DEMILTIX is an antihistamine that provides relief of seasonal hay fever.
1. WHAT DEMILTIX IS AND WHAT IT IS USED FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DEMILTIX
Do not use DEMILTIX
- If you are hypersensitive (allergic) to Desloratadine or any of the other ingredients of DEMILTIX (listed in section 6).
- If you are pregnant
- If you are breastfeeding
- If you have porphyria
Warnings and precautions
Take special care with DEMILTIX:
- 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 DEMILTIX
- Efficacy and safety of DEMILTIX in children under 2 years of age has not been established.
- Safety and efficacy of DEMILTIX has not been established for both treatment periods in excess of 4 weeks.
- Weight gain has been reported with the use of desloratadine.
- DEMILTIX should be discontinued 48 hours before skin allergen tests are performed as it may affect the results
- DEMILTIX 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 DEMILTIX. DEMILTIX should not be used during pregnancy and breastfeeding.
Driving and using machinery
DEMILTIX 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 DEMILTIX
DEMILTIX contains sorbitol and maltitol. If you have been told that you have an intolerance to some sugars, you should not take DEMILTIX.
Other medicines and DEMILTIX:
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 DEMILTIX, 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
3. HOW TO TAKE DEMILTIX
Always take DEMILTIX 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 DEMILTIX on alternate days initially.
If you use more DEMILTIX 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 DEMILTIX is symptomatic (relating to symptoms) and supportive.
If you forget to take DEMILTIX
Do not take a double dose to make up for forgotten individual doses.
4. POSSIBLE SIDE EFFECTS
DEMILTIX can have side effects. Not all side effects reported for DEMILTIX are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking DEMILTIX, please consult your healthcare professional for advice.
The following side effects may be experienced while taking DEMILTIX:
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 DEMILTIX. May also report to Adcock Ingram Limited using the following email: [email protected]
5. HOW TO STORE DEMILTIX
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).