PANADOL COLD AND FLU

Active substance: PSEUDOEPHEDRINE HYDROCHLORIDE

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PACKAGE LEAFLET : INFORMATION FOR THE USER

Panadol Cold and Flu 500 mg /
30 mg Film Coated Tablets
Paracetamol and Pseudoephedrine Hydrochloride
Please read right through this leaflet before you start using this medicine.
This medicine is available without prescription, but you still need to use Panadol
Cold and Flu carefully to get the best results from it.
• Keep this leaflet. You may need to read it again.
• If you have any questions, or there is something you do not understand, ask
your pharmacist.

In this leaflet:
1. What Panadol Cold and Flu does
2. Check before you take Panadol Cold and Flu
3. How to take Panadol Cold and Flu
4. Possible side effects
5. How to store Panadol Cold and Flu
6. Further information

1. What Panadol Cold and Flu does
Panadol Cold and Flu is used for the relief of nasal congestion when combined
with fever and/or pain such as sore throat, sinus pain or headache in the common
cold or flu. The medicine contains two active ingredients. Paracetamol is a
painkiller and reduces your temperature when you have a fever. Pseudoephedrine
hydrochloride is a decongestant which unblocks your nose and sinuses helping
you breathe more easily without drowsiness.

2. Check before you take Panadol Cold and Flu
Do not take Panadol Cold and Flu:
• If you have ever had an allergic reaction to paracetamol, pseudoephedrine
hydrochloride or other sympathomimetics (such as decongestants, appetite
suppressants or stimulant drugs called amfetamines), or any of the other
ingredients (listed in Section 6).
• If you have high blood pressure, overactive thyroid gland, enlarged prostate,
heart problems, glaucoma (excessive pressure inside your eyes).
• If you have kidney problems, unless your doctor tells you to.

• 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 antibiotics furazolidone or linezolid, appetite
suppressants, or stimulant drugs called amfetamines (sometimes used to treat
attention deficit disorders or excessive sleepiness).
• For more than 5 days unless your doctor tells you to.
• If you are under 12 years.
Do not take with any other paracetamol containing products.
Do not take with any other flu, cold or decongestant product.

Driving and using machines:
This product can cause dizziness as a side effect which could affect your ability
to drive or use machines.

Ask your doctor before you take this medicine:
If you are due to undergo general anaesthesia, or have liver disease, including
alcoholic liver disease, diabetes, irregular heart beat or phaeochromacytoma
(a tumour near the kidney).

If you are taking other medicines:
Talk to your doctor or pharmacist before taking these tablets if you are taking
any prescribed medicines; particularly:
• anticoagulants (used to thin the blood, e.g. warfarin);
• metoclopramide or domperidone (for nausea [feeling sick] or vomiting
[being sick]);
• cholestyramine (to lower blood cholesterol);
• medicines for high blood pressure;
• medicines for depression (tricyclic antidepressants);
• sodium bicarbonate (used to treat indigestion and certain kidney conditions).

Pregnancy and breastfeeding:
Do not take Panadol Cold and Flu if you are pregnant or breastfeeding.

3. How to take Panadol Cold and Flu
ake the tablets with a glass of water.
T



Adults (including the elderly):
Swallow 2 tablets up to 3 times daily, every 4 hours as needed.
Do not take more than 6 tablets (3 doses) in 24 hours.





Adolescents aged 12 to 18 years:
Give 1 to 2 tablets every 4 hours as needed.
Do not give more than 6 tablets in 24 hours.
Do not take more than every 4 hours.
Do not take for more than 5 days.
Do not take more than the recommended dose.

• High blood pressure and hallucinations are rare side effects, (occurring in
fewer than 1 in every 1,000 patients treated).
This product may have side effects that you would not notice yourself. These
include changes in some liver test results.
If you do get any side effects, even those not mentioned in this leaflet, tell your
doctor or pharmacist.

5. How to Store Panadol Cold and Flu
Keep out of the reach and sight of children.
Do not take the medicine after the “EXP” date shown on the blister and outer carton.
Do not use the medicine if you notice the tablets are soft.
Do not store above 25ºC.

If you take too many tablets:

6. Further Information

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

Active ingredients. Each tablet contains Paracetamol 500 mg and Pseudoephedrine
Hydrochloride 30 mg.
Other ingredients. Cellulose microcrystalline (E460), silica, colloidal anhydrous
(E551), stearic acid (E570), magnesium stearate (E572), starch pregelatinised,
povidone, crospovidone, croscarmellose sodium (E468), hypromellose (E464),
macrogol, carnuba wax (E903), indigo carmine (E132).

If your symptoms persist, see your doctor or pharmacist.

4. Possible Side Effects
Like all medicines Panadol Cold and Flu can have side effects, but not everybody
gets them:
Stop taking this medicine and tell your doctor immediately if you experience:
• Allergic reactions such as skin rash or itching, sometimes with breathing
problems (or a hissing sound when you breathe) or swelling of the lips,
tongue, throat or face. These reactions are rare (occurring in fewer than 1 in
every 1,000 patients treated).
• Breathing problems, especially if you have experienced a similar reaction with
aspirin or non-steroidal anti-inflammatories. These are very rare (occurring in
fewer than 1 in 10,000 patients treated).
• Skin rash or peeling, or mouth ulcers. These effects are very rare (occurring in
fewer than 1 in 10,000 patients treated).
• Unexplained bruising or bleeding, or infections such as sore throat - this may
be a sign of very rare changes in the blood. These occur in fewer than 1 in
10,000 patients treated.
• Difficulty in passing urine. This is uncommon (occurring in fewer than 1 in
every 100 patients treated) and is more likely to occur if you have an enlarged
prostate gland.
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, (occurring in fewer
than 1 in every 10 patients treated).
• Rapid or irregular heart rate, agitation and restlessness. These are uncommon
side effects (occurring in fewer than 1 in every 100 patients treated).

What Panadol Cold and Flu 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.
Marketing Authorisation Holder and Manufacturer
The marketing authorisation holder is and all
enquiries should be sent to .
The manufacturer is Famar S.A., Anthoussa, Athens, Greece.
This leaflet was last revised in December 2009.
Panadol is a registered trademark of the GlaxoSmithKline group of companies.
This medicinal product is authorised in the Member States of the EEA under the
following names:
Greece
Panadol Cold & Flu 500mg / 30mg
Ireland 
Panadol Fever and Congestion Film-coated Tablets Paracetamol 500mg
Pseudoephedrine Hydrochloride 30mg
UK
Panadol Cold and Flu 500 mg/ 30 mg Film-coated Tablets

* Delete as appropriate

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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