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MIDODRINE HYDROCHLORIDE 2.5 MG TABLETS

Active substance(s): MIDODRINE HYDROCHLORIDE / MIDODRINE HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Midodrine Hydrochloride 2.5mg and
5mg Tablets
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 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.
See section 4.
What is in this leaflet
1. What Midodrine Hydrochloride Tablets are and what are they
used for
2. What you need to know before you take Midodrine
Hydrochloride Tablets
3. How to take Midodrine Hydrochloride Tablets
4. Possible side effects
5. How to store Midodrine Hydrochloride Tablets
6. Contents of the pack and other information
1. What Midodrine Hydrochloride Tablets are and what are
they used for
The name of your medicine is Midodrine Hydrochloride Tablets.
They contain the medicine midodrine hydrochloride which raises
the blood pressure. Midodrine Hydrochloride Tablets are used
in the treatment of certain severe forms of low blood pressure
when other treatments are proven unsatisfactory.
2. What you need to know before you take Midodrine
Hydrochloride Tablets
Do not take Midodrine Hydrochloride Tablets if you:
− are allergic to midodrine hydrochloride or any of the other
ingredients of this medicine (listed in section 6)
− have high blood pressure
− have a slow pulse
− are finding it difficult to urinate
− have certain forms of cardiac and vascular disease
− have increased eye ball pressure (glaucoma) or poor vision
due to diabetes
− have an overactive thyroid gland
− have hormonal disorders resulting from a tumour in the
adrenal medulla (pheochromocytoma)
− have a severe kidney disease
− have an enlargement of the prostate gland.
Warnings and precautions
Talk to your doctor or pharmacist before taking Midodrine
Hydrochloride Tablets if you have been told that you have high
blood pressure when you lie down. If this applies to you then:
- regular monitoring of your blood pressure will be required
when you are lying down and standing up as there may be
a risk of your blood pressure rising when you lie down, for
example, at night. If your blood pressure rises when you lie
down and reducing the dose does not correct this problem,
then treatment with this medicine must be stopped
- it is important that you do not take this medicine late in the
evening.Take your last daily dose at least 4 hours before you
go to bed
- keep your head elevated when you lie down at night. This
reduces the potential risk of rise in your blood pressure.
You should be monitored by your doctor for possible secondary
effects of high blood pressure.
You should also take special care and talk to your doctor if you:
- have a severe nervous system disorder (autonomous nervous
system), since taking midodrine hydrochloride tablets can
lead to a further fall in blood pressure when standing straight.
If this is the case, further treatment with midodrine should be
stopped
- suffer from blood circulation problems
- suffer from prostate disorders, as the medicine can make
passing urine difficult.
You should have your kidney function and blood pressure
checked by your doctor before you start using this medicine.
During treatment with this medicine, your blood pressure will be
checked from time to time, and if necessary your dose shall be
adjusted.
It is important that you immediately report symptoms related to
high blood pressure, such as elevated heart rate, headache and
blurred vision. Your doctor will then decide whether to adjust the
dose or discontinue your treatment with Midodrine Hydrochloride
tablets.
Consult your doctor if one of the above warnings applies to you
or applied to you in the past.

