Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects
- Contact a doctor immediately if you experience any of the following symptoms of angioedema: swollen face, tongue and/or throat and/or difficulty swallowing or hives potentially with difficulty breathing (see also section “Warnings and precautions” on the Rigevidon Package leaflet: Information for the user).
- An increased risk of blood clots in the veins (venous thromboembolism (VTE)) or blood clots in the arteries (arterial thromboembolism (ATE)) is present for all women using combined hormonal contraceptives. For more detailed information on the different risks from taking combined hormonal contraceptives please see section 2 “What you need to know before you take Rigevidon” on the Rigevidon Package leaflet: Information for the user).
The following side effects have been reported in women using the pill, which can occur in the first few months after starting Rigevidon, but they usually stop once your body has adjusted to the pill.
Common side effects (may affect up to 1 in 10 people)
- vaginitis, including vaginal candidiasis
- mood swings including depression
- changes in interest in sex
- nervousness
- dizziness
- feeling sick
- being sick
- abdominal pain
- acne
- tender breast
- breast pain
- breast enlargement and discharge
- painful menstruation
- abnormality of cervix (change in cervical ectropion) and vaginal secretion
- no or reduced bleeding
- fluid retention/edema
- changes in weight
Uncommon side effects (may affect up to 1 in 100 people)
- changes in appetite
- elevated blood pressure
- abdominal cramps
- bloating
- rash
- chloasma (yellow brown patches on the skin), which may persist
- excessive hair growth
- hair loss
- changes in serum lipid levels including hypertriglyceridemia
Rare side effects (may affect up to 1 in 1,000 people)
Severe allergic reaction (anaphylactic reaction with very rare cases of hives, swelling of face, tongue, severe circulatory and respiratory disorders), glucose intolerance, eye irritation when wearing contact lenses, yellowing of the skin (jaundice), the skin condition erythema nodosum (characterized by painful reddish skin nodules), harmful blood clots in a vein or artery for example:
- in a leg or foot (i.e. DVT)
- in a lung (i.e. PE)
- heart attack
- stroke
- mini-stroke or temporary stroke-like symptoms, known as a transient ischaemic attack (TIA)
- blood clots in the liver, stomach/intestine, kidneys or eye
The chance of having a blood clot may be higher if you have any other conditions that increase this risk (See section 2 for more information on the conditions that increase risk for blood clots and the symptoms of a blood clot).
Very rare side effects (may affect up to 1 in 10,000 people)
- benign or malignant tumour of liver
- aggravation of immune system disease (lupus)
- aggravation of porphyria
- exacerbation of chorea (an involuntary movement disorder)
- inflammation of the optic nerve
- blood clots in the blood vessels of the eye
- aggravation of varicose veins
- inflammation of the large intestine (ischaemic colitis)
- inflammation of the pancreas
- gallbladder disease (including gallstones)
- erythema multiforme (characterized by rash with target-shaped reddening or sores)
- a blood disorder called haemolytic uraemic syndrome - HUS (a disorder where blood clots cause the kidneys to fail)
- decrease in serum folate levels
Not known (frequency cannot be estimated from the available data)
Inflammatory bowel disease (Crohn’s Disease, ulcerative colitis), hepatocellular injury (e.g. hepatitis, hepatic function abnormal).
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed here.
