{ "schema_version": 1, "kind": "condition", "id": "premenstrual-syndrome", "name": "Premenstrual Syndrome (PMS)", "category": "acute", "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", "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)", "verified_date": "2026-08", "treatments": [ { "id": 1524, "generic": "Ibuprofen", "line": 1, "is_adjunct": false, "form": "oral.solid", "strength_mg": 400.0, "adult_dose": "200-400 mg PO Q6-8H PRN, max 1200 mg/day.", "adult_duration": "Up to 10 days", "dose_source": "SmPC section 4.2, https://www.medicines.org.uk/emc/product/4560/smpc", "rationale": "Standard NSAID dose for the cyclical pain of PMS; the anti-inflammatory dose used for genuine inflammatory disease is not needed here.", "cautions": [ "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." ], "peds_mgkg_low": null, "peds_mgkg_high": null, "peds_max_mg": null, "peds_basis": null, "peds_unit": null, "peds_note": "20 mg/kg/day in divided doses", "peds_min_weight_kg": null, "peds_max_weight_kg": null, "peds_age_min_months": null, "peds_age_max_months": null, "peds_age_bands": null, "peds_doses": null, "brands": [ { "trade_name": "DAJUANOFEN 400 MG 20 F.C. TABS.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "COPAD PHARMA", "price_egp": 5.0, "pack_count": 20, "unit_price": 0.25, "strength_mg": 400.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "FLABU 400MG 10 F.C.TAB.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "DELTA PHARMA", "price_egp": 3.75, "pack_count": 10, "unit_price": 0.38, "strength_mg": 400.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "NOVA-PROFEN 400MG 30 F.C. TABLETS", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "SANOFI", "price_egp": 12.75, "pack_count": 30, "unit_price": 0.42, "strength_mg": 400.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "IBUPROFEN 400 MG 10 TAB.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "SEDICO", "price_egp": 6.0, "pack_count": 10, "unit_price": 0.6, "strength_mg": 400.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "MAFO 400 MG 30 F.C.TABS", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "EIPICO", "price_egp": 42.0, "pack_count": 30, "unit_price": 1.4, "strength_mg": 400.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "BRUFEN 400 MG 30 TABS.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "KAHIRA > ABBOTT LABORATORIES", "price_egp": 78.0, "pack_count": 30, "unit_price": 2.6, "strength_mg": 400.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "PROFUSOL 400MG 20 S.G CAPS.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "EUROPEAN EGYPTIAN PHARM. IND.", "price_egp": 31.0, "pack_count": null, "unit_price": null, "strength_mg": 400.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "ANALGIPROF 400 MG 25 SACHETS", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "EVA PHARMA", "price_egp": 37.5, "pack_count": null, "unit_price": null, "strength_mg": 400.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "NOVA-PROFEN 100MG/5ML ORAL SUSP. 100ML", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "SANOFI", "price_egp": 2.25, "pack_count": null, "unit_price": null, "strength_mg": 100.0, "exact_strength": false, "exact_form": false, "discontinued": false, "also_contains": null }, { "trade_name": "BRUFEMOL-N SUSP. 60 ML", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "ARAB DRUG COMPANY (ADCO)", "price_egp": 4.5, "pack_count": null, "unit_price": null, "strength_mg": null, "exact_strength": false, "exact_form": false, "discontinued": false, "also_contains": null } ], "condition_id": "premenstrual-syndrome" }, { "id": 1525, "generic": "Referral & safety-netting (no drug therapy)", "line": 1, "is_adjunct": false, "form": null, "strength_mg": null, "adult_dose": null, "adult_duration": null, "dose_source": "Premenstrual Syndrome - disease-level clinical article (premenstrual-syndrome-clinical.txt)", "rationale": "Carries the referral criteria and warning signs for this condition, which apply whichever treatment is chosen.", "cautions": [ "RED FLAG - There is an increased suicidal risk in hormone-sensitive females with PMS." ], "peds_mgkg_low": null, "peds_mgkg_high": null, "peds_max_mg": null, "peds_basis": null, "peds_unit": null, "peds_note": null, "peds_min_weight_kg": null, "peds_max_weight_kg": null, "peds_age_min_months": null, "peds_age_max_months": null, "peds_age_bands": null, "peds_doses": null, "brands": [], "condition_id": "premenstrual-syndrome" }, { "id": 1526, "generic": "Ethinylestradiol + Drospirenone", "line": 2, "is_adjunct": false, "form": "oral.solid", "strength_mg": null, "adult_dose": "0.02 mg ethinyl estradiol + 3 mg drospirenone daily for 24 days followed by hormone-inactive pills for 4 days", "adult_duration": null, "dose_source": "Premenstrual Syndrome (PMS) - disease-level clinical article (premenstrual-syndrome-clinical.txt)", "rationale": "Combined oral contraceptive pill with anti-mineralocorticoid progestin used to suppress ovulation and manage severe premenstrual dysphoric symptoms.", "cautions": [ "CONTRAINDICATED, label verbatim (ELOINE 0.02 mg / 3 mg film coated tablets, section 4.3): \"Presence or risk of venous thromboembolism (VTE)\" ( AMRIYA", "price_egp": 103.0, "pack_count": 28, "unit_price": 3.68, "strength_mg": 3.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "ESTRAMARK 0.03/3MG 21 F.C.TABS.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "GLENMARK PHARMACEUTICALS", "price_egp": 84.0, "pack_count": 21, "unit_price": 4.0, "strength_mg": 3.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "DROSPADIOL 0.03/3MG 21 F.C.TABS.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "ANDALOUS PHARMA", "price_egp": 87.0, "pack_count": 21, "unit_price": 4.14, "strength_mg": 3.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "DROSPIFEM 0.03/3MG 21 TABS.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "MARCYRL PHARMACEUTICAL INDUSTRIES (MPI)", "price_egp": 87.0, "pack_count": 21, "unit_price": 4.14, "strength_mg": 3.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "YAZ 0.02/3MG 28 TABS.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "BAYER SCHERING > BAYER HEALTHCARE", "price_egp": 268.0, "pack_count": 28, "unit_price": 9.57, "strength_mg": 3.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "YASMIN 0.03/3 MG 21 TABS.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "BAYER SCHERING > BAYER HEALTHCARE", "price_egp": 205.0, "pack_count": 21, "unit_price": 9.76, "strength_mg": 3.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null } ], "condition_id": "premenstrual-syndrome" }, { "id": 1527, "generic": "Vitex agnus-castus", "line": 2, "is_adjunct": false, "form": "oral.solid", "strength_mg": null, "adult_dose": "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.", "adult_duration": "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.\"", "dose_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)", "rationale": "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.", "cautions": [ "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." ], "peds_mgkg_low": null, "peds_mgkg_high": null, "peds_max_mg": null, "peds_basis": null, "peds_unit": null, "peds_note": "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.\"", "peds_min_weight_kg": null, "peds_max_weight_kg": null, "peds_age_min_months": null, "peds_age_max_months": null, "peds_age_bands": null, "peds_doses": null, "brands": [], "condition_id": "premenstrual-syndrome" } ] }