Patient leaflet - Buttercup Bronchostop Cough syrup
1. WHAT BUTTERCUP BRONCHOSTOP COUGH SYRUP IS AND WHAT IT IS USED FOR
Buttercup Bronchostop Cough Syrup is a traditional herbal medicinal product used for the relief of coughs, such as chesty coughs and dry, tickly, irritating coughs and catarrh based on traditional use only.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE BUTTERCUP BRONCHOSTOP COUGH SYRUP
Do not take Buttercup Bronchostop Cough Syrup
- If you are allergic to Marshmallow root, Thyme or other members of the Lamiaceae family (e.g. Basil, Rosemary, Sage), or to any of the other ingredients of this medicine (listed in section 6).
If you are pregnant or breast-feeding.
Warnings and precautions
Consult your doctor before taking Buttercup Bronchostop Cough Syrup if you:
- are prone to develop allergic reactions. There is a possible risk that this medicine may trigger severe and life-threatening allergic reactions in patients who have a tendency to develop allergic reactions.
have asthma, as Buttercup Bronchostop Cough Syrup may make asthma symptoms worse. LF06439H / 13988_9_UK / 25
File title: CR08139_LF06439H_Bronchostop Syrup 120ml_Leaflet_UK v03
Item No.: 13988_9_UK
OPI No.: LF06439H
Replacement No.: 13988_8_UK
Last edit: 19th April 2023
Brand: Bronchostop
Variant: Syrup
Component: Leaflet
Market/s: UK
Dimensions: 148 x 210 mm
Reel Unwind: …
Spec. Ref.: …
Substrate: Paper
EAN Code: …
Other Code/Spec.: …
Manufacturing Site: Kwizda
No. of Colours: 1
Process Black
Page 1 of 2 512 Metal Box Factory,
30 Great Guildford Street, London, SE1 0HS, UK
+44 (0)20 3982 8471 london@oneagency.co
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Children
Do not give this medicine to children under 12 years.
Other medicines and Buttercup Bronchostop Cough Syrup
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
Absorption of concomitantly administered medicines may be delayed. As a precautionary measure, the product should not be taken ½ to 1 hour before or after intake of other medicinal products. Pregnancy and breast-feeding
Do not take this medicine if you are pregnant or breast-feeding.
Driving and using machines
No studies on the effects on the ability to drive and to use machines have been performed. Buttercup Bronchostop Cough Syrup contains no ingredients that are known to cause drowsiness. Buttercup Bronchostop Cough Syrup contains the preservatives
Methyl parahydroxybenzoate (E218) and Propyl parahydroxybenzoate (E216).
These may cause allergic reactions which may also appear as a delayed reaction (see the ”Do not take” section).
Buttercup Bronchostop Cough Syrup contains raspberry juice concentrate which contains sucrose, glucose and fructose.
This medicine contains 66 mg fructose in each 15 ml of syrup.
If your doctor has told you that you (or your child) have an intolerance to some sugars or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which a person cannot break down fructose, talk to your doctor before you (or your child) take or receive this medicine as patients with HFI should not take or be given this medicinal product. Buttercup Bronchostop Cough Syrup contains propylene glycol
This medicine contains 38.9 mg of propylene glycol in each 15 ml of syrup. Buttercup Bronchostop Cough Syrup contains sodium.
This medicine contains less than 1 mmol sodium (23 mg) per 15 ml dose that is to say essentially ‘sodium-free’.
3. HOW TO TAKE BUTTERCUP BRONCHOSTOP COUGH SYRUP
Always take this medicine exactly as described in this leaflet or as your doctor, pharmacist or qualified healthcare practitioner has told you. Check with your doctor, pharmacist or qualified healthcare practitioner if you are not sure.
Always use the enclosed measuring cup.
Buttercup Bronchostop Cough Syrup can be taken undiluted or can be diluted in water or warm tea.
Dosage
Adults, the elderly and children from 12 years old: Using the measuring cup provided, 15 ml of syrup to be taken every 4 hours, 4 times per day.
If required, up to a maximum of 6 doses (90 ml) can be taken per day.
Do not give to children under 12 years.
DO NOT EXCEED THE STATED DOSE.
