What Midodrine is and what it is used for

Midodrine contain the active ingredient midodrine hydrochloride, which acts on the blood vessels via the sympathetic nervous system to correct imbalances of blood distribution, such as preventing too much blood pooling in the legs when standing up.

Midodrine, hereinafter referred to as Midodrine hydrochloride, is a medicinal product used to stop the fall in your blood pressure as a result of your sympathetic nervous system not working correctly. This should help to relieve the symptoms which you might be suffering such as dizziness, fainting, blurred vision and weakness when you sit or stand up.

2

What you need to know before you take Midodrine

Do not take Midodrine

– if you are allergic to midodrine hydrochloride or any of the other ingredients of this medicine (listed in section 6);
– if you are suffering from high blood pressure or a form of low blood pressure known as vasovagal hypotension;
– if you have tumour near the kidney, known as phaeochromocytoma;
– if you have narrowing vascular disorders;
– if you have elevated eye pressure (glaucoma);
– if you have a slow pulse;
– if you are finding it difficult to urinate, especially due to enlargement of the prostate gland
– if you have damage to the retina in your eye as a result of diabetes (known as proliferative diabetic retinopathy)
– if you have an overactive thyroid gland;
– if your blood pressure and heart beat rate in standing test increases due to circulatory disorders with lower blood pressure;

– if you have some forms of heart or blood vessel disease;

– if you have inflammation of the kidneys, kidney disease, poor kidney function or if you are having problems passing urine

If you do not currently suffer from the listed diseases, but you did suffer from any of them in the past, talk to your doctor or pharmacist before taking Midodrine.

Warnings and precautions

Talk to your doctor or pharmacist or nurse before taking Midodrine if you have:

! been told you have high blood pressure when you lie down

! high blood sugar (diabetes mellitus)

Your blood pressure will be monitored before starting, and during, treatment. Regular monitoring of your blood pressure when you are lying down and when you are standing up will be required as there may be a risk of your blood pressure rising when you lie down, for example, at night. If your blood pressure does go up when you lie down, reducing the dose does not correct the problem, treatment with this medicine must be stopped.

You should take your last dose of Midodrine at least four hours before bedtime. This is because Midodrine can cause high blood pressure if you are lying down for any period of time (for example, sleeping or sunbathing).

You should have your blood pressure, kidney and liver function checked by your doctor before you start using this medicine. During treatment with this medicine, your blood pressure will be checked regularly.

If you experience palpitations, headaches, blurred vision, especially before going to sleep, stop taking the product and seek medical help immediately. Your doctor will then decide whether to adjust your dose or stop your treatment with Midodrine completely.

You should not continue with the treatment if you have severe fluctuations of blood pressure when you are undergoing treatment with Midodrine.

When you are undergoing treatment with Midodrine, talk to your doctor or pharmacist before taking any new prescribed drugs and other over the counter drugs (see also “Taking Midodrine with other medicinal products”).

Package leaflet: Information for the user midodrine hydrochloride

lllllllllll

3050

Talk to your doctor or pharmacist if you know you are at increased risk of eye problems such as glaucoma.

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.

Elderly patients (older than 60 years)

The initial dosage is small and the increase in dose is dependent on the patient's clinical condition and should be done with caution.

Patients with renal function disorders

Due to lack of data, information regarding dosage adjustment cannot be provided for patients with renal function disorders. In general, Midodrine should not be administered in patients with acute renal disorders and severe renal function disorders (see section 2).

Patient with hepatic impairment

Since sufficient experience in patients with hepatic impairments is not available, the liver function should be regularly monitored before and during treatment with Midodrine.

Taking Midodrine with other medicinal products

Please inform your doctor or pharmacist if you take other medicinal products, have taken other medicines a while ago or intend to take other medicinal products, including medicines obtained without a prescriprion.

The active ingredient midodrine hydrochloride can influence the way some medicines work and may strengthen their effectiveness.

Midodrine hydrochloride may increase the effect of Amiodarone (used to control heart arrhythmias) and metoclopramide (used to stop you feeling and being sick). Midodrine hydrochloride may also increase the effect of this drug phenothiazines and atypical antipsychotics for schizophrenia or psychosis.

