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SYNDOL

Active substance(s): CAFFEINE / CODEINE PHOSPHATE / DOXYLAMINE SUCCINATE / CAFFEINE / DOXYLAMINE SUCCINATE / CAFFEINE / CODEINE PHOSPHATE / DOXYLAMINE SUCCINATE

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PACKAGE LEAFLET

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Package leaflet: Information for the user
Syndol® Film Coated Tablets
Paracetamol 450mg, Codeine Phosphate 10mg, Doxylamine Succinate 5mg and Caffeine 30mg
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Phone 08453727101 for help
Important things you should know about Syndol
 This medicine can only be used for the short term treatment of acute moderate pain when
other painkillers have not worked
 You should only take this product for a maximum of 3 days at a time. If you need to take it for
longer than three days you should see your doctor or pharmacist for advice
 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 this medicine for headaches for more than 3 days it can make them worse
Read all of this leaflet carefully before you start taking this medicine because it contains important
information for you.
 Keep this leaflet. You may need to read it again.
 If you have any further questions, ask your doctor or pharmacist
 If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects
not listed in this leaflet (see section 4)

What is in this leaflet:
1. What Syndol is and what it is used for
2. What you need to know before you take Syndol
3. How to take Syndol
4. Possible side effects
5. How to store Syndol
6. Contents of the pack and other information

1. What Syndol is and what it is used for
The name of your medicine is Syndol Film Coated Tablets (called Syndol throughout this leaflet).
Syndol contains four different medicines called caffeine, codeine phosphate, doxylamine succinate and
paracetamol.Paracetamol acts as an analgesic (painkiller) and an antipyretic (lowers body temperature),
codeine phosphate is an analgesic, doxylamine succinate is an antihistamine and caffeine is a mild stimulant.
.
Syndol is used for the short term treatment of acute moderate pain which is not relieved by paracetamol,
ibuprofen and aspirin alone such as headache, including muscle contraction or tension headache, migraine,
neuralgia, period pain, toothache and other dental pain, muscular and rheumatic aches and pains and for pain
relief following surgery or dental procedures.
Codeine belongs to a group of medicines called opioid analgesics which act to relieve pain. It can be used on
its own or in combination with other painkillers such as paracetamol
Codeine can be used in children over 12 years of age for the short-term relief of moderate pain that is not
relieved by other painkillers such as paracetamol or ibuprofen alone.

2. What you need to know before you take Syndol

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 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
Do not take Syndol if
 you are allergic to codeine, paracetamol, doxylamine succinate, caffeine or any of the ingredients of this
medicine (listed in section 6) Signs of an allergic reaction include a rash and breathing problems. There
can also be swelling of the legs, arms, face, throat or tongue
 you have severe asthma attacks or severe breathing problems
 you have recently had a head injury
 you have been told by your doctor that you have increased pressure in your head
Signs of this include headaches, being sick (vomiting) and blurred eyesight
 you have recently had an operation on your liver, gall bladder or bile duct (biliary tract)
 you are taking other medicines containing codeine or any other paracetamol- containing products
 you are taking a medicine of the class known as Monoamine Oxidase Inhibitors (MAOIs, e.g. selegiline,
moclobemide), which are used as antidepressants, or if you had taken any medicine of this group in the
past 14 days.
 you are an alcoholic
 The person going to take the tabletsis under 12 years of age
 you are under 18 years of age and have had your tonsils or adenoids removed due to obstructive
 sleep apnoea syndrome
 you know that you metabolise very rapidly codeine into morphine
 you are breast-feeding or planning to breastfeed
Do not take Syndol if any of the above apply to you.
Warnings and precautions
Talk to your doctor or pharmacist before taking Syndol if:
• You have liver, kidney, thyroid or heart problems and/or are elderly;
• You have high blood pressure, problems with the prostate gland, obstructive bowel problems, acute
abdominal conditions (e.g. peptic ulcer), hormonal problems, problems passing urine or have had recent
gastroinstestinal surgery;
• You are in shock, have gallstones, glaucoma, or a disease called myasthenia gravis ( a condition which
weakens muscles) or a history of fits;
• You have a history of mood swings, alcohol or drug abuse or are under psychiatric treatment;
• You are taking any of these medicines: warfarin (or other coumarins), colestyramine, metoclopramide,
domperidone, hydroxyzine, mexiletine, diuretics, antihypertensives, medicines of the group known as
antimuscarinics (e.g. atropine, hyoscine) and any of the group called neuromuscular blockers (e.g
tubocurarine), medicines for the treatement of diarrhoea (e.g. kaolin, loperamide), naloxone, naltrexone,
drugs known as central nervous system depressants (e.g. barbiturates, hypnotics, opioid analgesics,
axiolytic sedatives, tricyclic antidepressants, phenothiazines), drugs known as antipyschotics, cimetidine,
cisapride or quinidine.
• You are sensitive to aspirin or other medicines used for the treatment of inflammation (Non Steroidal
Antiinflammatory Drugs) such as Ibuprofen
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.
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking this
medidne.
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Other medicines and Syndol Please tell your doctor or pharmacist if you are taking or have recently taken
any other medicines.
This includes medicines obtained without a prescription, including herbal medicines. This is because
Syndol can affect the way some other medicines work. Also, some other medicines can affect the way
Syndol works.
While taking Syndol you should not take any other medicines which contain paracetamol.
This includes some painkillers, cough and cold remedies. It also includes a wide range of medicines
available from your doctor and more widely in shops.
Do not take this medicine and tell your doctor or pharmacist, if you are taking
 Medicines to treat depression called MAOIs (monoamine oxidase inhibitors) or have recently taken
them in the last two weeks. MAOIs are medicines such as moclobemide, phenelzine, tranylcypromine
Tell your doctor or pharmacist if you are taking any of the following medicines:
 Medicines which make you drowsy or sleepy (CNS depressants) (e.g. barbiturates, anaesthetics,

