Syndol film-coated tablets – patient leaflet, side effects, dosage

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

• 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

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 an underlying sensitivity to aspirin and/or to non-steroidal anti-inflammatory drugs
• you are having an asthma attack or have 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 severe liver problems
• you have recently had an operation on your liver, gall bladder or bile duct (biliary tract)
• you are at risk of blocked intestine (paralytic ileus)
• 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 tablets is 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 close to giving birth or there is a risk of premature birth
• you are breast-feeding or planning to breastfeed

Do not take Syndol if any of the above apply to you.

Warnings and precautions

Tolerance, dependence, and addiction

This medicine contains codeine which is an opioid medicine. It can cause dependence and/or addiction.

Repeated use of opioids can result in the drug being less effective (you become accustomed to it, known as tolerance). Repeated use of Syndol can also lead to dependence, abuse and addiction, which may result in life-threatening overdose. The risk of these side effects can increase with a higher dose and longer duration of use. Dependence or addiction can make you feel that you are no longer in control of how much medicine you need to take or how often you need to take it.

The risk of becoming dependent or addicted varies from person to person. You may have a greater risk of becoming dependent on or addicted to Syndol if:

• You or anyone in your family have ever abused or been dependent on alcohol, prescription medicines or illegal drugs (“addiction”).
• You are a smoker.

• You have ever had problems with your mood (depression, anxiety, or a personality disorder) or have been treated by a psychiatrist for other mental illnesses.

  If you notice any of the following signs whilst taking Syndol, it could be a sign that you have become dependent or addicted:

  • You need to take the medicine for longer than advised by your doctor
  • You need to take more than the recommended dose
  • You might feel that you need to carry on taking your medicine, even when it doesn’t help to relieve your pain.
  • You are using the medicine for reasons other than prescribed, for instance, ‘to stay calm’ or ‘help you sleep’
  • You have made repeated, unsuccessful attempts to quit or control the use of the medicine
  • When you stop taking the medicine you feel unwell, and you feel better once taking the medicine again (‘withdrawal effects’)

If you notice any of these signs, speak to your doctor to discuss the best treatment pathway for you, including when it is appropriate to stop and how to stop safely (See section 3, If you stop taking Syndol).

Stop taking Syndol and seek medical advice if:

• You develop skin rashes with blistering, peeling or bleeding of the skin around the lips, eyes, mouth, nose, and genitals. You may also have flu-like symptoms and a high temperature. These could be signs of something called ‘Stevens-Johnson Syndrome’ or ‘toxic epidermal necrolysis’.
• You take this medicine for headaches and they get worse.

Talk to your doctor or pharmacist before taking Syndol if:

• You have liver, kidney, thyroid or heart problems and/or are elderly or of a weakened state
• You have high or low 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 gastrointestinal 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 dependence or are under psychiatric treatment
• You regularly drink, or have recently stopped drinking, excessive amounts of alcohol
• You are taking a benzodiazepine (used for treatment of anxiety or sleep disorders), e.g. diazepam, clobazam, lorazepam, chlordiazepoxide, oxazepam, temazepam, nitrazepam, loprazolam, lormetazepam or clonazepam
• You have low glutathione reserves
• You have Glucose-6-phosphate-dehydrogenase deficiency
• You have Gilbert’s syndrome
• You have chronic constipation
• You are addicted to opioids or are being treated for opioid addiction
• You suffer from breathing difficulties
• You have Addison’s disease
• You have thyroid problems
• You are elderly
• You suffer from anxiety
• You have an irregular heartbeat

During treatment with Syndol, tell your doctor straight away if:

• you have severe illnesses, including severe renal impairment or sepsis (when bacteria and their toxins circulate in the blood leading to organ damage), or you suffer from malnutrition, chronic alcoholism or if you are also taking flucloxacillin (an antibiotic). A serious condition called metabolic acidosis (a blood and fluid abnormality) has been reported in patients in these situations when paracetamol is used at regular doses for a prolonged period or when paracetamol is taken together with flucloxacillin. Symptoms of metabolic acidosis may include: serious breathing difficulties with deep rapid breathing, drowsiness, feeling sick (nausea) and being sick (vomiting).
• you experience pain or increased sensitivity to pain (hyperalgesia) which does not respond to a higher dosage of your medicine.

Contact your doctor if you experience severe upper abdominal pain possibly radiating to the back, nausea, vomiting or fever as this could be symptoms associated with inflammation of the pancreas (pancreatitis) and the biliary tract system.