You must talk to a doctor or qualified healthcare practitioner if you do not feel better or if you feel worse after 7 days.
If you are short of breath, have a high temperature (fever), your phlegm is yellow-green or brown in colour (purulent sputum), you must consult your doctor or qualified healthcare practitioner. If you take more Buttercup Bronchostop Cough Syrup than you should
Talk to a doctor straight away, or contact your nearest hospital casualty department. Take the carton and this leaflet with you.
If you forget to take Buttercup Bronchostop Cough Syrup
Take the next dose when it is due. Do not take a double dose to make up for a forgotten dose. If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them. The frequency of the following side effects occurring is not known.
This medicine may cause the following serious allergic reactions.
If you experience any of the following effects, stop taking the syrup and seek medical advice immediately:
- severe and potentially life-threatening reactions, with symptoms that may include feeling lightheaded or faint, breathing difficulties or wheezing, a fast heartbeat, skin rash, confusion and anxiety, or loss of consciousness (anaphylactic reaction)
- swelling of the face, lips, tongue, mouth or throat (angioedema),
- blistering of the mouth and throat
- worsening of asthma symptoms
- difficulty breathing (including shortness of breath)
Other possible side effects
If any of the following side effects get serious or concern you, or you notice any other side effect, stop taking the syrup and seek medical advice as soon as possible:
- Allergic skin reactions including urticaria (red bumps on the skin), and itching. Gastrointestinal disorders such as pain or discomfort in the abdomen, diarrhoea, vomiting, and nausea. 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 App Store. By reporting side effects you can help provide more information on the safety of this medicine.
File title: CR08139_LF06439H_Bronchostop Syrup 120ml_Leaflet_UK v03
Item No.: 13988_9_UK
OPI No.: LF06439H
Replacement No.: 13988_8_UK
Last edit: 19th April 2023
Brand: Bronchostop
Variant: Syrup
Component: Leaflet
Market/s: UK
Dimensions: 148 x 210 mm
Reel Unwind: …
Spec. Ref.: …
Substrate: Paper
EAN Code: …
Other Code/Spec.: …
Manufacturing Site: Kwizda
No. of Colours: 1
Process Black
Page 2 of 2 512 Metal Box Factory,
30 Great Guildford Street, London, SE1 0HS, UK
+44 (0)20 3982 8471 london@oneagency.co
25 ➙
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Version: 3
Version ID: 00002_0000173166
Downloaded: Apr 27, 2023 at 3:33 PM GMT+02:00
By: Regulatory, Kwizda (KWIZDA.REGULATORY)
Approval state: Draft
5. HOW TO STORE BUTTERCUP BRONCHOSTOP COUGH SYRUP
Do not store above 25°C.
Store in the original package in order to protect the contents from light.
Keep out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.
Close tightly after use. After opening, use within 4 weeks.
Do not throw away medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures help protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Buttercup Bronchostop Cough Syrup contains
15 ml of oral syrup (15.45 g) contains the actives substances:
120 mg of extract (as dry extract) from Thyme herb (Thymus vulgaris L. and Thymus zygis L.,herb ) (DER 7-13:1) extraction solvent: water
830 mg of extract (as liquid extract) from Marshmallow root (Althaea officinalis L.) (DER 1:12-14) extraction solvent: water
The other ingredients are:
Maltodextrin, Acacia (E414), Xylitol (E967), Methyl parahydroxybenzoate (E218), Raspberry juice concentrate (containing sucrose, glucose and fructose), Xanthan gum, Citric acid monohydrate, Propyl parahydroxybenzoate (E216), Raspberry aroma flavouring (synthetic and natural flavourings, propylene glycol (E1520)), glycerol (E422), saccharin-sodium (E954), neohesperidin-dihydrochalcone, Purified water
What Buttercup Bronchostop Cough Syrup looks like and contents of the package
Buttercup Bronchostop Cough Syrup is a brown-red, viscous liquid. The syrup is contained in brown glass bottles with a sealed screw cap, in 120 ml, 200 ml and 240 ml sizes. Not all pack sizes may be marketed.
The package includes a measuring cup with a scale from 2.5 ml to 20 ml which allows precise measuring of the recommended dose.
THR Holder
Omega Pharma Ltd, 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
THR 02855/0336
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