Colcaps ® Children’S Syrup

Preparation for common cold

The symptomatic relief of colds and flu associated with cough in children 2 years and older.

Do not take/give COLCAPS CHILDREN’S SYRUP:

• If your child is hypersensitive (allergic) to codeine phosphate, promethazine, pseudoephedrine, paracetamol or any of the other ingredients of COLCAPS CHILDREN’S SYRUP.
• If your child has problems with their liver or kidneys.
• If your child is taking medicine for depression, hyperactivity or personality disorders or is going to be taking such medicines within the next 14 days.
• If you are a breastfeeding mother
• If your child is taking medicines which quickly convert codeine to its active form. This may lead to more codeine available and symptoms such as being very sleepy, confused or shallow breathing. This is serious and can cause death.
• If your child suffers from a breathing disorder of slow and poor breathing and suffer from a lung disease that block airflow and make it difficult to breathe (obstructive airway disease) especially when their skin turns blue and there is lots of sputum. This breathing disorder can happen after surgery on the organs and ducts that make and store bile.
• If your child is at risk of having a condition in which the muscles that contracting which help move food through their intestines are temporarily paralyzed.
• If your child has uncontrollable muscle contraction disorders, head injuries and conditions which increase pressure between the brain and the skull.
• If your child has had alcohol poisoning
• If your child has a long-term lung disease or in heart disease.
• If your child is under 2 years of age as it can cause the unexpected death of infants.

Take special care with COLCAPS CHILDREN’S SYRUP:

• Do not use continuously for more than ten days without consulting your doctor.
• If your child has liver and kidney disease, medicines containing paracetamol should be supervised by your doctor. Taking more than they should may cause severe liver damage.
• If your child has inflammation of the liver or had alcohol poisoning or recovering from any form of liver disease should not take excessive quantities of COLCAPS CHILDREN’S SYRUP. COLCAPS CHILDREN’S SYRUP contains paracetamol which may be fatal in overdose. In the event of overdosage or suspected overdose and notwithstanding the fact that the person may be asymptomatic, the nearest doctor, hospital or poison control centre must be contacted immediately.
• If your child suffers from an overactive thyroid gland (hyperthyroidism).
• If your child has heart problems such as an irregular heartbeat or a fast heartbeat.
• If your child has a condition in which narrowed blood vessels reduce blood flow to the limbs, including build-up of fats, cholesterol and other substances in and on the blood vessel walls, high blood pressure (hypertension) or suffer from a ballooning and weakened area in an artery (aneurysms).
• If your child has diabetes mellitus.
• If your child has high pressure in the eye.
• If your child is taking medicine for anxiety, depression, hyperactivity or personality disorders, or is going to be taking such medicines within the next 14 days.
• If your child has an underactive thyroid, a condition where their glands don’t produce enough hormones, impaired liver function, or is in shock.
• If your child has a condition in which digested material is prevented from passing normally through the bowel and can cause inflammation
• If your child has a condition that causes weakness and rapid fatigue of any of the muscles under your voluntary control.
• If your child has been taking COLCAPS CHILDREN’S SYRUP for a long period, at a higher than recommended dose with continuous use.
• If your child has a breathing disorder characterized by slow and ineffective breathing,
• COLCAPS CHILDREN SYRUP can be fatal in children under 2 years of age.
• If your child has asthma, inflammation of the lungs or a condition in which the lungs’ airways become damaged, making it hard to clear mucus.
• If your child has seizures
• If your child has a condition where you have an obstruction in your stomach or bladder.
• If your child has Reye's Syndrome which is a rare but serious condition that causes confusion, swelling in the brain and liver damage.
• If your child is taking medicines e.g. salicylates that causes damage to your inner ear and hearing.
• Stop using COLCAPS CHILDREN’S SYRUP, if your child suffers from hallucinations or restlessness

Do not share medicines prescribed for you with any other person. Always take COLCAPS CHILDREN’S SYRUP exactly as described in this leaflet or as your doctor, or pharmacist have told you. Check with your doctor or pharmacist, if you are not sure.

The usual dose is: DO NOT EXCEED THE RECOMMENDED DOSE.

• 2 years - 5 years: One medicine measureful (5,0 ml) three times a day.
• 5 years - 12 years: One to two medicine measurefuls (5,0 ml - 10,0 ml) three times a day.

Not for use in children under 2 years of age (see Do not take COLCAPS CHILDREN’S SYRUP).

