30 mg film-coated tablets
What Nimotop is and what it is used for
The active substance in Nimotop tablets is a nimodipine. Nimodipine is a calcium antagonist, ie an agent that reduces the influx of calcium ions into certain cells. By reducing the influx of calcium ions, contractions of blood vessels and thus lack of oxygen are prevented.
Nimotop tablets are used to prevent or treat symptoms of hypoxia due to vasoconstriction (vasospasm) that occurs after a so-called subarachnoid hemorrhage (bleeding in the fluid-filled cavity surrounding the brain) caused by varicose veins.
What you need to know before taking Nimotop
Do not take Nimotop
- if you are allergic to nimodipine or any of the other ingredients of this medicine (listed in section 6).
- concomitantly with rifampicin (for tuberculosis ).
- concomitantly with phenobarbital, phenytoin, carbamazepine (for epilepsy ) or St. John’s wort .
Warnings and cautions
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Some medicines can affect or be affected by treatment with Nimotop if taken at the same time. Examples are drugs that contain:
- rifampicin (for tuberculosis )
- cimetidine (against acid stomach)
- phenobarbital, phenytoin , carbamazepine and valproic acid (for epilepsy )
- fluoxetine , nefazodone, nortriptyline (for depression)
- St. John’s wort (herbal remedy for depression)
- quinopristine, dalfopristine (for infection )
- erythromycin and macrolide class antibiotics (for infection )
- telithromycin, clarithromycin (against bacterial infection)
- ketoconazole , intraconazole, fluconazole , posaconazole, voriconazole (for fungal infection)
- ritonavir and nelfinavir, zidovudine (for HIV )
- verapramil, diltiazem (for heart disease)
- aprepitant (for nausea in cancer treatment).
Nimotop tablets may potentiate the effect of other blood pressure medications used at the same time and your blood pressure may therefore need to be monitored.
Other medicines and Nimotop
Nimotop with food and drink
Concomitant intake of grapefruit juice and Nimotop tablets may lead to elevated levels of the drug in the blood. You should therefore avoid taking Nimotop tablets and grapefruit or grapefruit juice at the same time.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
There is a risk that the fetus will be affected. Therefore, always consult a doctor before using Nimotop tablets during pregnancy.
Nimodipine passes into breast milk and breastfed babies may be affected. Therefore, do not use Nimotop tablets while breastfeeding other than on a doctor’s prescription.
Nimotop may affect men’s ability to have children. Nimotop is a calcium antagonist, in in vitro fertilization (IVF) there have in some cases been signs that the use of calcium antagonists can lead to impaired sperm function. It is unknown if this has any significance for short-term use.
Driving and using machines
Due to the risk of dizziness, the ability to react may be reduced when taking Nimotop tablets. This should be taken into account when sharper attention is required e.g. while driving.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened vigilance. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
How to take Nimotop
Always take Nimotop tablets exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
The usual dose is 2 tablets 6 times daily. The tablets should be swallowed whole with liquid and can be taken independently of meals. The time between doses should be at least 4 hours.
Treatment with Nimotop is often started in the hospital as an infusion for up to 14 days. Thereafter, tablets are given for about 7 days as prescribed by a doctor.
Use for children and adolescents
The safety and efficacy of Nimotop in children and adolescents below 18 years have not been established.
If you take more Nimotop than you should
If you have ingested too much medicine, or if e.g. a child ingested the medicine by mistake, contact a doctor or hospital for risk assessment and advice.
Possible side effects
Like all medicines, Nimotop tablets can cause side effects, although not everybody gets them.
If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information.
Uncommon (affects less than 1 user in 100): Decreased platelets, allergic reactions, rash, headache, fast pulse, low blood pressure, vasodilation, nausea.
Rare (affects less than 1 user in 1,000): Slow pulse, bowel movements, altered liver values.
How to store Nimotop
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 carton. The expiration date is the last day of the specified month.
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.
Contents of the pack and other information
- The active substance is nimodipine 30 mg per tablet.
- The other ingredients are povidone, microcrystalline cellulose, maize starch, crospovidone, magnesium stearate, hypromellose, macrogol 4000, titanium dioxide (dye E 171), yellow iron oxide (dye E 172).
What the medicine looks like and contents of the pack
The tablets are yellow, round (10 mm in diameter), and marked with SK and Bayer crosses.
Pressure pack with 100 tablets.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Bayer AB, Box 606, SE-169 26 Solna
Bayer AG, 51368 Leverkusen, Germany