Last Updated on eMC 25-02-2015 View medicine  | Thornton & Ross Ltd Contact details

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC.  For each version, we show the dates it was published on the eMC and the reasons for change.

Reasons for adding or updating:

  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:18-02-2015

Legal Category:P

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

In section 4.8, MHRA wording on reporting of suspected adverse reactions has been added.

Reasons for adding or updating:

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Fertility, pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose

Date of revision of text on the SPC:15-10-2013

Legal Category:P

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



4.2       Posology and method of administration

 

For oral administration.

 

Adults and children over 12 years:

 

One tablet four times daily.

 

Elderly:

 

Adult dose is appropriate.

 

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 Ppatients receiving monoamine oxidase inhibitors or who have received these agents in the last two weeks.  Patients using other sympathomimetic decongestants or beta-blockers. (See Section 4.5).

 

Patients with cardiovascular disease including ischaemic heart disease, occlusive vascular disease and hypertension.

 

Children under 12 years of age.

 

Patients with:

·         Severe renal impairment

·         Phaeochromocytoma

·         Diabetes

·         Hyperthyroidism

·         Closed angle glaucoma.


4.4       Special warnings and precautions for use

 

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

 

Also use with caution in patients with severe hepatic impairment, or with mild to moderate renal impairment.

 

If any of the following occur, the product should be stopped

·         Hallucinations

·         Restlessness

·         Sleep disturbances.

 

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

 

Do not exceed the stated dose.

Keep out of the sight and reach of children.



4.5       Interaction with other medicinal products and other forms of interaction

 

Caution should be exercised with patients receiving other sympathomimetic agents (e.g. avoid use with apraclonidine), appetite suppressants or other amphetamine type agents -like psychostimulants, as there is a risk of hypertension

 

Pseudoephedrine may antagonise the effects of antihypertensive agents, such as adrenergic neurone blockers, and severe hypertension may occur in patients receiving beta-blockers.  Hypertensive crisis may occur if pseudoephedrine is co-administered with MAOIs.  Concomitant use of pseudoephedrine should be avoided with MAOIs including rasagiline and selegiline, or RIMAs such as moclobemide.

 

There may be increased risk of arrhythmias if pseudoephedrine is given to patients receiving cardiac glycosides, quinidine, or volatile anaesthetics such as cyclopropane, or halothane, or anticholinergic drugs such as tricyclic antidepressants.  Pseudoephedrine also increases the risk of ergotism if used with ergot alkaloids, ergotamine and methysergide.

 

The effects of pseudoephedrine may be antagonised by antipsychotics and its absorption rate may be reduced by kaolin.

 

The effects of pseudoephedrine may be increased by doxapram and oxytocin (as there is a risk of hypertension) and its absorption may be increased by aluminium hydroxide.

 

The antibacterial agent furazolidone is known to cause progressive inhibition of monoamine oxidase (a metabolite of furazolidone is a MAOI).  Although there have been no reports of hypertensive crisis, it may not be administered concurrently with pseudoephedrine.

 


4.6       Fertility, pregnancy and lactation

 

No data are available for the use of this product in pregnancy.  There are limited data from the use of pseudoephedrine in pregnant women. 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. It is advised that pseudoephedrine should be avoided during pregnancy, particularly during the first trimester, as defective closure of the abdominal wall (gastroschisis) has been reported very rarely in new-borns after first trimester exposure.

 

Pseudoephedrine has been detected in human milk with a small percentage of the total maternal dose potentially administered to the suckling infant.  The use of pseudoephedrine should be avoided during breast feeding as lactation may be suppressed, and irritability and disturbed sleep have been reported in breast fed infants. Although the effects on the infant have not been monitored the risk is judged to be low.

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.

The following side effects may be associated with the use of pseudoephedrine:

(frequencies not known: cannot be estimated from the available data).

 

Immune system disorders:

Hypersensitivity reactions – cross-sensitivity may occur with other sympathomimetics.

 

Psychiatric disorders:

Hallucinations (particularly in children), insomnia, sleep disturbances, anxiety, restlessness, irritability, excitability, psychotic disorder has occurred rarely following misuse of pseudoephedrine.

 

Nervous system disorders:

Headache, tremor, dry mouth.

 

Eye disorders:

Angle-closure glaucoma.

 

Cardiac disorders:

Tachycardia, palpitations, arrhythmia.

 

Vascular disorders:

Hypertension, impaired circulation to the extremities.

 

Gastrointestinal disorders:

Nausea, vomiting.

 

Skin and subcutaneous tissue disorders:

Fixed drug eruption in the form of erythematous nodular patches, rash.

 

Renal and urinary disorders:

Urinary retention.

 

4.9       Overdose

 

The symptoms of overdose include irritability, nervousness, tremor, cardiac arrhythmias, palpitations, tachycardia, convulsions, urinary retention and hypertension, restlessness, dry mouth, anxiety, insomnia, nausea, vomiting and possible tolerance to pseudoephedrine.

 

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. 

 

The benefit of gastric decontamination is uncertain.  Consider activated charcoal (charcoal dose: 50 g for adults; 1g/kg for children). Optimal effects are within 1 hour of ingestion of more than a toxic dose. Volunteer studies suggest that there is reduced absorption within 2 hours and efficacy declines thereafter.  Alternatively consider gastric lavage in adults within 1 hour of a potentially life-threatening overdose.  Monitor pulse, blood pressure and cardiac rhythm.  Treat any hypertension or convulsions as necessary.

           

Asymptomatic patients should be observed for 4 hours or 8 hours if a slow release product has been taken.

If desired, the elimination of pseudoephedrine can be accelerated by acid diuresis or by dialysis.


Reasons for adding or updating:

  • Change to section 1 - Name of the medicinal product

Date of revision of text on the SPC:13-12-2012

Legal Category:P

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Deletion of non marketed names

Reasons for adding or updating:

  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC

Date of revision of text on the SPC:01-01-0001

Legal Category:P

Black Triangle (CHM): NO