TRANDATE 400MG FILM COATED TABLETS
Active substance(s): LABETALOL HYDROCHLORIDE / LABETALOL HYDROCHLORIDE / LABETALOL HYDROCHLORIDE
Patient Information Leaflet: Trandate 50 mg film-coated Tablets
and Trandate 400 mg film-coated Tablets
1. What Trandate is for
Read all of this leaflet carefully before you
start taking this medicine.
• Keep this leaflet. You may need to read
• If you have any further questions, ask
your doctor or pharmacist.
• This medicine has been prescribed for
you. Do not pass it on to others. It may
harm them, even if their symptoms are
the same as yours.
• In this leaflet Trandate 50 mg film-coated
Tablets and Trandate 400 mg film-coated
Tablets will be called Trandate.
In this leaflet:
1. What Trandate is for
2. Before you take Trandate
3. How to take Trandate
4. Possible side effects
5. How to store Trandate
6. Further information
Trandate belongs to a group of medicines
called beta blockers.
Trandate works by causing the heart to
beat more slowly and with less force. It
also widens the arteries in the body. This
helps to lower the pressure of the blood as
it travels around the body. The result is a
lower blood pressure and the prevention of
angina (chest pain).
Trandate are used to treat:
• High blood pressure
• High blood pressure in pregnant women
• Angina (chest pains) if you already have
high blood pressure
High blood pressure often causes no
obvious symptoms but if it is not treated it
can damage blood vessels in the long-term.
This can lead to heart attacks, kidney
failure, stroke or blindness. This is why it is
important not to stop taking this medicine
without talking to your doctor.
2. Before you take Trandate
Do not take Trandate if:
• You are allergic to labetalol
• You are allergic to any of the other
ingredients of Trandate (see section 6)
• You suffer from wheezing, obstructive
airways disease or asthma – taking
Trandate can make your breathing worse
• You have a problem that is common in the
elderly, related to poor control of the
working of your heart (sick sinus syndrome)
• You have a heart defect that leads to a
decreased function of the heart (heart
• Your heart cannot maintain adequate
circulation of blood (cardiogenic shock)
• You have weak heart or a very slow heart
beat (less than 45 or 50 beats per minute)
• You have low blood pressure
• You have heart failure that is out of
control or not responding to treatment
• You suffer from angina (chest pains)
when at rest
• You have very bad circulation
• You have liver disease or your liver was
affected when taking labetalol in the past
• You have a tumour near your kidneys
• You have increased acid levels in the
blood (metabolic acidosis)
If any of the above applies to you, talk to
Check with your doctor before taking
• You are about to receive an anaesthetic:
as Trandate may mask the effects of a
sudden loss of blood
• You suffer or have suffered from any
serious allergic reactions
• You have ever suffered from a skin
condition called psoriasis
• You are receiving a procedure called
MIBG scintigraphy (often used to detect
Tell your doctor if you are taking any of
the following medicines
• Medicines used to treat your heart or
blood pressure such as digitalis,
amiodarone, nifedipine, enalapril,
lisinopril, ramipril, losartan, valsartan,
indapamide, terazosin, doxazosin
• Medicines to treat depression such as
monoamine oxidase inhibitors or tricyclic
• Medicines for anxiety and sedation such
as temazepam, diazepam, lorazepam
• Non-steroidal anti-inflammatory drugs
(NSAIDs), corticosteroids or other
medicines such as ibuprofen, naproxen,
betamethasone used to treat pain or
inflammatory conditions such as
rheumatoid arthritis or asthma
• Cimetidine used to treat stomach ulcers
• Insulin or oral anti-diabetic drugs
• Treatment for mental disturbances such a
• Antimalarial medicines such as
mefloquine or quinine
• Medicines used to treat acute migraine
such as ergotamine
• Alprostadil to treat impotence
• Moxisylyte to treat Raynaud's disease a
condition that affect the blood circulation
to the fingers and toes causing them to
suddenly become white, numb and cold
• Aldesleukin for the treatment of
secondary cancer of the kidney
• Hormones such as oestrogen and
progesterone used as contraceptives or
for hormone replacement therapy
• Medicines for stimulating the heart e.g.
• Any other medicine, including medicines
obtained without a prescription.
Taking Trandate at the same time as the
drugs mentioned for treating your heart or
blood pressure can lead to a severe drop in
blood pressure, reduced heart rate, heart
failure or heart block. It is important to tell
your doctor if you are taking these or any
of the other drugs listed above.
The results of blood or urine tests may be
affected by taking Trandate. If you need to
have a blood or urine test, tell your doctor
that you have been given Trandate tablet.
Taking Trandate with food and drink
Always take your tablets with food. As a
safety precaution it is recommended to
Pregnancy and breast-feeding
Trandate should only be used during the
first 3 months of pregnancy if it is
absolutely necessary. Therefore tell your
doctor if you are pregnant or trying to
Trandate is not recommended whilst breast
Driving and using machines
You may feel dizzy or tired when taking
Trandate. If this happens to you, do not
drive or operate machinery.
Warnings about the ingredients in Trandate
Trandate contains sodium benzoate which
is a mild irritant to the eyes, nose and
mucous membranes. It may increase the
risk of jaundice in new born babies. If you
think this medicine has upset you (or your
baby) in any way, please tell your doctor as
soon as possible.
Trandate contains lactose. If you have been
told by your doctor that you have an
intolerance to some sugars, contact your
doctor before taking this medicine.
3. How to take Trandate tablets
Always take Trandate exactly as your
doctor has told you to.
Your doctor will choose the dose that is
right for you. Your dose will be shown
clearly on the label that your pharmacist
puts on your medicine. If it does not, or
you are not sure, ask your doctor or
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Remember: Your tablets should be swallowed
whole and should be taken with food.
