Actifed 60 mg / 2.5 mg Tablets: SPC Overview

What are Actifed tablets?

Multi-Action Actifed is a combination medicine for adults and adolescents aged 12 years and over. Each tablet contains:

• Pseudoephedrine hydrochloride 60 mg, a decongestant that narrows swollen blood vessels in the nasal passages.
• Triprolidine hydrochloride 2.5 mg, a sedating antihistamine that helps reduce symptoms such as sneezing and a runny nose.

This article refers specifically to the UK tablet containing both ingredients. Other products sold under the Actifed name may have different ingredients, strengths or directions.

What are Actifed tablets used for?

According to the UK Summary of Product Characteristics (SmPC), the tablets are used for the symptomatic relief of upper respiratory tract conditions where a nasal decongestant and an antihistamine are needed. This includes allergic rhinitis and the common cold when congestion occurs with symptoms such as sneezing or a runny nose.

The medicine relieves symptoms; it does not treat the cause of an infection or shorten a cold.

How to take Actifed tablets

Adults and adolescents aged 12 years and over

The SmPC dose is one tablet every four to six hours, up to four times a day. Do not exceed four tablets in 24 hours.

Children and older adults

• Children under 12: do not use.
• Older adults: the SmPC does not provide a separate routine dose, but age-related heart, blood-pressure, prostate, kidney or liver problems may make the medicine unsuitable. Ask a pharmacist or doctor first.

Use the lowest effective dose for the shortest time. If symptoms persist, worsen or are accompanied by a high fever, seek medical advice rather than continuing treatment.

Who should not take Actifed?

Do not take the tablets if you are allergic to pseudoephedrine, triprolidine or any ingredient in the product. The current product information also lists important situations in which pseudoephedrine-containing medicines should not be used, including:

• severe hypertension or hypertension that is not controlled;
• severe acute or chronic kidney disease or kidney failure;
• current or recent use of a monoamine oxidase inhibitor (MAOI), including within the previous 14 days;
• use of another sympathomimetic decongestant;
• certain serious cardiovascular conditions;
• phaeochromocytoma, diabetes, hyperthyroidism, closed-angle glaucoma or urinary retention, as specified in the product information.

Ask a pharmacist or doctor before use if you have heart disease, high blood pressure, kidney or liver impairment, an enlarged prostate, breathing problems, epilepsy or another long-term condition.

Important safety warnings

Drowsiness and driving

Triprolidine can cause drowsiness and reduce alertness. Do not drive, cycle or operate machinery if affected. Alcohol and sedating medicines may make this worse.

PRES and RCVS

Rare cases of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) have been reported with pseudoephedrine. Stop taking the medicine and seek urgent medical help for a sudden severe headache, vomiting, confusion, seizures or changes in vision.

Other urgent warning signs

Stop treatment and seek medical advice for sudden abdominal pain or rectal bleeding, which may indicate ischaemic colitis. Sudden loss or reduction of vision also needs urgent assessment.

Side effects

Possible effects include:

• drowsiness, dizziness or impaired coordination;
• dry mouth;
• headache, nervousness, restlessness or difficulty sleeping;
• nausea or vomiting;
• palpitations, a fast heartbeat or increased blood pressure;
• difficulty passing urine;
• skin rash or an allergic reaction.

Get emergency help for facial or throat swelling, breathing difficulty, collapse, severe chest pain, a seizure or another serious reaction.

Interactions

Check with a pharmacist before combining Actifed with:

• MAOIs, other decongestants or stimulant medicines;
• medicines for high blood pressure;
• sedatives, sleeping tablets, opioid pain medicines or other sedating antihistamines;
• alcohol;
• some medicines with anticholinergic effects.

Read labels carefully to avoid taking more than one pseudoephedrine product. For example, Non-Drowsy Sinutab contains pseudoephedrine with paracetamol, whereas this Actifed product contains pseudoephedrine with triprolidine. They should not be combined unless a healthcare professional specifically advises it.

Pregnancy and breastfeeding

The SmPC advises against using this combination during pregnancy. Pseudoephedrine and triprolidine pass into breast milk, so the product should not be used while breastfeeding unless a doctor decides that the expected benefit outweighs the potential risk. Ask a healthcare professional for an alternative suited to your symptoms.

Storage and responsible use

Keep the medicine out of the sight and reach of children and follow the storage instructions on the pack. Do not use it after the expiry date. Because this is a short-term symptom-relief medicine, do not continue it for longer than directed on the leaflet.

Official sources

• Electronic Medicines Compendium: Multi-Action Actifed Tablets SmPC
• MHRA: safety review of pseudoephedrine-containing medicines
• European Medicines Agency: pseudoephedrine-containing medicinal products

This article provides general information and does not replace the package leaflet or advice from a doctor or pharmacist.