Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - efmody

Document Subject

Generated Narrative: MedicinalProductDefinition mpd70366d9de20b85af1c498f11302a348

identifier: http://ema.europa.eu/identifier/EU/1/21/1549/001 (50 capsules)

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Efmody 5 mg modified-release hard capsules

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

part

part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-d70366d9de20b85af1c498f11302a348

identifier: http://ema.europa.eu/identifier/EU/1/21/1549/001 (50 capsules)

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - efmody

Attesters

What is in this leaflet

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

Medicine contains the active substance hydrocortisone. Hydrocortisone belongs to a group of medicines known as corticosteroids.

Hydrocortisone is a copy of the hormone cortisol. Cortisol is made by the adrenal glands in the body.
Efmody is used when the adrenal gland are not making enough cortisol due to an inherited condition called congenital adrenal hyperplasia. It is for use in adults and adolescents from 12 years of age.

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 Talk to your doctor or pharmacist before taking Efmody if the following apply:

Adrenal crisis

• You have an adrenal crisis. If you are vomiting or seriously unwell, you may need an injection of hydrocortisone. Your doctor will train you how to do this in an emergency. Infections
• You have an infection or you do not feel well. Your doctor may need to prescribe extra hydrocortisone temporarily.
  Immunisation
• You are due to be vaccinated. Usually, taking Efmody should not stop you receiving vaccination.

Fertility

• If you had lower fertility due to congenital adrenal hyperplasia, your fertility may be restored, sometimes soon after starting Efmody. This applies to both men and women. Talk to your doctor about your contraceptive needs before starting Efmody.

Other

• You are due for an operation. Tell the surgeon or anaesthetist that you are receiving Efmody before your operation.
• You have a long-term condition of your digestive system (such as chronic diarrhoea) that affects how well your gut absorbs food. Your doctor may prescribe another medicine instead or monitor you more closely to check that you are getting the right amount of the medicine.

You should not stop taking Efmody without checking with your doctor as this could make you seriously unwell very quickly.

As Efmody is replacing the normal hormone your body lacks, side effects are less likely, however:

• Too much Efmody can affect your bones so your doctor will monitor the dose closely.

• Some patients taking hydrocortisone Efmody became anxious, depressed or confused.Tell your doctor if you develop any unusual behaviour or feel suicidal after starting medication (see section 4).

• In rare cases allergy to hydrocortisone can occur. People who already have allergies to other medicines may be more likely to develop allergy to hydrocortisone.Tell your doctor straight away if you have any reaction like swelling or shortness of breath after being given Efmody (see section 4).

• Hydrocortisone may cause diabetes. If you have symptoms of excessive thirst or need to pass urine excessively tell your doctor straight away.

• Treatment with steroids can lead to low blood potassium. Your doctor will monitor your potassium levels to check for any changes.

• Hydrocortisone can reduce growth in children.Your doctor will monitor your growth while you are on Efmody.

• Children with congenital adrenal hyperplasia taking hydrocortisone might show signs of sexual development or puberty earlier than usually expected.Your doctor will monitor your development while you are on Efmody.

• Contact your doctor if you have 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 can affect the way that Efmody works and may mean that your doctor needs to alter your dose of Efmody.

Your doctor may need to increase your dose of Efmody if you take certain medicines, including:

• Medicines used to treat epilepsy: phenytoin, carbamazepine, oxcarbazepine and barbiturate medicines such as phenobarbital and primidone.
• Medicines used to treat infections (antibiotics): rifampicin and rifabutin.
• Medicines used to treat human immunodeficiency virus (HIV) infection and AIDS: efavirenz and nevirapine.
• Herbal medicine used to treat depression e.g. St. John's wort.

Your doctor may need to decrease your dose of Efmody if you take certain medicines including:

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

Efmody with food and drink Some food and drink may affect the way Efmody works and may need your doctor to decrease your dose. These include:

• Grapefruit juice.
• Liquorice.

Pregnancy, breast-feeding and fertility Hydrocortisone is known to cross the placenta in pregnancy and is present in breast milk, however there is no evidence this causes any harm to the infant. If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

If you are a woman who has not gone through menopause your periods might return or become more regular. The restored fertility may lead to unexpected pregnancy even before the reoccurrence of menstrual bleeding. See also section Warnings and Precautions regarding fertility in both men and women.

Driving and using machines Efmody has 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 when taking Efmody.

Always use this medicine exactly as your doctor, nurse or pharmacist has told you. Check with them if you are not sure.

