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MIDAZOLAM ORPHA 15 MG FILM-COATED TABLETS

Active substance(s): MIDAZOLAM

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Package leaflet: Information for the user
Midazolam Orpha 15 mg film-coated tablets
Midazolam
Read all of this leaflet carefully before you start using 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 or pharmacist.
- 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 or pharmacist. This includes any possible side
effects not listed in this leaflet.
What is in this leaflet
1. What Midazolam Orpha is and what it is used for
2. What you need to know before you use Midazolam Orpha
3. How to use Midazolam Orpha
4. Possible side effects
5. How to store Midazolam Orpha
6. Contents of the pack and other information

1. What Midazolam Orpha is and what it is
used for
Midazolam Orpha contains the active ingredient
midazolam. Midazolam belongs to a group of
medicinal products known under the name
benzodiazepines. It is a medicinal product used
to treat sleep disturbances. The reason for
the sleep disturbances is, however, not solved
by Midazolam Orpha. In addition, Midazolam
Orpha has a calming effect.
Midazolam Orpha is prescribed for the short-term
treatment of people with sleep disturbances.
Midazolam Orpha is only prescribed if the
disturbance is serious and physical and/or
mental functioning is impaired, or if you suffer
seriously from the consequences of these sleep
disturbances.
2. What you need to know before you use
Midazolam Orpha
Do not take Midazolam Orpha
• if you are allergic (hypersensitive) to
midazolam or other types of medicinal
products from the benzodiazepine group or
any of the other ingredients of this medicine
(see section 6). If you experience skin
reactions, such as hives or itching, it may
mean that you are hypersensitive. Maybe you
have already experienced this previously.
• if you suffer from myasthenia gravis (a serious
muscular disorder) because Midazolam Orpha
may cause muscle weakness.
• if you suffer from the so-called “sleep apnoea
syndrome” (a brief interruption of breathing
during sleep, often occurring together with
snoring).
• if you have serious breathing problems.
• if you have serious liver function impairment.
• if you are under the age of 18.
• together with strong CYP3A4 inhibitors.
The following medicines are seen as strong
inhibitors:
ketoconazole,
itraconazole,
voriconazole, HIV inhibitors, clarithromycin
and thelithromycin (antibiotics), boceprevir
(hepatitis C inhibitor), nefazodone (for
depression) and grapefruit juice.
Warnings and precautions
Talk to your doctor before taking Midazolam
Orpha
• If you have ever had problems with alcohol
and/or drugs, you should only use Midazolam
Orpha if your doctor is aware of your problem
and has discussed the advantages and
disadvantages with you.
• If your liver does not function well.
• If your kidneys do not function well.
• If you are older than 60 years of age or if you
are weakened.
• If you have breathing problems or
cardiovascular problems.
• If you suffer from a serious mental illness in
which control over one’s own behaviour and
actions is disturbed (psychosis), Midazolam
Orpha should not be prescribed as the first
medication.
• If you suffer from serious depression or anxiety
with depression, Midazolam Orpha may never
be prescribed as the only medication, but
must always be used together with other
types of medicinal products.
• If you suffer from obesity.
• If you are critically ill.
• If you experience symptoms such as
restlessness, excitation, delusions, irritability,
aggression, seeing and possibly hearing
things that do not exist (hallucinations),
rage, nightmares, impaired control of one’s
own behaviour and actions (psychosis),
inappropriate behaviour and other behavioural
disorders with the use of Midazolam Orpha,
you must stop taking Midazolam Orpha and
consult your doctor. These symptoms often
occur in children and elderly people.
In addition, it is important to know the following:
• After a few weeks of use, Midazolam Orpha
may start having a weaker effect on you.
• The use of Midazolam Orpha and other
benzodiazepines may lead to psychological
and physical dependence, which means that
you will want more tablets. The chance of
this occurring is higher if you have taken
Midazolam Orpha for a longer period of time
or if you take a high dosage or if you have
problems with alcohol and/or drugs.
• After you have taken Midazolam Orpha,
memory loss may occur for events which take
place within the few hours directly following
the intake. In order to be disturbed by this
aspect as little as possible, it is essential that
you can sleep for 7 to 8 hours after intake.
• When using Midazolam Orpha, keep in mind
that carrying out activities or your ability to
take the right decisions may be affected.
Consult your doctor if one of the above warnings
apply to you now or has applied to you in the
past.
Children:
Midazolam Orpha is contraindicated in children.
Other medicines and Midazolam Orpha
Always tell your doctor that you are treated
with midazolam since several medicines and
herbs may alter the effect and side effects of
midazolam.
This also applies to medicinal products that
you bought without prescription or for herbal
medicines. The reason is that Midazolam Orpha
may have an impact on the way in which other
types of medicinal products work. At the same
time, other medicinal products may influence
the effect of Midazolam Orpha.
Inform your doctor particularly if you are using
one of the following types of medicinal products:

