Patient leaflet - Toussistop Cold Relief oral solution
1. What Toussistop Cold Relief oral solution is and what it is used for
Toussistop Cold Relief oral solution contains marshmallow root, lime flower and ribwort plantain extracts.
Toussistop Cold Relief oral solution is a traditional herbal medicinal product used for relief of symptoms of the common cold such as chills, sore throat and cough, based on traditional use only.
The product is a traditional herbal medicinal product for use in the specified indications exclusively based upon long-standing use.
You must talk to a doctor if you feel worse or if you do not feel better after 7 days.
2. What you need to know before you take Toussistop Cold Relief oral solution
Do not take Toussistop Cold Relief oral solution
- if you are allergic to marshmallow root, lime flower, ribwort plantain, ribwort plantain pollen or any of the other ingredients of this medicine (listed in section 6)
- if you are pregnant or breast-feeding
- if you are under 12 years old
Warnings and precautions
Talk to your doctor or pharmacist if while taking Toussistop Cold Relief oral solution:
- you do not feel better or if you feel worse
- you are short of breath (dyspnoea)
- you have a high temperature (fever)
- your phlegm is yellow-green or brown in color (purulent sputum)
If the symptoms worsen or if adverse effect not mentioned in the package leaflet occurs during the use of the medicinal product, a doctor or pharmacist should be consulted.
This medicine may delay the absorption of other medicines taken at the same time.
Other medicines and Toussistop Cold Relief oral solution
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines before taking this medicine.
It is not known if this medicine may affect the actions of other medicines. It may delay the absorption of other medicines taken at the same time. As a precautionary measure, do not take this medicinal product for 30 minutes to 1 hour before or after taking other medicines.
Pregnancy and breast-feeding
Do not take this medicine if you are pregnant or breast-feeding.
Driving and using machines
No studies on the effect on the ability to drive and use machines have been performed.
Toussistop Cold Relief oral solution with food and drink
Avoid drinking for 30 minutes to 1 hour after taking this medicine.
Toussistop Cold Relief oral solution contains xylitol (E967)
This medicine contains 11.04 g xylitol (calorific value is 2.4 kcal/g xylitol, corresponding to 26.5 kcal) in the maximum daily dose (60 ml). It may have a laxative effect.
Toussistop Cold Relief oral solution contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216)
This medicine contains methyl parahydroxybenzoate and propyl parahydroxybenzoate. May cause hypersensitivity (allergic) reactions, possibly delayed.
Toussistop Cold Relief oral solution contains 13.6 mg of propylene glycol and 0.002 mg benzyl alcohol per 15 ml.
Benzyl alcohol may cause allergic reactions.
3. How to take Toussistop Cold Relief oral solution
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Start at the first sign of the common cold symptoms, such as chills, sore throat and cough.
Always use the enclosed measuring cup.
For oral use (undiluted).
The recommended dose is:
Adults, the elderly and children from 12 years and over:
Using the measuring cup provided, take 15 ml up to 4 times a day with a last dose taken at bedtime if required. Maximum daily dose 60 ml.
Do not give to children under 12 years old.
Do not take more medicine than the label tells you to.
If the symptoms worsen, or persist longer than 7 days during the use of the medicinal product, a doctor, pharmacist or a qualified health care practitioner should be consulted.
If you take more Toussistop Cold Relief oral solution than you should
Consult a doctor or contact your nearest hospital casulty department. Take this leaflet with you.
If you forget to take Toussistop Cold Relief oral solution
Do not take a double dose to make up for a forgotten dose. Take the next recommended dose when it is due.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine may cause side effects, although not everybody gets them.
There are no reported side effects for this medicine. If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
Reporting of side effects
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 Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Toussistop Cold Relief oral solution
Keep this medicine out of the sight and reach of children.
This medicinal product does not require any special storage conditions. Store in the original package.
After first opening the product, use within 2 months.
Do not use this medicine after the expiry date which is stated on the carton and on the bottle label. The expiry date refers to the last day of that month.
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 Toussistop Cold Relief oral solution contains
The active substances are:
Each 15 ml (= 16.3 g) dose of oral solution contains:
187.5 mg of extract (as dry extract) from Althaea officinalis L., radix (Marshmallow root) (7- 9:1). Extraction solvent: water
136.4 mg of extract (as dry extract) from Tilia cordata Miller, Tilia platyphyllos Scop., Tilia x vulgaris Heyne or their mixtures, flos (Lime flower) (3-8:1). Extraction solvent: water
150.0 mg of extract (as dry extract) from Plantago lanceolata L., folium (Ribwort plantain) (4-6:1). Extraction solvent: water
The other ingredients are:
- Maltodextrin
- Silica colloidal anhydrous
- Glycerol
- Xylitol (E 967)
- Methyl parahydroxybenzoate (E 218)
- Propyl parahydroxybenzoate (E 216)
- Citric acid monohydrate
- Xanthan gum
- Strawberry flavour (contains benzyl alcohol (E 1519) and propylene glycol (E 1520))
- Water, purified
What Toussistop Cold Relief oral solution looks like and contents of the pack
Toussistop Cold Relief oral solution is a brown, opaque oral solution contained in a brown glass bottle with a nozzle and plastic screw cap packed in a carton box. It is provided with a plastic cup with a scale from 2.5 ml to 20 ml for measuring the recommended dose.
Toussistop Cold Relief oral solution is available in 120 ml, 200 ml and 240 ml pack sizes. Not all pack sizes may be marketed.
Traditional Herbal Registration Holder
Omega Pharma Limited, Wrafton, Braunton, Devon, EX33 2DL, UK
Manufacturer
Kwizda Pharma GmbH Effingergasse 21, 1160 Vienna, Austria
Distributed by Omega Pharma Ltd, Wrafton, Braunton, Devon, EX33 2DL, UK
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