Efmody 5 mg Modified-Release Hydrocortisone – 50 Capsules

Description

Efmody 5 mg modified-release hydrocortisone overview

Efmody 5 mg is a prescription modified-release hydrocortisone capsule designed to provide hydrocortisone at two planned times, usually with the larger part of the daily replacement dose taken at bedtime and the remainder in the morning. Hydrocortisone replaces cortisol, a hormone made by the adrenal glands. This page explains the authorised uses, dosing principles, emergency rules, interactions and storage information for the photographed 50-capsule European pack.

Important market-authorisation note: the European Medicines Agency (EMA) authorisation lists congenital adrenal hyperplasia (CAH) in adolescents aged 12 years and older and adults. The current UK Summary of Product Characteristics additionally lists adrenal insufficiency (AI) from age 12. The authorised indication can therefore differ by country and pack. Always use the local leaflet supplied with your medicine and the diagnosis written by your prescriber.

9 essential Efmody 5 mg safety checks

1. Confirm the authorised use: follow the indication in the local pack leaflet and your endocrinologist’s prescription.
2. Confirm the exact total daily dose: replacement dosing is individual and must not be copied from another patient.
3. Keep the timing consistent: the morning dose is taken on an empty stomach at least one hour before food; the evening dose is taken at bedtime at least two hours after the last meal.
4. Swallow the capsule whole with water: do not chew it because chewing can alter modified release.
5. Carry steroid identification: wear or carry the steroid emergency card or medical alert advised by your clinical team.
6. Know the sick-day rules: fever, infection, injury, surgery, vomiting or diarrhoea may require extra immediate-release or injected hydrocortisone.
7. Never stop suddenly: abrupt withdrawal can trigger life-threatening adrenal crisis.
8. Review interacting medicines: several anti-seizure, antibiotic, antifungal, antiviral and herbal products can change hydrocortisone exposure.
9. Attend monitoring: the lowest effective replacement dose is sought to reduce both under-replacement and long-term over-replacement.

Pack facts and product identity

Packaging and local identifiers can vary. The images on this page show a German/Austrian European presentation and should not be interpreted as proof of Turkish manufacture or Turkish registration.

What is Efmody 5 mg used for?

In the EU, Efmody 5 mg is authorised for congenital adrenal hyperplasia in adolescents from 12 years of age and adults. CAH is a group of inherited conditions in which the adrenal glands cannot make normal amounts of certain hormones. Replacement hydrocortisone supplies cortisol and helps clinicians control excess adrenal androgen production while avoiding excessive glucocorticoid exposure.

The current UK SmPC also authorises Efmody for adrenal insufficiency in adolescents from age 12 and adults. Adrenal insufficiency means that the body cannot produce enough cortisol. Because authorisations are not identical in every market, the medicine must be used only for the locally authorised indication and under specialist supervision.

How modified release and dose timing work

Cortisol normally follows a day–night rhythm. Efmody’s modified-release formulation is intended to release hydrocortisone after a delay and then over time. The bedtime dose is designed to provide exposure before waking, while the morning dose supports daytime replacement. It is not the same as an immediate-release hydrocortisone tablet and should not be substituted dose-for-dose without specialist direction.

For grown adolescents and adults, the current SmPC describes a usual total replacement range of 15–25 mg daily, but this is not a personal dose recommendation. At initiation, about two-thirds to three-quarters of the daily dose may be prescribed at bedtime and the remainder in the morning. The clinician adjusts treatment using symptoms, clinical examination and appropriate biochemical assessment. Growing adolescents require especially careful follow-up.

How to take Efmody 5 mg correctly

• Take the morning dose on an empty stomach, at least one hour before eating.
• Take the evening dose at bedtime, at least two hours after the last meal.
• Swallow each capsule with water. Do not chew the modified-release capsule.
• Use the exact combination of capsule strengths prescribed. Do not change the dose split yourself.
• If a dose is missed, the current patient information advises taking it as soon as possible. Contact the clinical team if doses are repeatedly missed or if you are unsure.
• Do not stop Efmody 5 mg abruptly, even when you feel well.