• Neuroleptics (medicinal products for certain
serious mental disorders).
• Sleeping pills and tranquilizers.
• Antidepressants (in case of depression).
• Painkillers with opiate-like effect. They may
create in you an exaggerated feeling of
happiness or excitement (euphoria), which
will increase your dependence on them.
• Anti-epileptic medication.
• Anaesthetics.
• Certain types of medicinal products against
allergic reactions (antihistamines).
Certain types of medicinal products can speed
up the breakdown of Midazolam Orpha in the
liver. This applies primarily to:
• rifampicin (in case of tuberculosis)
• carbamazepine and phenytoin (in case of
epilepsy, among others)
and to a lower extent to:
• efavirenz (an HIV inhibitor)
• St John’s wort (a herbal medicine in case of
depression)
The combination of Midazolam Orpha with
these medicinal products is not recommended.
(see also “What you need to know before you
use Midazolam Orpha” in section 2). Please be
aware that a maximum dose of 15 mg must not
be exceeded.
Certain types of medicinal products can slow
down the breakdown of Midazolam Orpha in the
liver. This applies primarily to:
• aprepitant (to prevent nausea and vomiting
following an operation)
• diltiazem and verapamil (in case of heart
conditions and high blood pressure)
• clarithromycin, telithromycine, erythromycin
and ciprofloxacine (antibiotics)
• nefazodon (for depression)
• tabimoreline
• fluconazole,
ketoconazole,
itraconazole,
voriconazole, posaconazole (against fungal
infections)
• HIV inhibitors
• dronedarone (for the treatment of cardiac
arrhythmias)
• crizotinib (for treatment of lung carcinoma)
• casopitant (to prevent nausea and vomiting
following chemotherapy)
• imatinib (for treatment of leukemia)
• cyclosporine (immunosuppressant drug)
• cimetidine (used to treat ulcers and
indigestion)
• lomitapide
(for
treatment
of
familial
hypercholesterolemia)
The combination of Midazolam Orpha with
these medicinal products is not recommended
(see also “What you need to know before you
use Midazolam Orpha” in section 2).
Midazolam Orpha with food, drink and
alcohol
Do not drink alcohol after having taken
Midazolam Orpha. You may become very sleepy,
which may cause breathing problems.
Pregnancy, breast-feeding and fertility
Consult your doctor or pharmacist before taking
any medicinal product. If you think you may be
pregnant or you are planning to get pregnant,
you must first consult your doctor before using
Midazolam Orpha. There is insufficient data
regarding the use of Midazolam Orpha during
pregnancy, which does not allow an assessment
of the possible negative impact of Midazolam
Orpha on the unborn child.
In any case, you are strongly advised against
using Midazolam Orpha during the last months
of the pregnancy and during delivery, as this
may have a negative impact on your baby
(for example, decreased body temperature
[hypothermia],
decreased
muscle
tone
[hypotonia],decreased breathing, irregularities
in the foetal heart rate and poor sucking).
Midazolam Orpha may not be used during
pregnancy unless it is absolutely necessary.
Midazolam Orpha passes into breast milk in
small amounts. Midazolam Orpha may not
be used during the breastfeeding period and
should be discontinued for 24 hours in case of
administration of midazolam.
Studies have shown that Midazolam does not
have any negative effects on male or female
fertility.
Driving and using machines
Midazolam Orpha may cause sleepiness and
diminish your ability to concentrate, your
memory and the functioning of your muscles.
This effect may be increased if you sleep too
little or if you use alcohol and/or drugs.
You must keep this in mind when you are driving
a car or using machines.
Important information about some of the
ingredients of Midazolam Orpha
Midazolam Orpha contains lactose. If your
doctor has advised you that you do not tolerate
certain sugars, contact your doctor before
taking this medicinal product.
3. How to use Midazolam Orpha
When taking Midazolam Orpha, closely follow
your doctor’s advice. If in doubt, consult your
doctor or pharmacist. The doctor shall prescribe
a dosage that corresponds to your specific
problems and situation.
The usual dosage is 15 mg per day.
If your liver does not function well, if your
kidneys do not function well, if you are older
than 60 years of age or weakened, if you have
breathing problems or cardiovascular problems,
if you suffer from obesity or if you are critically
ill, the doctor shall prescribe you a lower dosage
(7.5 mg).

