You should not use this medicine if you have liver disease, if you have ever had liver problems caused by TASMAR, or if you have ever had muscle damage or fever and confusion caused by using any medication.

Do not use TASMAR if you have taken an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, and tranylcypromine.

TASMAR can cause liver failure. Your doctor will perform blood tests to make sure you do not have conditions that would prevent you from safely using TASMAR.

Call your doctor at once if you have nausea, upper stomach pain, feeling tired, loss of appetite, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes).

Your liver function will need to be checked often: Every 2 to 4 weeks for the first 6 months of treatment, and then as often as your doctor recommends.

In rare cases, TASMAR can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. Call your doctor right away if you have unexplained muscle pain, tenderness, or weakness especially if you also have fever, unusual tiredness, and dark colored urine.

You should not use this medicine if you are allergic to TASMAR, or if you have:

• liver disease;
• a history of liver problems caused by TASMAR; or
• a history of muscle damage or fever and confusion caused by using any medication.

Do not use TASMAR if you have taken an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, and tranylcypromine.

TASMAR can cause liver failure. Your doctor will perform blood tests to make sure you do not have conditions that would prevent you from safely using TASMAR. You may be required to read and sign a Patient Consent form before you get a prescription for TASMAR.

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

• kidney disease; or
• low blood pressure.

You may have increased sexual urges, unusual urges to gamble, or other intense urges while taking this medication. Talk with your doctor if this occurs.

Some people taking Parkinson's disease medications have developed skin cancer (melanoma). However, people with Parkinson's disease may have a higher risk of melanoma. Talk to your doctor about this risk and what skin symptoms to watch for. You may need to have regular skin exams.

It is not known whether TASMAR will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether TASMAR passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

TASMAR may cause hallucinations (the sensation of hearing or seeing something that is not there), most commonly among elderly people. Call your doctor if you have hallucinations.

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

Call your doctor at once if you have:

• nausea, upper stomach pain, feeling tired, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• confusion, hallucinations, unusual thoughts or behavior;
• severe or ongoing diarrhea;
• worsening tremors, stiffness, or muscle spasms; or
• a light-headed feeling, like you might pass out.

Common side effects may include:

• drowsiness;
• mild diarrhea;
• sleep problems; or
• increased sweating.

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

This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

Drinking alcohol can increase certain side effects of TASMAR.

Taking this medicine with other drugs that make you sleepy or slow your breathing can worsen these effects. Ask your doctor before taking TASMAR with a sleeping pill, narcotic pain medicine, muscle relaxer, or medicine for anxiety, depression, or seizures.

Other drugs may interact with TASMAR, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Do not take TASMAR as your only Parkinson's medication. TASMAR must be used in combination with carbidopa and levodopa.

TASMAR is usually taken three times a day. The first dose is taken with your first daily dose of carbidopa and levodopa. The second and third doses of TASMAR are taken 6 and 12 hours later.

TASMAR may be taken with or without food.

Call your doctor if your symptoms do not improve after 3 weeks of treatment.

TASMAR may cause you to fall asleep during normal daytime activities such as working, talking, eating, or driving. You may fall asleep suddenly, even after feeling alert. Tell your doctor if you have any problems with daytime sleepiness or drowsiness.

Your liver function will need to be checked often: Every 2 to 4 weeks for the first 6 months of treatment, and then as often as your doctor recommends.

Do not stop using TASMAR suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using TASMAR.

Store at room temperature in a tightly closed container, away from moisture and heat.

Seek emergency medical attention or call the Poison Help line.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Do not use this medication if you are allergic to trifluridine. This medication will not treat an infection that is caused by bacteria or fungus.

The usual dose of VIROPTIC ophthalmic is one drop into the affected eye every 2 hours while you are awake. Do not use more than 9 drops in the course of one full day.

Once your condition improves, you may need to keep using the medication 4 times daily (up to 5 drops per day) for another 7 days. Your doctor should check your eyes to determine how long you need to use the medicine.

If you wear contact lenses, remove them before applying VIROPTIC ophthalmic. Ask your doctor if contact lenses can be reinserted after putting in the eye drops.

Avoid using other eye medications while using VIROPTIC ophthalmic, unless your doctor has told you to.

VIROPTIC ophthalmic may cause blurred vision. Be careful if you drive, operate machinery, or do anything else that requires you to be able to see clearly.

Do not allow the dropper tip to touch any surface, including the eyes or hands. If the dropper becomes contaminated it could cause an infection in your eye, which can lead to vision loss or serious damage to the eye.

Do not use the eye drops if the liquid has changed colors or has particles in it.

Contact your doctor if your symptoms do not improve, or if they get worse after using this medication for 7 days.

Do not use this medication if you are allergic to trifluridine. This medication will not treat an infection that is caused by bacteria or fungus.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether VIROPTIC ophthalmic passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Do not use this medication in a child younger than 6 years old.

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

Stop using VIROPTIC ophthalmic and call your doctor at once if you have any of these serious side effects:

• severe swelling around your eyes;
• tunnel vision; or
• severe pain, burning, or other irritation of your eyes.

Keep using the medication and talk to your doctor if you have any of these less serious side effects:

• mild eye pain, burning, stinging, itching, or redness;
• blurred vision; or
• feeling of pressure inside the eye.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

This medication may cause blurred vision. Be careful if you drive, operate machinery, or do anything else that requires you to be able to see clearly.

Avoid using other eye medications while using VIROPTIC ophthalmic, unless your doctor has told you to.

There may be other drugs that can affect VIROPTIC ophthalmic. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Use this medication exactly as it was prescribed for you. Do not use the medication in larger amounts, or use it for longer than recommended by your doctor. Follow the instructions on your prescription label.

The usual dose of VIROPTIC ophthalmic is one drop into the affected eye every 2 hours while you are awake. Do not use more than 9 drops in the course of one full day.

Once your condition improves, you may need to keep using the medication 4 times daily (up to 5 drops per day) for another 7 days. Your doctor should check your eyes to determine how long you need to use the medicine.

Wash your hands before using the eye drops.

If you wear contact lenses, remove them before applying VIROPTIC ophthalmic. Ask your doctor if contact lenses can be reinserted after putting in the eye drops.

To apply the eye drops:

• Tilt your head back slightly and pull down your lower eyelid. Hold the dropper above the eye with the dropper tip down. Look up and away from the dropper as you squeeze out a drop, then close your eye. Gently press your finger to the inside corner of the eye (near your nose) for about 1 minute to keep the liquid from draining into your tear duct.
• Do not allow the dropper tip to touch any surface, including the eyes or hands. If the dropper becomes contaminated it could cause an infection in your eye, which can lead to vision loss or serious damage to the eye.

Do not use the eye drops if the liquid has changed colors or has particles in it.

Contact your doctor if your symptoms do not improve, or if they get worse after using this medication for 7 days.

Store the eye drops at room temperature away from heat and moisture. Keep the bottle tightly closed when not in use.

Rinse the eye with water and seek emergency medical attention if you think you have used too much of this medicine.

An overdose of VIROPTIC ophthalmic is not expected to produce life-threatening symptoms.

Use the medication as soon as you remember the missed dose. If it is almost time for your next dose, skip the missed dose and use the medicine at your next regularly scheduled time. Do not use extra medicine to make up the missed dose.

Serious Warnings and Precautions

VISANNE can decrease the bone mineral density (BMD) in adolescent girls (12 to <18 years). This effect may not be completely reversible once treatment is stopped.

Effects on BMD may be greater with increasing duration of use. It is unknown if the use of VISANNE during adolescence will reduce peak bone mass and increase the risk of developing osteoporosis (brittle bones).

The risks and benefits of this treatment in adolescents should be re-evaluated on a regular basis.

Before starting VISANNE, you must be sure that you are not pregnant and must stop taking any form of birth control that contains hormones such as the pill, patch, intrauterine system, injection, or ring.

While using VISANNE you must use a nonhormonal birth control method such as condoms or a diaphragm. DO NOT use any form of birth control that contains hormones.

VISANNE is not a birth control method and will not prevent pregnancy.

