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SCHEDULING STATUS S2
PROPRIETARY NAME, STRENGTH AND PHARMACEUTICAL FORM
POLLENTYME ND 5 mg film coated tablet
Read all this patient information carefully because it contains important information for you.
POLLENTYME ND is available without a doctor’s prescription, for you to treat a mild illness. Nevertheless you still need to use POLLENTYME ND carefully to get the best results from it.
- Keep this information. You may need to read it again.
- Do not share POLLENTYME ND with any other person.
- Ask your pharmacist if you need more information or advice.
- You must see a doctor if your symptoms worsen or do not improve after 10 days.
WHAT POLLENTYME ND CONTAINS
The active substance is desloratadine.
Each POLLENTYME ND tablet contains 5 mg desloratadine.
The other ingredients are hypromellose, lactose anhydrous, magnesium oxide, microcrystalline cellulose, Opadry blue, pregelatinised starch, zinc stearate.
WHAT POLLENTYME ND IS USED FOR
POLLENTYME ND tablets are used for the relief of seasonal hay fever.
BEFORE YOU TAKE POLLENTYME ND
Do not take POLLENTYME ND:
- If you are hypersensitive (allergic) to desloratadine or any of the ingredients of POLLENTYME ND (see “WHAT POLLENTYME ND CONTAINS”)
- If you are pregnant or breastfeeding (see “Pregnancy and Breastfeeding”)
- If you have a condition called porphyria.
Take special care with POLLENTYME ND:
- If you suffer from a liver or kidney disorder, the dosage you should take may need to be adjusted.
- If you are an elderly patient (as the safety has not been established).
- Safety has not been established in children under the age of 12 years.
- If you have one of the following medical conditions:
- Emphysema (a condition of the lungs)
- Prostatic hypertrophy (enlarged prostate)
- Narrow angle glaucoma (a condition of the eyes)
- Cardiovascular disorder (a heart condition)
POLLENTYME ND may lead to drowsiness and impaired concentration, which may be aggravated by simultaneous intake of alcohol or nervous system depressants (e.g. sedatives and tranquilisers).
You should stop taking POLLENTYME ND at least 48 hours before having skin allergen testing, as POLLENTYME ND may interfere with the results of such testing.
Do not use POLLENTYME ND for more than 4 weeks without consulting your doctor, pharmacist or healthcare provider as the safety and effectiveness of POLLENTYME ND have not been established if treatment continues for more than 4 weeks.
Pregnancy and breastfeeding:
POLLENTYME ND should not be used if you are pregnant or breastfeeding your baby.
If you are pregnant or breastfeeding your baby, please consult your doctor, pharmacist or other healthcare professional for advice before taking this medicine.
Driving and using machinery:
POLLENTYME ND may make you drowsy or impair your ability to drive and use machinery. Take care if you feel dizzy, tired or drowsy while using POLLENTYME ND.
Important information about some of the ingredients of POLLENTYME ND:
POLLENTYME ND contains lactose so if you have hereditary galataose intolerance, the enzyme lactase deficiency (Lapp lactase deficiency) or a malabsorption of glucose-galactose then you should not take this medicine.
Taking other medicines with POLLENTYME ND:
Always tell your healthcare professional if you are taking any other medicine. (This includes complementary or traditional medicines.) Medicines known to influence POLLENTYME ND are certain anti- fungal medicines (such as ketoconazole) and certain antibiotic medicines (such as erythromycin).
HOW TO TAKE POLLENTYME ND
Do not share medicines prescribed for you with any other person. Always take POLLENTYME ND exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure.
The usual dose for adults (over 12 years of age) is one tablet, once daily.
If you take more POLLENTYME ND than you should:
In event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre. Take this leaflet and any remaining tablets with you so that the doctor may know what you have taken.
If you forget to take POLLENTYME ND:
If you forget to take a dose, take it as soon as you remember. Do not take a double or larger dose to make up for the forgotten individual doses. Continue to take the next tablet at the usual time. If you have trouble remembering when to use your medicine, ask your pharmacist for some advice.
POSSIBLE SIDE EFFECTS
POLLENTYME ND can have side effects.
Not all side effects reported for POLLENTYME ND are includes in this leaflet. Should your general health worsen or if you experience any untoward effects while taking this medicine, please consult your doctor, pharmacist or other healthcare professional for advice.
If any of the following happens, stop taking POLLENTYME ND and tell your doctor immediately or go to the casualty department at your nearest hospital:
- Anaphylaxis (cough; difficulty swallowing; dizziness; fast heartbeat; hives; itching; puffiness or swelling of the eyelids, face, lips or tongue; shortness of breath; skin rash; tightness in chest and wheezing)
- Dyspnoea (shortness of breath)
These are all very serious side effects. If you have them, you may have had a serious allergic reaction to POLLENTYME ND. You 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:
- fast, pounding or irregular heartbeat or pulse
These are all serious side effects. You may need urgent medical attention.
Tell your doctor if you notice the following:
- headache, unusual tiredness or weakness, dizziness
- pharyngitis (body aches or pain, congestion, cough, hoarseness, runny nose)
- dry mouth, nausea, acid or sour stomach
- itching and redness of skin, hives or welts and skin rash
- muscle aching or cramping
- difficult or painful menstruation
- swelling of legs and ankles
If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.
STORING AND DISPOSING OF POLLENTYME ND
- Store at or below 25 °C in a well closed container.
- Protect from light.
- Do not remove from the outer carton until required for use.
- Return all unused medicine to your pharmacist.
- Do not use the tablets after the expiry date printed on the blisters and containers.
- Do not dispose of unused medicine in drains and sewerage systems (e.g. toilets).
PRESENTATION OF POLLENTYME ND
POLLENTYME ND is packed into hard, silver-coloured aluminium foil/transparent PVC/PCTFE film blister strips of 3 x 10 tablets each inside an outer cardboard box.
POLLENTYME ND is also packed into white, HDPE bottles with a desiccant and a white HDPE screw cap with 30 tablets inside.
Not all pack types may be marketed.
IDENTIFICATION OF POLLENTYME ND
POLLENTYME ND is a blue, round, film coated tablet debossed with a “D” on one side of the tablet and plain on the other.
RSA S2 42/5.7.1/0849
NAM NS1 11/5.7.1/0099
NAME AND ADDRESS OF REGISTRATION HOLDER
Pharma Dynamics (Pty) Ltd
1st Floor, Grapevine House
Steenberg Office Park
DATE OF PUBLICATION
12 October 2010