Minesse ^TM

/ Pfizer

Oral hormonal contraception: The decision to prescribe this drug should take into consideration the individual woman’s current risk factors, particularly those for venous thromboembolism (VTE), and how the risk of VTE with this formulation compares with other combined hormonal contraceptives (CHCs). Take regularly and without omission, one tablet daily at the same time of the day, for 28 consecutive days (one pale-yellow, active tablet during the first 24 days, one white, inactive tablet during the 4 following days) with no free interval between each blister pack. A withdrawal bleed usually starts on day 2-3 after the last active tablet and may not have finished before the next pack is started.
How to start: No preceding hormonal contraceptive use in the past month: Take the first tablet on the first day of menstrual bleeding.
Changing from another combined oral contraceptive (COC): The woman should start the drug on the day after the last active tablet of her previous COC. Changing from a progestin-only method (minipill, injection, implant): The woman may switch any day from the minipill and should begin the drug the next day. She should start the pills on the day of an implant removal or, if using an injection, the day the next injection would be due. In all of these situations, the woman should be advised to additionally use a non-hormonal back-up method for the first 7 days of tablet-taking.
Following first-trimester abortion: The woman may start the drug immediately. Additional contraceptive measures are not needed.
Following delivery or second-trimester abortion: Since the immediate post-partum period is associated with an increased risk of thromboembolism, COCs should be started no earlier than days 21 to 28 after delivery or second-trimester abortion. The woman should be advised to additionally use a non-hormonal back-up method for the first 7 days of tablet-taking. However, if intercourse has already occurred, pregnancy should be excluded before the actual start of COC use or the woman has to wait for her first menstrual period.
Omission of one or more tablets: Contraceptive reliability may be reduced if pale-yellow tablets are missed, and particularly if tablets are missed during the first days of the pack. If the woman becomes aware of the omission of a pale-yellow tablet within 12 hours of the normal time of intake, the tablet should be taken immediately and treatment pursued normally, the next tablet being taken at the usual time. If the woman becomes aware of the omission of a pale-yellow tablet more than 12 hours after the normal time of intake, contraception is no longer assured. The last forgotten tablet should be taken immediately, even if this means taking two tablets in one day, and oral contraceptive treatment pursued to the end of the blister pack, together with a non-hormonal back-up method of contraception (condoms, spermicides, etc.) which should be used for the next seven days. If the seven days where a back-up method is required run beyond the last active tablet in the current pack, the next pack must be started on the day following the intake of the last active tablet in the current pack and all inactive tablets should be discarded. The user is unlikely to have a withdrawal bleed until the inactive-tablet interval of the second pack, but she may experience spotting or breakthrough bleeding. If the user does not have a withdrawal bleed at the end of the second pack, the possibility of pregnancy must be excluded before resuming tablet-taking. Errors in taking one or more white tablets have no consequence, provided the interval between the last pale-yellow tablet of the current pack and the first pale-yellow tablet of the following pack does not exceed four days.
In case of gastrointestinal upset: The onset of intercurrent digestive disorders within four hours after taking the tablet, such as vomiting or severe diarrhoea, may cause transient inefficacy of the method by reducing COC hormone absorption and such events should be dealt with in the same way as the case where a tablet has been forgotten for less than 12 hours. The extra tablet should be taken from a back-up pack. If these episodes recur over several days, a non-hormonal back-up contraceptive method should then be used, (condom, spermicide, etc.) until the beginning of the next blister pack.
Paediatric population: Safety and efficacy was evaluated in subjects aged 18 years and above. Limited data available for use in adolescents below 18 years.
Patients with hepatic impairment: Contraindicated in women with severe hepatic diseases.
Patients with renal impairment: This drug  has not been specifically studied in renally impaired patients.

Oral hormonal contraception.
The decision to prescribe this drug should take into consideration the individual woman’s current risk factors, particularly those for venous thromboembolism (VTE), and how the risk of VTE with this drug compares with other combined hormonal contraceptives (CHCs).

