Details for: NIMOTOP
Company: BAYER INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02325926 | NIMOTOP | NIMODIPINE | 30 MG | TABLET | ORAL |
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
NIMOTOP Tablets are used for the treatment subarachnoid hemorrhage (medical term for bleeding inside the head) and help to prevent brain damage that may result from the bleeding.
What it does
Following subarachnoid hemorrhage (medical term for bleeding inside the head), the blood vessels may go into spasm. This may result in inadequate circulation in the affected areas of the brain and thus damage the nervous system. NIMOTOP Tablets are used to prevent and, if necessary, to treat such damage.
When it should not be used
Do not take NIMOTOP Tablets:
- if you have suffered from a head injury resulting in a traumatic subarachnoid hemorrhage
- during or within one month of a heart attack
- if you suffer from angina and notice an increase in the frequency and severity of attacks
- if you are taking the antibiotic rifampin or the antiepileptics phenobarbital, phenytoin or carbamazepine as the effect of NIMOTOP Tablets may be reduced
- if you are breastfeeding
- if you are allergic (hypersensitive) to nimodipine or to any of the ingredients in this product. The ingredients are listed in the “What the nonmedicinal ingredients are” section of this leaflet
What the medicinal ingredient is
The active substance is nimodipine
What the non-medicinal ingredients are
Crospovidone, ferric oxide yellow, hypromellose, macrogol, magnesium stearate, maize starch, microcrystalline cellulose, povidone, and titanium dioxide
What dosage form it comes in
Film-coated tablets, 30 mg
Warnings and precautions
BEFORE you use NIMOTOP Tablets, talk to your doctor or pharmacist if you have or have had any of the following conditions:
- have hypotension (systolic blood pressure below 100 mmHg)
- have been told that you have cerebral edema or severely raised intracranial pressure
- have a history of liver disease
- have a history of heart disease
- may be pregnant or are breastfeeding
Interactions with this medication
Drugs that may interact with NIMOTOP Tablets include:
- drugs used for the treatment of epilepsy (eg, phenytoin, carbamazepine, phenobarbital, valproic acid); tuberculosis (eg, rifampin) and HIV infections (eg, ritonavir)
- antibiotics (eg, erythromycin) for infectious disease
- antihypertensive drugs (for high blood pressure), including other calcium channel blockers
- drugs used to treat fungal infections (eg, ketoconazole), unless they are applied only to the skin
- antidepressants (eg, fluoxetine, nortriptyline)
- drugs used to treat indigestion (eg, cimetidine)
- herbal remedy St. John’s Wort (primarily used for the treatment of depressive moods)
NIMOTOP Tablets should not be taken at the same time as grapefruit juice, or near the time of eating grapefruit. This is because grapefruit juice is known to increase the blood levels of the active ingredient, nimodipine.
This is not a complete list of possible drug interactions with NIMOTOP Tablets. Talk to your doctor for more information about drug interactions.
See also ABOUT THIS MEDICATION: When it should not be used, and SIDE EFFECTS AND WHAT TO DO ABOUT THEM.
Proper use of this medication
Usual dose
For the management of neurological deficits following
subarachnoid hemorrhage (SAH), therapy with NIMOTOP
Tablets should start as soon as possible or within 4 days of the
diagnosis of SAH.
The recommended dosage of NIMOTOP Tablets is 60 mg (two
tablets of 30 mg) administered orally every 4 hours for 21
consecutive days after diagnosis of SAH. Doses up to 90 mg
every 4 hours have been used in some patients, although the
safety of higher doses in severely ill patients has not been well
established.
The tablets should be swallowed whole with plenty of fluid
(preferably a glass of water), independently of meal times.
Grapefruit juice should be avoided. It is recommended that the
tablets are not taken while lying down.
Children and Adolescents
Do not give NIMOTOP Tablets to patients under 18 years of age. There is not enough information on their use in children and adolescents.
Pregnancy and Breastfeeding
If you are pregnant or are planning a family, tell your doctor
before taking NIMOTOP Tablets. Investigations have not been
carried out into the damaging effects of NIMOTOP during
pregnancy. NIMOTOP should therefore only be taken during
pregnancy after careful consideration of the benefits and
potential risks arising from the severity of the clinical situation.
Since nimodipine (the active ingredient in NIMOTOP Tablets)
may pass into breast milk, breastfeeding should be discontinued
while taking this drug.
