BOOTS PHARMACY TENSION HEADACHE TABLETS

Active substance: PARACETAMOL

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Information for the user
Boots Pharmacy Tension Headache Tablets
Read all of this leaflet carefully because it contains important information for
you.
This medicine is available without prescription to treat minor conditions.
However, you still need to take it carefully to get the best results from it.










This medicine can only be used for the short term treatment of acute
moderate pain such as headache including those involving tense
muscles or tension headache, migraine, rheumatic and muscular aches
and pains, period pain, neuralgia, toothache and pain relief after dental
or surgical operations that is not relieved by aspirin, ibuprofen or
paracetamol alone
You should only take this product for a maximum of 3 days at a
time. If you need to take it for longer than 3 days you should see your
doctor or pharmacist for advice.
This medicine contains codeine which can cause addition if you
take it continuously for more than 3 days. This can give you
withdrawal symptoms from the medicine when you stop taking it
If you take this medicine for headaches for more than 3 days it can
make them worse
Keep this leaflet, you may need to read it again
Ask your pharmacist if you need more information or advice

What this medicine is for
This medicine contains Codeine (an opioid analgesic) and Paracetamol which
belong to a group of medicines called analgesics which act to relieve pain. It
can be used on its own or in combination with other pain killers. This
medicine also contains Doxylamine Succinate which acts to relax muscles
and Caffeine which helps to increase the pain relief.
This medicine (which contains codeine) can be used in children over 12
years of age for the short-term relief of acute moderate pain such as
headache including those involving tense muscles or tension headache,
migraine, rheumatic and muscular aches and pains, period pain, neuralgia,
toothache and pain relief after dental or surgical operation that is not relieved
by other painkillers such as aspirin, ibuprofen or paracetamol alone.
Before you take this medicine

This medicine contains codeine which can cause addiction if you
take it continuously for more than 3 days. This can give you withdrawal
symptoms from the medicine when you stop taking it.

If you take a painkiller for headaches for more than 3 days it can
make them worse
This medicine can be taken by adults and children aged 12 years and over.
However, some people should seek the advice of their pharmacist or doctor

first.
Do not take:

If you are allergic to paracetamol, codeine, or other similar “ opioid”
painkillers, or to any of the other ingredients in this medicine ( see “ What
is in this medicine”)

If you are taking any other medicines containing codeine, or
paracetamol

If you are taking monoamine oxidase inhibitors ( MAOIs for
depression), or have taken them in the last 14 days

For pain relief in children and adolescents (0-18 years of age) after
removal of their tonsils or adenoids due to obstructive sleep apnoea
syndrome

If you know that you metabolise codeine into morphine very rapidly

If you are breastfeeding
Talk to your pharmacist or doctor:

If you have kidney or liver problems (including a disease caused by
drinking alcohol)

If you have high blood pressure, heart problems or a history of irregular
heart beats

If you have underactive thyroid, you are not producing enough of a
hormone from the adrenal gland, you are in shock or you are elderly or
infirm

If you have stomach ulcer, gallstones, recently had surgery on your
stomach or bowel problem

If you are constipated, or have any condition that may cause constipation
or where constipation should be avoided

If you have myasthenia gravis ( a condition that weakens muscles)

If you are prone to fits and convulsions

If you have raised pressure in the eye (glaucoma)

If you have a history of alcohol or drug abuse, experience mood swings or
are under psychiatric treatment

If you have difficulty passing urine, or be a man with prostate problems

If you are pregnant
Warnings and precautions
Codeine is transformed to morphine in the liver by an enzyme. Morphine is the
substance that produces pain relief. Some people have a variation of this
enzyme and this can affect people in different ways. In some people, morphine
is not produced or produced in very small quantities, and it will not provide
enough pain relief. Other people are more likely to get serious side effects
because a very high amount of morphine is produced. If you notice any of the
following side effects, you must stop taking this medicine and seek immediate
medical advice: slow or shallow breathing, confusion, sleepiness, small pupils,
feeling or being sick, constipation, lack of appetite.

Children and adolescents
Use in children and adolescents after surgery:
Codeine should not be used for pain relief in children and adolescents after
removal of their tonsils or adenoids due to Obstructive Sleep Apnoea Syndrome.
Use in children with breathing problems:
Codeine is not recommended in children with breathing problems, since the
symptoms of morphine toxicity may be worse in these children.
Pregnancy and breastfeeding
Do not take codeine while you are breastfeeding. Codeine and morphine passes
into breast milk.
Other Important Information
This medicine contains caffeine.
If you are having any medical tests:
Codeine in this medicine may interfere with the results of certain blood and
medical tests. If you are having any tests tell the doctor or hospital staff that you
are taking this medicine
Driving and using machines:
The medicine can affect your ability to drive as it may make you sleepy or dizzy.
Do not drive while taking this medicine until you know how it affects you.
It may be an offence to drive when taking this medicine. However, you would not
be committing an offence if:
- The medicine has been taken to treat a medical or dental problem and
- You have taken it according to the information provided with the medicine
and
- It was not affecting your ability to drive safely
Talk to your doctor or pharmacist if you are not sure whether it is safe for you to
drive while taking this medicine.
Details regarding a new driving offence concerning driving after drugs have
been taken in the UK may be found here: https://www.gov.uk/drug-driving-law
Do not drink alcohol (wine, beer, spirits) whilst taking this medicine. Alcohol
increases the risk of side effects occurring and may make you feel more drowsy.
If you take other medicines
This medicine contains paracetamol.
Do not take with any other paracetamol-containing or codeine-containing
products.
Before you take these tablets, make sure that you tell your pharmacist about
ANY other medicines you might be using at the same time, particularly the

following:




