Nimotop 0.02% Solution for Infusion

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

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

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 of this medicine (listed in section 6).

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

Talk to your doctor or pharmacist before receiving Nimotop solution

• 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.
• If you are on a controlled salt (sodium) diet.

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

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:

• 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).

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.

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.

If you experience:

• Signs of allergic reaction such as swelling of the face, lips, tongue or throat, difficulty breathing, rash, itching, nausea or vomiting
• 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.

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)

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

Rare side effects

(These may affect up to 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 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

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.

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