Overdose
Symptoms of acute overdosage to be anticipated are marked
lowering of the blood pressure, an irregular heart beat, flushing,
headache, digestive upset and nausea.
In the event of acute overdose, discontinue use of NIMOTOP
Tablets immediately and contact your doctor or your regional
Poison Control Centre immediately
Missed Dose
If you have forgotten to take a dose, take it as soon as you
remember. Carry on with the remaining tablets at the normal
four-hour intervals.
Do not take a double dose to make up for a forgotten tablet.
Stopped Treatment
You should always consult your doctor before deciding to interrupt or stop the course of NIMOTOP Tablet treatment (eg, on account of side effects) since NIMOTOP Tablets prevent the development of serious neurological deficits.
Side effects and what to do about them
Like all medicines, NIMOTOP can cause side effects, although
not everybody gets them.
The most common side effects seen with NIMOTOP are
allergic reaction (eg, rash), decreased blood pressure, irregular
heartbeat, headache, sweating, flushing, nausea.
There is a possibility that you may feel dizzy; if you are
affected you should not drive or operate machinery.
Please inform your doctor or pharmacist if you experience any
side effects. If necessary, your doctor may reduce or stop
treatment with NIMOTOP Tablets.
You should be aware that prescription medications carry some
risks and that all possible risks may not be known at this stage.
| Symptom/ Effect | Talk with your doctor or pharmacist Only if severe | Talk with your doctor or pharmacist In all cases | Stop taking drug and seek emergency medical treatment |
|---|---|---|---|
| Common | |||
| Low blood pressure (lightheadedness, dizziness, and/or fainting) | ✔ | ||
| Allergic reactions: difficulty breathing or swallowing, rash or hives (redness, intense itching), swelling of face, throat, tongue, lips, eyes, hands, feet, ankles, lower legs) | ✔ | ||
| Localized swelling, swelling in your limbs | ✔ | ||
| Increased frequency and looseness in bowel movement | ✔ | ||
| Unease and discomfort in the stomach with an urge to vomit | ✔ | ||
| Uncommon | |||
| Headache, pain in the neck and/or upper back | ✔ | ||
| Yellowing of the skin or eyes (jaundice) | ✔ | ||
| Anemia (exceptional weakness, paleness, dizziness, headache) | ✔ | ||
This is not a complete list of side effects. For any unexpected effects while taking NIMOTOP Tablets, contact your doctor or pharmacist.
How to store
NIMOTOP tablets should be stored in the original packaging
between 15°C and 30°C. Protect from humidity.
Keep out of reach of children.
Medications should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medications you no longer require. These measures will help to
protect the environment.
Reporting side effects
| Canada Vigilance Program
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways: |
|||
| Report online: | www.healthcanada.gc.ca/medeffect | ||
| Call toll-free at: | 1-866-234-2345 | ||
| Complete a Canada Vigilance Reporting Form and: | |||
| Fax toll-free to: | 1-866-678-6789, or | ||
| Mail to: | Canada Vigilance Program Health Canada Postal Locator 0701E Ottawa ON K1A 0K9 |
||
| Postage paid labels, Canada Vigilance Reporting Form and
the adverse reaction reporting guidelines are available on the
MedEffect™ Canada website at: www.healthcanada.gc.ca/medeffect. NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice. |
|||
| Bayer Inc. You can report any suspected adverse reactions associated with the use of health products to Bayer Inc. by one of the following 3 ways: |
|||
| Toll-free telephone: | 1-800-265-7382 | ||
| Email: | canada.medinfo@bayer.com | ||
| Regular Mail: | Bayer Inc. 77 Belfield Road Toronto, Ontario M9W 1G6 Canada |
||
| NOTE: Should you require information related to the management of side effects, contact your health professional. Bayer Inc. does not provide medical advice. | |||
More information
This document plus the full Product Monograph, prepared for
health professionals, can be found at: http://www.bayer.ca or by
contacting the sponsor, Bayer Inc., at: 1-800-265-7382.
This leaflet was prepared by:
Bayer Inc.
77 Belfield Road
Toronto, Ontario
M9W 1G6
Canada
Date of preparation: November 1, 2011
© 2011, Bayer Inc.
® NIMOTOP is a trademark of Bayer AG, used under license
by Bayer Inc.