Patient Leaflet Updated 03-Aug-2020 | Bayer plc
Nimotop 0.02% Solution for Infusion
Due to regulatory changes, the content of the following Patient Information Leaflet may vary from the one found in your medicine pack. Please compare the 'Leaflet prepared/revised date' towards the end of the leaflet to establish if there have been any changes.
If you have any doubts or queries about your medication, please contact your doctor or pharmacist.
Nimotop® 0.02% Solution for Infusion
Nimodipine
1. What Nimotop solution is and what it is used for
2. What you need to know before you are given Nimotop solution
3. How you are given Nimotop solution
4. Possible side effects
5. How to store Nimotop solution
6. Contents of the pack and other information
Nimotop solution contains nimodipine, which belongs to a group of medicines called calcium antagonists.
Nimotop solution is used to prevent changes in brain function after bleeding around the brain (subarachnoid haemorrhage).
You should not be given Nimotop solution:
Talk to your doctor or pharmacist before receiving Nimotop solution
Do not give Nimotop solution to children under the age of 18 as the safety and efficacy of Nimotop have not been established.
You will not be given Nimotop solution if you are taking Nimotop tablets.
You are not to be given injectable beta-blockers if you are given Nimotop solution.
Tell your doctor if you are taking, have recently taken or might take any other medicines. It’s especially important to tell your doctor about these medicines:
Do not drink grapefruit juice or eat grapefruit while taking Nimotop solution.
Do not start treatment with Nimotop solution within 4 days of drinking grapefruit juice or eating grapefruit. Tell your doctor if you have had grapefruit or grapefruit juice in this time. Also, do not drink grapefruit juice or eat grapefruit whilst being treated with Nimotop solution.
Grapefruit juice is known to increase the blood levels of the active ingredient, nimodipine. This effect can last for at least four days.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. Follow his/her instructions carefully.
Do not breast-feed while you are being treated with Nimotop solution.
If you are trying to father a child, talk to your doctor. Medicines like Nimotop solution can sometimes affect male fertility.
Nimotop solution may make you feel less alert, or dizzy. Do not drive or operate machinery if you are affected in this way. The amount of alcohol in the solution may also make you feel less alert.
If you continue your treatment with Nimotop (for example if your doctor prescribes tablets), do not drive or operate machinery if you think you might be affected.
This medicine contains 2 g of alcohol (ethanol) in each hourly dose of 10 ml (23.7 vol%). The amount in 10 ml of this medicine is equivalent to 50 ml beer or 20 ml wine. The amount of alcohol in this medicine is not likely to have an effect in adults and adolescents, and its effects in children are not likely to be noticeable. It may have some effects in younger children, for example feeling sleepy.
The alcohol in this medicine may alter the effects of other medicines. Talk to your doctor or pharmacist if you are taking other medicines.
Because this medicine is given slowly by continuous infusion, the effects of alcohol may be reduced.
If you are pregnant or breast-feeding, talk to your doctor or pharmacist before taking this medicine.
If you are addicted to alcohol, talk to your doctor or pharmacist before taking this medicine.
Harmful for those suffering from alcoholism.
To be taken into account in pregnant or breast-feeding women, children and high-risk groups such as patients with liver disease or epilepsy. The amount of alcohol in this medicinal product may alter the effects of other medicines.
The amount of alcohol in this medicinal product may impair your ability to drive or use machines.
This medicine contains 23 mg sodium (main component of cooking/table salt) per 50ml bottle or 115 mg sodium per 250 ml bottle. This is equivalent to 1.15 % or 5.75 %, respectively, of the recommended maximum daily dietary intake of sodium for an adult. To be taken into consideration by patients on a controlled sodium diet.
Nimotop solution is given by a doctor or nurse, as a slow injection through a vein into the bloodstream.
The recommended dose is 5 ml per hour in the first two hours of treatment. This will be increased to 10ml per hour, if there is no sign of a drop in blood pressure.
Treatment will last for at least 5 days, up to a maximum of 14 days. After the intravenous therapy you may be given Nimotop tablets for a further period of time, but the total length of treatment with nimodipine (Nimotop solution followed by Nimotop tablets) will not exceed 21 days.
If you weigh less than 70 kg or have unstable blood pressure, your doctor will calculate the dose of Nimotop solution required.
The amount of Nimotop solution you receive is carefully controlled by your doctor. It is highly unlikely that you will be given too much medicine.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience:
In addition to the serious side effects listed above, these are the other less serious side effects of Nimotop solution:
Uncommon side effects
(These may affect up to 1 in 100 people)
Rare side effects
(These may affect up to 1 in 1,000 people)
If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine.
United Kingdom
Malta
Keep this medicine out of the sight and reach of children.
Store below 25°C and protect from light.
Store in the outer carton until just before use. Your doctor or hospital pharmacist will store Nimotop solution appropriately before it is used.
This medicine should not be used after the expiry date which is stated on both the outer carton and on each vial after EXP. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
The active substance is nimodipine.
The other ingredients are ethanol, macrogol, sodium citrate, citric acid and water for injection.
Each glass vial contains 10mg of nimodipine in 50ml of solution (0.02% solution).
Each pack contains
1 x 50ml vial with 1 polyethylene infusion line or
5 x 50ml vials with 5 polyethylene infusion lines.
Marketing Authorisation holder:
Manufacturer:
This leaflet was last revised in June 2020.
Marketing authorisation number: PL 00010/0138
019_0
400 South Oak Way, Reading, Berkshire, RG2 6AD
+44 (0)118 206 3000