Pharmacy Guide

Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.

Pharmacy Guide

Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.

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Labetalol 100 mg Film-coated Tablets

Active substance: Labetalol hydrochlorideRx — prescription only

Equivalent medicines (same active substance, strength and form)

Source: electronic medicines compendium (emc)
Official leaflet: Read the PIL on emc

Contents of the pack and other information

• You have a skin disease which causes scaly pink patches (psoriasis) • You have any allergies • You are due to have an anaesthetic or cataract surgery (see 'Having an anaesthetic or cataract surgery' section) Other medicines and Labetalol Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those obtained without prescription. This includes herbal medicines. Medicines which should not be taken with Labetalol: • Calcium channel blockers for high blood pressure or chest pain (angina), such as verapamil and, to a lesser extent, diltiazem • Medicines for heart failure or irregular heartbeat, such as digoxin (digitalis glycosides) • Medicines for depression, such as moclobemide (Monoamine Oxidase Inhibitors − MAOIs) • Clonidine, used to treat high blood pressure and migraine. Labetalol should be stopped several days before you stop taking Clonidine. Other medicines which may interact with or be affected by Labetalol: • Medicines for irregular heartbeat, such as disopyramide, quinidine and amiodarone (class I antiarrhythmics) • Medicines for diabetes, such as metformin and insulin. Labetalol may increase the effects of low levels of sugar in your blood (hypoglycaemia) and hide the warning signs such as shaking (tremors) and faster heartbeat (tachycardia) • Cimetidine, for stomach ulcers and indigestion • Hydralazine, for high blood pressure • The following groups of medicines may increase the blood pressure lowering effect of Labetalol: o ACE inhibitors, angiotensin-II antagonists and alpha blockers, used to treat high blood pressure o Aldesleukin, used to treat some cancers o Alprostadil, used to treat sexual disorders such as impotence o Medicines used to treat anxiety e.g. diazepam (anxiolytics) o Medicines used to treat sleep problems e.g. zolpidem (hypnotics) o Moxisylyte, used to treat poor circulation o Medicines used to increase frequency of urination e.g. furosemide (diuretics) • The following groups of medicines may decrease the blood pressure lowering effect of Labetalol: o Non-Steroidal Anti-Inflammatory Drugs (NSAIDS), and corticosteroids, used to treat pain and inflammation such as ibuprofen o Hormones such as oestrogen and progesterone, used as contraceptives or Hormone Replacement Therapy (HRT) • Other medicines for high blood pressure or chest pains (angina), including calcium antagonists, such as nifedipine • Medicines for reducing inflammation, relieving pain, swelling and stiffness in the joints and muscles, such as indomethacin (prostaglandin synthetase inhibitors) • Medicines used to treat severe allergic reactions such as adrenaline (sympathomimetics) • The following groups of medicines may increase the frequency of shaking (tremor) and the blood pressure lowering effect of Labetalol: o Tricyclic antidepressants for depression, such as amitriptyline o Barbiturates for epilepsy, sleeping disorders and Parkinson's disease such as phenobarbital o Phenothiazines for anxiety, mental disorders, feeling and/or being sick (nausea, vomiting) such as trifluoperazine o Other medicines used to treat high blood pressure (antihypertensives) • Anti-malarial medicines such as mefloquine or quinine • Medicines used to treat migraine such as ergotamine Having an anaesthetic or cataract surgery You must tell the medical staff that you are taking Labetalol if you are going to have surgery under anaesthetic or cataract surgery. Anaesthetics may interfere with this medicine, in particular anaesthetics such as cyclopropane, trichloroethylene.

