Efmody 5mg modified release hard capsules

• 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.

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

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

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).
• High doses of hydrocortisone can increase the risk of heart disease and circulatory problems by causing raised blood pressure, salt and water retention, obesity and 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 (hypokalaemia). See section 4. 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.

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.

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

• Medicines used to maintain sodium (salt) levels: mineralocorticoids, such as fludrocortisone.
• Medicines used to reduce fluid content: 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.

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

• Grapefruit juice.
• Liquorice. (This may also lower your potassium levels).

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.

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.

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.

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, contact your doctor or pharmacist for further advice as soon as possible.

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

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

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 take another corticosteroid medicine instead of, or as well as, Efmody (see section 2).

Poisoning or death are rare with too much Efmody, but you should inform your doctor immediately.

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
• Changes in blood tests of low density lipoprotein (raised LDL-cholesterol)
• Changes in blood tests of potassium (hypokalaemia or low potassium)

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).

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 Yellow Card Scheme

Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.

• 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
• 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)

Printing ink

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

• 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 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.