Azel 160 Tablet 7 Nos

• Prostate cancer that has come back after prior treatment (biochemical recurrence) and has not yet spread to other parts of the body, in patients where further radiation treatment is not possible, is used alone or with ADT.
• Prostate cancer that has spread to other parts of the body and still responds to hormone treatment (metastatic hormone-sensitive), used with ADT.
• Prostate cancer that has stopped responding to standard hormone treatment and has not yet spread to other parts of the body (high-risk non-metastatic castration-resistant).
• Prostate cancer that has spread to other parts of the body and no longer responds to hormone treatment, in patients with no or mild symptoms, where chemotherapy is not yet needed.
• Prostate cancer that has spread and no longer responds to hormone treatment, in patients who have already received a chemotherapy medicine called docetaxel.

• If you are allergic to enzalutamide or any of the other ingredients in this medicine, as a serious allergic reaction may occur.
• If you are a woman who is pregnant or could become pregnant, as this medicine can seriously harm an unborn baby, it is intended for use only in adult men.

• Headache
• Hot flushes
• High blood pressure
• Broken bones (fractures)
• Falls
• Tiredness and weakness (fatigue and asthenia)

• Feeling anxious
• Memory problems, difficulty concentrating, or cognitive difficulties
• Changes in taste and restless legs
• Reduced blood supply to the heart (ischaemic heart disease), including angina and heart attacks
• Dry skin and itching
• Breast swelling (gynaecomastia) and nipple or breast tenderness (more common when taken without ADT)

• Low white blood cell count
• Seeing or hearing things that are not there (visual hallucinations)
• Fits (seizures)
• Raised liver readings in blood tests

• Low platelet count, causing easy bruising or bleeding
• A rare brain condition called posterior reversible encephalopathy syndrome (PRES), with symptoms of fits, severe headache, confusion, or vision changes
• Heart rhythm changes (QT prolongation)
• Swelling of the face, tongue, lips, or throat (allergic reaction)
• Feeling sick, vomiting, or diarrhoea
• Difficulty swallowing
• Muscle pain, muscle spasms, muscle weakness, or back pain
• Serious skin reactions, including severe rashes, blistering, or peeling skin (Stevens-Johnson syndrome)
• Loss of appetite

Other General Warnings

• You have a fit (seizure) at any time during treatment, as your doctor will need to decide whether it is safe to carry on taking this medicine.
• You develop a sudden, severe headache, confusion, changes in your vision, or fits, as these may be signs of a rare but serious brain condition called PRES, which needs immediate medical attention and stopping of this medicine.
• You have a history of fits, strokes, brain tumours, brain spread from cancer, or other conditions that could make fits more likely, as this medicine can lower the threshold at which fits occur.
• You develop chest pain, shortness of breath, or pressure in your chest, as Azel tablet has been linked with reduced blood supply to the heart.
• You had a heart attack in the past 6 months, have unstable chest pain, severe heart failure (NYHA Class III or IV), or an uncontrolled fast or irregular heartbeat, as this medicine has not been well studied in these situations.
• You develop a widespread rash, blistering, or peeling skin, or notice swelling of the face, lips, tongue, or throat, as Azel tablet has been linked with serious skin reactions and severe allergic reactions that need urgent medical attention.
• You notice blood in your urine, pain when passing urine, or signs of bowel bleeding, as this medicine has been linked with a small increased risk of developing new types of cancer during treatment.
• You have severe kidney problems (creatinine clearance below 30 mL/min), as this medicine has not been studied in this group and extra care is needed.
• You are taking any medicines that can affect heart rhythm, as combining them with Azel tablet and ADT can increase this risk further.
• You are starting or stopping any other medicine during treatment, as Azel tablet can reduce the effectiveness of a very large number of other medicines and doses may need to be adjusted.
• You are a man planning to have children in the future, as this medicine may affect male fertility based on animal studies.

• Take Azel tablet exactly as your doctor tells you, at around the same time each day.
• Swallow the tablets whole with a full glass of water; do not cut, crush, or chew them.
• Azel tablet can be taken with or without food.
• Women who are pregnant or could become pregnant must not handle broken or damaged tablets; protective gloves should be worn if contact is necessary.