Illness, surgery and the emergency steroid plan

Hydrocortisone replacement needs can rise quickly during fever, significant infection, trauma, surgery or other major physical stress. Vomiting or severe diarrhoea can also prevent capsules being absorbed. Follow the written sick-day and emergency plan supplied by the endocrine team. It may require extra immediate-release hydrocortisone or parenteral hydrocortisone rather than extra modified-release capsules.

Possible adrenal-crisis warning signs include severe weakness, repeated vomiting, abdominal pain, marked dizziness, low blood pressure, confusion, collapse or loss of consciousness. This is a medical emergency. Use the prescribed emergency injection if trained and instructed, and seek urgent medical help immediately.

Who needs extra caution?

Tell the prescriber about all health conditions, especially diabetes or glucose intolerance, high blood pressure, osteoporosis, glaucoma, cataracts, current infection, previous tuberculosis exposure, stomach or intestinal disease, psychiatric history, epilepsy, thyroid disease and liver or kidney problems. The clinician balances the danger of cortisol deficiency against the harms of unnecessary glucocorticoid exposure.

Long-term over-replacement can contribute to weight gain, Cushingoid features, hypertension, raised blood glucose, lower bone density, muscle weakness, eye problems and growth effects. Under-replacement can cause fatigue, nausea, poor appetite, weight loss, dizziness and adrenal-crisis risk. Regular review is therefore part of safe treatment.

Medicine, food and herbal interactions

Some CYP3A4 inducers can reduce hydrocortisone exposure, including phenytoin, carbamazepine, oxcarbazepine, rifampicin, rifabutin, phenobarbital, primidone, efavirenz, nevirapine and St John’s wort. Some inhibitors can raise exposure, including itraconazole, posaconazole, voriconazole, erythromycin, clarithromycin and ritonavir. Grapefruit juice and liquorice may also affect exposure. This list is not complete. A clinician or pharmacist should review every prescription medicine, over-the-counter product and supplement.

Possible side effects

Fatigue is reported very commonly in the current SmPC. Common effects include headache, dizziness, nausea, upper abdominal pain and diarrhoea. Appetite or weight change, altered glucose control, muscle or joint symptoms, sleep disturbance and mood effects can occur. Acute adrenal insufficiency events require prompt treatment rather than waiting for a routine appointment.

Seek urgent advice for symptoms of adrenal crisis, a severe allergic reaction, black stools or vomiting blood, severe infection, major visual change, or severe psychiatric symptoms. Report persistent or troubling effects to the treating clinician.

Pregnancy, breastfeeding and fertility

Physiological hydrocortisone replacement can be continued in pregnancy and breastfeeding when clinically needed, but pregnancy may change dose requirements. The endocrine and obstetric teams should supervise treatment and delivery planning. Do not stop replacement therapy because of pregnancy without medical direction.

Storage and disposal

Keep Efmody 5 mg in the original container with the child-resistant cap tightly closed because the capsules are moisture-sensitive. Keep it out of the sight and reach of children. Do not use it after the printed expiry date. Return unused or expired medicine to a pharmacy where local services allow; do not discard it in wastewater.

Frequently asked questions

Can I chew or open Efmody 5 mg?

The current product information states that the capsule should be swallowed with water and not chewed, because chewing can affect modified release. Ask a pharmacist or prescriber for a safe alternative if swallowing is difficult.

Is Efmody taken with food?

The morning dose is taken at least one hour before food. The bedtime dose is taken at least two hours after the last meal. Consistent timing helps reduce variation in exposure.

Can I use the bedtime dose during vomiting?

If vomiting prevents the dose being retained, oral modified-release treatment may be unreliable. Follow the emergency steroid instructions and obtain urgent clinical advice.

Is the photographed pack made in Turkey?

No Turkish manufacturing or registration claim is made here. The photographed carton is a German/Austrian European presentation. Availability, labelling and authorisation should be verified for the pack supplied.

Where can I read official information?

Read the EMA Efmody overview and the current UK Efmody 5 mg SmPC. You can also browse another relevant page in our hormonal medicines catalogue.

Medical disclaimer: This product page is educational and does not replace the local package leaflet, a prescription or emergency instructions. Hydrocortisone replacement must be managed by an experienced clinician. Reviewed for medical accuracy using official product information current in July 2026.