Tanilive 200 mg Capsules

TANILIVE VAGINAL CAPSULES contains a female hormone called progesterone. TANILIVE VAGINAL CAPSULES are used:

• when your ovaries are not functioning normally
• during in vitro fertilisation cycles (IVF)
• in cases of threatened miscarriage or prevention of repeated miscarriages.

Do not take TANILIVE VAGINAL CAPSULES:

• if you are hypersensitive (allergic) to progesterone, or to any of the ingredients of TANILIVE VAGINAL CAPSULES (see section 6)
• if you have or have ever had a severe liver disease and your liver function tests have not returned to normal
• if you have any undiagnosed vaginal bleeding
• if you suffer from any of the following disorders: herpes gestationis (a type of skin rash with sores that starts during pregnancy), jaundice of pregnancy (yellowing of the skin), otosclerosis (an abnormal growth of bone near the middle ear, causing impaired hearing), severe itching, or porphyria (a condition that affects your blood)
• if you or any of your family members have or had breast cancer
• if you have or have ever had a blood clot in a vein (thrombosis), such as in the legs (deep venous thrombosis) or the lungs (pulmonary embolism)
• if you have ever suffered from inflammation of the wall of a vein with associated thrombosis, often occurring in the legs during pregnancy (thrombophlebitis)
• if you have or recently have had a disease caused by blood clots in the arteries, such as a heart attack, stroke or angina
• if you have bleeding on the brain (cerebral haemorrhage)
• if you have been told by a doctor that you have inherited genetic mutation of the Breast cancer genes (BRCA 1 and BRCA 2)
• if you had an early onset of menstrual periods (before the age of 12 years)
• if you have a history of non-cancerous breast diseases such as atypical hyperplasia (Abnormal cells found during a breast biopsy) and lobular carcinoma in situ (a rare condition where you have abnormal cells in your lobules—the glands that produce breast milk)
• if you’ve had treatment using radiation therapy to the chest or breast
• if you have previously used medicines containing diethylstilbestrol (DES), which is a female hormone estrogen prescribed to pregnant women to prevent miscarriage, premature labor, and related complications of pregnancy
• if you are breastfeeding your baby.

Warnings and precautions

Take special care with TANILIVE VAGINAL CAPSULES:

• treatment with TANILIVE VAGINAL CAPSULES should be stopped if your liver function test indicates any abnormalities or if you develop cholestatic jaundice (yellowing of the eyes and/or skin)
• before starting TANILIVE VAGINAL CAPSULES treatment you should undergo a thorough examination and special care should be given to the breasts, pelvic organs and a “pap” smear should be conducted
• TANILIVE VAGINAL CAPSULES should not be used as a contraceptive medicine as the dosage is not sufficient
• TANILIVE VAGINAL CAPSULES is only for use in the first trimester of pregnancy
• TANILIVE VAGINAL CAPSULES is not a treatment for the threat of premature birth
• TANILIVE VAGINAL CAPSULES can cause depressed mood, depression and the risk of having suicidal thoughts.

Do not share medicines prescribed for you with any other person. Always use TANILIVE VAGINAL CAPSULES exactly as your doctor has instructed. You should check with your doctor or pharmacist if you are unsure.

Your doctor will aim to prescribe the lowest dose to treat your symptoms as short as necessary.

Vaginal route: The usual daily dose is as follows (in addition to estrogen):

• 100 mg TANILIVE VAGINAL CAPSULES per day on days 13 and 14 of the transfer cycle, then
• 200 mg of TANILIVE VAGINAL CAPSULES per day on days 15 and 25 of the transfer cycle, split over one or two doses per day, then
• from day 26 of the cycle, and in cases of an early pregnancy, the dose may be increased up to a maximum of 600 mg per day, split over three doses.

This dosage should be followed up to day 60, or until week 12 of pregnancy at the latest.

Children

TANILIVE VAGINAL CAPSULES are not indicated for use in children. Your doctor will tell you how long your treatment with TANILIVE VAGINAL CAPSULES will last. If you have the impression that the effect of TANILIVE VAGINAL CAPSULES is too strong or too weak, tell your doctor or pharmacist.

Method of administration: Insert the capsule(s) deep into the vagina.

If you take more TANILIVE VAGINAL CAPSULES than you should: In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control centre. Symptoms of overdose may include:

• nausea, vomiting, sleepiness, dizziness, fatigue, a feeling or state of intense excitement and happiness, painful menstruation, typically involving abdominal cramps.

If you forget to take TANILIVE VAGINAL CAPSULES: If you forget to take TANILIVE VAGINAL CAPSULES, take as soon as you remember on the same day. If you do not take a tablet that same day, take your normal dose the next day. Do not take a double dose to make up for forgotten individual doses.

If you stop taking TANILIVE VAGINAL CAPSULES: Do not stop taking TANILIVE VAGINAL CAPSULES without first discussing with your doctor or healthcare provider.

You may feel sleepy and dizzy within 1 to 3 hours of using TANILIVE VAGINAL CAPSULES. The information given below is based on extensive post marketing experience from vaginal administration of progesterone.

• itchy skin is often caused by dry skin (pruritus)
• abnormal vaginal bleeding (vaginal haemorrhage)
• vaginal discharge
• changes in your weight
• difficulty sleeping (insomnia), depression, dementia (characterized by, loss of memory, confusion, disorientation, difficulty handling tasks)
• gall bladder diseases
• skin rash, blisters (urticaria), dark patches (chloasma/melasma), hair loss (alopecia), redness of the skin (erythema), blood spots on the skin (vascular purpura)
• change in menstruation, absence of menstruation, breast pain and swelling, change in sex drive
• fever (pyrexia), water retention and swelling.

Not all side effects reported for TANILIVE VAGINAL CAPSULES are included in this leaflet. Should your general health worsen, or if you experience any untoward effects while using TANILIVE VAGINAL CAPSULES, please consult your healthcare provider for advice.

Reporting of side effects

If you get side effects, talk to your doctor or, pharmacist or nurse. You can also report side effects to SAHPRA via the Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who-umc.org) found on the SAHPRA website. An email can be sent directly to the company, [email protected] to ensure safety of the product. By reporting side effects, you can help provide more information on the safety of TANILIVE VAGINAL CAPSULES.

Store all medicines out of reach of children. Store at or below 25 ºC. Protect from excessive moisture. Do not remove from outer carton until required for use. Do not use after the expiry date stated on the carton. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).