Care Decongestant Oral Liquid

1. Name Of The Medicinal Product

Galsud Linctus or Care Decongestant Oral Liquid

2. Qualitative And Quantitative Composition

Active Ingredient:

Pseudoephedrine hydrochloride BP 30.0mg (Per 5ml Dose).

For full list of excipients, see section 6.1

3. Pharmaceutical Form

Oral Liquid

A deep orange coloured liquid

4. Clinical Particulars

4.1 Therapeutic Indications

Indicated for the relief of nasal, sinus and upper respiratory congestion.

4.2 Posology And Method Of Administration

For oral administration.

Adults and children over 12 years:

Two 5ml spoonfuls three times daily.

Elderly:

Adult dose is appropriate.

4.3 Contraindications

Galsud Linctus should not be used in patients hypersensitive to pseudoephedrine, or any of the other ingredients. It is contra-indicated in patients receiving monoamine oxidase inhibitors or who have received these agents in the last two weeks. Galsud Linctus is contra-indicated in patients with severe renal impairment.

Children under 12 years of age

4.4 Special Warnings And Precautions For Use

Caution should be used in prescribing Galsud Linctus for patients with cardiovascular disease including hypertension, those with diabetes, hyper-thyroidism, raised intraoccular pressure, prostatic enlargement, bladder dysfunction or renal impairment.

Amaranth (E123) and Sunset Yellow (E110) may cause allergic reactions. Sodium Hydroxybenzoates (E215, E217 & E219) may cause allergic reactions (possibly delayed).

Galsud linctus contains 1.0 vol % ethanol (alcohol), ie, up to 154 mg per dose (10ml), equivalent to 4ml beer or 2ml of wine. Harmful for those suffering from alcoholism. To be taken into account in pregnant or breast feeding women, children and high risk groups such as patients with liver disease or epilepsy.

Do not exceed the stated dose

Do not take with other cough and cold medicines

Do not give to children under 12 years

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Caution should be exercised with patients receiving other sympathomimetic agents, appetite suppressants or amphetamine type agents. Pseudoephedrine may antagonise the pressor effects of antihypertensive agents, severe hypertension may occur in patients receiving beta blockers. Hypertensive crisis may occur if pseudoephedrine is co-administered with MAOIs.

There may be an increased risk of arrhythmias if pseudoephedrine is given to patients receiving cardiac glycosides or tricyclic antidepressants.

The antibacterial agent furazolidone is known to cause progressive inhibition of monoamine oxidase. Although there have been no reports of hypertensive crisis, it may not be administered concurrently with Galsud Linctus.

4.6 Pregnancy And Lactation

No data are available on the use of Galsud Linctus in pregnancy. Pseudoephedrine has been used for many years without reports of serious problems.

However, caution is required and pseudoephedrine should be avoided during the first trimester of pregnancy. Pseudoephedrine has been detected in human milk with a small percentage of the total maternal dose potentially administered to the suckling infant. Although the effects on the infant have not been monitored the risk is judged to be low.

4.7 Effects On Ability To Drive And Use Machines

None stated.

4.8 Undesirable Effects

Pseudoephedrine may cause insomnia, anxiety, restlessness, tremor, tachycardia, cardiac arrhythmias, palpitations, hypertension, nausea, vomiting and headache in some patients. Skin rashes and urinary retention in men have occasionally been reported. Sleep disturbances and hallucinations have been reported rarely. A fixed drug eruption, in the form of erythematous nodular patches, has been rarely associated with pseudoephedrine. Rare cases of psychosis have occurred following misuse of pseudoephedrine.

4.9 Overdose

The symptoms of overdose include irritability, nervousness, tremor, palpitations, convulsions, urinary retention, hypertension, restlessness, difficulty in micturition, nausea, vomiting, tachycardia and cardiac arrhythmias.

Overdose should be treated by general supportive measures. In the event of gross overdose, the stomach should be emptied using airway protective gastric lavage. Respiratory and circulatory function should be maintained by supportive measures. Convulsions should be controlled using anti-convulsant therapy. Catheterisation of the bladder may be required.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic Group: Nasal decongestant for systemic use

Sympathomimetics: ATC code: R01B A02

Pseudoephedrine has direct and indirect sympathomimetic activity and is an orally effective upper respiratory tract decongestant. Pseudoephedrine is substantially less potent than ephedrine in producing both tachycardia and elevation in systolic blood pressure and considerably less potent in causing stimulation of the central nervous system.

5.2 Pharmacokinetic Properties

Pseudoephedrine hydrochloride is readily and completely absorbed from the gastro-intestinal tract. It is resistant to metabolism by monoamine oxidase and is largely excreted unchanged in the urine.

5.3 Preclinical Safety Data

There are no pre-clinical data of relevance that are additional to the presciber, which are additional to those already included in other sections of the SmPC.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Citric Acid Monohydrate

Sodium Hydroxybenzoates (E215, E217 & E219)

Alcohol 96%

Amaranth (E123)

Sunset Yellow FCF (E110)

Carmellose Sodium

Saccahrin Sodium

Menthol

Condensed Milk Flavour (F12516)

Orange Flavour (17.40.7040)

Glycerol

Purified Water

6.2 Incompatibilities

None stated.

6.3 Shelf Life

24 months.

6.4 Special Precautions For Storage

Store below 25°C. Protect from light.

6.5 Nature And Contents Of Container

100ml amber glass bottle with a 28mm tamper evident child resistant closure with a low density polyethylene plug.

The 100ml bottle will be cartonned and a 5ml/2.5 ml double-ended CE marked spoon included.

6.6 Special Precautions For Disposal And Other Handling

None stated.

7. Marketing Authorisation Holder

Thornton & Ross Ltd

Linthwaite

Huddersfield

HD7 5QH

United Kingdom

8. Marketing Authorisation Number(S)

PL 00240/0107

9. Date Of First Authorisation/Renewal Of The Authorisation

08 July 2002

30 January 2004

10. Date Of Revision Of The Text

17/02/2010