Loading…
QLAIRA is a brand name for Dienogest. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Oral contraception. Treatment of heavy menstrual bleeding in women without organic pathology who desire oral contraception. The decision to prescribe Qlaira should take into consideration the individual woman’s current risk factors, particularly those for venous thromboembolism (VTE), and how the risk of VTE with…
Verbatim from this product's MHRA label. Tap a section to expand.
Method of administration Oral use Posology How to take Qlaira Tablets must be taken in the order directed on the package every day at about the same time with some liquid as needed. Tablet taking is continuous. One tablet is to be taken daily for 28 consecutive days.
Each subsequent pack is started the day after the last tablet of the previous wallet. Withdrawal bleeding usually starts during the intake of the last tablets of a wallet and may not have finished before the next wallet is started. In some women, the bleeding starts after the first tablets of the new wallet are taken.
e. the first day of her menstrual bleeding). • Changing from a combined hormonal contraceptive (combined oral contraceptive /COC), vaginal ring, or transdermal patch The woman should start with Qlaira on the day after the last active tablet (the last tablet containing the active substances) of her previous COC.
In case a vaginal ring or transdermal patch has been used, the woman should start using Qlaira on the day of removal. • Changing from a progestogen-only method (progestogen-only pill, injection, implant) or from a progestogen-releasing intrauterine system (IUS) The woman may switch any day from the progestogen-only pill (from an implant or the IUS on the day of its removal, from an injectable when the next injection would be due), but should in all of these cases be advised to additionally use a barrier method for the first 9 days of tablet-taking.
• Following first-trimester abortion The woman may start immediately. When doing so, she needs not take additional contraceptive measures. 6. Women should be advised to start at day 21 to 28 after delivery or second-trimester abortion.
When starting later, the woman should be advised to additionally use a barrier method for the first 9 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.
Management of missed tablets Missed (white) placebo tablets can be disregarded. However, they should be discarded to avoid unintentionally prolonging the interval between active-tablet taking.
The following advice only refers to missed active tablets:
If the woman is less than 12 hours late in taking any tablet, contraceptive protection is not reduced. The woman should take the tablet as soon as she remembers and should take further tablets at the usual time. If she is more than 12 hours late in taking any tablet, contraceptive protection may be reduced.
Summary of the safety profile The most commonly reported adverse reactions with Qlaira when used as an oral contraceptive or in the treatment of heavy menstrual bleeding in women without organic pathology who desire oral contraception are acne, breast discomfort, headache, intracyclic bleeding, nausea and weight increased.
4. Tabulated list of adverse reactions The table below reports adverse reactions (ARs) by MedDRA system organ classes (MedDRA SOCs). 0) to describe a certain adverse reaction is listed. Synonyms or related conditions are not listed, but should be taken into account as well.
The frequencies are based on clinical trial data. The adverse reactions were recorded in 5 phase III clinical studies (N=2,266 women at risk for pregnancy, N=264 women suffering from dysfunctional uterine bleeding without organic pathology who desire oral contraception) and considered at least possibly causally related to Qlaira use.
1%. 0%) System Organ Class Common (≥ 1/100 to <1/10) Uncommon (≥ 1/1,000 to <1/100) Rare (≥ 1/10,000 to < 1/1,000) Infections and infestations Fungal infection Vulvovaginal mycotic infection1 Vaginal infection Candidiasis Oral herpes Pelvic inflammatory disease Presumed ocular histoplasmosis syndrome Tinea versicolor Urinary tract infection Vaginitis bacterial Metabolism and nutrition disorders Increased appetite Fluid retention Hypertriglyceridaemia Psychiatric disorders Depression/depressed mood Emotional disorder2 Insomnia Libido decreased3 Mental disorder Mood change4 Aggression Anxiety Dysphoria Libido increased Nervousness Nightmare Restlessness Sleep disorder Stress Nervous system disorders Headache5 Dizziness Migraine6 Disturbance in attention Paraesthesia Vertigo Eye disorders Contact lens intolerance Dry eye Eye swelling Cardiac disorders Myocardial infarction Palpitations Vascular disorders Hot flush Hypertension Bleeding varicose vein Venous thromboembolism (VTE) Arterial thromboembolism (ATE) Hypotension Phlebitis superficialis Vein pain Gastrointestinal disorders Abdominal pain7 Nausea Diarrhoea Vomiting Constipation Dry mouth Dyspepsia Gastrooesophageal reflux disease Hepatobiliary disorders Liver enzymes increased8 Focal nodular hyperplasia of the liver Cholecystitis chronic Skin and subcutaneous tissue disorders Acne9 Alopecia Hyperhidrosis Pruritus10 Rash11 Allergic skin reaction12 Chloasma Dermatitis Hirsutism Hypertrichosis Neurodermatitis Pigmentation disorder Seborrhoea Skin disorder13 Musculoskeletal and connective tissue disorders Muscle spasms Back pain Pain in jaw Sensation of heaviness Renal and urinary disorders Urinary tract pain Reproductive system and breast disorders Amenorrhea Breast discomfort14 Dysmenorrhoea Intracyclic bleeding (Metrorrhagia)15 Breast enlargement16 Breast mass Cervical dysplasia Dysfunctional uterine bleeding Dyspareunia Fibrocystic breast disease Menorrhagia Menstrual disorder Ovarian cyst Pelvic pain Premenstrual syndrome Uterine leiomyoma Uterine spasm Uterine/ vaginal bleeding incl.
Warnings If any of the conditions or risk factors mentioned below is present, the suitability of Qlaira 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 Qlaira should be discontinued.
In case of suspected or confirmed VTE or ATE, CHC use should be discontinued. In case anticoagulant therapy is started, adequate alternative contraception should be initiated because of the teratogenicity of anticoagulant therapy (coumarins).