In any case a maximum dosage of 15 mg must
not be exceeded.
You may not change the prescribed dosage
yourself.
You must take Midazolam Orpha for as short
a period of time as possible and in the lowest
possible dosage. Treatment does not generally
last longer than 2 weeks. Only your doctor can
decide whether the treatment may last longer.
You must take Midazolam Orpha right before
going to sleep, next to or in the bed, without
chewing it and with a glass of water. You may
take Midazolam Orpha at any moment of the
day provided you can be sure of at least seven
to eight hours of undisturbed sleep.
If you notice that the effect of Midazolam Orpha
is too strong or too weak, consult your doctor
or pharmacist.
If you take more Midazolam Orpha than
you should
If you have taken too much Midazolam Orpha,
immediately contact your doctor or pharmacist.
Usual symptoms are sleepiness, lack of
muscle coordination, problems speaking and
involuntary eye movement (nystagmus). An
overdose of Midazolam Orpha is not usually
life-threatening if you are not taking other
medicinal products at the same time. It may,
however, lead to a loss of reflexes, temporary
interruption of breathing (apnoea), low muscle
tone, low blood pressure, delay and ceasing
of breathing and heartbeat and, in rare cases,
coma.
If you forget to take Midazolam Orpha
Never take a double dosage of Midazolam Orpha
in order to compensate for a forgotten dosage.
If you stop taking Midazolam Orpha
• If you stop taking Midazolam Orpha it may
happen that the conditions for which you
were prescribed Midazolam Orpha return in a
stronger form. For this reason, you should not
suddenly stop taking Midazolam Orpha, but
rather gradually take fewer tablets.
• If you have become physically dependent and
you suddenly stop taking the tablets, you may
have withdrawal symptoms. These withdrawal
symptoms may manifest themselves as:
- A feeling of serious agitation (being anxious),
tension, restlessness, being confused or in a
bad mood (quick irritation).
- Headache.
- Myalgia.
Occasionally, there may be more serious
symptoms, such as:
- Self-alienation.
- Loss of sense of reality.
- Increased auditory acuity.
- Numbness and tingling sensations in the
limbs.
- Seeing and possibly hearing things that are
not there (hallucinations).
- Convulsions (epileptic fits).
- Hypersensitivity to light, noise and touch.
For this reason, you may not stop suddenly
but, in consultation with your doctor, slowly
decrease the intake of Midazolam Orpha.
If you have any further questions regarding the
intake of this medicinal product, consult your
doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side
effects, although not everybody gets them.
The following side effects may occur with this
medicinal product (the frequency is not known
and may not be assessed based on the available
data).
Immune system
• Allergic reactions.
Psychological disorders
• Confusion, an exaggerated feeling of happiness
or excitement (euphoria), a certain degree of
affective flattening and indifference. These
symptoms occur primarily at the beginning of
the treatment and disappear if you continue
using Midazolam Orpha.
• A change in sex drive.
• A depression that is present but was not
noticed previously may be uncovered while
using benzodiazepines (such as Midazolam
Orpha).
• Restlessness,
excitation,
irritability,
aggression,
delusions,
fits
of
rage,
nightmares, seeing and possibly hearing
things that are not there (hallucinations),
serious mental disorders in which control over
one’s own behaviour and actions are disturbed
(psychosis), inappropriate behaviour and
other behavioural disorders. These effects
often occur in elderly people (see also under
“Warnings and precautions” in section 2).
• Psychological and physical dependence (see
“Warnings and precautions” in section 2).
• Abuse

