You should not take this medicine if you are allergic to TEMODAR or to another cancer medication called dacarbazine (DTIC).

To make sure TEMODAR is safe for you, tell your doctor if you have:

• liver disease; or
• kidney disease.

Using TEMODAR may increase your risk of developing certain types of bone marrow cancer. Ask your doctor about your specific risk.

Do not use TEMODAR if you are pregnant. It could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment.

Use birth control to prevent pregnancy while you are receiving TEMODAR, whether you are a man or a woman. TEMODAR use by either parent may cause birth defects.

It is not known whether TEMODAR passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• seizure (convulsions);
• fever, chills, dry cough, feeling short of breath;
• easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;
• low white blood cell counts--fever, swollen gums, painful mouth sores, pain when swallowing, skin sores, cold or flu symptoms, cough, trouble breathing; or
• liver problems--nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Common side effects may include:

• bruising, skin rash;
• loss of movement on one side of the body;
• nausea, vomiting, loss of appetite;
• diarrhea, constipation;
• headache, tired feeling, memory problems;
• dizziness, weakness, loss of coordination;
• sleep problems (insomnia);
• low white blood cell counts (fever, flu symptoms); or
• hair loss.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.

Avoid activities that may increase your risk of bleeding or injury. Use extra care to prevent bleeding while shaving or brushing your teeth.

This medicine can pass into body fluids (urine, feces, vomit). Caregivers should wear rubber gloves while cleaning up a patient's body fluids, handling contaminated trash or laundry or changing diapers. Wash hands before and after removing gloves. Wash soiled clothing and linens separately from other laundry.

Tell your doctor about all medicines you use, and those you start or stop using during your treatment with TEMODAR, especially:

• steroid medicine (dexamethasone, prednisone, and others); or
• valproic acid (Depakene, Stavzor).

This list is not complete. Other drugs may interact with TEMODAR, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

TEMODAR is given in a 28-day treatment cycle, and you may only need to take the medicine during the first few days of each cycle.

If you are also receiving radiation treatment, you may need to take TEMODAR for 6 to 7 weeks in a row during your first treatment cycle. Then you may be switched to a 28-day maintenance treatment cycle.

Your doctor will determine how long to treat you with TEMODAR. Follow your doctor's dosing instructions very carefully.

Your doctor may occasionally change your dose to make sure you get the best results. The size, color, and number of TEMODAR capsules you take may sometimes be different from earlier treatment cycles. Be sure you know the correct number of capsules to take and on which days to take them. Ask your doctor or pharmacist if you have any questions.

Take all of your capsules for the day (one entire daily dose) at the same time on each dosing day of a treatment cycle. Swallow the capsules whole with a full glass of water.

Take this medicine at the same time each day.

You may need to take TEMODAR at bedtime or on an empty stomach if the medicine upsets your stomach.

If you vomit shortly after taking the medicine, do not take another capsule until your next regularly scheduled dose.

Do not open the TEMODAR capsule. Do not use a broken pill. The medicine from an open or broken capsule can be dangerous if it gets in your mouth or nose, or on your skin. If this occurs, rinse thoroughly with water. Ask your doctor or pharmacist how to safely handle and dispose of a broken tablet or capsule.

You may be given medication to prevent nausea or other side effects while you are receiving TEMODAR.

TEMODAR can lower blood cells that help your body fight infections and help your blood to clot. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. Your blood may need to be tested often.

Tell your doctor if you have any changes in height or weight. TEMODAR doses are based on body surface area (height and weight), and any changes may affect your dose.

Your doctor will need to check your progress while you are using TEMODAR.

Store at room temperature away from moisture and heat.

Seek emergency medical attention or call the Poison Help line.

Taking TEMODAR for more than 5 days in a row can cause a life-threatening overdose.

Overdose can cause severe forms of some of the side effects listed in this medication guide.

Call your doctor for instructions if you miss a dose of TEMODAR.

Before using CLOBEX, tell your doctor if you have, or have ever had:

•Diabetes

•A skin infection

•Thinning of the skin

•Acne, perioral dermatitis, rosacea, or any other skin problems

•Cushing's syndrome (an adrenal gland disorder)

•A recent vaccination

•Measles

•Tuberculosis (TB)

•Chickenpox or shingles

•Circulation problems

•Immune disorders

•Intracranial hypertension (increased pressure in the head)

•Glaucoma or cataracts (eye conditions)

•Allergies to medicines

Don't use CLOBEX for longer than two consecutive weeks (or four consecutive weeks for some formulations that are used on the scalp), unless your doctor tells you otherwise.

Let your doctor know if your symptoms don't improve, or if they worsen during your treatment with CLOBEX.

If you have diabetes, CLOBEX may raise your blood sugar levels. Be sure to monitor your condition carefully.

Using too much CLOBEX — or using this medicine for a long period of time — may increase your risk of developing adrenal gland problems.

