Night Time Formula

Read all of this section carefully before you start using Covonia Night Time Formula. It includes other information which might be especially important for you. Always use this medicine exactly as described or as your doctor or pharmacist has told you.

Recommended doses:

• Adults, the elderly and children over 12 years: take 3 x 5ml spoonfuls at bedtime. Repeat after 6 hours if required

Warnings:

• Do not give to children under 12 years old
• Do not take more medicine than the label tells you to
• Do not take with any other cough and cold medicine
• Avoid alcoholic drink. The medicine can lead to dependence. Therefore, the treatment should be of short duration
• Shake bottle before use

Do not use this medicine if you have…

• An allergy to any of the ingredients listed
• Taken MAOIs (monoamine oxidase inhibitors) for depression within the last two weeks or are taking SSRIs for depression
• Shortage of breath
• Liver problems
• Porphyria
• Asthma or a cough that produces phlegm

Talk to your doctor if you have…

• Glaucoma
• Difficulty passing urine
• Prostate trouble
• A blocked intestine
• Epilepsy
• Heart problems
• A cough that lasts a long time
• Or you are prone to allergies

Talk to your doctors or pharmacist if you are taking…

• Medicines such as certain antidepressants or antipsychotics – Covonia Night Time Formula 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 39 degrees Celsius, increased heart rate, unstable blood pressure, and exaggeration of reflexes, muscular rigidity, lack of coordination and/or gastrointestinal symptoms (e.g. nausea, vomiting, diarrhoea).
• Alcohol
• Cimetidine for stomach ulcers
• Medicines for Parkinson’s disease (e.g. rasagiline, moclobemide, venlafaxine)
• Medicines for anxiety or to help you sleep (e.g. diazepam)
• Memantine for Alzheimer’s disease
• Medicines for irregular heartbeat (e.g. amiodarone, propafenone, quinidine, beta blockers)
• Antihistamines
• Betahistine for vertigo or histamine for some types of cancer
• Strong pain killers (e.g. codeine)
• Medicine for a runny nose or to control the bladder, or atropine used to treat eye problems
  

Driving and using machines: This medicine causes drowsiness and you should not drive or operate machinery until the effects have worn off.

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 medical or dental problems and
• You have taken it according to the instructions given by the prescriber or in the information provided with this 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.

Pregnant or breastfeeding: Ask your doctor or pharmacist for advice before using if you are pregnant, might be pregnant or are breastfeeding. This medicine should not be used unless the doctor has told you so.

Possible side effects:

Like all medicines, Covonia Night Time Formula can have side effects, although these don’t affect everyone

Important side effects: if you get any of these side effects, stop use immediately and see a doctor as soon as possible:

• Swelling of the lips, mouth, eyes or tongue
• Difficulty breathing
• Fits

Other possible side effects:

• Drowsiness and lack of concentration
• Dizziness
• Feeling excited or confused
• Feeling depressed
• Sleeping problems
• Headache
• Muscle twitching
• Trembling
• Blurred vision
• Stomach upsets (e.g. feeling sick, being sick, diarrhoea)
• Rash
• Skin blisters
• Pins and needles
• Dry mouth
• Thick salvia
• Low blood pressure, palpitations or irregular heartbeat
• Difficulty passing urine
• Blood or liver problems
• Eye problems (glaucoma)
• Sweating
• Muscle pain
• Ringing in the ears
• Hair loss

If you notice these or any other side effects not listed stop use and tell 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 here. 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.

Overdose: if you take more Covonia Night Time Formula 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 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.

Take the take with you to show which medicine you have swallowed.

The active ingredient per 5ml is: dextromethorphan hydrobromide 6.65mg, diphenhydramine hydrochloride 10mg

The other ingredients are: Sodium Benzoate (E211) ethanol (E422), sorbitol (E420), liquid maltitol (contains maltitol (E965) and sorbitol (E420)), hydroxyethylcellulose (natrosol G PH), povidone (E1202), saccharin sodium, capsicum tincture (capsicum oleoresin), menthol, peppermint oil, anise oil, citric acid (E330), macrogol cetostearyl ether, caramel, blackcurrant Flavour 1122267 (contains propylene glycol (E1520)) and purified water.

Dietary properties:

• Suitable for vegetarians and coeliacs
• Free from artificial colours