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SAINSBURYS COLD RELIEF CAPSULES

Active substance: PHENYLEPHRINE HYDROCHLORIDE

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Transcript
PATIENT INFORMATION LEAFLET FOR
SAINSBURY’S COLD RELIEF CAPSULES
This leaflet provides some important information about your medicine. Please
read it carefully before you start taking Sainsbury’s Cold Relief Capsules. If
you have any further questions, or if there is anything you do not understand,
ask your Doctor or Pharmacist.
WHAT IS YOUR MEDICINE?
Your medicine is called Sainsbury’s Cold Relief Capsule, and are white and
orange coloured gelatin capsules. Each capsule contains the active ingredients
paracetamol 300mg, caffeine 25mg and phenylephrine hydrochloride 5mg.
The capsules also contain the inactive ingredients starch, colloidal anhydrous
silica, magnesium stearate, E104, E127, E171 and gelatin. The actives belong
to the following Pharmacotherapeutic groups: paracetamol is a non-narcotic
analgesic; caffeine is a weak central nervous stimulant and phenylephrine
hydrochloride is a sympathomimetic causing vasoconstriction (raises blood
pressure).
PACK SIZE
Available in packs of 12 Capsules. Packs of 24 Capsules are only available
form your Pharmacist.
Marketing Authorisation Holder: Wockhardt UK Ltd, Ash Road North,
Wrexham, LL13 9UF, UK. (PL29831/0171)
Manufacturer: CP Pharmaceuticals Ltd, Ash Road North, Wrexham, LL13
9UF, UK.
WHAT IS THIS MEDICINE FOR?
To relieve the symptoms of cold and ‘flu including headache, fatigue,
tiredness and blocked nose.
BEFORE YOU TAKE YOUR CAPSULES:
If your answer to any of the following questions is YES, then you should ask
your Pharmacist or Doctor before taking them.








Are you pregnant or breastfeeding?
Do you suffer from depression, high blood pressure, heart, kidney or
liver problems including alcoholic liver disease?
Do you suffer from diabetes mellitus, glaucoma, a condition called
phaechromocytoma or an enlarged prostate?
Are you or have you been allergic to paracetamol and/ or any of the
ingredients listed above?
Do you suffer from or have you ever suffered from stomach problems
such as ulcers?
Are you taking any other medicines – particularly medicines containing
paracetamol, diflunisal (a painkiller), adrenergic neurone blockers such
as guanethidine (used to treat high blood pressure), medicines to lower
blood cholesterol / fat levels (such as colestyramine), isoniazid and
quinolone antibiotics such as ciprofloxacin (used to treat infections),
tricyclic antidepressants (used to treat depression including imipramine),
monoamine oxidase inhibitors (MAOI) such as fluvoxamine or
moclobemide (used to treat depression), atropine (used to treat muscle
spasm in the stomach), warfarin and other anticoagulants (used to thin
the blood), other sympathomimetics agents (used most commonly to
treat asthma and as a decongestant), metoclopramide and domperidone
(used to treat nausea), certain antiepileptics such as carbamazepine,
phenytoin, phenobarbital, primidone and lamotrigine, theophylline (used
to treat asthma), phenylpropanolamine (used as a decongestant), oral

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contraceptives (“the Pill”) or hormone replacement therapy (HRT),
probenecid (used to treat gout), diazepam (a tranquilizer), disulfiram
(used to treat alcohol dependence), lithium (used to treat manic
depressive disorder), mexilitene (used to treat irregular heart rhythm),
ergotamine (used to treat migraines) and oxytocin (used in pregnant
women to help labour)?
Do you suffer from hyperthyroidism or disease of the blood vessels
(aneurysm, arteriosclerosis)?
Do you have an alcohol problem?
Have you ever had an asthma attack brought on by aspirin?

Very occasionally this medicine causes dizziness in those taking it. Do not
drive, operate machinery or undertake other complicated or potentially
hazardous tasks whilst taking this medicine until you have tried it and are sure
you are not affected.
TAKING YOU MEDICINE:
Follow the instructions on the label about how to take your medicine. Your
Pharmacist may also help you if you are not sure. Dose: Unless otherwise
directed by your Doctor –
Adults and children over 12 years: 1 to 2 Capsules every four hours, as
required. Take whole with water – do not chew. If possible, take with or after
food. The dose should not be taken more frequently than every 4 hours and
not more than 4 times in any 24 hour period. Maximum Dose: 8 Capsules in
divided doses in any 24 hour period. Do not break or cut these capsules.
Children under 12 years: Do not give to children under 12 years of age
except on the advice of a Doctor.
WARNING: DO NOT EXCEED THE STATED DOSE

Do not take for more than three days unless your doctor agrees.
Do not take with any other paracetamol-containing products.
If symptoms persist consult your Doctor.
Do not drink alcohol while taking this medicine.
If you miss a single dose of Sainsbury’s Cold Relief Capsules, do not worry
and take your next one at the normal time. DO NOT DOUBLE UP ON A
DOSE TO MAKE UP FOR THE MISSING ONE.
WHAT SHOULD YOU DO IF YOU TAKE TOO MANY SAINSBURY’S
COLD RELIEF 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.
If you accidentally take a large number of capsules contact the nearest
hospital casualty department or tell you Doctor immediately.
WHILE TAKING YOUR MEDICINE:
All medicines may cause unwanted effects (side effects) in some people. If
after taking this medicine for the first time, you develop a rash or other
allergic reaction, stop taking Sainsbury’s Cold Relief Capsules and consult
you Doctor or Pharmacist. Patients with asthma that is made worse by taking
aspirin or other painkillers may find that this medicine also causes wheezing.
Most patients do not have any problems, but other unwanted effects may

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include anxiety, shaking, headache, vomiting, high blood pressure, slowed or
irregular heart beat, palpitations, difficulty in getting to sleep or restlessness,
excitement, muscle tremor, reaction affecting the blood, dizziness, difficulty
in passing urine and urine retention. Taking a high dose of Sainsbury’s Cold
Relief Capsules for a long time can cause kidney problems. Some people may
get headache after stopping the medicine. If you experience any other unusual
or unexpected symptoms, which persist or are troublesome, consult a Doctor
or Pharmacist.
STORING YOU MEDICINE:
Keep your medicine in a safe place out of the reach and sight of children.
Sainsbury’s Cold Relief Capsules could be harmful to them. Store below 25°C
in a dry place. Protect form light. Do not use these capsules after the expiry
date embossed on the pack.
Date of leaflet preparation: December 2007.

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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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