Combined hormonal contraceptives (CHCs) should not be used in the following conditions. If one of these disorders occurs during the use of this drug , it must be discontinued immediately.
Hypersensitivity to the active substances or to any of the excipients.
Presence or risk of venous thromboembolism (VTE):
– Venous thromboembolism – current VTE (on anticoagulants) or history of (e.g. deep venous thrombosis [DVT] or pulmonary embolism [PE]).
– Known hereditary or acquired predisposition for venous thromboembolism, such as APC-resistance, (including Factor V Leiden), antithrombin-III-deficiency, protein C deficiency, protein S deficiency.
– Major surgery with prolonged immobilization.
– A high risk of venous thromboembolism due to the presence of multiple risk factors.
Presence or risk of arterial thromboembolism (ATE):
– Arterial thromboembolism – current arterial thromboembolism, history of arterial thromboembolism (e.g. myocardial infarction) or prodromal condition (e.g. angina pectoris).
– Cerebrovascular disease – current stroke, history of stroke or prodromal condition (e.g. transient ischaemic attack, TIA).
– Known hereditary or acquired predisposition for arterial thromboembolism, such as hyperhomocysteinaemia and antiphospholipid-antibodies (anticardiolipin-antibodies, lupus anticoagulant).
– History of migraine with focal neurological symptoms.
– A high risk of arterial thromboembolism due to multiple risk factors or to the presence of one serious risk factor such as: Diabetes mellitus with vascular symptoms; Severe hypertension; Severe dyslipoproteinaemia.
– Known or suspected carcinoma of the breast.
– Carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia.
– Hepatic adenomas or carcinoma, or active liver disease, as long as liver function tests have not returned to normal.
– Undiagnosed genital bleeding.
This medicinal product is contraindicated for concomitant use with certain anti-viral hepatitis C virus (HCV) medicinal products such as ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir or sofosbuvir/velpatasvir/voxilaprevir.

