Document: leaflet MAH GENERIC_PL 41947-0017 change

• leaflet MAH GENERIC_PL 41947-0017
• leaflet MAH GENERIC_PL 44124-0006

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

■Flumazenil 0.1 mg/ml

solution for injection/infusion

Flumazenil

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

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

-    If you have any further questions, ask your doctor, pharmacist or nurse.

-    This medicine has been prescribed for you only.

Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

-    If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1.    What Flumazenil is and what it is used for

2.    What you need to know before you are given Flumazenil

3.    How Flumazenil is given

4.    Possible side effects

5.    How to store Flumazenil

6.    Contents of the pack and other information

1.    WHAT FLUMAZENIL IS AND WHAT IT IS USED FOR

Flumazenil contains a medicine called flumazenil. It is used to wake you up after you have been made sleepy by a medicine called a ‘benzodiazepine’.

Flumazenil reverses the effects of the ‘benzodiazepine’ medicine. It is used to:

•    Wake you up after an operation or medical test.

•    Help you to breathe for yourself and wake up if you have been on a ventilator in intensive care.

Flumazenil is also used in children (more than 1 year old) to wake them up after they have been given a ‘benzodiazepine’ medicine to make them sleepy during a medical procedure.

2.    WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN FLUMAZENIL

You must not be given Flumazenil if you are allergic (hypersensitive) to:

•    Flumazenil or any of the other ingredients of Flumazenil (listed in Section 6).

•    ‘Benzodiazepine’ medicines. These include diazepam, midazolam and temazepam.

You must not be given Flumazenil if any of the above apply to you. If you are not sure, talk to your doctor or nurse before having this medicine.

You must not be given Flumazenil if:

•    You are already taking a ‘benzodiazepine’ medicine to treat a very serious illness (such as raised intra-cranial pressure or status epilepticus).

•    You have taken a ‘benzodiazepine’ medicine and certain anti-depressant medicines at the same time and this has made you ill. These anti-depressant medicines (known as tricyclic or tetracyclic anti-depressants) include medicines such as amitriptyline, imipramine and dothiepin hydrochloride.

You must not be given Flumazenil if any of the above applies to you. If you are not sure, talk to your doctor or nurse before having this medicine.

Warnings and precautions

Talk to your doctor or nurse before having Flumazenil.

Take special care with Flumazenil and check with your doctor or nurse if:

•    You have a head injury.

•    You have epilepsy and are being treated with a ‘benzodiazepine’ medicine.

•    You are very nervous about having your operation or medical test.

•    You have a history of anxiety.

•    You have heart or liver problems.

If any of the above applies to you, or if you are not sure, talk to your doctor or nurse before having Flumazenil.

Other medicines and Flumazenil

Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines. This includes medicines that you buy without a prescription and herbal medicines. This is because Flumazenil can affect the way some other medicines work. Also some other medicines can affect the way Flumazenil works.

In particular, tell your doctor or nurse if you are taking any of the following medicines:

•    ‘Benzodiazepine’ medicines, even if you have not taken them in the last few weeks. These include diazepam, midazolam and temazepam.

•    Zopiclone (used to help you sleep).

•    Medicines that change your mood or behaviour. These include medicines called tranquillizers, antidepressants and sedatives.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or nurse for advice before having this medicine.

Driving and using machines

•    Do not drive or use any tools or machines for at least 24 hours after having Flumazenil.

•    Do not do anything that is physically or mentally demanding for at least 24 hours after having Flumazenil. This is because the effects of the ‘benzodiazepine’ medicine may return and you may start to feel sleepy again.

Flumazenil contains sodium

This medicine contains 3.7 mg sodium per ml (18.5 mg per 5 ml ampoule and 37 mg per 10 ml ampoule). To be taken into consideration by patients on a controlled sodium diet.

3. HOW FLUMAZENIL IS GIVEN

Flumazenil will be given to you by a doctor. It will be given to you as a slow injection into one of your veins.

The dose of Flumazenil varies from one patient to another. It depends on your age, weight, how well your liver and kidneys are working and what you need the medicine for. The doctor will work out how much to give you.

