EFMODY 5 mg Kapsułka Twarda O Przedłużonym Uwalnianiu

Treść ulotki

1. Efmody 5 mg modified-release hard capsules, 10 mg modified-release hard capsules
   1. What is Efmody and what is it used for
   2. What you need to know before taking Efmody
   3. How to take Efmody
   4. Possible side effects
   5. How to store Efmody
   6. Contents of the pack and other information

Efmody 5 mg modified-release hard capsules, 10 mg modified-release hard capsules

hydrocortisone

Read this leaflet carefully before you start taking this medicine as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of 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

1. What is Efmody and what is it used for

The medicine contains the active substance hydrocortisone, which belongs to a group of medicines known
as corticosteroids.
Hydrocortisone is the synthetic version of the hormone cortisol, which is produced by the adrenal
glands of the body. Efmody is used when the adrenal gland does not produce enough cortisol due to a
hereditary condition called congenital adrenal hyperplasia. It is used in adults and
adolescents starting from 12 years of age.

2. What you need to know before taking 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
Talk to your doctor or pharmacist before taking Efmody if any of the following apply:

Adrenal crisis

• you have an adrenal crisis. If you vomit or feel very unwell, you may need an injection of hydrocortisone. Your doctor will teach you how to do this in case of an emergency Infections
• you have an infection or are feeling unwell. Your doctor may need to prescribe temporary additional hydrocortisone

Immunization

• you are going to have a vaccination. Usually, taking Efmody should not prevent you from receiving a vaccination

Fertility

• if you have reduced fertility due to congenital adrenal hyperplasia, your fertility may be restored, sometimes shortly after starting treatment with Efmody. This can happen in both men and women. Talk to your doctor about your contraceptive needs before starting treatment with Efmody.

Other

• you are going to have an operation. Tell the surgeon or anaesthetist that you are taking Efmody before the operation
• you have a long-term condition of the digestive system (such as chronic diarrhoea) that affects how your gut absorbs food. Your doctor may need to prescribe you another medicine or monitor you more closely to make sure you are taking the right amount of medicine.

Do not stop taking Efmody without consulting your doctor, as this could
quickly make you very ill.
Because Efmody replaces the normal hormone that your body is missing, side effects are
less likely. However:

• too much Efmody can affect your bones, so your doctor will carefully monitor the dose;
• some patients taking hydrocortisone Efmody have experienced anxiety, depression or confusion. Tell your doctor if you show unusual behaviour or have suicidal thoughts after starting treatment (see section 4);
• in rare cases, an allergy to hydrocortisone can occur. People who already have allergies to other medicines may be more likely to develop an allergy to hydrocortisone. Tell your doctor immediately if you experience any reactions such as swelling or shortness of breath after taking Efmody (see section 4);
• high doses of hydrocortisone can increase the risk of heart disease and circulatory problems, causing increased blood pressure, salt and water retention, obesity and diabetes. If you have symptoms of excessive thirst or need to urinate excessively, tell your doctor immediately;
• treatment with steroids can lead to a low level of potassium in the blood (hypokalaemia). See section 4. Your doctor will monitor potassium levels for any changes;
• hydrocortisone can reduce growth in children. Your doctor will monitor growth during treatment with Efmody;
• children with congenital adrenal hyperplasia taking hydrocortisone may show signs of sexual development or puberty earlier than expected. Your doctor will monitor 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 can affect the action of Efmody and this may mean your doctor
needs to change your 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 barbiturate medicines such as phenobarbital and primidone;
• medicines used to treat infections (antibiotics) - rifampicin and rifabutin;
• medicines used to treat human immunodeficiency virus (HIV) and acquired immunodeficiency syndrome (AIDS) infection: efavirenz and nevirapine;
• herbal medicine used to treat depression, for example, 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 diseases - itraconazole, posaconazole and voriconazole;
• medicines used to treat infections (antibiotics) - erythromycin and clarithromycin;
• medicine used to treat human immunodeficiency virus (HIV) and acquired immunodeficiency syndrome (AIDS) infection - ritonavir.

If you are taking medicines that can lower potassium levels, the risk of developing hypokalaemia
(low potassium levels) will be higher than when taking Efmody alone and will be monitored by your
doctor. These medicines include:

• medicines used to control sodium (salt) levels - mineralocorticoids, such as fludrocortisone;
• medicines used to reduce fluid in the body - diuretics;
• medicines used to increase bowel movement - stimulant laxatives;
• medicines used to treat infections (antibiotics) - amphotericin B;
• medicines used to test the adrenal gland - Synacthen or tetracosactide.

Efmody with food and drink
Some foods and drinks can affect the action of Efmody and this may mean your doctor
needs to reduce your dose. These include:

• grapefruit juice,
• licorice. (This may also lower potassium levels).

Pregnancy, breastfeeding and fertility
Hydrocortisone is known to cross the placenta during pregnancy and is present in breast milk, however
there is no evidence that this causes any harm to the baby. If you are pregnant, suspect or
are planning a pregnancy, or if you are breastfeeding, ask your doctor for advice before
taking this medicine.
If you are a woman who has not yet gone through the menopause, your periods may return or
become more regular. Restored fertility may lead to an unwanted pregnancy, even
before your periods return. See also the “Warnings and precautions” section in
relation to fertility in men and women.