Taking certain medicines, which belong to the class of tricyclic antidepressants (medicines to treat depression), medicines for blood pressure stabilisation, thyroid hormones, anti-histamines (medicines to treat allergies), MAO inhibitors (medicines to treat depression) and corticosteroids (medicines to treat asthma, skin eczema, autoimmune disorders), may enhance the blood pressure increasing effect of midodrine hydrochloride. It may result in an undesirable increase in blood pressure. Therefore, combination with Midodrine is not recommended.

Alpha- and beta-receptor blockers (medicines which reduce blood pressure) can weaken the blood pressure-increasing effect of Midodrine. The cardiac frequency reducing effect of medicinal products, which are called beta blockers, can be enhanced. Careful monitoring by the doctor is required.

If you are taking glycosides to increase the force of your heart beat e.g. digitalis, combination of these products with Midodrine is not recommended.

The combination of midodrine hydrochloride with medicines used against migraines and Parkinson, called Ergot alkaloid are to be avoided due to increase in blood pressure. If concomitant use cannot be avoided, the blood pressure is to be monitored closely.

Pregnancy, breastfeeding and fertility

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.

If you get pregnant during treatment with Midodrine, you must stop the treatment immediately once pregnancy is confirmed.

Midodrine is not recommended during pregnancy.

The administration of Midodrine is not recommended during breastfeeding.

Driving and using machines

Intake of Midodrine may result in dizziness or drowsiness, which may restrict ability to drive and operate machinery. Do not drive a vehicle and do not operate any tools or machinery if you are not feeling well during treatment. In general, the impact of midodrine hydrochloride on the ability to drive and operate machinery is very negligible.

Important information about some of the ingredients of Midodrine 5 mg tablets

Midodrine 5 mg tablets contain Sunset yellow (E110), which may cause allergic reactions.

3

How to take Midodrine

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

The tablet can be divided into equal doses.

Midodrine 2.5 mg

The usual initial dosage is 2.5 mg (1 tablet) 2 to 3 times daily orally. Your doctor may increase this dose each week until the best effect is seen..

The maximum daily dosage is 30 mgand this limit should be exceeded only in exceptional cases.

Midodrine 5 mg

The usual initial dosage is 2.5 mg 2 to 3 times daily orally. Your doctor may increase this dose each week until the best effect is seen.

The maximum daily dosage is 30 mg and this limit should be exceeded only in exceptional cases.

Timing of the evening dose

Please take Midodrine with a glass of water. Midodrine can be taken with meals. You should take your last dose of Midodrine at least four hours before bedtime. This is because Midodrine can cause high blood pressure if you are lying down for any period of time (for example, sleeping or sunbathing).

Use in 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.

Use in elderly patients

The initial dosage is small and the increase in dose is dependent on the patient's clinical condition and should be done with caution.

Patients with renal function disorders

Due to lack of data, information regarding dosage adjustment cannot be provided for patients with renal function disorders. In general, Midodrine should not be administered in patients with acute renal disorders and severe renal function disorders (see section 2).

Patients with hepatic impairment

No specific studies have been performed in this patient population for dosage adjustment. Therefore, information regarding dosage adjustment is not available for this group.

Duration of use

The duration is based on the progression of the disease.

Please talk to your doctor if you have the feeling that the effect of Midodrine is strong or weak.

If you take more Midodrine than you should

If you take more Midodrine, contact your doctor immediately or go to your nearest hospital accident and emergency department. Take this package leaflet to your doctor.

Overdose may result in very high blood pressure, feeling of cold, urination difficulties as well as prolongation of pulse and “goose bumps”, especially in the neck and scalp area.

Depending on the severity of overdose, the doctor may initiate measures such as induced vomiting and administration of an antidote (alpha receptor blocker such as Phentolamine, Nitroprusside or Nitroglycerin).

A slowing down of pulse can be rectified with Atropin. Treatment with dialysis is a further possibility.

If you forget to take Midodrine

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

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.

Please contact your doctor or pharmacist if you have any questions regarding the use of this medicinal product.

