Oral contraceptives in Romania: types, prescribing, contraindications

Pe scurt: COC, POP, patches, ring, IUD, implant — a guide to contraception in Romania. WHO MEC criteria, absolute contraindications, prescribing and CNAS reimbursement.

In Romania, oral hormonal contraception is used by under 10% of women of fertile age, according to Eurostat and ESHRE — one of the lowest figures in the EU. More than half of the women who take contraceptives get their first prescription after the age of 25, although the indications begin much earlier. Here is how the types are ranked, what the prescribing criteria are and which contraindications are non-negotiable.

Types of hormonal contraceptives

  • Combined oral (COC) — ethinylestradiol + a progestogen. The most prescribed.
  • Progestogen-only (POP, the "mini-pill") — desogestrel, levonorgestrel, drospirenone. Indicated in recent pregnancy, breastfeeding, oestrogen contraindications.
  • Transdermal patch — Evra. Changed weekly.
  • Vaginal ring — NuvaRing. In place for 3 weeks, 1 week break.
  • Subcutaneous implant — etonogestrel (Implanon NXT) — 3 years.
  • Hormonal IUD — levonorgestrel (Mirena, Kyleena, Jaydess) — 3-8 years.
  • Non-hormonal IUD — Cu (copper) — 5-10 years.
  • Quarterly injection — medroxyprogesterone (Depo-Provera) — every 13 weeks.
  • Emergency contraception — levonorgestrel 1.5 mg (Postinor) or ulipristal acetate (EllaOne).

COCs on the Romanian market — examples

ProductEE (μg)ProgestogenParticularities
Yasmin / Yaz / Midiana30 / 20DrospirenoneReduces oedema, useful in severe PMS
Diane-35 / Belara / Cleyana35 / 30Cyproterone / Chlormadinone / DrospirenoneAntiandrogenic, useful in acne/hirsutism
Logest / Lindynette20 / 20GestodeneMini-dose oestrogen
Marvelon / Mercilon / Novynette30 / 20DesogestrelThrombotic risk slightly higher than levonorgestrel
Microgynon / Femoden30 / 30Levonorgestrel / GestodeneSecond generation, favourable thrombotic profile

Prices and availability vary between Catena, Dona, Help Net, Tei, Dr.Max — check on HartaFarmacii.

How they are prescribed and dispensed

Hormonal contraceptives are P-RF — a prescription retained at the pharmacy. The usual prescribers: a family doctor with prescribing rights, a gynaecologist, an endocrinologist. The first prescription requires an assessment:

  • Family and personal history of venous thrombosis, pulmonary embolism, stroke, early MI.
  • Blood pressure, BMI.
  • Gynaecological examination + Pap smear (every 3 years).
  • Possibly a pelvic ultrasound.

CNAS partially reimburses some forms for non-contraceptive medical indications (endometriosis, hyperandrogenism, dysfunctional bleeding) — check the updated list.

Absolute contraindications (WHO MEC category 4 criteria)

  • Active or past deep vein thrombosis or pulmonary embolism.
  • A known thrombophilic mutation (Factor V Leiden, protein C/S deficiency, antithrombin III).
  • Migraine with aura.
  • Active or recently past breast cancer.
  • Active hepatitis, decompensated cirrhosis, liver tumours.
  • Severe uncontrolled hypertension.
  • Smoking >15 cigarettes/day over the age of 35.
  • Pregnancy.
  • Planned prolonged immobilisation (major surgery).

Frequent side effects vs. rare-serious

  • Frequent: breakthrough bleeding in the first 3 months (resolves spontaneously), breast tenderness, mild nausea, decreased libido, mood changes.
  • Rare but serious: venous thromboembolism (RR 2-4 vs. non-users; absolute risk ~10/10,000 woman-years on COC vs. 4/10,000 without and 20-30/10,000 in pregnancy).
  • New-onset migraine with aura — an alarm signal, stop the COC, neurological evaluation.
  • Increased cardiovascular risk in smokers >35 years — forbidden.

Emergency contraception

  • Levonorgestrel 1.5 mg (Postinor) — maximum efficacy in the first 24h, declining towards 72h. Available OTC.
  • Ulipristal 30 mg (EllaOne) — effective up to 120 hours. OTC.
  • Copper IUD — the most effective (over 99%) up to 5 days post-coital.

Emergency contraception is NOT the same as abortion. It delays or prevents ovulation. If fertilisation has already occurred — it no longer has an effect.

