Syndol
PACKAGE LEAFLET
Package leaflet: Information for the user
Syndol® Caplets
Paracetamol 450mg, Codeine Phosphate 10mg, Doxylamine Succinate 5mg and Caffeine 30mg
• This medicine can only be used for a short term treatment of acute moderate pain when other
painkillers have not worked.
• You should only take this product for a maximum of three 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 continously for more than
three 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 three days it can make them worse.
What are these tablets used for?
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, migrane, neuralgia, period pain, toothache and other dental pain, muscular and rheumatic aches and pains and for pain relief following surgery or dental procedures.
Before taking these tablets
• This medicine contains codeine which can cause addiction if you take it continously for more than
three days. This can give you withdrawal symptoms from the medicine when you stop taking it.
• If you take a pain killer for headaches for more than three days it can make them worse
Do not take Syndol...
• If you are allergic to any of the ingredients in this product. See ‘What these tablets contain’ for the
full list of ingredients.
• If you are taking other medicines containing codeine or any other paarcetamol- containing products
• If 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.
Speak to your doctor or pharmacist if you
• have liver, kidney, thyroid or heart problems and/or are elderly;
• 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;
• are in shock, have gallstones, glaucoma, or a disease called myasthenia gravis ( a condition which
weakens muscles) or a history of fits;
• have a history of mood swings, alcohol or drug abuse or are under psychiatric treatment;
• are taking any of these medicines: warfarin (or other coumarins), cholestyramine, 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 depressants (e.g. barbiturates, hypnotics, opiod analgesics, axiolytic sedatives, tricyclic antidepressants, phenotiazines), drugs known as antpyschotics, cimetidine, cisapride or quinidine.
Take speacial care.
• If you take a painkiller for headaches for more than three days it can make them worse.
• If you need to use this medicine for more than three days at a time, see your doctor, pharmacist or
healthcare professional.
• Avoid alcohol whilst taking Syndol If you are pregnant or breast feeding
• Syndol is not recommended for use during pregnancy
• Usually it is safe to take Syndol while breast feeding as the levels of the active ingredient of this
medicine in breast milk are too low to cause your baby any problems. However , some women who are at increased risk of developing side effects at any dose may have higher levels in their breast milk. If any of the following side effects develop in you or your baby, stop taking this medicine and seek immediate medical advice; feeling sick, vomiting, constipation, decreased or lack of appetite, feeling tired or sleeping for longer than normal , and shallow or slow breathing.
Driving and using machines...
• Do not drive or operate machinery after taking Syndol as it may cause hallucinations, double vision or make you feel dizzy, drowsy or confused.
Important information about some of the ingredients
• This product contains lactose. If you have been told by your doctor that you have an intolelance to some sugars, speak to your doctor before taking.
• It also conatins sunset yellow (E110) and quinoline yellow (E104) which may cause allergic reactions
How to take these tablets
• Do not take 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.
Adults, the elderly and children over 12 years
• Take one or two tablets every four to six hours as needed for relief
• 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 under 12 years
• Not recommended for children under 12 years.
Possible withdrawal effects
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.
If you take too many of the 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.
Possible side effects
Important: 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. Also you can help to make sure that medicines remain as safe as possible by reporting any unwanted side-effects via the internet at www.mhra.gov.uk/yellowcard; alternatively you can call Freephone 08081003352 (available between 10am-2pm Monday-Friday) or fill in a paper form available at your local pharmacy.
• If you get any of the following side effects, stop taking Syndol and see a doctor immediately, as you may be allergic to this product; rash, fever, swelling, bruising or tiredness.
• Other effects that may occur are; constipation, headache, drowsiness, dizziness, restlessness, difficulties passing urine, dry mouth, blurred vision, feeling or being sick, diarrhoea, thick phlegm.
• These effects may occur but less frequently; nausea, vomiting, low blood pressure (causing lightheadedness or fainting when standing up), confusion, depression, difficulties sleeping, shaking, fits, irregualar heartbeat, stomach pain, yellowing of the skin or the white of the eyes, sweating, facial flushing, general discomfort, loss of appetite, very slow or shallow breathing, shortness of breath, hallucinations, nightmares, cramps or stifness.
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.
How to store these tablets
Keep out of the reach and sight of children.
• There are no specific storage conditions required for this product.
• Do not use after the expiry date shown on the details of packaging.
• If you find that you still have this medicine afer its expiry date, return it to your local pharmacist who will dispose of it properly.
What these tablets contain
Each Syndol tablet conatins 450mg of the active ingredient paracetamol, 10mg of the active ingredient codeine phosphate, 5mg of the active ingredient doxylamine succinate and 30mg of the active ingredient caffeine. Paracetamol acts as an analgesic (pain killer) and an antipyretic (lowers body temparature), codeine phosphate is an analgesic, doxylamine succinate is an antihistamine and caffeine is a mild stimulant.
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).
Syndol are yellow film coated caplet 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, 20 and 30 tablets.
Marketing Authorisation Holder:
Sanofi,
One Onslow Street,
Guildford,
Surrey,
GU1 4YS,
UK
Tel: 0845 372 7101
Email: uk-medicalinformation@sanofi .com
Manufactured by: SSL International plc, Whitehouse Industrial Park, Traynor Way, Peterlee, Durham. SR8 2RU, UK.
Date of revision: October 2014 © Sanofi, 2014