4

Possible side effects

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

You may suffer from any of the following side effects:

Very common: may affect more than 1 in 10 people:

– goose bumps

– difficulty/pain in urination

Common: may affect up to 1 in 10 people:

– discomfort of skin, e.g. tingling (paraesthesia) – rash, itching of the scalp

– chills

– flushing

– high blood pressure in supine position (blood pressure > 180 to 110 mmHg) with daily maximum dosage of more than 30 mg per day (this might cause headaches, blurred vision, a ‚pounding‘ heartbeat, chest pain or shortness of breath)

– nausea, vomiting, indigestion

– inflammation of mucous membrane

– inability to pass urine

Uncommon: may affect up to 1 in 100 people:

– insomnia and problems in sleeping

– headaches, restlessness, irritability, excitability

– reflex slowing of pulse

– palpitation

– cardiac rhythm disorders

– increased pulse frequency

– high blood pressure in supine position (blood pressure > 180 to 110 mmHg) with daily maximum dosage of up to 7.5 mg

– stomach pain
– sudden urge to urinate

Rare: may affect up to 1 in 1000 people:

– dizziness or lightheadedness
– visual disturbances
– chest pain, stroke
– liver function disorders
– increased liver enzymes

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

– anxiety
– confusion

– increased tear production

– diarrhoea

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 Website: or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.

5

How to store Midodrine

Keep this medicine out of the sight and reach of children.

For HDPE bottle pack: This medicinal product does not require any special storage condition.

For blister pack: Store below 25°C

Do not use this medicine after the expiry date which is stated on the carton and the blister after EXP. The expiry date refers to the last day of that month.

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.

What Midodrine looks like and contents of the pack

Midodrine 2.5mg tablets are white to off-white, round, scored tablets debossed with ‚H‘ above the score and ‚P‘ below the score on one side and ‚504‘ on the other side. The diameter of the tablet is 7.10 mm ±0.2 mm.

Midodrine 5 mg tablets are light orange coloured, round, scored tablets debossed with ‚H‘ above the score and ‚P‘ below the score on one side and ‚505‘ on the other side. The diameter of the tablet is 7.10 mm ±0.2 mm.

Pack sizes:

Midodrine 2.5 mg Tablets

The tablets are available in pack sizes containing 30 × 1, 90 × 1 and 100 × 1 tablets in PVC/PVDC/ Aluminium perforated unit dose blisters.

They are also available in High Density Polyethylene (HDPE) bottle pack with 100 tablets.

Midodrine 5 mg Tablets

The tablets are available in pack sizes containing 100 × 1 tablets in PVC/PVDC/Aluminium perforated unit dose blisters.

They are also available in High Density Polyethylene (HDPE) bottle pack with 100 tablets.

530 mm

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Tillomed Laboratories Limited

220 Butterfield, Great Marlings

Luton, LU2 8DL

United Kingdom

Manufacturer

MIAS Pharma Limited

Suite 2, Stafford House,

Strand Road,

Portmarnock,

Co. Dublin,

Ireland

This leaflet was last revised in 04/2021.

v?

4--- cn

3050

lllllllllll i

5 mm

V2G 010421

Front

Back

LO

159 mm

Package leaflet: Information for the user midodrine hydrochloride

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

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

E E

CXI co

ssoe^ lllllllllll

siaiqei Bui g ’g Bui gz auupopiMi

What is in this leaflet

□ what midodrine is and what it is used for

0 What you need to know before you take Midodrine

0 How to take Midodrine

0 Possible side effects

0 How to store Midodrine

0 Contents of the pack and other information

E E

CXI co

510520544GB01

lllllllllll

^ 3055

□ what midodrine is and what it is used for

Midodrine contain the active ingredient midodrine hydrochloride, which acts on the blood vessels via the sympathetic nervous system to correct imbalances of blood distribution, such as preventing too much blood pooling in the legs when standing up.

Midodrine, hereinafter referred to as Midodrine hydrochloride, is a medicinal product used to stop the fall in your blood pressure as a result of your sympathetic nervous system not working correctly. This should help to relieve the symptoms which you might be suffering such as dizziness, fainting, blurred vision and weakness when you sit or stand up.

0

What you need to know before you take Midodrine

Do not take Midodrine

– if you are allergic to midodrine hydrochloride or any of the other ingredients of this medicine (listed in section 6);
– if you are suffering from high blood pressure or a form of low blood pressure known as vasovagal hypotension;
– if you have tumour near the kidney, known as phaeochromocytoma;
– if you have narrowing vascular disorders;
– if you have elevated eye pressure (glaucoma);
– if you have a slow pulse;
– if you are finding it difficult to urinate, especially due to enlargement of the prostate gland
– if you have damage to the retina in your eye as a result of diabetes (known as proliferative diabetic retinopathy)
– if you have an overactive thyroid gland;
– if your blood pressure and heart beat rate in standing test increases due to circulatory disorders with lower blood pressure;
– if you have some forms of heart or blood vessel disease;
– if you have inflammation of the kidneys, kidney disease, poor kidney function or if you are having problems passing urine

If you do not currently suffer from the listed diseases, but you did suffer from any of them in the past, talk to your doctor or pharmacist before taking Midodrine.

