SCHEDULING STATUS
S2
Product Name
SINUCON 200 mg/6 mg/20 mg/2 mg tablets
Active Ingredients
Each tablet contains:
| Active ingredient | Quantity |
|---|---|
| Paracetamol | 200 mg |
| Ephedrine hydrochloride | 6 mg |
| Caffeine | 20 mg |
| Chlorpheniramine maleate | 2 mg |
Sugar Information
SINUCON contains sugar: lactose 148,00 mg.
Read Before Taking SINUCON
SINUCON is available without a doctor’s prescription for the treatment of a mild illness. It should still be used carefully to get the best results.
Keep this information because it may be needed again. Do not share SINUCON with any other person. Ask a healthcare provider or pharmacist if more information or advice is needed.
A doctor should be consulted if symptoms worsen or do not improve after 10 days.
What Is in This Article
- What SINUCON is and what it is used for
- What you need to know before you take SINUCON
- How to take SINUCON
- Possible side effects
- How to store SINUCON
- Contents of the pack and other information
1. What SINUCON Is and What It Is Used For
SINUCON contains four active substances:
| Active substance | Purpose |
|---|---|
| Paracetamol | Relieves pain and reduces fever |
| Ephedrine hydrochloride | Acts as a decongestant to relieve nasal congestion |
| Caffeine | Helps combat tiredness associated with a cold |
| Chlorpheniramine maleate | Acts as an antihistamine |
SINUCON is used for the relief of symptoms associated with colds, influenza and hay fever, including:
| Symptoms relieved |
|---|
| Nasal congestion |
| Sniffing |
| Headache |
2. What You Need to Know Before You Take SINUCON
Do Not Take SINUCON
Do not take SINUCON if any of the following apply:
| Do not take SINUCON if | Details |
|---|---|
| You are allergic to paracetamol | This includes allergy to the active ingredient |
| You are allergic to ephedrine hydrochloride | This includes allergy to the active ingredient |
| You are allergic to caffeine | This includes allergy to the active ingredient |
| You are allergic to chlorpheniramine maleate | This includes allergy to the active ingredient |
| You are allergic to any other ingredient in SINUCON | See the contents section |
| You have severe liver problems | SINUCON may not be suitable |
| You are taking a monoamine oxidase inhibitor | These are medicines used for depression |
| You stopped monoamine oxidase inhibitor treatment less than 14 days ago | SINUCON should not be used during this period |
| You suffer from hyper-excitability | SINUCON may not be suitable |
| You have a tumour of the adrenal gland | Also called phaeochromocytoma |
| You are having an asthma attack | SINUCON should not be used |
Warnings and Precautions
Take Special Care With SINUCON
In the event of overdose or suspected overdose, contact the nearest doctor, hospital or Poison Centre immediately, even if you feel well and have no symptoms.
Take special care with SINUCON if any of the following apply:
| Condition or situation requiring care |
|---|
| Kidney problems |
| Liver problems, including alcoholic liver disease |
| Alcohol dependence |
| Taking other medicines that affect the liver |
| Taking medicines for depression such as monoamine oxidase inhibitors or tricyclic antidepressants |
| Taking barbiturates, also known as sleeping tablets |
| Haemolytic anaemia |
| Dehydration |
| Chronic malnutrition |
| Glucose-6-phosphate dehydrogenase deficiency |
| Gilbert’s syndrome |
| Glutathione deficiency |
| Blood circulation problems such as Reynaud’s Syndrome |
| Asthma with sensitivity to aspirin |
| Heart disease |
| Angina |
| Problems with heartbeat |
| Severe hypertension |
| Bronchitis |
| Chronic lung condition |
| Glaucoma |
| Hyperthyroidism |
| Diabetes |
| Prostate enlargement |
| Previous stomach ulcers |
| Excessive acid in the stomach |
| Uncontrolled seizures or fits |
Serious Skin Reactions
Serious skin reactions have been reported in patients receiving paracetamol.
These may include:
| Serious skin reaction |
|---|
| Exfoliative dermatitis |
| Stevens-Johnson syndrome |
| Toxic epidermal necrolysis |
Stop using SINUCON immediately and contact your doctor if you experience signs of serious skin reactions such as:
| Warning signs |
|---|
| Swelling |
| Itching |
| Severe red rash |
Alcohol, Drowsiness and Caffeine Warning
Avoid drinking alcohol or taking other medicines that may make you drowsy while using SINUCON, because this may cause excessive sleepiness.
Avoid taking other medicines that contain paracetamol or antihistamines together with SINUCON, because this may lead to overdose.