Domperidone or metoclopramide for feeling sick or being sick
Colestyramine for reducing blood fat levels
Warfarin or other blood thinners – if you take warfarin you can take
occasional amounts of this medicine, but talk to your doctor first before
you take it on a regular basis
• Medicines that make you sleepy or drowsy (e.g. for depression or
mental health conditions, anxiety, epilepsy, to help you sleep or strong
opioid painkillers)
• Medicines which cause a dry mouth
• Water tablets (diuretics), or medicines to treat high blood pressure,
quinidine or mexiletine ( for heart rhythm problems)
• Medicines for diarrhoea (e.g. loperamide, kaolin), cimetidine or
cisapride (for stomach problems)
• Hydroxyzine used for allergies and mild anxiety
• Naloxone or naltrexone (used for treatment of opioid dependence or
overdose)
If you are unsure about interactions with any other medicines, talk to
your pharmacist. This includes medicines prescribed by your doctor and
medicine you have bought for yourself, including herbal and
homeopathic remedies.
How to take
Check the foil is not broken before use. If it is, do not take that tablet.

Age

How many

How often

Children
aged 12
years to 18
years
Adults

One or two

Every 6 hours, if you
need to. Don’t take
more than 8 tablets
in 24 hours.
Every 4 to 6 hours, if
you need to. Don’t
take more than 8
tablets in 24 hours.

One or two

Do not take more often than every 4 hours
If you are elderly your pharmacist or doctor may advise you to take fewer
tablets. If this applies to you follow their instructions.
Swallow each tablet with water.
This medicine should not be taken for more than 3 days. If the pain does
not improve after 3 days, talk to your doctor for advice.
This medicine should not be taken by children below the age of 12 years, due to
the risk of severe breathing problems.
Do not take more than the amount recommended in the table.

If symptoms do not go away talk to your doctor.

If you take too many tablets:
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. Go to your
nearest hospital casualty department. Take your medicine and this leaflet with
you.
Possible withdrawal effects when stopping treatment
This medicine contains codeine and can cause addiction if you take it
continuously for more than 3 days. When you stop taking you may get
withdrawal symptoms.
You should talk your doctor or pharmacist if you think you are suffering
withdrawal symptoms.
Possible side effects
Most people will not have problems, but some people may have side effects
when taking this medicine. If you have any unwanted side effects you should
seek advice from your doctor, pharmacist or other healthcare professional.
If you get any of these serious side effects, stop taking the tablets.
See a doctor at once:
Difficulty in breathing, swelling of the face, neck, tongue or throat (severe allergic
reactions
Other allergic reactions e.g. red, raised, itchy skin rash

These other effects are less serious. If they bother you talk to a
pharmacist:

Fits or convulsions, drowsiness, dizziness or spinning (vertigo), headache,
loss of appetite

Feeling tired, difficulty sleeping, depressed, restlessness, delirium,
confusion, generally feeling unwell

Constipation, feeling sick, being sick, dry mouth, stomach cramps or
irritation

Blurred or double vision

Sweating, facial flushing

Slow or shallow breathing

Low blood pressure, especially on standing up ( you may feel faint or
dizzy), changes in heart rate, a thumping or flutter feeling in the chest

Difficulty in passing urine increased frequency in urination (sometimes
passing only small amounts of urine), pain when passing urine

Nightmares, hallucinations (seeing or hearing things that are not there)

Rigid muscles, uncontrolled o impaired muscle movements

Yellowing of skin or eyes (these may be signs of liver problems)

Unusual bruising, bleeding, fever or infections such as sore throats – his

may be a sign of very rare changes in the blood
If any side effect becomes severe, or you notice any side effect not
listed here, please tell your pharmacist or doctor.
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.
How do I know if I am addicted?
If you take the medicine according to the instructions on the pack it is unlikely
that you will become addicted to the medicine.
However, if the following apply to you it is important that you talk to your
doctor:

You need to take the medicine for longer periods of time

You need to take more than the recommended amount

When you stop taking the medicine you feel very unwell but you feel
better if you start taking the medicine again

How to store this medicine
Keep this medicine in a safe place out of the sight and reach of children,
preferably in a locked cupboard.
Use by the date on the end flap of the carton
What is in this medicine?
Each tablet contains Caffeine 30 mg, Codeine Phosphate 10mg, Doxylamine
Succinate 5mg, Paracetamol 450 mg which are the active ingredients.
As well as the active ingredients, the tablets also contain corn starch,
povidone, croscarmellose sodium, talc, magnesium stearate, purified water
This pack contains 24 tablets
Who makes this medicine
Manufactured for Boots Pharmacy Nottingham NG2 3AA by SSL International
PLC Whitehouse Industrial Park Traynor Way Peterlee Co Durham SR8 2RU.
Marketing Authorisation held by SSL International PLC, Venus 1 Old Park
Lane Manchester M41 7HA
Leaflet prepared June 2014
If you would like any further information about this medicine, please contact The

Boots Company PLC Nottingham NG2 3AA
Other formats
To request a copy of this leaflet in Braille, large print or audio please call,
free of charge:
0800 198 5000 (UK only)
Please be ready to give the following information:
Product Name: Paracetamol, Codeine, Caffeine & Doxylamine
Compound Reference Number: 17905/0065
This is a service provided by the Royal National Institute of Blind People.

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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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