# Premenstrual Syndrome (PMS)

- Category: acute
- Review status: reviewed (every claim checked against a document named on this page)
- Sources: Egyptian National Drug Formulary - Cardiovascular 2024 (spironolactone monograph) · Fluoxetine 20 mg Capsules SmPC section 4.2 Posology and method of administration (eMC product 11909) · Ibuprofen 100 mg/5 ml SmPC section 4.2 (eMC product 4560) · European Union herbal monograph on Vitex agnus-castus L., fructus, EMA/HMPC/606742/2017, final 27 March 2018, sections 4.1 Therapeutic indications, 4.2 Posology and method of administration, 4.3 Contraindications and 4.4 Special warnings and precautions for use (well-established use column) · ELOINE 0.02 mg / 3 mg film coated tablets SmPC section 4.3 Contraindications (eMC product 6967)
- Verified date: 2026-08

## Verified against

- SmPC section 4.2, https://www.medicines.org.uk/emc/product/11909/smpc
- SmPC section 4.2, https://www.medicines.org.uk/emc/product/4560/smpc
- Premenstrual Syndrome - disease-level clinical article (premenstrual-syndrome-clinical.txt)
- European Union herbal monograph on Vitex agnus-castus L., fructus, EMA/HMPC/606742/2017, final 27 March 2018, sections 4.1 Therapeutic indications, 4.2 Posology and method of administration, 4.3 Contraindications and 4.4 Special warnings and precautions for use (well-established use column)
- Premenstrual Syndrome - disease-level clinical article (premenstrual-syndrome-full.txt)
- ELOINE 0.02 mg / 3 mg film coated tablets SmPC section 4.3 Contraindications (eMC product 6967)

## Treatment metadata

- Ibuprofen — 400 mg — oral.solid
- Referral & safety-netting (no drug therapy)
- Ethinylestradiol + Drospirenone — oral.solid
- Vitex agnus-castus — oral.solid