Children and adolescents
Do not give this medicine to children and adolescents under
the age of 18 because the safety and efficacy of Midodrine
Hydrochloride Tablets in patients aged below 18 years has not
been established.
Other medicines and Midodrine Hydrochloride Tablets
Tell your doctor or pharmacist if you are taking, have recently
taken or might take any other medicines.
In particular tell your doctor or pharmacist if you are taking any
of the following:
- reserpine and guanethidine (medicines used to reduce high
blood pressure), antihistamines (used to treat allergies),
hormones for the thyroid (used when the thyroid is not working
properly), tricyclic antidepressants and MAO-inhibitors
(both used to treat depression) and other vasoconstrictors
(medicines that narrow blood vessels), or sympathomimetic
agents (medicines that have a stimulating effect on certain
parts of the nervous system) because concomitant use with
this medicine may cause a large increase in blood pressure
- prazosin and phentolamine (medicines used to treat heart
disease) because the effect of this medicine is blocked by
these drugs
- digitalis preparations (medicines used to treat heart disease)
because concomitant use with this medicine may lead to
cardiac dysfunction
- fludrocortisone acetate (an anti-inflammatory medicine)
because this medicine may increase its effect
- medicines which directly or indirectly reduce your heart rate
because if this medicine is combined with these medicines, it
is advisable that your doctor closely monitors you.
Midodrine Hydrochloride Tablets with food
Midodrine Hydrochloride Tablets may be taken with food.
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 pharmacist for
advice before taking this medicine.
The use of Midodrine Hydrochloride Tablets in pregancy is not
recommend and you should speak to your doctor if you have
any concerns.
Do not breast-feed if you are taking Midodrine Hydrochloride
Tablets.
Driving and using machines
This medicine should not affect your ability to drive or use
machines. However, you must be careful if dizziness or lightheadedness occurs after taking this medicine.
Midodrine Hydrochloride 5mg Tablets contains Sunset
Yellow FCF (E110)
Sunset yellow can cause allergic reactions.
3. How to take Midodrine Hydrochloride Tablets
Always take this medicine exactly as your doctor or pharmacist
has told you. Check with your doctor or pharmacist if you are not
sure.
The recommended starting dose is normally one tablet of 2.5 mg,
three times a day. This dose can be increased weekly up to four
2.5 mg tablets, or two 5 mg tablets (10 mg) three times daily,
which is the usual maintenance dose of 30 mg per day.
The recommended total daily dose should be spread evenly into
three doses per day.
You should not take your last dose of midodrine less than
4 hours before going to bed. This is to prevent the occurrence
of increased blood pressure upon lying down (supine
hypertension).
If you take more Midodrine Hydrochloride Tablets than you
should
Contact your doctor or the nearest hospital emergency
department immediately. Take the medicine pack or any
remaining tablets with you.
Possible side effects include:
- high blood pressure
- slow heart rhythm (bradycardia)
- difficulty urinating
- goose bumps
- sensation of coldness.
If you forget to take Midodrine Hydrochloride Tablets
If you forget to take a dose, take your next dose at the usual time
and then keep taking your medicine as told by your doctor.
Do not take a double dose to make up for a forgotten dose.
If you stop taking Midodrine Hydrochloride Tablets
If you stop taking your medicine, there should not be a sudden
drop in your blood pressure, however it is important that you
discuss with your doctor before you consider stopping this
medicine.

If you have any further questions on the use of this medicine, ask
your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects,
although not everybody gets them.
Very common (may affect more than 1 in 10 people)
- goosebumps, itching of the scalp and pain when urinating.
Common (may affect more than 1 in 100 but less than 1 in
10 people)
- tingling and itching, increased blood pressure when
lying down, headache, nausea (feeling sick), heartburn,
inflammation of the lining inside the mouth, flushing, rash,
chills, difficulty urinating.
Uncommon (may affect more than 1 in 1,000 but less than 1 in
100 people)
- sleep disturbances including difficulty sleeping, restlessness,
agitation and irritability, slowed heart rate, urge to urinate.
Rare (may affect more than 1 in 10,000 but less than 1 in
1,000 people)
- palpitations, rapid heartbeat, abnormal liver function including
an increase in the number of liver enzymes.
Not known (frequency cannot be estimated from the available data)
- abdominal pain, being sick (vomiting), diarrhoea, anxiety,
feelings of confusion.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this leaflet.
You can also report side effects directly via the Yellow Card
Scheme (Website: 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 Midodrine Hydrochloride Tablets
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 carton or blister. The expiry date refers to the last day of that
month.
Do not store above 30°C.
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 the pack and other information
What Midodrine Hydrochloride Tablets contain
The active substance(s) is midodrine hydrochloride and each
tablet contains either 2.5 mg or 5 mg midodrine hydrochloride.
The other ingredients are microcrystalline cellulose, maize
starch, magnesium stearate, and silica colloidal anhydrous.
Midorine Hydrochloride 5 mg tablets also contain Sunset Yellow
FCF (E110).
What Midodrine Hydrochloride Tablets looks like and
contents of the pack
The 2.5 mg tablets are white, round tablet with M2 debossed on
one side and score line on the other side.
The 5 mg tablets are orange, round tablet with M5 debossed on
one side and score line on the other side.
The tablets are supplied in blisters and are available in packs of
7, 10, 14, 20, 28, 30, 56, 60, 84, 90, 100, 112 or 120 tablets.
Not all packs may be marketed.
Marketing Authorisation Holder
Morningside Healthcare Limited
115 Narborough Road
Leicester LE3 0PA
UK
Manufacturer
Morningside Pharmaceuticals Ltd
5 Pavilion Way
Loughborough LE11 5GW
UK
This leaflet was last revised in February 2017.

M0275LAMUKNAS-001

Expand Transcript

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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