Having a laboratory test This medicine is known to interfere with the results of catecholamine testing and MIBG scans (tests for diagnosing a tumour in the adrenal glands). Taking Labetalol with food and drink and alcohol • These tablets should be taken with food • It is recommended that you do not drink alcohol whilst being treated with Labetalol. Pregnancy and breast−feeding If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. Pregnancy This medicine should not be taken during the first 3 months of pregnancy (first trimester) unless your doctor thinks the benefits outweigh the risks. Breast-feeding If you are breast−feeding, you should not take Labetalol as it passes into breast milk. Nipple pain and Raynaud's phenomenon of the nipple have been reported (see section 4). Driving and using machines Labetalol may make you feel tired or dizzy. If this happens, do not drive or operate machinery. Labetalol contains lactose If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicine. Labetalol contains the colouring agent sunset yellow FCF (E110) It may cause allergic reactions. 3 How to take Labetalol Always take Labetalol exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. • These tablets are to be taken orally. • These tablets should be taken with food. High blood pressure with or without chest pain (angina) • The usual starting dose is 100mg twice daily. • Your doctor may increase this dose by 100mg twice daily every 14 days. • For severely high blood pressure, a daily dose of 2400mg may be prescribed, to be taken in three or four divided doses. High blood pressure in pregnancy • The usual starting dose is 100mg twice daily. • This may be increased each week by 100mg twice daily. • During the second and third trimesters (months 4 − 9), the dose may be increased further ranging from 100mg-400mg three times daily. • The maximum dose is 2400mg daily, to be taken in three or four divided doses. • If admitted to hospital, the dose may be increased daily, if required. General • If a rapid reduction in blood pressure is required, you may be given Labetalol by injection. Elderly The usual starting dose is 50mg twice a day. Use in children Children should not take Labetalol.

If you take more Labetalol than you should If you accidentally take too many tablets, contact your doctor or nearest hospital emergency department immediately for advice. Remember to take this leaflet or any remaining tablets with you, Symptoms of overdose include: low blood pressure (hypotension), slower heartbeat (bradycardia), difficulty in breathing or wheezing (bronchospasm) and sudden heart failure (acute cardiac insufficiency) If you forget to take your Labetalol Take it as soon as you remember, unless it is nearly time for your next dose. If you miss a dose, do not take a double dose to make up for a forgotten dose. If you stop taking Labetalol It is important that you keep taking Labetalol for as long as your doctor has told you to. Your doctor will gradually reduce your dose before you stop taking this medicine. If you do not gradually reduce your dose you may develop high blood pressure and an irregular heartbeat If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 4 Possible side effects Like all medicines, Labetalol can cause side effects, although not everybody gets them. Seek medical advice immediately if you develop the following symptoms: • Allergic reactions: swelling of the face, throat or tongue, difficulty breathing or dizziness • Difficulty breathing (if you have asthma or a history of asthma) • Hypersensitivity (rash, severe itching [pruritus], swelling of the deeper layers of the skin caused by a build-up of fluid [angioedema], shortness of breath or difficulty in breathing [dyspnoea]) Side effects • Headache • A lack of energy (lethargy) • Tiredness • Depression • Dizziness • Blocked nose • Sweating • Tingling scalp • Swollen ankles • Slower heartbeat (bradycardia) • Positive autoimmune blood tests • Irregular or slower heartbeat than normal (heart block) • Long-term inflammation of skin and/or intestines (Systemic Lupus Erythematosus [SLE]) • Liver failure or damage (hepatic necrosis) • Increase in liver enzymes (detected through blood test) • Yellowing of the skin or whites of the eyes (jaundice) • Inflammation of the liver (hepatitis) • Medicine-induced fever • Pain or weakness in the muscles (toxic myopathy) • Feeling (nausea) or being sick (vomiting) • Stomach pain • Poor vision • Dry eyes • Confusion • Sleep disturbances • Nightmares • Diarrhoea • Feeling light−headed and dizzy when you get up from sitting or lying down (postural hypotension) (usually due to the initial dose being too high or increases in doses being too rapid)

