Patient leaflet - Bramox 2.5 mg tablets
1 What Bramox tablets are and what they are used 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 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.
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 nevous 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 Please Turn Over Package leaflet: Information for the user
Bramox 2.5 mg tablets
Bramox 5 mg tablets
Bramox 10 mg tablets
Midodrine Hydrochloride
XXXXXXX
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 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 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 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, with “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.
This leaflet was last revised in 12-2021
Marketing Authorisation Holder
Brancaster Pharma Limited, Church
House, 48 Church Street, Reigate,
Surrey RH2 0SN, United Kingdom.
Manufacturer
CampusPharma AB
Karl Gustavsgatan 1 A
Gothenburg, 411 25, 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 Brancaster
5 mg tabletten and Midodrine
HCl Brancaster 10 mg tabletten.
UK: Bramox 2.5 mg tablets, Bramox 5 mg tablets and Bramox 10 mg tablets. 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.
Detailed information on this medicine is available on the Medicines and Healthcare Products Regulatory Agency (MHRA) website:
http://www.mhra.gov.uk