Numark Night Cold and Flu Oral Solution 200ml

A night time cold and flu liquid with three active ingredients

Numark Night Cold and Flu Oral Solution is a clear green, mint flavoured, sugar-free cold and flu liquid for the symptomatic night time relief of colds, chills and influenza. Every 20 ml adult dose contains 1000 mg paracetamol, 20 mg promethazine hydrochloride and 15 mg dextromethorphan hydrobromide monohydrate, and each active ingredient has its own role:

• Paracetamol reduces fever.
• Promethazine, a sedating antihistamine, dries up a runny nose and aids restful sleep.
• Dextromethorphan, a cough suppressant, relieves a dry, irritating tickly cough.

Because promethazine can make you feel sleepy, it's taken once a night, just before going to bed. You'll find more on managing symptoms in our colds and flu section and our guide to cold and flu symptoms and treatments.

About Numark Night Cold and Flu Oral Solution 200ml:

• One dose per night: 20 ml for adults and children aged 16 years and over, 10 ml to 15 ml for children aged 12 to 15 years.
• Short-term use: do not take for longer than 3 days.
• Sugar-free and mint flavoured: sweetened with liquid maltitol and acesulfame K.
• Measuring cup included: always use the cup supplied with the pack.
• 200 ml glass bottle with a child-resistant cap.

Before you take it: paracetamol, alcohol and other cold remedies

Numark Night Cold and Flu Oral Solution contains paracetamol, so don't take anything else containing paracetamol while taking it, or any other flu, cold or decongestant product. It also contains alcohol (ethanol) and can make you feel sleepy, so avoid alcoholic drinks and don't drive until you know how it affects you. It isn't suitable for everyone. Don't take it if you have kidney or liver problems or lung disease, if you're taking or have taken in the last two weeks MAOI antidepressants, or if you're taking SSRI antidepressants. Read the Warnings below, and if you're unsure whether it's right for you, ask one of our pharmacists.

Always use the measuring cup supplied with the pack. Shake the bottle before use. Always take the product exactly as directed. You should check with your doctor or pharmacist if you are not sure.

Adults and children aged 16 years and over: One 20 ml dose to be taken just before going to bed.

Children aged 12 to 15 years: A 10 ml to 15 ml dose to be taken just before going to bed.

Children under 12: Do not give to children under 12 years of age.

Elderly: Dose as for adults above. Carers should be aware that this medicine should not be given to elderly patients with confusion. The elderly are more likely to develop adverse effects including confusion with this medicine.

Maximum dose: Only take one dose of Numark Night Cold and Flu Oral Solution per night. Do not take for any longer than 3 days. Do not take more medicine than the label tells you to.

Paracetamol: Do not take anything else containing paracetamol while taking this medicine. Do not take with any other flu, cold or decongestant product. If you have taken other paracetamol containing products during the day, this night time dose is considered as part of the maximum daily dose and should not be taken if you have already taken four doses of paracetamol during the day.

If you forget to take Numark Night Cold and Flu Oral Solution: 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.

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

Before taking Numark Night Cold and Flu Oral Solution

Can cause addiction. Contains paracetamol. This medicine may cause opioid-like effects when used at high doses.

Do not take Numark Night Cold and Flu Oral Solution:

• if you are allergic (hypersensitive) to paracetamol, promethazine hydrochloride, dextromethorphan hydrobromide monohydrate or any of the other ingredients.
• if you have kidney or liver problems.
• if you suffer from lung disease.
• if you are taking, or have taken in the last two 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.

Check with your doctor or nurse before having Numark Night Cold and Flu Oral Solution if:

• You have any serious heart problems.
• You have any personal or family history of heart disease.
• You have an irregular heartbeat.

Addiction: 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 or sweating. Speak to your doctor if you experience withdrawal symptoms.

During treatment, tell your doctor straight away if you have severe illnesses, including severe renal impairment or sepsis (when bacteria and their toxins circulate in the blood leading to organ damage), or you suffer from malnutrition, chronic alcoholism or if you are also taking flucloxacillin (an antibiotic). A serious condition called metabolic acidosis (a blood and fluid abnormality) has been reported in patients in these situations when paracetamol is used at regular doses for a prolonged period or when paracetamol is taken together with flucloxacillin. Symptoms of metabolic acidosis may include: serious breathing difficulties with deep rapid breathing, drowsiness, feeling sick (nausea) and being sick (vomiting).

Other medicines: 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. quinidine, 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, perphenazine and thioridazine.
• flucloxacillin (antibiotic), due to a serious risk of blood and fluid abnormality (called metabolic acidosis) that must have urgent treatment.

Talk to your doctor or pharmacist before taking Numark Night Cold and Flu Oral Solution if you are taking medicines such as certain antidepressants or antipsychotics. Numark Night Cold and Flu 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). Also tell your doctor or pharmacist if you are taking, have recently taken or might take medicines that can affect your heart rhythm.

Alcohol: Do not consume alcoholic drinks while you are taking Numark Night Cold and Flu Oral Solution.

Pregnancy tests: Promethazine may interfere with pregnancy tests to produce false results.

Pregnancy and breast-feeding: Ask your doctor or pharmacist for advice before taking any medicines during pregnancy. If necessary, Numark Night Cold and Flu 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 for 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.

Driving and using machines: The 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 at https://www.gov.uk/drug-driving-law.

Important information about some of the ingredients:

• Ethanol: 2916 mg of alcohol (ethanol) in each 20 ml of this medicine, which is 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 affect your ability to drive or use machines. This is because it may affect your judgement and how fast you 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 breast-feeding, talk to your doctor or pharmacist before taking this medicine. If you are addicted to alcohol, talk to your doctor or pharmacist before taking this medicine.
• 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 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 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.

If you take more than you should: 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.

Possible side effects

Like all medicines, Numark Night Cold and Flu Oral Solution can cause side effects, although not everybody gets them.

If you experience any of the following stop using the medicine and seek immediate medical help:

• Swelling of the lips, eyes, tongue, or difficulty in breathing may be signs of an allergic reaction. Stop taking Numark Night Cold and Flu 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).

If you experience any of the following stop using the medicine and talk to your doctor:

• Rash, itchy skin, hives.

Other effects which may occur include: feeling sleepy (drowsiness), disorientation or dizziness, nausea, vomiting, diarrhoea, upset stomach, mental and physical slowness, 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 "How do I know if I am addicted?" below).

Not known frequency (frequency cannot be estimated from the available data):

• A serious condition that can make blood more acidic (called metabolic acidosis), in patients with severe illness using paracetamol.
• Abnormal electrical activity of the heart that affects its rhythm, including life-threatening rhythm disturbance.
• A serious reaction with fever, rigid muscles, changing blood pressure and coma (neuroleptic malignant syndrome).
• Low levels of blood platelets (which can lead to bleeding and bruising).
• Restlessness.
• Hallucinations.
• Aggression.

Drug withdrawal: When you stop taking Numark Night Cold and Flu 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.

How do I know if I am addicted? If you notice any of the following signs whilst taking Numark Night Cold and Flu 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.

Reporting of side effects: If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in the 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.

Storage

Do not store above 25°C. Keep out of the sight and reach of children. Store in the original container and keep the bottle in the outer carton (in order to protect from light). Do not use after one month from first opening. Do not use after the expiry date which is stated on the label or carton.

Active ingredients (per 20 ml): Paracetamol 1000 mg, Promethazine Hydrochloride 20 mg, Dextromethorphan Hydrobromide Monohydrate 15 mg.

Other ingredients: 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), purified water.

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We cannot guarantee the Patient Information Leaflet is accurate and is for reference only.