Rupatadine 1mg/ml oral solution

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Rupatadine is and what it is used for
2. What you need to know before you take Rupatadine
3. How to take Rupatadine
4. Possible side effects
5. How to store Rupatadine
6. Contents of the pack and other information

• If you are allergic to rupatadine or any of the other ingredients in this medicine (listed in section 6).

Talk to your doctor or pharmacist before taking Rupatadine.

If you suffer from kidney or liver insufficiency, ask your doctor for advice. The use of Rupatadine is at present not recommended in patients with impaired kidney or liver functions.

If you have low blood levels of potassium and/or if you have a certain abnormal pattern to your heartbeat (known prolongation of the QTc interval on the ECG) which can occur in some forms of heart disease, ask your doctor for advice.

This medicine is not for use in children under 2 years of age or weighing less than 10kg.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

If you are taking Rupatadine do not take medicines containing ketoconazole (drug for fungal infections) or erythromycin (drug for bacterial infections).

If you are taking central nervous system depressant medicines, statin medicines (medicines used to treat high cholesterol levels) or midazolam (drug used for sedation of short duration), ask your doctor for advice before taking Rupatadine.

Rupatadine may be taken with or without food.

Rupatadine should not be taken in combination with grapefruit juice, as this may increase the level of Rupatadine in your body.

Rupatadine, at a dose of 10mg, does not increase the drowsiness produced by alcohol.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

At the recommended dosage, Rupatadine is not expected to influence your ability to drive or use machinery.

However, when you first start taking Rupatadine you should take care to see how the treatment affects you before driving or using machines.

This medicinal product contains sucrose, so it may be harmful to the teeth. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

This medicinal product contains methyl parahydroxybenzoate, which may cause allergic reactions (possibly delayed).

This medicine contains 200mg propylene glycol in each ml.

If your child is less than 5 years old, talk to your doctor or pharmacist before giving them this medicine, in particular if they use other medicines that contain propylene glycol or alcohol.

If you are pregnant or breast-feeding, do not take this medicine unless recommended by your doctor. Your doctor may carry out extra checks while you are taking this medicine.

If you suffer from a liver or kidney disease, do not take this medicine unless recommended by your doctor. Your doctor may carry out extra checks while you are taking this medicine.

This medicine contains less than 1mmol sodium (23mg) per 1ml, that is to say essentially ‘sodium free’.

• To open the bottle press the cap and turn it anticlockwise.
• Take the syringe and put it in the perforated stopper and turn the bottle upside down.
• Fill the syringe with the prescribed dose.
• Administer directly from the dosing syringe.
• Wash the syringe after use.

If you have accidentally taken a high dose of your medicine, talk to your doctor or pharmacist immediately.

Do not take a double dose to make up for forgotten individual doses.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme (website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store). By reporting side effects you can help provide more information on the safety of this medicine.

• The active substance is rupatadine. Each ml contains 1mg of rupatadine (as fumarate).
• The other ingredients are:
  propylene glycol (E1520), citric acid anhydrous, disodium phosphate anhydrous, saccharin sodium, sucrose, methyl parahydroxybenzoate (E218), quinoline yellow (E104), banana flavour, purified water. See section 2 “Rupatadine contains sucrose, methyl parahydroxybenzoate and propylene glycol”.

Rupatadine is a clear yellow oral solution.

Rupatadine is packaged in an amber plastic bottle with a perforated stopper and a child-resistant cap. Each bottle contains 120ml Rupatadine solution. A 5ml oral syringe graduated at 0.25ml intervals is provided in the pack.

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