Your doctor will decide on the right starting dose of Efmody and then adjust the dose as needed. During illnesses, around the time of surgery and during times of serious stress, your doctor may ask you to take another corticosteroid medicine instead of, or as well as, Efmody.

The initial daily dose may be divided into 2 doses with two thirds to three quarters of your daily dose in the evening at bedtime and the rest given in the morning.

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

Use in Children No information on the safety and efficacy of Efmody in children under 12 years is available. Other hydrocortisone containing medicines are available for children under 12 years.

How to take this medicine Swallow the capsules with water .
Do not chew the capsules as it could change the release of the medicine.

If you take more Efmody than you should If you take more Efmody than you should, contact your doctor or pharmacist for further advice as soon as possible.

If you forget to take Efmody If you forget to take a dose, take the dose as soon as possible.

If you stop taking Efmody Do not stop taking Efmody without asking your doctor first. Stopping the medicine suddenly could quickly lead to an adrenal crisis.

If you become unwell Tell your doctor or pharmacist if you become ill, suffer severe stress, get injured or are about to have surgery because your doctor may advise that you another corticosteroid medicine instead of, or as well as, Efmody (see section 2).

If you take too much Efmody Poisoning or death are rare with too much Efmody, but you should inform your doctor immediately. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

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

• If you have any reaction like swelling or shortness of breath after taking Efmody, get medical help straight away and tell your doctor as soon as possible as these can be signs of an severe allergic reaction (anaphylactoid reactions) (see section 2).

• Adrenal crisis and adrenal insufficiency symptoms have been reported commonly (may affect up to 1 in 10 people). If you get less hydrocortisone than you need you may become seriously unwell. If you feel unwell and particularly if you start vomiting you must tell your doctor straight away as you may need extra hydrocortisone or an injection of hydrocortisone.

Tell your doctor about any of the following side effects as soon as possible:

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

• Tiredness

Common (may affect up to 1 in 10 people)

• Feeling sick (nausea)

• Belly (abdominal) pain

• Loss of energy or weakness

• Increased or decreased appetite and weight gain or loss

• Muscle pains and weakness

• Joint pains

• Headache

• Dizziness

• Pain or tingling in the thumb or fingers (carpal tunnel syndrome)

• Tingling

• Insomnia, sleep difficulties or unusual dreams

• Depressed mood

• Acne

• Hair growth

• Changes in blood tests of kidney and glucose

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

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

Long term treatment with hydrocortisone can affect growth in children and young people. Your doctor will monitor your growth in young people. Some children with congenital adrenal hyperplasia treated with hydrocortisone can have an earlier puberty than expected. Your doctor will monitor your development (see section 2).

Reporting of side effects If you get 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.

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 bottle and carton after EXP.
The expiry date refers to the last day of that month.

This medicine does not have any special temperature storage requirements.

Store in the original package.

Keep the bottle tightly closed in order to protect from moisture.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

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 from gelatin.

Efmody 5 mg modified-release hard capsules (white/blue) Titanium dioxide (E171) and indigotine (E132)

Efmody 10 mg modified-release hard capsules (white/green) Titanium dioxide (E171), indigotine (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 on the capsules contains shellac, black iron oxide (E172), propylene glycol and potassium hydroxide

What Efmody looks like and contents of the pack

• Efmody 5 mg modified-release hard capsules A capsule (approx.19 mm long) with an opaque blue cap and opaque white body printed with CHC 5mg containing white to off white granules.

• Efmody 10 mg modified-release hard capsules A capsule (approx.19 mm long) with an opaque green cap and opaque white body printed with CHC 10mg containing white to off white granules.

• Efmody 20 mg modified-release hard capsules A capsule (approx. 22 mm long) with an opaque orange cap and opaque white body printed with CHC 20mg containing white to off white granules.

Efmody comes in a high density polyethylene bottles with child resistant, tamper-evident polypropylene screw cap with integrated desiccant. Each bottle contains 50 modified-release hard capsules.

Pack size:
Carton containing 1 bottle of 50 modified-release hard capsules.
Carton containing 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
The Netherlands

Manufacturer Delpharm Lille SAS
Parc d'Activit s Roubaix-Est
22 rue de Toufflers CS 50Lys Lez Lannoy, 59 France

Wasdell Europe Limited IDA Dundalk Science and Technology Park Mullagharlin Dundalk
Co. Louth, A91 DET0 Ireland

This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: