100 mg and 200 mg film-coated tablets
labetalol hydrochloride
What Trandate is and what it is used for
Trandate contains the active substance labetalol. It is used to treat mild, moderate, or severe hypertension (high blood pressure ), pregnancy-related hypertension (high blood pressure caused by pregnancy), and high blood pressure associated with angina (chest pain).
Labetalol (Trandate) belongs to a group of drugs called alpha and beta blockers. These drugs lower blood pressure by blocking receptors in the cardiovascular system (circulatory system), which lowers blood pressure in blood vessels far away from the heart.
You should be aware that your doctor may have prescribed this medicine for different use and/or a different dosage than that stated in the package insert. Always follow the doctor’s instructions on the pharmacy label on the can.
What you need to know before you take Trandate
Do not take Trandate:
- if you have certain heart disease (for example heart block II or III unless you have a pacemaker, untreated heart failure )
- if you have low blood pressure
- if you have an extremely slow heart rate (severe bradycardia )
- if you have a condition called Prinzmetal’s angina
- if you have asthma or a similar lung disease ( obstructive airway disease ).
- if you are allergic to labetalol or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before taking Trandate:
– if you have impaired liver function or liver damage
– if you have impaired kidney function
– if you have vascular disease, for example, Raynaud’s syndrome, window-viewing disease.
– if you have diabetes mellitus (type 1 or type 2)
– if you have an overactive thyroid gland ( thyrotoxicosis, hyperthyroidism )
– if you previously had a severe allergic reaction (allergic shock ) to any substance
– if you have heart failure or other problems with your heart (for example reduced systolic function of the left ventricle, atrioventricular block degree I)
– if you know that you will undergo a planned operation
– if you have metabolic acidosis (when your body produces too much acid or when the kidneys do not remove enough acid from your body)
– if you have pheochromocytoma (a special form of tumor of the adrenal gland)
– if you have a condition called ischemic heart disease
If you get a low heart rate ( bradycardia ) as a result of taking Trandate, your doctor may lower your dose.
If you get a skin rash and/or dry eyes or some kind of allergic reaction when taking Trandate, you should contact a doctor who may then reduce the dose or stop your treatment. Always follow your doctor’s instructions.
Do not stop taking Trandate suddenly, especially if you have heart disease (ischemic heart disease or angina pectoris). Talk to your doctor if you think you should stop taking Trandate.
Operation
If you are going to have surgery with general anesthesia (narcosis), you must tell the surgeon before the operation that you are taking Trandate.
Labetalol can affect your pupils during cataract surgery. Tell the eye surgeon before the operation that you are taking this medicine. Do not stop taking labetalol before surgery unless your surgeon tells you to.
Other medicines and Trandate
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines before you are prescribed Trandate. This is particularly important for the following medicines:
- non-steroidal anti-inflammatory/anti-rheumatic medicines ( NSAIDs ) eg: sulindac, and indomethacin, used to treat pain and inflammation
- digoxin (heart medication)
- adrenaline which can be used to treat severe anaphylactic (allergic) reactions
- medicines for heart failure ( antiarrhythmics class I eg disopyramide and quinidine ) and ( antiarrhythmics class II eg amiodarone )
- other medicines that lower blood pressure et ( calcium blockers such as verapamil)
- tricyclic antidepressants, e.g. imipramine (used to treat depression)
- cimetidine, which can be used to treat stomach ulcers and heartburn
- oral antidiabetic drugs such as biguanides (eg, metformin ), sulfonylureas (eg, glimepiride), meglitinides (eg, repaglinide), and α-glucosidase inhibitors (eg, acarbose) used to lower blood sugar levels
- ergotamine derivatives, for example, ergotamine or dihydroergotamine used to treat migraine cholinesterase inhibitors,: donepezil, galantamine, or rivastigmine used to treat mild cognitive impairment, Alzheimer’s disease, and Parkinson’s disease
- nitrates, antipsychotics (eg phenothiazine derivatives, chlorpromazine), antidepressants
- clonidine used to treat high blood pressure
Tests
This medicine may interfere with certain medical/laboratory tests and possibly give false test results. Make sure that all laboratory personnel and all of your doctors know that you are taking this medicine.
Pregnancy, breastfeeding, and fertility
If you are pregnant or planning to have a baby, consult your doctor before using Trandate. The fetus may be affected, but Trandate can be taken during pregnancy if necessary.
Trandate is excreted in breast milk in small amounts. Nipple pain and Raynaud’s phenomenon in the nipples have been reported (see section 4). If you are breastfeeding, consult your doctor before taking Trandate.
Driving ability and use of machinery
Likely, Trandate does not affect the ability to drive and use machines. However, some people may occasionally experience dizziness and/or fatigue. You should be aware that this may affect your ability to react and therefore you should be careful until you get used to your reactions to this medicine.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. A description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with your doctor or pharmacist if you are unsure.
Trandate contains lactose and paraorange
Trandate contains lactose
If you have been told by your doctor that you have difficulty tolerating certain sugars, contact your doctor before taking this medicine.
Trandate contains para orange
Trandate contains the dye para orange (E110) which can cause allergic reactions.
