Rhineton 2 mg/5 ml Syrup

Rhineton syrup is used to relieve or prevent the symptoms of hay fever and other types of allergy. Rhineton syrup may also be used to prevent cough.

Do not take RHINETON SYRUP:

• If you are hypersensitive (allergic) to chlorpheniramine maleate or any of the other ingredients of Rhineton syrup (listed in section 6).
• If your child is a premature infant or neonate.
• If you are experiencing acute attacks of asthma.
• If you suffer from epilepsy (recurrent seizures or fits).

Warnings and precautions

Take special care with RHINETON SYRUP:

• If you have narrow angle glaucoma, urinary retention and prostatic hypertrophy.
• This medicine may cause some people to become drowsy or less alert than they are normally.
• Make sure you know how you react to Rhineton syrup before you drive, use machines, or do anything else that could be dangerous if you are not alert.
• Rhineton syrup may add to the effects of alcohol and other CNS depressants (medicines that slow down the nervous system, possibly causing drowsiness). Some examples of CNS depressants are sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; barbiturates; medicine for seizures; muscle relaxants; or anaesthetics, including some dental anaesthetics.
• Check with your doctor before taking any of the above while you are using this medicine.

Other medicines and RHINETON SYRUP

Tell your health care professional if you are taking any of the following medicines:

• Monoamine oxidase inhibitors, antimuscarinic drugs such as atropine and tricyclic antidepressants – *Side - effects, such as dryness of mouth, of antihistamines or anticholinergics may be more likely to occur.
• Central nervous system (CNS) depressants (medicines that cause drowsiness) – Effects, such as drowsiness, of CNS depressants including alcohol, barbiturates, hypnotics, opioid analgesics, anxiolytic sedatives and antipsychotics may be worsened.
• Before you have any skin tests for allergies, tell the doctor in charge that you are taking this medicine. The results of the test may be affected by this medicine.
• Always tell your health care provider if you are taking any other medicine. (This includes all complementary or traditional medicines.)
• Talk to your doctor or pharmacist before taking this syrup if you are taking any prescribed medicines; particularly phenytoin (for epilepsy) or medicines for anxiety or to help you sleep.

Pregnancy, breast - feeding and fertility

The safety of Rhineton syrup has not been studied in pregnant women.

• Use is not recommended in nursing mothers, since babies are more susceptible to the side - effects of Rhineton syrup, such as unusual excitement or irritability.
• If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, please consult your doctor, pharmacist or other health care provider for advice before taking this medicine.

Driving and using machines

RHINETON SYRUP may cause drowsiness and impair your concentration. Do not drive or operate machinery if you experience drowsiness, dizziness or blurred vision while taking RHINETON SYRUP. It is not always possible to predict to what extent RHINETON SYRUP may interfere with the daily activities of a patient. Patients should ensure that they do not engage in the above activities until they are aware of the measure to which RHINETON SYRUP affects them.

RHINETON SYRUP contains 1,6 g of liquid glucose per 5 ml. This should be taken into account in patients with diabetes mellitus. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before RHINETON SYRUP. RHINETON SYRUP contains methyl hydroxybenzoate and propyl hydroxybenzoate which may cause allergic reactions (possibly delayed).

Do not share medicines prescribed for you with any other person. Always take RHINETON SYRUP exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Adults

5 ml - 20 ml daily in divided doses.

Children

• 1 - 2 years: 2,5 ml (1 / 2 medicine measure) orally twice daily.
• 2 - 5 years: 2,5 ml (1 / 2 medicine measure) orally every 4 to 8 hours to a maximum of 15 ml daily.
• 6 - 12 years: 5 ml (1 medicine measure) orally every 4 to 8 hours to a maximum of 30 ml daily.

If you have the impression that the effect of Rhineton syrup is too strong or too weak, talk to your doctor or pharmacist.

If you take more RHINETON SYRUP than you should

Overdosage may lead to death, especially in infants and children in whom the following symptoms may occur: ataxia (incoordination), excitement, hallucinations, muscle tremors, convulsions (seizures), dryness of mouth, dilated pupils (widened pupils), flushed or red face and extremely high fever. In adults, the usual symptoms are drowsiness, coma and convulsions (seizures). Low blood pressure may occur. Elderly patients are usually more sensitive to the effects of Rhineton syrup. In the event of overdosage, consult your doctor or pharmacist. If neither is available, seek help at the nearest hospital or poison control centre.

If you forget to take RHINETON SYRUP

Do not take a double dose to make up for a forgotten individual doses. If you forget to take a dose, take it as soon as you remember. If it is almost time for your next dose, do not take the dose that you missed.

If you stop taking RHINETON SYRUP

Take RHINETON SYRUP for as long as your doctor recommends. Don’t stop unless your doctor advises you to.

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

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

• Allergic reactions can be severe. Signs include:
• Raised and itchy rash (hives)
• Swelling, sometimes of the face or mouth causing difficulty in breathing
• collapse

These are all very serious side effects. If you/your child have them, you/your child may have had a serious allergic reaction to RHINETON SYRUP. You/your child may need urgent medical attention or hospitalisation.

Tell your doctor if you notice any of the following:

Frequent side effects

• sedation (calming or relaxing state)
• somnolence (sleepiness)
• disturbance in attention
• abnormal coordination
• dizziness
• headache
• blurred vision
• nausea (feeling that one is about to vomit)
• dry mouth
• fatigue

Side effects with an unknown frequency

• serious blood disorders
• allergic reactions
• angioedema
• anaphylactic reactions (sudden, life - threatening severe allergic reaction)
• anorexia (lack of appetite)
• confusion
• excitation
• irritability
• nightmares
• depression
• tinnitus (ringing in the ears)
• palpitations (rapid irregular action of the heart)
• tachycardia (increased heart rate)
• arrhythmias (irregular heart beat)
• hypotension (low blood pressure)
• thickening of bronchial secretions (secretions of lungs)
• vomiting (to be sick)
• abdominal pain (stomach pain)
• diarrhea (frequent or loose watery stools)
• dyspepsia (heartburn or indigestion)
• hepatitis (liver disease), including jaundice (yellow pigmentation of skin and eyes)
• exfoliative dermatitis (shedding of scaly dead skin)
• rash
• urticaria (allergic skin reaction)
• photosensitivity (sensitivity to light)
• muscle twitching
• muscle weakness
• urinary retention
• chest tightness

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 or nurse. 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 RHINETON SYRUP.

• Store all medicines out of reach of children.
• Store at or below 25 ºC in a cool place.
• Protect from light.
• Keep well closed.
• Do not refrigerate / freeze.
• Do not store in bathrooms in order to protect from light.
• Do not take medicine 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).