Patient leaflet - Midodrine 2.5 mg tablets
1. 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 Tablets are 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 have tumour near the kidney, known as phaeochromocytoma;
- if you have elevated eye pressure (narrow angle glaucoma);
- if you have thryoid gland problems called thyrotoxicosis or hyperthyroidism i.e. overactive thyroid;
- if you suffer from high blood pressure or a form of low blood pressure known as vasovagal hypotension;
- if you have some types 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 have damage to the retina in your eye as a result of diabetes (known as proliferative diabetic retinopathy)
Men only:
- if you have an enlarged prostate that causes problems emptying your bladder.
Warnings and precautions
Talk to your doctor or pharmacist before taking Midodrine if you have:
- any kidney problems
- had a stroke in the past or been told that you are at risk of a stroke
- any heart problems
Your blood pressure will be monitored before starting, and during, treatment. If you experience any chest pain, palpitations, shortness of breath, headache, blurred vision, pulse slowing, increased dizziness or faintness during treatment, STOP taking the product and seek medical help immediately.
Taking Midodrine with other medicines
Please tell your doctor if you taking, or have recently taken any other medicines, including medicines obtained without a prescription. This includes herbal medicines.
Particularly if you are taking:
- high blood pressure medicines e.g. alpha blockers or beta blockers
- glycosides to increase the force of your heartbeat e.g. digitalis
- tricyclic antidepressants for depression or monoamine oxidase inhibitors (MAOIs)
amiodarone (used to control heart arrhythmias). Midodrine may increase the effect of this medicine
- metoclopramide (used to stop you feeling and being sick). Midodrine may increase the effect of this medicine
- phenothiazines and atypical antipsychotics for schizophrenia or psychosis
- antihistamines (medicines to treat allergies)
- appetite suppressants
- nasal/ sinus congestion relievers, especially those purchased without a prescription
- thyroid hormones
- steroids (e.g. fludrocortisone). In combination with Midodrine, steroids may increase the risk of eye problems or a high blood pressure whilst lying down. (These medicines are sometimes used together with Midodrine, and your doctor may have prescribed this combination for you)
- Ergot alkaloid, medicines used to treat migraines and Parkinsons.
Taking Midodrine with food and drink
You can take these tablets with or without food.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to have a baby or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
As safe use during pregnancy has not been established, Midodrine is not recommended. If you become pregnant whilst being treated with Midodrine, you must stop taking this medicine immediately.
Midodrine is not recommended during breastfeeding unless advised to by a doctor.
Driving and using machinery
Midodrine may make you feel dizzy or drowsy. If this happens to you, do not drive a vehicle or operate any tools or machinery during treatment.
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.
- Swallow the tablet whole with 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 (e.g. sleeping)
- The tablet can be divided into equal doses.
Adults and the Elderly
The usual starting dose is 2.5 mg taken 2 to 3 times daily. Your doctor may increase this dose each week until the best effect is seen.
The maximum daily dose is 30 mg.
Children
Do not give this medicine to children under the age of 18 because the safety and efficacy has not been established.
Patients with renal disorders
Midodrine should not be administered in patients with severe kidney disorders.
Patients with hepatic impairment
If you have liver problems, you should consult your doctor. The safety of Midodrine in patients with liver problems has not been established.
If you take more tablets than you should
If you have taken more Midodrine tablets than you should, contact your doctor immediately or go to your nearest hospital accident and emergency department. Take this leaflet with you.
Symptoms of overdose include: high blood pressure, feeling cold, urgent desire to urinate, slow heartbeat and “goose bumps”.
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 missed dose.
If you stop taking Midodrine
Do not stop taking these tablets without talking to your doctor first.
Contact your doctor or pharmacist if you have any further questions on the use of this medicinal product. PACKAGE LEAFLET: INFORMATION FOR THE PATIENT Midodrine 2.5 mg & 5 mg
Tablets
Midodrine hydrochloride
BACK
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. STOP taking Midodrine and seek medical advice immediately if you experience any of the following signs of an allergic reaction:
- difficulty breathing or swallowing
- swelling of the face, lips, tongue or throat
- severe itching of the skin, with a red rash or raised bumps.
