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PBH COLD RELIEF CAPSULES

Active substance(s): CAFFEINE ANHYDROUS / PARACETAMOL / PHENYLEPHRINE HYDROCHLORIDE

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Transcript
PATIENT INFORMATION LEAFLET
PARACETAMOL COLD RELIEF WITH DECONGESTANT
PLEASE READ THIS LEAFLET CAREFULLY BEFORE TAKING PARACETAMOL
COLD RELIEF WITH DECONGESTANT.
This leaflet will give you some important information about your medicine. Please
read it carefully before you start taking Paracetamol Cold Relief with Decongestant. If
there is anything you do not understand, please ask your Doctor or Pharmacist.
Keep this leaflet safe, you may want to read it again.
Your medicine
Your medicine is in the form of green and yellow hard gelatin capsules. Each capsule
contains the active ingredients Paracetamol PhEur 300mg, Caffeine PhEur 25mg and
Phenylephrine Hydrochloride PhEur 5mg. Each capsule also contains the inactive
ingredients Maize Starch, Colloidal Anhydrous Silica, Magnesium Stearate, Gelatin,
Patent Blue V (E131), Iron Oxide (E172), Quinoline Yellow (E104) and Titanium
Dioxide (E171).
Paracetamol Cold Relief with Decongestant are available in packs of 10, 12, 16, 20 &
24 capsules.
The Product Licence Holder for Paracetamol Cold Relief with Decongestant is Max
Remedies Ltd, William Nadin Way, Swadlincote, Derbyshire, DE11 0BB, UK
What is your medicine used for?
Paracetamol Cold Relief with Decongestant consist of a combination of ingredients
which are effective in relieving aches, pains, headache, sore throat, fever and nasal
congestion associated with colds and influenza. Paracetamol is a well known
'analgesic' (pain killer). It is effective against aches and pains including headaches. It
can also reduce fever (antipyretic). Phenylephrine hydrochloride reduces swelling in
the passages of the nose (nasal decongestant) and so relieves a blocked or runny
nose. Paracetamol Cold Relief with Decongestant also contain caffeine which acts
as a mild stimulant.
Before taking your medicine
Make sure it is safe for you to take Paracetamol Cold Relief with Decongestant. If you
answer YES to any of the following questions, or you are not sure about your answer,
tell your doctor or pharmacist. If you don't, this medicine may make your condition
worse.

Have you ever been allergic to Paracetamol, Phenylephrine, Caffeine or any of
the other ingredients listed?

Do you suffer from heart, liver or kidney problems?

Have you ever suffered with hypertension?

Have you ever had a peptic ulcer, suffered from an over active thyroid or
diabetes?

Have you ever been an alcoholic? Alcohol reduces liver capacity to deal with
paracetamol.

Are you pregnant or breast-feeding?

Are you taking any other medicines such as drugs for depression, heart
problems, to treat infections, anxiety, migraine, lower blood cholesterol, treat
nausea and vomiting or thin the blood (anti-coagulants)?

Are you taking any of the following medications, metoclopramide, domperidone,
chloramphenicol, NSAIDs, aspirin, isoniazid, meprobamate, debrisoquine?

May cause drowsiness. If affected, do not drive or operate machinery.
Avoid alcoholic drinks.
Taking your medicine
Adults and children over 12 years: 1 to 2 capsules to be taken up to 4 times a day,
every 4 hours.
The elderly: 1 capsule every 4 hours.
It is important that you do not take more than 8 capsules in 24 hours and do not take
more than two capsules at any one time. The capsules should be swallowed whole
with a drink of water.
Do not give to children under 12 years of age.
Do not continue taking these capsules for more than 3 days without consulting a
doctor.
If you miss a dose of Paracetamol Cold Relief with Decongestant do not worry - take
your next dose at the normal time. Do not take extra capsules when it is time for your
next dose to make up for the capsules you have missed. If you are unsure, ask your
doctor or pharmacist.
Avoid drinking too much tea or coffee before taking these capsules.

What should you do if you take too many capsules?
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.
Does your medicine have any unwanted effects?
Most people taking this medicine will find that it causes no problems. Allergic
reactions (such as skin rashes), blood disorders (which may cause you to bruise
more easily), high blood pressure with headache, urine infection, vomiting and rarely
palpitations and increased excited feeling may occasionally occur. Less common
effects include stomach ulcers, restlessness, insomnia, irritability, muscle tremor,
tinnitus (ringing in the ear) and visual disturbances, out of rhythm heart beats,
increased feeling of worry and may cause nose bleeds. Rarely may cause
kidney pain, concentrated cloudy urine, sudden occurrence of severe pain in
the abdomen and back and inflammation of the liver have occurred. If you
experience any of these effects or any other symptoms, stop taking these capsules
and consult your doctor.
Storage and disposal of your medicine
Do not take these capsules after the expiry date printed on the pack.
Keep your medicine in a safe place away from children - it could be harmful to them.
Do not store above 25ºC. Keep the blisters in the cartons in order to protect from
light.
Remember
If you have any questions, more information is available from your doctor or
pharmacist.
Date of Leaflet preparation: November 2003
Product Licence No: 31308/0041

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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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