Tilia Fe is a triphasic pregnancy prevention drug. It contains norethindrone, ethinyl estradiol and ferrous fumarate. The course lasts 28 for days.
Indications for use
Mechanism of action
The contraceptive effect of this birth control drug, as well as other combined oral contraceptives, is based on the combination of various factors. This combination includes the suppression of ovulation and the change in cervical mucus secretion.
The progestin – norethindrone suppresses the synthesis of gonadotropic hormones, to a greater degree – LH, thus prevents the maturation of the follicle implying the blockade of ovulation.
The estrogen component of the drug – ethinyl estradiol – a synthetic analog of the follicular hormone known as estradiol, regulates the menstrual cycle.
Along with these central and peripheral mechanisms that prevent the maturation of an oocyte capable of fertilization, the contraceptive effect is maintained due to an increase in the cervix secretion viscosity, which makes it difficult for sperm to penetrate the uterine cavity.
In addition to Tilia Fe contraceptive properties have a number of effects that can be considered when choosing a method of contraception. Menstruation becomes more regular, less painful.
Mode of application and dosage
Tilia Fe is a course including 28 pills with a various hormone dosage. The regimen is specified on the blister. Every pill should be taken at one and the same time washed down with a glass of water. The latter 7 pills contain ferrous fumarate which application provokes the beginning of the menstruation. If you have any questions it is better to contact your gynecologist.
Tilia Fe, as any other birth control drug, has a number of contraindications about which you should inform your doctor. These are the following medical conditions:
- hypersensitivity to Tilia Fe;
- the currently diagnosed or found in the medical history venous thrombosis inclusively of deep vein thrombosis of the lower leg, pulmonary embolism;
- the currently diagnosed or established in the anamnesis arterial thrombosis inclusively of myocardial infarction, stroke or predisposition to thrombosis such as transient ischemic attack, angina pectoris;
- clinically defined predisposition to venous or arterial thrombosis;
- prior diagnosed migraine with focal neurological symptoms;
- diabetes mellitus complicated by diabetic angiopathy;
- uncontrolled hypertension;
- pancreatitis (including found in the anamnesis) accompanied by severe hypertriglyceridemia;
- dyslipoproteinemia of severe form;
- endometrial hyperplasia;
- suspected or diagnosed hepatic failure, acute or severe liver disease;
- hepatic tumors (benign and malignant), including in the medical history;
- hormone-dependent malignant neoplasms of the genital organs or mammary glands;
- vaginal bleeding of unknown etiology;
- smoking over the age of 35 (more than 15 cigarettes per day);
- breastfeeding period;
- adolescence under 18 years of age;
- lactose intolerance, lactase deficiency, glucose-galactose malabsorption.
- Infectious and parasitic diseases: infrequently – vaginitis/vulvovaginitis, vaginal candidiasis or other fungal vulvovaginal infections; rarely, salpingo-oophoritis (adnexitis), urinary tract infections, cystitis, mastitis, cervicitis, fungal infections, candidiasis, herpetic oral cavity disease, influenza, bronchitis, sinusitis, upper respiratory infections, viral infection.
- Benign, malignant and unspecified neoplasms (including cysts and polyps): rarely – uterine fibroids, breast lipoma.
- Hematopoietic system: rarely – anemia.
- Immune system: rarely – allergic reactions.
- Endocrine system: rarely – virilism.
- Metabolism and nutrition: infrequently – increased appetite; rarely – anorexia.
- Mental Disorders: Infrequently – swings in mood; rarely – depression, mental disorders, insomnia, sleep disorders, aggression; frequency unknown – mood change, decreased libido, increased libido.
- Nervous system: often – headache; infrequently – dizziness, migraine; rarely – ischemic stroke, cerebrovascular disorders, dystonia.
- Organs of vision: rarely – dryness of the mucous eyes membrane, irritation of the mucous eyes membrane, oscillopsia, visual impairment; frequency is unknown – intolerance to contact lenses (discomfort when wearing them).
- Organ of hearing and labyrinth disorders: rarely – sudden hearing loss, tinnitus, dizziness, hearing loss.
- Cardiovascular system: infrequently – increased arterial blood pressure, decreased blood pressure; rarely – cardiovascular disorders, tachycardia, venous and arterial thromboembolic complications, thrombophlebitis, diastolic hypertension, orthostatic circulatory dystonia, “hot flashes”, varicose veins, venous pathology, pain in the veins.