The following side effects may occur:
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:
- tingling sensation of the skin (“pins and needles”)
- rash, itching (particularly of the scalp)
- chills
- flushing
- high blood pressure when lying down at daily doses of more than 30 mg (this might cause headaches, blurred vision, a ‘pounding’ heartbeat, chest pain or shortness of breath)
- nausea, vomiting, indigestion, sore mouth
- 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
- slowing of pulse
- high blood pressure when lying down at daily doses 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
- fast or irregular heartbeat, chest pain
- stroke
- increased liver enzymes (detected in blood test)
Not known (frequency cannot be estimated from the available data):
- anxiety
- confusion
- increased tear production
- diarrhoea
Midodrine can cause high blood pressure whilst lying down, particularly if the last dose of the day is taken too close to bedtime. This might cause headaches, blurred vision, a “pounding” heartbeat, chest pain or shortness of breath. If these occur when you lie down or go to bed, tell your doctor. This is very important as, rarely, strokes have occurred.
If you are using Midodrine in combination with other medicines that raise blood pressure e.g. fludrocortisone, and you find that your eyes are hurting, you experience visual disturbances (blurred vision) or you have a headache, especially behind the eye, you should tell your doctor.
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 at: www.mhra.gov.uk/yellowcard 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.
6. Contents of the pack and other information
What Midodrine contains
The active substance is Midodrine hydrochloride. Each tablet contains 2.5 mg or 5 mg Midodrine hydrochloride.
The other ingredients are:
For both tablets:
Hydrophobic colloidal anhydrous silica Microcrystalline cellulose
Pregelatinized starch
Magnesium stearate
For Midodrine 5 mg tablets only:
Sunset yellow FCF-Lake (E110)
What Midodrine looks like and contents of the pack
Midodrine 2.5 mg 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. The tablets are available in pack sizes containing 30 x 1, 90 x 1 and 100 x 1 tablets in PVC/PVDC/ Aluminium and OPA/Alu/PVC/Alu perforated unit dose blisters.
They are also available in High Density Polyethylene (HDPE) bottle pack with 100 tablets.
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. The tablets are available in pack sizes containing 100 x 1 tablets in PVC/PVDC/Aluminium and OPA/Alu/PVC/Alu perforated unit dose blisters. They are also available in High Density Polyethylene (HDPE) bottle pack with 100 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Tillomed Laboratories Limited
220 Butterfield, Great Marlings
Luton, LU2 8DL, United Kingdom
This leaflet was last revised in 11/2024
510522071GB02 Hard to read?
To get this information in large print or another format, please email medical.information@tillomed.com or call 0800 970 6115.
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 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
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 Tablets are 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.
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 have tumour near the kidney, known as
phaeochromocytoma;
if you have elevated eye pressure (narrow angle
glaucoma);
if you have thryoid gland problems called thyrotoxicosis
or hyperthyroidism i.e. overactive thyroid;
if you suffer from high blood pressure or a form of low
blood pressure known as vasovagal hypotension; - if you have some types 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 have damage to the retina in your eye as a result
of diabetes (known as proliferative diabetic retinopathy) Men only:
if you have an enlarged prostate that causes problems
emptying your bladder.
Warnings and precautions
Talk to your doctor or pharmacist before taking Midodrine if you have:
- any kidney problems
had a stroke in the past or been told that you are at risk
of a stroke
- any heart problems
Your blood pressure will be monitored before starting, and during, treatment. If you experience any chest pain,
Midodrine 2.5 mg & 5mg Tablets
Adults and the Elderly
The usual starting dose is 2.5 mg taken 2 to 3 times daily. Your doctor may increase this dose each week until the best effect is seen.
The maximum daily dose is 30 mg.
Children
Do not give this medicine to children under the age of 18 because the safety and efficacy has not been established.
Patients with renal disorders
Midodrine should not be administered in patients with severe kidney disorders.
Patients with hepatic impairment
If you have liver problems, you should consult your doctor. The safety of Midodrine in patients with liver problems has not been established.
