Demazin 1,25 mg/5 ml/2,5 mg Syrup

DEMAZIN syrup belongs to a group of medicines called “Preparations for the common cold, including nasal decongestants and antihistaminics”. DEMAZIN Syrup provides relief of nasal congestion and other symptoms associated with sinusitis, hay fever, nasal allergies or other respiratory allergies.

Do not take DEMAZIN Syrup:

• if you are hypersensitive (allergic) to chlorphenamine maleate, phenylephrine hydrochloride or any of the other ingredients of DEMAZIN Syrup (listed in section 6)
• if you are receiving antidepressants called monoamine oxidase inhibitors, or within 14 days of you stopping such treatment
• if you are pregnant or breastfeeding (see section Pregnancy, breastfeeding and fertility)
• if you suffer from severe high blood pressure or coronary heart disease.

DEMAZIN syrup should not be given to children under 2 years of age.

Warnings and precautions

Special care should be taken with DEMAZIN Syrup if you suffer from:

• an overactive thyroid
• heart disease, such as coronary heart disease
• irregular heartbeat
• rapid heartbeat
• disorders in which narrowed blood vessels reduce blood flow to the limbs (occlusive vascular disorders), including build-up of fats, cholesterol and other substances in and on the artery walls (arteriosclerosis)
• high blood pressure
• ballooning and weakened area in an artery (aneurysms)
• high blood sugar (diabetes)
• a condition in which the pressure inside of your eye becomes too high, called closed-angle glaucoma
• an enlarged prostate gland (prostatic hypertrophy)
• a rare tumor of the adrenal glands, which sit above the kidneys, called phaeochromocytoma
• a lung condition that causes shortness of breath (emphysema)
• chronic bronchitis
• a disorder resulting from build-up of certain chemicals related to red blood cell proteins, called porphyria.

Special care should be taken with DEMAZIN Syrup:

• If you are elderly, you will be especially susceptible to dizziness, sedation, confusion, low blood pressure and anticholinergic effects such as dry mouth and difficulty urinating and completely emptying the bladder.
• Do not take DEMAZIN Syrup for more than 7 days. After 5 to 7 days a sudden decrease in response to the medicine may occur, and the medicine loses effect. If your symptoms do not improve, or are accompanied by fever, consult a doctor.
• Long term use of antihistamines may decrease the flow of saliva and contribute to development of tooth decay, gum disease, oral thrush and discomfort.
• DEMAZIN Syrup contains sucrose which may have an effect on the control of your blood sugar if you have diabetes mellitus.

Do not share medicines prescribed for you with any other person. Always take DEMAZIN 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 as follows:

• Children two to three years: 2,5 to 5 ml every three or four hours.
• Three to six years: 5 to 10 ml every three or four hours. (Refer to section Warnings and precautions)
• Adults: 10 ml every three or four hours.

Elderly population: You may need to reduce the dose (refer to section Warnings and precautions).

If you take more DEMAZIN Syrup than you should

The following are possible signs and symptoms of overdose:

• Drowsiness or paradoxical excitement.
• Impaired coordination.
• Involuntary shaking or moving.
• Movement dysfunction that includes involuntary twisting, squirming movements (athetosis).
• Hallucinations.
• Convulsions.
• Fixed, dilated pupils with blushing.
• Faster heart beat (Sinus tachycardia).
• Difficult or laboured breathing.
• Difficulty urinating and completely emptying the bladder.
• Dry mouth.
• Fever.
• Terminally there may be deepening coma and sudden, unexpected loss of heart function, breathing and consciousness (cardiorespiratory collapse).
• Severe increase in blood pressure may occur.
• Central excitatory effects (stimulating effect on the neurons) constitute the greatest danger, particularly in children who are more likely to exhibit central nervous system stimulation. Adults more frequently exhibit central nervous system depression and the aged are particularly prone to experience low blood pressure.

In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre. If you forget to take DEMAZIN Syrup, do not take a double dose to make up for forgotten individual doses.

DEMAZIN Syrup can have side effects. Not all side effects reported for DEMAZIN Syrup are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking DEMAZIN Syrup, please consult your health care provider for advice.

If any of the following happens, stop taking DEMAZIN Syrup and tell your doctor immediately or go to the casualty department at your nearest hospital:

• swelling of the hands, feet, ankles, face, lips and mouth or throat, which may cause difficulty in swallowing or breathing,
• rash or itching,
• fever,
• sudden headache,
• sudden nausea and vomiting,
• sudden tingling, numbness, weakness or paralysis of face, arm or leg,
• sudden difficulty speaking or walking, loss of balance or problems with coordination,
• cardiac arrest.

These are all very serious side effects. If you have them, you may have had a serious reaction to DEMAZIN 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:

• convulsions,
• tight chest,
• palpitations,
• fast heart rate,
• sudden fever, chills, sore throat and weakness, rapid heart rate or rapid breathing (caused by an extremely low number of granulocytes (a type of white blood cell) in the blood),
• coughing up blood or bloody froth,
• difficulty breathing that worsens with activity or when lying down,
• rapid, irregular heartbeat.

These are all serious side effects. You may need urgent medical attention. Tell your doctor if you notice any of the following:

• sedation,
• dizziness,
• fatigue,
• incoordination,
• involuntary shaking or movement,
• confusion,
• blurred vision,
• double vision,
• ringing or buzzing in the ears,
• feeling intense excitement or happiness,
• nervousness,
• tingling,
• weakness of the hands,
• irritability,
• nightmares,
• insomnia,
• hallucinations,
• dryness of the mouth and respiratory passages,
• thickening of mucous,
• cough,
• increased sweating,
• difficult urinating and completely emptying the bladder,
• change in frequency of urination,
• discomfort, pain or burning when urinating,
• headache,
• low blood pressure,
• loss of appetite,
• nausea,
• vomiting,
• epigastric distress (pain above the stomach, under the rib cage),
• diarrhoea,
• reduction in tone and motility of the gastrointestinal tract, resulting in acid reflux and constipation,
• photosensitization (extreme sensitivity to ultraviolet rays from the sun and other light sources),
• fatigue, shortness of breath, dizziness, headache, coldness in your hands and feet, pale skin and chest pain caused by a disorder in which red blood cells are destroyed faster than they can be made (haemolytic anaemia),
• a low level of white blood cells in the blood which can interfere with the ability to fight infection (leukopenia),
• easy or excessive bruising, superficial bleeding into the skin, prolonged bleeding from cuts,
• bleeding from your gums or nose, blood in urine or stools caused by a low number of platelets in the blood (thrombocytopenia),
• fear,
• anxiety,
• restlessness,
• weakness,
• psychotic states,
• reduced appetite,
• low blood pressure with dizziness and fainting and flushing,
• difficult or laboured breathing,
• altered metabolism, including disturbances of glucose metabolism,
• sweating,
• hypersalivation.

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 DEMAZIN Syrup.

Store all medicines out of reach of children.

Store at or below 25 ºC. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).