Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Midodrine hydrochloride may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
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
Also talk to your doctor if you:
e Hydrochloride Tablets Midodrine Hydrochloride Tablets Tell your doctor or pharmacist if you are taking, have recently taken or might take any other Do not take Midodrine Hydrochloride medicines. Tablets if you: In particular tell your doctor or pharmacist if
to be, while you are being treated with this medicine. Do not use this medicine while breast-feeding. Driving and using machines This medicine should not affect your ability to drive or use machines. However, you must be careful if dizziness or light-headedness occurs after taking this medicine. Midodrine Hydrochloride 5 mg and 10 mg Tablets contains Sunset Yellow FCF (E110) Sunset yellow can cause allergic reactions.
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. Swallow tablets with a drink of water. How much you should take Your doctor will decide your dose and tell you how long you should take this medicine. The treatment is usually long-term. 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, or one 10 mg tablet 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. Timing of the evening dose Avoid taking this medicine in the late evening. The last dose should be taken at least 4 hours before your bedtime. Elevating your head at night reduces the potential risk of high blood pressure when you lie down. More information can be found in the section "Warnings and precautions" of this leaflet. If you feel that the effect of this medicine is too strong, or too weak, talk to your doctor or pharmacist. If you take more Midodrine Hydrochloride Tablets than you should If you have used too much of this medicine please contact your doctor or pharmacist immediately. Taking too much of this medicine can cause:
, although not everybody gets them. Very common (may affect more than 1 in 10 people)
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)
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 25°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.
What Midodrine Hydrochloride Tablets contain The active substance(s) is midodrine hydrochloride and each tablet contains either 2.5 mg or 5 mg or 10 mg midodrine hydrochloride. The other ingredients are microcrystalline cellulose, maize starch, magnesium stearate, and silica colloidal anhydrous. Midorine Hydrochloride 5 mg and 10 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 10 mg tablets are orange, round tablets with MX debossed on one side and plain 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 Unit C, Harcourt Way Leicester, LE19 1WP UK Manufacturer Morningside Pharmaceuticals Ltd 5 Pavilion Way Loughborough LE11 5GW UK This leaflet was last revised in May 2024. M0275LAMUKNA-P1-004
Midodrine 2.5 mg tablets comes as tablet containing 2.5mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Midodrine 2.5 mg tablets is midodrine hydrochloride.
Medicines with the same active substance, strength and form include: Bramox 2.5 mg tablets, Midodrine 2.5mg tablets. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Midodrine 2.5 mg tablets, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
Midodrine hydrochloride 2.5 mg tablets are indicated in adults for the treatment of severe orthostatic hypotension due to autonomic dysfunction when corrective factors have been ruled out and other forms of treatment are inadequate.
Posology
Initial dose: 2.5 mg three times a day. Depending on the results of supine and standing blood pressure recordings, this dose may be increased weekly up to a dose of 10 mg three times a day (Midodrine hydrochloride 5 mg tablets are also available).
This is the usual maintenance dosage.
A careful evaluation of the response to treatment and of the overall balance of the expected benefits and risks needs to be undertaken before any dose increase and advice to continue therapy for long periods.
The last daily dose should be taken at least 4 hours before bedtime in order to prevent supine hypertension (see also section 4.4).
Midodrine hydrochloride 2.5 mg tablets may be taken with food (see section 5.2).
Paediatric population
The safety and efficacy of midodrine hydrochloride in children have not been established. No data are available.
Elderly population
There is limited data on dosing in the elderly and there are no specific studies which have focused on a possible dose reduction in the elderly population. Cautious dose titration is recommended.
Patients with renal impairment
There are no specific studies that have focused on a possible dose reduction in patients with renal impairment. Typically, midodrine hydrochloride is contraindicated in patients with acute renal impairment and severe renal impairment (see section 4.3).
Patients with hepatic impairment
There are no specific studies in this patient population (see also section 4.4).
Method of administration
For oral use.