## Complete treatment card

```text
PREMENSTRUAL SYNDROME (PMS)
Sources: Egyptian National Drug Formulary - Cardiovascular 2024 (spironolactone monograph) ·
         Fluoxetine 20 mg Capsules SmPC section 4.2 Posology and method of administration (eMC
         product 11909) · Ibuprofen 100 mg/5 ml SmPC section 4.2 (eMC product 4560) · European Union
         herbal monograph on Vitex agnus-castus L., fructus, EMA/HMPC/606742/2017, final 27 March
         2018, sections 4.1 Therapeutic indications, 4.2 Posology and method of administration, 4.3
         Contraindications and 4.4 Special warnings and precautions for use (well-established use
         column) · ELOINE 0.02 mg / 3 mg film coated tablets SmPC section 4.3 Contraindications (eMC
         product 6967)
Review status: REVIEWED against SmPC section 4.2,
               https://www.medicines.org.uk/emc/product/11909/smpc, SmPC section
               4.2, https://www.medicines.org.uk/emc/product/4560/smpc,
               Premenstrual Syndrome - disease-level clinical article
               (premenstrual-syndrome-clinical.txt), European Union herbal
               monograph on Vitex agnus-castus L., fructus, EMA/HMPC/606742/2017,
               final 27 March 2018, sections 4.1 Therapeutic indications, 4.2
               Posology and method of administration, 4.3 Contraindications and 4.4
               Special warnings and precautions for use (well-established use
               column), Premenstrual Syndrome - disease-level clinical article
               (premenstrual-syndrome-full.txt), ELOINE 0.02 mg / 3 mg film coated
               tablets SmPC section 4.3 Contraindications (eMC product 6967)
               (2026-08)

IS IT THIS? - reference only, to read alongside your own examination
  SYMPTOMS - what the patient reports (8)
    - Physical and mood complaints include bloating, breast tenderness, headache, low back pain,
      nausea, constipation, irritability, anger, fatigue, and crying spells  [abdominal distension ·
      back pain · breast pain · constipation · fatigue · headache · irritability · nausea]
    - Symptoms usually last a few days up to two weeks, worsening about a week beforehand and
      peaking two days before menses
    - Alcohol use carries a moderately higher risk of developing the condition
    - The complaints belong to the second half of the cycle, after ovulation, and they disable
      rather than merely annoy
    - They go within a few days of the period starting, which is the feature that makes the
      diagnosis
    - Close to half of women of reproductive age worldwide are affected
    - About 1 in 5 of those are disrupted in daily life by it; the rest are mild to moderate
    - Appetite change, weight gain, abdominal pain, restlessness and mood swings belong on the list
      too  [abdominal pain · irritability · weight gain]
  TESTS (2)
    - A symptom diary kept across consecutive cycles confirms whether the pattern repeats cycle to
      cycle
    - FSH, estradiol, TSH, prolactin, and cortisol are drawn to exclude thyroid disease, Cushing
      syndrome, and hyperprolactinemia
  IF NOT THIS - what else fits (3)
    - Substance abuse and mood disorders such as depression, anxiety, dysthymia, or panic, along
      with anemia, can mimic the picture
    - Anorexia, bulimia, endometriosis, dysmenorrhea, hypothyroidism, oral contraceptive use, and
      perimenopause are also on the list
    - Premenstrual dysphoric disorder is the severe form of the same thing, and DSM-5 lists it as a
      psychiatric diagnosis
  Source  StatPearls "Premenstrual Syndrome" - disease-level clinical article
  Status  traced to the source above

Rx: Main treatment  |  Herbal medicinal product with a European monograph - the one herbal the
    article endorses

MAIN TREATMENT - choose one
1. IBUPROFEN                                              [1st line]
   Adult    200-400 mg PO Q6-8H PRN, max 1200 mg/day. - Up to 10 days
   Peds     20 mg/kg/day in divided doses
   Source   SmPC section 4.2, https://www.medicines.org.uk/emc/product/4560/smpc
   Why      Standard NSAID dose for the cyclical pain of PMS; the anti-inflammatory dose used for
            genuine inflammatory disease is not needed here.
   Caution  First-line for premenstrual cramping, headache, and general aches; take with or after
            food.
            Avoid in NSAID-exacerbated asthma, active peptic ulcer disease, or pregnancy.
            For predictable symptoms, can be started a day or two before the expected onset of pain.
   Egypt    DAJUANOFEN 400 MG 20 F.C. TABS.  COPAD PHARMA         5.00 EGP (0.25/unit)
            FLABU 400MG 10 F.C.TAB.          DELTA PHARMA         3.75 EGP (0.38/unit)
