Pseudoephedrine 60mg Tablets – patient leaflet, side effects, dosage

1. WHAT PSEUDOEPHEDRINE TABLETS ARE AND WHAT THEY ARE USED FOR

This medicine contains pseudoephedrine hydrochloride, a decongestant. It can be used to provide relief from cold, flu and allergy symptoms such as a blocked nose, stuffy nose and blocked sinuses to help you breathe more easily without causing drowsiness.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PSEUDOEPHEDRINE TABLETS

Do not take Pseudoephedrine Tablets if you:

! are allergic to pseudoephedrine or any of the other

ingredients of this medicine (listed in section 6) ! have very high blood pressure (severe hypertension)

or hypertension not controlled by your medication ! have diabetes

! have a phaeochromocytoma (rare tumour that affects

your heart rate and blood pressure)

! have an overactive thyroid gland

! have gluacoma (increased pressure in the eye) ! have severe acute (sudden) or chronic (long-term)

kidney disease or kidney failure

! are taking beta blockers (used to treat high blood

pressure)

! 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 A (RIMAs)

! are taking stimulants or appetite suppressants or

drugs used to treat congestion and asthma (Sympathomimetic drugs)

! are taking any other cough and cold medicine ! are a child under 12 years old.

Warnings and precautions

Talk to your doctor or pharmacist before taking Pseudoephedrine Tablets if you:

! have kidney or severe liver problems

! have blocked arteries or veins (occlusive vascular

disease)

! are being treated for a thyroid disorder

! have prostate problems (difficulty with passing water

or needing to pass water more often).

! Cases of posterior reversible encephalopathy

syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) have been reported following use of medicines containing pseudoephedrine. PRES and RCVS are rare conditions that can involve reduced blood supply to the brain. Stop using Pseudoephedrine 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 experience any of the following, stop taking this medicine immediately and contact your doctor:

! a feverish generalised erythema associated with

pustules (see section 4)

! sudden severe headaches, nausea, vomiting,

confusion, fits, visual disturbances

! sudden abdominal pain or rectal bleeding. This may

be due to inflammation of the colon (ischaemic colitis). If you develop these gastrointestinal symptoms, stop taking this medicine and contact your doctor or seek medical attention immediately. (See section 4)

! reduction of blood flow to your optic nerve may occur

with this medicine. If you develop sudden loss of vision, stop taking this medicine and contact your doctor or seek medical attention immediately. (See section 4).

Other medicines and Pseudoephedrine Tablets

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, especially any of the following:

! drugs for depression known as Monoamine Oxidase

Inhibitors (MAOIs) (e.g. phenelzine) or Reversible Inhibitors of Monoamine Oxidase A (RIMAs). Pseudoephedrine Tablets should not be taken at the same time as or within 2 weeks of stopping taking a MAOI.

! antihypertensives (drugs used to treat high blood

pressure such as guanethidine, methyldopa, adrenergic neurone blockers, beta blockers, debrisoquine, bretylium and betanidine) ! stimulants or appetite suppressants or drugs used to

treat congestion and asthma (Sympathomimetic drugs)

! tricyclic antidepressants (used to treat mood

disorders) e.g. imipramine

! anticholinergic drugs (drugs used to treat cramps or

spasms)

! 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 (drug used to help contractions during

childbirth).

Pregnancy and 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. Your doctor will decide whether you should take this medicine.

Pseudoephedrine Tablets contain lactose, sunset yellow (E110) and ponceau 4R (E124)

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Sunset yellow and ponceau 4R may cause allergic reactions.

3. HOW TO TAKE PSEUDOEPHEDRINE TABLETS

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Taking this medicine

Check the table that follows to see how much medicine to take.! For oral use only

! Swallow the tablets whole with a glass of water. Do

not crush or chew your tablets.

Children under 12 years

Do not give to children under 12 years old.

If you take more Pseudoephedrine Tablets than you should

This medicine is to be taken at regular intervals. If you take too many tablets by mistake contact your nearest hospital casualty department or tell your doctor immediately. Take your tablet pack and this leaflet with you.

If you forget to take Pseudoephedrine Tablets

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 to make up for a forgotten dose. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop using Pseudoephedrine 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.

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)

! 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)

! swelling of the face, lips, mouth, tongue or throat

which may cause difficulty in swallowing or breathing ! allergic reactions including skin rashes such as hives

(which may be severe and include blistering and peeling of the skin) and itching

! hallucinations or paranoid delusions

! 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).

If you experience any of the following, stop taking 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 or dizziness ! dry mouth or nausea.

Not known (frequency cannot be estimated from the available data)

! vomiting

! anxiety, irritability, feeling jittery or feelings of extreme

happiness

! restlessness or sleep disturbances

! a fast or irregular heartbeat or an increased awareness of the heartbeat (palpitations) ! pain when passing water

! high blood pressure

! drowsiness

! reduced blood flow to the optic nerve (ischaemic optic neuropathy)

! pins and needles in your fingers and toes ! tremor

! serious conditions affecting blood vessels in the brain known as posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS).

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 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. HOW TO STORE PSEUDOEPHEDRINE TABLETS

Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.

Do not store above 25°C. Store in the original package. In case of any visible signs of deterioration, you should discard the package.

Do not throw away any medicines via waste water or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Pseudoephedrine Tablets contain:

Pseudoephedrine Tablets contain pseudoephedrine hydrochloride. Each tablet contains 60mg of pseudoephedrine hydrochloride.

The other ingredients are: cellactose, magnesium stearate, colloidal anhydrous silica, lactose, hypromellose, macrogol 4000, Ponceau 4R aluminium lake (E124), titanium dioxide (E171), sunset yellow aluminium lake (E110), macrogol 6000 and indigo carmine (E132).

What Pseudoephedrine Tablets look like and contents of the pack

Pseudoephedrine Tablets are orange, round, film-coated tablets. They are packed in blister packs of 12 tablets.

Marketing Authorisation Holder

Ennogen IP Ltd

Unit G4, Riverside Industrial Estate,

Riverside Way, Dartford, DA1 5BS, UK.

Manufacturer

Fine Foods & Pharmaceuticals N.T.M S.p.A. via Grignano, 43

24041 Brembate (Bergamo), Italy

This leaflet was last revised in March 2024.

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