Boots Night Cold and Flu Relief Oral Solution

This medicine is available without prescription, however, you still need to take Boots Night Cold & Flu Relief Oral Solution carefully to get the best results from it. Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.

• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information or advice.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
• You must talk to a doctor if you do not feel better or if you feel worse after a few days.

1. What Boots Night Cold & Flu Relief Oral Solution is and what it is used for
2. What you need to do before you take Boots Night Cold & Flu Relief Oral Solution
3. How to take Boots Night Cold & Flu Relief Oral Solution
4. Possible side effects
5. How to store Boots Night Cold & Flu Relief Oral Solution
6. Contents of the pack and other information

• If you are allergic (hypersensitive) to paracetamol, promethazine hydrochloride, dextromethorphan hydrobromide or any of the other ingredients of Boots Night Cold & Flu Relief Oral Solution (see Section 6 below)
• If you suffer from lung disease
• If you are taking, or have taken in the last 2 weeks, drugs for depression known as Monoamine Oxidase Inhibitors (MAOIs)
• If you are taking selective serotonin re-uptake inhibitors (used to treat depression and anxiety such as fluoxetine, paroxetine and sertraline)
• If your child is under 12 years old

Do not take with any other paracetamol containing products.

Do not take with any other flu, cold or decongestant product.

This medicine can lead to dependence. Therefore the treatment should be of short duration.

Tell your doctor if you:

• Have kidney or liver problems
• Have a chronic or persistent cough such as occurs with asthma or produces a lot of mucus (phlegm)
• Are taking any other cough and cold medicines
• Have difficulty in passing urine (urinary retention)
• Have glaucoma
• Have prostate problems
• Have heart problems
• Have epilepsy
• Are elderly and suffer from confusion
• Have an intolerance to some sugars
• If your child is susceptible to developing certain allergic reactions
• If you have been told by your doctor that you are a slow metabolizer of CYP2D6
• If you are or have ever been addicted to opioids, alcohol, prescription medicines, or illegal drugs.
• If you have previously suffered from withdrawal symptoms such as agitation, anxiety, shaking or sweating, when you have stopped taking alcohol or drugs.

Taking this medicine regularly, particularly for a long time, can lead to addiction. Only use this medicine as described in the leaflet.

Addiction can cause withdrawal symptoms when you stop taking this medicine. Withdrawal symptoms can include restlessness, difficulty sleeping, irritability, agitation, anxiety, feeling your heartbeat (palpitations), increased blood pressure, feeling or being sick, diarrhoea, loss of appetite, shaking, shivering of sweating. Speak to your doctor if you experience withdrawal symptoms.

If you do not get better, talk to your doctor.

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, even medicines obtained without a prescription.

In particular, tell your doctor if you are taking medicines which:

• Thin the blood (e.g. warfarin)
• Control nausea or vomiting (e.g. domperidone or metoclopramide)
• Reduce levels of cholesterol and other fats in the blood (e.g. cholestyramine)
• Have been prescribed by your doctor to improve sleep, for anxiety or depression (including monoamine oxidase inhibitors (MAOIs) and antimuscarinic drugs)
• Medicines to control your heart rhythm e.g. quinide, amiodarone, flecainide or propafenone
• Antifungal medicines e.g. terbinafine
• Medicines to help with quitting smoking e.g. bupropion
• Medicines to help with certain addictions or treat pain e.g. methadone
• Medicines to help with overactive parathyroid e.g. cinacalcet
• Antipsychotic medicines e.g. haloperidol, prephenazine and thioridazine
• Flucloxacillin (antibiotic), due to a serious risk of blood and fluid abnormality (high anion gap metabolic acidosis) that must have urgent treatment and which may occur particularly in case of severe renal impairment, sepsis (when bacteria and their toxins circulate in the blood leading to organ damage), malnutrition, chronic alcoholism, and if the maximum daily doses of paracetamol are used.

Talk to your doctor or pharmacist before taking Boots Night Cold & Flu Relief Oral Solution:

• If you are taking medicines such as certain antidepressants or antipsychotics. Boots Night Cold & Flu Relief Oral Solution may interact with these medicines and you may experience mental status changes (e.g. agitation, hallucinations, coma), and other effects such as body temperature above 38° C, increase in heart rate, unstable blood pressure, and exaggeration of reflexes, muscular rigidity, lack of coordination and/or gastrointestinal symptoms (e.g. nausea, vomiting, diarrhoea).

Do not consume alcoholic drinks while you are taking Boots Night Cold & Flu Relief Oral Solution.

Promethazine may interfere with pregnancy tests to produce false results.

Ask your doctor or pharmacist for advice before taking any medicines during pregnancy.

If necessary, Boots Night Cold & Flu Relief Oral Solution can be used during pregnancy.

If you are pregnant or breast-feeding, think you may be pregnant, or planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. You should use the lowest possible dose that reduces your pain and/or your fever and use it the shortest time possible. Contact your doctor if the pain and/or fever are not reduced or if you need to take the medicine more often.

This medicine can affect your ability to drive as it may make you sleepy or dizzy.

• Do not drive while taking this medicine until you know how it affects you
• It is an offence to drive if this medicine affects your ability to drive
• However, you would not be committing an offence if:
  • The medicine has been prescribed to treat a medical or dental problem and
  • You have taken it according to the instructions given by the prescriber or in the information provided with the medicine and
  • It was not affecting your ability to drive safely

Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking this medicine. There is further information for patients who are intending to drive in the UK go to https://www.gov.uk/drug-driving-law.