- Respiratory system: rarely – bronchial asthma, hyperventilation.
- Gastrointestinal tract: infrequently – abdominal pain, including pain in the upper and lower abdomen, discomfort/bloating, nausea, vomiting, diarrhea; rarely – gastritis, enteritis, dyspepsia.
- Skin and subcutaneous tissues: infrequently – acne, alopecia, rash, pruritus; rarely, allergic dermatitis, atopic dermatitis/neurodermatitis, eczema, psoriasis, hyperhidrosis, chloasma, pigmentation disorder/hyperpigmentation, seborrhea, dandruff, skin pathology, skin reactions, orange peel, vascular spiders; frequency is unknown – urticaria, erythema nodosum, erythema multiforme.
- Musculoskeletal system: rarely – back pain, discomfort in the muscles and skeleton, myalgia, pain in the limbs.
- Genital organs and the mammary gland: often – pain in the mammary gland, discomfort; infrequently – changes in the size, change in the duration and interval of menstrual bleeding, increased size of the mammary glands, swelling, acyclic bleeding, increased swelling; painful menstrual bloody discharge, ovarian cysts, pain in the pelvic area; rarely – cervical dysplasia, uterine cysts, breast cyst, fibrocystic mastopathy, dyspareunia, galactorrhea, menstrual disorders; frequency is unknown – secretion from the mammary glands.
- General disorders and disorders at the injection site: infrequently – fatigue, asthenia; rarely – chest pain, peripheral edema, flu-like symptoms, inflammation, fever, irritability; frequency unknown – fluid retention.
Hepatic metabolism: interactions with inducers of liver microsomal enzymes may be possible which can facilitate to an increase in the clearance of sex hormones (for example, hydantoins, barbiturates, primidone, carbamazepine, rifampicin; and also oxcarbazepine, topiramate, felbamate, ritonavir, ketamine, felbamate, ceramide; rifabutin and preparations containing St. John’s wort). The maximum induction of microsomal enzymes is not manifested in the first 2-3 weeks of taking the combination of norethindrone + ethinyl estradiol, but it can be maintained for at least 4 weeks after the drug discontinuation. A violation of the contraceptive effect was also reported when taking the combination of norethindrone + ethinyl estradiol with antibiotics such as ampicillin and tetracyclines. The mechanism of this effect is unclear.
The combined use of atorvastatin and some COCs containing ethinyl estradiol increases the AUC of ethinyl estradiol by approximately 20%.
Ascorbic acid may increase the concentration of ethinyl estradiol in the blood plasma, possibly due to inhibition of conjugation.
Tilia Fe reduces the effectiveness of indirect anticoagulants, anxiolytics (diazepam), tricyclic antidepressants, theophylline, caffeine, hypoglycemic drugs, clofibrate and GCS.
In the case of the simultaneous use of microsomal enzyme inducers, an additional barrier method of contraception (for example, a condom) should be used throughout the course of treatment and for 28 days after therapy discontinuation. It is recommended to use other non-hormonal effective methods of contraception. During antibiotics application, it is necessary to use a barrier method of contraception throughout the course of treatment and for 7 days after the end of therapy.
COCs can affect the metabolism of other drugs and, accordingly, change their concentrations in blood plasma and tissues: increase (for example, cyclosporine) or decrease (lamotrigine, salicylic acid, morphine).
What if I miss a dose?
Missing a placebo pill from the fourth row in a blister can be neglected.
The given recommendations are related only to the missing of the active pills. If the delay in Tilia Fe intake was less than 24 hours, the contraceptive reliability is not reduced. A woman should take the missed pill as soon as possible and take the next pill at the usual time.
If the delay in taking the Tilia Fe pills is more than 24 hours, contraceptive reliability can be decreased. The more skipped pills and the closer the pill missing to the inactive placebo pills, the chance of becoming pregnant is higher.
Tilia Fe and pregnancy
The use of Tilia Fe during pregnancy is contraindicated. In the event of pregnancy when using this birth control drug it should stop taking it. The drug can affect lactation because COCs reduce the amount and change the composition of breast milk. The drug is contraindicated until the termination of breastfeeding. Small amounts of sex hormones and/or their metabolites can be excreted in breast milk.