Each white-to-off-white, round, flat-faced, bevelled-edged tablet embossed “B” on one side contains 2 mg dienogest. Nonmedicinal ingredients: crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, potato starch, povidone K 25 and talc.

The recommended dose of dienogest is 2 mg taken by mouth once daily. This medication should be taken at the same time every day, if possible.

Take the medication continuously (every day) even if you are on your period. Once you have completed a pack of tablets, begin the new package on the next day. Dienogest is not intended to be used as birth control. Do not take a break from the medication.

Take dienogest with some liquid as needed. Dienogest may be taken with food or without food.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important that this medication be taken exactly as prescribed by your doctor.

If you miss a dose or if you vomit or have diarrhea within 3 to 4 hours of taking a tablet, take a dose as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store this medication at room temperature, protect it from light and moisture, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• acne
• breast discomfort
• constipation
• decreased interest in sexual activity
• diarrhea
• difficulty sleeping
• dry eyes, skin or nails
• fluid retention (puffiness of hands, wrists, feet or ankles)
• gas (flatulence)
• hair loss
• headache
• hot flushes
• increased appetite
• increased migraine headache
• increased sensitivity to sun
• irritability
• nausea
• nervousness
• vomiting
• weakness
• weight gain

Although most of the side effects listed below don’t happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• abdominal pain or discomfort
• anxiety
• back or bone pain
• breast lump
• breast pain or enlargement
• changes in vaginal bleeding (spotting, breakthrough bleeding, prolonged or heavier bleeding, or complete stoppage of menstrual periods)
• mood swings
• dry skin or patchy change of skin colour
• muscle spasms
• ringing in the ears
• rapid or pounding heartbeat
• signs of depression (e.g., poor concentration, changes in weight, changes in sleep, decreased interest in activities, thoughts of suicide)
• signs of liver problems (e.g., nausea, vomiting, diarrhea, loss of appetite, weight loss, yellowing of the skin or whites of the eyes, dark urine, pale stools)
• symptoms of a urinary tract infection (e.g. pain when urinating, urinating more often than usual, low back or flank pain)
• vaginal yeast infection

Stop taking the medication and seek immediate medical attention if any of the following occur:

• signs of a blood clot in blood vessels, such as sudden vision change or dizziness, chest pain, difficulty breathing, heart palpitations, pain and swelling in leg or arm

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Birth control: Dienogest is not a birth control pill. While taking this medication a non-hormonal method of birth control should be used, such as condoms or a diaphragm. Hormonal methods of birth control (e.g., birth control pills, patches, rings) should not be used in combination with dienogest.

Blood clots: Dienogest may increase the risk of developing blood clots in the lungs and legs. This risk also increases with age, a personal or family history of blood clots, smoking, and obesity. The risk of blood clots is also increased if you are immobilized for prolonged periods and with major surgery. If possible, this medication should be stopped 4 weeks before major surgery. Talk about the risk of blood clots with your doctor.

Breast cancer: Some studies have shown that the risk of developing breast cancer does not appear to be increased by using progestin-only medication such as dienogest. However, more studies are needed to confirm that there is no increased risk. The most significant risk factors for breast cancer are increasing age and a strong history of breast cancer in the family (sister or mother).

Let your doctor know if you notice any breast lumps. Talk to your doctor about regular breast exams.

Cigarette smoking: Cigarette smoking increases the risk of serious side effects on the heart and blood vessels. This risk increases with age and becomes significant after age 35. Do not smoke if you use this medication, especially if you are over 35. Consider stopping smoking before taking this medication. If you smoke, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Depression: Hormones, such as estrogen and progestins, have been known to cause mood swings and symptoms of depression. If you have depression or a history of depression, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

If you experience symptoms of depression such as poor concentration, changes in weight, changes in sleep, decreased interest in activities, or notice them in a family member who is taking this medication contact your doctor as soon as possible.

Diabetes: As with other progestins, dienogest may cause changes in blood glucose control. Women with diabetes should monitor their blood glucose closely to detect any changes in blood glucose control that sometimes occur with use of hormones. If you have diabetes or are at risk for developing diabetes, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. If you experience symptoms of high blood glucose such as increased need to urinate at night, a fruity odour to your breath or wounds that require longer than normal to heal, contact your doctor.

