Generic Name: Medroxyprogesterone Acetate

Formulation:

Each ml contains:
150 mg Medroxyprogesterone Acetate
Each vial contains 1 ml

Each box contains one vial of 150 mg Medroxyprogesterone Acetate suspension for intramuscular injection.

INDICATION

Medroxyprogesterone Acetate (LYNDAVEL®) is used for the following reasons:

• Prevention of pregnancy
• Treatment of menorrhagia (heavy menstrual bleeding)
• Secondary amenorrhea (Absence of menstrual period for 6 months or more in a woman who has menstruated normally in the past)
• Mild to moderate endometriosis (A condition in which cells that form the inside of the uterus abnormally grow outside the uterus)

DOSAGE AND ADMINISTRATION

Consult your doctor for a medical and gynecological examination before using Medroxyprogesterone Acetate.

Your doctor will give Medroxyprogesterone Acetate (LYNDAVEL*) as an injection into the muscles of the hip, the upper arm, or the buttocks, whichever you prefer.

You are advised not to massage the injection site.

For contraception and treatment of menorrhagia: The recommended dosage is 150 mg Medroxyprogesterone Acetate (a single vial) of Medroxyprogesterone Acetate (LYNDAVEL®) every three months.

You can start any day as long as you are not pregnant and be sure to use a condom during sexual intercourse for the first seven days after injection as a precaution to avoid getting pregnant.

If you want to start using Medroxyprogesterone Acetate (LYNDAVEL®) after giving birth and you are not breastfeeding, the first injection should be given within 4 weeks after the birth of your baby.

If you are breastfeeding, you must delay your first injection 6 weeks after giving birth.

For secondary amenorrhea: The recommended dosage is 5 to 10 mg daily, given by injection into the muscles for about five to ten days until two days before the expected start of your menstruation.

For mild to moderate endometriosis: The recommended dosage is 50 mg weekly or 100 mg every two weeks, given by injection into the muscles.

Treatment of mild to moderate endometriosis is for at least 6 months.

ADVERSE EFFECTS

You may experience side effects while taking Medroxyprogesterone Acetate (LYNDAVEL®).

​ You are advised to consult your doctor if you are worried about any of the following side effects, which you think may be due to Medroxyprogesterone Acetate (LYNDAVEL®):

• Gastrointestinal disturbances (abdominal problems, example nausea or diarrhea)
• Changes in appetite or weight
• Fluid retention (accumulation of excess fluids in certain body parts)
• Acne or pimples
• Chloasma (melasma) (characterized by patches of dark skin commonly seen on the cheeks, upper lip, forehead, and chin, that can resemble a mask pattern)
• Allergic skin rashes
• Urticaria or hives (Raised, itchy areas of skin that are usually a sign of an allergic reaction)
• Migraine (severe headache that is often accompanied by sensitivity to light, sound, or smells)
• Mental depression
• Breast changes including discomfort
• Changes in sexual desire
• Hair loss
• Hirsutism (abnormal growth of hair on a woman’s face and body)
• Fatigue (extreme tiredness)
• Drowsiness (a feeling of being sleepy)
• Insomnia (habitual sleeplessness; inability to sleep)
• Fever
• Headache
• Premenstrual syndrome-like symptoms (refers to physical and emotional symptoms that occur in one to two weeks before a woman’s period e.g., acne, tender breasts, bloating, feeling tired, irritability, and mood swings)
• Altered menstrual cycles

Manufactured by:

Umeda Co., Ltd.
​26/18-21 Soi Yuyen, Ram-Indra Road Moo 9, Taraeng,
Bang Khen Bangkok 10230, Thailand

Imported and Distributed by:
DKT Health, Inc.
80 E. Rodriguez Jr. Avenue (C5),
Bagumbayan, Quezon City
1110 Philippines