Labetalol Synchrony 5mg/ml solution for injection

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Labetalol Synchrony is and what it is used for

2. What you need to know before you are given Labetalol Synchrony

3. How to use Labetalol Synchrony

4. Possible side effects

5. How to store Labetalol Synchrony

6. Contents of the pack and other information

• you are allergic to labetalol or any of the other ingredients of this medicine (listed in section 6)
• your heart cannot maintain adequate circulation of blood (cardiogenic shock)
• you have heart failure that is out of control or not responding to treatment with digitalis
• you have a heart defect that leads to a decreased function of the heart (heart block)
• your heart has difficulty pumping the proper amount of blood to the body’s tissues
• 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 low blood pressure (hypotension)
• you have a weak heart or a very slow heartbeat (less than 45 or 50 beats per minute)
• you suffer from angina (chest pains) when at rest
• you suffer from wheezing, obstructive airways disease or asthma – taking labetalol can make
• your breathing worse
• you have a tumour near your kidneys (phaeochromocytoma)
• you have increased acid levels in the blood (metabolic acidosis)
• you have very bad circulation, especially in your hands and feet

If any of the above applies to you, talk to your doctor.

Talk to your doctor or nurse before you are treated with Labetalol Synchrony if:

• you are about to receive an anaesthetic: as labetalol may mask the effects of a sudden loss of blood
• you suffer or have suffered from any serious allergic reactions in the past
• you have ever suffered from a skin condition called psoriasis
• you have kidney or liver problems
• you are receiving a procedure called MIBG scintigraphy (often used to detect certain tumours)
• you are elderly (65 years and over)
• you are scheduled for cataract surgery as labetalol may affect your pupils during this procedure. Please tell your eye surgeon before your surgery about your treatment with this medicine. You do not need to stop treatment with this medicine unless your surgeon advises otherwise
• your heart rate slows to less than 50 -55 beats per minute while at rest (bradycardia)
• you have a reduced blood supply to the heart muscle (ischaemic heart disease)
• you have poor circulation e.g. fingers and toes go numb and pale (Raynaud’s syndrome) or you sometimes limp (intermittent claudication)
• you have an irregular heart beat (first degree atrioventricular block)

If treatment with this medicine leads to a slow heartbeat (bradycardia) your doctor may lower your dosage.

If you suffer from skin rash, dry eyes, or an allergic reaction during your treatment with this medicine, please contact your doctor for the dosage to be lowered or the treatment to be discontinued.

Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines.

In particular tell your doctor if you are taking any of the following:

• Medicines used to treat your heart or blood pressure (such as digitalis, clonidine, hydralazine, disopyramide, quinidine, amiodarone, calcium antagonists such as verapamil, alpha blockers such as doxazosin, diltiazem, nifedipine, ACE inhibitors, angiotensin-II antagonists, xamoterol and diuretics (water tablets).
• Medicines to treat depression (such as monoamine oxidase inhibitors or tricyclic antidepressants).
• Anxiolytic and hypnotic medicines for anxiety and sedation
• NSAIDs, corticosteroids or other medicines to treat pain or inflammatory conditions
• Cimetidine used to treat stomach ulcers.
• Medicines for stimulating the heart e.g. adrenaline
• Anaesthetic drugs (such as cyclopropane, trichloroethylene, alcohol, barbiturates)
• Insulin or oral anti-diabetic drugs
• Ergot derivatives used to treat Parkinson’s disease
• Phenothiazines such as chlorpromazine
• Antimalarial medicines such as halofantrine, mefloquine or quinine
• Tropisetron used to treat nausea.
• Alprostadil and moxisylyte to treat impotence
• Aldesleukin for the treatment of secondary cancer of the kidney
• Hormones such as oestrogen and progesterone used as contraceptives or for hormone replacement therapy
• Any other medicine, including medicines obtained without a prescription.

Taking labetalol 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.

This medicine may have a disruptive effect on certain medical or laboratory tests. This may lead to incorrect test results. Tell your doctor and the laboratory staff that you have been given this medicine if you need to have a blood or urine test.

Labetalol should only be used during the first three months of pregnancy if it is absolutely necessary.

If you are pregnant or think you may be pregnant or are planning to have ask your doctor for advice before being treated with this medicine.

Nipple pain and Raynaud's phenomenon of the nipple have been reported (see section 4).

Labetalol is not recommended whilst breast-feeding.

You may feel dizzy or tired when taking labetalol. If this happens to you, do not drive or operate machinery.

This medicinal product contains less than 1mmol (23mg) of sodium (salt) per vial, i.e. essentially sodium (salt) free.

Injection into a vein (to reduce blood pressure very quickly)

• A dose of 50mg of labetalol will be given into your vein over a period of one minute.
• If necessary this dose can be repeated every five minutes up to three times until your blood pressure has been lowered.
• The total dose should not exceed 200mg.