If you take more tablets than you should
If you have taken more Midodrine tablets than you should, contact your doctor immediately or go to your nearest hospital accident and emergency department. Take this leaflet with you. Symptoms of overdose include: high blood pressure, feeling cold, urgent desire to urinate, slow heartbeat and “goose bumps”.
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 missed dose.
If you stop taking Midodrine
Do not stop taking these tablets without talking to your doctor first.
Contact your doctor or pharmacist if you have any further questions on the use of this medicinal product.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
STOP taking Midodrine and seek medical advice immediately if you experience any of the following signs of an allergic reaction:
- difficulty breathing or swallowing
- swelling of the face, lips, tongue or throat
severe itching of the skin, with a red rash or raised
bumps.
The following side effects may occur:
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:
- tingling sensation of the skin (“pins and needles”) - rash, itching (particularly of the scalp)
- chills
- flushing
high blood pressure when lying down at daily doses of
more than 30 mg (this might cause headaches, blurred vision, a 'pounding' heartbeat, chest pain or shortness of breath)
- nausea, vomiting, indigestion, sore mouth - 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 - slowing of pulse
Product Name
Packaging Material
Midodrine 2.5 mg & 5 mg Tablets 510520544GB02
Outsert A/W Alu Alu pack addition variation
--------------------
L. 32 x H. 32 mm
--------------- 9
510520544GB01
Size : Carton/Label
palpitations, shortness of breath, headache, blurred vision, pulse slowing, increased dizziness or faintness during treatment, STOP taking the product and seek medical help immediately.
Taking Midodrine with other medicines
Please tell your doctor if you taking, or have recently taken any other medicines, including medicines obtained without a prescription. This includes herbal medicines. Particularly if you are taking:
high blood pressure medicines e.g. alpha blockers or
beta blockers
glycosides to increase the force of your heartbeat e.g.
digitalis
tricyclic antidepressants for depression or monoamine
oxidase inhibitors (MAOIs)
amiodarone (used to control heart arrhythmias).
Midodrine may increase the effect of this medicine - metoclopramide (used to stop you feeling and being
sick). Midodrine may increase the effect of this medicine - phenothiazines and atypical antipsychotics for
schizophrenia or psychosis
- antihistamines (medicines to treat allergies) - appetite suppressants
nasal/ sinus congestion relievers, especially those
purchased without a prescription
- thyroid hormones
steroids (e.g. fludrocortisone). In combination with
Midodrine, steroids may increase the risk of eye problems or a high blood pressure whilst lying down. (These medicines are sometimes used together with Midodrine, and your doctor may have prescribed this combination for you)
Ergot alkaloid, medicines used to treat migraines and
Parkinsons.
Taking Midodrine with food and drink
You can take these tablets with or without food.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to have a baby or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
As safe use during pregnancy has not been established, Midodrine is not recommended. If you become pregnant whilst being treated with Midodrine, you must stop taking this medicine immediately.
Midodrine is not recommended during breastfeeding unless advised to by a doctor.
Driving and using machinery
Midodrine may make you feel dizzy or drowsy. If this happens to you, do not drive a vehicle or operate any tools or machinery during treatment.
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.
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.
- Swallow the tablet whole with 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 (e.g. sleeping)
- The tablet can be divided into equal doses.
V2G
- high blood pressure when lying down at daily doses 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
- fast or irregular heartbeat, chest pain
- stroke
- increased liver enzymes (detected in blood test)
Not known (frequency cannot be estimated from the available data):
- anxiety
- confusion
- increased tear production
- diarrhoea
Midodrine can cause high blood pressure whilst lying down, particularly if the last dose of the day is taken too close to bedtime. This might cause headaches, blurred vision, a “pounding” heartbeat, chest pain or shortness of breath. If these occur when you lie down or go to bed, tell your doctor. This is very important as, rarely, strokes have occurred.
If you are using Midodrine in combination with other medicines that raise blood pressure e.g. fludrocortisone, and you find that your eyes are hurting, you experience visual disturbances (blurred vision) or you have a headache, especially behind the eye, you should tell your doctor.
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 at: www.mhra.gov.uk/yellowcard 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.
