Alkindi

Package leaflet: Information for the user

Alkindi 0.5 mg granules in open capsules, 1 mg granules in open capsules, 2 mg granules in open capsules, 5 mg granules in open capsules

hydrocortisone
Warning Alkindi granules are

contained in a capsule which must be
opened before use; after use, discard the empty capsule
and keep it out of the reach of
children. DO NOT swallow the capsule – young children may choke.
Please read all of this leaflet carefully before administering this medicine as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for your child only. Do not give it to other people, even if their symptoms are the same as your child's, as it could be harmful.
• If your child experiences any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What Alkindi is and what it is used for

Alkindi contains the active substance hydrocortisone. Hydrocortisone belongs to a group of medicines known as corticosteroids.
Hydrocortisone is a synthetic version of the natural hormone cortisol. Cortisol is produced by the adrenal glands in the body. Alkindi is intended for use in children and adolescents from birth up to 18 years of age when the body does not produce enough cortisol, due to part of the adrenal gland not functioning properly (adrenal insufficiency, often caused by an inherited condition called congenital adrenal hyperplasia).

2. What you need to know before administering Alkindi

Do not administer Alkindi:

• if the child is allergic to hydrocortisone or to any of the other ingredients of this medicine (listed in section 6);
• if the child has difficulty swallowing food or is premature and cannot yet be fed orally.

Warnings and precautions
Talk to the endocrinologist or pharmacist before administering Alkindi:

• if the child is unwell or has an infection. The endocrinologist may need to temporarily increase the dose of Alkindi; contact the endocrinologist if the child becomes unwell;
• if the child has an adrenal crisis. If the child vomits or becomes very unwell, they may need an injection of hydrocortisone. The endocrinologist will teach you how to administer this in an emergency;
• if the child is due to receive a vaccination. Taking Alkindi should not interrupt the child’s vaccination schedule. Inform the endocrinologist if the child is due to be vaccinated;
• if the child is due to undergo surgery. Inform the anaesthetist that the child is taking Alkindi before any surgical procedure;
• if the child is fed through a nasogastric tube. Alkindi granules are not suitable for administration via nasogastric tube, as they may cause blockage;
• if the child is switching to Alkindi from another hydrocortisone preparation. Differences between hydrocortisone preparations when switching to Alkindi may result in the child receiving an incorrect dose of hydrocortisone during the first week after the switch. This could increase the risk of an adrenal crisis. The child should be closely observed during the week following the switch to Alkindi. The doctor will advise you when to increase the dose of Alkindi if symptoms of adrenal crisis occur, such as unusual tiredness, headache, high or low temperature, or vomiting. If this happens, consult a doctor immediately.

Do not stop administering Alkindi without first consulting the endocrinologist, as this could cause the child to become seriously unwell very quickly.
Since Alkindi replaces the natural hormone that the child lacks, side effects are less likely. However:

• excessive intake of Alkindi may affect the child’s growth. Therefore, the endocrinologist will adjust the dose according to the child’s size and will carefully monitor growth. Inform the endocrinologist of any concerns regarding the child’s growth (see section 4);
• excessive intake of Alkindi may affect the child’s bones; therefore, the endocrinologist will adjust the dose according to the child’s size;
• some adult patients taking hydrocortisone have experienced anxiety, depression, or confusion. It is not known whether this occurs in children, but inform the endocrinologist if the child develops unusual behaviour after starting Alkindi (see section 4);
• allergic reactions to hydrocortisone have been observed in some patients who are allergic to other medicines. Report immediately to the endocrinologist if the child shows any reaction such as swelling or difficulty breathing after administration of Alkindi;
• contact the endocrinologist if the child experiences blurred vision or other visual disturbances.

Sometimes, Alkindi granules may appear in the child’s diaper or faeces after administration. This occurs because the central core of the granule is not absorbed in the intestine after the medicine has been released. This does not mean that the medicine is ineffective or that another dose should be given to the child.
Other medicines and Alkindi
Inform the doctor or pharmacist if the child is taking, has recently taken, or might take any other medicines.
Some medicines may affect the action of Alkindi, which may require the endocrinologist to adjust the dose.
The endocrinologist may need to increase the child’s dose of Alkindi if they are taking any of the following medicines:

• medicines used to treat epilepsy – phenytoin, carbamazepine, and oxcarbazepine;
• medicines used to treat infections (antibiotics) – rifampicin and rifabutin;
• medicines called barbiturates, which may be used to treat seizures (including phenobarbital and primidone);
• medicines used to treat AIDS – efavirenz and nevirapine.

The endocrinologist may need to reduce the child’s dose of Alkindi if they are taking any of the following medicines:

• medicines used to treat fungal infections – 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.

Alkindi with food and drinks
Some foods and drinks may affect the action of Alkindi, and the doctor may need to reduce the child’s dose. These include:

• grapefruit juice,
• liquorice.

Pregnancy, breastfeeding, and fertility
Hydrocortisone may be used during pregnancy and breastfeeding when the body does not produce enough cortisol.
There are no data available on any potential effects of Alkindi on fertility.
Driving and use of machinery
Alkindi does not affect a child’s ability to perform tasks requiring special skills (such as riding a bicycle) or to operate machinery.

3. How to administer Alkindi

Use this medicine exactly as directed by the doctor, nurse, or pharmacist. Consult them if you have any doubts.
The endocrinologist will determine the correct dose of Alkindi based on the child's weight or body size (body surface area) and will adjust the dose as the child grows. In case of illness, surgery, or severe stress, the endocrinologist may recommend additional doses of Alkindi and may also advise that the child receive another corticosteroid instead of or in addition to Alkindi.