            NOVA-PROFEN 400MG 30 F.C. TABLETS SANOFI                           12.75 EGP (0.42/unit)
            IBUPROFEN 400 MG 10 TAB.         SEDICO               6.00 EGP (0.60/unit)
            MAFO 400 MG  30 F.C.TABS         EIPICO              42.00 EGP (1.40/unit)
            BRUFEN 400 MG 30 TABS.           KAHIRA > ABBO...    78.00 EGP (2.60/unit)
            PROFUSOL 400MG 20 S.G CAPS.      EUROPEAN EGYP...    31.00 EGP
            ANALGIPROF 400 MG 25 SACHETS     EVA PHARMA          37.50 EGP
            NOVA-PROFEN  100MG/5ML ORAL SUSP. 100ML SANOFI                                  2.25 EGP
                -> ? strength differs, ? different route - not oral solid
            BRUFEMOL-N SUSP. 60 ML           ARAB DRUG COM...     4.50 EGP
                -> ? strength differs, ? different route - not oral solid

2. REFERRAL & SAFETY-NETTING (NO DRUG THERAPY)            [1st line]
   Adult    
   Source   Premenstrual Syndrome - disease-level clinical article (premenstrual-syndrome-
            clinical.txt)
   Why      Carries the referral criteria and warning signs for this condition, which apply
            whichever treatment is chosen.
   Caution  RED FLAG - There is an increased suicidal risk in hormone-sensitive females with PMS.

3. ETHINYLESTRADIOL + DROSPIRENONE                        [2nd line]
   Adult    0.02 mg ethinyl estradiol + 3 mg drospirenone daily for 24 days followed by hormone-
            inactive pills for 4 days
   Peds     No paediatric dose is stated in the sources held for this drug.
   Source   Premenstrual Syndrome (PMS) - disease-level clinical article (premenstrual-syndrome-
            clinical.txt)
   Why      Combined oral contraceptive pill with anti-mineralocorticoid progestin used to suppress
            ovulation and manage severe premenstrual dysphoric symptoms.
   Caution  CONTRAINDICATED, label verbatim (ELOINE 0.02 mg / 3 mg film coated tablets, section
            4.3): "Presence or risk of venous thromboembolism (VTE)" (<meta name="description"
            content="ELOINE 0.02 mg / 3 mg film coated tablets SmPC, eMC product 6967); "Presence or
            risk of arterial thromboembolism (ATE)" (<meta name="description" content="ELOINE 0.02
            mg / 3 mg film coated tablets SmPC, eMC product 6967); "Presence or history of severe
            hepatic disease as long as liver function values have not returned to normal" (<meta
            name="description" content="ELOINE 0.02 mg / 3 mg film coated tablets SmPC, eMC product
            6967); "Severe renal insufficiency or acute renal failure" (<meta name="description"
            content="ELOINE 0.02 mg / 3 mg film coated tablets SmPC, eMC product 6967); "Known or
            suspected sex-steroid influenced malignancies (e.g. of the genital organs or the
            breasts)" (<meta name="description" content="ELOINE 0.02 mg / 3 mg film coated tablets
            SmPC, eMC product 6967); "Undiagnosed vaginal bleeding" (<meta name="description"
            content="ELOINE 0.02 mg / 3 mg film coated tablets SmPC, eMC product 6967).
            Increased risk of venous thromboembolism relative to older progestin generations.
            Monitor blood pressure and serum potassium.
   Egypt    DORMOVARIN 0.03/3MG 21 TABS.     CID                 27.60 EGP (1.31/unit)
            DROSMING 0.03/3MG 21 TABS.       P & C LABS          50.50 EGP (2.40/unit)
            NOROCARMENA 0.02/3MG 28 F.C.TAB. LABORATOIRES ...   103.00 EGP (3.68/unit)
            ESTRAMARK 0.03/3MG 21 F.C.TABS.  GLENMARK PHAR...    84.00 EGP (4.00/unit)
            DROSPADIOL 0.03/3MG 21 F.C.TABS. ANDALOUS PHARMA     87.00 EGP (4.14/unit)
            DROSPIFEM 0.03/3MG 21 TABS.      MARCYRL PHARM...    87.00 EGP (4.14/unit)
            YAZ 0.02/3MG 28 TABS.            BAYER SCHERIN...   268.00 EGP (9.57/unit)
            YASMIN 0.03/3 MG 21 TABS.        BAYER SCHERIN...   205.00 EGP (9.76/unit)


HERBAL MEDICINAL PRODUCT WITH A EUROPEAN MONOGRAPH - THE ONE HERBAL THE ARTICLE ENDORSES
4. VITEX AGNUS-CASTUS                                     [2nd line]
   Adult    20 mg of the dry extract, once a day. EU herbal monograph verbatim, well-established use
            column: "Female adults. Daily dose: Once daily 20 mg dry extract", by "Oral use". The
            extract is specified, not any agnus castus preparation: "Dry extract (DER 6-12:1),
            extraction solvent ethanol 60% m/m", as a "Herbal preparation in solid dosage form for
            oral use." The monograph's separate traditional-use column carries four other
            preparations at quite different doses - 400 mg twice daily of the powdered herbal