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 both tablets:
Hydrophobic colloidal anhydrous silica, Microcrystalline cellulose , Pregelatinized starch, Magnesium stearate
For Midodrine 5 mg tablets only:
Sunset yellow FCF-Lake (E110)
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.
The tablets are available in pack sizes containing 30 x 1, 90 x 1 and 100 x 1 tablets in PVC/PVDC/Aluminium and OPA/Alu/PVC/Alu perforated unit dose blisters. They are also available in High Density Polyethylene (HDPE) bottle pack with 100 tablets.
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.
The tablets are available in pack sizes containing 100 x 1 tablets in PVC/PVDC/Aluminium and OPA/Alu/PVC/Alu perforated unit dose blisters.
They are also available in High Density Polyethylene (HDPE) bottle pack with 100 tablets.
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
Tillomed Laboratories Limited
220 Butterfield,
Great Marlings,
Luton,
LU2 8DL,
United Kingdom
This leaflet was last revised in 11/2024
Suite 2, Stafford House,
Strand Road,
Portmarnock,
Co. Dublin,
Ireland
510520544GB02 Midodrine 2.5 mg & 5 mg Tablets
Midodrine 2.5 mg
& 5 mg Tablets
Front Back Product Name
Packaging Material
Midodrine Tabs 2.5 & 5 mg 510522340GB01
Packinsert A/W CC PR#221231
AW developed for Uhlmann machine
-------------
--------------- 9 pt.
FOR THE PATIENT Midodrine 2.5 mg & 5 mg
Tablets
Midodrine hydrochloride
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 is and what it is used for
- 2.
What you need to know before you take
Midodrine
- 3. How to take Midodrine
- 4. Possible side effects
- 5. How to store Midodrine
- 6.
- 1. 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 Tablets are 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 have tumour near the kidney, known as
phaeochromocytoma;
if you have elevated eye pressure (narrow
angle glaucoma);
if you have thryoid gland problems called
thyrotoxicosis or hyperthyroidism i.e. overactive thyroid;
if you suffer from high blood pressure or a form
of low blood pressure known as vasovagal hypotension;
if you have some types 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 have damage to the retina in your eye as
a result of diabetes (known as proliferative diabetic retinopathy)
Men only:
if you have an enlarged prostate that causes
problems emptying your bladder.
Warnings and precautions
Talk to your doctor or pharmacist before taking Midodrine if you have:
- any kidney problems
had a stroke in the past or been told that you
are at risk of a stroke
- any heart problems
Your blood pressure will be monitored before starting, and during, treatment. If you experience any chest pain, palpitations, shortness of breath, headache, blurred vision, pulse slowing, increased dizziness or faintness during treatment, STOP taking the product and seek medical help immediately.
Taking Midodrine with other medicines
Please tell your doctor if you taking, or have recently taken any other medicines, including medicines obtained without a prescription. This includes herbal medicines.
Particularly if you are taking:
high blood pressure medicines e.g. alpha
blockers or beta blockers
glycosides to increase the force of your
heartbeat e.g. digitalis
- tricyclic antidepressants for depression or monoamine oxidase inhibitors (MAOIs)
amiodarone (used to control heart
arrhythmias). Midodrine may increase the effect of this medicine
- metoclopramide (used to stop you feeling and being sick). Midodrine may increase the effect of this medicine
- phenothiazines and atypical antipsychotics for schizophrenia or psychosis
- antihistamines (medicines to treat allergies)
- appetite suppressants
- nasal/ sinus congestion relievers, especially those purchased without a prescription
- thyroid hormones
- steroids (e.g. fludrocortisone). In combination with Midodrine, steroids may increase the risk of eye problems or a high blood pressure whilst lying down. (These medicines are sometimes used together with Midodrine, and your doctor may have prescribed this combination for you)
Ergot alkaloid, medicines used to treat
migraines and Parkinsons.
Taking Midodrine with food and drink
You can take these tablets with or without food.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to have a baby or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
As safe use during pregnancy has not been established, Midodrine is not recommended. If you become pregnant whilst being treated with Midodrine, you must stop taking this medicine immediately.
