Dehrin 2,5 mg/5 ml Solution

DEHRIN SOLUTION is an antihistamine that reduces the natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose. DEHRIN SOLUTION is used to treat these symptoms of allergies.

Do not take DEHRIN SOLUTION, or give it to your child, if she/he/you are:

• allergic to desloratadine, loratadine, other antihistamines, or any of the ingredients of DEHRIN SOLUTION (see section 6 “What DEHRIN contains”);
• pregnant, trying to become pregnant or breastfeeding.

Do not use DEHRIN SOLUTION in children under the age of two years, as safety and efficacy have not been established in children in this age group.

Warnings and precautions

Take special care with DEHRIN SOLUTION: The presence of other medical problems may affect the use of DEHRIN SOLUTION. Talk to your doctor, pharmacist or health care provider before you or your child take DEHRIN SOLUTION, if he/she/you:

• have a kidney or liver problem;
• are an elderly patient;
• have epilepsy (seizures or convulsions).

DEHRIN SOLUTION may increase appetite and lead to weight gain (see POSSIBLE SIDE EFFECTS.) You should monitor your child’s weight and talk to your doctor if the weight gain becomes marked.

Do not share medicines prescribed for you or your child with any other person. Always take DEHRIN SOLUTION, or give it to your child, exactly as your doctor, your child’s doctor or pharmacist has told you. Check with your doctor or your child’s doctor or your pharmacist if you are unsure.

Your or your child’s doctor will tell you how long your/his/her treatment with DEHRIN SOLUTION will last. Safety and efficacy have not been confirmed for more than 4 weeks of treatment.

If you have the impression that DEHRIN SOLUTION is too strong or too weak, you should talk to your or your child’s doctor or pharmacist.

Children 2 to 5 years old

2,5 ml (half of a 5 ml medicine spoonful) once daily with or without food.

Children 6 to 11 years old

5 ml (one 5 ml medicine spoonful) once daily with or without food.

Adults and children 12 years of age and older

10 ml (two 5 ml medicine spoonfuls) once daily with or without food.

If an oral measuring syringe is provided with the bottle of DEHRIN SOLUTION, you can use it to take or give the appropriate amount of oral solution.

If you take more DEHRIN SOLUTION than you should, or if you give your child more DEHRIN SOLUTION than you should In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control centre. Take this leaflet and any remaining medicine with you, so that the doctor knows what you have taken. Overdose symptoms may include fast heart rate and sleepiness. You may experience an increase in side effects and their frequency.

If you forget to take DEHRIN SOLUTION, or if you forget to give it to your child If you or your child miss a dose of DEHRIN SOLUTION, take or give it as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and go back to the regular dosing schedule. Do not take a double dose or give a double dose to your child to make up for forgotten individual doses.

If you stop taking DEHRIN SOLUTION Should you wish to stop treatment early, ask your doctor, pharmacist of nurse for advice.

DEHRIN SOLUTION can have side effects. Not all side effects reported for DEHRIN SOLUTION are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking DEHRIN SOLUTION, please consult your health care provider for advice.

If any of the following happens to you or your child, stop taking DEHRIN SOLUTION, or stop giving it to your child. Tell your doctor/your child’s doctor immediately, or go to the casualty department at your nearest hospital:

Severe allergic reactions (anaphylaxis, angioedema):

• Hives; itchy rash, difficulty breathing; swelling of your/his/her face, lips, tongue, or throat, trouble swallowing or breathing (dyspnoea).

These are all very serious side effects. If you or your child have them, you may have had a serious reaction to DEHRIN SOLUTION. You or your child may need urgent medical attention or hospitalisation.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• A fast, pounding, or uneven heartbeat, or a slow heartbeat;
• Yellow eyes and skin, nausea and abdominal pain (these could be signs of jaundice or hepatitis).

These are all serious side effects. You/your child may need urgent medical attention.

Tell your doctor if you notice any of the following:

Frequent side effects

• Headache
• Fatigue (tiredness)
• Dry mouth
• Sore throat

Frequent side effects in children :

• Diarrhoea
• Fever
• Insomnia (sleeping problems)

Less frequent side effects

• Muscle pain, joint pain, swollen joints, muscle aching, cramping or stiffness, difficulty in moving
• Drowsiness, sleepiness, sleeplessness
• Nausea, diarrhoea, stomach pain, vomiting, heartburn
• Dizziness, blurred vision
• Low blood pressure
• Urticaria (hives or welts, itching, redness of skin, skin rash)
• Painful menstruation
• Hallucinations (seeing and hearing things that do not exist)
• Hyperactivity, seizures (“fits”)

Unknown frequency

• Asthenia (abnormal physical weakness or lack of energy)
• Swelling
• Sweating
• Increased sensitivity of the skin to the sun, even in case of hazy sun, and to UV light, for instance to UV lights of a solarium
• Changes in the way the heart beats
• Shortness of breath and/or a tightness in the chest
• Abnormal behaviour
• Aggression
• Increased appetite, weight increased (see “Take special care with DEHRIN SOLUTION”)

Unknown frequency in Children

• Slow heartbeat
• Change in the way the heart beats
• Abnormal behaviour
• Aggression

If you notice any side effects not mentioned in this leaflet, please inform your or your child’s doctor, or your pharmacist.

Reporting of side effects

If you get side effects, talk to your doctor, pharmacist or nurse. You can also report side effects to SAHPRA via the Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who-umc.org) found on the SAHPRA website. By reporting side effects, you can help provide more information on the safety of DEHRIN SOLUTION.

Store all medicines out of reach of children. Store in the original packaging at or below 25 °C. Keep bottle in carton until required for use. Keep the bottle tightly closed. Use within 4 months from first opening. Do not store your medicine in the bathroom. Do not use DEHRIN SOLUTION after the expiry date printed on the label or carton.

Return any expired or unused medicine to your pharmacist for safe disposal. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).