If any of the conditions or risk factors mentioned below is present, the suitability of this formulation should be discussed with the woman. In the event of aggravation, or first appearance of any of these conditions or risk factors, the woman should be advised to contact her doctor to determine whether the use of formulation should be discontinued.
Risk of venous thromboembolism (VTE): The use of any combined hormonal contraceptive (CHC) increases the risk of venous thromboembolism (VTE) compared with no use.
Products that contain levonorgestrel, norgestimate or norethisterone are associated with the lowest risk of VTE. Other products such as this formulation may have up to twice this level of risk. The decision to use any product other than one with the lowest VTE risk should be taken only after a discussion with the woman to ensure she understands the risk of VTE with this formulation, how her current risk factors influence this risk, and that her VTE risk is highest in the first ever year of use. There is also some evidence that the risk is increased when a CHC is re-started after a break in use of 4 weeks or more.
In women who do not use a CHC and are not pregnant about 2 out of 10,000 will develop a VTE over the period of one year. However, in any individual woman the risk may be far higher, depending on her underlying risk factors (see below). It is estimated1 that out of 10,000 women who use a CHC containing gestodene between 9 and 12 women will develop a VTE in one year; this compares with about 62 in women who use a levonorgestrel-containing CHC.
Risk factors for VTE: The risk for venous thromboembolic complications in CHC users may increase substantially in a woman with additional risk factors, particularly if there are multiple risk factors (see table). This formulation is contraindicated if a woman has multiple risk factors that put her at high risk of venous thrombosis . If a woman has more than one risk factor, it is possible that the increase in risk is greater than the sum of the individual factors – in this case her total risk of VTE should be considered. If the balance of benefits and risks is considered to be negative a CHC should not be prescribed.
Symptoms of VTE (deep vein thrombosis and pulmonary embolism): In the event of symptoms women should be advised to seek urgent medical attention and to inform the healthcare professional that she is taking a CHC. Symptoms of deep vein thrombosis (DVT) can include:
– unilateral swelling of the leg and/or foot or along a vein in the leg;
– pain or tenderness in the leg which may be felt only when standing or walking,
– increased warmth in the affected leg; red or discoloured skin on the leg
Symptoms of pulmonary embolism (PE) can include:
– sudden onset of unexplained shortness of breath or rapid breathing;
– sudden coughing which may be associated with haemoptysis;
– sharp chest pain;
– severe light headedness or dizziness;
– rapid or irregular heartbeat.
Some of these symptoms (e.g. “shortness of breath”, “coughing”) are non-specific and might be misinterpreted as more common or less severe events (e.g. respiratory tract infections).
Other signs of vascular occlusion can include: sudden pain, swelling and slight blue discoloration of an extremity. If the occlusion occurs in the eye symptoms can range from painless blurring of vision which can progress to loss of vision. Sometimes loss of vision can occur almost immediately.
Risk of arterial thromboembolism (ATE): Epidemiological studies have associated the use of CHCs with an increased risk for arterial thromboembolism (myocardial infarction) or for cerebrovascular accident (e.g. transient ischaemic attack, stroke). Arterial thromboembolic events may be fatal.
Gynaecological Cancers: A meta-analysis of data from 54 international studies demonstrated a slightly higher risk of breast cancer diagnosis among users of oral contraceptives. This increased risk does not appear to be dependent upon the duration of use. The influence of risk factors such as nulliparity or a family history of breast cancer is not established. This increased risk is transient and disappears 10 years after the oral contraceptive is discontinued.
It is possible that the more regular clinical monitoring of women taking oral contraceptives, with increased likelihood of earlier diagnosis, may play an important role in the higher number of breast cancers diagnosed.
Because breast cancer is rare in women under 40 years of age, the excess number of breast cancer diagnoses in current and recent COC users is small in relation to the lifetime risk of breast cancer. Breast cancers diagnosed in ever-users tend to be less advanced clinically than the cancers diagnosed in never-users.
An increased risk of cervical cancer in long-term users of COCs has been reported in some epidemiological studies. However, there continues to be controversy about the extent to which these findings may be due to the confounding effects of sexual behaviour and other factors such as human papilloma virus (HPV).
The published data do not compromise the use of oral contraceptives, as the potential risks appear to be outweighed by the benefits.
In addition, oral contraception decreases the risk of ovarian and endometrial cancers.
Hepatic Neoplasia /Liver Disease: In rare cases benign liver tumours (e.g. focal nodular hyperplasia, hepatic adenomas) and even more rarely, malignant liver tumours have been reported in users of COCs. In isolated cases, these tumours have led to life-threatening intra-abdominal haemorrhage.
Cholestasis has been reported to occur or deteriorate with both pregnancy and COC use, but the evidence of an association with COC use is inconclusive.
Hepatic and hepatobiliary disorders have been reported with COC use. Acute or chronic disturbances of liver function may necessitate the discontinuation of COC use until markers of liver function return to normal.
Headache: The onset or exacerbation of migraine or development of headache with a new pattern that is recurrent, persistent, or severe requires discontinuation of COCs and evaluation of the cause.
Hypertension: Although uncommon, increases in blood pressure have been reported in women taking COCs. In women with hypertension, a history of hypertension or hypertension related diseases (including certain renal diseases), another method of contraception may be preferable. If COCs are used in such cases, close monitoring is recommended and, if a significant increase in blood pressure occurs, COCs should be discontinued.
Medical examination/consultation: Prior to the initiation or reinstitution of this drug a complete medical history (including family history) should be taken and pregnancy must be ruled out. Blood pressure should be measured and a physical examination should be performed, guided by the contra-indications and warnings.
Women should be advised that hormonal contraceptives do not protect against HIV infections (AIDS) and other sexually transmitted diseases.
Caution should be exercised in women with:
– Metabolic disorders such as uncomplicated diabetes.
– Hyperlipidemia (hypertriglyceridemia, hypercholesterolemia). Women who are being treated for hyperlipidemias should be followed closely if they elect to use COCs. Persistent hypertriglyceridemia may occur in a small proportion of COC users.
In patients with elevated triglycerides, estrogen-containing preparations may be associated with rare but large elevations of plasma triglycerides that may lead to pancreatitis.
Obesity
Benign tumours of the breast and uterine dystrophy (hyperplasia, fibroma)
Hyperprolactinemia with or without galactorrhea.
Close surveillance should also be ensured in the presence of conditions, which have been reported to occur or deteriorate with pregnancy or COC use, respectively in patients presenting or with a history of: epilepsy, migraine, otosclerosis, asthma, family history of vascular disease, varicose veins, herpes gestationis, gallstones, systemic lupus erythematosus, cardiac, renal or hepatic dysfunction, depression, hypertension, chorea, haemolytic uremic syndrome.
Exogenous estrogens may induce or exacerbate symptoms of hereditary and acquired angioedema.
Depressed mood and depression are well-known undesirable effects of hormonal contraceptive use. Depression can be serious and is a well-known risk factor for suicidal behaviour and suicide. Women should be advised to contact their physician in case of mood changes and depressive symptoms, including shortly after initiating the treatment.
If melasma/chloasma has appeared during pregnancy or with previous COC use, exposure to sunlight should be avoided to minimize exacerbation of this condition.
Diarrhea and/or vomiting may reduce COC hormone absorption.
Women should be advised that hormonal contraceptives do not protect against HIV infection (AIDS) or other sexually transmitted diseases.
Due to the presence of lactose, this medicinal product is not recommended for use in women with lactose intolerance.
See prescribing information for full details.

