Bramox 10mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Midodrine hydrochloride

Available from:

Brancaster Pharma Ltd

ATC code:

C01CA17

INN (International Name):

Midodrine hydrochloride

Dosage:

10mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 02070200; GTIN: 05060432470234

Patient Information leaflet

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:
• Concomitant use with these medicines may cause a large increase in
blood pressure:
• Reserpine and guanethidine (medicines used to reduce high blood
pressure)
• Antihistamines (used to treat allergies)
• Hormones for the thyroid (used when the thyroid is not working
properly)
• Tricyclic antidepressants and MAO-inhibitors (both used to treat
depression)
• 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 dysfunc

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Bramox 10 mg tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10 mg of midodrine hydrochloride.
Excipients with known effect:
Each tablet contains 0.1 mg Brilliant blue FCF aluminium lake (E133).
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet.
Blue, round tablet of diameter 7 mm. Debossed “APO” on one side
with “MID”
debossed above the score line and “10” debossed below the score
line on the other
side.
The scoreline is only to facilitate breaking for ease of swallowing
and not to divide
into equal doses.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Bramox 10 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 (Bramox 2.5 mg tablets are also
available).
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. 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 10 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