2.5 mg orodispersible tablets 
Desloratadine

Read all of this leaflet carefully before you start taking 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 may harm them, even if they show symptoms 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.

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

1. What Caredin is and what it is used for

What Caredin is

Caredin contains desloratadine which is an antihistamine.

How Caredin  works

Caredin 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 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.

Use 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

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 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, and 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, fatiguedry 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 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, and 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

Muhammad Nadeem

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