0.5 mg / ml + 1 mg / ml oral solution
bromhexine hydrochloride and ephedrine hydrochloride
1. What Coldypect is and what it is used for
Codepect contains bromhexine and ephedrine. Bromhexine is considered to make the mucus in the airways thinner. It can facilitate the expectoration of mucus. Ephedrine dilates the trachea and has a decongestant effect on the mucous membranes.
Codepect is used for coughs with viscous mucus and at the same time needs a tracheal dilating effect.
Bromhexine and ephedrine contained in Coldypect 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 Codepect
Do not use Codepect
- 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, pharmacist, or nurse before using Coldypect if you:
- previously had heart disease, irregular heartbeat, or angina
- have a cardiovascular disease
- have high blood pressure
- has high levels of thyroid hormone in the blood ( hyperthyroidism )
- has enlarged prostate
- has glaucoma
- have diabetes
- have stomach ulcers.
If you have a bloody cough, consult a doctor.
As dry mouth occurs, careful oral hygiene (brushing with fluoride toothpaste twice a day) while using Codepect is 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 Coldypect and contact a doctor immediately.
At high doses and long-term use, there is a certain risk of developing an addiction.
Other medicines and Codepect
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 Coldypect, for example:
- MAO inhibitors (antidepressants)
- medicines for high blood pressure
- dexamethasone (cortisone preparation).
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.
No adverse effects in the fetus have been shown, but normal caution applies especially during the first 3 months of pregnancy.
Bromhexine is likely to pass into breast milk and should therefore be avoided during breast-feeding.
Driving and using machines
During treatment with Coldypect, 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.
Codepect contains ethanol
This medicine contains 3.8% by volume of ethanol (alcohol), ie up to 450 mg per dose, equivalent to 11.4 ml of beer or 4.8 ml of wine. Harmful to people suffering from alcoholism. Attention should be paid to pregnant or lactating women, children, and high-risk groups such as patients with liver disease or epilepsy.
3. How to use Codepect
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: Show larger
| Adults and children over 15 years: Children 11-14 years: Children 6-10 years: Children 2-5 years: Children from 6 months | 15 ml 3-4 times a day10-15 ml 3 times a day10 ml 3 times a day5 ml 3 times a day2.5 ml 3 times a day |
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.
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, palpitations, tremors, and anxiety.
- Hives and rash.
- Difficulty urinating.
Uncommon (may affect up to 1 in 100 people):
- Nausea, diarrhea, vomiting, and insomnia.
Rare (may affect up to 1 in 1,000 people):
- Hallucinations, confusion, aggression, transient increase in certain liver values.
- Dry mouth.
- Hypersensitivity reaction.
Has been reported (occurs in an unknown number of users):
- Decreased appetite.
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 Codepect
Keep this medicine out of the sight and reach of children.
No special storage instructions.
Keep the bottle upright to prevent leakage.
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 substances are bromhexine hydrochloride 0.533 mg and ephedrine hydrochloride 1 mg.
- The other ingredients are polysorbate 20, glycerol, ethanol (total alcohol content 3%), citric acid monohydrate, sodium hydroxide (for pH adjustment), peppermint blood orange flavor, and water.
What the medicine looks like and the contents of the pack
A clear, colorless solution.
Amber-colored glass bottle with child-resistant plastic screw cap: 300 and 500 ml. A 20 ml plastic dosing cup is attached to the bottle.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Orifarm Generics A / S
Energizer 15
5260 Odense S
Denmark
Local representative:
Orifarm Generics AB,
Box 56048
102 17 Stockholm
info@orifarm.com