EFMODY 5 mg PROLONGED-RELEASE HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Efmody 5 mg modified-release hard capsules

Efmody 10 mg modified-release hard capsules

Efmody 20 mg modified-release hard capsules

hydrocortisone

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Efmody and what is it used for
2. What you need to know before you take Efmody
3. How to take Efmody
4. Possible side effects
5. Storing Efmody
6. Contents of the pack and other information

1. What is Efmody and what is it used for

Efmody contains the active substance hydrocortisone. Hydrocortisone belongs to a group of medicines called corticosteroids.

Hydrocortisone is a copy of the hormone cortisol. Cortisol is produced in the body by the adrenal glands. Efmody is used when the adrenal glands do not produce enough cortisol due to a hereditary disorder called congenital adrenal hyperplasia. It is indicated in adults and adolescents from 12 years of age.

2. What you need to know before you take Efmody

Do not take Efmody

• If you are allergic to hydrocortisone or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Tell your doctor or pharmacist before you start taking Efmody if any of the following conditions apply to you:

Acute adrenal insufficiency

• You have acute adrenal insufficiency. If you are vomiting or have an acute condition, you may need an injection of hydrocortisone. Your doctor will teach you how to administer it in case of an emergency.

Infections

• You have an infection or do not feel well. Your doctor may need to prescribe you additional hydrocortisone temporarily.

Vaccination

• You are going to receive a vaccine. Normally, treatment with Efmody should not prevent vaccination.

Others

• You are scheduled for surgery. Inform the surgeon or anesthesiologist that you are taking Efmody before the operation.
• You have a chronic gastrointestinal disease (such as chronic diarrhea) that affects the intestinal absorption of food. Your doctor may prescribe you another medicine or monitor you more closely to ensure you are receiving the correct amount of the medicine.

Do not stop taking Efmody without consulting your doctor, as you may become very ill quickly.

Since Efmody replaces the normal hormone that your body lacks, side effects are less likely; however:

• Excessive Efmody may affect the bones, so your doctor will closely monitor the dose.

• Some patients treated with hydrocortisone Efmody experience anxiety, depression, or confusion. Tell your doctor if you exhibit any unusual behavior or have suicidal thoughts after starting treatment (see section 4).

• Rarely, an allergy to hydrocortisone may occur. People who are already allergic to other medicines may be more prone to an allergy to hydrocortisone. Tell your doctor immediately if you experience any reaction such as swelling or difficulty breathing after taking Efmody (see section 4).

• Hydrocortisone may cause diabetes. If you notice excessive thirst or need to urinate too frequently, tell your doctor immediately.

• Steroid treatment may decrease blood potassium levels. Your doctor will monitor your potassium levels to check for changes.

• Hydrocortisone may delay growth in children. Your doctor will monitor the patient's growth during treatment with Efmody.

• Children with congenital adrenal hyperplasia who take hydrocortisone may show signs of sexual development or puberty earlier than expected. Your doctor will monitor the patient's sexual development during treatment with Efmody.

• Contact your doctor if you experience blurred vision or other visual disturbances.

Other medicines and Efmody

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Some medicines affect the way Efmody works, which may require your doctor to modify the dose of Efmody.

Your doctor may need to increase the dose of Efmody if you are taking certain medicines, including:

• Medicines used to treat epilepsy: phenytoin, carbamazepine, oxcarbazepine, and barbiturates such as phenobarbital and primidone.
• Medicines used to treat infections (antibiotics): rifampicin and rifabutin.
• Medicines used to treat HIV and AIDS: efavirenz and nevirapine.
• Herbal medicines used to treat depression, such as St. John's Wort.

Your doctor may need to decrease the dose of Efmody if you are taking certain medicines, including:

• Medicines used to treat fungal infections: itraconazole, posaconazole, and voriconazole.
• Medicines used to treat infections (antibiotics): erythromycin and clarithromycin.
• Medicine used to treat HIV and AIDS: ritonavir.

Taking Efmody with food and drinks

Some foods and drinks affect the way Efmody works, and your doctor may need to decrease the dose. Some of these include:

• Grapefruit juice.
• Licorice.

Pregnancy, breastfeeding, and fertility

Hydrocortisone is known to cross the placenta during pregnancy and is present in breast milk, but it has not been shown to cause harm to the breastfed child. If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.

Driving and using machines

Efmody has a minor influence on the ability to drive and use machines. Untreated adrenal insufficiency may affect the ability to drive and use machines. Tell your doctor immediately if you feel tired or dizzy after taking Efmody.

3. How to take Efmody

Always take this medicine exactly as your doctor, nurse, or pharmacist has told you. If you are not sure, check with your doctor.

Your doctor will decide the correct initial dose of Efmody and then adjust the dose according to your needs. During illness, before and after surgery, and in situations of intense stress, your doctor may ask you to take another corticosteroid instead of or in addition to Efmody.

The initial daily dose may be divided into two doses, with two-thirds to three-quarters of the daily dose taken at bedtime and the rest taken in the morning.

The morning dose of hydrocortisone in modified-release hard capsules should be taken on an empty stomach, at least 1 hour before food intake, and the evening dose should be taken at least 2 hours after the last meal of the day.

Use in children

There is no information on the safety and efficacy of Efmody in children under 12 years of age. Other hydrocortisone medicines are available for children under 12 years of age.

