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TAJ PHARMA INDIA / Product / Rupatadine (Rupatadine Fumarate 10mg Tablet)

Rupatadine (Rupatadine Fumarate 10mg Tablet)

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Patient Information Leaflet

Summary of Product Characteristics pdfIcon



Rupatadine is an antihistamine.
Rupatadine relieves the symptoms of allergic rhinitis such as sneezing, runny nose, itching in the eyes and nose.
Rupatadine is also used to relieve the symptoms associated with urticaria (an allergic skin rash) such as itching and hives (localized skin redness and swelling).


Do not take Rupatadine
• If you are allergic (hypersensitive) to Rupatadine or any of the other ingredients of Rupatadine.
Take special care with Rupatadine
If you suffer from kidney or liver insufficiency, ask your doctor for advice. The use of Rupatadine 10 mg tablets 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 heart beat (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 12 years of age. If you are older than 65, ask your doctor or your pharmacist.
Using other medicines
Please tell your doctor or pharmacist if you are using or have recently used any other medicines, including medicines obtained without a prescription. If you are taking Rupatadine do not take medicines containing ketoconazole or erythromycin.
If you are taking central nervous system depressant medicines or statin medicines, ask your doctor for advice before taking Rupatadine.
Taking Rupatadine with food and drink Rupatadine should not be taken in combination with grapefruit juice, as this may increase the level of Rupatadine in your body.
Rupatadine, at recommended dose (10 mg), does not increase the drowsiness produced by alcohol.

Pregnancy and breast-feeding
Do not take Rupatadine during pregnancy and breastfeeding, unless clearly indicated by your doctor. Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
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.
Important information about some of the ingredients of Rupatadine
This medicinal product contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Always take Rupatadine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Rupatadine is for adolescents (from 12 years and older) and adults. The usual dose is one tablet (10 mg of Rupatadine) once daily 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 Rupatadine will last.
If you take more Rupatadine than you should
If you have accidentally taken a high dose of your medicine, talk to your doctor or pharmacist immediately.
If you forget to take Rupatadine
Take your dose as soon as possible and then continue with your tablets at the usual times. Do not take a double dose to make up for forgotten individual doses.


Like all medicines, Rupatadine can cause side effects, although not everybody gets them.
Common side effects (may affect up to 1 in 10 people) are: Sleepiness, headache, dizziness, dry mouth, sensation of weakness and fatigue.
Uncommon side effects (may affect up to 1 in 100 people) are:
Increased appetite, irritability, difficulty concentrating, nosebleed, nasal dryness, sore throat, cough, dry throat, rhinitis, nausea, abdominal pain, diarrhoea, indigestion, vomiting, constipation, rash, back pain, joint pain, muscle pain, thirst, general discomfort, fever, abnormal liver function test and increased weight.
Rare side effects (may affect up to 1 in 1,000 people) are: palpitations and increased heart rate.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.


Keep out of the reach and sight of children.
Do not use Rupatadine after the expiry date which is stated on the carton and blister. The expiry date refers to the last day of that month.
Keep the blisters in the outer carton in order to protect from light.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment


What Rupatadine contains:
The active substance is rupatadine. Each tablet contains 10 mg of rupatadine (as fumarate).
The other ingredients are pregelatinised maize starch, microcrystalline cellulose, red iron oxide (E-172), yellow iron oxide (E-172), lactose monohydrate and magnesium stearate.
What Rupatadine looks like and contents of the pack
Rupatadine are round, light salmon coloured tablets packed in unit blister doses of 100 tablets.
Not all pack sizes may be marketed..

Additional Information

If you are a distributor, please inquire with us about product , importing and/or marketing our products in your country or region. If you are a consumer, don’t hesitate to contact us about more information for this product.

To inquire more about cost effective Taj Brands products, hospital imports, non-available life saving products, please contact us.

The most common markets for this product include the following state . Please inquire with us if your state is not listed:

North India : Jammu & Kashmir ,Himachal Pradesh,Uttar Pradesh ,Uttaranchal , Punjab ,Haryana.
South India : Kerala, Karnataka ,Tamil Nadu,Andhra Pradesh.
East India : Assam ,Manipur, Meghalaya,West Bengal ,Orissa,Sikkim ,Mizoram, Tripura
West India : Goa ,Gujarat ,Rajasthan ,Maharashtra
Central India : Madhya Pradesh, Chattisgarh

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