VISANNE should not be used in women who have not had their first menstrual cycle.

Cigarette smoking increases the risk of serious adverse effects on the heart and blood vessels. Smoking may also increase adverse effects on bone density. You should not smoke while taking VISANNE.

BEFORE you use VISANNE, talk to your doctor or pharmacist if you:

• have ever had a medical condition related to a blood clot (thromboembolic disorder) or anyone in your immediate family has had a blood clot at a relatively early age.
• have a close relative who has had breast cancer.
• suffer or have suffered from depression.
• have uncontrolled high blood pressure.
• have a history of liver disease. Symptoms may include yellowing of the skin or eyes or itching all over your body. Inform your doctor also if such symptoms occurred during a previous pregnancy.
• have diabetes or had diabetes temporarily during a previous pregnancy.
• have ever had chloasma (golden-brown patches on the skin, particularly on the face).
• have lactose intolerance. VISANNE tablets contain lactose.

The Risks of Using VISANNE

1. Circulatory Disorder (including blood clots in the legs, lungs, heart, eyes, or brain)
2. Some studies have suggested that women who use progestin-only medications might have a slightly higher risk of blood clots; however, the results are not certain. You should discuss risk factors for blood clots with your doctor.
3. Be alert for the following symptoms and signs of serious adverse effects associated with blood clots. Call your doctor immediately if they occur:
   • Sharp pain in the chest, coughing blood, or sudden shortness of breath.
   • Pain and/or swelling in the calf.
   • Crushing chest pain or heaviness.
   • Sudden, severe, or worsening headache or vomiting, dizziness or fainting, disturbances of vision or speech, or weakness or numbness in an arm or leg.
   • Sudden partial or complete loss of vision.
4. Breast Cancer
5. The most significant risk factors for breast cancer are increasing age and a strong history of breast cancer in the family (mother or sister). Other established risk factors include onset of menstrual periods before age 12 years, never having children, having your first full-term pregnancy after the age of 30 years, never having breastfed a child, and daily alcohol consumption.
6. Some studies have shown that the risk of developing breast cancer does not appear to be increased by using progestin-only therapies like VISANNE. However, more thorough studies are needed to confirm that there is no increased risk. You should also discuss breast self-examination with your doctor and report any breast lumps. A yearly breast examination by a health care professional is recommended for all women.
7. Diabetes
8. Patients with diabetes who use VISANNE should have their blood glucose levels closely monitored.
9. Ectopic Pregnancy
10. If you become pregnant while taking VISANNE, you are at a slightly increased risk of having an ectopic pregnancy (the embryo develops outside the womb). Before you start taking VISANNE, tell your doctor if you had an ectopic pregnancy in the past or have an impaired function of the fallopian tubes.
11. Liver Tumors
12. In rare cases, benign liver tumors, and in even fewer cases malignant liver tumors, have been reported in women taking hormones. Contact your doctor if you have unusually severe stomach pain.
13. Changes in Bone Mineral Density
14. The long-term use of VISANNE may decrease the bone mineral density of adolescents (12 to <18 years) and, therefore, your doctor will carefully weigh the benefits of using VISANNE against other potential risks for bone loss. Your doctor may decide that your bone mineral density should be monitored.
15. If you use VISANNE, it will help your bones if you engage in regular weight-bearing exercise and have a healthy diet, including an adequate intake of calcium (e.g. in dairy products) and vitamin D (e.g. in oily fish such as salmon).

Like all medicines, VISANNE can cause side effects. These effects are more common during the first months after you start VISANNE and usually disappear or lessen with continued use. You may also experience changes in your menstrual bleeding pattern, such as spotting, irregular bleeding, or your periods may stop completely. You should consult your physician if your periods become longer or heavier.