How to take this medicine

Swallow the capsules with water.

Do not chew them, as this may alter the release of the medicine.

If you take more Efmody than you should

If you have taken more Efmody than you should, contact your doctor or pharmacist as soon as possible for advice on what to do.

If you forget to take Efmody

If you miss a dose, take it as soon as possible.

If you stop taking Efmody

Do not stop taking Efmody without consulting your doctor first. Stopping the medicine abruptly may cause acute adrenal insufficiency.

If you become ill

Tell your doctor or pharmacist if you become ill, are under stress, are injured, or are going to have surgery, as your doctor may advise you to take another corticosteroid instead of or in addition to Efmody (see section 2).

If you take too much Efmody

Rarely, overdose or death associated with excessive Efmody may occur, but you should tell your doctor immediately.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

• If you experience any reaction such as swelling or difficulty breathing after taking Efmody, seek medical attention immediately and tell your doctor as soon as possible, as it may be an allergic reaction (anaphylactoid reactions) (see section 2).

• Adrenal insufficiency and acute adrenal insufficiency have been observed frequently (may affect up to 1 in 10 people). If you receive less hydrocortisone than you need, you may become seriously ill. If you feel unwell and, in particular, start vomiting, tell your doctor immediately, as you may need additional hydrocortisone or an injection of hydrocortisone.

Tell your doctor as soon as possible if you experience any of the following side effects:

Very common (may affect more than 1 in 10 people)

• Fatigue

Common (may affect up to 1 in 10 people)

• Nausea
• Abdominal pain
• Lack of energy or weakness
• Increased or decreased appetite and weight gain or loss
• Muscle pain and weakness
• Joint pain
• Headache
• Dizziness
• Pain or tingling in the fingers (carpal tunnel syndrome)
• Tingling
• Insomnia, difficulty sleeping, or vivid dreams
• Depression
• Acne
• Increased hair growth
• Changes in blood tests that evaluate kidney function and glucose

Long-term treatment with hydrocortisone may reduce bone density. Your doctor will monitor the condition of your bones (see section 2).

People who require steroid treatment may have a higher risk of heart disease. Your doctor will monitor you for this.

Long-term treatment with hydrocortisone may affect growth in children and adolescents. Your doctor will monitor the growth of young patients. Some children with congenital adrenal hyperplasia treated with hydrocortisone may enter puberty earlier than expected. Your doctor will monitor the sexual development of these patients (see section 2).

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Efmody

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and blister after EXP.

The expiry date refers to the last day of the month stated.

This medicine does not require any special storage conditions.

Store in the original package.

Keep the bottle tightly closed to protect from moisture.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Efmody contains

• The active substance is hydrocortisone.

? Efmody 5 mg modified-release hard capsules: each modified-release capsule contains 5 mg of hydrocortisone

? Efmody 10 mg modified-release hard capsules: each modified-release capsule contains 10 mg of hydrocortisone

? Efmody 20 mg modified-release hard capsules: each modified-release capsule contains 20 mg of hydrocortisone

• The other ingredients are microcrystalline cellulose, povidone, methacrylic acid - methyl methacrylate copolymer, talc, and dibutyl sebacate.

Capsule

The capsule is made of gelatin.

Efmody 5 mg modified-release hard capsules (white/blue)

Titanium dioxide (E171) and indigo carmine (E132)

Efmody 10 mg modified-release hard capsules (white/green)

Titanium dioxide (E171), indigo carmine (E132), and yellow iron oxide (E172)

Efmody 20 mg modified-release hard capsules (white/orange)

Titanium dioxide (E171), yellow iron oxide (E172), and red iron oxide (E172)

Printing ink

The printing ink of the capsules contains shellac, black iron oxide (E172), propylene glycol, and potassium hydroxide.

Appearance and packaging

• Efmody 5 mg modified-release hard capsules

Capsule (approximately 19 mm in length) with a blue opaque cap and a white opaque body with the imprint «CHC 5 mg» containing a white or off-white granulate.

• Efmody 10 mg modified-release hard capsules

Capsule (approximately 19 mm in length) with a green opaque cap and a white opaque body with the imprint «CHC 10 mg» containing a white or off-white granulate.

• Efmody 20 mg modified-release hard capsules

Capsule (approximately 22 mm in length) with an orange opaque cap and a white opaque body with the imprint «CHC 20 mg» containing a white or off-white granulate.

Efmody is available in high-density polyethylene bottles with a child-resistant polypropylene screw cap and a desiccant integrated in the cap. Each bottle contains 50 modified-release hard capsules.

Pack size:

Bottle with 1 bottle of 50 modified-release hard capsules.

Bottle with 2 bottles of 50 modified-release hard capsules (100 capsules).

Not all pack sizes may be marketed.

Marketing authorisation holder

Diurnal Europe B.V.

Van Heuven Goedhartlaan 935 A

1181LD Amstelveen

Netherlands

Manufacturer

Delpharm Lille SAS

Parc d'Activités Roubaix-Est

22 rue de Toufflers CS 50070

Lys Lez Lannoy, 59 452

France

Wasdell Europe Limited

IDA Dundalk Science and Technology Park

Mullagharlin

Dundalk

Co. Louth, A91 DET0

Ireland

Date of last revision of this leaflet:

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.