Slow drip into a vein (to reduce blood pressure more slowly)

• A solution containing 1mg/ml Labetalol Synchrony will be made up by the doctor or nurse.
• The solution will then be given to you via a drip into your vein.
• The amount of the solution you will be given will depend on why your blood pressure needs to be lowered:

1. To lower high blood pressure in pregnancy

• 20mg of Labetalol Synchrony will be given over one hour.
• The dose may then be doubled every 30 minutes until your blood pressure has been reduced or the dose has reached 160mg per hour.
• Your doctor may occasionally need to use a higher dose.

2. To lower high blood pressure after a heart attack

• 15mg of Labetalol Synchrony will be given over one hour.
• The dose may then be gradually increased up to a maximum of 120mg per hour if needed.

3. To lower high blood pressure for other reasons

• 2mg of Labetalol Synchrony will be given per minute.
• When your blood pressure is low enough, the doctor will stop your drip.
• Your doctor may change the rate at which the drip goes in depending on how well you are responding to the medicine.
• The total dose given is usually between 50mg and 200mg, but occasionally higher doses may be needed.

To lower blood pressure during an operation

• Whilst you are under anaesthetic, 10-20mg Labetalol Synchrony (depending on your age and health) will be injected into your vein.
• If after five minutes your blood pressure has not been reduced, a dose of 5-10mg can be given every five minutes until your blood pressure is low enough.

Maintaining your blood pressure

• After you have had Labetalol Synchrony, your doctor may suggest you take labetalol tablets to keep your blood pressure low.
• If this applies to you, your doctor or pharmacist will tell you exactly how many tablets to take and when to take them.

If you have problems with your liver or kidneys, your doctor may give you a lower dose of Labetalol Synchrony.

Your doctor may start you on a lower dose than the usual adult dose to make sure that the medicine is working properly.

Labetalol Synchrony is not recommended for use in children.

Symptoms of an overdose of Labetalol Synchrony are, among others, extreme dizziness when you sit up and sometimes a slowing heartbeat, which can be measured by a low pulse (bradycardia).

Remember:

You should avoid sitting upright for three hours after being given Labetalol Synchrony as you may feel very dizzy and lightheaded.

Tell your doctor or nurse immediately if you have an allergic reaction. This includes any of the following symptoms:

• difficulty in breathing
• swelling of your eyelids, face or lips
• rash or itching

Common (may affect up to 1 in 10 people)

• Congestive heart failure
• Dizziness due to low blood pressure when sitting upright or standing up too quickly (postural hypotension). This can happen within the first three hours after this medicine has been given, and is short-lasting in nature. This will occur in the first weeks of treatment.
• Nasal congestion, this is usually short-lived and will occur in the first weeks of treatment
• Increased liver function. This will usually be short-lived after treatment has stopped.
• Erectile dysfunction (impotency).

Rare (may affect up to 1 in 1,000 people)

• Slow heart beat which can be measured by a low pulse (bradycardia).
• Constriction of the muscles in the walls of the bronchioles causing breathlessness (bronchospasm).

Very rare (may affect up to 1 in 10,000 people)

• Blocking of the electrical signals controlling the heart rhythm (heart block)
• Worsening of blood circulation leading to nipple pain, cold or blue extremities with numbness or tingling in your fingers and toes
• Inflammation of the liver (hepatitis), usually short-lived when the treatment is discontinued.
• Hepatocellular jaundice (skin and whites of the eyes become yellow), cholestatic jaundice (symptoms include tiredness and nausea followed by itchiness, dark urine, and jaundice, and also skin rash and fever) and liver necrosis (damaged liver tissue). These symptoms will disappear after the treatment with this medicine has stopped.

Not known (cannot be estimated from the available data)

• Nipple pain
• Intermittent decrease in blood flow to your nipples, which may cause your nipples to go numb, pale, and painful (Raynaud's phenomenon)

Most of the side effects related to Labetalol Synchrony will wear off after the first few weeks.

These include:

• headaches, tiredness or dizziness
• depression or exhaustion (lethargy)
• tingling of the scalp
• swollen ankles or sweating
• difficulty passing urine or not being able to pass urine
• stomach pain, feeling sick or being sick
• the shakes after taking labetalol when pregnant
• low blood pressure (hypotension)
• increase of existing leg pain on walking
• mental disturbances such as delusions and altered thought patterns, hallucinations or confusion
• sleep disturbances including nightmares
• diarrhoea
• 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 hidden
• high blood potassium levels (hyperkalaemia) especially if you have reduced kidney function
• hair loss; this may grow back after stopping treatment
• worsening of psoriasis

• 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 sun exposure
• 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
• cramps
• cough or breathing problems that may indicate inflammation of the lungs (interstitial lung disease)

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 after birth:

• low blood pressure
• slow heartbeat
• shallow or slow breathing
• low blood sugar
• feeling cold

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.

You can also report side effects directly via the Yellow Card Scheme, at www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information the safety of this medicine.

• The active ingredient is labetalol hydrochloride.
• The other ingredients are dilute hydrochloric acid (E507), sodium hydroxide (E524) for pH adjustment, and water for injections.

Labetalol is a clear colourless solution.

Labetalol comes in 10ml amber glass ampoules with a white break ring, with ten ampoules in each pack.