Multi-action Actifed tablets – patient leaflet, side effects, dosage

1 What the medicine is for

Multi-Action Actifed Tablets is a medicine which is used to relieve the symptoms of colds, flu and allergies including sneezing, runny nose, watery eyes, nasal congestion and blocked sinuses. The tablets contain pseudoephedrine hydrochloride, which is a decongestant that relieves nasal and

sinus congestion and triprolidine hydrochloride which is an antihistamine that helps stop sneezing, runny nose and watery eyes. This medicine is for use in adults and children aged over 12 years.

2 Before taking this medicine

This medicine is suitable for most people but a few people should not use it. If you are in any doubt, talk to your doctor or pharmacist.

Do not take/use Muti-Action Actifed Tablets

• If you have ever had a bad reaction to any of the ingredients.
• If you have very high blood pressure (severe hypertension) or hypertension not controlled by your medication
• If you have heart disease.
• If you have diabetes
• If you have a phaeochromocytoma (a rare tumour that affects your heart rate and blood pressure)
• If you have an overactive thyroid gland
• If you have glaucoma (increased pressure in the eye)
• If you have severe acute (sudden) or chronic (long-term) kidney disease or kidney failure
• If you are taking beta blockers (used to treat high blood pressure)

• If you are taking, or have taken in the last two weeks, drugs for depression known as Monoamine Oxidase Inhibitors (MAOIs) or

  Reversible Inhibitors of Monoamine Oxidase (RIMAs).

  • If you are taking stimulants or appetite suppressants and drugs used to treat congestion and asthma (sympathomimetic drugs)

If any of these apply to you, get advice from a doctor or pharmacist without taking Multi-Action Actifed Tablets.

Talk to your doctor or pharmacist…

• If you have kidney or liver problems.

• If you have alcohol dependence.

• If you have bronchitis, emphysema or asthma.
• If you are susceptible to glaucoma (increased pressure in the eye)
• If you have blocked arteries or veins (occlusive vascular disease).
• If you are being treated for a thyroid disorder
• If you have difficulty with passing water and / or an enlarged prostate (which may mean you need to pass water more often).

• If you are taking any other medicines, including:

  • Hypnotics (sleeping tablets including barbiturates)
  • Opioid analgesics (drugs used to relieve pain e.g. codeine, tramadol, morphine)
  • Antipsychotics (drugs used to treat mood disorders)
  • Sedatives (drugs used to treat anxiety and tension).
  • Anticholinergic drugs (drugs used to treat cramps or spasms such as atropine)
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• Leave at least 4 hours between doses.
• Do not give more than 4 doses in 24 hours.
• If symptoms persist or worsen, stop use and talk to your doctor.

Age

Adults and children aged

12 years and over

pseudoephedrine. PRES and RCVS are rare conditions that can involve reduced blood supply to the brain. Stop using Multi-Action Actifed Tablets immediately and seek immediate medical assistance if you develop symptoms that may be signs of PRES or RCVS (see section 4 "Possible side effects" for symptoms). If you are pregnant or breast-feeding

• If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Special warnings about this medicine

• This medicine may cause drowsiness. If affected, do not drive or operate machinery. Avoid alcoholic drink.

Some of the ingredients can cause problems

• This medicine contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3 How to take this medicine Check the table that follows to see how much medicine to take.

• For oral use only.

• Do not take more medicine than the label tells you to.

  Children under 12 years.

  This medicine is not recommended for children under 12 years old.

  Adults and children aged 12 years and over

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• Allergic reactions including skin rashes such as hives (which may be severe and include blistering or peeling of the skin) and itching.
• Hallucinations or paranoid delusions (seeing or hearing things that are not there, irrational thoughts or feelings).
• Sudden onset of fever, reddening of the skin, or many small pustules (possible symptoms of Acute Generalized Exanthematous Pustulosis - AGEP) may occur within the first 2 days of treatment with this medicine (See section 2).
• Sudden onset of severe headache, nausea, vomiting, confusion, fits, visual disturbances.
• Inflammation of the colon due to insufficient blood supply (ischaemic colitis). Symptoms may include sudden abdominal pain or rectal bleeding.
• Sudden loss or reduction of vision which may be due to reduced blood flow to the optic nerve (ischaemic optic neuropathy).
• Feeling unusually tired, unexpected bruising or bleeding and getting more infections (such as colds) than normal.

