Patient Leaflet Updated 11-Mar-2021 | SANOFI Consumer Healthcare
Syndol Film-coated Tablets
Package leaflet: Information for the user
Paracetamol, Codeine Phosphate, Doxylamine Succinate and Caffeine
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Important things you should know about Syndol
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you.
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 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 but not if they are under 18 years of age and have had their tonsils or adenoids removed due to Obstructive Sleep Apnoea Syndrome.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE SYNDOL
Do not take Syndol if
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:
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 medicine.
Other medicines and Syndol
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
Tell your doctor or pharmacist if you are taking or have recently taken any of the following medicines:
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Syndol.
Concomitant use of opioids and benzodiazepines increases the risk of drowsiness, difficulties in breathing (respiratory depression), coma and may be life-threatening. Because of this, you should only take these together if prescribed by a doctor. Please follow your doctor’s dosage recommendation closely. It could be helpful to inform friends or relatives to be aware of signs and symptoms stated above. Contact your doctor when experiencing such symptoms.
Taking Syndol with food and drink
Avoid alcohol whilst taking Syndol.
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 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.
Do not take Syndol and speak to your doctor if
Driving and using machines
Syndol can affect your ability to drive as it may make you sleepy or dizzy.
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), quinoline yellow (E104) and sodium
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.
Adults, including the elderly
If you are elderly or of a weakened state 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 up 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.
If you take more Syndol than you should
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 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.
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:
Talk to your doctor straight away if you notice the following serious side effects:
Tell your doctor or pharmacist if any of the following side effects gets serious or lasts longer than a few days:
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:
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 or search for MHRA Yellow Card in the Google Play or Apple App Store.
By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE SYNDOL
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Syndol tablets contain
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.The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. They are in blister strips packed into cartons of 10 and 30 tablets.
Marketing Authorisation Holder:
The leaflet was last revised in July 2020
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