Details for: GIOTRIF

Like all medicines, GIOTRIF can have side effects.

The very common side effects (more than 1 out of 10 patients) include:

• Diarrhea;
• Inflammation of the lining of the mouth (stomatitis);
• Infection of the nail bed (paronychia);
• Loss of appetite;
• Nosebleed;
• Rash;
• Skin eruptions resembling acne;
• Itchy/scratchy skin;
• Dry skin.

The common side effects (less than 1 out of 10 patients) include:

• Inflammation of the urinary bladder resulting in a burning sensation during urination and frequent urgent need to urinate (cystitis);
• Excessive loss of body water (dehydration);
• Low blood potassium levels;
• Taste disturbance or loss of taste;
• Inflammation or infection of the membrane lining the eyelids (conjunctivitis);
• Dry eye;
• Runny nose;
• Indigestion, stomach pain;
• Inflammation of the lips;
• Redness, swelling, and pain on the palms of the hands and/or the soles of the feet (Palmar-plantar erythrodysaesthesia syndrome);
• Muscle spasm;
• Kidneys not working properly or failing;
• Fever or high temperature;
• Loss in weight;
• Increase in liver enzymes;
• Inflammation of the cornea;
• Inflammation or scarring of the lungs (interstitial lung disease);
• Nail disorders.

Seek medical advice promptly if the following signs or symptoms occur:

Diarrhea:
Talk to your doctor before you take GIOTRIF on how best to control and minimize any symptoms of diarrhea.

Your doctor should prescribe diarrhea medicine before you start GIOTRIF therapy. You should not change your medicine without talking to your doctor. You should have the medicine with you at all times.

If you have diarrhea, call your doctor as soon as possible.

Diarrhea should be treated as soon as it starts. Take the diarrhea medicine exactly as your doctor has told you. Drink plenty of fluids. If you don’t drink enough fluids, you could become dehydrated and it could affect your kidneys. Call your doctor right away if your diarrhea becomes worse.

To help control your diarrhea you should modify your diet to include bananas, rice, apple sauce and toast (BRAT diet), and increase your fluid intake with clear liquids. The daily fluid intake should be greater than 2 litres a day (about 8 glasses of 250 mL) to avoid dehydration. Some fluids should contain sugar or salt to avoid low blood sugar or salt. The use of caffeinated drinks should be avoided. Make a follow-up appointment with your doctor. You should avoid foods that contain lactose, are greasy, spicy and/or fried, and are difficult to digest.

Skin Reactions:
It is important to seek treatment for a rash as soon as you notice it. Take medicines to help your rash exactly as your doctor tells you to. Seek medical attention right away if your rash becomes severe (for example, you have peeling or blistering of the skin).

Interstitial Lung Disease:
Tell your doctor right away if you have any new or worsening lung symptoms, or any combination of the following symptoms: trouble breathing or shortness of breath, cough, and fever.

Liver Problems:
Tell your doctor right away if you get any of these symptoms of a liver problem during treatment:

• your skin or the whites of your eyes turn yellow;
• you feel tired;
• your urine turns dark or brown (tea colored);
• you have nausea or vomiting;
• you have decreased appetite;
• you have a pain on the right side of your stomach;
• you bleed or bruise more easily than normal.

Eye Problems:
Tell your doctor right away if you get any of these symptoms during treatment:

• eye pain, swelling, or redness;
• blurred vision or other vision changes.

Paronychia:
This is a painful, red, swollen area around the nail, often at the cuticle or at the site of a hangnail or other injury. It can be caused by bacteria, yeast or fungus. Nail changes may occur. For example, the nail may look detached, abnormally shaped, or have an unusual color. Your doctor will prescribe the proper medicine to treat your nails. You should be careful to take good care of your skin. Avoid injury to your nails or finger tips. Avoid harsh chemicals such as soap, detergent, and nail products. Keep your hands clean and dry.

Stomatitis:
This is an inflammation anywhere in the mouth and includes the inside of the cheeks, gums, tongue, lips, and roof of the mouth (palate). Your doctor will be able to advise you on how best to treat it.

GIOTRIF can affect your heart function and cause abnormal blood test results. Your healthcare provider will monitor your heart and do blood tests. This occurs before you start taking GIOTRIF and periodically during treatment. The doctor will interpret the results.

Serious side effects, how often they happen and what to do about them

Symptom / effect	Talk with your doctor, nurse, or pharmacist only if severe	Talk with your doctor, nurse, or pharmacist in all cases	Stop taking drug and talk with your doctor or pharmacist
Very Common
Diarrhea		✔
Rash		✔
Inflammation of the lining of the mouth		✔
Infection of the nail bed		✔
Common
Abnormal laboratory test results		✔
Little or no urine output		✔
Inflammation of the cornea (eye pain and worsening/loss of vision)		✔
Inflammation of the lungs (sudden difficulty in breathing with cough or fever)		✔
Uncommon
Gastrointestinal perforation (abdominal pain-severe, fever, nausea and vomiting)		✔

This is not a complete list of side effects. For any unexpected effects while taking GIOTRIF, contact your doctor or pharmacist.