If you experience any of the following, stop using this medicine and talk to your doctor:

• Trouble passing water (especially in men with prostate problems)

Other effects which may occur include: Very common (may affect more than 1 in 10 people)

• Headache

  Common (may affect up to 1 in 10 people)

  • Difficulty sleeping, nervousness, dizziness
  • Difficulty performing tasks
  • Drowsiness
  • Blurred Vision
  • Thickened mucus, dry mouth or nausea

Rare (may affect up to 1 in 1000 people)

• Confusion or depression
• Tremors, shakiness or slurred speech
• Low blood pressure
• An increased awareness of the heartbeat (palpitations)
• Sleep disturbances

Other effects which may occur but it is unknown how often

• Serious conditions affecting blood vessels in the brain known as posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS). Stop using Multi-Action Actifed Tablets immediately and seek urgent medical attention if you develop symptoms, that may be signs of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS). These include:

  • severe headache with a sudden onset
  • feeling sick
  • vomiting
  • confusion
  • seizures changes in vision
• A fast or irregular heartbeat
• Anxiety, restlessness, irritability or feeling jittery or feelings of extreme happiness

• Tingling or numbness of hands or feet (Pins and needles)

  Dose

  One tablet every 4 - 6 hours, up to 4 times a day

  If anyone has too much

  If anyone has taken too many tablets contact a doctor or your nearest Accident and Emergency Department (Casualty) taking this leaflet and pack with you.

  If you forget to take the medicine

  If you forget to take a dose, take the next dose when needed provided that the last dose was taken at least 4 hours ago. Do not take a double dose.

4 Possible side-effects

Like all medicines Multi-Action Actifed Tablets can have side-effects, although not everybody gets them.

If you experience any of the following, stop taking this medicine and seek immediate medical help:

• Reduced blood flow to the heart which can cause angina (discomfort or pain in the chest, neck, back, jaw, shoulders or arms), or heart attack.
• Stroke (weakness of the face, arms or legs, or speech problems).
• Swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing.
• Antihypertensives (drugs used to treat high blood pressure such as guanethidine, methyldopa, adrenergic neurone blockers, debrisoquine, bretylium and betanidine).
• Tricyclic antidepressants (used to treat mood disorders).
• Moclobemide (used to treat mood disorders).
• Cardiac glycosides (drugs used to control heart rhythms or contractions such as digoxin).
• Ergot alkaloids (drugs used to treat migraine such as ergotamine and methysergide).
• Oxytocin (drugs used to help contractions during childbirth).

If you are not sure about any of the medicines you are taking, show the bottle or pack to your pharmacist. If any of these bullet points apply to you now or in the past, talk to a doctor or pharmacist.

If you experience the following, stop taking this medicine immediately and contact your doctor:

• A feverish generalised redness of the skin (erythema) associated with pustules

(See section 4).

• Sudden severe headaches, nausea, vomiting, confusion, fits, visual disturbances.
• Sudden abdominal pain or rectal bleeding due to inflammation of the colon (ischemic colitis). (See section 4).
• Sudden loss of vision. Reduction of blood flow to your optic nerve may occur with this medicine. (See section 4).

• Cases of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) have been reported following use of medicines containing

  • High blood pressure
  • Nose bleeds, dry nose or dry throat
  • Stomach pain or vomiting
  • Pain when passing water
  • Feeling tired

Reporting of side-effects

If you get any side-effects, talk to your doctor, pharmacist or nurse. This includes any possible side-effects not listed in this leaflet. You can also report side-effects directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side-effects, you can help provide more information on the safety of this medicine.

5 Storing this medicine

Store below 25°C.

Store in the original package to protect from light and moisture.

Keep this medicine out of the sight and reach of children. Do not use this medicine after the end of the month shown as an expiry date on the packaging.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6 Further information

What’s in this medicine?

The active ingredients in Multi-Action Actifed Tablets are: Pseudoephedrine hydrochloride 60 mg and triprolidine hydrochloride 2.5 mg in each tablet. Other ingredients are: Lactose, maize starch, povidone and magnesium stearate.

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What the medicine looks like

Multi-Action Actifed Tablets are white tablets available in packs of 12.

Marketing Authorisation holder: McNeil Products Ltd, High Wycombe, HP12 4EG, UK.

Manufacturer: JNTL Consumer Health (France) SAS, Domaine de Maigremont, 27100 Val de Reuil, France. This leaflet was revised May 2024. Actifed is a registered trade mark.

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