Betalin Syrup 5 ml Syrup

The alleviation of cough.

Should not be given to children under 6 years.

Children: 6 to 12 years: A half to one medicine measure (2,5 ml u2013 5 ml) every four hours.

Adults: One to two medicine measures (5 ml u2013 10 ml) every three to four hours.

• Hypersensitivity (allergy) to any of the ingredients listed in section 6.1.
• BETALINu00ae is contra-indicated in the presence of impaired hepatic function (decrease in liver function) or impaired renal function (decrease in kidney function).
• During an attack of asthma. Safety in pregnancy and lactation has not been established.
• Porphyria.
• BETALINu00ae is contra-indicated under the age of 6 years.

• Use with caution in patients with heart disease. Doses must be taken with an adequate amount of fluid (half to one glass).
• A persistent cough may be a sign of a serious condition. If cough persists for more than 1 week, tend to recur or is accompanied by high fever, rash or persistent headache, consult a doctor.
• Do not take this product for persistent or chronic cough such as occur with smoking, asthma, emphysema or where cough is accompanied by excessive phlegm (mucous) unless directed by a doctor.
• Caution should be used when the following medical conditions exist: Prostatic hypertrophy, Narrow angle glaucoma, Emphysema or chronic bronchitis.
• The positive results of skin allergy (hypersensitivity) tests may be suppressed.
• BETALINu00ae should be used cautiously in patients with hypertension.
• Paediatric population: May cause excitability especially in children. Use is not recommended in newborn or premature infants. This age group has an increased susceptibility to anticholinergic side effects such as central nervous system excitation and an increased tendency towards convulsions.
• Elderly population: The elderly are particularly prone to dizziness, sedation, confusion, hypotension and anticholinergic effects.
• BETALINu00ae contains sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

Extreme caution should be exercised by patients taking BETALINu00ae in conjunction with nervous system depressants such as alcohol, barbiturates, hypnotics (causes sleep), narcotic analgesics (dependence producing substances used for the relief of pain), sedatives (for calming) and tranquillisers (agent used for calming nerves) and anticholinergic agents (a substance to stop the release of certain nerve impulses involving acetylcholine) and tricyclic antidepressants as their effects may be enhanced by diphenhydramine. Monoamine-oxidase inhibitors will potentiate both the drowsiness effect and the anticholinergic effects of diphenhydramine, Concurrent use is not recommended. The effects of drugs with anticholinergic activity such as tricyclic antidepressants or maprotiline will be potentiated. The warning signs of damage caused by ototoxic medicines may be masked by diphenhydramine.

Pregnancy: Safety in pregnancy has not been established (see section 4.3).

Breastfeeding: Safety in lactation has not been established (see section 4.3).

The use of BETALINu00ae leads to drowsiness and impaired concentration which is aggravated by the simultaneous intake of alcohol and it is unsafe to drive a vehicle or be in charge of machinery while using this medicine, as impaired decision making could lead to an accident.

a) Summary of the safety profile: The most commonly reported adverse reactions caused by diphenhydramine is sedation which includes drowsiness, inability to concentrate, lassitude, dizziness, hypotension, muscular weakness and incoordination.

b) Tabulated list of adverse reactions:

System Organ Class Frequency Adverse reaction

Blood and lymphatic system disorders Less Frequent Haemolytic anaemia, leukopenia, thrombocytopenia

Immune system disorder Less Frequent Hypersensitivity (allergic) reactions

Metabolism and nutrition disorders Less Frequent Anorexia, hyper-chloraemic acidosis and hypokalaemia

Psychiatric disorders Frequent Elation or depression, irritability, nightmares, euphoria, extra-pyramidal effects, mental confusion

Nervous system disorders Frequent Headache, drowsiness or progressive drowsiness, inability to concentrate, lassitude, dizziness, insomnia, nervousness, tremors, tingling, epileptiform seizures and convulsions

Eye disorders Less Frequent Blurred vision

Ear and labyrinth disorders Less Frequent Tinnitus

Cardiac disorders Less Frequent Hypotension, tachycardia, hyperventilation

Gastrointestinal disorders Frequent Gastro-intestinal disturbances, constipation, diarrhoea, epigastric pain, nausea, vomiting, dryness of mouth and thirst

Skin and subcutaneous tissue disorders Less Frequent Photosensitisation of the skin

Musculoskeletal, and connective tissue disorders Less Frequent Muscular weakness and incoordination, muscle twitching, tightness of chest, heaviness and weakness of the hands

Renal and urinary disorders Less frequent Difficulty in micturition

Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Health care providers are asked to report any suspected adverse reactions to SAHPRA via the u201c6.04 Adverse Drug Reaction Reporting Formu201d, found online under SAHPRAu2019s publications: https://www.sahpra.org.za/Publications/Index/8

Retention of sodium leads to the accumulation of fluid, with cerebral oedema (accumulation of fluid on the brain), peripheral oedema (swelling of the hands and feet due to retained fluid) and pulmonary oedema (excessive fluid accumulation in the lungs).

Symptoms of hypernatraemia (too much sodium in the blood) may include restlessness, weakness, thirst, reduced salivation (secretion of saliva) and lachrymation (secretion of tears), swollen tongue, flushing of the skin, pyrexia (fever), dizziness, headache, oliguria (reduced urine production), hypotension (low blood pressure), tachycardia (increased rate of heart beat), delirium (rapid succession of confused and unconnected ideas often associated with illusions and hallucinations), hyperpnoea (abnormally rapid and deep breathing) and respiratory arrest (loss of effective ability to breathe). Other symptoms of overdosage are gastro-intestinal (affecting the stomach and intestines) upset, drowsiness, hyperchloraemic acidosis (abnormally high levels of chloride in the blood causing the blood to be acidic), and hypokalaemia (low blood levels of potassium). Diphenhydramine hydrochloride overdosage may be fatal especially in children whose main symptoms are central nervous system (brain) stimulation and antimuscarinic (the opposite effect of acetylcholine) effects including ataxia (loss of muscle coordination), excitement, hallucinations (false perceptions), muscle tremor, convulsions (fits), dilated pupils, dry mouth, flushed face and hyperpyrexia (abnormally high body temperature), respiratory collapse (failure of the breathing process), death may occur from respiratory failure (inability to breathe). Ataxia (loss of muscle coordination), drowsiness, hyperpyrexia (abnormally high body temperature), hypotension (low blood pressure) may occur. Treatment is symptomatic and supportive.