Avoid excessive caffeine intake while taking SINUCON. This includes products such as:
| Caffeine-containing products |
|---|
| Coffee |
| Tea |
| Some canned drinks |
Laboratory Tests
Paracetamol in SINUCON may interfere with some uric acid and blood sugar tests.
Chlorpheniramine maleate in SINUCON may suppress positive skin test results and should be stopped several days before the test.
Children
Do not give SINUCON to children below the age of 12 years.
Other Medicines and SINUCON
Always tell your healthcare provider if you are taking any other medicine, including complementary or traditional medicines.
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines, especially:
| Medicine or medicine group | Use or concern |
|---|---|
| Monoamine oxidase inhibitors | Used for depression |
| Tricyclic antidepressants | Used for depression |
| Barbiturates | Sleeping tablets |
| Sedatives and tranquilisers | Used for sleep or calming |
| Opioids or narcotic analgesics | Used for severe pain |
| Colestyramine | Used to lower blood cholesterol |
| Metoclopramide or domperidone | Used to treat nausea and vomiting |
| Warfarin or other blood thinners | Used to prevent blood clots |
| Aspirin | Pain reliever |
| Rifampicin and isoniazid | Used to treat tuberculosis |
| Probenecid | Used to treat gout |
| Flucloxacillin | Antibiotic |
| Phenytoin, lamotrigine and carbamazepine | Used for epilepsy |
| Sympathomimetic medicines | Stimulants, appetite suppressants and medicines used for congestion and asthma |
| Anaesthetics | Used during surgery |
| Atenolol or alpha-methyl dopa | Used to treat hypertension |
| Ergot alkaloids | Used to treat severe headaches |
| Digoxin or quinidine | Used to treat irregular heartbeats |
| Corticosteroids such as dexamethasone | Used for inflammation, especially in asthmatic patients |
| Oxytocin | Used during childbirth |
| Urinary acidifiers or alkalinisers | May affect medicine handling in the body |
| Lithium | Used to treat depression or bipolar disorder |
SINUCON With Food, Drink and Alcohol
Alcohol should be avoided when taking SINUCON.
Excessive intake of caffeine-containing products should be avoided while taking SINUCON.
Pregnancy, Breastfeeding and Fertility
If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, consult your doctor, pharmacist or other healthcare provider before taking SINUCON.
Driving and Using Machines
SINUCON may cause drowsiness and impaired concentration.
These effects may be worsened by alcohol or other central nervous system depressants.
Do not drive a motor vehicle, operate dangerous machinery or climb dangerous heights until you know how SINUCON affects you.
SINUCON Contains Lactose
SINUCON contains lactose.
If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking SINUCON.
3. How to Take SINUCON
Do not share medicines prescribed for you with any other person.
Always take SINUCON exactly as described in the leaflet or as your doctor, pharmacist or nurse has told you. Check with your doctor, pharmacist or nurse if you are not sure.
The Usual Dose Is
| Patient group | Dose |
|---|---|
| Adults | Two tablets every four hours |
DO NOT EXCEED THE RECOMMENDED DOSE.
Duration of Administration
Do not use SINUCON continuously for longer than 10 days without medical supervision.
Talk to your doctor if:
| When to contact your doctor |
|---|
| No relief is obtained with the recommended dosage |
| Symptoms persist longer than 10 days |
| Symptoms worsen |
| Symptoms recur periodically |
Method of Administration
Take the tablets with a sufficient quantity of liquid, such as one glass of water.
If You Take More SINUCON Than You Should
Prompt treatment is essential.
In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre.
SINUCON contains paracetamol, which can cause delayed, serious liver damage. A delay in starting treatment may mean that the antidote is given too late to be effective. Seek medical help even if you do not experience any symptoms and feel well.
Possible overdose symptoms include:
| Possible overdose symptoms |
|---|
| Nausea |
| Vomiting |
| Thirst |
| Loss of appetite |
| Stomach pain |
| Drowsiness |
| Convulsions or fits |
| Palpitations |
| Increased heart rate |
| Difficulty breathing |
| Delusions |
| Hallucinations |
| Coma |
| Death |
If You Forget to Take SINUCON
Do not take a double dose to make up for forgotten individual doses.
4. Possible Side Effects
SINUCON can have side effects.
Not all side effects reported for SINUCON are included here. If your general health worsens or if you experience any untoward effects while taking SINUCON, consult your healthcare provider for advice.
