Rupastral 10 mg Tablets

RUPASTRAL is an antihistamine. RUPASTRAL is used to relieve symptoms in adults and adolescents (over 12 years of age) of:

• Allergic rhinitis such as sneezing, runny nose, itching in the eyes and nose.
• Urticaria (an allergic skin rash) such as itching and hives (localised skin redness and swelling).

Do not take RUPASTRAL:

• If you are hypersensitive (allergic) to rupatadine or any of the other ingredients of RUPASTRAL (listed in section 6).
• If the patient is younger than 12 years of age.
• If you are pregnant or breastfeeding.

Warnings and precautions:

Take special care with RUPASTRAL:

• If you have, or have had liver or kidney disease, ask your doctor for advice. The use of RUPASTRAL is not recommended in patients with impaired kidney or liver functions.
• If you have heart conditions or low potassium blood levels, talk to your doctor or pharmacist, as RUPASTRAL can worsen these conditions.
• If you are over the age of 65 years, as you can be more sensitive and can experience side effects.

Do not share medicines prescribed for you with any other person. Always take RUPASTRAL exactly as described in this leaflet or as your doctor or pharmacist have told you. Check with your doctor or pharmacist if you are not sure. RUPASTRAL is for adolescents (from 12 years and older) and adults.

The usual dose is one tablet per day. Take the tablet at the same time of day, with a glass of water.

If you take more RUPASTRAL than you should

In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre.

If you forget to take RUPASTRAL

Do not take a double dose to make up for forgotten individual doses. If it is almost time for your next dose, skip the missed dose and take your next dose when you are meant to. Otherwise, take it as soon as you remember, and then go back to taking your tablets as you would normally. If you are not sure whether to skip the dose, talk to your doctor or pharmacist.

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

If any of the following happens, stop taking RUPASTRAL and tell your doctor immediately or go to the casualty department at your nearest hospital:

• Allergic (itching, hives and swelling of the face, lips, tongue or throat). These are all very serious side effects. You may need urgent medical attention or hospitalisation.

Tell your doctor if you notice any of the following:

• Frequent: Sleepiness, headache, dizziness, dry mouth, sensation of weakness and fatigue.
• Less frequent: Sore throat, running nose, increased appetite, irritability, difficulty concentrating, rapid or regular heartbeat, nosebleed, nasal dryness, sore throat, cough, dry throat, pain in tonsils area, nausea, stomach pain, diarrhoea, indigestion, vomiting, constipation, rash, back pain, joint pain, muscle pain, thirst, general discomfort, fever, changes in some laboratory blood tests.

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

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 “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications:

https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of RUPASTRAL.

Store all medicines out of reach of children.

• Store at or below 25 °C.
• Keep blister in original container to protect from light.
• Do not use after the expiry date stated on the blister or carton. Return all unused medicine to your pharmacist.
• Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).