Caredin 2.5mg, 5mg Orodispersible Desloratadine Tablets
1. What Caredin Is And What It Is Used For
What Caredin is
Caredin contains desloratadine which is an antihistamine.
How Caredin works
Caredin 5 mg is an anti-allergic drug that does not make you drowsy. It helps keep your allergic reactions and their symptoms under control.
When to use Caredin
Caredin English relieves the symptoms of allergic rhinitis ( inflammation of the nasal mucosa caused by allergies, such as hay fever or allergies to dust mites) in adults, adolescents, and children 6 years and older. These symptoms include sneezing, runny or itchy nose, palate itching and itchy, red, or watery eyes.
Caredin is also used to relieve symptoms associated with urticaria (a skin condition caused by allergies ). These symptoms include itching and hives.
Relieving these symptoms lasts all day and helps you maintain normal daily activities and normal sleep.
Desloratadine contained in Caredin may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions and always follow their instructions.
2. What You Need To Know Before You Use Caredin
Do Not Use Caredin
- If you are allergic to desloratadine or any of the other ingredients of this medicine (listed in section 6) or to loratadine.
Warnings And Cautions
Talk to your doctor, pharmacist, or nurse before taking Caredin:
- If you have impaired kidney function
- If you or someone in your family has had seizures.
Children And Young People
Do not give this medicine to children under 6 years of age.
Other Medicines And Caredin
There are no known interactions between Caredin and other medicines.
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Caredin With Food, Drink, And Alcohol
Caredin does not need to be taken with water or liquid. In addition, Caredin can be taken with or without food. Be careful if you take Caredin with alcohol.
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.
Taking Caredin is not recommended if you are pregnant or breast-feeding.
Fertility
There are no fertility data for men or women
Driving And Using Machines
At the recommended dose, this medicine is not expected to affect your ability to drive or use machines. Although most people do not feel drowsy, it is recommended that you do not perform activities that require increased attention, such as driving a vehicle or using machinery until you know how you react to the medicine.
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
Caredin Contains Aspartame
The product contains aspartame. Aspartame is a source of phenylalanine that can be harmful to people with phenylketonuria.
3. How To Use Caredin
Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
Adults and adolescents 12 years and older
The recommended dose is two tablets once daily with or without food.
This medicine should be taken orally.
Open the blister before ingestion by gently pulling on the tab and taking out the orodispersible tablet without crushing it. Place it in your mouth where it dissolves immediately. Water or other liquid is not needed to swallow the tablet. Take the tablet immediately after opening the blister.
Caredin Uses For Children And Adolescents
Children from 6 to 11 years
The recommended dose is one tablet once a day with or without food.
Regarding the duration of treatment, your doctor will determine the type of allergic rhinitis you are suffering from and decide how long to take Caredin. If your allergic rhinitis is recurrent (presence of symptoms for less than 4 days a week or for less than 4 weeks), your doctor will recommend a treatment schedule based on the assessment of your medical history.
If your allergic rhinitis is persistent (presence of symptoms for 4 days or more per week and for more than 4 weeks) then your doctor may recommend a longer-term treatment.
In urticaria, the duration of treatment may vary from patient to patient and you should therefore follow your doctor’s prescription
If You Forget To Use Caredin English
If you forget to take your dose on time, take it as soon as possible and then go back to your regular dosing schedule. Do not take a double dose to make up for a forgotten dose.
If You Stop Using Caredin
If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.
4. Possible Caredin Side Effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
During the marketing of desloratadine, cases of severe allergic reactions
- Difficulty breathing
- Wheezing
- Itching
- Hives
- Swelling
Have been reported in very rare cases. If you have any of these serious side effects is, stop taking the drug and seek immediate emergency medical attention.
In clinical trials in adults, the side effects were about the same as with an inactive tablet. However, fatigue, dry mouth, and headache were reported more often than with an inactive tablet. In adolescents, headache was the most commonly reported side effect.
In clinical trials with desloratadine the following adverse reactions have been reported:
Common (may affect up to 1 in 10 people):
- Fatigue
- Dry mouth
- Headache
Adults
During the marketing of desloratadine the following side effects have been reported:
Very rare (may affect up to 1 in 10,000 people):
| Severe allergic reactions | Rash | Throbbing or irregular heartbeat |
| Fast heartbeat | Stomach ache | Nausea |
| Vomiting | Upset stomach | Diarrhea |
| Dizziness | Drowsiness | Difficulty sleeping |
| Muscle pain | Hallucinations | Seizures |
| Restlessness with increased body movement | Hepatitis | Abnormal liver function tests |
Has been reported (occurs in an unknown number of users):
- Unusual weakness
- Yellowing of the skin and/or eyes
- Increased sensitivity of the skin to sunlight, even in sunlight and to UV light, for example for UV light in solarium
- Change in how the heartbeats
- Deviant behavior
- Aggression
- Weight gain
- Increased appetite
Additional Caredin Side Effects In Children And Adolescents
Has been reported (occurs in an unknown number of users):
- Slow heartbeat
- Change in how the heartbeats
- Deviant behavior
- Aggression
Reporting of side effects ar
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. You can also report side effectsdirectly (see details below). By reporting side effects , you can help increase drug safety information.
The Medical Products Agency
Box 26
751 03 Uppsala
www.lakemedelsverket.se
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 Caredin
- 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 blister after EXP. The expiration date is the last day of the specified month.
- No special storage instructions.
Do not use this medicine if you notice any changes in the appearance of Caredin orodispersible tablets.
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 desloratadine 2.5 mg.
- The other ingredients are
- Polyacrylic potassium
- Citric acid monohydrate
- Red iron oxide (E172), magnesium stearate
- Croscarmellose sodium
- Tutti-frutti flavoring (also contains propylene glycol)
- Aspartame (E951)
- Microcrystalline cellulose
- Mannitol
- Potassium hydroxide (pH)
What The Medicine Looks Like And Contents Of The Pack
- Caredin 2.5 mg orodispersible tablets are brick red, round, flat tablets with beveled edges, debossed with “2.5”.
- Blister packs of 10, 30, 50, 90, and 100 orodispersible tablets.
- Not all pack sizes may be marketed.
Marketing Authorization Holder And Manufacturer
Marketing Authorisation Holder
2care4 Generics ApS
Stenhuggervej 12-14
6710 Esbjerg V
Denmark
Manufacturer
Genepharm SA
18th km Marathonos Avenue
15351 Pallini Attiki
Greece