Warnings and precautions

Talk to your doctor or pharmacist or nurse before taking

Midodrine if you have:

been told you have high blood pressure when you lie down
high blood sugar (diabetes mellitus)

Your blood pressure will be monitored before starting, and during, treatment. Regular monitoring of your blood pressure when you are lying down and when you are standing up will be required as there may be a risk of your blood pressure rising when you lie down, for example, at night. If your blood pressure does go up when you lie down, reducing the dose does not correct the problem, treatment with this medicine must be stopped.

You should take your last dose of Midodrine at least four hours before bedtime. This is because Midodrine can cause high blood pressure if you are lying down for any period of time (for example, sleeping or sunbathing).

You should have your blood pressure, kidney and liver function checked by your doctor before you start using this medicine. During treatment with this medicine, your blood pressure will be checked regularly.

If you experience palpitations, headaches, blurred vision, especially before going to sleep, stop taking the product and seek medical help immediately. Your doctor will then decide whether to adjust your dose or stop your treatment with Midodrine completely.

You should not continue with the treatment if you have severe fluctuations of blood pressure when you are undergoing treatment with Midodrine.

When you are undergoing treatment with Midodrine, talk to your doctor or pharmacist before taking any new prescribed drugs and other over the counter drugs (see also „Taking Midodrine with other medicinal products“).

Talk to your doctor or pharmacist if you know you are at increased risk of eye problems such as glaucoma.

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.

Elderly patients (older than 60 years)

The initial dosage is small and the increase in dose is dependent on the patient's clinical condition and should be done with caution.

Patients with renal function disorders

Due to lack of data, information regarding dosage adjustment cannot be provided for patients with renal function disorders. In general, Midodrine should not be administered in patients with acute renal disorders and severe renal function disorders (see section 2).

Patient with hepatic impairment

Since sufficient experience in patients with hepatic impairments is not available, the liver function should be regularly monitored before and during treatment with Midodrine.

Taking Midodrine with other medicinal products

Please inform your doctor or pharmacist if you take other medicinal products, have taken other medicines a while ago or intend to take other medicinal products, including medicines obtained without a prescription.

The active ingredient midodrine hydrochloride can influence the way some medicines work and may strengthen their effectiveness.

Midodrine hydrochloride may increase the effect of Amiodarone (used to control heart arrhythmias) and metoclopramide (used to stop you feeling and being sick).

Midodrine hydrochloride may also increase the effect of this drug phenothiazines and atypical antipsychotics for schizophrenia or psychosis.

Taking certain medicines, which belong to the class of tricyclic antidepressants (medicines to treat depression), medicines for blood pressure stabilisation, thyroid hormones, anti-histamines (medicines to treat allergies), MAO inhibitors (medicines to treat depression) and corticosteroids (medicines to treat asthma, skin eczema, autoimmune disorders), may enhance the blood pressure increasing effect of midodrine hydrochloride. It may result in an undesirable increase in blood pressure. Therefore, combination with Midodrine is not recommended.

Alpha- and beta-receptor blockers (medicines which reduce blood pressure) can weaken the blood pressureincreasing effect of Midodrine. The cardiac frequency reducing effect of medicinal products, which are called beta blockers, can be enhanced. Careful monitoring by the doctor is required.

If you are taking glycosides to increase the force of your heart beat e.g. digitalis, combination of these products with Midodrine is not recommended.

The combination of midodrine hydrochloride with medicines used against migraines and Parkinson, called Ergot alkaloid are to be avoided due to increase in blood pressure. If concomitant use cannot be avoided, the blood pressure is to be monitored closely.

Pregnancy, breastfeeding and fertility

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.

If you get pregnant during treatment with Midodrine, you must stop the treatment immediately once pregnancy is confirmed.

Midodrine is not recommended during pregnancy.

The administration of Midodrine is not recommended during breastfeeding.

