Haleon Day Nurse 500 mg / 30 mg Film-Coated Tablets

Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.

• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information or advice.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
• You must talk to a doctor if you do not feel better or if you feel worse after 5 days.

1. What Haleon Day Nurse is and what it is used for
2. What you need to know before you take Haleon Day Nurse
3. How to take Haleon Day Nurse
4. Possible side effects
5. How to store Haleon Day Nurse
6. Contents of the pack and other information

• If you are allergic to paracetamol, pseudoephedrine hydrochloride or any of the other ingredients in the product (listed in section 6).
• If you are taking other sympathomimetics (such as decongestants, tricyclic antidepressants).
• If you have very high blood pressure (severe hypertension) or hypertension not controlled by your medication.
• If you have an overactive thyroid gland, enlarged prostate, heart problems, glaucoma (excessive pressure inside your eyes).
• If you have severe acute (sudden) or chronic (long term) kidney disease or kidney failure.
• If you have taken monoamine oxidase inhibitors (MAOIs), usually prescribed for depression, in the last two weeks.
• If you are taking the drug moclobemide for depression, beta-blockers for high blood pressure, the oxazolidinone class of antibiotics (e.g. furazolidone or linezolid), appetite suppressants, stimulant drugs called amphetamines (sometimes used to treat attention deficit disorders or excessive sleepiness).
• If you develop a feverish generalised erythema associated with pustules, stop taking Haleon Day Nurse and contact your doctor or seek medical attention immediately. See section 4.
• If you are under 12 years.

Do not take anything else containing paracetamol while taking this medicine.

Contains paracetamol.

Do not take more than the recommended dose as it may cause serious harm to your liver. Do not use this medicine if you are taking any other medicines which may contain paracetamol including prescription or nonprescription medicines to treat pain, fever, symptoms of cold and flu.

Do not take with other flu, cold or decongestant products.

One of the active ingredients in Haleon Day Nurse, pseudoephedrine, has the potential to be abused and large doses of pseudoephedrine can be toxic. Continuous use may lead to taking more Haleon Day Nurse than the recommended dose to get the desired effect, resulting in an increased risk of overdosing. The recommended maximum dose and treatment duration should not be exceeded (see section 3).

Pseudoephedrine causes narrowing of blood vessels (vasoconstriction). This action may be associated with the occurrence of the following sudden medical conditions. These conditions require immediate medical attention:

Acute Coronary Syndrome (ACS): This includes conditions such as a heart attack or unstable angina. Both are associated with a type of severe chest pain caused by blocked blood supply to parts of the heart. The sudden chest pain or discomfort (a feeling of pressure or tightness) can spread from your chest to your arms, jaw, neck, back or tummy. You may also feel lightheaded or dizzy, be sweating or experience shortness of breath while at rest. Stop using this medicine immediately and seek immediate medical assistance if you develop symptoms that may be signs of ACS.

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 this medicine 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).

Sudden abdominal pain or rectal bleeding may occur with Haleon Day Nurse, due to inflammation of the colon (ischaemic colitis). If you develop these gastro-intestinal symptoms, stop taking Haleon Day Nurse and contact your doctor or seek medical attention immediately. See section 4.

This medicine contains less than 1 mmol sodium (23mg) per tablet, that is to say essentially ‘sodium-free’.

Reduction of blood flow to your optic nerve may occur with Haleon Day Nurse. If you develop sudden loss of vision, stop taking Haleon Day Nurse and contact your doctor or seek medical attention immediately. See section 4.

• If you are due to undergo general anaesthesia, or have liver disease, including alcoholic liver disease, or kidney problems, diabetes (too much sugar in your blood), psychosis (severe mental health problems in which the person loses contact with reality and is unable to think and judge clearly) irregular heart beat or phaeochromocytoma (a tumour near the kidney). You may need to avoid using this product altogether or limit the amount of paracetamol that you take.
• if you suffer from glutathione depletion due to metabolic deficiencies.
• If you are more than 60 years old, as there is increased possibility of unwanted effects.
• If you are taking medicines that affect your liver.

Check with your doctor before use if you have liver or kidney problems, are underweight (< 50kg), become malnourished or regularly drink alcohol, as this may increase your risk of liver damage.

You may need to reduce the amount of paracetamol that you take or avoid using this product altogether.

