0.5 mg, 1 mg, 2 mg, 5 mg Granules in capsules designed to be opened 
Hydrocortisone

1. What Alkindi is and what it is used for

Alkindi contains a medicine called hydrocortisone. Hydrocortisone belongs to a group of medicines called corticosteroids.

Hydrocortisone is a synthetic variant of the hormone et cortisol. Cortisol is produced naturally in the body by the adrenal glands. Alkindi is used when the body does not produce enough cortisol due to the adrenal glands not functioning properly (adrenal insufficiency, often caused by a hereditary condition called congenital adrenal hyperplasia).

2. What you need to know before using Alkindi

Do not use Alkindi

  • if your child is allergic to hydrocortisone or any of the other ingredients of this medicine (listed in section 6)
  • if your baby has difficulty swallowing food or is a premature baby who is not yet able to ingest food by mouth.

Warnings and cautions

Warning Alkindi granules are available in capsules that must be opened before use. Discard the empty capsule after use, out of reach of children. The capsule must NOT be swallowed – small children may suffocate.

Talk to your endocrinologist or pharmacist before giving Alkindi to your child about the baby:

  • is ill or has an infection. The endocrinologist may need to increase the dose ofAlkindi temporarily. Talk to your endocrinologist if your child is sick. If the child vomits or is very ill, he or she may need an injection of hydrocortisone. The endocrinologist will show you how to give such injection in an emergency. 
  • to be vaccinated. Alkindi treatment should not be an obstacle to the child being vaccinated. Inform the endocrinologist about when the child should be vaccinated. 
  • to be operated on. Tell your anesthesiologist that your child is receiving Alkindi before the child has surgery.
  • sonatas. Alkindi granules are not suitable to give via probe because the granules can clog the probe.

Do not stop giving Alkindi without the advice of the endocrinologist. It can make your child seriously ill very quickly.

Because Alkindi replaces hormones that your child lacks, side effects are uncommon, but:

  • Too high a dose of Alkindi can inhibit the child’s growth. The endocrinologist adjusts the dose according to your child’s body size and closely monitors the child’s growth. Talk to your endocrinologist if you are concerned about your baby’s growth (see section 4).
  • Too high a dose of Alkindi can affect the skeleton. The endocrinologist adjusts the dose according to your child’s body size.
  • Some adult patients taking hydrocortisone (the same as Alkindi) suffered from anxiety, depression, or confusion. It is not known if this applies to children, but tell your endocrinologist if your child’s behavior changes after starting treatment with Alkindi (see section 4).
  • Some patients who are allergic to other drugs have also developed allergies to hydrocortisone. Tell your endocrinologist immediately if your child develops a reaction such as swelling or shortness of breath after receiving Alkindi (see section 4).
  • Contact the endocrinologist if your child sees worse (blurred vision) or has other visual disturbances.

It happens that you discover Alkindi granules in the baby’s diaper or stool when it has received Alkindi. This is because the core of the granules is not absorbed by the intestine when the drug itself has been released. This does not mean that the medicine does not work and you do not need to give the child an extra dose.

Other medicines and Alkindi

Tell your doctor or pharmacist if your child is taking, has recently taken, or might take any other medicines. This also applies to over-the-counter medicines.

Some medicines may affect the way Alkindi works. The endocrinologist may therefore need to change the child’s dose of Alkindi.

Drugs that can cause the doctor to increase the child’s dose of Alkindi include:

  • drugs for the treatment of epilepsy: phenytoin, carbamazepine, and oxcarbazepine 
  • drugs for the treatment of infections ( antibiotics ): rifampicin and rifabutin 
  • so-called barbiturates, which can be used to treat seizures (such as phenobarbital and primidone) 
  • drugs for the treatment of AIDS: efavirenz and nevirapine. 

Drugs that can help a doctor reduce a child’s dose of Alkindi include:

  • drugs for the treatment of fungal infections: itraconazole, posaconazole, and voriconazole
  • drugs for the treatment of infections ( antibiotics ): erythromycin and clarithromycin
  • drugs for the treatment of HIV (human immunodeficiency virus) and AIDS: ritonavir.

Alkindi with food, drink, and alcohol

Some foods and beverages may affect the way Alkindi works. The endocrinologist may therefore need to reduce the child’s dose of Alkindi. This applies:

  • grapefruit juice
  • licorice

Pregnancy, breastfeeding, and fertility

Hydrocortisone can be used during pregnancy and lactation if the body does not produce enough cortisol.