The medicinal product contains:

• Ethanol: 2916 mg of alcohol (ethanol) in each 20 ml of this medicine, which is the equivalent to 18.08 v/v %. The amount in 20 ml of this medicine is equivalent to 73 ml of beer, or 29 ml of wine. The alcohol in this preparation is likely to affect children. These effects may include feeling sleepy and changes in behaviour. It may also affect their ability to concentrate and take part in physical activities. The amount of alcohol in this medicine can effect your ability to drive or use machines. This is because it may affect your judgement and how fast you may react. If you have epilepsy or liver problems, talk to your doctor or pharmacist before taking this medicine. The amount of alcohol in this medicine may alter the effects of other medicines. Talk to your doctor or pharmacist if you are taking other medicines. If you are pregnant or breastfeeding talk to your doctor or pharmacist before taking this medicine. It you are addicted to alcohol, talk to your doctor or pharmacist before taking this medicine.
• Liquid maltitol (hydrogenated glucose syrup): If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. May have a mild laxative effect.
• Sodium: This medicine contains up to 23.52 mg of sodium (main component of cooking salt) in each 20 ml dose. This is equivalent to 1.2% of the recommended maximum daily dietary intake of sodium for an adult.
• Propylene glycol: 5180 mg propylene glycol in each 20 ml of this medicine, which is equivalent to 259 mg/ml or 220 mg/g. If you are pregnant or breast-feeding, do not take this medicine unless recommended by your doctor. Your doctor may carry out extra checks while you are taking this medicine. If you suffer from a liver or kidney disease, do not take this medicine unless recommended by your doctor. Propylene glycol in this medicine can have the same effects as drinking alcohol and increase the likelihood of side effects. Your doctor may carry out extra checks while you are takingthis medicine.

You may experience the following symptoms: nausea and vomiting, involuntary muscle contractions, agitation, confusion, somnolence, disturbances in consciousness, involuntary and rapid eye movements, cardiac disorders (rapid heart beating), coordination disorders, psychosis with visual hallucinations, and hyperexcitability.

Other signs may include dizziness, restlessness, nervousness or irritability.

Other symptoms in case of massive overdose may be: coma, severe breathing problems, and convulsions.

Contact your doctor or hospital straight away if you experience any of the above symptoms.

Talk to a doctor at once if you take too much of this medicine, even if you feel well. This is because too much paracetamol can cause delayed serious liver damage.

Also seek immediate medical advice if you take other paracetamol-containing medicines by mistake.

If you miss a dose, take it as soon as you remember. Do not take a double dose to make up for the forgotten dose.

• Swelling of the lips, eyes, tongue, or difficulty breathing, may be signs of an allergic reaction. Stop taking Boots Night Cold & Flu Relief Oral Solution immediately.
• Fits
• Skin rash, peeling of the skin or blistering
• Breathing problems, these are more likely if you have experienced them before when taking other painkillers (such as ibuprofen or aspirin)
• Unexplained bruising or bleeding
• Being sick (vomiting), feeling sick (nausea), stomach ache, sudden weight loss, loss of appetite, and yellowing of the skin and eyes (jaundice)

• Rash, itchy skin, hives

• Feeling sleepy (drowsiness)
• Disorientation or dizziness
• Nausea, vomiting, diarrhoea
• Upset stomach
• Mental and physical slowness
• Restlessness
• Dry mouth, blurred vision
• Sensitivity to light
• Inability to pass urine
• Difficulty concentrating
• Headache
• Confusion
• Sweating
• Shaking
• Shivering
• Sudden jerks of muscles
• Increased blood pressure
• Nervousness
• Irritability
• Sleep disturbances

Very rare cases of serious skin reactions have been reported.

Unknown frequency: dependence and addiction

(see section "How do I know if I am addicted?").

Drug Withdrawal

When you stop taking Boots Night Cold & Flu Relief Oral Solution, you may experience drug withdrawal symptoms, which include restlessness, difficulty sleeping, irritability, agitation, anxiety, feeling your heartbeat (palpitations), increased blood pressure, feeling or being sick, diarrhoea, shaking, shivering or sweating.

If you notice any of the following signs whilst taking Boots Night Cold & Flu Relief Oral Solution, it could be a sign that you have become addicted.

• You need to take the medicine for longer than advised
• You feel you need to use more than the recommended dose
• You are using the medicine for reasons other than those indicated
• When you stop taking the medicine you feel unwell, and you feel better once taking the medicine again

If you notice any of these signs, it is important you talk to your doctor or pharmacist.

If you get 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 at 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.

• The active substances: 1000 mg paracetamol, 20 mg promethazine hydrochloride, 15 mg dextromethorphan hydrobromide
• The other ingredients are: ethanol, propylene glycol, liquid maltitol (E965), sodium citrate, ascorbic acid, acesulfame K, citric acid monohydrate, natural mint flavour, patent blue V (E131), quinoline yellow (E104) and purified water

Boots Night Cold & Flu Relief Oral Solution is a clear green, mint flavoured sugar-free solution, available in 200 ml clear glass bottles with child resistant caps. A measuring cup is provided.

PL 04917/0053