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Sections Updated:
New Indication:
Treatment of heavy menstrual bleeding in women without organic pathology who desire oral contraception. Section 5.1 :Pharmacodynamic properties Additional Information: Qlaira is dosed using an estrogen step-down and a progestin step-up regimen that can be used to treat heavy menstrual bleeding in the absence of an organic pathology, symptoms sometimes referred to as dysfunctional uterine bleeding (DUB). Two multicenter, double blind randomised studies of similar design were performed to evaluate the efficacy and safety of Qlaira in women with symptoms of DUB who desired oral contraception. In total, 269 women were randomised on Qlaira and 152 patients on placebo. After 6 months of treatment the median menstrual blood loss (MBL) was decreased by 88% from 142 mL to 17 mL in the Qlaira group compared to 24% from 154 mL to 117 mL in the placebo group. After 6 months of treatment, the proportion of women who were completely cured from any DUB symptom was 29% in the Qlaira group compared to 2% in the placebo group. 10.0 DATE OF REVISION OF THE TEXT Updated: October 2010 Section 4.8 : Undesirable effects Updated Section: The table below reports adverse reactions (ARs) by MedDRA system organ classes (MedDRA SOCs). The most appropriate MedDRA term (version 12.0) 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. All ADRs listed in the category ‚rare’ occurred in 1 to 2 volunteers resulting in < 0.1%. N= 2,530 women (100.0%) System Organ Class Common (³ 1/100 to 1/10) Uncommon (³ 1/1,000 to <1/100) Rare (³ 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 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 System Organ Class Common (³ 1/100 to 1/10) Uncommon (³ 1/1,000 to <1/100) Rare (³ 1/10,000 to < 1/1,000) 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. spotting17 Vaginal discharge Vulvovaginal dryness Abnormal withdrawal bleeding Benign breast neoplasm Breast cancer in situ Breast cyst Breast discharge Cervical polyp Cervix erythema Coital bleeding Galactorrhea Genital discharge Hypomenorrhoea Menstruation delayed Ovarian cyst ruptured Vaginal odour Vulvovaginal burning sensation Vulvovaginal discomfort Blood and lymphatic system disorders Lymphadenopathy Respiratory, thoracic and mediastinal disorders Asthma Dyspnoea Epistaxis General disorders and administration site conditions Fatigue Irritability Oedema18 Chest pain Malaise Pyrexia Investigations Weight increased Weight decreased Blood pressure changes19 Smear cervix abnormal 1 including vulvovaginal candidiasis and fungus cervical specimen identified 2 including crying and affect lability 3 including loss of libido 4 including mood altered and mood swings 5 including tension headache and sinus headache 6 including migraine with aura and migraine without aura 7 including abdominal distension, abdominal pain upper and abdominal pain lower 8 including alanine aminotransferase increased, aspartate aminotransferase increased and gamma- glutamyltransferase increased 9 including acne pustular 10 including pruritus generalized and rash pruritic 11 including rash macular 12 including dermatitis allergic and urticaria 13 including skin tightness 14 including breast pain, breast tenderness, nipple disorder and nipple pain 15 including menstruation irregular 16 including breast swelling 17 including vaginal hemorrhage, genital hemorrhage and uterine hemorrhage 18 including oedema peripheral 19 including blood pressure increased and blood pressure decreased
Additional Information:
Qlaira is dosed using an estrogen step-down and a progestin step-up regimen that can be used to treat heavy menstrual bleeding in the absence of an organic pathology, symptoms sometimes referred to as dysfunctional uterine bleeding (DUB).
Two multicenter, double blind randomised studies of similar design were performed to evaluate the efficacy and safety of Qlaira in women with symptoms of DUB who desired oral contraception. In total, 269 women were randomised on Qlaira and 152 patients on placebo.
After 6 months of treatment the median menstrual blood loss (MBL) was decreased by 88% from 142 mL to 17 mL in the Qlaira group compared to 24% from 154 mL to 117 mL in the placebo group.
After 6 months of treatment, the proportion of women who were completely cured from any DUB symptom was 29% in the Qlaira group compared to 2% in the placebo group.
Updated:
October 2010
Section 4.8 : Undesirable effects Updated Section: The table below reports adverse reactions (ARs) by MedDRA system organ classes (MedDRA SOCs). The most appropriate MedDRA term (version 12.0) 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. All ADRs listed in the category ‚rare’ occurred in 1 to 2 volunteers resulting in < 0.1%. N= 2,530 women (100.0%) System Organ Class Common (³ 1/100 to 1/10) Uncommon (³ 1/1,000 to <1/100) Rare (³ 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 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 System Organ Class Common (³ 1/100 to 1/10) Uncommon (³ 1/1,000 to <1/100) Rare (³ 1/10,000 to < 1/1,000) 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. spotting17 Vaginal discharge Vulvovaginal dryness Abnormal withdrawal bleeding Benign breast neoplasm Breast cancer in situ Breast cyst Breast discharge Cervical polyp Cervix erythema Coital bleeding Galactorrhea Genital discharge Hypomenorrhoea Menstruation delayed Ovarian cyst ruptured Vaginal odour Vulvovaginal burning sensation Vulvovaginal discomfort Blood and lymphatic system disorders Lymphadenopathy Respiratory, thoracic and mediastinal disorders Asthma Dyspnoea Epistaxis General disorders and administration site conditions Fatigue Irritability Oedema18 Chest pain Malaise Pyrexia Investigations Weight increased Weight decreased Blood pressure changes19 Smear cervix abnormal
Updated Section:
The table below reports adverse reactions (ARs) by MedDRA system organ classes (MedDRA SOCs). The most appropriate MedDRA term (version 12.0) 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. All ADRs listed in the category ‚rare’ occurred in 1 to 2 volunteers resulting in < 0.1%.
N= 2,530 women (100.0%)
System Organ Class
Common (³ 1/100 to 1/10)
Uncommon (³ 1/1,000 to <1/100)
Rare (³ 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
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. spotting17
Vaginal discharge
Vulvovaginal dryness
Abnormal withdrawal bleeding
Benign breast neoplasm
Breast cancer in situ
Breast cyst
Breast discharge
Cervical polyp
Cervix erythema
Coital bleeding
Galactorrhea
Genital discharge
Hypomenorrhoea
Menstruation delayed
Ovarian cyst ruptured
Vaginal odour
Vulvovaginal burning sensation
Vulvovaginal discomfort
Blood and lymphatic system disorders
Lymphadenopathy
Respiratory, thoracic and mediastinal disorders
Asthma
Dyspnoea
Epistaxis
General disorders and administration site conditions
Fatigue
Irritability
Oedema18
Chest pain
Malaise
Pyrexia
Investigations
Weight increased
Weight decreased
Blood pressure changes19
Smear cervix abnormal
1 including vulvovaginal candidiasis and fungus cervical specimen identified
2 including crying and affect lability
3 including loss of libido
4 including mood altered and mood swings
5 including tension headache and sinus headache
6 including migraine with aura and migraine without aura
7 including abdominal distension, abdominal pain upper and abdominal pain lower
8 including alanine aminotransferase increased, aspartate aminotransferase increased and gamma- glutamyltransferase increased
9 including acne pustular
10 including pruritus generalized and rash pruritic
11 including rash macular
12 including dermatitis allergic and urticaria
13 including skin tightness
14 including breast pain, breast tenderness, nipple disorder and nipple pain
15 including menstruation irregular
16 including breast swelling
17 including vaginal hemorrhage, genital hemorrhage and uterine hemorrhage
18 including oedema peripheral
19 including blood pressure increased and blood pressure decreased