Side Effects Table
| Side-effect category | Side effects / symptoms | Recommended action |
|---|---|---|
| Very serious allergic reactions | Swelling of the hands, feet, ankles, face, lips, mouth or throat, which may cause difficulty swallowing or breathing | Stop taking SINUCON and seek urgent medical attention immediately |
| Very serious allergic reactions | Rash or itching | Stop taking SINUCON and seek urgent medical attention immediately |
| Very serious allergic reactions | Fainting | Stop taking SINUCON and seek urgent medical attention immediately |
| Very serious skin reactions | Blistering, peeling or ulceration of the skin, mouth, eyes and genitals, with or without fever | Stop taking SINUCON and seek urgent medical attention immediately |
| Very serious skin reactions | Possible Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis, Drug Rash with Eosinophilia and Systemic Symptoms, Drug-induced hypersensitivity syndrome or Acute Generalised Exanthematous Pustulosis | Stop taking SINUCON and seek urgent medical attention immediately |
| Serious cardiovascular side effects | Tightness or pain in the chest, neck, back or arms, fatigue, light-headedness, abnormal heartbeat and anxiety, which may indicate myocardial infarction or heart attack | Tell your doctor immediately or go to the nearest casualty department |
| Serious neurological side effects | Numbness or weakness in part of the face or body, difficulty speaking or difficulty walking, or other signs of stroke or cerebral haemorrhage | Tell your doctor immediately or go to the nearest casualty department |
| Serious breathing-related side effects | Coughing, wheezing or difficulty catching a breath, especially in asthmatics | Tell your doctor immediately or go to the nearest casualty department |
| Serious heart-related side effects | Changes in heartbeat, faster heartbeat, palpitations, slower or faster pulse | Tell your doctor immediately |
| Serious lung-related side effects | Cough, chest pain and fatigue, which may indicate pulmonary oedema | Tell your doctor immediately |
| Serious blood-related side effects | Abnormal laboratory results for white blood cell counts, including neutropenia, leucopenia, agranulocytosis and eosinophilia, possibly with high temperature, chills, sore throat, mouth sores, tiredness or flu-like symptoms | Tell your doctor immediately |
| Serious blood-related side effects | Tiredness, weakness, shortness of breath, irregular heartbeat, dizziness or light-headedness, chest pain and cold hands and feet, which may indicate aplastic anaemia | Tell your doctor immediately |
| Serious bleeding-related side effects | Easy bruising, abnormal bleeding from nose or gums, blood in the urine or stool, or cuts that continue bleeding, which may indicate thrombocytopenia or pancytopenia | Tell your doctor immediately |
| Serious nervous system side effects | Convulsions or fits | Tell your doctor immediately or go to the nearest casualty department |
| Serious pancreas-related side effects | Upper abdominal pain, nausea and vomiting, fat in stool, fast heart rate and sweating, which may indicate pancreatitis | Tell your doctor immediately |
| Serious liver-related side effects | Yellow skin or eyes, with possible nausea, abdominal pain, fatigue and fever, which may indicate hepatitis or liver failure | Tell your doctor immediately |
| Serious kidney-related side effects | Decreased or increased urine output, fluid retention causing swelling in legs, ankles or feet, which may indicate renal failure or nephropathy | Tell your doctor immediately |
| Serious kidney-related side effects | Sharp intense pain around the abdominal area, which may indicate renal colic | Tell your doctor immediately |
| Serious mental health side effects | Confusion, hallucinations, or difficulty telling reality from fantasy, which may indicate psychotic states | Tell your doctor immediately |
| Serious gastrointestinal side effects | Bleeding in the gut or haemorrhage | Tell your doctor immediately |
| Dependence-related effects | Feeling that more medicine is needed to achieve the effect, or taking the medicine without a medical reason | Tell your doctor immediately |
| Frequent side effects | Extreme sleepiness, falling asleep, difficulty concentrating, uncoordinated movements, dizziness, lassitude or extreme tiredness | Tell your doctor if troublesome |
| Frequent side effects | Headache | Tell your doctor if troublesome |
| Frequent side effects | Blurred vision | Tell your doctor if troublesome |
| Frequent side effects | Nausea and dry mouth | Tell your doctor if troublesome |
| Frequent side effects | Feeling anxious or restless | Tell your doctor if troublesome |
| Frequent side effects | Insomnia | Tell your doctor if troublesome |
| Less frequent side effects | Low blood sugar levels, with dizziness, confusion or heart palpitations | Tell your doctor |
| Less frequent side effects | Feeling depressed or confused, malaise, fear | Tell your doctor |