Irregular menstruation: Irregular menstrual patterns are common among women taking progestin like dienogest. If you notice changes in your usual menstrual patterns, check with your doctor. If you go a prolonged time without bleeding, you should have a pregnancy test.

Liver disease: Dienogest may affect liver function. This medication is not recommended for people with liver problems. If you have a history of liver problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately.

Osteoporosis: Dienogest may decrease estrogen levels in the body and increase the risk of osteoporosis (a condition where parts of the bone become weak and prone to fracture). When this medication is taken by adolescents, it may cause a decrease in the development of bones and increase the risk of developing osteoporosis. If you are at an increased risk of osteoporosis, your doctor will monitor you while you are taking dienogest.

Pregnancy: This medication should not be used during pregnancy. If you become pregnant while taking this medication, contact your doctor immediately. Women who become pregnant while taking dienogest are at a slightly increased risk of having an ectopic pregnancy (a pregnancy where the embryo develops outside the uterus).

Breast-feeding: It is not known if dienogest passes into breast milk. This medication should not be taken while breast-feeding.

Children: The safety and effectiveness of using this medication have not been established for females who have not begun to menstruate.

There may be an interaction between dienogest and any of the following:

• apixaban
• aprepitant
• argatroban
• azole antifungals (e.g., ketoconazole, itraconazole, voriconazole)
• benzodiazepines (e.g., alprazolam, diazepam, lorazepam)
• barbiturates (e.g., butalbital, phenobarbital)
• bosentan
• calcium channel blockers (e.g., diltiazem, nifedipine, verapamil)
• carbamazepine
• cholestyramine
• clobazam
• colestipol
• cobicistat
• colesevelam
• conivaptan
• cyclosporine
• dabigatran
• dabrafenib
• danazol
• deferasirox
• dexamethasone
• diabetes medications (e.g., glyburide, insulin, linagliptin, metformin, rosiglitazone)
• grapefruit juice
• heparin
• HIV non-nucleoside reverse transcriptase inhibitors (NNRTIs; e.g., delavirdine, efavirenz, etravirine, nevirapine)
• HIV protease inhibitors (e.g., atazanavir, indinavir, ritonavir, saquinavir)
• hormonal birth control (e.g., birth control pills, patches, rings)
• lamotrigine
• low molecular weight heparins (e.g., dalteparin, enoxaparin, tinzaparin)
• macrolide antibiotics (e.g., clarithromycin, erythromycin)
• mifepristone
• mycophenolate
• mitotane
• modafinil
• nefazodone
• oxcarbazepine
• perampanel
• phenytoin
• primidone
• prucalopride
• ranitidine
• retinoic acid derivatives (e.g., acitretin, alitretinoin, bexarotene, isotretinoin, tretinoin)
• rifabutin
• rifampin
• rivaroxaban
• St. John’s wort
• selective serotonin reuptake inhibitors (SSRIs; e.g., citalopram, fluoxetine, paroxetine, sertraline)
• selegiline
• thalidomide
• tocilizumab
• topiramate
• tranexamic acid
• ulipristal
• warfarin

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

Fibrotic disorders (scar-like tissues in the heart, lungs, or stomach), history of or

Heart problems (e.g., heart valve disease), history of or

Hypertension (high blood pressure), uncontrolled—Should not be used in patients with these conditions.

Heart disease or

Lung disease or other breathing problems—Use with caution. May make these conditions worse.

High blood pressure, controlled or

High blood pressure of pregnancy, or history of—Cabergoline usually decreases blood pressure but at times it may increase blood pressure and worsen these conditions.

Liver disease—Use with caution. You may need a lower dose of this medicine.

It is important that your doctor check your progress at regular visits while you are taking this medicine to make sure that this medicine is working properly. Blood and other tests for the heart may be needed to check for unwanted effects.

