Gravol Immediate Release & Long Acting Caplets: Uses, Side Effects and Dosage

What is GRAVOL used for?

GRAVOL is used to prevent and relieve symptoms such as:

• nausea
• vomiting and/or
• vertigo

These symptoms may be the result of:

• motion sickness
• radiation sickness
• postoperative recovery
• taking other drugs
• an ear condition (Menière’s disease and other labyrinthine disturbances)

How does GRAVOL work?

GRAVOL belongs to a family of drugs called antiemetics. It works by:

• affecting the brain and inner ear to help prevent problems with the body’s balance
• blocking processes that are involved in the vomiting reflex

What are the ingredients in GRAVOL?

Medicinal ingredient: dimenhydrinate

Non-medicinal ingredients:

GRAVOL Immediate Release & butyl hydroxytoluene, calcium carbonate, calcium

Long-Acting Caplets phosphate, FD&C Red 40 aluminum lake, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyethylene oxide, starch (corn)

GRAVOL TasteFree Liquid Gel D&C Red 33, gelatin, glycerin, mannitol,

Capsules methylparaben, polyethylene glycol, povidone, propylparaben, sorbitol, water

GRAVOL Kids Liquid citric acid, D&C Yellow 10, FD&C Yellow 6, flavour, polysorbate 80, propylene glycol, sodium benzoate, sorbitol, sucrose and water

GRAVOL Comfort Shaped polyethylene glycol, silicon dioxide and titanium

Suppositories dioxide

GRAVOL Kids Comfort Shaped polyethylene glycol, silicon dioxide and titanium

Suppositories dioxide

GRAVOL Easy To Swallow Tablets Croscarmellose sodium, FD&C yellow 6 aluminum lake, iron oxide yellow, lactose monohydrate, magnesium hydroxide, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, starch (corn), talc and titanium dioxide

GRAVOL Kids Quick Dissolve acetylated monoglycerides, amino methacrylate

Chewable Tablets copolymer, aspartame, citric acid, crospovidone, ethylcellulose, FD&C Red 40 aluminum lake, flavour, magnesium stearate, mannitol, polyethylene glycol, silicon dioxide and sorbitol

GRAVOL Quick Dissolve acetylated monoglycerides, amino methacrylate,

Chewable Tablets aspartame, citric acid crospovidone, ethylcellulose, FD&C Yellow 6 aluminum lake, flavour, magnesium stearate, mannitol, polyethylene glycol, silicon dioxide and sorbitol

Gravol IM 50% propylene glycol, water for injection, hydrochloric acid and sodium hydroxide for pH adjustment

GRAVOL comes in the following dosage forms:

• Solution for injection: 50 mg/mL
• Quick Dissolve Chewable Tablets: 15 mg and 50 mg
• Easy to Swallow Tablets: 50 mg
• Immediate Release & Long Acting Caplets: 100 mg
• Liquid Gel Capsules: 50 mg
• Suppositories: 25 mg and 100 mg
• Liquid: 15mg/5 ml

Do not use GRAVOL if you:

• are allergic to dimenhydrinate or any of the other ingredients in GRAVOL (see What are the ingredients in GRAVOL)

• take a Monoamine Oxidase Inhibitor (MAOI). Ask your healthcare provider or pharmacist if you are not sure if you take an MAOI, including the antibiotic linezolid and methylene blue. Do not:

  • Take an MAOI within 2 weeks of stopping GRAVOL unless told to do so by your doctor
  • Start GRAVOL if you stopped taking an MAOI in the last 2 weeks unless told to do so by your doctor
• Have glaucoma

• Have chronic lung disease including:

  • asthma
  • chronic obstructive pulmonary disease
  • lower respiratory tract symptoms
• Have difficulty urinating due to an enlarged prostate
• Are 2 years old or younger

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take GRAVOL. Talk about any health conditions or problems you may have, including if you:

• have a history of heart problems, including high blood pressure
• have a history of seizures
• have problems with your thyroid
• have or had liver problems
• are pregnant or planning to become pregnant
• are breastfeeding or planning to breastfeed
• have porphyria (a condition that affects your hemoglobin)

Other warnings you should know about:

Do not take more than the recommended dose. At high doses, GRAVOL can cause:

• confusion
• hallucinations
• temporary amnesia
• paranoia

Abuse: chronic abuse of GRAVOL can lead to accidents, overdose, and in extreme cases to death. GRAVOL should not be used for prolonged periods except on the advice of your doctor.

Driving and using machines: Before doing tasks that require special attention, wait until you know how you respond to GRAVOL.

Pregnancy: Do not take GRAVOL for nausea or vomiting while pregnant unless told to do so by your doctor.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with GRAVOL:

• Alcohol
• Some drugs used to treat depression (MAO inhibitors)

• Drugs used to help you sleep such as:

  • barbiturates
  • sedatives
  • hypnotics
• Drugs used to reduce tension or anxiety (such as tranquilizers)

To avoid an overdose, you should use caution when taking GRAVOL with these types of drugs.

