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Package leaflet

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 125-milliliter bottle (Over-the-counter) 

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Leaflet: Information for the user

Bisolvon Strawberry

0.8 mg / ml oral solution 
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 you will find information about: 
1. What Bisolvon Strawberry is and what it is used for 
2. What you need to know before you use Bisolvon Strawberry 
3. How to use Bisolvon Strawberry 
4. Possible side effects 
5. How to store Bisolvon Strawberry 
6. Contents of the pack and other information 

1. What Bisolvon Strawberry is and what it is used for

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

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 Bisolvon Strawberry

Do not use Bisolvon Strawberry

  • 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 or pharmacist before using Bisolvon Strawberry:

  • If you have stomach ulcers or bloody coughs.

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

Other medicines and Bisolvon Strawberry

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

Bisolvon Strawberry with food and drink

Bisolvon Strawberry can be taken with or without food.

Pregnancy and breastfeeding

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, Bisolvon Strawberry should only be used during pregnancy if necessary. This is especially true during the first three months of pregnancy.

Bromhexine passes into breast milk and Bisolvon Strawberry 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 increased vigilance. 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.

Bisolvon Strawberry contains maltitol

Bisolvon Strawberry contains liquid maltitol. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine. If you take more than 20 ml per day, Bisolvon Strawberry can have a mild laxative effect. Caloric value 2.3 kcal / g.

3. How to use Bisolvon Strawberry

The recommended dose for adults and children over 12 years: 10 ml 3 times daily.

The recommended dose for children 6-12 years: 2.5-5 ml 3 times daily.

The recommended dose for children 1-5 years: 2.5 ml 3 times daily.

Ask your doctor or pharmacist if you are unsure.

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

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.

Stop taking Bisolvon Strawberry and contact a doctor immediately if you get any of the following symptoms:

  • swelling of the face, tongue, or throat, difficulty swallowing, hives, difficulty breathing, or itching. This may be a sign of anaphylactic reactions including anaphylactic shock, angioedema
  • skin rash (including ulcers in the mucous membranes of eg mouth, throat, nose, eyes, or genitals). These may be signs of severe skin reactions (including erythema multiforme, Stevens-Johnson syndrome / toxic epidermal necrolysis, and acute generalized exanthematous pustulosis )
  • respiratory distress. It can be caused by a sharp contraction of the trachea ( bronchospasm )

The above side effects have been reported (may occur in an unknown number of users).

Other side effects that may occur:

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

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

Itching

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 Bisolvon Strawberry

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

The opened bottle is durable for 12 months. The opened bottle should not be stored above 25 ° C.

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 0.8 mg/ml.
  • The other ingredients are purified water, liquid maltitol, sucralose, benzoic acid ( preservative E 210), hydroxyethylcellulose, and flavorings (strawberry and cherry).

What the medicine looks like and the contents of the pack

Bisolvon Strawberry oral solution is colorless.

Brown glass bottles with sealed plastic caps: 60 ml, 100 ml, 125 ml, and 250 ml.

A dosing measurement graded for 1.25 ml, 2.5 ml, and 5 ml is included in all packages.

Not all packaging may be marketed.

Marketing Authorization Holder and Manufacturer

Sanofi AB

Box 30052

104 25 Stockholm

Manufacturer:

Delpharm Reims

10 Rue Colonel Charbonneaux

51100 Reims

France

Muhammad Nadeem

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