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TEVA COLD RELIEF CAPSULES

Active substance(s): CAFFEINE / PHENYLEPHRINE HYDROCHLORIDE

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Health Essentials Cold Relief Capsules
Paracetamol, Phenylephrine, Caffeine

PATIENT INFORMATION LEAFLET

Read all of this leaflet carefully before you
take this medicine because it contains
important information you need to know.
This medicine is available without prescription,
however, you still need to use this product
carefully to get the best results from it. Keep this
leaflet as you may need to read it again. Ask your
pharmacist if you need more information or advice.

taken them within the last 14 days - these are
medicines such as phenelzine and isocarboxazid
• are taking tricyclic antidepressants, such as
imipramine, amitriptyline.
Please see your doctor or pharmacist before
taking this medicine if you:
• are breastfeeding
• suffer from kidney or liver problems, including
alcoholic liver disease or have alcohol dependence
1. What is this medicine and what is • have a blood vessel disease such as Raynaud’s
phenomenon
it used for?
• have an enlarged prostate or other prostate
This medicine contains:
problems
• paracetamol which is a pain reliever (analgesic) • have heart or circulation disease
and helps reduce your temperature when you
If you are taking any of the following
have a fever
medicines please see your doctor:
• phenylephrine which is a decongestant to
• medicines to treat high cholesterol levels which
reduce swelling in the passages of the nose to
reduce the amount of fat in the blood such as
help you breathe more easily
colestyramine
• caffeine which helps to increase the pain relief • medicines to control feeling sick or being sick
from paracetamol and makes you more alert.
such as metoclopramide or domperidone
These capsules are used for the relief of the
• medicines called anti-coagulants, which are
symptoms of colds and flu, including headache,
used to thin the blood such as warfarin or other
feverishness (high temperature), nasal and sinus
coumarins - you may take occasional doses of
paracetamol but should consult your doctor if
congestion and its associated pressure and pain,
you need to take it on a regular basis
catarrh, aches and pains.
• medicines to lower blood pressure, treat heart
2. Is this medicine suitable for you?
or circulatory problems such as beta blockers
(e.g. atenolol), methyldopa, or ganglion
Do not take this medicine if you:
blocking agents (e.g. trimetaphan camsilate).
• are allergic to paracetamol, phenylephrine,
caffeine or any of the other ingredients
Contains paracetamol.
• are under 12 years of age
Do not take anything else containing
• have a serious heart condition or cardiovascular paracetamol while taking this medicine.
disorder(s)
3. How to take this medicine
• have high blood pressure (hypertension)
Swallow the capsules whole with water. Do not chew.
• have an overactive thyroid
• are pregnant
Adults, the elderly and children 12 years and
• are taking antidepressant drugs called
over: 2 capsules every 4 to 6 hours, as required.
monoamine oxidase inhibitors (MAOI’s), or have
Please turn over ➥

Do not take more than 12 capsules in any 24
hour period.
Do not give to children under 12 years.
Do not take more medicine than the label tells you
to. If you do not get better, talk to your doctor.
Avoid too much caffeine in drinks like coffee and tea.
High caffeine intake can cause difficulty sleeping,
shaking and an uncomfortable feeling in the chest.
Talk to a doctor at once if you take too much
of this medicine even if you feel well. This is
because too much paracetamol can cause
delayed, serious liver damage. Go to your
nearest hospital casualty department. Take your
medicine and this leaflet with you.

The following side effects may occur. Tell your
doctor if you get them.
• Raised blood pressure, headache, dizziness,
difficulty sleeping, nervousness, anxiety,
diarrhoea or sickness.
Very rare cases of serious skin reactions have
been reported.
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.
By reporting side effects you can help provide
more information on the safety of this medicine.

4. Possible side effects

5. How to store your medicine

Most people do not have any side effects while
taking this medicine. However, if you experience
any of the following side effects, or anything else
unusual happens, stop taking the medicine
immediately, and see your doctor or pharmacist.
Stop taking this medicine and tell your doctor
immediately if you experience:
• Allergic reactions which may be severe such
as skin rash and itching sometimes with swelling
of the mouth or face or shortness of breath.
• 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 or aspirin.
• Unexplained bruising or bleeding.
• Reoccurring fevers or infections.
• Nausea, sudden weight loss, loss of appetite
and yellowing of the eyes and skin.
• Visual disturbances. This is rare but is more
likely in those with glaucoma.
• Unusually fast pulse rate or a sensation of an
unusually fast or irregular heartbeat.
• Difficulty passing water. This is more likely to
occur in men with an enlarged prostate gland.
These reactions are rare.

Health Essentials Cold Relief Capsules

BLACK

MAGENTA

YELLOW

Clinical Changes

4

9942

L101

25/01/16

2753135

139.7x150mm

DH

436

Wrafton

BLACK

PANTONE

PANTONE

877

485

CUTTER

VARNISH

BRAILLE

Keep out of the sight and reach of children.
Do not use this medicine after the expiry date
printed on the pack.
Do not store above 25°C.

6. What is in this medicine?
Each green / yellow capsule contains the active
ingredients: paracetamol 300 mg, caffeine 25 mg
and phenylephrine hydrochloride 5 mg.
The other ingredients are: maize starch,
croscarmellose sodium, sodium lauryl sulphate
and magnesium stearate. The capsule shell is
made of gelatin and contains the colours titanium
dioxide (E171), iron oxide yellow (E172), patent
blue V (E131) and quinoline yellow (E104).
This product is available in a pack size of 16
capsules.

7. Who makes this medicine?
The Marketing Authorisation holder and
manufacturer is Wrafton Laboratories Limited,
Braunton, Devon, EX33 2DL, UK.
Text revised: January 2016.
PL 12063/0003

2753135

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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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