Bio-Dienogest: Uses, Side Effects and Dosage

What the medication is used for:

Bio-DIENOGEST is a treatment for the painful symptoms caused by endometriosis in women who have had the first menstrual cycle (menarche).

What it does:

Bio-DIENOGEST works to help reduce pelvic pain associated with endometriosis (endometrium-like tissues outside the uterus which cause a chronic inflammation).

When it should not be used:

You should not use Bio-DIENOGEST if you:

• are pregnant

• are breastfeeding
• are suffering from a medical condition related to a blood clot (thromboembolic disorder). This may occur, for example, in the blood vessels of the legs (deep vein thrombosis) or the lungs (pulmonary embolism).
• have or have ever had a disease affecting the arteries, including cardiovascular disease, such as a heart attack, stroke, or heart disease which causes a reduced blood supply (angina pectoris)
• have diabetes with blood vessel damage
• have or have ever had severe liver disease (and your liver function values have not returned to normal). Symptoms of liver disease may be yellowing of the skin and/or itching of the whole body.
• have or have ever had a benign or malignant liver tumor
• have ever suffered from a malignant tumor such as cancer of the breast or the reproductive organs
• have any unexplained vaginal bleeding
• loss of vision due to blood vessel disease of the eye

• migraine headache

  • are allergic to dienogest or any of the other ingredients of Bio-DIENOGEST (see What the medicinal ingredient is and What the nonmedicinal ingredients are)

If any of these conditions appear for the first time while you are using Bio-DIENOGEST, stop taking it at once and consult your healthcare professional.

What the medicinal ingredient is:

dienogest

What the nonmedicinal ingredients are:

Crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, potato starch, povidone, and talc.

What dosage forms it comes in:

Bio-DIENOGEST (dienogest) tablets are available in 28’s (2 x 14’s) tablet blister packs with amber coloured PVDC foil.

Each white to off-white, round biconvex tablet, is debossed as “SG” and “11” on one side and plain on other side.

WARNINGS AND PRECAUTIONS

Serious Warnings and Precautions

Dienogest can decrease the bone mineral density (BMD) in adolescent girls (12 to < 18years). 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 Bio-DIENOGEST 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 Bio-DIENOGEST, 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 Bio-DIENOGEST 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.

ABOUT THIS MEDICATION

IMPORTANT: PLEASE READ

Bio-DIENOGEST is not a birth control method and will not prevent pregnancy.

Bio-DIENOGEST 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 Bio-DIENOGEST.

BEFORE you use Bio-DIENOGEST, talk to your healthcare professional 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 healthcare professional 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. Bio-DIENOGEST tablets contain lactose.

The Risks of Using Bio-DIENOGEST

1. 1. Circulatory Disorder (including blood clots in the legs, lungs, heart, eyes, or brain)

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 healthcare professional.

Be alert for the following symptoms and signs of serious adverse effects associated with blood clots. Call your healthcare professional 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.
  • Breast Cancer

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.

Some studies have shown that the risk of developing breast cancer does not appear to be increased by using progestin-only therapies like Bio-DIENOGEST. However, more thorough studies are needed to confirm that there is no increased risk. You should also discuss breast self-examination with your healthcare professional and report any breast lumps. A yearly breast examination by a health care professional is recommended for all women.

1. 3. Diabetes

Patients with diabetes who use Bio-DIENOGEST should have their blood glucose levels closely monitored.

1. 4. Ectopic Pregnancy

If you become pregnant while taking Bio-DIENOGEST, you are at a slightly increased risk of having an ectopic pregnancy (the embryo develops outside the womb). Before you start taking Bio-DIENOGEST, tell your healthcare professional if you had an ectopic pregnancy in the past or have an impaired function of the fallopian tubes.

1. 5. Liver Tumors

In rare cases, benign liver tumors, and in even fewer cases malignant liver tumors, have been reported in women taking hormones. Contact your healthcare professional if you have unusually severe stomach pain.

1. 6. Changes in Bone Mineral Density

The long-term use of Bio-DIENOGEST may decrease the bone mineral density of adolescents (12 to < 18 years) and, therefore, your healthcare professional will carefully weigh the benefits of using Bio-DIENOGEST against other potential risks for bone loss. Your healthcare professional may decide that your bone mineral density should be monitored.

If you use Bio-DIENOGEST, 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).

IMPORTANT: PLEASE READ

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

Drugs that may interact with Bio-DIENOGEST 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 Bio-DIENOGEST include:

• St. John’s wort
• Grapefruit juice

See also ABOUT THIS MEDICATION: When it should not be used, and SIDE EFFECTS AND WHAT TO DO ABOUT THEM.

Usual dose

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

Overdose

Missed Dose

Bio-DIENOGEST 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.

Like all medicines, Bio-DIENOGEST can cause side effects. These effects are more common during the first months after you start Bio-DIENOGEST 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 healthcare professional.

PROPER USE OF THIS MEDICATION

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

SERIOUS SIDE EFFECTS AND WHAT TO DO ABOUT THEM

INTERACTIONS WITH THIS MEDICATION

If you think you, or a person you are caring for, have taken too much Bio-DIENOGEST, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms.

IMPORTANT: PLEASE READ

SERIOUS SIDE EFFECTS AND WHAT TO DO ABOUT THEM

This is not a complete list of side effects. For any unexpected effects while taking Bio-DIENOGEST, contact your healthcare professional.

Bio-DIENOGEST should be stored in the original package, between 15°C and 30°C.

Keep out of reach of children and pets.

If you want more information about Bio-DIENOGEST:

• Talk to your healthcare professional
• Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html; or by contacting Biomed Pharma : info@biomed-pharma.ca or +1 (888) 731-6701

MORE INFORMATION

REPORTING SIDE EFFECTS

HOW TO STORE IT