0.5 mg / ml + 1 mg / ml oral solution 
Bromhexine hydrochloride and ephedrine hydrochloride

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

  • Save this information, you may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not give it to others. It can harm them, even if they show signs of illness similar to yours.
  • 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.

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

1. What Etrilect is and what it is used for

Etrilect contains bromhexine and ephedrine. Bromhexine is considered to make the mucus in the airways thinner. It can facilitate the expectoration of mucus. Ephedrinedilates the trachea and has a decongestant effect on the mucous membranes.

Etrilect is used for coughs with tough mucus and at the same time needs a tracheal dilating effect.

The bromhexine and ephedrine contained in it 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.

2. What you need to know before using Etrilect

Do not use Etrilect

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

Warnings and cautions

Talk to your doctor or pharmacist before using Etrilect.

You must talk to a doctor before using this medicine:

  • if you have a history of heart disease, irregular heartbeat, or angina
  • if you have heart disease, high blood pressure, high levels of thyroid hormone in the blood ( hyperthyroidism ), enlarged prostate, glaucoma, diabetes, or stomach ulcers
  • if you have a bloody cough

Etrilect can cause dry mouth. Careful oral hygiene (brushing with fluoride toothpaste twice a day) while using Etrilect is therefore important.

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

At high doses and long-term use, there is a certain risk of developing an addiction.

Other medicines and Etrilect

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Some medicines may affect or be affected by treatment with Etrilect, for example:

  • MAO inhibitors and tricyclic antidepressants ( antidepressants ).
  • medicines for high blood pressure
  • dexamethasone (cortisone preparation)
  • cardiac glycosides (for the treatment of heart problems)
  • quinidine (for the treatment of heart rhythm problems)
  • ergot alkaloids (for the treatment of migraines )
  • oxytocin (to initiate labor)
  • anesthetics (anesthetics) such as cyclopropane or halothane

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.

Pregnancy

No adverse effects in the fetus have been shown, but normal caution applies especially during the first 3 months of pregnancy.

Breast-feeding

Bromhexine is likely to pass into breast milk and should therefore be avoided during breast-feeding. Therefore, you should not use Etrilect while breast-feeding.

Driving and using machines

During treatment with Etrilect, dizziness may occur. This should be taken into account when sharpened attention is required, for example when driving a car.

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.

Etrilect contains ethanol and sodium

Etrilect contains ethanol

This medicine contains 30.26 mg alcohol ( ethanol ) per ml.

The amount in 5 ml of this medicine corresponds to less than 4 ml of beer or 2 ml of wine. 

The low amount of alcohol in this medicine does not produce any noticeable effects.

Etrilect contains sodium

This medicine contains less than 1 mmol (23 mg) sodium per ml, ie essentially ‘sodium-free’.

3. How to use Etrilect

Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

The recommended dose is:

Adults and children over 15 years: 15 ml 3-4 times a day.
Children 11-14 years: 10-15 ml 3 times a day.
Children 6-10 years: 10 ml 3 times a day.
Children 2-5 years: 5 ml 3 times a day.
Children from 6 months: 2.5 ml 3 times a day.

If you use more Etrilect than you should 

If you have ingested too much medicine or if e.g. If a child has inadvertently ingested the medicine, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.

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.

If you experience any of the following serious side effects, stop using the medicine immediately and contact a doctor:

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

  • Spasm of the musculoskeletal system, which may cause difficulty breathing ( bronchospasm ).

Has been reported (occurs in an unknown number of users):

  • Severe allergic reactions including anaphylactic shock and angioedema with symptoms such as rapidly increasing swelling of the face, tongue, and throat; difficulty swallowing; hives and itching, dizziness, and difficulty breathing.
  • Severe skin reactions with symptoms such as:
    • circular, irregular, red spots on the skin of the hands and arms (erythema multiforme),
    • skin rash, usually in the form of blisters or sores in the oral cavity and eyes and other mucous membranes such as e.g. in the genitals ( Stevens-Johnson syndrome ),
    • severe, extensive skin damage with separation of the skin from superficial mucous membranes ( toxic epidermal necrolysis ),
    • skin rash with blisters and fever ( acute generalized exanthematous pustulosis).

Other side effects that may occur are:

Common (may affect up to 1 in 10 people):

  • Dizziness
  • Headache
  • Palpitation
  • Tremors
  • Concern
  • Rash
  • Hives
  • Difficulty urinating

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

  • Nausea
  • Diarrhea
  • Vomiting
  • Insomnia

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

  • Hallucinations
  • Confusion
  • Aggressiveness
  • Transient increase in certain liver values
  • Dry mouth
  • Hypersensitivity s

Has been reported (occurs in an unknown number of users):

  • Decreased appetite

5. How to store Etrilect

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

Sensitive to light. Store in the original package.

Do not store above 25 ° C.

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 bromhexine hydrochloride and ephedrine hydrochloride.
  • 1 ml of Etrilect contains 0.533 mg of bromhexine hydrochloride and 1.0 mg of ephedrine hydrochloride.
  • The other ingredients are glycerol, polysorbate 20, citric acid monohydrate, ethanol (96%), levomenthol, peppermint flavor, blood orange flavor, sodium hydroxide (E524), purified water.

What the medicine looks like and the contents of the pack

Etrilect is a clear, colorless to light yellow solution.

Etrilect is supplied in amber-colored glass bottles with child-resistant plastic caps, and in amber-colored glass bottles with safety-sealed plastic caps and pouring rings.

Each package contains a dosing cup (made of plastic).

Pack sizes:

300 ml, 500 ml oral solution.

Not all pack sizes may be marketed.

Muhammad Nadeem

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