Coldamin 1.5 mg/ml Oral Spray, Benzydamine Hydrochloride Solution
1. What Coldamin is and what coldamin used for?
Coldamin treats pain and irritation in the oral cavity and throat of adults and children over 6 years. This medicine works by relieving pain and swelling ( inflammation ). Benzydamine hydrochloride contained in Coldamin spray may also be approved for treating conditions not mentioned in this leaflet.
Ask your doctor, pharmacist, or healthcare professional for further questions, and always follow their instructions. You must talk to a doctor if you do not feel better or 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 spray if you have or have had any of the following conditions:
- Asthma (inflamed airways)
- Hypersensitivity to acetylsalicylic acid or 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 worsen within 3 days
- You should contact a doctor or dentist if you get a fever or other symptoms
- Alcoholism
- Liver disease
- Epilepsy
Other Drugs And Coldamin:
Tell your doctor or pharmacist if you are taking, have recently taken, or might take 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 of 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 as described in this leaflet or as directed by your doctor, pharmacist, or nurse. If unsure, 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?
- Hold the bottle in an upright position.
- Remove the protective sleeve.
- You must activate the spray the first time (max. 5 puffs). Aim the spray pipe away from the face. Press down firmly until a fine spray comes out.
- Aim the spray pipe at the back of the oral cavity or the pharynx and press down. A pressure corresponds to a puff/dose.
- Wipe the spray pipe with a napkin after spraying the desired number of puffs, preventing the spray pipe from stopping.
- 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.
Ask your doctor, pharmacist, or nurse if you have any further questions about using this product.
4. Possible Coldamin Side Effects:
This medicine can cause side effects like all medicines, although not everybody gets them.
Uncommon benzydamine hydrochloride side effects (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 tightness in the chest and feeling dizzy/fainting, severe itching or increased rash on the skin, swelling of the face, lips, tongue, and 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
Talk to your doctor, pharmacist, or nurse if you get any side effects. 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 sight and reach of children.
- Store in a cold place. Do not freeze.
- Do not use this medicine after the expiry date 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 that are 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 Does The Medicine Look Like And The Contents Of The Pack?
Coldamin is an oral spray. It is a clear, colourless solution with a dosing pump in an amber glass bottle. 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