There are no data on the possible effects of Alkindi on fertility.

Driving and using machines

Alkindi does not affect the child’s ability to perform actions that require some skill (eg cycling) or using machines.

3. How to use Alkindi

Use for children and adolescents

Always use this medicine exactly as your endocrinologist, nurse or pharmacist has told you. If you are not sure, consult an endocrinologist, nurse, or pharmacist.

The endocrinologist determines an appropriate dose of Alkindi based on the child’s weight or size (body surface area) and then adjusts dose one as the child grows. In case of illness, if the child is to undergo surgery or is under severe stress, the endocrinologist may recommend that more doses of Alkindi be given. Your child may also be given other types of hydrocortisone instead of, or in addition to, Alkindi.

How to give the medicine

Granules must be given orally and should not be chewed. The capsule cover should not be swallowed but should be carefully opened as follows:

picture 1

If you use more Alkindi than you should 

If you have given too much Alkindi to your child, contact your endocrinologist or pharmacist for advice as soon as possible.

If you forget to use Alkindi

If you forget to give your child a dose, give it as soon as you remember. The next dose should be given at the usual time, even if it means that your child receives two doses at the same time.

If you stop using Alkindi

Do not stop giving your child Alkindi without first asking the endocrinologist. If you stop treatment suddenly, the child can quickly become very ill.

If your child becomes ill

Tell your endocrinologist or pharmacist if your child becomes ill, is under severe stress, is injured, or needs surgery. The endocrinologist may need to increase the dose of Alkindi in such cases (see section 2).

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

4. Possible side effects

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

  • If your child develops a reaction with swelling or shortness of breath after receiving Alkindi, seek medical attention immediately, and inform the endocrinologist as soon as possible. This may be a sign of an allergic reaction(see section 2).

No side effects of Alkindi have been observed, but the following side effects have occurred with other hydrocortisone medicines used to replace cortisol:

Has been reported (occurs in an unknown number of users):

Behavioral changes such as:

  • lost contact with reality ( psychosis ) with hallucinations and mental confusion ( delirium )
  • strong arousal and overactivity (mania)
  • strong feelings of happiness and excitement ( euphoria )

Contact the endocrinologist if the child’s behavior changes dramatically (see section 2).

  • Stomach pain ( gastritis ) or nausea.

Contact the endocrinologist if the child complains of this.

  • Altered potassium levels in the blood, which leads to body tissues and fluids becoming alkaline (hypokalemic alkalosis ).

The endocrinologist will monitor the baby’s potassium levels to see if they change.

Long-term treatment with hydrocortisone may be associated with changes in skeletal development and stunted growth. The endocrinologist will monitor the baby’s growth and skeleton (see section 2).

Reporting of side effects:

If your child has any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. You can also report side effects directly via the national reporting system listed in Appendix V.. By reporting side effects, you can help increase drug safety information.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. 

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 which is stated on the can and carton after “EXP”. The expiration date is the last day of the specified month.

Do not store above 30 ° C. Store in the original jar. Sensitive to light.

Once the jar has been opened, the capsules should be used within 60 days.

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

6. Contents of the packaging and other information

Content declaration

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

What the medicine looks like and the contents of the pack

White to off-white granules in a transparent colorless hard capsule intended to be opened. The strength is pressed on the capsule.

  • Alkindi 0.5 mg granules in capsules to be opened: the capsule is marked with “INF-0.5” in red ink.
  • Alkindi 1 mg granules in capsules to be opened: the capsule is marked with “INF-1.0” in blue ink.
  • Alkindi 2 mg granules in capsules to be opened: the capsule is marked with “INF-2.0” in green ink.
  • Alkindi 5 mg granules in capsules to be opened: the capsule is marked with “INF-5.0” in gray ink.

Alkindi is packaged in plastic cans of high-density polyethylene containing 50 capsules. Each carton contains a jar.

Marketing Authorization Holder and Manufacturer

Diurnal Europe BV

Van Heuven Goedhartlaan 935 A

1181LD Amstelveen

Netherlands

Tel: +31 (0) 20 6615 072

info@diurnal.co.uk

Manufacturer

Delpharm Lille SAS

Roubaix-Est Activity Park

22 rue de Toufflers CS 50070

Lys Lez Lannoy, 59 452

France

Muhammad Nadeem

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