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Document: leaflet MAH BRAND_PL 44673-0073 change

Day Nurse Sinus and Pain Relief, 500 mg/30 mg Film-Coated Tablet

pseudoephedrine hydrochloride, paracetamol

Please read right through this leaflet before you start using this medicine. This medicine is available without prescription, but you still need to use Day Nurse Sinus and Pain Relief 500 mg/30 mg, Film-Coated Tablet carefully to get the best results from it.

•    Keep this leaflet you may need to read it again.

•    If you have any questions, or if there is anything you do not understand, ask your pharmacist.

In this leaflet:

1.    What Day Nurse Sinus and Pain Relief, 500 mg/30 mg Film-Coated Tablet does.

2.    Check before you take Day Nurse Sinus and Pain Relief, 500 mg/30 mg Film-Coated Tablet

3.    How to take Day Nurse Sinus and Pain Relief, 500 mg/30 mg Film-Coated Tablet

4.    Possible side effects

5.    How to store Day Nurse Sinus and Pain Relief, 500 mg/30 mg Film-Coated Tablet

6.    Further information

1. What Day Nurse Sinus and Pain Relief, 500 mg/30 mg Film-Coated Tablets does

Day Nurse Sinus and Pain Relief, 500 mg/30 mg Film-Coated Tablets provide relief from the symptoms of colds and flu including nasal congestion, sinus pain, pressure and congestion, headaches, fever, sore throat, aches and pains.

The tablets contain paracetamol which is a pain killer and pseudoephedrine which is a decongestant.

2. Check before you take Day Nurse Sinus and Pain Relief, 500 mg/30 mg Film-Coated Tablets

Do not take Day Nurse Sinus and Pain Relief, 500 mg/30 mg Film-Coated Tablet:

   if you have ever had an allergic reaction to pseudoephedrine hydrochloride, paracetamol or to any of the other ingerdients (listed in Section 6).

•    if you have high blood pressure or heart disease.

•    if you have kidney problems.

•    if you have an overactive thyroid gland, enlarged prostate, diabetes, glaucoma or phaeochromocytoma (tumour of the adrenal gland).

•    if you are taking appetite supressants or stimulant drugs called amphetamines (sometimes used to treat ADHD).

•    if you have taken monoamine oxidase inhibitors (MAOIs) e g. moclobemide, prescribed for depression in the last two weeks.

•    if you are taking medicines to control your blood pressure (e.g. beta blockers like atenolol).

Do not take with any other paracetamol-containing products.

Do not take with any other flu, cold or decongestant product.

[!] Take special care with Day Nurse Sinus and Pain Relief, 500 mg/30 mg Film-Coated Tablets

• Do not drive if the medicine makes you feel dizzy.

[!] Ask your doctor before you take this medicine:

•    If you have liver problems or an irregular heartbeat.

[!]If you are taking other medicines:

Talk to your doctor or pharmacist before taking these tablets if you are taking any prescribed medicines; particularly metoclopramide or domperidone (for nausea [feeling sick] or vomiting [being sick]) or colestyramine (to lower blood cholesterol), or if you take blood thinning drugs (anti-coagulants eg. warfarin), or medicines to control your blood pressure (e.g. alpha or beta blockers, or methyldopa) or medicines for depression e.g. tricyclic antidepressants).

[!]Pregnancy and breast feeding

Do not take Day Nurse Sinus and Pain Relief, 500 mg/30 mg Film-Coated Tablets if you are pregnant or breast feeding unless your doctor tells you to.

3. How to take Day Nurse Sinus and Pain Relief, 500 mg/30 mg Film-Coated Tablets

[^]For oral use.

Adults (including the elderly) and children aged 12 years and over:

2 tablets to be taken every four to six hours as required for symptom relief.

[!]

•    Do not take more than 6 tablets in 24 hours.

•    Do not take more frequently than every 4 hours.

•    Do not take for more than 7 days.

•    Do not give to children under 12 years or age.

•    Do not take more than the stated dose.

If symptoms persist consult your doctor.

If you take too many tablets

Immediate medical advice should be sought in the event of overdose, even if you feel well, because of the risk of delayed, serious liver damage.

4. Possible side effects

Like all medicines, Day Nurse Sinus and Pain Relief, 500 mg/30 mg Film-Coated Tablets can have side effects, but not everybody gets them.

The following side effects may occur:

•    Nervousness, difficulty sleeping

•    Nausea and vomiting

•    Dizziness

•    Dry mouth

•    Agitation, restlessness

•    Tachycardia, palpitations

•    Hallucinations have been reported rarely.

Stop using this product and consult your doctor immediately if you experience:

•    Sudden severe headache

•    Difficulty passing urine. This is more likely to occur if you have an enlarged prostate gland

•    Allergic reactions such as skin rash, itching sometimes with breathing problems or swelling of the lips, tongue, throat or face

•    Skin rash or peeling or mouth ulcers

•    Breathing problems. These are more likely if you have experienced them before when taking other painkillers (such as ibuprofen and aspirin)

•    Unexplained bruising and bleeding

•    Nausea, sudden weight loss, loss of appetite and yellowing of the eyes and skin.

5. How to store Day Nurse Sinus and Pain Relief, 500 mg/30 mg Film-Coated Tablets

Keep out of the reach and sight of children.

Do not use this medicine after the ‘EXP’ date shown on the pack. Do not store above 25°C.

6. Further information

Active ingredient Each tablet contains Paracetamol 500 mg and Pseudoephedrine Hydrochloride 30 mg.

Other ingreidents Cellulose microcrystalline (E 460), colloidal anhydrous silica (E 551), stearic acid (E 570), magnesium stearate (E 572), starch pregelatinised, povidone, crospovidone, croscarmellose sodium (E 468), hypromellose (E 464), macrogol, carnauba wax (E 903), indigo carmine (E 132).

Packs of Day Nurse Sinus and Pain contain 18 tablets. The tablets are blue and white and marked with ®.

The marketing authorisation holder is GlaxoSmithKline Consumer Healthcare

(UK) Trading Limited, Brentford, TW8 9GS, U.K. and all enquiries should be sent to this address.

The manufacturer is Famar SA, 153-44 Anthoussa, Athens, Greece.

This leaflet was was last revised in July 2016.

DAY NURSE is a registered trade mark owned by or licensed to the GSK group of companies.