• Severe organic heart disease (e.g. bradycardia, heart attack, congestive heart failure, cardiac conduction disturbances or aortic aneurysm).
• Hypertension.
• Serious obliterative blood vessel disease, cerebrovascular occlusions and vessel spasms.
• Acute kidney disease.
• Severe renal impairment (creatinine clearance of less than 30 ml/min).
• Serious prostate disorder.
• Urinary retention.
• Proliferative diabetic retinopathy.
• Pheochromocytoma.
• Hyperthyroidism.
• Narrow angle glaucoma
• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Severe orthostatic hypotension with supine hypertension
Regular monitoring of supine and standing blood pressure is necessary due to the risk of hypertension in the supine position, e.g. at night. Patients should be told to report symptoms of supine hypertension immediately such as chest pain, palpitations, shortness of breath, headache and blurred vision, and should be monitored for these side effects by the treating physician. Supine hypertension may often be controlled by an adjustment to the dose. If supine hypertension occurs, which is not overcome by reducing the dose, treatment with midodrine hydrochloride must be stopped.
The time of administration of the drug is important in this context. Avoid administration in the late evening. The last daily dose should be taken at least 4 hours before bedtime in order to prevent supine hypertension. The risk of supine hypertension occurring during the night can be reduced by elevating the head.
Severe disturbances of the autonomic nervous system
In patients suffering from a severe disturbance of the autonomic nervous system, administration of midodrine hydrochloride may lead to a further reduction of blood pressure when standing. If this occurs, further treatment with midodrine hydrochloride should be stopped.
Atherosclerotic disease
Caution must be observed in patients with atherosclerotic disease especially with symptoms of intestinal angina or claudication of the legs.
Prostate disorders
Caution is advised in patients with prostate disorders. Use of the drug may cause urinary retention.
Renal and hepatic function
This medicinal product is contraindicated in patients with acute renal impairment or severe renal impairment (see Section 4.3). Treatment with midodrine hydrochloride has not been studied in patients with hepatic impairment. It is therefore recommended to evaluate the renal and hepatic parameters before starting treatment with midodrine hydrochloride and on a regular basis.
Heart rate
Slowing of the heart rate may occur after midodrine hydrochloride administration, due to vagal reflex. Caution is advised when midodrine hydrochloride is used concomitantly with cardiac glycosides (such as digitalis preparations) and other agents that directly or indirectly reduce heart rate. Patients should be monitored for signs or symptoms suggesting bradycardia.
Sympathomimetics and other vasopressor agents
Concomitant treatment with sympathomimetics and other vasoconstrictive substances such as reserpine, guanethidine, tricyclic antidepressants, antihistamines, thyroid hormones and MAO-inhibitors, including treatments that are available without prescription, should be avoided as a pronounced increase in blood pressure may occur.
Alpha-adrenergic antagonists
As with other specific α-adrenergic agonists, the effect of midodrine hydrochloride is blocked by α-adrenergic antagonists such as prazosin and phentolamine.
Heart rate reducing drugs
Monitoring is recommended if midodrine hydrochloride is combined with other drugs that directly or indirectly reduce the heart rate.
Glycosides
Simultaneous use of digitalis preparations is not recommended, as the heart rate reducing effect may be potentiated by midodrine hydrochloride and heart block may occur.
Corticosteroid preparations
Midodrine hydrochloride may potentiate or enhance the hypertensive effects of corticosteroid preparations. Patients being treated with midodrine hydrochloride in combination with mineralocorticoids or glucocorticoids (e.g. fludrocortisone) may be at increased risk of glaucoma/increased intraocular pressure, and should be carefully monitored.
Potential pharmacokinetic interactions
The potential for pharmacokinetic interaction is limited as the metabolic pathways do not involve cytochrome P450 enzymes (see section 5.2). However, decreased clearance of medicinal products metabolised by CYP2D6 (e.g. promethazine) has been reported.
