Stilpane 6,5 mg/5 mg/120 mg/5 ml Syrup

STILPANE SYRUP is used to treat the symptoms of mild to moderate pain and fever. It contains promethazine hydrochloride which helps with allergies, codeine phosphate to relieve pain and paracetamol for pain and fever.

Do not give or take STILPANE SYRUP:

• If you are hypersensitive (allergic) to promethazine hydrochloride (or any other anti-histamine), paracetamol, codeine phosphate (or other opioid analgesic) or any of the other ingredients of STILPANE SYRUP (listed in section 6).
• If you have severe liver or kidney problems.
• If you have obstructive breathing problems or other severe breathing problems, especially in the presence of cyanosis (condition where your skin or lips turn blue due to an insufficient level of oxygen in the blood) and excessive mucus and fluid secretion in the airways.
• If you have just had an operation on your bile tract.
• If you suffer from acute alcoholism.
• If you suffer from convulsions (fits and seizures).
• If you have had head injuries and conditions in which the pressure inside the skull is increased.
• If your child is younger than two years of age. STILPANE SYRUP has been associated with sudden infant death syndrome (SIDS) i.e. "cot death".
• If you are pregnant of breastfeeding your baby.
• If you are taking a medicine classified as a monoamine oxidase inhibitor (a medicine used to treat depression), or within 14 days of stopping such treatment.
• If you have any of the following conditions where inhibition of contractions of the digestive tract (peristalsis) should be avoided: where there is a risk of a condition where the movement of the bowel is impaired (paralytic ileus), where bloating and swelling in the belly area (abdominal distension) develops, or in acute diarrhoeal conditions such as acute ulcerative colitis or antibiotic associated colitis (e.g. pseudomembranous colitis) or diarrhoea caused by poisoning.
• If you are a paediatric patient and you are undergoing a procedure to remove your tonsils or adenoids for obstructive sleep apnoea syndrome.
• During an asthma attack.
• If you have heart disease caused by chronic lung disease.

Always take or give STILPANE SYRUP exactly as described in this leaflet or as your doctor, pharmacist or nurse have told you. Check with your doctor, pharmacist or nurse if you are not sure.

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

The usual dose of STILPANE SYRUP is:

• Age 2 to 5 years: One medicine measure (5 ml) three times daily.
• Age 6 to 12 years: One to two medicine measures (5 ml to 10 ml) three times daily.

DO NOT EXCEED THE RECOMMENDED DOSE

A lower dosage should be used in elderly and weak patients.

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

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

• Swelling of your hands, feet, ankles, face, lips, mouth or throat, which may cause difficulty in swallowing or breathing,
• rash or itching,
• fainting,
• blistering of the skin, mouth, eyes and genitals as these may be due to a serious allergic reaction known as severe cutaneous adverse reactions (SCARs) such as Toxic Epidermal Necrolysis (TEN), Stevens - Johnson syndrome (SJS), acute generalised exanthematous pustulosis (AGEP), drug reaction with eosinophilia and systemic symptoms (DRESS)/Drug - induced hypersensitivity syndrome (DIHS), fixed drug eruption (FDE). These are all very serious side effects. If you have them, you may have had a serious allergic reaction to STILPANE SYRUP. You may need urgent medical attention or hospitalisation.

Store all medicines out of reach of children. Store at or below 25 °C, in a well closed container. Protect from light. Keep in original packaging until required for use. Do not store in a bathroom. Do not use 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).