How to take Trandate
Always take this medicine as directed by your doctor or pharmacist. Ask your doctor or pharmacist if you are unsure.
Trandate should be taken with food.
The dose is determined by the doctor who adjusts it individually for you. The usual starting dose is 100 mg twice a day. Usually, doses up to 800 mg per day can keep your blood pressure under control. Up to 2,400 mg (divided into three or four doses ) per day can be given.
If you are older or if have impaired liver function, the doctor may prescribe a lower dose.
If you have taken too much Trandate
Labetalol (Trandate) overdose symptoms include extreme dizziness when changing to an upright position (sitting or standing) and sometimes a low heart rate that you feel as a low pulse. ( bradycardia )
If you have ingested too much medicine or if, for example, a child has ingested the medicine by mistake, contact a doctor or hospital for an assessment of the risk and advice. Take the medication packages to the emergency department.
If you forget to take Trandate
Do not take a double dose to make up for a missed dose. Contact a doctor or pharmacist if you are unsure.
If you have further questions about this medicine, contact your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any of the following side effects, seek emergency medical help:
Very rare: may affect up to 1 in 10,000 users
– systemic lupus erythematosus which causes symptoms including joint pain, fever, rash, and fatigue
– total inability to urinate despite a full bladder (a medical emergency)
– angioedema which can cause symptoms including swollen lips, face, and tongue, which can result in breathing difficulties
Other side effects include:
Very common: may affect more than 1 in 10 users
– antibodies that are not related to disease
Common: may affect up to 1 in 10 users
– heart failure
– elevated liver function tests. These usually go away when the drug is discontinued
– dizziness, headache, and tingling sensation in the scalp, which is usually transient and occurs during the first weeks of treatment
– blurred vision
– difficulty urinating
– dizziness if you move too quickly from a lying to a sitting position, or from a sitting to a standing position, due to low blood pressure (postural hypotension ). More common with very high doses or if the initial dose is too high or if the doses are increased too quickly. This is usually transient and occurs during the first few weeks of treatment
– stuffy nose, which is usually transient and occurs during the first weeks of treatment
– nausea
– erectile dysfunction ( impotence ) and ejaculation problems
– fatigue and lack of energy, which are usually transient and occurs during the first weeks of treatment
– allergic reactions (hypersensitivity) may also include rash (of varying severity), itching, shortness of breath, and, very rarely, fever or rapid swelling of the skin.
Uncommon: may affect up to 1 in 100 users
– depression, which is usually transient and occurs during the first weeks of treatment
– contraction of the lower airways ( bronchospasm )
– vomiting and pain in the abdomen immediately below the ribs
– sweating, which is usually transient and occurs during the first weeks of treatment
– muscle cramp
Rare: may affect up to 1 in 1,000 users
– low heart rate, which can feel like a low pulse ( bradycardia )
Very rare: may affect up to 1 in 10,000 users
– disturbance in the electrical impulses that control the heartbeat (heart block)
– inflammation of the liver ( hepatitis ), which usually goes away when the drug is discontinued
– hepatocellular jaundice (yellowing of the skin and whites of the eyes), cholestatic jaundice (symptoms include tiredness and nausea followed by itching, dark urine, and jaundice and may include rash or fever), and liver necrosis (damaged liver tissue). These symptoms usually go away when the drug is discontinued
– worsening symptoms of Raynaud’s syndrome (cold fingers due to reduced blood circulation)
– swollen ankles. This is usually transient and occurs during the first few weeks of treatment
– muscle inflammation and weakness caused by the drug (toxic myopathy )
– tremors when Trandate is used to treat high blood pressure associated with pregnancy
– eye irritation
Has been reported (may occur in an unknown number of users)
- Pain in the nipples
- Periodic reduction in blood flow to the nipples, can cause the nipples to become numb, pale, and painful (Raynaud’s phenomenon)
How to store Trandate
Store out of sight and reach of children.
Use before the expiry date stated on the can after “Exp.” The expiration date is the last day of the specified month.
Store at a maximum of 30° C.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to deal with medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
- The active substance is labetalol hydrochloride. One tablet contains 100 mg and 200 mg of labetalol hydrochloride respectively.
- Other ingredients are anhydrous lactose 14.6 mg and 29.3 mg respectively per tablet, magnesium stearate, microcrystalline cellulose, sodium benzoate (E 211), hypromellose, titanium dioxide (E 171), and para-orange (E 110).
Appearance and package sizes of the medicine
Trandate 100 mg film-coated tablet is orange, round, beveled, 8 mm, and marked with TT01 on one side. A package consists of a plastic jar containing 100 tablets.
Trandate 200 mg film-coated tablet is orange, round, beveled, 9.5 mm, and debossed with TT02 on one side. A package consists of a plastic jar containing 100 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Aspen Pharma Trading Limited
3016 Lake Drive,
Citywest Business Campus,
Dublin 24, Ireland
Phone: +46 856 642572
Manufacturer:
Aspen Bad Oldesloe GmbH
Industriestr 32-36
D-23843 Bad Oldesloe
Germany