Make sure your doctor knows if you are pregnant or planning to become pregnant. Tell your doctor right away if you think you might be pregnant at any time while you are using this medicine. If you are pregnant, make sure your doctor knows if you also have high blood pressure. You and your doctor should discuss whether you should continue to take this medicine during pregnancy.

This medicine may cause some people to become drowsy, dizzy, or less alert than they are normally. Make sure you know how you react to this medicine before you drive, use machines, or do other jobs that require you to be alert.

Dizziness, lightheadedness, or fainting may occur, especially when you get up from a lying or sitting position. Getting up slowly may help.

Check with your doctor right away if you have symptoms of fainting, hallucinations (seeing, hearing, or feeling things that are not there), lightheadedness, stuffy nose, or racing heartbeat.

This medicine may increase your risk of having serious heart, kidney, lung, or stomach problems. Check with your doctor right away if you have chest pain or tightness; extreme tiredness; lower back or side pain; lump or tenderness in the stomach; persistent cough; shortness of breath; troubled breathing; or swelling in your hands, ankles, lower legs, or feet.

Also tell your doctor if you have persistent cough along with shortness of breath or troubled breathing while you are using this medicine. This could be symptoms of a serious lung disorder called pulmonary fibrosis.

Some people who have used this medicine had unusual changes in their behavior. Talk with your doctor if you start having problems with gambling or increased sex drive while using this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

What should I watch for?

Visit your doctor or health care professional for regular checks on your progress.

Your mouth may get dry. Chewing sugarless gum or sucking hard candy, and drinking plenty of water may help. Contact your doctor if the problem does not go away or is severe.

This medicine can sometimes cause a temporary drop in blood pressure. This may happen suddenly causing dizziness or light headedness if you try to stand up too quickly. Make sure to get up slowly from a lying or sitting position while taking this medicine.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Alcohol may interfere with the effect of this medicine. Avoid alcoholic drinks.

Common and Rare Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common

Bloating or swelling of the face, arms, hands, lower legs, or feet

burning, crawling, itching, numbness, prickling, “pins and needles”, or tingling feelings

chills

cold sweats

confusion

dizziness, faintness, or lightheadedness when getting up from lying or sitting position

fast, irregular, pounding, or racing heartbeat or pulse

general feeling of discomfort or illness

rapid weight gain

swelling around the eyes

tingling of the hands or feet

unusual tiredness or weakness

unusual weight gain or loss

Incidence not known

Chest pain or tightness

continuing loss of appetite

continuing or severe abdominal or stomach pain

continuing or severe nausea and vomiting

cough

decreased ability to exercise

fever

increased frequency of urination

loss of appetite

lower abdominal or stomach pain

lower back pain

nausea

shortness of breath

trouble with breathing

vomiting

weakness

Get emergency help immediately if any of the following symptoms of overdose occur:

ymptoms of overdose

Fainting

seeing, hearing, or feeling things that are not there

stuffy nose

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Difficulty having a bowel movement (stool)

dizziness

excess air or gas in the stomach or intestines

full feeling

headache

lack or loss of strength

passing gas

Less common

Abdominal or stomach pain

acid or sour stomach

anxiety

belching

blemishes on the skin

breast pain

burning, itching, or stinging of the skin

changes in vision

cramps

depression

diarrhea

difficulty with moving

dry mouth or toothache

feeling of constant movement of self or surroundings

feeling of warmth

gas

heartburn

heavy bleeding

indigestion

itching skin

joint pain

muscle aches and pains

muscle stiffness

pimples

redness of the face, neck, arms, and occasionally, upper chest

runny nose

sensation of spinning

shivering

sleeplessness

leepiness or unusual drowsiness

sneezing

sore throat

stomach discomfort or upset

sudden sweating

trouble with sleeping

unable to sleep

weight loss

Rare

Bloody nose

difficulty in concentrating

increased in sexual ability, desire, drive, or performance

increased interest in sexual intercourse

Incidence not known

Attack, assault, or force

feeling that others are watching you or controlling your behavior

feeling that others can hear your thoughts

hair loss or thinning of the hair

pathological gambling

severe mood or mental changes

unusual behavior

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.