Tell your doctor right away if you experience any of the following symptoms:

•Blurred vision

•Dizziness or fainting

•Fast or irregular heartbeat

•Irritability, depression, or anxiety

•Unusual tiredness or weakness

•Increased thirst or urination

•Unusual weight gain (especially in the face)

•New or worsening high blood pressure

•Loss of appetite or weight loss

•Muscle weakness

Steroids may affect growth in some children and teens. Talk to your doctor if this is a concern.

Don't use this medicine on a child under age 12 without consulting with a doctor.

Tell your healthcare provider you're using CLOBEX before having any type of medical or dental procedure.

Pregnancy and CLOBEX

It's not known whether CLOBEX could harm an unborn baby if used during pregnancy.

Tell your doctor if you're pregnant or might become pregnant.

It's also unknown whether this medicine passes into breast milk. Talk to your doctor before using CLOBEX while breastfeeding.

Common Side Effects of CLOBEX

Tell your doctor if any of the following side effects become severe or don't go away:

•Mild irritation

•Stinging

•Headache

Serious Side Effects of CLOBEX

Tell your doctor right away if you experience any of the symptoms in the CLOBEX Warnings section above, or the following serious side effects:

•Severe burning, itching, or redness

•Skin thinning or discoloration

•Severe skin rash

•Acne

•Swelling

•Nausea or vomiting

•Excessive hair growth

•Inflamed hair follicles

•Signs of an infection, which may include redness, swelling, or oozing of the skin

•Signs of anaphylaxis, which may include rash, hives, itching, difficulty breathing, tightness in the chest, or swelling of the face, mouth, lips, or tongue

Tell your doctor about all prescription, nonprescription, illegal, recreational, herbal, nutritional, or dietary drugs you're taking, especially:

•Other steroids

•Other topical medicines

•Any drug that affects your immune system

•Vitamins

CLOBEX comes as a cream, gel, ointment, or spray to apply to the skin.

It's also prescribed as a foam, lotion, or shampoo to use on the scalp.

This medicine is typically applied once or twice daily.

Your dose will depend on the formulation you're using and your medical condition.

Follow the instructions on your package label carefully. Don't use more or less CLOBEX than is recommended.

Clean the affected area before use. Then apply a thin layer of CLOBEX, and rub it in gently.

Wash your hands after applying this medicine, unless your hands are being treated.

Don't wrap or bandage treated areas of your skin unless your doctor tells you to do so. Follow your healthcare provider's instructions carefully if you need to apply a wrap or bandage.

The scalp lotion form of CLOBEX should be applied directly from the squeeze bottle.

Don't cover your scalp with a shower cap while it's being treated.

If you're using the shampoo, don't wet your hair first.

This medicine should be used only on the skin. Don't get CLOBEX in your eyes, mouth, nose, or vagina.

Don't apply CLOBEX to your face, underarms, or groin area unless your doctor tells you otherwise.

Some formulations of CLOBEX may not be suitable to use on a baby's diaper area.

If your healthcare provider has told you to use CLOBEX on your child's diaper area, avoid dressing your child in plastic pants or tight-fitting diapers.

Ask your doctor before using cosmetics or other skin products on areas of your body that are treated with CLOBEX.

Before using CLOBEX, tell your doctor if you have, or have ever had:

•Diabetes

•A skin infection

•Thinning of the skin

•Acne, perioral dermatitis, rosacea, or any other skin problems

•Cushing's syndrome (an adrenal gland disorder)

•A recent vaccination

•Measles

•Tuberculosis (TB)

•Chickenpox or shingles

•Circulation problems

•Immune disorders

•Intracranial hypertension (increased pressure in the head)

•Glaucoma or cataracts (eye conditions)

•Allergies to medicines

Don't use CLOBEX for longer than two consecutive weeks (or four consecutive weeks for some formulations that are used on the scalp), unless your doctor tells you otherwise.

Let your doctor know if your symptoms don't improve, or if they worsen during your treatment with CLOBEX.

If you have diabetes, CLOBEX may raise your blood sugar levels. Be sure to monitor your condition carefully.

Using too much CLOBEX — or using this medicine for a long period of time — may increase your risk of developing adrenal gland problems.

Tell your doctor right away if you experience any of the following symptoms:

•Blurred vision

•Dizziness or fainting

•Fast or irregular heartbeat

•Irritability, depression, or anxiety

•Unusual tiredness or weakness

•Increased thirst or urination

•Unusual weight gain (especially in the face)

•New or worsening high blood pressure

•Loss of appetite or weight loss

•Muscle weakness

Steroids may affect growth in some children and teens. Talk to your doctor if this is a concern.

Don't use this medicine on a child under age 12 without consulting with a doctor.

Tell your healthcare provider you're using CLOBEX before having any type of medical or dental procedure.

Pregnancy and CLOBEX

It's not known whether CLOBEX could harm an unborn baby if used during pregnancy.

Tell your doctor if you're pregnant or might become pregnant.

