Care Decongestant Tablets

1. Name Of The Medicinal Product

Galsud Tablets

Care Decongestant Tablets

2. Qualitative And Quantitative Composition

Active Ingredient:

Pseudoephedrine hydrochloride BP 60.0mg (Per Tablet).

For full list of excipients, see section 6.1

3. Pharmaceutical Form

Tablets.

Round, curved white tablets embossed with “60” on one side.

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:

One tablet four times daily.

Children under 12 years:

Not recommended.

4.3 Contraindications

This product 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.

4.4 Special Warnings And Precautions For Use

Caution should be used when prescribing pseudoephedrine for patients with cardiovascular disease including hypertension, those with diabetes, hyperthyroidism, raised intraocular pressure, prostatic enlargement or bladder dysfunction.

Patients with rare hereditary problems of galactose intolerance, the LAPP lactase deficiency or glucose-galactose malabsorption should not take this medicine.

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 other amphetamine type agents. Pseudoephedrine may antagonise the effects of antihypertensive agents, severe hypertension may occur in patients receiving beta-blockers. Hypertensive crisis may occur if pseudoephedrine is co-administered with MAOIs.

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 pseudoephedrine.

4.6 Pregnancy And Lactation

No data are available for the use of this product 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 in some patients. Sleep disturbances and hallucinations have been reported rarely. A fixed drug eruption, in the form of erythematous nodular patches, has been associated rarely with pseudoephedrine.

4.9 Overdose

The symptoms of overdose include irritability, nervousness, tremor, palpitations, convulsions, urinary retention and hypertension.

Overdose should be treated by general supportive measures. In the event of gross overdose, the stomach should be emptied using airways 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 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

Lactose

Microcrystalline cellulose

Magnesium stearate

6.2 Incompatibilities

None stated.

6.3 Shelf Life

Three years from the date of manufacture.

6.4 Special Precautions For Storage

Store in a cool dry place.

Protect from light.

6.5 Nature And Contents Of Container

White opaque PVC blister 250 microns thick backed by hard temper aluminium foil 20 microns thick.

Pack sizes 4, 8 and 12 tablets.

6.6 Special Precautions For Disposal And Other Handling

None stated.

7. Marketing Authorisation Holder

Thornton & Ross Limited

Linthwaite

Huddersfield

West Yorkshire

HD7 5QH

United Kingdom

8. Marketing Authorisation Number(S)

PL 00240/0109

9. Date Of First Authorisation/Renewal Of The Authorisation

31 May 2003

10. Date Of Revision Of The Text

13/03/2009