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Estradiol valerate and (estradiol valerate with dienogest) oral


Tablets containing estradiol valerate and estradiol valerate with dienogest

Drugs List

  • estradiol valerate and (estradiol valerate with dienogest) tablets
  • QLAIRA tablets
  • Therapeutic Indications


    Contraception - oral
    Menorrhagia where oral contraception is also desired



    One tablet is taken daily for 28 consecutive days at the same time each day. Tablet taking is continuous.

    Patients must take the tablets in the order directed on the packaging.

    Each subsequent pack is to be started the day after the last tablet of the previous pack.

    Starting therapy
    No preceding hormonal contraceptive use (in the past month)
    Tablet taking is to start on day 1 of the patient's menstrual cycle (i.e. on the first day of menstrual bleeding).

    Changing from an oral combined hormonal contraceptive, vaginal ring or transdermal patch
    Tablet taking is to start on the day after the last active tablet or on the day of removal of the previous hormonal contraceptive.

    Changing from a progestogen-only method (minipill, implant or injection) or from a progestogen-releasing intrauterine system (IUS)
    Patients taking the minipill may switch therapy on any day of the cycle. Patients using an IUS or implant should start treatment on the day of the removal of the previous contraceptive device. Patients receiving progestogen injection should start therapy on the day in which the next injection would be due. Additional contraceptive precautions should be taken for the first 9 days.

    Following first-trimester abortion
    Patient may start immediately. When doing so, no additional contraceptive methods are required.

    Following delivery (not breastfeeding) or second-trimester abortion
    Patient should be advised to begin therapy between days 21 and 28 following delivery or abortion. If therapy is started later, additional barrier contraceptive will be required for the first 9 days of therapy. If intercourse has already occurred, pregnancy should be excluded before initiating therapy.

    Additional Dosage Information

    If vomiting occurs within 3 to 4 hours of taking an active tablet, the next tablet should be taken as soon as possible. This tablet should be taken within 12 hours of the usual time. Where more than 12 hours have elapsed, the advice concerning missed tablets below should be followed.

    Missed tablets
    If the patient is less than 12 hours late, the tablet should be taken and no additional contraceptive protection will be required. Tablet taking may continue as normal.

    If the patient is more than 12 hours late, contraceptive efficacy may be reduced and the patient should follow the following advice:

    Tablet missed between days 1 to 17
    Take missed tablet immediately and the following tablet as normal, even if this means taking two tablets during the same day.
    Continue with tablet taking in the normal way, use additional contraception for the next 9 days.

    Tablet missed between days 18 to 24
    Discard current pack and immediately start with the first pill of the next pack.
    Continue this pack as normal, use additional contraception for the next 9 days.

    Tablet missed between days 25 to 26
    Take missed tablet immediately and the following tablet as usual (even if this means taking two tablets on the same day).
    Continue with tablet taking in the normal way, no additional contraception required.

    Tablet missed between days 27 to 28 (inactive tablets)
    Discard missed tablet and continue with tablet taking in the normal way.
    No additional contraception required.

    No more than two tablets are to be taken on a given day.

    If the patient has forgotten to start a new pack or has missed a tablet during days 3 to 9 of the pack, she may be pregnant if she has had intercourse in the previous 7 days. Risk of pregnancy increases between tablets 3 to 24 and with increased number of missed tablets. If the patient misses tablets and has no withdrawal bleed at the end of the pack the possibility of pregnancy should be considered. In all these cases, pregnancy should be excluded before continuing therapy.


    Children under 18 years
    Major surgery with prolonged post-operative immobilisation
    Predisposition to thromboembolic disease
    Abnormal liver function test
    Atherogenic lipid profile
    Breastfeeding - until weaning or 6 months post partum
    Cerebrovascular disorder
    Diabetes mellitus with vascular involvement
    Focal migraine
    Hepatic neoplasm
    History of hepatic neoplasm
    History of myocardial infarction
    History of thromboembolic disorder
    Myocardial infarction
    Oestrogen dependent neoplasm
    Severe dyslipoproteinaemia
    Severe hepatic impairment
    Severe hypertension
    Undiagnosed gynaecological haemorrhage

    Precautions and Warnings

    Body mass index above 30kg per square metre
    Family history of thromboembolic disorder
    Females over 35 years
    Major surgery
    Severe trauma
    Tobacco smoking
    Atrial fibrillation
    Cardiac valvulopathy
    Chronic inflammatory bowel disease
    Diabetes mellitus
    Epileptic disorder
    Familial hypertriglyceridaemia
    Glucose-galactose malabsorption syndrome
    Haemolytic uraemic syndrome
    History of angioedema
    History of chloasma
    History of cholelithiasis
    History of cholestatic jaundice during pregnancy
    History of herpes gestationis
    History of migraine
    History of pruritus during pregnancy
    Lactose intolerance
    Malignant neoplasm
    Non focal aura migraine
    Renal impairment
    Sickle cell disease
    Sydenham's chorea
    Systemic lupus erythematosus