Driving and using machines

Intake of Midodrine may result in dizziness or drowsiness, which may restrict ability to drive and operate machinery. Do not drive a vehicle and do not operate any tools or machinery if you are not feeling well during treatment. In general, the impact of midodrine hydrochloride on the ability to drive and operate machinery is very negligible.

Important information about some of the ingredients of Midodrine 5 mg tablets

Midodrine 5 mg tablets contain Sunset yellow (El 10), which may cause allergic reactions.

0

How to take Midodrine

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

The tablet can be divided into equal doses.

Midodrine 2.5 mg

The usual initial dosage is 2.5 mg (1 tablet) 2 to 3 times daily orally. Your doctor may increase this dose each week until the best effect is seen..

The maximum daily dosage is 30 mgand this limit should be exceeded only in exceptional cases.

Midodrine 5 mg

The usual initial dosage is 2.5 mg 2 to 3 times daily orally. Your doctor may increase this dose each week until the best effect is seen.

The maximum daily dosage is 30 mg and this limit should be exceeded only in exceptional cases.

5 mm|

Afa'S 010421

286 mm

Front

LULU LLP

Timing of the evening dose

Please take Midodrine with a glass of water. Midodrine can be taken with meals. You should take your last dose of Midodrine at least four hours before bedtime. This is because Midodrine can cause high blood pressure if you are lying down for any period of time (for example, sleeping or sunbathing).

Use in 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.

Use in elderly patients

The initial dosage is small and the increase in dose is dependent on the patient's clinical condition and should be done with caution.

Patients with renal function disorders

Due to lack of data, information regarding dosage adjustment cannot be provided for patients with renal function disorders. In general, Midodrine should not be administered in patients with acute renal disorders and severe renal function disorders (see section 2).

Patients with hepatic impairment

No specific studies have been performed in this patient population for dosage adjustment. Therefore, information regarding dosage adjustment is not available for this group.

Duration of use

The duration is based on the progression of the disease.

Please talk to your doctor if you have the feeling that the effect of Midodrine is strong or weak.

If you take more Midodrine than you should

If you take more Midodrine, contact your doctor immediately or go to your nearest hospital accident and emergency department. Take this package leaflet to your doctor.

Overdose may result in very high blood pressure, feeling of cold, urination difficulties as well as prolongation of pulse and „goose bumps“, especially in the neck and scalp area.

Depending on the severity of overdose, the doctor may initiate measures such as induced vomiting and administration of an antidote (alpha receptor blocker such as Phentolamine, Nitroprusside or Nitroglycerin).

A slowing down of pulse can be rectified with Atropin. Treatment with dialysis is a further possibility.

If you forget to take Midodrine

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

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.

Please contact your doctor or pharmacist if you have any questions regarding the use of this medicinal product.

0

Possible side effects

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

You may suffer from any of the following side effects:

Very common: may affect more than 1 in 10 people:

– goose bumps
– difficulty/pain in urination

Common: may affect up to 1 in 10 people:

– discomfort of skin, e.g. tingling (paraesthesia)
– rash, itching of the scalp
– chills
– flushing
– high blood pressure in supine position (blood pressure > 180 to 110 mmHg) with daily maximum dosage of more than 30 mg per day (this might cause headaches, blurred vision, a ‚pounding‘ heartbeat, chest pain or shortness of breath)
– nausea, vomiting, indigestion
– inflammation of mucous membrane
– inability to pass urine

Uncommon: may affect up to 1 in 100 people:

– insomnia and problems in sleeping
– headaches, restlessness, irritability, excitability
– reflex slowing of pulse
– palpitation
– cardiac rhythm disorders
– increased pulse frequency
– high blood pressure in supine position (blood pressure > 180 to 110 mmHg) with daily maximum dosage of up to 7.5 mg
– stomach pain
– sudden urge to urinate

Rare: may affect up to 1 in 1000 people:

– dizziness or lightheadedness
– visual disturbances
– chest pain, stroke
– liver function disorders
– increased liver enzymes

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

– anxiety
– confusion
– increased tear production
– diarrhoea

How to store Midodrine

Keep this medicine out of the sight and reach of children. For HDPE bottle pack: This medicinal product does not require any special storage condition.

For blister pack: Store below 25°C

Do not use this medicine after the expiry date which is stated on the carton and the blister after EXP. The expiry date refers to the last day of that month.

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.

