Deslomed 2,5 mg Syrup

DESLOMED SYRUP is an antihistamine that provides relief of seasonal hay fever.

Do not use DESLOMED SYRUP

• If you are hypersensitive (allergic) to Desloratadine or any of the other ingredients of DESLOMED SYRUP (listed in section 6).
• If you are pregnant
• If you are breastfeeding
• If you have porphyria

Warnings and precautions

Take special care with DESLOMED SYRUP:

• Tell your doctor if you suffer from liver or kidney disease.
• Tell your doctor if you have ever had any unusual or allergic reaction to DESLOMED SYRUP
• Efficacy and safety of DESLOMED SYRUP in children under 2 years of age has not been established.
• Safety and efficacy of DESLOMED SYRUP has not been established for both treatment periods in excess of 4 weeks.
• Weight gain has been reported with the use of desloratadine.
• DESLOMED SYRUP should be discontinued 48 hours before skin allergen tests are performed as it may affect the results
• DESLOMED SYRUP contains sodium benzoate which may increase jaundice (yellowing of the skin and eyes) in newborn babies (up to 4 weeks old).

Pregnancy, breastfeeding and fertility:

If you are pregnant or breastfeeding your baby, please consult your doctor, pharmacist or other healthcare professional for advice before taking DESLOMED SYRUP. DESLOMED SYRUP should not be used during pregnancy and breastfeeding.

Driving and using machinery

DESLOMED SYRUP lacks significant sedative effects. However, a small number of individuals may experience sedation. It is therefore advisable to determine individual patients’ responses before driving or performing complicated tasks.

Important information about some of the ingredients of DESLOMED SYRUP

DESLOMED SYRUP contains sorbitol and maltitol. If you have been told that you have an intolerance to some sugars, you should not take DESLOMED SYRUP.

Other medicines and DESLOMED SYRUP:

Always tell your health care provider if you are taking any other medicine. (This includes all complementary or traditional medicines.) Tell your doctor if you are taking any other medicines before you start treatment with DESLOMED SYRUP, especially if you are taking medicines containing the following active substances:

• Ketoconazole
• Erythromycin

Tell your doctor if you are being treated for any of the following medical conditions:

• Emphysema
• Enlarged prostate
• Narrow angle glaucoma
• Heart conditions
• Epilepsy
• Acute asthma attacks

Always take DESLOMED SYRUP exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. It is important not to take more or less medication than the amount prescribed.

Do not share medicines prescribed for you with any other person.

The usual dose is as follows:

• Children 2 to 5 years of age: 2,5 ml (1,25 mg) once a day, with or without food.
• Children 6 to 11 years of age: 5 ml (2,5 mg) once a day, with or without food.
• Adults and adolescents (12 years of age and over): 10 ml (5 mg) once a day, with or without food.
• Patients with hepatic or renal impairment should be given 5 mg DESLOMED SYRUP on alternate days initially.

If you use more DESLOMED SYRUP than you should

In the event of overdosage, consult your doctor or pharmacist. If neither is available, seek help at the nearest hospital or poison control centre. Treatment: Treatment of an overdose with DESLOMED SYRUP is symptomatic (relating to symptoms) and supportive.

If you forget to take DESLOMED SYRUP

Do not take a double dose to make up for forgotten individual doses.

DESLOMED SYRUP can have side effects. Not all side effects reported for DESLOMED SYRUP are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking DESLOMED SYRUP, please consult your healthcare professional for advice.

The following side effects may be experienced while taking DESLOMED SYRUP:

Cardiac disorders:

Increased heart rate, palpitations.

Gastrointestinal disorders:

Dry mouth, indigestion, nausea.

General disorders and administration site conditions:

Fatigue, sudden severe allergic response, swelling.

Investigations:

Increase in liver enzymes and bilirubin have been reported.

Metabolism and nutritional disorders:

Increased appetite

Musculoskeletal and connective tissue disorders:

Muscle pain.

Nervous system disorders:

Drowsiness, headache, dizziness, fatigue, sedation, nervousness, blurred vision, confusion and nightmares.

Reproductive system and breast disorders:

Painful menstruation.

Respiratory, thoracic and mediastinal disorders:

Sore throat, difficulty in breathing.

Skin and subcutaneous tissue disorders:

Itching, rash, itchy rash, baldness.

Reporting of side effects: If you get side effects, talk to your doctor or pharmacist. You can also report side effects to SAHPRA via the Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who-umc.org) found on SAHPRA website. By reporting side effects, you can help provide more information on the safety of DESLOMED SYRUP. May also report to Adcock Ingram Limited using the following email: [email protected]

Store all medicines out of reach of children.

Store at or below 25 ºC in a tightly closed container.

Do not use after the expiry date stated on the label/carton.

Return all unused medicine to your pharmacist.

Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).