• Store at room temperature. No special storage conditions are needed.
• Keep the tablets in their original packaging.
• Keep out of reach of children and pets.

• Take Azel tablet at the same time every day; it can be taken with or without food, whichever suits your routine.
• Never cut, crush, or chew the tablets; swallow them whole with a glass of water.
• Because Azel tablet can reduce the strength of many other medicines, make sure all your doctors and pharmacists know you are on this treatment before anything new is prescribed or dispensed, including over-the-counter medicines.
• If you take warfarin or another blood thinner, attend all your scheduled INR checks, as your dose may need to be adjusted.
• Take steps to reduce the risk of falls and bone fractures, such as wearing non-slip footwear, removing loose rugs, and using handrails; ask your doctor about bone-strengthening supplements or medicines if needed.
• Tell your doctor straight away if you have a fit, see or hear things that are not there, or develop a sudden severe headache, confusion, or vision changes, as these may need urgent medical attention.
• Men with partners who are pregnant or could become pregnant must use a condom plus another form of contraception during treatment and for 3 months after the last dose
• Women who are pregnant or could become pregnant must not handle broken or damaged tablets without wearing protective gloves.
• Inform all your doctors, dentists, and emergency care providers that you are on Azel tablet, as it interacts with a very wide range of other medicines.

Overdose

• There is no antidote for Azel tablet overdose. If you think you have taken too many tablets, stop taking the medicine and contact your doctor or go to the nearest emergency department straight away. Taking too much of this medicine can raise the risk of having a fit (seizure). Your doctor will stop the medicine and provide supportive care as needed.
• Because Azel tablet takes several days to leave the body (its half-life is about 5.8 days), careful monitoring may be needed for some time after an overdose.

Missed a Dose

• If you miss a dose, take it as soon as possible on the same day, then resume your normal schedule the following day. If you miss the dose for a full day, simply take your usual dose the next day.
• Do not take a double dose to make up for a missed dose. If you are unsure what to do, contact your doctor or pharmacist for advice.

Interactions with other medicines

• Azel tablet is a strong enzyme inducer, meaning it significantly reduces the levels of many other medicines in your blood by speeding up how quickly your body breaks them down; a full check of all your medicines must be done before starting treatment and again if any medicines are started or stopped during treatment.
• The groups of medicines most likely to be affected include blood thinners (such as warfarin), cholesterol medicines (such as simvastatin and atorvastatin), epilepsy medicines (such as carbamazepine and valproic acid), heart medicines (such as digoxin, bisoprolol, diltiazem), antipsychotics (such as haloperidol), HIV medicines (such as ritonavir), sedatives (such as diazepam and midazolam), thyroid medicine (levothyroxine), stomach acid medicines (such as omeprazole), and some pain medicines (such as fentanyl and tramadol).
• This enzyme-inducing effect may take up to one month to reach full strength after starting Azel tablet, and can continue for up to one month after stopping the medicine; doses of other medicines may need to be adjusted when you stop as well as when you start.
• Avoid gemfibrozil (used for high cholesterol or triglycerides) if possible, as it can significantly raise the level of Azel tablet in your blood; if it cannot be avoided, your doctor will reduce the dose of Azel tablet to 80 mg once daily.
• Avoid warfarin and other blood thinners if possible; if needed, your INR must be checked more frequently during treatment.
• Medicines that can cause an irregular heartbeat (QT prolongation) must be used with care alongside this medicine, especially when combined with ADT, which can itself affect heart rhythm.
• Always tell your doctor about all medicines, supplements, vitamins, and herbal products you take before starting and during treatment.

Interactions with food items

• Azel tablet can be taken with or without food, as eating does not change how much medicine your body absorbs.
• Eating small, light meals through the day can help manage nausea if it occurs.
• Drink enough water and fluids throughout the day to support your health during treatment.
• Avoid alcohol during treatment, as it can worsen dizziness, tiredness, and confusion, which are known side effects of this medicine.