| Less frequent side effects | Muscle cramps or tremors | Tell your doctor |
| Less frequent side effects | Abnormal vision | Tell your doctor |
| Less frequent side effects | Abnormal swelling of the body due to fluid retention | Tell your doctor |
| Less frequent side effects | Diarrhoea, vomiting or stomach pain | Tell your doctor |
| Less frequent side effects | Rash with redness, raised itchy skin, hives, sweating or swelling of the skin | Tell your doctor |
| Less frequent side effects | Fever | Tell your doctor |
| Less frequent side effects | Low or high blood pressure, which may cause dizziness or fainting | Tell your doctor |
| Less frequent side effects | Purple or brownish-red spots on the skin or mucous membranes | Tell your doctor |
| Less frequent side effects | Redness of the face or flushing | Tell your doctor |
| Less frequent side effects | Decrease of appetite | Tell your doctor |
| Less frequent side effects | Large amount of white blood cells in urine, seen on a urine test | Tell your doctor |
| Frequency unknown side effects | Loss of appetite or increased appetite | Tell your doctor or pharmacist |
| Frequency unknown side effects | Ringing in the ears | Tell your doctor or pharmacist |
| Frequency unknown side effects | Indigestion, heartburn, increased stomach secretions that may cause ulcers, hypersalivation or thirst | Tell your doctor or pharmacist |
| Frequency unknown side effects | Constriction of the pupil of the eye | Tell your doctor or pharmacist |
| Frequency unknown side effects | Skin very sensitive to light | Tell your doctor or pharmacist |
| Frequency unknown side effects | Pain or difficulty urinating | Tell your doctor or pharmacist |
| Frequency unknown side effects | Tingling or pricking of the skin, also called pins and needles | Tell your doctor or pharmacist |
| Frequency unknown side effects | Chest tightness | Tell your doctor or pharmacist |
| Frequency unknown side effects | Feeling excited | Tell your doctor or pharmacist |
| Frequency unknown side effects | Nervousness, restlessness, tension, irritability or nightmares | Tell your doctor or pharmacist |
| Frequency unknown side effects | Muscle twitching and weakness | Tell your doctor or pharmacist |
| Frequency unknown side effects | Shortness of breath, tight chest and thick mucus from the lungs | Tell your doctor or pharmacist |
| Frequency unknown side effects | A spot or flickering near the centre of vision that prevents seeing | Tell your doctor or pharmacist |
| Frequency unknown side effects | Swelling of the larynx | Tell your doctor immediately |
| Frequency unknown side effects | Fixed drug eruption, a rash that occurs in the same place each time the medicine is taken | Tell your doctor or pharmacist |
| Side effects not listed | Any side effect not mentioned or any unexpected health change | Inform your doctor or pharmacist |
Reporting of Side Effects
If side effects occur, talk to your doctor, pharmacist or nurse.
Side effects may be reported to SAHPRA through the adverse drug reaction reporting process. Reporting side effects helps provide more information on the safety of SINUCON.
Suspected side effects may also be reported directly to the Holder of the Certificate of Registration.
5. How to Store SINUCON
Store all medicines out of reach of children.
Store at or below 25 °C.
Protect from light and moisture.
Do not store in a bathroom.
Do not use after the expiry date stated on the label, carton or bottle.
Return all unused medicine to your pharmacist.
Do not dispose of unused medicine in drains or sewerage systems, including toilets.
6. Contents of the Pack and Other Information
What SINUCON Contains
The active substances are:
| Active substance | Quantity |
|---|---|
| Paracetamol | 200 mg |
| Ephedrine hydrochloride | 6 mg |
| Caffeine | 20 mg |
| Chlorpheniramine maleate | 2 mg |
Other Ingredients
The other ingredients are:
| Other ingredients |
|---|
| Maize starch |
| Lactose |
| Gelatin |
| Carmoisine Red |
| Green S |
| Magnesium stearate |
| Talc |
| Sodium starch glycollate |
What SINUCON Looks Like and Contents of the Pack
SINUCON 200 mg/6 mg/20 mg/2 mg tablets are round, biconvex, red and blue mottled tablets, plain on both sides, with a diameter of 11,10 mm.
SINUCON is supplied in containers of 20 tablets.
Holder of Certificate of Registration
Shanur Healthcare (Pty) Ltd
Loch House Unit 003
3A Eton Road, Parktown
Johannesburg, 2193
Tel: +27 87 405 9660
This Leaflet Was Last Revised In
31 October 2024
Registration Number
G979, Act 101/1965
Access to the Corresponding Professional Information
Professional Information and the Afrikaans Patient Information Leaflet for this medicine are available from the Holder of Certificate of Registration.
Medical Disclaimer
This article is intended as patient information based on the approved leaflet structure. It does not replace advice from a doctor, pharmacist, nurse or other healthcare provider. For regulated medical product use, follow the approved patient information leaflet and healthcare professional guidance.
