Nimotop 0.02% Solution for Infusion

Read all of this leaflet carefully before you start taking this medicine.

Keep this leaflet. You may need to read it again.

If you have more questions, ask your doctor or pharmacist.

This medicine has been prescribed for you.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet

1 What Nimotop solution is
2 Before you are given Nimotop solution
3 How you are given Nimotop solution
4 Possible side effects
5 How to store Nimotop solution
6 Further information

You should not be given Nimotop solution:

• If you have had a heart attack within the last month.
• If you suffer from angina and notice an increase in the frequency and severity of attacks.
• If you are allergic to nimodipine or any of the ingredients in this product. The ingredients are listed in section 6.

• Tell your doctor and do not take Nimotop solution if any of these apply to you.

Your doctor will take special care:

• If you had a head injury which caused bleeding around the brain (traumatic subarachnoid haemorrhage).
• If you have fluid in the brain or severely raised pressure in your skull. Your doctor will be able to advise you about this.
• If you have low blood pressure.
• If you have liver disease. You will probably need to have your blood pressure measured regularly.
• If you have kidney problems. Your doctor may want to monitor your kidney function during treatment.
• If you are susceptible to alcohol. Nimotop solution contains up to 50g alcohol (ethanol) per daily dose. This is equivalent to 1200 ml beer or 500 ml wine per dose. This may be harmful for those suffering from alcoholism. It should also be taken into account in pregnant or breastfeeding women, children and high-risk groups such as patients with liver disease or epilepsy.
• If you are on a controlled salt (sodium) diet. Nimotop solution contains up to 23 mg sodium per 50 ml bottle or 115 mg sodium per 250 ml bottle.

• Tell your doctor before you take Nimotop, if any of these apply to you.

Other medicines and Nimotop solution

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 about any other medicines that you are taking, or took recently. This includes any products you bought without a prescription. It’s especially important to tell your doctor about these medicines:

• high blood pressure tablets (including nifedipine, diltiazem, verapamil, methyldopa, alpha-blockers or beta-blockers, such as atenolol, propanolol). Nimotop solution may increase the effect of these medicines.
• an anti-ulcer drug called cimetidine or an anti-epilepsy drug called sodium valproate. These medicines may increase the effect of Nimotop solution.
• the antidepressant drugs fluoxetine or nefazodone.
• medicines causing harm to the kidney (nephrotoxic medicines) such as aminoglycosides, cephalosporins, furosemide). Your doctor will monitor your kidney function during treatment.
• the anti-HIV drug zidovudine (AZT).
• the HIV protease inhibitor drugs indinavir, ritonavir, nelfinavir or saquinavir.
• the antibiotic erythromycin or the anti-fungal drug ketoconazole.
• the antibiotic drug combination quinupristin / dalfopristin.
• any other medicines you are on whose effects may be changed by the amount of alcohol in Nimotop solution. Your doctor should know which these are (for example, metronidazole or tinidazole).

Food and drink with Nimotop solution

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.

Fertility, Pregnancy and breastfeeding

If you are pregnant or are planning a family, tell your doctor before taking Nimotop. Follow his/her instructions carefully.

Do not breastfeed while you are being treated with Nimotop solution.

If you are trying to father a child, talk to your doctor. Medicines like Nimotop can sometimes affect male fertility.

Driving and using machines

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.

If you are given too much or too little

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.

• Tell your doctor if you feel faint or if your heartbeats are slower or faster than normal.

Potentially serious side effects

If you experience:

• allergic reaction
• low blood pressure (may cause dizziness)
• slow heart beat
• easier bruising and bleeding caused by a reduced number of blood platelets

• Contact your doctor immediately as these side effects can sometimes be serious.

Less serious side effects

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 less than 1 in 100 people)

• rash
• headache
• fast heart beat
• flushing, sweating, feeling of warmth
• feeling sick (nausea)

Rare side effects

(These may affect less than 1 in 1,000 people)

• constipation (lack of bowel movement)
• a slight rise in liver enzymes (this will show up in blood tests)
• pain and/or swelling in a vein (possibly caused by a blood clot) where the needle was inserted

If you get side effects

• Tell your doctor if any side effect gets severe, or if you get any effects not listed in this leaflet.

What Nimotop solution contains

Nimotop solution is a sterile solution for infusion, which contains the active ingredient, nimodipine.

Nimotop solution also contains ethanol, macrogol, sodium citrate, citric acid and water for injection.

What’s in the pack

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.

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