1.5 mg/ml mouthwash 
benzydamine 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, pharmacist, or nurse.
  • 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 Andolex is and what it is used for 
2. What you need to know before using Andolex 
3. How to use Andolex 
4. Possible side effects 
5. How to store Andolex 
6. Contents of the packaging and other information 

1. What Andolex is and what it is used for

Andolex is a topical painkiller that works by stabilizing cell membranes and inhibiting the formation of prostaglandins (substances that can amplify pain signals in the body).

Andolex is a mouthwash used for short-term treatment of local pain conditions in the mouth and throat.

2. What you need to know before using Andolex

Do not use Andolex

– if you are allergic to benzydamine 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 taking Andolex.

– if you have or have had asthma  
– if you are allergic to acetylsalicylic acid or other anti-inflammatory painkillers ( NSAIDs ).

Avoid contact with eyes.

Children and young people

Andolex should not be used by children under 12 years of age.

Other medicines and Andolex

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This also applies to over-the-counter medicines and herbal 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.

Driving and using machines

Andolex contains alcohol. Uptake into the body when rinsing the mouth is expected to be minimal, but caution is recommended when driving and using 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.

Andolex contains methyl parahydroxybenzoate, ethanol, and sodium.

Andolex contains methyl parahydroxybenzoate which may cause an allergic reaction(possibly delayed

This medicine contains 1126 mg of alcohol ( ethanol ) per dose (15 ml). The amount in 15 ml of this medicine corresponds to less than 30 ml of beer, or 12 ml of wine. Andolex should not be swallowed so the amount of alcohol that enters the bloodstream is very small and gives no noticeable effects.

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

This medicine has a mint flavor that contains benzyl alcohol, cinnamyl alcohol, citral, citronellol, eugenol, geraniol, isoeugenol, limonene, and linalool. These substances can cause allergic reactions.

3. How to use Andolex

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

Adults and children over 12 years: 15 ml for about 30 seconds every 1.5-3 hours according to regulations. Rinse mouth or gargle; the solution should not be swallowed but spit out.

As with other non-chronic pain conditions, treatment longer than one week should be avoided unless the cause of the pain is known and the treating physician has prescribed it for a longer period of time.

Use for children and adolescents

Andolex should not be given to children under 12 years of age.

If you forget to use Andolex

Do not take a double dose to make up for a forgotten dose.

4. Possible side effects

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

Stop using Andolex and contact a doctor immediately or go to the nearest emergency department if you experience the following symptoms ( angioedema ):

Swelling of the face, tongue, or throat; difficulty swallowing; hives and difficulty breathing

This side effect has been reported and occurs in an unknown number of users.

Other side effects that may occur:

Common (may affect up to 1 in 10 people): Tingling and numbness in the mouth.

Rare (may affect up to 1 in 1,000 people ): photosensitivity (rash or sun damage), hives, skin rash, itching.

Very rare (may affect up to 1 in 10,000 people): Cramps in the throat and trachea.

Has been reported (occurs in an unknown number of users):  Allergic reaction (hypersensitivity). Severe allergic reaction (anaphylactic shock ), with signs such as difficulty breathing, chest pain or feeling of tightness in the chest and/or feeling dizzy/fainting, severe itching or increased rash on the skin, swelling of the face, lips, tongue, and/or throat. This can be life-threatening.

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 Andolex

Store in the outer carton. Sensitive to light.


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 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 substance is benzydamine hydrochloride 1.5 mg/ml.
  • The other ingredients are ethanol, glycerol, methyl parahydroxybenzoate (E 218), saccharin, sodium bicarbonate, polysorbate, dyes (quinoline yellow E 104, patent blue E 131), mint aroma (52503T, contains benzyl alcohol), and purified water.

What the medicine looks like and the contents of the pack

Glass bottle 300 ml with dosing cup (mark at 15 ml and 30 ml).

Marketing Authorization Holder and Manufacturer

Meda AB

Box 906

170 09 Solna

Tel: 08-630 19 00

Email: info@medasverige.se

Manufacturer

Aziende Chimiche Riunite Angelini Francesco 
ACRAFSpA

Via Vecchia del Pinocchio, 22

60131 ANCONA

Italy

Muhammad Nadeem

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