Betafed Syrup

BETAFED SYRUP is a medicine which is used to relieve the symptoms of colds and allergies including sneezing, runny nose, watery eyes, nasal congestion and blocked sinuses. The liquid contains pseudoephedrine hydrochloride, which is a decongestant that relieves nasal and sinus congestion and triprolidine hydrochloride which is an antihistamine that helps stop sneezing, runny nose and watery eyes.

Do not take BETAFED SYRUP :

• if you are hypersensitive (allergic) to triprolidine, pseudoephedrine or any of the other ingredients of BETAFED SYRUP (listed in section 6)
• if you are taking, or have taken in the last two weeks, drugs for depression known as Monoamine Oxidase Inhibitors (MAOIs), as this may cause a rise in blood pressure.
• if you or your child have asthma i.e. breathing problems
• if your child is under the age of 2 years.
• if you have very high blood pressure (severe hypertension) or hypertension not controlled by your medication
• if you have severe acute (sudden) or chronic (long-term) kidney disease or kidney failure

Warnings and precautions

Take special care with BETAFED SYRUP:

• if you have high blood pressure or heart disease such as dysrhythmia, (changes in heart rate), tachycardia (fast heart beat), atherosclerosis (disease of the arteries in which blood vessel walls thicken), or aneurysm (swelling and weakening of part of a blood vessel)
• if you have an overactive thyroid
• if you have diabetes (high level of blood sugar)
• if you have glaucoma (increased pressure in the eye)
• if you have prostate problems (difficulty with passing water or needing to pass water often)
• if you have liver or kidney problems
• if you are elderly

Cases of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) have been reported following use of medicines containing pseudoephedrine. PRES and RCVS are rare conditions that can involve reduced blood supply to the brain. Stop using BETAFED SYRUP immediately and seek immediate medical assistance if you develop symptoms that may be signs of PRES or RCVS (see section 4 "Possible side effects" for symptoms)

Do not share medicines prescribed for you with any other person. Always take BETAFED 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.

The usual dose is:

• Adults and children over 12 years: 2 medicine measures (10 ml) orally three times daily.
• Children 6 to 12 years: 1 medicine measure (5 ml) orally three times daily.
• Children 2 to 5 years: ½ medicine measure (2,5 ml) orally three times daily.

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

If you take more BETAFED SYRUP than you should

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 BETAFED SYRUP

If you miss a dose, take it as soon as you remember, but if it is within 4 hours of your next dose, skip the dose you missed and take the next one at the usual time. Then continue your treatment as before. Do not take a double dose to make up for a single missed dose.

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

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

• sudden onset of fever, reddening of the skin, or many small pustules (possible symptoms of Acute Generalized Exanthematous Pustulosis - AGEP) may occur.
• sudden stomach pains, passing blood in your stools or bleeding from your back passage and diarrhoea.
• severe headache, nausea, vomiting, confusion, fits, visual disturbances
• swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing.
• allergic reaction including skin rashes such as hives (which may be severe and include blistering and peeling of the skin) and itching.

These are a very serious side effects. If you have them, you may have had a serious allergic reaction to BETAFED SYRUP. You may need urgent medical attention or hospitalisation. Stop using BETAFED SYRUP immediately and seek urgent medical attention if you develop symptoms, that may be signs of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS). These include:

• severe headache with a sudden onset
• feeling sick
• Vomiting
• Confusion
• seizures changes in vision

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

• restlessness or sleep disturbances
• a fast or irregular heartbeat or an increased awareness of your heartbeat (palpitations).
• trouble passing water (especially men with prostate problems).
• reduced blood flow to the optic nerve (Ischaemic optic neuropathy).

These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

• Frequent side effects:
• headache
• difficulty sleeping, nervousness, dizziness or feeling jittery
• drowsiness
• blurred vision
• thickened mucus, dry mouth, nausea or an upset stomach.

Less frequent side effects:

• confusion or depression
• tremor, shakiness or slurred speech
• low blood pressure.

Frequency unknown:

• stroke
• heart attack/reduced blood flow to the heart which can cause discomfort or pain in the chest, neck, back, jaw, shoulders or arms (known as angina)
• agitation, anxiety, irritability or feelings of extreme happiness
• tingling or numbness of the hands or feet (pins and needles)
• high blood pressure
• inflammation of the colon due to insufficient blood supply (ischaemic colitis)
• vomiting or stomach discomfort
• pain when passing urine
• feeling tired
• very high fever
• serious conditions affecting blood vessels in the brain known as posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS)

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, 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 BETAFED SYRUP.

• Store all medicines out of reach of children.
• Store in well-closed containers at or below 25 ° C.
• Protect from light.
• Do not refrigerate
• Store in the original package / container
• Keep the container in the outer carton
• Keep the container tightly closed
• Do not use after the expiry date stated in the packaging material
• Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets)