Product Description:

• RINVOQ contains the active substance upadacitinib.


• It belongs to a group of medicines called Janus kinase inhibitors.

 By reducing the activity of an enzyme called ‘Janus kinase’ in the body, RINVOQ lowers inflammation in the following diseases:

• Rheumatoid arthritis.


• psoriatic arthritis.


• ankylosing spondylitis.


• atopic dermatitis.

Warnings and precautions:

Do not take RINVOQ:

• If you are allergic to upadacitinib or any of the other ingredients of this medicine


• if you have a severe infection (such as pneumonia or bacterial skin infection)


• if you have active tuberculosis (tb)


• if you have severe liver problems


• if you are pregnant (see section pregnancy, breast-feeding and contraception)

 Talk to your doctor or pharmacist before and during treatment with RINVOQ if:

• You have an infection (fever, sweating, or chills, shortness of breath, warm, red, or painful skin or sores on your body, feeling tired, cough, burning sensation when you pass urine or passing urine more often than normal, severe headache with stiff neck.


• RINVOQ can reduce your body’s ability to fight infections and so may worsen an infection that you already have, or make it more likely for you to get a new infection.


• You have had tuberculosis or have been in close contact with someone with tuberculosis.


• Your doctor will test you for tuberculosis before starting RINVOQ and may retest during treatment.


• You have had a herpes zoster infection (shingles), because RINVOQ may allow it to come back.


• Tell your doctor if you get a painful skin rash with blisters as these can be signs of shingles.


• You have ever had hepatitis B or C.


• You have recently had or plan to have a vaccination (immunisation) - this is because live vaccines are not recommended while using RINVOQ


• You have cancer - because your doctor will have to decide if you can still be given RINVOQ


• You are at high risk of developing skin cancer, your doctor may recommend preventive measures such as regular skin examinations while taking RINVOQ.


• Talk to your doctor if you develop a new lesion or any change in the appearance of an area on the skin.


• Some patients receiving RINVOQ have developed skin cancers.


• You have heart problems, high blood pressure, or high cholesterol.


• Your liver does not work as well as it should.


• You have had blood clots in the veins of your legs (deep vein thrombosis) or lungs (pulmonary embolism).


• Tell your doctor if you get a painful swollen leg, chest pain, or shortness of breath as these can be signs of blood clots in the veins


• You have kidney problems.


• You have tears (perforation) in the stomach or intestines.

How To Use:

• Always take this medicine exactly as your doctor or pharmacist has told you.


• Check with your doctor or pharmacist if you are not sure.

How much to take:

If you have rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis

The recommended dose is one 15 mg tablet once a day.

If you have atopic dermatitis 

Adults:

• The recommended dose is 15 mg or 30 mg as prescribed by your doctor, as once daily.


• Your doctor may increase or decrease your dose depending on how well the medicine is working.

Elderly:

• If you are 65 years of age or older, the recommended dose is 15 mg once a day.


• Adolescents (from 12 to 17 years of age) weighing at least 30 kg:


• The recommended dose is one 15 mg tablet once a day.

How to take

• Swallow the tablet whole with water.
• Do not split, crush, chew or break the tablet before swallowing as it may change how much medicine gets into your body.


• To help you remember to take RINVOQ, take it at the same time every day.


• The tablets can be taken with or without food.


• Do not swallow the desiccant.

If you take more RINVOQ than you should:

• If you take more RINVOQ than you should, contact your doctor.


• You may get some of the side effects listed in section 4.

If you forget to take RINVOQ

• If you miss a dose, take it as soon as you remember.


• If you forget your dose for an entire day, just skip the missed dose and take only a single dose, as usual, the following day.


• Do not take a double dose to make up for a forgotten tablet

If you stop taking RINVOQ:

• Do not stop taking RINVOQ unless your doctor tells you to stop taking it.

How to open the bottle:

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

Possible side effects:

Like all medicines, RINVOQ can cause side effects, although not everybody gets them.

Serious side effects

Talk to your doctor or get medical help straight away if you get any signs of infection such as:

• shingles or painful skin rash with blisters (herpes zoster) – common (may affect up to 1 in 10 people).


• infection of the lung (pneumonia), which may cause shortness of breath, fever, and a cough with mucus – uncommon (may affect up to 1 in 100 people).

How to store this product:

• Keep this medicine out of the sight and reach of children.


• Do not use this medicine after the expiry date which is stated on the carton after ‘EXP’.


• Store below 25˚C.


• Keep it in the original container to protect it from moisture, Keep the bottle tightly closed.


• Do not throw away any medicines via wastewater or household waste.


• Ask your pharmacist how to throw away medicines you no longer use.


• These measures will help protect the environment.

Ingredients:

The active substance is upadacitinib.

RINVOQ 15 mg prolonged-release tablets:

• Each prolonged-release tablet contains upadacitinib hemihydrate, equivalent to 15 mg upadacitinib.

The other ingredients are:

Core tablet:

• microcrystalline cellulose, mannitol, tartaric acid, hypromellose, silica colloidal anhydrous, and magnesium stearate.

Film coating:

• poly(vinyl alcohol), macrogol, talc, titanium dioxide (E171), iron oxide red (E172), and iron oxide black (E172).

Product Details: