Read this leaflet carefully before use. It contains important information about this product. Keep this leaflet — you may need to read it again. This product is supplied for professional and research applications and must be used only under the direction of a qualified physician.
1. Name of the product
Exemestane 12.5 — 12.5 mg/tablet
Uncoated tablet for oral administration.
2. Qualitative and quantitative composition
| Active substance | Exemestane 12.5 |
|---|---|
| Strength | 12.5 mg/tablet |
| CAS number | 107868-30-4 |
| Molecular formula | C₂₀H₂₄O₂ |
| Pharmacotherapeutic class | Endocrine therapy — enzyme inhibitor (aromatase inhibitor). |
| Excipients | Lactose monohydrate, sodium starch glycolate, povidone, microcrystalline cellulose, magnesium stearate. |
3. Pharmaceutical form
Uncoated tablet for oral administration. Oral use.
4. Clinical particulars
4.1 Indications
Supplied for professional and research applications only. Any therapeutic application is determined exclusively by a qualified physician on the basis of individual clinical assessment. This product is not intended for self-medication.
4.2 Posology and method of administration
As directed by the physician. Dose and duration are established by the treating clinician on the basis of hormonal assessment. Tablets are taken with water, at the same time each day.
4.3 Contraindications
- Known hypersensitivity to the active substance or to any of the excipients.
- Pregnancy and breast-feeding.
- Pre-menopausal endocrine status, unless specifically directed by a physician.
- Severe hepatic or renal impairment.
- Hereditary galactose intolerance, total lactase deficiency or glucose-galactose malabsorption (contains lactose).
4.4 Special warnings and precautions for use
- Suppression of circulating oestrogen reduces bone mineral density; assessment of bone health is advised where administration is prolonged.
- Excessive suppression of oestradiol may produce arthralgia, dyslipidaemia, reduced libido and impaired mood.
- Periodic monitoring of serum oestradiol and of the lipid profile is recommended.
- Caution is required in subjects with pre-existing ischaemic heart disease.
4.5 Interaction with other medicinal products
Oestrogen-containing preparations counteract the pharmacological action and must not be administered concurrently. Caution with agents affecting hepatic enzymes. Tamoxifen may reduce plasma concentrations of aromatase inhibitors.
4.6 Fertility, pregnancy and lactation
Contraindicated in pregnancy and during breast-feeding. Women of child-bearing potential must use effective contraception during administration.
4.7 Effects on ability to drive and use machines
Asthenia and somnolence have been reported; caution is advised when driving or operating machinery if affected.
4.8 Undesirable effects
- Musculoskeletal: arthralgia, joint stiffness, bone pain, reduction of bone mineral density.
- Vascular: hot flushes.
- Nervous system: headache, somnolence, asthenia.
- Metabolic: altered lipid profile, elevated total cholesterol.
- Gastrointestinal: nausea, dry mouth.
- Dermatological: rash, thinning of the hair.
If any adverse effect becomes serious, or if an effect not listed in this leaflet is observed, medical advice must be sought without delay.
4.9 Overdose
There is no specific antidote. In the event of overdose, discontinue administration and institute symptomatic and supportive care under medical supervision.
5. Pharmacological properties
5.1 Pharmacodynamic properties
Exemestane 12.5mg tablets. Steroidal aromatase inactivator that irreversibly suppresses estrogen biosynthesis.
Pharmacotherapeutic group: Endocrine therapy — enzyme inhibitor (aromatase inhibitor).
5.2 Pharmacokinetic properties
| Elimination half-life | ~24 hours |
|---|---|
| Detection window | ~5–6 weeks |
| Route of administration | Oral use. |
5.3 Preclinical safety data
Each production lot is released against the full pharmaceutical testing protocol: identity and purity by HPLC (specification ≥ 98 %), verification of concentration against label claim (± 5 %), sterility in accordance with USP <71>, bacterial endotoxin quantification by LAL assay (< 0.25 EU/mL) and inspection of particulate matter in accordance with USP <788>.
6. Pharmaceutical particulars
6.1 List of excipients
Lactose monohydrate, sodium starch glycolate, povidone, microcrystalline cellulose, magnesium stearate.
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
36 months from the date of manufacture. Do not use after the expiry date printed on the carton and blister.
6.4 Special precautions for storage
Store below 30 °C in the original package in order to protect from light and moisture. Keep out of the reach and sight of children.
6.5 Nature and contents of container
Blister strips in a printed outer carton, 100 tablets for oral use.
6.6 Special precautions for disposal
Any unused product or waste material must be disposed of in accordance with local requirements. Do not dispose of via wastewater or household waste.
7. Authentication
Every unit carries a unique authentication code on the outer packaging. The code confirms that the product originates from Biomedica and has not been substituted. Verify it before use.
8. Manufacturer
Biomedica
Pharmaceutical manufacturing — GMP compliant
biomedicapharmacies@protonmail.com
biomedica.it.com
This leaflet was last revised in September 2026. For research and professional use only.