oral solution 
thyme extract / medicinal extract

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.

– Save this information, you may need to read it again.

– If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

– You should talk to a doctor if you do not feel better or if you feel worse after 5 days.

In this leaflet you will find information about: 
1. What Bronwel Comp is and what it is used for 
2. What you need to know before using Bronwel Comp 
3. How to use Bronwel Comp 
4. Possible side effects 
5. How to store Bronwel Comp 
6. Contents of the packaging and other information 

1. What Bronwel Comp is and what it is used for

Bronwel Comp is a traditional herbal medicine used for coughs in connection with colds, to facilitate the expulsion of viscous mucus and to relieve dry cough and irritation in the throat.

The indications for traditional herbal medicine are based solely on the experience of long-term use.

2. What you need to know before using Bronwel Comp

Do not take Bronwel Comp:

  • if you are allergic to thyme, other plants in the family Lamiaceae, medicinal mallow, or any of the other ingredients of this medicine (listed in section 6).

Warnings and cautions

Consult a physician or other healthcare professional in case of shortness of breath, fever, or purulent vomiting.

If you are allergic to birch pollen or celery, you may also be allergic to thyme (cross-allergy).

In rare cases, hypersensitivity reactions, including severe reactions with swelling of the face, shortness of breath/difficulty breathing, and a drop in blood pressure, have been observed after using products containing thyme. Stop taking Bronwel Comp and contact a doctor immediately if you get any of these serious reactions. 

Children

In the absence of sufficient data, use in children under 12 years of age is not recommended.

Other Medicines and Bronwel Comp

The effect of concomitant use of other drugs has not been studied.

In case of contact with a doctor or other healthcare professional, remember to tell them that you are taking or have recently taken this over-the-counter medicine.

Pregnancy, breastfeeding, and fertility

In the absence of adequate data, use during pregnancy or lactation is not recommended.

The potential effect of the drug on fertility has not been studied.

Driving and using machines

Bronwel Comp has no or negligible effect on the ability to drive and use machines.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Bronwel Comp contains methyl parahydroxybenzoate, propyl parahydroxybenzoate, xylitol, sucrose, glucose, fructose, and propylene glycol.

Methyl parahydroxybenzoate and propyl parahydroxybenzoate may cause allergic reactions (possibly delayed).

Xylitol may have a laxative effect. Caloric value: 2.4 kcal / g xylitol.

This medicine contains 66 mg fructose per dose (15 ml).

If you (or your child) cannot tolerate certain sugars, or if you (or your child) have been diagnosed with hereditary fructose intolerance, a rare, inherited disease that prevents the breakdown of fructose, consult a doctor before taking this medicine.

This medicine contains 33.3 mg of propylene glycol per dose (15 ml).

3. How to use Bronwel Comp

Always take Bronwel Comp exactly as described in this leaflet. Ask your doctor or pharmacist if you are unsure.

Dosage

Adults and adolescents over 12 years:

Take 15 ml every 4 hours 4 times a day. If necessary up to 6 times a day. The maximum daily dose is 90 ml.

Measure out the Bronwel Comp in the supplied dosing cup and preferably drink it undiluted.

If necessary, Bronwel Comp can be diluted with water or hot tea.

Processing time:

Self-care treatment with Bronwel Comp should be limited to five days. You should talk to a doctor if you do not feel better or if you feel worse after five days.

Use for children

Not recommended for children under 12 years when there is insufficient data.

If you forget to take Bronwel Comp

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, Bronwel Comp can cause side effects, although not everybody gets them.

Hypersensitivity reactions, including cases of anaphylactic shock and Quincke’s edema (swelling of the face, tongue, or throat; difficulty swallowing; hives and difficulty breathing and drops in blood pressure), and stomach upset have been reported following the use of thyme-containing medicines. The frequency is not known.

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 to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. 

5. How to store Bronwel Comp

Do not store above 25 ° C.

Store in the original package. Sensitive to light.

Close the bottle tightly after use. An opened bottle should be used within 4 weeks.

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 and label after EXP. The expiration date is the last day of the specified month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

The active substances are extracts of Thymus vulgaris L. and/or Thymus zygis L. (thyme) and extracts of Althaea Officinalis L. ( medicinal mallow ).

1 ml oral solution contains:

8 mg extract, of which 0.17-0.22 mg thyme oil, of Thymus vulgaris L. and/or Thymuszygis L. (thyme), herb, corresponding to 55-102 mg of dried herb from thyme.

55 mg extract of Althaea Officinalis L. ( medicinal mallow ), root, corresponding to 4.0 4.6 mg dried root from medicinal mallow.

The other ingredients are purified water, xylitol (E 967), raspberry juice concentrate (containing sucrose, glucose, and fructose), xanthan gum, maltodextrin, raspberry flavoring (containing propylene glycol (E 1520)), citric acid monohydrate, methyl parahydroxibene 21 ), acacia gum.

What the medicine looks like and the contents of the pack

Brown, viscous liquid with a scent of thyme and a taste of thyme and raspberries.

Packaging: Brown glass bottle, with sealed screw cap, supplied dosing cup.

Pack sizes: 120 ml, 200 ml, and 240 ml.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Kwizda Pharma GmbH, Effingergasse 21, A-1160 Vienna, Austria

Local representative

Perrigo Sverige AB, Kista

Muhammad Nadeem

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