8 mg tablets 
bromhexine hydrochloride

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

Always use this medicine exactly as described in this leaflet or as directed by your doctor, pharmacist, or nurse. 

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

– Contact the pharmacy staff if you need more information or advice.

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

– You must talk to a doctor if you do not feel better or if you feel worse after 14 days.

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

1. What Coldmexin is and what it is used for

Coldmexin is considered to dissolve viscous mucus so that it becomes thinner and thus easier to cough up. Coldmexin is used for temporary short-term cough with viscous mucus.


Bromhexine contained in Coldmexin may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.


You must talk to a doctor if you do not feel better or if you feel worse after 14 days.

2. What you need to know before using Coldmexin

Do not use Coldmexin

  • if you are allergic to bromhexine hydrochloride or any of the other ingredients of this medicine (listed in section 6).

Warnings and cautions

Talk to your doctor, pharmacist, or nurse before using Coldmexin:

– if you have stomach ulcers or bloody coughs.


Stop taking Coldmexin and contact a doctor immediately if swelling of e.g. face, tongue, and/or pharynx and/or difficulty swallowing or hives appearing together with difficulty breathing ( angioedema ).


Severe skin reactions have been reported with the use of bromhexine. If you get a skin rash (including ulcers in the mucous membranes of eg mouth, throat, nose, eyes, genitals), stop using Coldmexin and contact a doctor immediately.

Other medicines and Coldmexin

Coldmexin is not expected to affect or be affected by other medicines.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.


Bromhexine passes to the fetus, but no adverse effects have been demonstrated. However, you should only use Coldmexin during pregnancy if necessary. This is especially true during the first three months of pregnancy.


Bromhexine passes into breast milk and should therefore be avoided during breast-feeding.

Driving and using machines

No effects on the ability to drive have been observed.


You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened 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.

Coldmexin contains excipients

Coldmexin contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to use Coldmexin

Always take this medicine exactly as described in this leaflet or as directed by your doctor, pharmacist, or nurse. If you are not sure, talk to your doctor, pharmacist, or nurse.


Recommended dose: 

Adults and children over 12 years: 1 tablet 3 times daily. The tablets should be swallowed with liquid.


The breaker is not for dividing the tablet into equal doses but only for easier swallowing.


Coldmexin can be taken with or without food.


Ask your doctor or pharmacist if you are unsure.


If no improvement occurs within two weeks, consult a physician. Note that Coldmexin may initially increase the excretion of mucus in the airways.

If you forget to use Coldmexin

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, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.


Stop taking Coldmexin and contact your doctor immediately if you get any of the following symptoms:

  • anaphylactic reactions including anaphylactic shock, angioedema with
    • swelling of the face, tongue, or throat
    • difficulty swallowing
    • hives and difficulty breathing and itching
  • severe skin reactions (including erythema multiforme, Stevens-Johnson syndrome / toxic epidermal necrolysis, and acute generalized exanthematous pustulosis )
  • the sharp contraction of the trachea ( bronchospasm )(Has been reported – occurs in an unknown number of users)


Uncommon ( may affect up to 1 in 100 people):

  • pain from the upper part of the gastrointestinal tract, nausea, vomiting, diarrhea.


Rare (may affect up to 1 in 1,000 people):

  • hypersensitivity s
  • skin rash, hives.

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. Postal address

5. How to store Coldmexin

Keep this medicine out of the sight and reach of children.


No special storage instructions


Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. dat./EXP. The expiration date is the last day of the specified month.


The medicine 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 substance is bromhexine hydrochloride 8 mg.
  • The other ingredients are lactose monohydrate, corn starch, magnesium stearate.

What the medicine looks like and the contents of the pack

Coldmexin tablets are white and round, diameter about 7 mm, height about 2.5 mm. The tablets are scored on one side and marked with 8B on the other side.


Blister pack: 20, 30, or 50 tablets.


Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Orifarm Generics A / S

Energizer 15

5260 Odense S

Denmark


Local representative:

Orifarm Generics AB,

Box 56048

102 17 Stockholm 

info@orifarm.com

Muhammad Nadeem

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