Midodrine is not recommended during breastfeeding unless advised to by a doctor.
Driving and using machinery
Midodrine may make you feel dizzy or drowsy. If this happens to you, do not drive a vehicle or operate any tools or machinery during treatment.
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.
- Swallow the tablet whole with 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 (e.g. sleeping)
- The tablet can be divided into equal doses.
Adults and the Elderly
The usual starting dose is 2.5 mg taken 2 to 3 times daily. Your doctor may increase this dose each week until the best effect is seen.
The maximum daily dose is 30 mg.
Children
Do not give this medicine to children under the age of 18 because the safety and efficacy has not been established.
Patients with renal disorders
Midodrine should not be administered in patients with severe kidney disorders.
Patients with hepatic impairment
If you have liver problems, you should consult your doctor. The safety of Midodrine in patients with liver problems has not been established.
If you take more tablets than you should
If you have taken more Midodrine tablets than you should, contact your doctor immediately or go to your nearest hospital accident and emergency department. Take this leaflet with you.
Symptoms of overdose include: high blood pressure, feeling cold, urgent desire to urinate, slow heartbeat and “goose bumps”.
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 missed dose.
Front
If you stop taking Midodrine
Do not stop taking these tablets without talking to your doctor first.
Contact your doctor or pharmacist if you have any further questions on the use of this medicinal product.
- 4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. STOP taking Midodrine and seek medical advice immediately if you experience any of the following signs of an allergic reaction:
- difficulty breathing or swallowing
- swelling of the face, lips, tongue or throat
severe itching of the skin, with a red rash or
raised bumps.
The following side effects may occur:
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:
tingling sensation of the skin (“pins and
needles”)
- rash, itching (particularly of the scalp)
- chills
- flushing
high blood pressure when lying down at daily
doses of more than 30 mg (this might cause headaches, blurred vision, a ‘pounding’ heartbeat, chest pain or shortness of breath)
- nausea, vomiting, indigestion, sore mouth
- 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
- slowing of pulse
high blood pressure when lying down at daily
doses 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
- fast or irregular heartbeat, chest pain
- stroke
increased liver enzymes (detected in blood
test)
Not known (frequency cannot be estimated from the available data):
- anxiety
- confusion
- increased tear production
- diarrhoea
Midodrine can cause high blood pressure whilst lying down, particularly if the last dose of the day is taken too close to bedtime. This might cause headaches, blurred vision, a “pounding” heartbeat, chest pain or shortness of breath. If these occur when you lie down or go to bed, tell your doctor. This is very important as, rarely, strokes have occurred.
If you are using Midodrine in combination with other medicines that raise blood pressure e.g. fludrocortisone, and you find that your eyes are hurting, you experience visual disturbances (blurred vision) or you have a headache, especially behind the eye, you should tell your doctor.
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 at: www.mhra.gov.uk/yellowcard 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.
- 6. Contents of the pack and other information
What Midodrine contains
The active substance is Midodrine hydrochloride. Each tablet contains 2.5 mg or 5 mg Midodrine hydrochloride.
The other ingredients are:
For both tablets:
Hydrophobic colloidal anhydrous silica Microcrystalline cellulose Pregelatinized starch Magnesium stearate
For Midodrine 5 mg tablets only:
Sunset yellow FCF-Lake (E110)
What Midodrine looks like and contents of the pack
Midodrine 2.5 mg 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. The tablets are available in pack sizes containing 30 x 1, 90 x 1 and 100 x 1 tablets in PVC/PVDC/Aluminium and OPA/Alu/PVC/Alu perforated unit dose blisters.
They are also available in High Density Polyethylene (HDPE) bottle pack with 100 tablets.
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. The tablets are available in pack sizes containing 100 x 1 tablets in PVC/PVDC/Aluminium and OPA/Alu/PVC/Alu perforated unit dose blisters. They are also available in High Density Polyethylene (HDPE) bottle pack with 100 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Tillomed Laboratories Limited
220 Butterfield, Great Marlings
Luton, LU2 8DL, United Kingdom
This leaflet was last revised in 11/2024
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