During treatment with Haleon Day Nurse, tell your doctor straight away if:

• You have severe illnesses, including severe renal impairment or sepsis (when bacteria and their toxins circulate in the blood leading to organ damage), or you suffer from malnutrition, chronic alcoholism or if you are also taking flucloxacillin (an antibiotic). A serious condition called metabolic acidosis (a blood and fluid abnormality) has been reported in patients in these situations when paracetamol is used at regular doses for a prolonged period or when paracetamol is taken together with flucloxacillin. Symptoms of metabolic acidosis may include: serious breathing difficulties with deep rapid breathing, drowsiness, feeling sick (nausea) and being sick (vomiting).

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines particularly:

• anticoagulants (used to thin the blood, e.g. warfarin);
• metoclopramide or domperidone (for nausea [feeling sick] or vomiting [being sick]);
• colestyramine (to lower blood cholesterol);
• medicines for high blood pressure; or vasoconstrictor agents such as ergot derivates (sometimes prescribed for migraine or hyperprolactinemia)
• medicines for depression (tricyclic antidepressants e.g. amitriptyline);
• sodium bicarbonate (used to treat indigestion and certain kidney conditions).
• In case of surgery, it is advisable to stop treatment at least 24 hours before.
• The pseudoephedrine content in this product may induce a positive reaction during antidoping control tests.
• flucloxacillin (antibiotic), due to a serious risk of blood and fluid abnormality (called metabolic acidosis) that must have urgent treatment (see section 2).

Haleon Day Nurse is not recommended during pregnancy or whilst breastfeeding. If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

This product can cause dizziness as a side effect which could affect your ability to drive or use machines. Do not drive or operate machinery if affected.

Talk to your doctor immediately if you take too much of this medicine, even if you feel well. This is because too much paracetamol may cause delayed, serious and irreversible liver damage.

If your symptoms persist, see your doctor or pharmacist.

• Serious conditions affecting blood vessels in the brain known as posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS). Stop using 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.
• Inflammation of the colon due to insufficient blood supply (ischaemic colitis), breathing problems, especially if you have experienced a similar reaction with aspirin or non-steroidal anti-inflammatories.
• Skin rash or peeling, or mouth ulcers.
• Unexplained bruising or bleeding, or infections such as sore throat - this may be a sign of very rare changes in the blood.
• Allergic reactions such as skin rash or itching, sometimes with breathing problems (or a hissing sound when you breathe) or swelling of the mouth, lips, tongue, throat or face.
• Difficulty in passing urine. This is more likely to occur in men if you have an enlarged prostate gland.
• 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 Haleon Day Nurse. See section 2.
• Reduced blood flow to the optic nerve (ischaemic optic neuropathy). The frequency is “not known”. See section 2.
• A serious condition that can make blood more acidic (called metabolic acidosis), in patients with severe illness using paracetamol. Frequency “Not known’’ (frequency cannot be estimated from the available data) (see section 2).

The following side effects may occur. Tell your doctor or pharmacist if you get them.

• Nausea [feeling sick], vomiting [being sick], dry mouth, sleep disturbance, nervousness and dizziness. These are common side effects, (may affect up to 1 in every 10 patients treated).
• Rapid or irregular heart rate, agitation and restlessness. These are uncommon side effects (may affect up to1 in every 100 patients treated).
• High blood pressure, palpitations and hallucinations (particularly in children) are rare side effects, (may affect up to 1 in every 1,000 patients treated).
• Anxiety, headache and tremor [shivering]
• This product may have side effects that you would not notice yourself. These include changes in some liver test results.

If you get any side effects, tell your doctor, pharmacist or nurse. This includes any 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.

• The active ingredients are Paracetamol 500 mg and Pseudoephedrine Hydrochloride 30 mg.
• The other ingredients are cellulose microcrystalline (E460), silica, colloidal anhydrous (E551), stearic acid (E570), magnesium stearate (E572), starch pregelatinised, povidone, crospovidone, croscarmellose sodium (E468), hypromellose (E464), macrogol, carnauba wax (E903), indigo carmine (E132).

What Haleon Day Nurse looks like and contents of the pack The tablets are blue and white and marked with a figure “2” in a circle. Packs contain 2, 5, 6, 10, 12, 16, 18, 24, 30 or 32 tablets. Not all pack sizes may be marketed.

The marketing authorisation holder is

The manufacturer is