Common (may affect up to 1 in 10 users):

• weight gain
• depressed mood, problems sleeping, nervousness, or loss of interest in sex
• headache or migraine
• nausea or abdominal pain
• acne or hair loss
• breast discomfort
• ovarian cyst
• uterine/vaginal bleeding including spotting
• generalized weakness
• irritability

Uncommon (may affect up to 1 in 100 users):

• increase in appetite
• anxiety, depression, changed mood, or mood swings
• disturbed attention
• dry eyes
• ringing in the ears
• palpitations
• diarrhea, constipation, abdominal discomfort, gas, vomiting, inflammation of the stomach and intestines
• dry skin, severe itching of the whole body, brittle nails, dermatitis, light sensitivity or problems with skin pigmentation
• pains in your bones, back pain, muscle spasms, pains and/or a sensation of heaviness in your arms and hands or legs and feet
• urinary tract infection
• vaginal yeast infection, dryness of the genital area, vaginal discharge, pelvic pain, hot flushes, or a lump or lumps in the breast
• swelling due to fluid retention

If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Some medicines may interact with VISANNE. Let your healthcare professional know what other medicines you are taking.

Drugs that may interact with VISANNE include:

• Antifungals (eg, ketoconazole, itraconazole, fluconazole, voriconazole)

• Antibiotics (eg, erythromycin, clarithromycin, rifampicin)

• Anticonvulsants (eg, phenytoin, primidone, carbamazepine)

• Antacids (eg, cimetidine, ranitidine)

• Blood pressure medication (eg, diltiazem, verapamil)

• Drugs used for the treatment of HIV/Hepatitis C Virus infections (eg, ritonavir, saquinavir, indinavir, nelfinavir, boceprevir)

Herbal or food products that may interact with VISANNE include:

• St. John's wort

• Grapefruit juice

Usual dose:

One tablet should be swallowed daily, preferably at the same time, with some liquid as needed. VISANNE can be taken with or without food.

Overdose:

In cases of drug overdose talk to your doctor, or a poison control centre, or go to the emergency room of a hospital near you.

Missed dose:

VISANNE will be less effective if you miss a tablet or have vomiting or diarrhea. If you miss one or more tablets or in case of vomiting or diarrhea within 3-4 hours of taking a tablet, take a tablet as soon as you remember and then continue taking the tablet the next day at your usual time. Do not take more than one tablet per day.

Although the vast majority of ZOMIG and ZOMIG RAPIMELT users have not experienced any significant problems, you should be aware that the following side effects may occur.

Commonly reported side effects of ZOMIG and ZOMIG RAPIMELT are:

• feeling sick

• vomiting

• dizziness

• tiredness

• weakness

ZOMIG may commonly cause drowsiness. Do not drive or operate machinery until you are sure that you are not drowsy.

Other common side effects include:

• muscle aches and pains

• difficulty swallowing

• dry mouth

• headache

• stomach pain

Uncommon side effects include:

• increase in the production of urine or in the frequency of urination

Tell your doctor of these symptoms at your next visit.

Migraineurs may be at risk of certain cerebrovascular events such as cerebral bleeding and stroke. In very rare cases, as with other drugs of this type, such diseases have been reported in association with the use of zolmitriptan.

In very rare cases, as with other drugs of this type (5HT₁ agonists), the following side effects have been reported:

• spasm of the blood vessels of the heart

• spasm of the blood vessels of the Gastro-Intestinal tract and spleen with possible infarctions

For any unexpected effects while taking ZOMIG/ZOMIG RAPIMELT, contact your doctor or pharmacist.

Tell your doctor or pharmacist about any other drugs you take, including:

• other 5-HT₁ agonist migraine drugs (sumatriptan succinate, naratriptan hydrochloride, rizatriptan benzoate, almotriptan malate) or migraine drugs that contain ergotamine, dihydroergotamine, methysergide.

• drugs for depression such as selective serotonin reuptake inhibitors (SSRI's), for example, fluoxetine hydrochloride, sertraline hydrochloride, fluvoxamine maleate, paroxetine hydrochloride, etc., or serotonin norepinephrine reuptake inhibitors (SNRIs), for example, venlafaxine hydrochloride, or monoamine oxidase inhibitors (MAOIs), for example, phenelzine sulfate, tranylcypromine sulfate or moclobemide.

• drugs used to treat upset stomach or stomach ulcers (cimetidine).

• antibiotics from the quinolone family (for example ciprofloxacin).

Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, even those that can be bought without a prescription.