Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Bramox 2.5 mg tablets
⚠ This medicine appears to have been discontinued
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.
What it is and what it is used for
for
The name of your medicine is Bramox tablets. They contain the medicine midodrine hydrochloride. This belongs to a group of medicines called adrenergic and dopaminergic agents. Midodrine hydrochloride is a medicine that raises your blood pressure and is used to treat certain severe forms of low blood pressure in adults when other treatments have not worked. 2.
What you need to know before you take it
e Bramox tablets
Do not take Bramox tablets if:
- you are allergic to midodrine hydrochloride or any of the other ingredients of this medicine (listed in section 6 of this leaflet)
- you have high blood pressure
- you have a slow pulse
- you have difficulty urinating
- you have certain forms of cardiovascular disease
- you have elevated pressure in the eye (glaucoma) or poor vision as a result of diabetes
- you have an overactive thyroid gland
- you have hormonal disorders caused by a tumour in the adrenal medulla (pheochromocytoma)
- you have severe kidney disease
- you have an enlarged prostate Warnings and precautions Talk to your doctor or pharmacist before taking this medicine if you have been told you have high blood pressure when you lie down. If this applies to you then:
- 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 and reducing the dose does not correct this problem, then treatment with this medicine must be stopped.
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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. By keeping your head elevated at night the potential risk of your blood pressure rising when you lie down is reduced.
Also talk to your doctor if you:
- have a serious disorder of the nervous system (autonomic nervous system disorders), since taking this medicine may lead to a further drop in blood pressure when you stand up. If this occurs, further treatment with this medicine should be stopped.
- suffer from problems with your blood circulation, especially if you have symptoms such as pain or cramps in the stomach after eating, or pain or cramps in the legs while walking.
- suffer from a disease of the prostate, as you may find passing urine is difficult when taking this medicine. 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 adjusted. It is important that you immediately report symptoms related to high blood pressure, such as chest pain, palpitations, shortness of breath, headache and blurred vision. Your doctor will then decide whether to adjust dosage or discontinue your treatment with Bramox tablets. If any of the warnings apply to you, or have in the past, talk to your doctor. Children and adolescents Do not give this medicine to children and adolescents under the age 18 because the safety and efficacy of Bramox tablets in this age group have not been established. Other medicines and Bramox 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: –
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Concomitant use with these medicines may cause a large increase in blood pressure: o Reserpine and guanethidine (medicines used to reduce high blood pressure) o Antihistamines (used to treat allergies) o Hormones for the thyroid (used when the thyroid is not working properly) o Tricyclic antidepressants and MAO-inhibitors (both used to treat depression) o Other vasoconstrictors (medicines that narrow blood vessels), or sympathomimetic agents (medicines that have a stimulating effect on certain parts of the nervous system) 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. Corticosteroids, such as fludrocortisone acetate (an anti-inflammatory medicine), because these medicines 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.
Pregnancy and breast-feeding Using this medicine while pregnant is not recommended, or if you are a woman of childbearing potential not using contraception. Tell your doctor if you are pregnant, or want 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. Bramox 5 mg tablets contain Sunset Yellow FCF aluminium lake (E110) Sunset Yellow FCF aluminium lake (E110) can cause allergic reactions. 3.
How to take it
Bramox 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. This medicine may be taken with or without food. The scoreline is only to facilitate breaking for ease of swallowing and not to divide into equal doses. 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 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. 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 Bramox 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:
- high blood pressure (hypertension), e.g. palpitations, shortness of breath, chest pain, headache and blurred vision.
- slow heart rate (bradycardia)
- difficulty urinating
- goosebumps
- feelings of coldness If you forget to take Bramox tablets If you forget to take a dose, take your next dose as usual and then keep taking your medicine as your doctor has told you. Do not take a double dose to make up for a forgotten dose, because this will increase the risk of high blood pressure when you lie down. If you stop taking Bramox tablets There will be no sudden drop in your blood pressure.
Always talk to your doctor if you are considering stopping taking 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, Bramox tablets 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) 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 it
Bramox 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 outer carton and on the blister foil. The expiry date refers to the last day of that month. This medicinal product does not require any special storage conditions. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help to protect the environment. 6.
Contents of the pack and other information
What Bramox tablets contain
- The active substance is midodrine hydrochloride. Each tablet contains 2.5 mg. 5 mg or 10 mg midodrine hydrochloride.