If you have the impression that the effect of COLCAPS CHILDREN’S SYRUP is too strong or too weak, tell your doctor or pharmacist.

If you take more COLCAPS CHILDREN’S SYRUP than you should: In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control centre.

If you forget to take a dose of COLCAPS CHILDREN’S SYRUP:

COLCAPS CHILDREN’S SYRUP can have side effects. Not all side effects reported for COLCAPS CHILDREN’S SYRUP are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking COLCAPS CHILDREN’S SYRUP, please consult your healthcare provider for advice.

If any of the following happens, stop taking COLCAPS CHILDREN’S SYRUP and tell your doctor immediately or go to the casualty department at your nearest hospital:

• Swelling of the hands, feet, ankles, face, lips, mouth or throat, which may cause difficulty in swallowing or breathing;
• Rash or itching.

These are all very serious side effects. If you have them, you may have had a serious allergic reaction to COLCAPS CHILDREN’S SYRUP. You may need urgent medical attention or hospitalisation.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

System Organ Class Frequency Undesirable effect Blood and lymphatic system disorders Less frequent Low platelet counts, low white blood cell count, an abnormal condition or disease of the blood, a disorder in which red blood cells are destroyed faster than they can be made Unknown Low circulation of white blood cells in the body, too few blood cells, low white blood cell count, low red blood cells and haemoglobin. Immune system disorders Less frequent Allergic reactions (some serious), Hives Metabolism and nutrition disorders Less frequent An eating disorder characterized by markedly reduced appetite or total dislike to food. Unknown Reduced appetite, altered metabolism and disturbances of glucose metabolism. Psychiatric disorders Frequent Restlessness and sleeplessness. Less frequent Confusion. Unknown Changes of mood, hallucinations, depression, elation, irritability, nightmares and nervousness, fear, anxiety, and psychotic state. Nervous system disorders Frequent Drowsiness Less frequent Tremor Unknown Headache, dizziness, incoordination, tremors, muscular weakness, sedation, ringing in the ears, convulsions, tingling and brain stimulation (in infants and children). Eye disorders Less frequent excessive constriction of the pupil of the eye Unknown Increased pressure between the brain and spinal chord Ear and labyrinth disorders Less frequent Dizziness Unknown a sensation of feeling off balance Cardiac disorders Less frequent slow or irregular heart rhythm; rapid pulse; rapid beating of the heart; irregular heartbeat; abrupt loss of heart function, breathing and consciousness or sudden and severe shortness of breath, or difficulty in breathing Unknown chest pain caused by reduced blood flow to the heart, Swelling of the heart due to excess fluid in the tissues Vascular disorders Less frequent A drop in blood pressure that occurs when moving from a laying down position to a standing position, hypotension, dizziness Unknown a medical emergency that occurs when your body loses heat faster than it can produce heat, high blood pressure, loss of blood from damaged blood vessels in the brain, low blood pressure with dizziness and flushing Respiratory, thoracic & mediastinal disorders Frequent Tightness of chest. Unknown abnormal buildup of fluid in the lungs. Gastrointestinal disorders Frequent Constipation. Less frequent Nausea, vomiting and dry mouth. Unknown Inflammation of the pancreas, diarrhoea, epigastric pain and gastrointestinal disturbances, producing lots of saliva Hepato-biliary disorders Less frequent Inflammation of the liver, Gall bladder spasm. Skin and subcutaneous tissue disorders Less frequent Skin rash (usually abnormal redness and inflammed or like hives), sweating, facial flushing and itchy skin. Musculoskeletal and connective tissue disorders Unknown Muscle twitching, heaviness and weakness of hands. Renal and urinary disorders Less frequent Acute and severe loin pain, kidney failure, finding of white blood cells in the urine in the absence of bacteria, urinating may be difficult, spasm in the tube that carries urine from the kidney to the bladder, inability to voluntarily pass an adequate amount of urine General disorders and administration site conditions Unknown Inability to concentrate, weakness, fainting, fatigue.

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects If you get side effects, talk to your doctor or, pharmacist. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of COLCAPS CHILDREN’S SYRUP.

Store at or below 25 °C. Protect from light. Keep in original packaging until required for use. Do not store in a bathroom. Do not use after the expiry date stated on the label. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets). STORE ALL MEDICINES OUT OF REACH OF CHILDREN.