hypnotics, other opioid analgesics, anxiolytic sedatives, antipsychotics, tricyclic antidepressants
and phenothiazines)

 Medicines for the treatment of high blood pressure (diuretics and antihypertensives)
 Medicines to treat or prevent clinical depression (antidepressants)
 Medicines used to treat mental distress or disorder (antipsychotics)
 Any of the group called antimuscarinics (e.g. atropine)
 Any of the group called neuromuscular blockers
 Medicines used to thin the blood such as warfarin
 Chloramphenicol - an antibiotic used for infections
 Metoclopramide or domperidone - used to stop you feeling sick (nausea) or being sick (vomiting)
 Colestyramine -for lowering blood cholesterol levels
 Hydroxyzine - to treat anxiety and tension
 Mexiletine - to treat irregular heartbeat
 Kaolin or loperamide - for the treatement of diarrhoea
 Naloxone - to treat a narcotic overdose
 Naltrexone - used as part of a treatment program for drug or alcohol dependence
 Cimetidine - to treat stomach ulcers
 Cisapride - to treat gastro-oesophageal reflux disease
 Quinidine - to treat irregular heart rate
 The oral contraceptive pill
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Syndol.
Taking Syndol with food and drink
Avoid alcohol whilst taking Syndol
Children and adolescents
Use in children and adolescents after surgerv
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
Codine is not recommended in children with breathing problems, since the symptoms of morphine toxicity
may be worse in these children.
Pregnancy and breast-feeding
If you are pregnant or breast feeding, think you may be pregnant or are planning to have a baby, ask your
doctor or pharmacist for advice before taking this medicine.
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Paracetamol can be used during pregnancy. You should use the lowest possible dose that reduces your pain
and/or your fever and use it for the shortest time possible. Contact your doctor or midwife if the pain and/or
fever are not reduced or if you need to take the medicine more often.
Do not take Syndol and speak to your doctor if
 You are in the last three months of pregnancy
 In labour
 Do not take Syndol while breast-feeding. Codeine and morphine passes into breast milk.
Driving and using machines
Syndol 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 is an offence to drive if
this medicine affects your ability to drive.
 However, you would not be committing an offence if:
- The medicine has been prescribed to treat a medical or dental problem and
- You have taken it according to the instructions given by the prescriber or in 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
Syndol contains lactose, sunset yellow (E110), and quinoline yellow (E104)
 This product contains lactose. If you have been told by your doctor that you have an intolerance to some
sugars, speak to your doctor before taking this product.
 It also contains sunset yellow (E110) and quinoline yellow (E104) which may cause allergic reactions

3. How to take Syndol

Always take Syndol exactly as your doctor or pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.
 Do not take Syndol for more than 3 days. If you need to use this medicine for more than three days you
must speak to your doctor or pharmacist.


This medicine contains codeine and can cause addiction if you take it continuously for more than three
days. When you stop taking it you may get withdrawal symptoms. You should talk to your doctor or
pharmacist if you think you are suffering from withdrawal symptoms.