What suits which profile

  • Adolescent without risk factors: mini-dose COC (Logest, Mercilon).
  • Marked acne, hirsutism: Diane-35 or drospirenone (Yasmin, Yaz).
  • Mild migraines without aura: POP or IUD.
  • Migraine with aura: only non-hormonal or POP.
  • Postpartum with breastfeeding: POP, IUD.
  • Woman >40 without risk factors: mini-dose or hormonal IUD.
  • You want "set and forget" contraception: IUD, implant.

Frequently asked questions

I've been on the pill for 6 years, can I still have children?
Yes. Fertility returns within 1-3 cycles. Large studies show there is no long-term impact on fertility.
Do I need to take "breaks" every 1-2 years?
No. An outdated recommendation. Studies show no benefit, only a risk of unwanted pregnancy.
Do antibiotics "cut" the pill?
Only rifampicin and rifabutin. The other antibiotics — no clinically significant impact. If you vomit within <3 hours of taking it or have severe diarrhoea, yes, absorption falls.
Does the pill cause weight gain?
Randomised studies: a minimal or absent effect. Many modern formulations actually reduce water retention.
Can I take the pill continuously, without the 7-day break?
With a monophasic COC — yes, "extended" schemes are validated. Discuss it with the gynaecologist.
Can Postinor be taken several times a month?
Technically yes, but it is not regular contraception — efficacy falls, the cycle is disrupted. If the repeated need arises — switch to a baseline method.

Non-contraceptive benefits of COCs

Beyond contraception, COCs offer documented additional effects, some of them with a real medical indication:

  • Reduced ovarian and endometrial cancer risk — 50% or more with >5 years of use; the protection persists for decades after stopping (Lancet Oncology, Iversen et al.).
  • Reduced acne and hirsutism — formulations with cyproterone, drospirenone, chlormadinone.
  • Endometriosis treatment — a continuous scheme, without a break.
  • Heavy menstrual bleeding — a substantial reduction in flow.
  • Severe premenstrual syndrome (PMDD) — Yaz has an FDA indication.
  • Functional ovarian cysts — reduced recurrence.
  • Menstrual migraines — an extended scheme (90 continuous days) in women without aura.

The IUD — the "set and forget" option

The intrauterine device (IUD) has one of the highest efficacy rates (>99%) and the highest adherence — because, once inserted, it no longer depends on the daily "did I remember the pill?". Two types are available in RO:

  • Copper IUD (T380, NovaT, ParaGard) — non-hormonal, lasts 5-10 years. Indicated in women who avoid hormones. It may increase menstrual flow and cramps.
  • Hormonal IUD (Mirena 8 years, Kyleena 5 years, Jaydess 3 years) — local release of levonorgestrel. It reduces bleeding (many women become amenorrhoeic), treats endometriosis, symptomatic fibroids.

Insertion is done by a gynaecologist, ideally in the first days of the cycle. The discomfort is moderate — premedication with ibuprofen 400 mg an hour before.

Switching between methods

  • From COC to IUD — the IUD is inserted in the first 7 days after the last pill, without extra protection.
  • From COC to implant — the implant is placed in the first 7 days after the last pill, without protection.
  • From nothing to COC — the first pill in the first 5 days of menstruation, without protection; otherwise — 7 days of protection.
  • From POP to COC — at any time, 7 days of protection.
  • Postpartum (without breastfeeding) — COC after 21-28 days (the thromboembolic risk is highest in the first 21 days).
  • Postpartum with exclusive breastfeeding — POP immediately or an IUD after 4 weeks; COC is avoided until 6 months.

Real cases, real decisions

  • 22-year-old student, regular cycle, no risk factors: mini-dose COC (Logest) or Yaz if there is associated acne.
  • 35-year-old smoker: if <15 cigarettes/day — a mini-dose COC may be acceptable; >15 — forbidden. Alternatives: POP, IUD.
  • 38-year-old with heavy bleeding, a small fibroid: a hormonal IUD, Mirena.
  • Woman with migraine with aura: POP (Cerazette) or a hormonal IUD — never COC.
  • A couple wanting 3-5 years of spacing between children: the Implanon NXT implant.
  • Woman with a history of thrombosis: only non-hormonal (copper IUD) or barrier methods.

Sources

  • WHO — Medical Eligibility Criteria for Contraceptive Use 2015
  • ESHRE — European Society of Human Reproduction and Embryology guidelines
  • NICE — Long-acting reversible contraception NG30
  • ANMDMR — SmPCs for COC, POP, emergency contraception
  • EMA — drospirenone-containing combined oral contraceptives review
  • Iversen et al., Lancet Oncology — oncological risks and benefits of COC
  • Faculty of Sexual and Reproductive Healthcare (FSRH) — UK guidelines
  • CNAS — lists B and C; CANAMED