High blood pressure, with or without angina
• The starting dose is usually 100 mg twice
• Every two weeks your doctor may increase
the dose by 100 mg twice a day until your
blood pressure is controlled.
• In more serious cases of high blood
pressure your doctor may want to increase
the dose up to 2400 mg a day. In this case
you will need to take your medicine 3 or 4
times a day.
High blood pressure during pregnancy
• The usual starting dose is 100 mg twice a day.
• Your doctor may increase your dose every
week by 100 mg twice a day.
• As pregnancy continues your dose may
need to be increased to between 100 mg
and 400 mg three times a day.
• A total daily dose of 2400 mg should not
• The starting dose is 50 mg twice a day.
Children: Trandate is not recommended for
If you take more Trandate than you should
Do not take more Trandate than you should.
If you take too many tablets tell your doctor
immediately or contact your nearest hospital
emergency department. You should take
your tablets with you if possible.
If you forget to take Trandate
Do not take a double dose to make up for a
missed dose. Simply take the next dose as
If you stop taking Trandate
Do not stop taking Trandate suddenly.
Continue taking them until your doctor tells
you to stop. He or she will gradually reduce
the dose over a few weeks if necessary.
If you have any further questions about the
use of this medicine, ask your doctor or
4. Possible side effects
Like all medicines Trandate can cause side
effects, although not everybody gets them.
Stop using Trandate and seek immediate
medical help if you have an allergic reaction.
This includes any of the following
• Difficulties in breathing
• Swelling of your eyelids, face or lips
• Rash or itching
Most of the side effects related to Trandate will
wear-off after the first few weeks. These include:
• Headaches, tiredness or dizziness
• Depression or exhaustion (lethargy)
• Tingling of the scalp, or a blocked nose
swollen ankles or sweating
• Difficulty passing urine or not being able
to pass urine or to ejaculate
• Stomach pain, feeling sick or being sick
If any of these side effects occur, speak to
you doctor immediately.
• Problems with the immune system (e.g.
systemic lupus erythematosus) causing
shortness of breath, joint pain, or a rash
on the cheeks and arms that worsen with
• Thrombocytopenia causing nosebleeds or
bleeding in the mouth or bruising because
your blood does not clot as it should
• Drug fever making you feel hot and flu-like
• Muscle disease (toxic myopathy) causing
weakness and wasting of the muscles in
the arms and legs
• Flat topped bumps on your skin that join
up into scaly patches (lichenoid rash)
• Blurred vision or dry eyes
• Liver problems or jaundice causing
discomfort and tenderness in the upper
abdomen, yellowing of the skin and whites
of the eyes
• Slowing of the heart and heart block
(where the heart signals are delayed
causing your heart beat to slow to 20 - 40
beats per minute)
• Cough or breathing problems that may
indicate inflammation of the lungs
(interstitial lung disease)
Other side effects that may occur include:
• The shakes after taking Trandate when
• Dizziness when standing up (when taken
at very high doses)
• Low blood pressure (hypotension) causing
dizziness and possibly fainting
• Poor circulation in the hands, cold or blue
extremities, numbness or tingling of the
• Increase of existing leg pain on walking
• Mental disturbances such as delusions and
altered thought patterns, hallucinations or
• Sleep disturbances including nightmares
• Wheezing or shortness of breath (in
patients with asthma)
• The symptoms of an overactive thyroid
(increased heart rate) or low blood sugar
(as seen in blood test results) may be
• High blood potassium levels
(hyperkalaemia) especially if you have
reduced kidney function. This may cause
your heart beat to become irregular or
may be without symptoms and only show
on blood test results
• Hair loss. This may grow back after
• Worsening of psoriasis
• Heart failure causing shortness of breath
with swelling of the feet and ankles
Rare side effects on your baby
If you are being treated for high blood
pressure during pregnancy your baby may
suffer the following effects for a few days
• Low blood pressure
• Slow heart beat
• Shallow or slow breathing
• Low Blood sugar
• Feeling cold
If any of the side effects gets serious, or if
you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.
5. How to store Trandate
Keep out of the reach and sight of children.
Do not use Trandate after the expiry date
which is shown on the carton label, blister
foil and container label after EXP. The
expiry date refers to the last day of that
Store below 30ºC
Medicines should not be disposed of via
wastewater or household waste. Return any
medicine you no longer need to your
6. Further Information
What Trandate contains
The active ingredient is labetalol
hydrochloride. The tablets contain either 50
mg or 400 mg of the active ingredient.
The other ingredients are: In the tablet core:
lactose monohydrate, magnesium stearate
(E572), starch maize. In the film coating:
hypromellose (E464), sodium benzoate
(E211), titanium dioxide (E171), sunset yellow
(E110), methyl hydroxybenzoate (E218),
propyl hydroxybenzoate (E216), industrial
methylated spirit and purified water.
What Trandate looks like
The tablets are orange with either ‘Trandate
50’ or ‘Trandate 400’ written on one side.
Trandate 50 mg tablets come in packs
containing 56 tablets. Trandate 400 mg
tablets come in packs containing 56 or 250
tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder
RPH Pharmaceuticals AB, Lagervägen 7,
136 50 Haninge, Sweden.
Distributed in the UK by Focus
Recipharm Ltd, Vale of Bardsley,
Ashton-under-Lyne, OL7 9RR, UK.
This leaflet was last revised in July 2012.
If this leaflet is difficult to see or
read or you would like it in a
different format, please contact RPH
Pharmaceuticals AB, Lagervägen 7,
136 50 Haninge, Sweden.
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Trandate 50mg/400mg Tablets Leaflet - P1069F
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Source: Medicines and Healthcare Products Regulatory Agency