Roferon - A syringe

• This medicine may reduce your ability to drive or operate machinery safely. Do not drive or operate machinery until you know how this medicine affects you and you are sure it won't affect your performance.
• This medicine can cause flu-like symptoms such as aches and pains, fever, chills, sweating, headache, fatigue and nausea. These tend to be worse at the start of treatment and improve with continued treatment. You may want to take a medicine to reduce these symptoms, for example, paracetamol, aspirin or ibuprofen, before the injection and for 24 hours after the injection. Ask your doctor or pharmacist for advice.
• This medicine has been associated with psychiatric side effects, particularly depression, that can occur at any time during treatment and even after treatment has finished. You should discuss this with your doctor before starting treatment. It is important to talk to your doctor immediately if you have any distressing thoughts or feelings, thoughts about suicide or self-harm, mood changes, confusion, agressive behaviour or any other unusual change in behaviour while having treatment with this medicine. It may be necessary to stop treatment.
• This medicine has rarely been associated with side effects on the eyes. You should have an eye examination before starting treatment. Tell your doctor if you experience any disturbances in your vision during treatment.
• This medicine may rarely decrease the number of blood cells in your blood. Tell your doctor immediately if you experience any of the following symptoms during your treatment, as they may indicate problems with your blood cells: unexplained bruising or bleeding, purple spots, sore mouth or throat, mouth ulcers, high temperature (fever) or other signs of infection, or suddenly feeling tired, breathless, or generally unwell.
• During treatment with this medicine you will need to have regular blood tests. This is to monitor things such as your liver function, thyroid function and the levels of blood cells and lipids in your blood.
• Your ability to become pregnant or father a child may be affected by treatment with this medicine. It is important to discuss fertility with your doctor before starting treatment.

Use with caution in

• History of depression or other psychiatric disorders
• People who have recently had an organ transplant, eg kidney or bone marrow transplant, and are taking immunosuppressant medicines to prevent transplant rejection
• Diabetes
• High blood pressure (hypertension)
• Decreased kidney function
• Decreased liver function
• Heart disease
• Decreased blood cell production by the bone marrow, causing lower than normal levels of blood cells in the blood
• History of disease caused by the immune system attacking the body's own tissues (autoimmune disease, eg autoimmune hepatitis)
• Overactive or underactive thyroid gland
• Psoriasis
• Sarcoidosis

Not to be used in

• Premature babies, newborn babies, infants or young children. This medicine is also not recommended for older children.
• Severe heart disease
• Severely decreased kidney function
• Severely decreased liver function
• Severely decreased blood cell production by the bone marrow, causing lower than normal levels of blood cells in the blood
• Uncontrolled epilepsy
• People with chronic hepatitis who have liver cirrhosis, or who are being or have recently been treated with immunosuppressive medicines
• AIDS patients with CD4 counts less than 250/mm3, or those with a history of opportunistic infections

Adverse effects: Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Because a side effect is stated here, it does not mean that all people using this medicine will experience that or any side effect.

• Cold or flu-like symptoms
• Loss of appetite
• Headache
• Fatigue
• Feeling of weakness
• Disturbances of the gut such as diarrhoea, constipation, nausea, vomiting or abdominal pain
• Hair loss (alopecia)
• Disturbance in the components of the blood
• Depression
• Anxiety
• Disturbances in behaviour
• Difficulty in sleeping (insomnia)
• Dizziness
• Pins and needles sensations
• Numbness
• Visual disturbances
• Increase or decrease in blood pressure
• Skin reactions such as rash and itch
• Local pain and swelling at the site of injection
• Heart problems such as irregular heart beats and fluid retention
• Liver, kidney or lung disorders

The side effects listed above may not include all of the side effects reported by the drug's manufacturer.

Interactions: It is important to tell your doctor or pharmacist what medicines you are already taking, including those bought without a prescription and herbal medicines, before you start treatment with this medicine. Similarly, check with your doctor or pharmacist before taking any new medicines while using this one, to ensure that the combination is safe.
This medicine should not be used in AIDS patients who are taking protease inhibitors or reverse transcriptase inhibitors (except zidovudine).
The may be an increased risk of side effects if this medicine is used in combination with cancer chemotherapy or other treatments that can have effects on the blood cells.
Interferon alfa may increase the blood levels of the following medicines:

• theophylline
• zidovudine.

Additional Information: DO NOT SHARE THIS MEDICINE with others. DO NOT USE THIS MEDICINE for other health conditions. KEEP THIS PRODUCT, as well as syringes and needles, if needed during treatment, out of the reach of children. Do not reuse needles, syringes, or other materials.