ALKINDI SPRINKLE- hydrocortisone granule 
ALKINDI  SPRINKLE- hydrocortisone granule 
Eton Pharmaceuticals, Inc.

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provider needs to change your child’s dose of ALKINDI SPRINKLE.

Especially tell your healthcare provider if your child:

  • takes medicines used to treat fungal infections such as itraconazole, posaconazole, and voriconazole.
  • takes medicines used to treat bacterial infections such as rifampicin, rifabutin, erythromycin, andclarithromycin.
  • takes medicines used to treat human immunodeficiency virus (HIV) infection and AIDS such as ritonavir, efavirenz, and nevirapine.
  • takes seizure medicines such as phenytoin, carbamazepine, oxcarbazepine, phenobarbital, and primidone.
  • takes estrogen.
  • takes warfarin.
  • takes nonsteroidal anti-inflammatory medicines such as aspirin, ibuprofen.
  • takes cyclosporine.
  • takes diabetes medicines.
  • drinks grapefruit juice.

Know the medicines your child takes. Keep a list of them to show your healthcare provider and pharmacist when your child gets a new medicine.

How should I give ALKINDI SPRINKLE?

  • See the detailed Instructions for Use that comes with your ALKINDI SPRINKLE for information on how to give a dose of ALKINDI SPRINKLE the right way.
  • Give ALKINDI SPRINKLE exactly as prescribed by your healthcare provider.
  • Do not stop giving ALKINDI SPRINKLE without talking to your healthcare provider. See “ What is the most important information I should know about ALKINDI SPRINKLE?”
  • Do not let your child chew or crush the granules. Do not let your child swallow the capsule.
  • Do not let the capsules get wet as this may make some of the granules stick to the capsule.
  • Call your healthcare provider if granules come back up into your child’s mouth (regurgitation) or your child has vomiting after swallowing ALKINDI SPRINKLE. Your child may not have received the full dose of ALKINDI SPRINKLE and another dose of ALKINDI SPRINKLE may be needed.
  • Your child may sometimes pass the ALKINDI SPRINKLE granules in their stools (bowel movement). It does not mean that ALKINDI SPRINKLE is not working. Do not give your child another dose of ALKINDI SPRINKLE.
  • ALKINDI SPRINKLE granules should not be given through a nasogastric tube because the granules may block the tube.
  • If your child takes too much ALKINDI SPRINKLE, call your healthcare provider right away or go to the nearest emergency room.

What are the possible side effects of ALKINDI SPRINKLE? ALKINDI SPRINKLE may cause serious side effects, including:

  • See “What is the most important information I should know about ALKINDI SPRINKLE?”
  • Infections. Taking too much ALKINDI SPRINKLE can increase the risk of infections. Tell your healthcare provider if your child has any of these symptoms:
    • fever o stomach area (abdominal) pain
    • cough o diarrhea
    • flu-like symptoms
  • Slowed growth in children. Taking too much ALKINDI SPRINKLE and taking it for long periods of time can affect your child’s growth. Tell your healthcare provider if you are worried about your child’s growth. Your healthcare provider will change the dose depending on your child’s size.
  • Cushing’s syndrome. Taking too much ALKINDI SPRINKLE and taking it for long periods of time can cause Cushing’s syndrome. Tell your healthcare provider if your child has any of these symptoms:
    • weight gain o high blood o swelling o muscle o feeling sugar weakness depressed
    • slowed o high blood o bruising o red, round o mood swings growth in pressure easily face

height

  • Weak, brittle, or soft bones. ALKINDI SPRINKLE can affect your child’s bones. Your healthcare provider will change the dose depending on your child’s size and will monitor your child’s growth and bones.
  • Changes in behavior. Your child’s behavior may change after starting or during treatment with ALKINDI

SPRINKLE. Tell your healthcare provider right away if your child develops any changes inbehavior including:
  • strong feelings of happiness and excitement
  • overexcited and overactivity
  • loss of contact with reality, with feelings that are not real, and mental confusion
  • depression
  • Vision problems. Tell your healthcare provider if your child develops blurred vision or other vision problems during treatment with ALKINDI SPRINKLE. Your healthcare provider may have your child see an eye doctor.
  • Gastrointestinal problems. ALKINDI SPRINKLE can affect your child’s stomach or intestine. Tell your healthcare provider if your child has gastrointestinal illnesses such as stomach or intestinal ulcers, infections, or gastrointestinal surgery.

The most common side effects of ALKINDI SPRINKLE include:

  • fluid retention · change in blood sugar (glucose) · increase in blood pressure
  • behavioral and mood changes tolerance
    • increased appetite and weight gain

These are not all the possible side effects of ALKINDI SPRINKLE. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store ALKINDI SPRINKLE?

  • Store ALKINDI SPRINKLE at room temperature between 68°F to 77°F (20°C to 25°C).
  • Store in the original bottle to protect from light.
  • After the bottle has been opened, use the ALKINDI SPRINKLE capsules within 60 days.

Keep ALKINDI SPRINKLE and all medicines out of the reach of children.

General information about the safe and effective use of ALKINDI SPRINKLE.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use ALKINDI SPRINKLE for a condition for which it was not prescribed. Do not give ALKINDI SPRINKLE to other people, even if they

have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about ALKINDI SPRINKLE that is written for health professionals.

What are the ingredients in ALKINDI SPRINKLE? Active ingredient: hydrocortisone

Inactive ingredients:

granules: microcrystalline cellulose, hypromellose, magnesium stearate, ethyl cellulose. capsule: hypromellose

printing ink: shellac, propylene glycol, concentrated ammonia solution.

ALKINDI SPRINKLE is manufactured for Eton Pharmaceuticals, Inc. by Glatt Pharmaceutical Services GmbH & Co. KG Werner-Glatt-Strasse 1, Binzen, Baden- Wuerttemberg, 79589, Germany

ALKINDI SPRINKLE ®is a registered trademark of Diurnal Limited.

ALKINDI is covered by the following US patents: 9,649,280; 9,675,559; 9,717,740; and other patents in other countries internationally. For more information, go to www.alkindisprinkle.com or call 1-833-343-2500.

Revised: 12/2022
Document Id: ee8ae6c1-c177-7253-e053-2995a90a16dd
Set id: 26c13a5f-7119-4c6a-bf10-fda4e07d7682
Version: 5
Effective Time: 20221201
Eton Pharmaceuticals, Inc.