Boots Cough and Decongestant Syrup 6 Years Plus

This medicine is available without prescription to treat minor conditions. However, you still need to give it carefully to get the best results from it.

• Keep this leaflet, you may need to read it again
• Ask your pharmacist if you need more information or advice
• The leaflet is written in terms of giving this medicine to your child, but if you are an adult who is intending to take this medicine yourself the information in this leaflet will apply to you as well

If your child has a long-term cough or asthma (do not give this medicine to your child if they are wheezing or if they are having an asthma attack)

• If your child has other kidney problems (see “Do not give”)
• If your child also has a fever, rash or constant headache
• If your child has liver problems or epilepsy (this medicine contains alcohol, which may be harmful to your child)

If your child develops:

• A feverish generalised erythema associated with pustules, stop giving this medicine and contact your doctor or seek medical attention immediately. See Section 'Possible side effects'.
• Sudden abdominal pain or rectal bleeding may occur with this medicine, due to inflammation of the colon (ischaemic colitis). If your child develops these gastro-intestinal symptoms, stop giving this medicine and contact your doctor or seek medical attention immediately. See 'Possible side effects' section.
• Reduction of blood flow to the optic nerve may occur with pseudoephedrine- containing products. If your child develops sudden loss of vision, stop giving Boots 6 years plus Cough & Decongestant Syrup and contact your doctor immediately. See possible side effects section.
• 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 Boots 6 year plus Cough & Decongestant Syrup immediately and seek immediate medical assistance if you develop symptoms that may be signs of PRES or RCVS (see 'Possible side effects' for symptoms).

The decongestant effect of this medicine may be reduced if you give it for a long time.

This medicine may interfere with the results of some urine tests. If your child has any urine tests, tell the doctor or hospital staff that they are taking this medicine.

If your child goes into hospital for an operation tell the doctor that they are taking this medicine.

This medicine contains maltitol. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

This medicine contains 196 mg sorbitol in each 5mL which is equivalent to 39 mg/mL.

Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have an intolerance to some sugars or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which a person cannot break down fructose, talk to your doctor before you (or your child) take or receive this medicine.

This medicine contains less than 1 mmol sodium (23 mg) per 10 mL that is to say essentially ‘sodium-free’.

This medicine contains 42.4 mg of alcohol (ethanol) in each 10 mL which is equivalent to 4.24 mg/mL(4.24% w/v). The amount in 10 mL of this medicine is equivalent to less than 11 mL beer or 5 mL wine. The small amount of alcohol in this medicine will not have any noticeable effects.

The flavourings in this medicine contains 6 mg propylene glycol in each 10 mL which is equivalent to 0.6 mg/mL.

The flavourings in this medicine may contain traces of sulfites <20mg/kg. May rarely cause severe hypersensitivity reactions and bronchospasm.

Information for people with diabetes: This medicine contains 2.7 g of maltitol per 5 ml spoonful. This provides 6 kcal per 5 ml spoonful.

All of the information in this leaflet will apply to you as well.

This medicine may be harmful if you are dependent on alcohol. Each 5 ml spoonful contains 0.2 g alcohol equivalent to 4 ml of beer or 1.7 ml of wine.

Pregnancy and breastfeeding: Do not take this medicine.

Before you give this medicine, make sure that you tell your doctor or pharmacist about ANY other medicines you might be giving to the child at the same time, particularly the following:

• Water tablets (diuretics) and medicines to treat high blood pressure
• Medicines for heart problems (e.g. digoxin)
• Thyroid hormones
• Medicines which may cause a dry mouth (e.g. tricyclic antidepressants), medicines to reduce your child’s appetite or stimulant medicines
• Ergot alkaloids (for migraine)
• Oxytocin (to induce labour and stop excessive bleeding after the birth)

If you are unsure about interactions with any other medicines, talk to your pharmacist. This includes medicines prescribed by your doctor and medicine you have bought for your child, including herbal and homeopathic remedies.

• Difficulty in breathing, swelling of the face, neck, tongue or throat (severe allergic reactions)
• Sudden onset of fever, reddening of the skin, or many small pustules (possible symptoms of Acute Generalized Exanthematous Pustulosis - AGEP) may occur within the first 2 days of treatment with this medicine. See section ‘Before you take this medicine’.

Frequency not known: frequency cannot be estimated from the available data

• Serious conditions affecting blood vessels in the brain known as posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS)
  Stop using Boots 6 years plus Cough & Decongestant 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
• Inflammation of the colon due to insufficient blood supply (ischaemic colitis)
• Reduced blood flow to the optic nerve (Ischaemic optic neuropathy).

• Hallucinations
• Restlessness
• Sleep disturbances

• Other allergic reactions such as skin rash
• Feeling sick, being sick, stomach discomfort, dry mouth, thirst
• Anxiety, feelings of paranoia, irritability, feeling excited, difficulty sleeping, headache
• Tremors, muscle weakness, giddiness, sweating
• Fast, slow or irregular heart beat, palpitations
• High blood pressure
• Difficulty in passing urine
• Return of congestion, if you have given the medicine for a long time

If any side effect becomes severe, or you notice any side effect not listed here, please tell your pharmacist or doctor.

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.