It's also unknown whether this medicine passes into breast milk. Talk to your doctor before using CLOBEX while breastfeeding.

Common Side Effects of CLOBEX

Tell your doctor if any of the following side effects become severe or don't go away:

•Mild irritation

•Stinging

•Headache

Serious Side Effects of CLOBEX

Tell your doctor right away if you experience any of the symptoms in the CLOBEX Warnings section above, or the following serious side effects:

•Severe burning, itching, or redness

•Skin thinning or discoloration

•Severe skin rash

•Acne

•Swelling

•Nausea or vomiting

•Excessive hair growth

•Inflamed hair follicles

•Signs of an infection, which may include redness, swelling, or oozing of the skin

•Signs of anaphylaxis, which may include rash, hives, itching, difficulty breathing, tightness in the chest, or swelling of the face, mouth, lips, or tongue

Tell your doctor about all prescription, nonprescription, illegal, recreational, herbal, nutritional, or dietary drugs you're taking, especially:

•Other steroids

•Other topical medicines

•Any drug that affects your immune system

•Vitamins

CLOBEX comes as a cream, gel, ointment, or spray to apply to the skin.

It's also prescribed as a foam, lotion, or shampoo to use on the scalp.

This medicine is typically applied once or twice daily.

Your dose will depend on the formulation you're using and your medical condition.

Follow the instructions on your package label carefully. Don't use more or less CLOBEX than is recommended.

Clean the affected area before use. Then apply a thin layer of CLOBEX, and rub it in gently.

Wash your hands after applying this medicine, unless your hands are being treated.

Don't wrap or bandage treated areas of your skin unless your doctor tells you to do so. Follow your healthcare provider's instructions carefully if you need to apply a wrap or bandage.

The scalp lotion form of CLOBEX should be applied directly from the squeeze bottle.

Don't cover your scalp with a shower cap while it's being treated.

If you're using the shampoo, don't wet your hair first.

This medicine should be used only on the skin. Don't get CLOBEX in your eyes, mouth, nose, or vagina.

Don't apply CLOBEX to your face, underarms, or groin area unless your doctor tells you otherwise.

Some formulations of CLOBEX may not be suitable to use on a baby's diaper area.

If your healthcare provider has told you to use CLOBEX on your child's diaper area, avoid dressing your child in plastic pants or tight-fitting diapers.

Ask your doctor before using cosmetics or other skin products on areas of your body that are treated with CLOBEX.

Do not stop taking TENORETIC suddenly. This could cause chest pain or a heart attack. If your doctor decides that you should stop taking TENORETIC, your dose may be reduced so that you need to use it less and less before you stop the medication completely.

Tell your doctor if you are going into the hospital for an operation. If you go into the hospital, let the medical staff know and in particular the anaesthetist (if you are having an operation) that you are taking TENORETIC.

Driving and using machines:

Before doing tasks that require special attention, wait until you know how you respond to TENORETIC.

You may notice that your pulse rate becomes slower while taking TENORETIC. This is normal but if you are concerned, please talk to your doctor about it.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

These are not all the possible side effects you may feel when taking TENORETIC. If you experience any side effects not listed here, contact your healthcare professional.

Side effects may include:

• cough
• cold fingers and toes
• diarrhea
• dizziness
• dry mouth
• headache
• joint and back pain
• nausea
• tiredness
• trouble sleeping
• vertigo

The following may interact with TENORETIC:

• drugs used for lowering blood pressure or treating angina:
  • beta-blockers (such as clonidine)
  • calcium channel blockers (such as verapamil, diltiazem or nifedipine)
  • catecholamine-depleting drugs (such as reserpine or guanethidine)
  • vasodilators
• drugs used to treat irregular heartbeats (such as disopyramid or amiodarone)
• drugs used to treat heart failure (such as digoxin)
• non-steroidal anti-inflammatory agents (NSAIDs) (such as indomethacine or ibuprofen)
• anesthetic drugs used during surgery
• alcohol, sleeping pills (barbiturates) or strong pain medications (narcotics)
• norepinephrine, a heart stimulant
• lithium, a drug used to treat certain psychiatric disorders
• tubocurarine, a drug used to relax the muscles during surgery
• fingolimod, a drug used to treat multiple sclerosis

Take TENORETIC:

• exactly as prescribed by your doctor.
• by swallowing the tablet whole with water.
• once a day, at the same time each day.

Your doctor will decide how much TENORETIC you should take each day depending on your condition.

If you have the impression that the effect of TENORETIC is too strong or too weak, talk to your doctor or pharmacist as soon as possible.

Do not stop taking TENORETIC or change your dose without consulting your doctor. This can be dangerous.

Usual adult dose:

One tablet per day.

Overdose:

If you think you have taken too much TENORETIC, contact your healthcare professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Missed dose:

If you miss a dose, take the dose as soon as you remember. Do not take a double dose to make up for the missed dose.