Medazine S 12,5 mg Syrup

The active substance in MEDAZINE S is cyclizine hydrochloride, which belongs to a group of medicines called antihistamines which can be used to help stop you feeling sick (nausea) or being sick (vomiting). MEDAZINE S can also be used to treat sickness caused by some inner ear problems such as Meniere’s disease.

Do not give MEDAZINE S:

• If your child is allergic (hypersensitive) to cyclizine or to any of the inactive ingredients of MEDAZINE S (listed in section 6), or if your child has previously suffered an adverse reaction to cyclizine.
• To a pregnant or breastfeeding mother, as safety has not been established (see Pregnancy, breastfeeding and fertility).
• If your child suffers from an acute asthma attack, as MEDAZINE S may worsen your child’s condition.
• If your child has been diagnosed with a condition called narrow angle glaucoma [increased pressure inside the eye(s)].
• If your child has difficulty urinating.
• If your child has been diagnosed with enlargement of the prostate.
• If your child has been diagnosed with a condition called emphysema, or chronic lung disease.
• If your child suffers from shortness of breath or difficulty breathing.

Warnings and precautions

MEDAZINE S may lead to drowsiness and impaired concentration, which may be aggravated by simultaneously taking alcohol or certain other medicines, i.e. sleeping tablets or tranquillisers.

Do not share medicines prescribed for your child with any other person. Always give MEDAZINE S exactly as described in this leaflet or as your doctor, pharmacist or nurse has told you. Check with your doctor, pharmacist or nurse if you are not sure.

Children 6 to 12 years

Give 10 mL (2 medicine measures), may be repeated up to three times daily.

Children 1 to 5 years

Give 5 mL (1 medicine measure), may be repeated up to three times daily.

For the prevention of motion sickness, MEDAZINE S Syrup should be taken about half an hour before the journey.

If you take more MEDAZINE S 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/use MEDAZINE S just take the next dose at the usual time. Do not take a double dose to make up for forgotten individual doses.

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

Serious side-effects that you should report to your doctor immediately include: Those that occur with unknown frequency:

• Drowsiness
• Inability to concentrate
• Dizziness
• Feeling tired
• Headache
• Dry mouth, nose and throat
• Blurred vision
• Difficulty urinating
• Pain or discomfort when urinating
• Tightness of the chest
• Feeling restless
• Diarrhoea
• Constipation
• Nausea
• Vomiting
• Pain in the stomach
• Increased appetite
• An eating disorder called anorexia
• Headache
• Ringing in the ear
• Excitement
• Muscle weakness
• Low blood pressure
• Hallucinations
• Low white blood cell count
• Anaemia.

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 or by e-mail: [email protected] or telephone: 080 222 6662 (toll free). By reporting side effects, you can help provide more information on the safety of MEDAZINE S.

Store all medicines out of reach of children.

• Store at or below 25 °C.
• Do not take after the expiry date stated on the packaging material.
• Return all unused medicine to your pharmacist.
• Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).