Vaginitis, including candidiasis, Mood altered, including depression, nervousness, change in libido, Dizziness, Vomitting, nausea, bloating, Acne, rash, alopecia.
See prescribing information for full details.

Interactions between ethinylestradiol or gestodene and other substances may lead to decreased or increased plasma and tissue concentrations of ethinylestradiol or gestodene. Decreased ethinylestradiol serum concentrations may cause an increased incidence of breakthrough bleeding and menstrual irregularities and may possibly reduce efficacy of the COC. Concomitant use not recommended:
*Enzyme inducing agents such as: anticonvulsants (phenobarbital, phenytoin, primidone, carbamazepine, topiramate); rifabutin; rifampicine; griseofulvine, and possibly St. John’s Wort. Reduction in the efficacy of contraception through increased hepatic metabolism during treatment and for one cycle following treatment discontinuation. Preference should be given to a nonhormonal contraceptive method.
When co-administered with COCs many HIV/HCV protease inhibitors and non-nucleoside reverse transcriptase inhibitors can increase or decrease plasma concentrations of estrogen or progestin. These changes may be clinically relevant in some cases. Please see the corresponding SmPC of each HIV or HCV protease inhibitors and nonnucleoside reverse transcriptase inhibitors for specific recommendation.
Strong and moderate CYP3A4 inhibitors such as azole antifungals (e.g. itraconazole, voriconazole, fluconazole), macrolides (e.g. clarithromycin, erythromycin), verapamil, diltiazem and grapefruit juice can increase plasma concentrations of the estrogen or the progestin or both.
Etoricoxib doses of 60 to 120 mg/day have been shown to increase plasma concentrations of ethinylestradiol 1.4 to 1.6-fold, respectively when taken concomitantly with a combined hormonal contraceptive containing 0.035 mg ethinylestradiol.
The clinical relevance of potential interactions with enzyme inhibitors remains unknown.
*Modafinil: risk of a decreased contraceptive efficacy during treatment and for one cycle following treatment discontinuation.
*Flunarizine: risk of galactorrhea due to increased sensitivity of mammary tissue to prolactin through the action of flunarizine.
*Troleandomycin may increase the risk for intrahepatic cholestasis during co-administration with COCs.
Effects of COCs on other medicinal products
Oral contraceptives may affect the metabolism of certain other drugs. Accordingly, plasma and tissue concentrations may either increase (e.g. cyclosporin) or decrease (e.g. lamotrigine). Clinical data suggests that ethinylestradiol is inhibiting the clearance of CYP1A2 substrates leading to a weak (e.g., theophylline) or to moderate (e.g., tizanidine) increase in their plasma concentration. The labelling of concomitant medications should be consulted to identify potential interactions.
Pharmacodynamic interactions
During clinical trials with patients treated for hepatitis C virus infections (HCV) with medicinal products containing ombitasvir/paritaprevir/ritonavir, dasabuvir with or without ribavirin, transaminase (ALT) elevations higher than 5 times the upper limit of normal (ULN) occurred significantly more frequently in women using ethinylestradiol-containing medications such as combined hormonal contraceptives (CHCs). Additionally, also in patients treated with glecaprevir/pibrentasvir or sofosbuvir/velpatasvir/voxilaprevir, ALT elevations were observed in women using ethinylestradiol-containing medications such as CHCs.
Therefore, users must switch to an alternative method of contraception (e.g., progestagen-only contraception or non-hormonal methods) prior to starting therapy with these combination drug regimens. This drug can be restarted 2 weeks following completion of treatment with these combination drug regimens.
See prescribing information for full details.

Pregnancy: This medicine is not indicated during pregnancy.
Lactation: The use of this medicine in breast-feeding mothers is not advisable since estrogen-progestogens can be found in breast milk. During lactation a different method of contraception should be proposed.
See prescribing information for full details.

Symptoms of oral contraceptive overdose in adults and children may include nausea, vomiting, breast tenderness, dizziness, abdominal pain, drowsiness / fatigue; withdrawal bleeding may occur in females. There are no antidotes and further treatment should be symptomatic.

Storage: Store below 25°C.