If you have any further questions on the use of this medicine, ask your doctor or nurse.

4.    POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Common (may affect up to 1 in 10 people):

•    Feeling sick or being sick especially if you have also had any opiate drugs (e.g. morphine)

Uncommon (may affect up to 1 in 100 people):

•    Being aware of your heart rate (palpitations)

•    Feeling anxious or frightened

•    These effects are most likely to happen if you have woken up too quickly.

Rare (may affect up to 1 in 1,000 people):

•    Sudden swelling of the throat, face, lips or mouth (anaphylaxis). This can make it difficult to breathe or swallow.

•    Sudden swelling of the hands, feet or ankles (hypersensitivity)

•    Skin rash or itching (hypersensitivity)

Not known (frequency cannot be estimated from available data):

•    Panic attacks (in people who have had panic attacks in the past)

•    Abnormal crying

•    Feeling agitated

•    Being aggressive

•    Convulsions (seizures). These are more likely in people who already have epilepsy or severe liver problems or in people who have taken ‘benzodiazepine’ medicines for a long time. Convulsions are also more likely in people given Flumazenil after an overdose of more than one medicine, including at least one ‘benzodiazepine’, especially if taken with certain anti-depressants.

•    Increased blood pressure on waking up (short lived)

•    Increased heart rate on waking up (short lived)

•    Feeling cold (most likely to happen if you have woken up too quickly)

•    Redness of the face and neck (flushing)

•    Withdrawal symptoms, for example:

◦    Feeling agitated, anxious, confused, dizzy, sweaty,

◦    Having mood swings, distorted senses, an increased heart rate.

Withdrawal symptoms usually happen if you are given high doses of Flumazenil quickly and/or when you have recently taken ‘benzodiazepine’ medicines (for example to help you sleep or to treat anxiety). This may happen even if you stopped taking these medicines a few days or weeks before having Flumazenil.

The side effects seen in children are similar to those seen in adults. If Flumazenil has been used to wake up children after a medical test it may cause them to cry abnormally, feel agitated or be aggressive.

Reporting of side effects

If you get any side effects, talk to your doctor or, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

5.    HOW TO STORE FLUMAZENIL

Your doctor or pharmacist is responsible for storing this medicine.

They are also responsible for disposing of any unused Flumazenil correctly.

This medicinal product does not require any special storage conditions.

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 pack.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Flumazenil contains

The active substance in Flumazenil 0.1 mg/ml solution for injection or infusion is flumazenil.

Each millilitre (ml) of liquid medicine contains 0.1 milligrams of flumazenil.

Each 5 ml ampoule contains 0.5 milligrams of flumazenil (in 5 ml of liquid).

Each 10 ml ampoule contains 1 milligrams of flumazenil ( in 10 ml liquid).

The other ingredients are disodium edetate, glacial acetic acid, sodium chloride, sodium hydroxide, water for injections.

What Flumazenil looks like and contents of the pack

Flumazenil is a clear almost colourless sterile aqueous solution, practically free from visible particles.

Flumazenil is supplied in practically free from visible particles clear transparent one point-cut glass ampoules in packs of 5 and 10.

Not all packs may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing authorization holder

ELC GROUP s.r.o.

Karolinska 650/1, Karlm, Prague 8 186 00 Czech Republic

Manufacturer

ROTEXMEDICA Arzneimittelwerk-Bunsenstrasse 4 D-22946 TRITTAU

The following information is intended for healthcare professionals only:

This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.

After opening: The chemical and physical stability of flumazenil diluted in glucose 5%, lactated Ringer’s or Nacl 0.9% solution has been demonstrated for 48 hours at 25°C.

Flumazenil may be administered as an infusion, diluted in glucose 5%, lactated Ringer’s or NaCl 0.9% solution.

Any flumazenil solution drawn up into a syringe or diluted in sodium chloride 0.9% or glucose 5% should be discarded after 24 hours.

No preparations other than those recommended should be added to the Flumazenil ampoule or mixed with the Flumazenil infusion solution.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.