Driving and using machines
Efmody slightly impairs the ability to drive and use machines. Untreated adrenal
insufficiency can affect the ability to drive and use machines. Tell your
doctor immediately if you feel tired or dizzy while taking Efmody.

3. How to take Efmody

Use this medicine following exactly the instructions of your doctor, nurse or
pharmacist. If you have any doubts, ask your doctor, pharmacist or nurse.
The doctor will decide the correct initial dose of Efmody and then adjust the dose as needed based on
the severity of the disease, how you respond to Efmody and any changes in your
conditions, using blood tests to measure the effect on the adrenal gland and also to
check the levels of sodium and potassium. In case of illness, preoperatively and during periods of
severe stress, your doctor may ask you to take another corticosteroid medicine instead of
Efmody or in addition to it.
The initial daily dose may be divided into two doses with administration of two thirds or three quarters
of the daily dose in the evening at bedtime and the remainder in the morning.
The morning dose of modified-release hydrocortisone hard capsules must be taken on an
empty stomach at least 1 hour before a meal and the evening dose must be taken at bedtime at least 2 hours after the last meal of the day.

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

How to take the medicine
Swallow the capsules with water.
Do not chew the capsules as this may alter 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 as soon as possible for
further advice.

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

If you stop taking Efmody
Do not stop treatment with Efmody without consulting your doctor. Suddenly stopping treatment
may quickly lead to an adrenal crisis.

If you do not feel well
Tell your doctor or pharmacist if you become ill, if you suffer from severe stress, if you are injured or are about to
undergo surgery, because your doctor may advise taking another
corticosteroid medicine instead of Efmody or in addition to it (see paragraph 2).

If you take an excessive amount of Efmody
Poisoning or death is rare with excessive amounts of Efmody, but you should inform
your doctor immediately.
If you have any doubts about 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 a reaction such as swelling or shortness of breath after taking Efmody, seek immediate medical attention and tell your doctor as soon as possible, as these signs could herald a serious allergic reaction (anaphylactoid reactions) (see section 2).
• Adrenal crises and symptoms of adrenal insufficiency have been reported frequently (may affect up to 1 in 10 people). If you take less hydrocortisone than is necessary, you may feel very unwell. If you feel unwell and especially if you start to vomit, you should inform your doctor immediately, as you may need additional hydrocortisone or a hydrocortisone injection.

Inform 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)

• feeling unwell (nausea)
• abdominal pain
• loss of energy or weakness
• increase or decrease in appetite and weight gain or loss
• muscle pain or weakness
• joint pain
• headache
• dizziness
• pain or tingling in the thumb or fingers (carpal tunnel syndrome)
• tingling
• insomnia, sleep disturbances or abnormal dreams
• depressed mood
• acne
• hair or body hair growth
• changes in blood tests related to kidneys and glucose
• changes in blood tests related to low-density lipoproteins (increased LDL cholesterol)
• changes in blood tests related to potassium (hypokalaemia or low potassium levels)

Long-term treatment with hydrocortisone can reduce bone density. Your doctor will monitor your
bones (see section 2).
People requiring steroid treatment may have an increased risk of heart disease. Your doctor will monitor you for this.
Long-term treatment with hydrocortisone can affect growth in children and adolescents.
Your doctor will monitor growth in young people. Some children with congenital adrenal hyperplasia treated
with hydrocortisone may experience earlier than expected puberty. Your doctor will monitor
development (see section 2).

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist.
You can also report side effects directly through 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. How to store 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 vial and the packaging box after
Exp.
The expiry date refers to the last day of that month.
This medicine does not require any particular storage temperature.
Store in the original packaging.
Keep the vial tightly closed, to protect the medicine from humidity.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Efmody contains

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

Capsule
The capsule shell is made of 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)

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

Description of Efmody and contents of the pack

• Efmody 5 mg modified-release hard capsules Capsule (approximately 19 mm long) with an opaque blue cap and an opaque white body printed with «CHC 5 mg» containing granules ranging in colour from white to off-white.
• Efmody 10 mg modified-release hard capsules Capsule (approximately 19 mm long) with an opaque green cap and an opaque white body printed with «CHC 10mg» containing granules ranging in colour from white to off-white.

Efmody is packaged in high-density polyethylene plastic bottles with a child-resistant and tamper-evident screw cap, with an integrated desiccant. Each bottle contains
50 modified-release hard capsules.
Pack:
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
Neurocrine Netherlands B.V.
Van Heuven Goedhartlaan 935 A
1181LD Amstelveen
Netherlands
[email protected]

Manufacturer
Delpharm Lille SAS
Parc d’Activités Roubaix-Est
22 rue de Toufflers CS 50070
Lys Lez Lannoy, 59 452
France
Skyepharma Production SAS
Zone Industrielle Chesnes Ouest
55 rue du Montmurier
Saint Quentin Fallavier, 38070
France

Other sources of information
More detailed information on this medicine is available on the European Agency website