The following warnings and precautions are mainly derived from clinical and epidemiological data of ethinyl estradiol containing COCs. • Circulatory Disorders 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. Limited data suggests that Qlaira may have a risk of VTE in the same range. The decision to use any other product (such as Qlaira) than one known to have the lowest VTE risk should be taken only after a discussion with the woman to ensure she understands the risk of VTE with CHCs, 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). Epidemiological studies in women who use low dose (<50 μg ethinylestradiol) combined hormonal contraceptives have found that out of 10,000 women between about 6 and 12 will develop a VTE in one year It is estimated that out of 10,000 women who use a levonorgestrel-containing CHC about 61 will develop a VTE in one year.
3. Patients with renal impairment Qlaira has not been specifically studied in renally impaired patients. 3 Contraindications Combined hormonal contraceptives (CHCs) should not be used in the following conditions. Should any of the conditions appear for the first time during CHC use, the product should be stopped immediately.
g. g. g. g. transient ischaemic attack, TIA) o Known hereditary or acquired predisposition for arterial thromboembolism, such as hyperhomocysteinaemia and antiphospholipid-antibodies (anticardiolipin-antibodies, lupus anticoagulant). o History of migraine with focal neurological symptoms.
4) or to the presence of one serious risk factor such as: • diabetes mellitus with vascular symptoms • severe hypertension • severe dyslipoproteinaemia • Presence or history of severe hepatic disease as long as liver function values have not returned to normal.
• Presence or history of liver tumours (benign or malignant). g. of the genital organs or the breasts). • Undiagnosed vaginal bleeding. 1.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Dienogest in United Kingdom.
Know a brand we are missing in United Kingdom? Suggest a brand →
Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
g. 0 mg EV) - Take the missed tablet immediately - Take the next tablet at the same time as usual (even if this means taking two tablets at the same day) - Continue taking one tablet each day at the time as usual - No back-up contraception necessary 27-28 White tablets (Placebos) - Discard the missed tablet - Take the next tablet at the same time as usual - When the last tablet is missed in the current wallet, continue taking the first tablet from the new wallet at the same time as usual - No back-up contraception necessary Not more than two tablets are to be taken on a given day.
If a woman has forgotten to start a new wallet, or if she has missed one or more tablets during days 3 -9 of the wallet, she may already be pregnant (provided she has had intercourse in the 7 days before the oversight). The more tablets (of those with the two combined active ingredients on days 3 – 24) that are missed and the closer they are to the placebo tablet phase, the higher the risk of a pregnancy.
If the woman missed tablets and subsequently has no withdrawal bleed at the end of the wallet /beginning of new wallet, the possibility of a pregnancy should be considered. , vomiting or diarrhoea), absorption may not be complete and additional contraceptive measures should be taken.
If vomiting occurs within 3-4 hours after active tablet-taking, the next tablet should be taken as soon as possible. This tablet should be taken within 12 hours of the usual time of tablet-taking, if possible. 2 “Management of missed tablets”, is applicable.
If the woman does not want to change her normal tablet-taking schedule, she has to take the corresponding tablet(s) needed from another pack. Additional information on special populations Children and adolescents No data available for use in adolescents below 18 years.
Geriatric patients Qlaira is not indicated after menopause. Patients with hepatic impairment Qlaira is […]
4. 4 Cycle control. 4 Special warning and precautions for use: Tumours - The frequency of diagnosis of breast cancer is very slightly increased among COC users. As breast cancer is rare in women under 40 years of age the excess number is small in relation to the overall risk of breast cancer.
Causation with COC use is unknown. 4; - Liver tumours; Other conditions - Erythema nodosum, Erythema multiforme; - Breast discharge; - Hypertension; - Occurrence or deterioration of […]
Limited epidemiological evidence suggests that the risk of VTE with the use of Qlaira may be in the same range as the risk with other CHCs, including CHCs containing levonorgestrel. The number of VTEs per year with low dose CHCs is fewer than the number expected in women during pregnancy or in the postpartum period.
VTE may be fatal in 1-2% of the cases. g. hepatic, mesenteric, renal or retinal veins and arteries. 6 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).
3). 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. 3).
Table:
Risk factors for VTE Risk factor Comment Obesity (body mass index over 30 kg/m²) Risk increases substantially as BMI rises. Particularly important to consider if other risk factors also present. Prolonged immobilisation, major surgery, any surgery to the legs or pelvis, neurosurgery, or major trauma Note: temporary immobilisation including air travel >4 hours can also be a risk factor for VTE, particularly in women with other risk factors In these situations it is advisable to discontinue use of the pill (in the case of elective surgery at least four weeks in advance) and not resume until two weeks after complete remobilisation.
Another method of contraception should be used to avoid unintentional pregnancy. Antithrombotic treatment should be considered if Qlaira has not been discontinued in advance. g. before 50). If a hereditary predisposition is suspected, the woman should be referred to a specialist for advice before deciding about any CHC use Other medical conditions associated with VTE Cancer, systemic lupus erythematosus, haemolytic uraemic syndrome, chronic inflammatory bowel disease (Crohn’s disease or ulcerative colitis) and sickle cell disease Increasing age Particularly above 35 years There is no consensus about the possible role of varicose veins and superficial thrombophlebitis in the onset or progression of venous thrombosis.
6). 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: o unilateral swelling of the leg and/or foot or along a vein in the leg o pain or tenderness in the leg which may be felt only when standing or walking o increased warmth in the affected leg; red or discoloured skin on the leg.
Symptoms of pulmonary embolism (PE) can include: o sudden onset of unexplained shortness of breath or rapid breathing o sudden coughing which may be associated with haemoptysis o sharp chest pain o severe light headedness or dizziness o rapid or irregular heartbeat.
g. g. […]