- The other ingredients are microcrystalline cellulose, maize starch, magnesium stearate, and silica colloidal anhydrous. Bramox 5 mg tablets also contain Sunset Yellow FCF aluminium lake (E110). Bramox 10 mg tablets also contain Brilliant blue FCF aluminium lake (E133). What Bramox tablets look like and contents of the pack
The 2.5 mg tablets are white, round tablets marked on one side with "MID" above the score line and "2.5" below the score line. The 5 mg tablets are orange, round tablets marked on one side with "MID" above the score line and "5" below the score line. The 10 mg tablets are blue, round tablets marked "APO" on one side and "MID" above the score line and "10" below the score line on the other side. This medicine is available in cartons of 50 or 100 tablets in aluminium/aluminium blister packs. Not all pack sizes may be marketed. Marketing Authorisation Holder Brancaster Pharma Limited Church House 48 Church Street Reigate, Surrey RH2 0SN, United Kingdom Manufacturer CampusPharma AB Karl Gustavsgatan 1A 411 25 Gothenburg Sweden Cross Vetpharm Group UK Limited Unit 2, Bryn Cefni Llangefni, Anglesey LL77 7XA, United Kingdom This medicinal product is authorised in the Member States of the EEA under the following names: Netherlands:
Midodrine HCl Brancaster 2,5 mg tabletten, Midodrine HCl 5 mg tabletten and Midodrine HCl Brancaster 10 mg tabletten
Denmark, Norway, Sweden:
Hypotron 2,5 mg tabletter, Hypotron 5 mg tabletter and Hypotron 10 mg tabletter
Finland:
Hypotron 2,5 mg tabletit, Hypotron 5 mg tabletit and Hypotron 10 mg tabletit
Iceland:
Hypotron 2,5 mg töflur. Hypotron 5 mg töflur and Hypotron 10 mg töflur
UK:
Bramox 2.5 mg tablets, Bramox 5 mg tablets and Bramox 10 mg tablets
This leaflet was last revised in 12-2021 Detailed information on this medicine is available on the Medicines and Healthcare Products Regulatory Agency (MHRA) website: http://www.mhra.gov.uk
Frequently asked questions about Bramox 2.5 mg tablets
How do I take Bramox 2.5 mg tablets?
Bramox 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.
What is the active substance in Bramox 2.5 mg tablets?
The active substance in Bramox 2.5 mg tablets is midodrine hydrochloride.
Are there equivalent medicines to Bramox 2.5 mg tablets?
Medicines with the same active substance, strength and form include: Midodrine 2.5 mg tablets, Midodrine 2.5mg tablets. They are interchangeable only if your prescriber or pharmacist says so.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Bramox 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.
Can I get Bramox 2.5 mg tablets without a prescription?
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.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: midodrine hydrochloride
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Bramox 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.
4.2. Posology and method of administration
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 (Bramox 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).
Bramox 2.5 mg tablets may be taken with food (see section 5.2).
Paediatric population
The safety and efficacy of midodrine 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 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.
4.3. Contraindications
• 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.
4.4. Special warnings and precautions for use
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 physican. 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 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 may lead to a further reduction of blood pressure when standing. If this occurs, further treatment with midodrine 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 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 and on a regular basis.
Heart rate
Slowing of the heart rate may occur after midodrine administration, due to vagal reflex. Caution is advised when midodrine 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.
4.5. Interaction with other medicinal products and other forms of interaction
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 is blocked by α-adrenergic antagonists such as prazosin and phentolamine.
Heart rate reducing drugs
Monitoring is recommended if midodrine 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 and heart block may occur.
Corticosteroid preparations
Midodrine may potentiate or enhance the hypertensive effects of corticosteroid preparations. Patients being treated with midodrine 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 (MAO-inhibitors) 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.
4.6. Fertility, pregnancy and lactation
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.
Bramox 2.5 mg tablets are not recommended during pregnancy and in women of childbearing potential not using contraception.
Breastfeeding
It is unknown whether midodrine and its metabolites are excreted in human milk.
A risk to newborns/infants cannot be excluded. Bramox 2.5 mg tablets should not be used during breastfeeding.
Fertility
Animal studies are insufficient with respect to the assessment of fertility.
4.7. Effects on ability to drive and use machines
Bramox 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.
4.8. Undesirable effects
Summary of the safety profile
The most frequent and very common adverse reactions related to midodrine 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 (goosebumps)
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).
4.9. Overdose
The symptoms of overdose are the same as experienced with side effects. The following in particular may occur: hypertension, piloerection (goosebumps) 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, nitrogylcerine) is recommended, based on the pharmacology of the drug.
Bradycardia and bradycardic conduction disturbances can be blocked by atropine.
The active metabolite desglymidodrine is dialysable.
💬 Ask about this leaflet
Ask anything about Bramox 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.