Patient leaflet - Histalix syrup
1. What Histalix Syrup is and what it is used for
The name of your medicine is Histalix Syrup.
It is for the symptomatic relief of troublesome cough associated with upper respiratory tract congestion. It may also be used to aid restful sleep. The syrup contains the active ingredients diphenhydramine hydrochloride, ammonium chloride and levomenthol. Diphenhydramine hydrochloride is an antihistamine that is used to provide relief from the effects of an allergy. Ammonium chloride is an expectorant that helps loosen phlegm and catarrh. Levomenthol relieves the discomfort of congestion and also provides a cooling effect in mouth and throat.
2. What you need to know before you take Histalix Syrup
Do not take Histalix Syrup:
£ If you are allergic to diphenhydramine hydrochloride, ammonium chloride, levomenthol or any of the other ingredients of this medicine (listed in section 6)
£ Are taking or have taken monoamine oxidase inhibitors (MAOI) (a treatment for depression) within the previous 14 days. £ Are under 12 years old.
Warnings and precautions
Talk to your doctor or pharmacist before taking this medicine if you: £ Suffer from glaucoma
£ Have difficulty urinating
£ Have a cough with a lot of mucus
£ Suffer from an enlarged prostate
£ Have asthma
£ Have any disorder of the liver.
Other medicines and Histalix Syrup
Histalix Syrup may react with other medicines you are taking. Talk to a doctor or pharmacist if you are taking, have recently taken or may take: £ Any other antihistamines (typically used to treat allergies) £ Sedative drugs (used to provide a calming effect)
£ Anti-anxiety agents
£ Any other medication with a depressant action
£ Any other decongestant medication
£ Ephedrine (used to treat nasal congestion, diabetic swelling and other conditions)
£ Mono Amine Oxidase Inhibitors (MAOls) (a treatment for depression) £ Any other treatment for coughs or colds.
You should also be aware that:
£ Certain antibiotics may damage hearing and Histalix Syrup may mask this damage initially.
£ If you are having skin tests to test for allergies then Histalix Syrup may mask a positive result.
Histalix Syrup with food and alcohol
Avoid alcoholic drinks
Pregnancy and breast feeding
Do not take this medicine if you are pregnant or breastfeeding
Driving and using machines
Histalix Syrup may cause drowsiness. Do not drive or operate machinery.
This medicine contains:
£ 1.66g of Sucrose in 5ml. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine
£ Glycerin (also known as glycerol) may cause headache, stomach upset and diarrhoea
£ Parahydroxybenzoates may cause allergic reactions (possibly delayed) £ The colouring E124 (Ponceau 4R) may cause allergic reactions £ 0.5ml Propylene Glycol per 5ml. If you are pregnant or breastfeeding, or suffer from liver or kidney disease, do you take this medicine unless recommended by your doctor. Your doctor may carry out extra checks while you are taking this medicine.
3. How to take Histalix Syrup
Always take this medicine exactly as described in this leaflet or as your doctor or, pharmacist have told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose is one to two 5ml spoonfuls to be taken every 4 hours.
To aid sleep take two 5ml spoonfuls at bedtime followed by two 5ml spoonfuls every 6 hours.
Do not take more than 4 doses (one dose = two 5ml spoonfuls) in 24 hours. Not suitable for children under 12 years.
If you take more Histalix Syrup than you should
If you have taken an overdose of Histalix Syrup you should seek medical attention as soon as possible. When seeking medical advice you should, if possible, take the medicine and this leaflet with you provided it doesn’t cause a delay.
If you forget to take Histalix Syrup
Do not take a double dose to make up for a forgotten dose. If you have missed a dose then provided it is delayed by no more than an hour take your dose immediately, otherwise wait until your next dose is due.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects have been reported to the ingredients of Histalix Syrup:
Common Side Effects:
£ Drowsiness
£ Excitability
£ Headache
£ Poor co-ordination
£ Difficulty urinating
£ Dryness of the mouth
£ Stomach upset
£ Thickened mucus
Rare Side Effects:
£ Low blood pressure £ Muscle spasms £ Dizziness
£ Confusion
£ Depression
£ Disturbed sleep £ Tremor
£ Convulsions
£ Irregular heartbeat or palpitations £ Allergic reactions £ Liver problems
If you experience any unexpected side effects not mentioned above, or the side effect (as listed) is severe or persists for more than a few days, discontinue use of the medicine and consult your doctor.
If you suffer from spontaneous bruising or bleeding (possible signs of a blood disorder) discontinue treatment and seek immediate advice from your doctor.
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 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 Play Store. By reporting side effects you can help provide more information on the safety of this medicine.
5.How to store Histalix Syrup?
Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton. Store below 30°C.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Histalix Syrup contains:
The active substances are diphenhydramine hydrochloride, ammonium chloride and levomenthol.
The other ingredients are sucrose, sodium saccharin, ponceau 4R (E124), propylene glycol, raspberry flavouring, preservatives (E218, E215, E216 and butyl hydroxybenzoate), sodium citrate, glycerin and water.
What Histalix Syrup looks like and the contents of the pack:
Histalix Syrup is a clear red coloured syrup supplied in packs of 150ml. PL 00400/0007R
Marketing Authorisation Holder:
Wallace Manufacturing Chemists Limited,
51-53 Stert Street, Abingdon, Oxfordshire, OX14 3JF, UK.
Manufacturer:
Laleham Health and Beauty Limited, Greenhalgh, Preston, PR4 3JA, UK.
This Leaflet was revised October 2022