Allergies

“Every season can be an allergy season, depending on what you’re allergic to.”

- Clara Chung

Skin Allergies

Second Generation

pollentymeT_RGB

SCHEDULING STATUS S1

PROPRIETARY NAME, STRENGTH AND PHARMACEUTICAL FORM
Pollentyme tablets (10 mg Loratadine in each tablet)
Pollentyme S (5 mg Loratadine in each 5 ml of syrup)

Read all of this patient information carefully because it contains important information for you

  • Keep this information.  You may need to read it again.
  • Do not share Pollentyme 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.

WHAT POLLENTYME CONTAINS

The active ingredient is:
Loratadine (micronised).

The other ingredients are:
Magnesium stearate, maize starch, and microcrystalline cellulose. Contains sugar (lactose monohydrate).

Pollentyme S:
The active ingredient is:
Loratadine (micronised).

The other ingredients are:
Citric acid monohydrate, glycerol, peach flavour, propylene glycol and 0,1 % m/v sodium benzoate (as preservative). Contains sugar (sucrose).

WHAT POLLENTYME IS USED FOR?

Pollentyme tablets or syrup are used to relieve allergy symptoms such as sneezing, runny nose and itchy burning eyes whether these are due to hay fever or whether they occur all year round.  Pollentyme tablets or syrup may also be taken for allergic skin conditions such as rash, itching or urticaria (hives). 

BEFORE YOU USE POLLENTYME

Do not take Pollentyme:

  • If you are allergic (hypersensitive) to loratadine or any other ingredients of Pollentyme (see WHAT POLLENTYME CONTAINS).
  • If you have kidney disease.
  • If you are pregnant, suspect that you are pregnant or breastfeeding your baby (see Pregnancy and breastfeeding).

Take special care with Pollentyme:

  • Pollentyme may occasionally cause some drowsiness, therefore, whilst on this medication it is advisable to determine your response before driving or performing activities needing mental alertness.
  • If you are an elderly person you may experience dizziness, sleepiness, dry mouth or difficulty with urination. Take caution when using Pollentyme tablets or syrup.
  • Do not use any alcoholic beverages in combination with Pollentyme.

Taking Pollentyme with food or drink:
Pollentyme should be taken with or without food

Pregnancy and breast feeding:
DO NOT use Pollentyme if you are pregnant or suspect that you are pregnant.  Contact your doctor immediately.
DO NOT use Pollentyme if you are breastfeeding your baby.

Driving and using machinery:
Pollentyme may impair your ability to drive and use machinery. Do not drive, operate machinery, or do anything else that could be dangerous until you know how Pollentyme affects you.

Taking other medicines with Pollentyme:
Always tell your healthcare professional if you are taking any other medicine. Consult your doctor, pharmacist or healthcare professional for advice if you need to take any other medicines. If you are taking other medicines on a regular basis, including complementary or traditional medicines, the use of Pollentyme together with these medicines can cause undesirable effects.

Not all medicines that interact with Pollentyme are included in this leaflet.

Do not use the following medicines in combination with Pollentyme:

  • Sleeping tablets, used in the treatment of sleeping disturbances.
  • Antidepressants, used in the treatment of depression.
  • If you have to go for a skin test, stop using Pollentyme several days before, as it may influence the results of the test.
  • Erythromycin, used to treat bacterial infections.
  • Fluconazole, itraconazole, ketoconazole, metronidazole or miconazole, used to treat fungal infections.
  • Do not consume alcohol when you are on Pollentyme treatment.

HOW TO TAKE POLLENTYME

Do not share medicines prescribed for you to any other person.
Follow your doctor’s instructions.

Pollentyme tablets:
Adults and children over the age of 12 years:
One tablet once a day.

Patients with kidney disorders:
If you have a kidney disorder, you should start with 10 mg every other day.

Pollentyme S:
Adults and children over the age of 12 years:
10 ml (2 medicine measures) once a day.

Children 2 to 12 years:
Body weight less than 30 kg:      5 ml (1 medicine measure) once a day.
Body weight more than 30 kg:   5 ml (1 medicine measure) twice a day.
If you are not sure how many tablets to take, ask your doctor or pharmacist.

If you take more Pollentyme 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 tablets or syrup with you, so that the doctor knows what you have taken.

If you forget to take Pollentyme:
If you forget to take your medicine, take your recommended dose as soon as you remember.  Do not take a double dose to make up for missed doses.

POSSIBLE SIDE EFFECTS

Pollentyme can have side effects.  Not all side effects reported for Pollentyme are included 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.

Stop using Pollentyme and seek medical help if you have any of these signs of an allergic reaction:

  • hives;
  • difficulty breathing;
  • swelling of your face, lips, tongue, or throat.

These are very serious side effects. If you have them, you may have had a serious allergic reaction to Pollentyme. 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:

  • allergic shock
  • disturbances in heart rhythm

These are all serious side effects. You may need medical attention.

Tell your doctor if you notice any of the following:

  • tiredness,
  • nausea,
  • headache,
  • hair loss,
  • effects on the liver

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

STORING AND DISPOSING OF POLLENTYME

  • Store all medicines out of reach of children.
  • Store in a cool (at or below 25 °C), dry place.
  • Do not remove from outer carton until required for use.
  • Do not use after the expiry date printed on the label or carton.
  • Return all unused medicine to your pharmacist.
  • Do not dispose of unused medicine in drains and sewerage systems (e.g. toilets).

PRESENTATION OF POLLENTYME

Pollentyme tablets: Blister packs of 10 and 30 tablets.
Pollentyme S: Brown (amber) glass bottles of 100 ml and 150 ml.

IDENTIFICATION OF POLLENTYME

Pollentyme tablets:White or almost white, round, flat tablet scored on one side.

Pollentyme S: Clear to yellowish syrup, free from any visible particulate matter, with a characteristic peach flavour and odour.

REGISTRATION NUMBERS

Pollentyme tablets:
RSA:  S1  34/5.7.1/0507
NAM: NS 11 04/5.7.1/1661

Pollentyme S:
RSA: S1 37/5.7.1/0547
NAM: NS 11 06/5.7.1/0010

NAME AND ADDRESS OF REGISTRATION HOLDER

Pharma Dynamics (Pty) Ltd.
F02 Grapevine House
Steenberg Office Park
Westlake
7945.

DATE OF PUBLICATION

23 July 2010
Version: PD9050A (syrup) and PDPD9051 (tablets)

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