How to administer the medicine
The granules must be placed in the mouth without chewing. The capsule shell must not be swallowed; it should be opened carefully as follows:

How to open the Alkindi capsule and administer the granules
Hold the capsule so that

the text appears on the
top part and tap it
with your finger to

ensure the granules
are at the bottom.

OR pour all the granules directly onto a spoon and place them into the mouth.
DO NOT add the granules to liquids before administration, as this may result in an incomplete dose and could also remove the taste-masking coating, releasing the bitter taste of hydrocortisone.

OR, for children who are able to take soft foods,
sprinkle the granules onto a spoon containing cold or room-temperature soft food (e.g. yoghurt or fruit puree) and administer immediately.

Warning The Alkindi granules are contained

within a capsule that must be opened before use. Discard the empty capsule after use, keeping it out of the reach of children. DO NOT swallow the capsule – young children may choke.

If you administer more Alkindi than you should
If you give the child more Alkindi than prescribed, contact the endocrinologist or pharmacist as soon as possible for further advice.

If you forget to administer Alkindi or if the child has received an incomplete dose
If the child does not take a complete dose of Alkindi, administer it as soon as you remember, and give the next dose at the usual time, even if this means administering two doses close together.
Contact your healthcare provider if the child regurgitates, vomits, or spits out most of the granules in the administered dose, as re-administration may be necessary to prevent adrenal insufficiency.

If you stop treatment with Alkindi
Do not stop administering Alkindi without first consulting the endocrinologist.
Sudden discontinuation of the medicine may cause the child to become seriously ill very quickly.

If the child feels unwell
Inform the endocrinologist or pharmacist if the child becomes ill, experiences severe stress, suffers an injury, or requires surgery, as in such circumstances the endocrinologist may need to increase the dose of Alkindi (see section 2).
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

The following side effects have been reported for hydrocortisone-containing medicines used to replace cortisol.

Frequency not known (cannot be estimated from the available data):

• Changes in behaviour, including:
• Loss of contact with reality (psychosis) with sensations that are not real (hallucinations) and mental confusion (delirium);
• Excitement and hyperactivity (mania);
• Intense feeling of happiness and excitement (euphoria).

If the child shows a sudden change in behaviour, contact the endocrinologist (see section 2).

• Stomach pain (gastritis) or nausea.

If the child complains of any of these symptoms, contact the endocrinologist.

• Changes in blood potassium levels causing excessive alkalinity of body tissues or fluids (hypokalaemic alkalosis).

The endocrinologist will monitor the child's potassium levels to check for any changes.
Long-term treatment with hydrocortisone may be associated with changes in bone development and reduced growth. The endocrinologist will monitor the child's growth and bones (see section 2).

Reporting of side effects
If the child experiences any side effect, including those not listed in this leaflet, consult a doctor or pharmacist. You may also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Alkindi

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the bottle and the outer carton after
“EXP.” The expiry date refers to the last day of that month.
Do not store above 30°C and keep the medicine in the original bottle to protect it from light.
Once the bottle has been opened, use the capsules within 60 days.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Alkindi contains

• The active substance is hydrocortisone.
• Alkindi 0.5 mg granules in open capsules: each capsule contains 0.5 mg of hydrocortisone.
• Alkindi 1 mg granules in open capsules: each capsule contains 1 mg of hydrocortisone.
• Alkindi 2 mg granules in open capsules: each capsule contains 2 mg of hydrocortisone.
• Alkindi 5 mg granules in open capsules: each capsule contains 5 mg of hydrocortisone.
• The other components are microcrystalline cellulose, hypromellose, magnesium stearate, and ethylcellulose.
• The capsule shell is made of hypromellose.
• The printing ink on the 0.5 mg capsules contains shellac, propylene glycol, concentrated ammonia solution, potassium hydroxide, and red iron oxide (E172).
• The printing ink on the 1 mg capsule contains shellac, propylene glycol, concentrated ammonia solution, and indigo carmine (E132).
• The printing ink on the 2 mg capsule contains shellac, propylene glycol, concentrated ammonia solution, indigo carmine (E132), yellow iron oxide (E172), and titanium dioxide (E171).
• The printing ink on the 5 mg capsule contains shellac, propylene glycol, concentrated ammonia solution, potassium hydroxide, titanium dioxide (E171), and black iron oxide (E172).

Description of the appearance of Alkindi and contents of the pack
White/whitish granules contained in a colorless, transparent, hard capsule designed to be opened; the dosage is printed on the capsule.

• Alkindi 0.5 mg granules in open capsules: the capsule (approximately 25.3 mm long) is printed with "INF-0.5" in red ink.
• Alkindi 1 mg granules in open capsules: the capsule (approximately 25.3 mm long) is printed with "INF-1.0" in blue ink.
• Alkindi 2 mg granules in open capsules: the capsule (approximately 25.3 mm long) is printed with "INF-2.0" in green ink.
• Alkindi 5 mg granules in open capsules: the capsule (approximately 25.3 mm long) is printed with "INF-5.0" in grey ink.

Alkindi is packaged in plastic bottles made of high-density polyethylene. Pack size: 1 bottle containing 50 capsules.

Marketing Authorization Holder
Diurnal Europe B.V.
Van Heuven Goedhartlaan 935 A
1181LD Amstelveen
The Netherlands
Tel. +31 (0)20 6615 072
[email protected]

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

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu.