1.5 mg/ml oral spray, solution 
benzydamine hydrochloride

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 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 within 3 days.

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

1. What Coldamin is and what it is used for

Coldamin is used for the short-term treatment of pain and irritation in the oral cavity and throat of adults and children over 6 years.

Coldamin works by relieving pain and swelling ( inflammation ).

Benzydamine hydrochloride contained in Coldamin may also be approved for the treatment of other conditions not mentioned in this leaflet. 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 3 days.

2. What you need to know before using Coldamin

Do not use Coldamin

  • 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 using Coldamin if you have or have had any of the following conditions:

  • Asthma (inflamed airways).
  • Hypersensitivity to acetylsalicylic acid or to other NSAIDs (to pain and inflammation ). In these, it is recommended not to use drugs that contain benzydamine hydrochloride.
  • If your symptoms do not improve or if the symptoms worsen within 3 days.
  • If you get a fever or other symptoms, you should contact a doctor or possibly a dentist.
  • Alcoholism.
  • Liver disease.
  • Epilepsy.

Other drugs and Coldamin

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. No effects on concomitant use of other drugs have been identified.

Pregnancy and breastfeeding

Coldamin should not be used during pregnancy and lactation.

Driving and using machines

Coldamin does not affect the ability to drive or use machines.

Coldamin contains methyl parahydroxybenzoate (E218) and ethanol 96%

Coldamin contains methyl parahydroxybenzoate (E218) 1 mg/ml, which may cause an allergic reaction (possibly delayed).

3. How to use Coldamin

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.

The recommended dose is: 

Adults and adolescents (over 12 years): 4 to 8 puffs every 1-3 hours.

Children (6-12 years): 4 puffs every 1-3 hours.

Recommended treatment time is 5-7 days.

Use in children under 6 years

Do not use Coldamin in children under 6 years of age.

How to use the spray:

  1. Hold the bottle in an upright position.
  2. Remove the protective sleeve.
  3. You must activate the spray the first time you use it (max. 5 puffs). Aim the spray pipe away from the face. Press down firmly until a fine spray comes out.
  4. Aim the spray pipe at the back of the oral cavity or at the pharynx and press down. A pressure corresponds to a puff/dose.
  5. Wipe the spray pipe with a napkin after spraying the desired number of puffs, this prevents the spray pipe from stopping.
  6. Replace the protective sleeve after use, it prevents puffs from being accidentally sprayed.

Do not push anything into the end of the spray pipe if there is a blockage in the spray pipe. Return the spray to the pharmacy.

If you use more Coldamin than you should  

If you have any further questions, ask your doctor or pharmacist.

If you forget to take Coldamin

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.

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

  • Numbness and a stinging sensation in the mouth. It has been noted that the stinging sensation disappears with continued treatment, but if it persists, it is recommended to discontinue treatment.
  • Abnormally high sensitivity to sunlight ( photosensitivity ).

Very rare (may affect up to 1 in 10,000 people):

  • 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 – contact a doctor or emergency room immediately.
  • Sore throat with difficulty breathing – contact a doctor or emergency department immediately.

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

  • Anaphylactic reaction (hypersensitivity)

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 Coldamin

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

Store in a cold place. Do not freeze.

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 sodium bicarbonate, polysorbate 20, ethanol 96%, glycerol, saccharin sodium, methyl parahydroxybenzoate (E 218), peppermint oil, and purified water.

What the medicine looks like and the contents of the pack

Coldamin is an oral spray. It is a clear, colorless solution in an amber glass bottle with a dosing pump. A measured amount of the solution is sprayed each time Coldamin is used. One bottle contains 30 ml of solution and is delivered in an outer package.

Marketing Authorization Holder and Manufacturer

Orifarm Generics A / S

Energivej 15

5260 Odense S

Denmark

Local representative

Orifarm Generics AB

Box 56048

102 17 Stockholm

info@orifarm.com

Muhammad Nadeem

Leave a Reply