RUPAXINE relieves the symptoms of allergic rhinitis such as sneezing, runny nose, itching in the eyes and nose. RUPAXINE is also used to relieve the symptoms associated with urticaria (an allergic skin rash) such as itching and hives (localised skin redness and swelling).
1. WHAT RUPAXINE IS AND WHAT IT IS USED FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU USE RUPAXINE
Do not use RUPAXINE
- If you are hypersensitive (allergic) to rupatadine and/or any of the other ingredients of RUPAXINE.
- RUPAXINE is not recommended for use in children below 12 years of age.
- If you are pregnant and breastfeeding
Warnings and precautions
Special care should be taken with RUPAXINE
- If you have or have had liver or kidney disease, ask your doctor for advice. The use of RUPAXINE is not recommended in patients with impaired kidney or liver functions.
- RUPAXINE:
- Should be used with caution in patients with known prolongation or longer period of the QT Interval (abnormal heartbeat) which means the time between the Q wave and the end of the T wave in the heart’s electrical cycle.
- Patients with uncorrected low potassium.
- Patients with ongoing polydysrhythmic conditions which means it is a medicine caused or medicine aggravated heart rhythm condition, such as clinically significant slow heart rate.
- And acute decreased blood flow to your heart,
- If you are older than 65, ask your doctor or pharmacist before taking RUPAXINE.
Children: This medicine is not for use in children under 12 years of age.
3. HOW TO USE RUPAXINE
Always use RUPAXINE 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.
The recommended dosage for adults and adolescents (over 12 years of age) is 10 mg (one tablet) once a day with or without food. Swallow the tablet with a sufficient quantity of liquid (e.g., one glass of water). Your doctor will tell you how long your treatment with RUPAXINE will last.
If you use more RUPAXINE 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 use RUPAXINE
Do not use a double dose to make up for forgotten individual doses.
4. POSSIBLE SIDE EFFECTS
RUPAXINE can have side effects.
Not all side effects reported for RUPAXINE are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking RUPAXINE, please consult your doctor, pharmacist or other healthcare professional for advice.
If any of the following happens, stop taking RUPAXINE and tell your doctor immediately or go to the casualty department at your nearest hospital:
- Allergic reactions including sudden life-threatening allergic reaction, symptoms include rash, itching, hives and swelling of the face, lips, tongue or other parts of the body, shortness of breath, wheezing or trouble breathing (anaphylaxis and angioedema). These are all very serious side effects. If you have them, you may have had a serious reaction to RUPAXINE. 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:
- Changes in the way your heart beats – rapid or irregular. These are all serious side effects. You may need urgent medical attention.
Tell your doctor if you notice any of the following:
Frequent side effects:
- Dizziness,
- Headache,
- Sleepiness,
- Dry mouth,
- Weakness such as lack of energy and strength,
- Feeling tired.
Less Frequent side effects:
- Sore throat,
- Stuffy and runny nose,
- Increased appetite,
- Irritability,
- Disturbance in attention
- Rapid and irregular heartbeat,
- Cough,
- Dry throat,
- Nose bleeding,
- Nasal dryness,
- Stomach pain,
- Diarrhoea (loose stools),
- Indigestion,
- Nausea,
- Vomiting,
- Constipation,
- Rash,
- Joint pain,
- Back pain,
- Muscle pain,
- Feeling generally unwell,
- Fever,
- Thirst,
- Abnormal liver function tests (alanine aminotransferase, aspartate aminotransferase, blood creatine phosphokinase etc.)
- Weight increase.
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 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 RUPAXINE. May also report to Adcock Ingram Limited using the following email: [email protected]
5. HOW TO STORE RUPAXINE
Store all medicines out of reach of children.
Store at or below 25 ºC.
Keep blisters in outer carton until required for use.
KEEP OUT OF CHILDREN
Do not use after the expiry date stated on the label / carton / bottle
Return all unused medicine to your pharmacist.