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Sudafed (pseudoephedrine)

Travellers familiar with Sudafed (pseudoephedrine) from one of its registered markets are unlikely to encounter this exact registration elsewhere — it is recorded in only eight countries, clustered loosely across parts of Europe, the Middle East, and South Asia. The active ingredient is pseudoephedrine, classified among nasal preparations with antitussive activity.

Pseudoephedrine is used for the symptomatic relief of nasal congestion associated with the common cold and a blocked nose. It is a decongestant rather than a treatment for the underlying infection, and it is one of the more recognisable molecules in the over-the-counter cold and flu category internationally — even where this specific Sudafed registration is not present, products containing the same active ingredient are typically available under other brand names.

The eight-country footprint of this particular registration includes India, Poland, Oman, Portugal, and Estonia, among others. Outside these markets, a reader who knows Sudafed from home will often find a comparable pseudoephedrine-containing product on a pharmacy shelf abroad, but the brand, packaging, and regulatory pathway can look quite different. In several countries pseudoephedrine is kept behind the pharmacy counter and requires identification or a brief consultation, while in others it is sold more freely or only with a prescription.

Other decongestant and nasal-preparation ingredients are also marketed worldwide, and a local pharmacist is generally well placed to identify what is appropriate in the destination country. Because access rules and combination products vary so widely, anyone planning to use pseudoephedrine while travelling — particularly for a child or alongside other medication — should treat the choice as a conversation with a healthcare provider rather than a like-for-like swap.

Countries
Bangladesh Estonia India Lithuania Oman Poland Portugal Turkey
Diseases
Cold Blocked Nose
Ingredients
Pseudoephedrine
Drug Actions
Antitussive Nasal preparations

Drugs with the same active ingredients

Aerinaze Alerfedine d Alerpriv d Aliviagrip Allegra d (fexofenadine_pseudoephedrine) Allegra-d Aseptobron descongestivo Benadryl 24 d Cabal-d Cetriler d Cetriler d (cetirizine hydrochloride_pseudoephedrine) Ciprocort d Clarityne d (loratadine_pseudoephedrine) Clarityne-d Decidex Decidex (chlorphenamine,pseudoephedrine) Decidex plus Frenaler d Frenaler-d (desloratadine,pseudoephedrine) Hexaler plus

Overdose

As with other sympathomimetic agents, symptoms of overdose include irritability, restlessness, tremor, convulsions, palpitations, hypertension and difficulty in micturition.

Necessary measures should be taken to maintain and support respiration and control convulsions. Gastric lavage should be performed if indicated. Catheterisation of the bladder may be necessary. If desired, the elimination of pseudoephedrine can be accelerated by acid diuresis or by dialysis.

Shelf life

36 months unopened

Contraindications

This product is contraindicated in individuals with known hypersensitivity to the product or any of its components.

Concomitant use of other sympathomimetic decongestants, beta-blockers and monoamine oxidase inhibitors (MAOIs), or within 14 days of stopping MAOI treatment

Cardiovascular disease including hypertension

Diabetes mellitus

Phaeochromocytoma

Hyperthyroidism

Closed angle glaucoma

Severe renal impairment

Not to be used in children under the age of 6 years.

Incompatibilities

None known

List of excipients

Citric Acid Monohydrate

Sucrose

Glycerol

Methyl Hydroxybenzoate

Sodium Benzoate

Ponceau 4R, E124

Flavour, Raspberry Essence No 1NA

Purified Water

Pharmaceutical form

Liquid for oral administration.

Undesirable effects

Cardiovascular effects

- Tachycardia/palpitations

- Other cardiac dysrhythmias and hypertension

CNS effects

- Irritability

- Anxiety

- Restlessness

- Excitability

- Insomnia

- Hallucinations and paranoid delusion

Skin reactions including rash

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

Other reactions

- Nausea and/or vomiting

- Headache

- Urinary retention

Preclinical safety data

None stated.

Therapeutic indications

For the relief of nasal congestion and congestion of mucous membranes of the upper respiratory tract associated with the common cold.

Pharmacodynamic properties

Psuedoephedrine has direct and indirect sympathlomimetic activity and is an orally effective upper respiratory tract decongestant. Psuedoephedrine 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.

Pharmacokinetic properties

Pseudoephedrine is rapidly and completely absorbed after oral administration. After an oral dose of 180 mg to man, peak plasma concentrations of 500-900 ng/ml were obtained about 2 hours post dose. The plasma half life was about 5.5 hours and was increased in subjects with alkaline urine and decreased in subjects with acid urine. The only metabolism was n-demethylation which occurred to a small extent. Excretion was mainly via the urine.