Potential effect of other drugs on midodrine
No studies to evaluate the effect of other drugs on the pharmacokinetics of midodrine or the active metabolite desglymidodrine have been conducted. In vitro data indicate that desglymidodrine is a substrate of CYP2D6. Concomitant administration of drugs that inhibit this enzyme (e.g. quinidine, paroxetine, fluoxetine and bupropion) may cause increased plasma levels of desglymidodrine with a potential risk of increased adverse events.
Potential effect of midodrine on other drugs
Midodrine is an inhibitor of CYP2D6 and may affect the metabolism of other drugs. This may be of clinical relevance for active substances that are mainly metabolized by CYP2D6, e.g. tricyclic antidepressants, beta blockers, selective serotonin reuptake inhibitors (SSRI), antiarrhythmics (including class 1A, 1B and 1C) and monoamine oxidase inhibitors (MAOinhibitors) type B, especially if the active substance also has a narrow therapeutic index.
Falsely elevated plasma metanephrine
Patients taking midodrine may have falsely elevated plasma metanephrine as a result of analytical interference when measured by HILIC-based HPLC-MS/MS. This potential for interference should be considered in cases where patients taking midodrine require biochemical investigation for potential phaeochromocytomas and paragangliomas.
Pregnancy
There are no data from the use of midodrine hydrochloride in pregnant women. Studies in animals have shown reproductive toxicity at maternally toxic doses.
Midodrine hydrochloride 2.5 mg tablets are not recommended during pregnancy and in women of childbearing potential not using contraception.
Breastfeeding
It is unknown whether midodrine hydrochloride and its metabolites are excreted in human milk. A risk to newborns/infants cannot be excluded. Midodrine hydrochloride 2.5 mg tablets should not be used during breastfeeding.
Fertility
Animal studies are insufficient with respect to the assessment of fertility.
Midodrine hydrochloride 2.5 mg tablets have negligible influence on the ability to drive and use machines.
However patients who experience dizziness or light-headedness should refrain from driving or operating machinery.
Summary of the safety profile
The most frequent and very common adverse reactions related to Midodrine hydrochloride therapy are piloerection, pruritus of the scalp and dysuria.
Tabulated list of adverse reactions
Organ Class
Very Common
(> 1/10)
Common
(> 1/100, < 1/10)
Uncommon
(> 1/1,000, < 1/100)
Rare
(> 1/10,000, < 1/1,000)
Frequency not known (cannot be estimated from available data)
Psychiatric disorders
Sleep disorders
Insomnia
Anxiety
Confusional state
Nervous system disorders
Paraesthesia
Paraesthesia of the scalp
Headache
Restlessness
Excitability
Irritability
Cardiac disorders
Reflex bradycardia
Tachycardia
Palpitations
Vascular disorders
Supine hypertension (dose dependent effect)
Gastrointestinal disorders
Nausea
Dyspepsia
Stomatitis
Abdominal pain
Vomiting
Diarrhoea
Hepatobiliary disorders
Abnormal hepatic function
Raised liver enzymes
Skin and subcutaneous tissue disorders
Piloerection (goose bumps)
Pruritus of the scalp
Pruritus
Chills
Flushing
Rash
Renal and Urinary disorders
Dysuria
Urinary retention
Urinary urgency
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme (website: www.mhra.gov.uk/yellowcard) or search for MHRA Yellow Card in the Google Play or Apple App Store).
The symptoms of overdose are the same as experienced with side effects. The following in particular may occur: hypertension, piloerection (goose bumps) and feeling cold, bradycardia (reflex bradycardia) and urinary retention.
Treatment: In addition to the main general “life support” measures, induced vomiting and the administration of an α-sympatholytic agent (e.g. nitroprusside, phentolamine, nitro-glycerine) is recommended, based on the pharmacology of the drug.
Bradycardia and bradycardic conduction disturbances can be blocked by atropine. The active metabolite desglyMidodrine hydrochloride is dialysable.
Ask anything about Midodrine 2.5 mg tablets. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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