            substance, 165 mg of a tincture, 4 mg or 2-3 mg of two other dry extracts - so the
            milligram figure means nothing without the preparation it belongs to. - Three months
            before judging it, and a doctor if it has not worked by then. EU herbal monograph
            verbatim: "To achieve an optimal treatment effect, continued use over three months is
            recommended. If the symptoms persist after a continued use over three months, a doctor
            should be consulted."
   Peds     Not for under-18s. EU herbal monograph verbatim: "There is no relevant indication in
            prepubertal children. The use in pubertal children and adolescents under 18 years of age
            is not recommended due to lack of adequate data."
   Source   European Union herbal monograph on Vitex agnus-castus L., fructus, EMA/HMPC/606742/2017,
            final 27 March 2018, sections 4.1 Therapeutic indications, 4.2 Posology and method of
            administration, 4.3 Contraindications and 4.4 Special warnings and precautions for use
            (well-established use column)
   Why      The disease article names the plant and makes an unusually strong claim for it,
            verbatim: "The fruit extract Vitex agnus-castus is the only herbal medicine that is
            proven to control PMS-associated mood swings and irritability." The EU herbal
            monograph's indications section names the disease, verbatim: "Herbal medicinal product
            for the treatment of premenstrual syndrome" under well-established use, and "Traditional
            herbal medicinal product for the relief of minor symptoms in the days before
            menstruation (premenstrual syndrome)" under traditional use. It is here because the
            alternative is worse: women in Cairo buy agnus castus as a supplement anyway, at
            whatever dose the packet says, and the monograph is the only document that states which
            preparation and which dose were actually studied. Egypt registers no agnus castus
            medicinal product - the only register entry containing vitex extract is a multi-
            ingredient fertility supplement sachet, which is not this preparation and not this dose
            - so no brand and no price can be shown.
   Caution  Not in pregnancy or breastfeeding. EU herbal monograph verbatim: "There is no indication
            for the use during pregnancy." and "The use is not recommended during pregnancy." and
            "Data from reproductive studies suggest that agnus castus fruit may affect lactation. A
            risk to the suckling child cannot be excluded. The use during lactation is not
            recommended."
            It acts on the pituitary, so it is not a neutral supplement. EU herbal monograph
            verbatim: "Agnus castus fruit is thought to act on the pituitary-hypothalamic axis and
            therefore patients with a history of a pituitary disorder should consult a doctor before
            use. In cases of prolactin secreting tumours of the pituitary gland the intake of agnus
            castus fruit can mask symptoms of the tumour." A woman with galactorrhoea, amenorrhoea
            or headache with visual change needs a prolactin level and not this.
            Oestrogen-sensitive cancer and hormone therapy. EU herbal monograph verbatim: "Patients
            who suffer or suffered from an oestrogen-sensitive cancer should consult their doctor
            before using agnus castus fruit." and "Patients who are using dopamine agonists,
            dopamine antagonists, oestrogens and antioestrogens should consult their doctor before
            using agnus castus fruit."
            The dose belongs to one specific extract. A shop-bought agnus castus capsule of unstated
            extraction ratio at 400 mg is not 20 mg of a DER 6-12:1 ethanolic dry extract, and the
            monograph's own dose table is the proof - the same plant runs from 2 mg to 800 mg a day
            depending on the preparation. Ask to see the packet.
            Contraindicated in hypersensitivity to the active substance, and the monograph asks that
            a doctor or pharmacist be consulted "If the symptoms worsen during the use of the
            medicinal product".
            Premenstrual dysphoric disorder is a different and more severe diagnosis. Low mood that
            does not lift after the period, or that carries suicidal thoughts, is a psychiatric
            assessment rather than a herbal one.
   Egypt    no Egyptian brand matched - prescribe by generic name

Prices are indicative (dataset snapshot 2026-06); verify with the pharmacy.
```

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