Date of revision of the text

30 January 2013

Name of the medicinal product

NON-DROWSY SUDAFED CHILDREN'S SYRUP

Sudafed Decongestant Liquid

Marketing authorisation holder

McNeil Products Limited

Foundation Park

Roxborough Way

Maidenhead

Berkshire SL6 3UG

United Kingdom

Special precautions for storage

Store below 25°C.

Protect from light.

Nature and contents of container

100 ml amber glass bottles with a 2 piece or a 3 piece plastic child resistant, tamper evident closure fitted with a polyvinylidene chloride (PVDC) faced wad.

A spoon with a 5ml and 2.5ml measure is supplied with this product.

Marketing authorisation number(s)

PL 15513/0023

Qualitative and quantitative composition

This product contains -

Pseudoephedrine

30.0 mg per 5 ml

Hydrochloride

Special warnings and precautions for use

Use with caution in occlusive vascular disease

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

- Hallucinations

- Restlessness

- Sleep disturbances

Caution in moderate renal impairment

Effects on ability to drive and use machines

None known.

Dosage (Posology) and method of administration

Oral

Adults and Children aged 12 years and over:

10 ml elixir every 4-6 hours up to 4 times a day.

Children 6 - 12 years

5 ml elixir every 4-6 hours up to 4 times a day. Not to be used for more than five days without the advice of a doctor. Parents or carers should seek medical attention if the child's condition deteriorates during treatment.

This product may be diluted 1:1 (1 in 2) or 1:3 (1 in 4) with syrup BP. These dilutions are stable for 4 weeks if stored at 25°C.

Children under 6 years

This product is contraindicated in children under the age of 6 years.

Use in the Elderly

There have been no specific studies of this product in the elderly, experience has indicated that normal adult dosage is appropriate.

Hepatic Dysfunction

Caution should be exercised when administering this product to patients with severe hepatic impairment.

Renal Dysfunction

Caution should be exercised when administering this product to patients with moderate to severe renal impairment.

Do not exceed the stated dose.

Keep out of the reach and sight of children.

Special precautions for disposal and other handling

Not applicable

Administrative data

Date of first authorisation/renewal of the authorisation

28 March 1997

Frequently asked questions

What conditions does Sudafed (pseudoephedrine) treat?

Sudafed (pseudoephedrine) is used for the symptomatic relief of nasal congestion associated with the common cold and a blocked nose. It belongs to a category of nasal preparations with antitussive activity, intended to ease upper-respiratory congestion rather than to address the underlying viral infection itself. The structured indication block further down this page lists the registered uses recognised in the markets where this brand is sold.

Which active substance is in Sudafed (pseudoephedrine)?

The active ingredient is pseudoephedrine, classified among nasal preparations with antitussive properties. Pseudoephedrine is one of the most widely used decongestant molecules internationally and circulates under many different brand names worldwide, sometimes alone and sometimes paired with other cold and flu ingredients. The brand label varies substantially from country to country, but the underlying molecule is the same.

In how many countries is Sudafed (pseudoephedrine) available?

This particular Sudafed (pseudoephedrine) registration covers eight countries, with a footprint that spans Europe, the Middle East, and South Asia. Examples include India, Poland, Oman, Portugal, Estonia, Turkey, and Bangladesh. If your country is not represented on this list, a local pharmacist can usually confirm whether a pseudoephedrine-containing product is available under a different brand name in that market.

Are there alternatives to Sudafed (pseudoephedrine)?

Pseudoephedrine itself is sold under a wide variety of brand names internationally, both as a single ingredient and as part of multi-ingredient cold and flu preparations. Other decongestants and nasal preparations also exist, although they are not freely interchangeable — regulatory status, age restrictions, and pharmacy access differ markedly between countries. To identify a regional option, search the active ingredient on Pill2Trip or ask a local pharmacist.

Is Sudafed (pseudoephedrine) a prescription medication?

Prescription and pharmacy-access rules for pseudoephedrine vary significantly between countries — in some jurisdictions it is sold from behind the counter with identification, in others it requires a prescription, and in others it is more freely available. Travellers crossing borders with this product should check local rules in advance. Anyone using it regularly, or considering it for a child, should involve a healthcare provider in the decision.

Sudafed (pseudoephedrine)

Available in 8 countries