NON-DROWSY SINUTAB

Active substance: PSEUDOEPHEDRINE HYDROCHLORIDE

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Transcript
This medicine is for use in adults and children aged
12 years and over.
paracetamol, pseudoephedrine
This medicine is used to relieve the symptoms of
colds, flu and allergies including aches, pains, fever,
nasal and sinus congestion.
I This medicine is for use by adults and children aged
12 years and over.
I Do not take this medicine:
I There are some people who should not take this
medicine. To find out if you are one of them see
section 2 c
I If you have ever had a bad reaction to any of the
ingredients. For the list of ingredients see section 6 c
I Speak to your doctor:
I If you suffer from any of the conditions
mentioned in section 2. See section 2 c
I If you are taking any other medicines.
See section 2 c
I Follow the dosage instructions carefully. These are
shown in the table.
See section 3 c
Now read this whole leaflet carefully before you use
this medicine. Keep the leaflet: you might need it again.
I

1 What the medicine is for

Non-Drowsy Sinutab relieves the symptoms of colds,
flu and allergies including aches, pains, fever, nasal
and sinus congestion.
The tablets contain paracetamol, an analgesic and
antipyretic to relieve pain and fever, and pseudoephedrine,
a decongestant to clear nasal congestion and blocked
sinuses.

I
I

Do not take more than the stated dose shown.
Take with a glass of water.

3 How to take this medicine
(continued)
Children under 12 years

Do not give to children under 12 years old.

2 Before taking this
medicine

This medicine is suitable for most people but a few
people should not use it. If you are in any doubt,
talk to your doctor or pharmacist.

Do not use this medicine…
If you have ever had a bad reaction (e.g. rash,
swelling of the face and throat, difficulty
breathing) to any of the ingredients.
I If you have very high blood pressure or
severe heart disease.
I If you are taking any other medicines
containing paracetamol.
I If you are taking, or have taken in the last two
weeks, drugs for depression known as
Monoamine Oxidase Inhibitors (MAOIs).
I For children under 12 years old.
If any of these apply to you, get advice from a
doctor or pharmacist without using
Non-Drowsy Sinutab.
I

Talk to your doctor or pharmacist…
If you have liver or kidney problems.
I If you have alcohol dependence.
I If you have high blood pressure or heart
disease.
I If you have diabetes.
I If you have an overactive thyroid gland.
I If you have glaucoma (increased pressure in
the eye).
I If you have prostate problems (difficulty with

Dose
2 tablets every 4 - 6 hours,
up to 4 times a day

Leave at least 4 hours between doses.
I Do not take more than 4 doses in 24 hours.
I If symptoms persist talk to your doctor.
I

If you experience any of the following, stop
using this medicine and talk to your doctor:
I

I

I

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If you forget to take the medicine

If you forget to take a dose, take the next dose when
needed provided that the last dose was taken at least
4 hours ago. Do not take a double dose.

4 Possible side-effects
Non-Drowsy Sinutab can have side-effects, like all
medicines, although these don't affect everyone and
are usually mild.

A few people have had hallucinations, but this
is rare.
Occasionally people get skin rashes that are
sometimes itchy.
A few men, especially those with prostate
problems, may have trouble passing water.
There have been rare reports of blood disorders
in people taking paracetamol, the symptoms of
which include unusual tiredness, unexpected
bruising or bleeding and getting more infections
(such as colds) than normal.

Long-term use
I

If anyone has too much

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 are pregnant or breast-feeding:

I

Adults and children aged 12 years and over
Age
Adults and children
aged 12 years and over

passing water or needing to pass water often).
If you are taking any other medicines, including:
I Antihypertensives (drugs to treat high blood
pressure such as guanethidine, methyldopa,
alpha and beta blockers, debrisoquine,
bretylium and betanidine).
I Sympathomimetic drugs (stimulants or
appetite suppressants and drugs used to treat
congestion and asthma).
I Tricyclic antidepressants (used to treat mood
disorders).
I Colestyramine (to lower blood cholesterol).
I Metoclopramide and domperidone (to treat
nausea and vomiting).
I Anticoagulants (to thin the blood such as
warfarin).
I Barbiturates (used to treat anxiety or help
you sleep).
I Oral contraceptives ("the pill").
I Anticonvulsants (drugs used to treat epilepsy).
If you are not sure about any of the medicines
you are taking, show the bottle or pack to your
pharmacist.
If any of these bullet points apply to you now or in
the past, talk to a doctor or pharmacist.
I

People who use medicine containing
paracetamol every day for a long time (several
months or more) could get certain side-effects
including liver and kidney damage. People
taking paracetamol in the usual way for shorter
periods have not had these problems.

Other effects which may occur include:
I

Restlessness, having trouble getting to sleep or
bad dreams.

If you experience any side-effects not included in
this leaflet or are not sure about anything, talk to
your doctor or pharmacist.

I

Ask your doctor or pharmacist for advice before
taking this medicine if you are pregnant or
breast-feeding.

3 How to take this medicine
Check the table that follows to see how much
medicine to take.
I

For oral use only.

turn over

Medicines should not be disposed of via wastewater
or household waste. Ask your pharmacist how to
dispose of medicines no longer required. These
measures will help to protect the environment.

6 Further information
What's in this medicine?

The active ingredients in Non-Drowsy Sinutab are:
500 mg Paracetamol and
30 mg Pseudoephedrine hydrochloride per tablet.
Other ingredients are: Pregelatinised maize starch,
crospovidone, povidone K30, stearic acid,
microcrystalline cellulose, sodium starch glycollate,
magnesium stearate.

What the medicine looks like
Non-Drowsy Sinutab tablets are white round tablets,
available in packs of 15 tablets.
Product Licence holder:
McNeil Products Ltd, Maidenhead, Berkshire,
SL6 3UG, UK.
Manufacturer: Janssen-Cilag, Domaine de
Maigremont, 27100 Val de Reuil, France.
This leaflet was revised July 2012.
Sinutab is a registered trade mark.

5 Storing this medicine

Do not store above 25ºC.
Store in the original packaging.
Keep the product out of the reach and sight of children.
Do not use your medicine after the end of the month
shown as an expiry date on the packaging.

12-0086
365074D

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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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