□ contents of the pack and other information

What Midodrine contains

The active substance is Midodrine hydrochloride. Each tablet contains 2.5 mg or 5mg Midodrine hydrochloride

The other ingredients are:

For Midodrine 2.5 mg tablets

Hydrophobic Colloidal anhydrous Silica

Microcrystalline cellulose

Pregelatinized Starch

Magnesium stearate

For Midodrine 5 mg tablets

Hydrophobic Colloidal anhydrous Silica

Microcrystalline cellulose

Pregelatinized Starch

Magnesium stearate

Sunset yellow FCF-Lake (El 10)

What Midodrine looks like and contents of the pack

Midodrine 2.5mg tablets are white to off-white, round, scored tablets debossed with ‚H‘ above the score and ‚P‘ below the score on one side and ‚504‘ on the other side. The diameter of the tablet is 7.10 mm ±0.2 mm.

Midodrine 5 mg tablets are light orange coloured, round, scored tablets debossed with ‚H‘ above the score and ‚P‘ below the score on one side and ‚505‘ on the other side. The diameter of the tablet is 7.10 mm ±0.2 mm.

Pack sizes:

Midodrine 2.5 mg Tablets

The tablets are available in pack sizes containing 30 × 1, 90 × 1 and 100 × 1 tablets in PVC/PVDC/ Aluminium perforated unit dose blisters.

They are also available in High Density Polyethylene (HDPE) bottle pack with 100 tablets.

Midodrine 5 mg Tablets

The tablets are available in pack sizes containing 100 × 1 tablets in PVC/PVDC/Aluminium perforated unit dose blisters.

They are also available in High Density Polyethylene (HDPE) bottle pack with 100 tablets.

530 mm

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Tillomed Laboratories Limited

220 Butterfield, Great Marlings

Luton, LU2 8DL

United Kingdom

Manufacturer

MIAS Pharma Limited

Suite 2, Stafford House,

Strand Road,

Portmarnock,

Co. Dublin,

Ireland

This leaflet was last revised in 04/2021.

v?

4--- cn

3050

lllllllllll i

5 mm

V2G 010421

Front

Back

LO

159 mm

Package leaflet: Information for the user midodrine hydrochloride

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

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

E E

CXI co

ssoe^ lllllllllll

siaiqei Bui g ’g Bui gz auupopiMi

What is in this leaflet

□ what midodrine is and what it is used for

0 What you need to know before you take Midodrine

0 How to take Midodrine

0 Possible side effects

0 How to store Midodrine

0 Contents of the pack and other information

E E

CXI co

510520544GB01

lllllllllll

^ 3055

□ what midodrine is and what it is used for

Midodrine contain the active ingredient midodrine hydrochloride, which acts on the blood vessels via the sympathetic nervous system to correct imbalances of blood distribution, such as preventing too much blood pooling in the legs when standing up.

Midodrine, hereinafter referred to as Midodrine hydrochloride, is a medicinal product used to stop the fall in your blood pressure as a result of your sympathetic nervous system not working correctly. This should help to relieve the symptoms which you might be suffering such as dizziness, fainting, blurred vision and weakness when you sit or stand up.

0 What you need to know before you take Midodrine

Do not take Midodrine

– if you are allergic to midodrine hydrochloride or any of the other ingredients of this medicine (listed in section 6);
– if you are suffering from high blood pressure or a form of low blood pressure known as vasovagal hypotension;
– if you have tumour near the kidney, known as phaeochromocytoma;
– if you have narrowing vascular disorders;
– if you have elevated eye pressure (glaucoma);
– if you have a slow pulse;
– if you are finding it difficult to urinate, especially due to enlargement of the prostate gland
– if you have damage to the retina in your eye as a result of diabetes (known as proliferative diabetic retinopathy)
– if you have an overactive thyroid gland;
– if your blood pressure and heart beat rate in standing test increases due to circulatory disorders with lower blood pressure;
– if you have some forms of heart or blood vessel disease;
– if you have inflammation of the kidneys, kidney disease, poor kidney function or if you are having problems passing urine

If you do not currently suffer from the listed diseases, but you did suffer from any of them in the past, talk to your doctor or pharmacist before taking Midodrine.

Warnings and precautions

Talk to your doctor or pharmacist or nurse before taking

Midodrine if you have:

been told you have high blood pressure when you lie down
high blood sugar (diabetes mellitus)