Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent. The side effects listed below are not experienced by everyone who takes Sandomigran DS (Pizotifen). If you are concerned about side effects, discuss the risks and benefits of Sandomigran DS (Pizotifen) with your doctor.

Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• dizziness
• drowsiness
• Dry Mouth
• fatigue
• increased appetite
• nausea
• weight gain

Although most of these side effects listed below don't happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• aggressive behavior or agitation in children
• Low Blood Pressure
• muscle and joint pain
• sensation of tingling or prickling
• signs of Depression (e.g., poor concentration, changes in weight, changes in sleep, decreased interest in activities, thoughts of suicide)
• signs of liver problems (e.g., nausea, vomiting, Diarrhea, loss of appetite, weight loss, yellowing of the skin or whites of the eyes, dark urine, pale stools)
• vision changes

Stop taking the medication and seek immediate medical attention if any of the following occur:

• hallucinations
• seizures
• symptoms of a Anaphylaxis (severe allergic reaction) (e.g., Hives, difficulty breathing, swelling of the throat or mouth)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking Sandomigran DS (Pizotifen).

Each whitish, compressed tablet contains 1 mg of Sandomigran DS (Pizotifen). Nonmedicinal ingredients: lactose, magnesium stearate, and microcrystalline cellulose.

Do not take Sandomigran DS (Pizotifen) if you:

• are allergic to Sandomigran DS (Pizotifen) or any of the ingredients of the medication
• are taking monoamine oxidase (MAO) inhibitors (e.g., Tranylcypromine or Phenelzine)
• are under the age of 12 years
• have a pyloroduodenal obstruction or stenosing pyloric ulcer
• have lactose intolerance, galactose intolerance, or glucose malabsorption (a rare hereditary disease)

There may be an interaction between Sandomigran DS (Pizotifen) and any of the following:

• aclidinium
• alcohol
• amantadine
• amphetamines (e.g., Dextroamphetamine, Lisdexamfetamine)
• antihistamines (e.g., cetirizine, doxylamine, Diphenhydramine, Hydroxyzine, Loratadine)
• antipsychotics (e.g., Haloperidol, Perphenazine, Quetiapine, Olanzapine, Risperidone)
• atropine
• azelastine
• barbiturates (e.g., Phenobarbital, butalbital)
• belladonna
• benzodiazepines (e.g., Diazepam, Lorazepam)
• Benztropine
• Betahistine
• botulinum toxin
• brimonidine
• Buprenorphine
• Buspirone
• cannabis
• cholinesterase inhibitors (e.g., Donepezil, Galantamine, Rivastigmine)
• chloral hydrate
• Disopyramide
• Domperidone
• efavirenz
• Eluxadoline
• Flavoxate
• Glucagon
• glycopyrrolate
• glycopyrronium
• ipratropium
• ketotifen
• magnesium sulfate
• Metoclopramide
• Mirabegron
• Mirtazapine
• monoamine oxidase inhibitors (M.O.S. e.g., Moclobemide, Rasagiline, phenelzine, Selegiline, tranylcypromine)
• muscle relaxants (e.g., Baclofen, Cyclobenzaprine, methocarbamol, orphenadrine)
• Nabilone
• narcotic pain relievers (e.g., Codeine, Morphine)
• Nitroglycerin
• Oxybutynin
• potassium supplements
• Pramipexole
• Ropinirole
• Rotigotine
• scopolamine
• seizure medications (e.g., Clobazam, Levetiracetam, phenobarbital, Phenytoin, primidone, Topiramate, Valproic acid, zonisamide)
• selective serotonin reuptake inhibitors (SSRIs; e.g., Paroxetine, Sertraline)
• sodium oxybate
• Solifenacin
• suvorexant
• Tapentadol
• thalidomide
• thiazide diuretics (e.g., Hydrochlorothiazide, Chlorthalidone)
• tiotropium
• Tolterodine
• topiramate
• Tramadol
• tricyclic antidepressants (e.g., Amitriptyline, Desipramine)
• umeclidinium
• Zolpidem
• Zopiclone

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Sandomigran DS (Pizotifen). Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Sandomigran DS (Pizotifen).

Drowsiness/reduced alertness: Drowsiness or dizziness may occur with use of Sandomigran DS (Pizotifen) and this may impair your ability to drive or operate machinery. Avoid driving, operating machinery, or performing other potentially hazardous tasks until you have determined how Sandomigran DS (Pizotifen) affects you.

Liver problems: Decreased liver function or liver disease can cause Sandomigran DS (Pizotifen) to build up in the body, causing side effects. Long-term use of Sandomigran DS (Pizotifen) may also cause changes in liver function. If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately.

Medical conditions: People with narrow-angle Glaucoma, urinary retention (e.g., enlarged prostate), Diabetes, heart disease, seizures, or reduced kidney or liver function should discuss with their doctor how Sandomigran DS (Pizotifen) may affect their medical condition, how their medical condition may affect the dosing and effectiveness of Sandomigran DS (Pizotifen), and whether any special monitoring is needed.

Tolerance: With prolonged use of Sandomigran DS (Pizotifen), some people find that it no longer works successfully. If this happens, contact your doctor.

Withdrawal: If Sandomigran DS (Pizotifen) is stopped suddenly, you may experience withdrawal symptoms such as anxiety, sweating, trouble sleeping, shaking, pain, nausea, tremors, diarrhea, and hallucinations. Do not stop taking Sandomigran DS (Pizotifen) without talking to your doctor or pharmacist.

Pregnancy: Sandomigran DS (Pizotifen) should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking Sandomigran DS (Pizotifen), contact your doctor immediately.

Breast-feeding: It is not known if Sandomigran DS (Pizotifen) passes into breast milk. If you are a breast-feeding mother and are taking Sandomigran DS (Pizotifen), it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using Sandomigran DS (Pizotifen) have not been established for children under 12 years of age.