and sedative properties. Antihistamines act as competitive antagonists of histamine at H1 histamine receptors, thus inhibiting H1 receptor-mediated reactions, such as vasodilation, flare and itch reactions and sneezing. First-generation H1 antagonists easily cross the blood-brain barrier, consequently producing well-documented sedative and anticholinergic effects. First-generation antihistamines also have affinity for 5-HT receptors, alphaadrenoreceptors, and muscarinic receptors. They also reduce cyclic GMP concentrations, increase atrioventricular nodal conduction, and inhibit activation of airway vagal afferent nerves. Pharmacodynamic effects Hydroxyzine has CNS depressant, anticholinergic, antispasmodic, and local anaesthetic activity, in addition to antihistaminic effects. The drug also has sedative, antiemetic and primary skeletal muscle relaxant activity. An onset of sedative action of hydroxyzine is usually noted within 15 to 30 minutes after oral administration. Sedative effects persist for 4-6 hours following administration of a single dose. Hydroxyzine suppresses the inflammatory response (wheal and flare reaction) and pruritus for up to 4 days after intradermal skin tests with allergens and histamine. The therapeutic range for plasma hydroxyzine concentrations and the relationship of plasma concentration to clinical response or toxicity have not been established. Hydroxyzine does not appear to increase gastric secretions or acidity, and usually has mild antisecretory effects. It induces a calming effect in anxious tense adults. It is not a cortical depressant, but its action may be due to a suppression of activity in certain key regions of the subcortical area of the central nervous system Clinical efficacy and safety Hydroxyzine Tablets has been shown clinically to be a rapid-acting anxiolytic with a wide margin of safety. Antihistamine effects have been demonstrated experimentally and confirmed clinically; it is highly effective in alleviating pruritus Paediatric population The pharmacokinetics and antipruritic effects of hydroxyzine were studied in 12 children (mean age
## Pharmaceutical Particulars
6. Pharmaceutical particulars 6.1 List of excipients Tablet Core: Lactose monohydrate; Microcrystalline cellulose; Croscarmellose sodium; Silica, colloidal anhydrous; Magnesium stearate. Tablet Coating: Opadry white Y-1-7000 which contains Hypromellose 2910, Titanium dioxide (E 171), Polyethylene glycol 400 (E 1520). 6.2 Incompatibilities Hydroxyzine hydrochloride has been reported to be incompatible with aminophylline, benzylpenicillin salts, chloramphenicol sodium succinate, dimenhydrinate, doxorubicin hydrochloride (in a liposomal formulation), thioridazine, and some soluble barbiturates. 6.3 Shelf life 3 years 6.4 Special precautions for storage This medicinal product does not require any special storage conditions. 6.5 Nature and contents of container PVC/Aclar-Alu blister pack containing packs of 7, 10, 14, 15, 20, 28, 30, 56, 60, 84, 90, 100, 112 and 120 tablets are available. Not all pack sizes may be marketed. 6.6 Special precautions for disposal and other handling No special requirements.
- Company Detail Path
- /organization/morningside-healthcare-ltd