    Assess family medical history prior to commencing treatment
    Exclude oestrogen dependent neoplasm before treatment
    Contains lactose
    Resume use only after 2wks full ambulation from surgery/immobilisation
    Do breast & pelvic exam. before & during treatment if clinically indicated
    Exclude pregnancy prior to initiation of treatment
    If upper abdominal complaints/liver enlargement consider liver tumour
    May induce insulin resistance
    Monitor blood glucose closely in patients with diabetes mellitus
    Advise patient of thromboembolic symptoms and to report them if they occur
    Consider discontinuing treatment if hepatotoxicity occurs
    Increased risk of VTE during travel involving >5hr immobilisation
    Irregular vaginal bleeding may occur
    May affect results of some laboratory tests
    Discontinue 4 - 6 weeks before major surgery
    Discontinue if cholestatic jaundice occurs
    Discontinue if epilepsy is exacerbated
    Discontinue if first occurrence or worsening of migraine/severe headache
    Discontinue if headache assoc with weakness/numbness one side/part occurs
    Discontinue if headache associated with sudden dysphasia or vertigo occurs
    Discontinue if headache associated with syncope or collapse occurs
    Discontinue if headache with sudden partial/complete vision loss occurs
    Discontinue if severe pain in the calf of one leg occurs
    Discontinue if sudden breathlessness (or cough with blood stained sputum)
    Discontinue if sudden pain in the chest occurs
    Discontinue if suspicion of thrombosis/infarction
    Interrupt therapy if severe hypertension requiring medical treatment occurs
    Advise patient grapefruit products may increase plasma level
    Advise patient concurrent St John's wort may reduce contraceptive effect
    Missed dose, severe GI disturbances and vomiting may impair efficacy
    Advise patient to read the leaflet in the pack
    All contraceptive pills slightly increase the risk of breast cancer
    Treatment does not protect against risk of sexually transmitted disease
    Women with a history of chloasma should avoid exposure to sun/UV light

    Assessment of women prior to starting oral contraceptives (and at regular intervals thereafter) should include a personal and family medical history of each woman. Physical examination should be guided by this and by the contraindications, precautions and warnings for this product. The frequency and nature of these assessments should be based upon relevant guidelines and should be adapted to the individual woman, but should include measurement of blood pressure and, if judged appropriate by the clinician, breast, abdominal and pelvic examination including cervical cytology.

    Pregnancy and Lactation


    Estradiol valerate and (estradiol valerate with dienogest) is contraindicated in pregnancy.

    Should pregnancy occur, treatment should be discontinued immediately.

    Epidemiological studies with ethinylestradiol containing combined oral contraceptives (COCs) have revealed neither an increased risk of birth defects in children born to women who used COCs prior to pregnancy, nor a teratogenic effect when COCs were taken inadvertently during pregnancy. Animal studies do not indicate a risk for reproductive toxicity.

    Schaefer (2007) advises that accidental use of oral contraceptives during early pregnancy does not require termination or further diagnostic measures.

    The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( ) or if this is unavailable at the backup site ( ).


    Estradiol valerate and (estradiol valerate with dienogest) is contraindicated in breastfeeding.

    Manufacturer advises that combined oral contraceptives may adversely affect the quality and quantity of breast milk. Small amount of contraceptive steroids may be excreted within milk and these amounts may affect the child

    The use of non-hormonal contraceptive methods is preferred during breastfeeding. It is not recommended to initiate combined hormonal contraceptives until 6 weeks postpartum. During 6 weeks and 6 months postpartum the potential suppression of lactation usually outweighs the advantages of combined hormonal contraceptives. Progestin-only contraceptives are preferred over combined hormonal contraceptives.

    Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
    Specialist advice is available from the UK Drugs in Lactation Advisory Service at

    Side Effects

    "Spotting" bleeding
    Abdominal pain
    Allergic reaction
    Arterial thrombosis
    Attention disturbances
    Back pain
    Benign breast neoplasm
    Breast discomfort
    Breast enlargement
    Breast neoplasm
    Breast secretion
    Cervical dysplasia
    Changes in libido
    Chest pain
    Eye disorder
    Fibrocystic breast changes
    Fluid retention
    Fungal infection
    Gastroesophageal reflux disease
    Genital bleeding
    Hepatic tumours
    Herpes simplex
    Hypersensitivity reactions
    Increase in ALT level
    Increased appetite
    Increased skin pigmentation
    Intolerance to contact lenses
    Jaw pain
    Lability of affect
    Menstrual disturbances
    Mental status changes
    Mood changes
    Muscle spasm
    Myocardial infarction
    Ovarian cysts
    Pelvic inflammatory disease
    Pelvic pain
    Postcoital bleeding
    Premenstrual-like syndrome
    Sensation of heaviness
    Skin disorder
    Sleep disturbances
    Urinary tract infections
    Uterine bleeding
    Uterine fibroids
    Uterine spasm
    Vaginal discharge
    Vaginal odour
    Varicose veins
    Venous thrombosis
    Vulvovaginal disorders
    Weight changes


    It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

    The following number will direct the caller to the relevant local centre (0844) 892 0111

    Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( ) or if this is unavailable at the backup site ( ).

    Further Information

    Last Full Review Date: February 2016

    Reference Sources

    Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 2nd edition (2007) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

    Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 9th edition (2011) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia.

    Joint Formulary Committee. British National Formulary. 70th ed. London: BMJ Group and Pharmaceutical Press; 2015.

    Summary of Product Characteristics: Qlaira, film-coated tablets. Bayer plc. Revised November 2015.

    US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
    Available at:
    Contraceptives, Oral, Combined. Last revised: 10 December 2015

    The Norwegian Porphyria Centre (NAPOS).
    Available at:
    Last revised: 02 November 2015
    Last accessed: 22 February 2016

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