Sleep-related breathing disorders

Syndol can cause sleep-related breathing disorders such as sleep apnoea (breathing pauses during sleep) and sleep related hypoxemia (low oxygen level in the blood). The symptoms can include breathing pauses during sleep, night awakening due to shortness of breath, difficulties to maintain sleep or excessive drowsiness during the day. If you or another person observe these symptoms, contact your doctor. A dose reduction may be considered by your doctor. 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

• 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 or have recently taken 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) or a benzodiazepine used to treat anxiety or sleep disorders
• 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, hyoscine)
• Any of the group called neuromuscular blockers (e.g. tubocurarine)
• Medicines used to thin the blood such as warfarin (or other coumarins)
• 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 treatment 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
• Theophylline – used for wheezing or difficulty in breathing
• Medicines for infections (antibiotics) such as enoxacin, ciprofloxacin, rifampicin and flucloxacillin
• The oral contraceptive pill
• Cinacalcet – to treat thyroid problems
• Methadone – used for treating drug (opioid) dependence and severe chronic pain
• flucloxacillin (antibiotic), due to a serious risk of blood and fluid abnormality (high anion gap metabolic acidosis) that must have urgent treatment (see section 2).
• Gabapentin or pregabalin to treat epilepsy or pain due to nerve problems (neuropathic pain) 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.

Avoid drinking too much coffee, or other drinks containing caffeine, while taking these tablets. 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

Children 12 to 18 years of age who have breathing problems should not take this medicine. This includes breathing problems while sleeping, breathing problems related to obesity, or other lung 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

• you are pregnant
• in labour

• you are breast-feeding. Codeine and morphine pass 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.
• Syndol should be used for 3 days only to relieve symptoms. If no effective pain relief is achieved while taking the medicine, you should seek the advice of a healthcare professional.
• 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 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 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

• 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.
• Talk to a doctor at once if you take too much of this medicine even if you feel well. This is because too much paracetamol can cause 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 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:

• You have a rash, fever, swelling, bruising or tiredness
• You have difficulty in breathing, are wheezing or have tightness in the chest 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

• You get infections or bruise more easily than usual. This could be because of a blood problem (such as agranulocytosis, thrombocytopenia, neutropenia or leukopenia)
• Yellowing of the skin or the white of the eyes
• You get chest pain, shortness of breath, clammy, sweaty and a grey complexion
• Fever, chills, tiredness, loss of appetite, stomach pain, feeling sick, yellowing of your skin or eyes (jaundice). These can be signs of liver problems such as hepatitis (inflammation of the liver) or liver damage
• You have a fit (seizure)
• Ringing in the ears (tinnitus)
• Blurred vision.

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)
• Headache
• Dizziness
• Somnolence
• Feeling unusually tired
• Confusion
• Depression
• Feeling overly happy (euphoria)
• A feeling of unease or dissatisfaction
• Difficulties sleeping
• Restlessness
• Shaking, fits
• Irregular heart beat
• Increased heart rate
• Stomach pain
• Sweating
• Facial flushing
• General discomfort
• Loss of appetite
• Very slow or shallow breathing
• Shortness of breath
• Hallucinations, nightmares
• Cramps or stiffness
• Becoming dependent on codeine
• Difficulty in passing water
• A decrease in the number of red blood cells (anaemia) in patients with underlying glucose 6-phosphate-dehydrogenase deficiency

Other effects that may occur are; constipation, headache, drowsiness, dizziness, restlessness, difficulties passing urine, dry mouth, blurred vision, diarrhoea, thick phlegm. Frequency Not known (frequency cannot be estimated from the available data):

• A serious condition that can make blood more acidic (called metabolic acidosis), in patients with severe illness using paracetamol (see section 2).
• Problem affecting a valve in the intestines (sphincter of Oddi dysfunction). 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

• Store this medicine in a safe and secure storage space, where other people cannot access it. It can cause serious harm and be fatal to people when it has not been intended for them.
• 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.
• Store below 25°C in the original packaging, to protect from moisture.
• 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, croscarmellose sodium, pregelatinised maize starch, magnesium stearate, talc and water. The tablet film coating contains lactose monohydrate, hypromellose, titanium dioxide, polyethylene glycol 4000; quinoline yellow (E104) and sunset yellow (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. 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:

Phoenix Labs, Suite 12, Bunkilla Plaza, Bracetown Business Park, Clonee, Co. Meath, Ireland

Tel: +353-1-5742410 - Email: medicalinformation@phoenixlabs.ie

Manufacturer:

Custom Pharmaceuticals Ltd.

Conway Street, Hove, East Sussex, BN3 3LW, UK.

The leaflet was last revised in March 2026.