Adults, including the elderly
 Take one or two tablets every four to six hours as needed for relief
 Adults should wait at least 4 hours before taking another dose
 Do not take more than eight tablets in a 24 hour period
 Do not exceed the stated dose

If you are elderly, you should seek advice from your doctor before taking Syndol as dosage adjustment may
be required.
Children aged 16 to 18 years
1 to 2 tablets every 6 hours when necessary up to a maximum of 8 tablets in 24 hours.
Children aged 12 to 15 years
1 tablet every 6 hours when necessary to a maximum of 4 tablets in 24 hours.
Children under 12 years
Syndol should not be taken by children below the age of 12, due to the risk of severe breathing
problems.
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If you take more Syndol than you should
 Signs of overdose may include unusually pale skin, nausea, vomiting, loss of appetite, abdominal pain,
pupils that may be pin-point in size, a difficulty in breathing, an increased or irregular heart rate, and
loin (kidney) pain.
 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
 Remember to take any remaining tablets and the pack with you. This is so the doctor knows what you
have taken
If you have forgotten to take Syndol
If you forget to take a dose at the right time, take it as soon as you remember. However, if it is almost
time for your next dose, skip the missed dose. Do not take a double dose to make up for a forgotten dose.
Remember to leave at least 4 hours between doses.
If you stop taking Syndol
This medicine contains codeine and can cause addiction if you take it continously for more than three days.
When you stop taking it you may get withdrawal symptoms . You should talk to your doctor or pharmacist if
you think you are suffering from withdrawal sypmtoms.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The following
side effects may happen with this medicine:
Stop taking Syndol and see a doctor or go to a hospital straight away if:
 You have a rash, fever, swelling, bruising or tiredness
 You have difficulty in breathing or you feel dizzy
 You get swelling of the hands, feet, ankles, face, lips or throat which may cause difficulty in swallowing
or breathing
You could also notice an itchy, lumpy rash(hives) or nettle rash (urticaria)
This may mean you are having an allergic reaction
 You get serious skin reactions. Very rare cases have been reported.
Talk to your doctor straight away if you notice the following serious side effects
 Severe stomach pain, which may reach to your back. This could be a sign of inflammtion of the
pancreas (pancreatitis). This is a very rare side effect.
 You get infections or bruise more easily than usual. This could be because of a blood problem (such as
agranulocytosis, neutropenia or thrombocytopenia)
 Yellowing of the skin or the white of the eyes
Tell your doctor or pharmacist if any of the following side effects gets serious or lasts longer than a
few days:
 Feeling sick (nausea)
 Being sick (vomiting)
 Low blood pressure (causing light-headedness or fainting when standing up)
 Confusion
 Depression
 Difficulties sleeping
 Shaking, fits
 Irregular heart beat
 Stomach pain
 Sweating
 Facial flushing
 General discomfort
 Loss of appetite
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 Very slow or shallow breathing
 Shortness of breath
 Hallucinations, nightmares
 Cramps or stiffness
 Becoming dependent on codeine

Other effects that may occur are; constipation, headache, drowsiness, dizziness, restlessness, difficulties
passing urine, dry mouth, blurred vision, diarrhoea, thick phlegm.
How do I know if I’m 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 dose
 When you stop taking the medicine you feel very unwell but you feel better if you start taking the
medicine again.
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.






5. How to store Syndol

Keep out of the sight and reach of children.
Do not use after the expiry date shown on the details of packaging. The expiry date refers to the last date
of that month.
There are no specific storage conditions required for this product.
Do not throw away medicines via household waste. Ask your pharmacist how to throw away medicines
you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Syndol Tablets contain
 Each Syndol tablet contains the following active ingredients 450mg of paracetamol, 10mg of codeine
phosphate, 5mg of doxylamine succinate and 30mg of caffeine.
 They also contain povidone, croscamellose sodium, corn starch, magnesium stearate, talc and water. The
tablet film coating contains lactose, hydroxypropyl methyl cellulose, titanium dioxide, polyethylene
glycol 4000; quinoline yellow aluminium lake (E104) and sunset yellow aluminium lake (E110).
What Syndol Tablets look like and contents of the pack
Syndol are yellow film coated capsule shaped tablets. Each tablet has ‘Syndol’ embossed on one side, and
the other side is scored with a break line. They are in blister strips packed into cartons of 10 and 30 tablets.
Marketing Authorisation Holder:
Sanofi,
One Onslow Street,
Guildford,
Surrey,
GU1 4YS,
UK
Tel: 0845 372 7101
Email: uk-medicalinformation@sanofi.com
Manufacturer: SSL International plc,
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Whitehouse Industrial Park,
Traynor Way, Peterlee,
Durham. SR8 2RU, UK.
The leaflet was last revised in November 2016
© Sanofi, 2016

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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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