Gastrointestinal system
• Gastrointestinal problems may sometimes
occur (for example nausea and vomiting).
Skin
• Itching.
• Rashes, including rashes with bumps (hives).
Musculoskeletal and connective tissue
disorders
• Muscle weakness. This symptom occurs
primarily at the beginning of the treatment
and disappear if you continue using Midazolam
Orpha.
General disorders
• Fatigue. This symptom occurs primarily at the
beginning of the treatment and disappear if
you continue using Midazolam Orpha.
Injury
• Older patients who use benzodiazepine are at
a higher risk of falling and fractures.
Reporting of side effects
If you get any side effects, talk to your doctor,
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 Midazolam Orpha
Keep this medicine out of the sight and reach
of children.
Do not store above 30°C.
Do not use Midazolam Orpha film-coated tablets
after the expiry date which is stated on the
package following “EXP.”. The expiry date refers
to the last day of that month. After that date it
is no longer certain that Midazolam Orpha will
have the expected effect.
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.
6. Contents of
information

the

pack

and

other

What Midazolam Orpha contains
• The active substance is midazolam. It is
present in the form of midazolam maleate,
corresponding to 15 mg midazolam per tablet.
• The other ingredients are
Core of tablet:
Lactose
monohydrate,
microcrystalline
cellulose, pregelatinised starch, magnesium
stearate, talc.
Cover of tablet:
Hypromellose,
titanium
dioxide
(E171),
macrogol 400, indigo carmine (E132).
What Midazolam Orpha looks like and
contents of the pack
Midazolam Orpha 15 mg film-coated tablets are
available as blue round film coated tablets in a
pack of 10 or 30 tablets in blisters.
Not all pack sizes may be available on the
market.
Marketing
Authorisation
Holder
and
Manufacturer
Marketing Authorisation Holder:
Orpha-Devel Handels und Vertriebs GmbH
Wintergasse 85/1B
3002 Purkersdorf
Austria
Manufacturer:
Orpha Trade GmbH
Speckbacherstraße 13/2
6380 St. Johann in Tirol
Austria
This leaflet was last approved in March 2014.

Neurological disorders
• Decreased vigilance and attention, somnolence
during the day, headache, dizziness, lack of
muscle coordination, decrease of sensitivity.
These symptoms occur primarily at the
beginning of the treatment and disappear if
you continue using Midazolam Orpha.
• Sedation (after surgery)
• Memory loss for events which take place
within the few hours immediately after taking
the tablets. You must keep this in mind if you
have not slept enough. The memory loss may
occur along with inappropriate behaviour.
These effects often occur in elderly people
(see also under “Warnings and precautions”
in section 2).
Eyes disorders
• Double vision. These symptoms occur
primarily at the beginning of the treatment
and disappear if you continue using Midazolam
Orpha.
Heart
• Heart attack (cardiac arrest). Chest pain may
be one of the symptoms. If you experience
this, contact your doctor immediately.
Breathing
• Breathing
problems;
breathing
may
sometimes stop due to this. If you experience
breathing problems, contact your doctor
immediately.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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