• Drugs used to treat allergies or allergic reactions (antihistamines)
• Drugs that can cause damage to the ear (called ototoxic drugs). If you take dimenhydrinate in combination with certain antibiotics or other drugs that can cause damage to the ear, you may not be able to see the early symptoms of ototoxicity.

How to take GRAVOL:

GRAVOL IM is for intramuscular use only.

If used for intravenous (IV) administration, it must be diluted at least one to ten with a compatible physiological solution (such as sterile saline or 5% dextrose and water). Diluted GRAVOL IM, prepared for IV use, should be administered by SLOW INTRAVENOUS INJECTION ONLY (over 2 minutes).

For Motion Sickness

Adults

Oral:

Usual dose: 50 mg - 100 mg every 4 hours

Maximum daily dose: 400 mg a day

For extended relief:

Usual dose: 1 GRAVOL 100 mg Immediate Release & Long Acting caplet every 8 to 12 hours

Maximum daily dose: 300 mg a day

Rectal:

Usual dose: 50 mg - 100 mg GRAVOL Comfort Shaped suppository every 6 to 8 hours as needed. For ease and comfort, smooth any edges on suppository prior to use

Children

12 years of age and older:

Oral:

Usual dose: 50 mg every 4 to 6 hours as needed

Maximum daily dose: 400 mg a day

Rectal:

Usual dose: 50 mg every 8 to 12 hours as needed

8 to 11 years of age:

Oral:

Usual dose: 25 mg - 50 mg every 6 to 8 hours as needed

Maximum daily dose: 150 mg a day

Rectal:

Usual dose: 25 mg - 50 mg every 8 to 12 hours as needed

6 to 7 years of age:

Oral:

Usual dose: 25 mg - 50 mg every 6 to 8 hours as needed

Maximum daily dose: 150 mg a day

Rectal:

Usual dose: 12.5 mg - 25 mg every 8 to 12 hours as needed.

2 to 6 years of age:

Oral:

Usual dose: 15mg - 25 mg every 6 to 8 hours as needed

Maximum daily dose: 75 mg a day

Rectal:

Usual dose: 12.5 mg - 25 mg only once. Do not give another dose unless directed by your doctor

For Radiation Sickness

Pre-Therapy:

Usual adult dose: 50 mg – 100 mg given rectally or by injection, 30 to 60 minutes before treatment

Maximum daily dose: This dose can be given again up to 400 mg a day

Post-therapy:

Usual adult dose: 50 mg given IM or by IV 1.5 hours after therapy and 50 given mg IM or by IV 3 hours - after therapy

Postoperative Nausea/Vomiting

Adults

Usual pre-operative dose: 50 mg - 100 mg may be given orally or 50 mg IM or by IV

Usual post-operative dose: 50 mg - 100 mg may be given orally or 50 mg IM or by IV

Maximum daily dose: 400 mg a day

Children

Usual dose for Over 12 years of age: 50 mg given IM or by IV 2 or 3 times a day

Usual dose for 8 to 12 years of age: 25 mg - 50 mg given IM or by IV 2 or 3 times a day

Usual dose for 6 to 7 years of age: 15 mg - 25 mg given IM or by IV 2 or 3 times a day

Post-surgical/Post-anesthetic

Adults:

Usual dose: 50 mg given IM or by IV immediately after surgery. Then 50 mg given IM or by IV every 4 hours for 3 doses

Children:

Usual dose for Over 12 years of age: 50 mg given IM or by IV 2 or 3 times a day

Usual dose for 8 to 12 years of age: 25 mg - 50 mg given IM or by IV 2 or 3 times a day

Usual dose for 6 to 7 years of age: 15 mg - 25 mg given IM or by IV 2 or 3 times a day

Overdose:

Missed dose:

If you miss a dose and you are taking it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once. Do not exceed the maximum daily dose.

What are possible side effects from using GRAVOL?

These are not all the possible side effects you may feel when taking GRAVOL. If you experience any side effects not listed here, contact your healthcare professional.

• drowsiness
• dizziness
• pain may occur at the site of IM injection
• dry mouth
• fatigueexcitement
• nausea

Skin Rash: If you experience a skin rash after taking GRAVOL, you should contact your doctor or pharmacist for assessment and advice.

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.

Reporting Side Effects

Storage:

GRAVOL IM should be stored at controlled room temperature (15°C – 30°C). Protect from freezing.

Keep out of reach and sight of children.

If you want more information about GRAVOL:

• Talk to your healthcare professional
• Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website; the manufacturer’s website www.gravol.ca, or by calling 1-800-268-3186.

Last Revised 25-01-2016