• Unable or difficult to urinate • Shaking (tremor) during pregnancy • Difficulty for men to ejaculate • Heart failure • Poor blood circulation leading to nipple pain, cold or blue extremities with numbness or tingling in your finger and toes • Seeing or hearing things that are not real (hallucinations) • Mental illness (psychoses) • Hiding the symptoms of high levels of thyroid hormones in the blood (thyrotoxicosis) • Hiding the symptoms of low blood sugar levels (hypoglycaemia) • Increase of existing cramping pain in the calf, thigh or buttocks (intermittent claudication) • Abnormally high levels of potassium in blood (hyperkalaemia) • A reduction in blood platelets, which increases risk of bleeding or bruising (thrombocytopenia) • Low blood pressure (hypotension) • Inflammation of the lungs (interstitial lung disease) • (Reversible) non-infectious, itchy rash that can affect many areas of the body (lichenoid rash) • Worsening of psoriasis (skin disease causing scaly pink patches) • Cramps • (Reversible) hair loss (alopecia) 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) 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 at 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 Labetalol • Keep this medicine out of the sight and reach of children. • Do not use Labetalol after the expiry date, which is stated on the carton after EXP. The expiry date refers to the last day of that month. • Store in the original package in order to protect from moisture. • Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment. 6 Contents of the pack and other information What Labetalol contains: • Each 100mg tablet contains Labetalol Hydrochloride 100mg • Each 200mg tablet contains Labetalol Hydrochloride 200mg The other ingredients are: lactose, starch, povidone, isopropanol, sodium starch glycollate, magnesium stearate. Coating: hydroxypropyl methylcellulose, sunset yellow (E110), triacetin, water, IMS. What Labetalol looks like and content of the pack: • Labetalol 100mg are orange, round, biconvex, film-coated tablets coded 'LTL 100' on one side • Labetalol 200mg are orange, round, biconvex, film-coated tablets coded 'LTL 200' on one side Labetalol is available in: Labetalol Tablets are available in containers or blister packs of 7, 14, 21, 28, 30, 50, 56, 60, 84, 90, 100, 112, 120, 250, 500 or 1000 tablets Not all pack sizes or pack types may be marketed.

Product Licence Numbers: • Labetalol 100mg Tablets: PL 11311/0375 • Labetalol 200mg Tablets: PL 11311/0376 Marketing Authorisation Holder: Tillomed Laboratories Ltd 220 Butterfield Great Marlings Luton LU2 8DL UK Manufacturer Kleva Pharmaceuticals S.A 189 Parnithos Ave 13675 Acharnai-Attiki Greece This leaflet was last revised in January 2022 Till Ver.12

Frequently asked questions about Labetalol 100 mg Film-coated Tablets

How do I take Labetalol 100 mg Film-coated Tablets?

Labetalol 100 mg Film-coated Tablets comes as tablet containing 100mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.

What is the active substance in Labetalol 100 mg Film-coated Tablets?

The active substance in Labetalol 100 mg Film-coated Tablets is labetalol hydrochloride.

Are there equivalent medicines to Labetalol 100 mg Film-coated Tablets?

Medicines with the same active substance, strength and form include: Trandate 100 mg film-coated tablets, Labetalol 100 mg Film-coated Tablets. They are interchangeable only if your prescriber or pharmacist says so.

Where does this information come from?

This leaflet reproduces the patient information leaflet approved for Labetalol 100 mg Film-coated Tablets, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.

Can I get Labetalol 100 mg Film-coated Tablets without a prescription?

Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.

About this leaflet

The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.

Medical disclaimer: This page is for information only and does not replace advice from your doctor or pharmacist. Always read the leaflet supplied with your medicine. If you are unwell, call NHS 111; in an emergency, call 999.

Medicines with the same active substance: Labetalol hydrochloride (13 medicines)
See every medicine containing this substance, or browse the full A–Z of active substances.
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
Technical information intended for healthcare professionals (doctors and pharmacists). The Summary of Product Characteristics (SmPC) is the official document approved by the MHRA/EMA. It does not replace the patient leaflet or a doctor’s advice.

4.1. Therapeutic indications

Labetalol Tablets are indicated for the treatment of:

• Mild, moderate and severe hypertension

• Hypertension in pregnancy

• Angina pectoris with existing hypertension

4.2. Posology and method of administration

Adults

Hypertension

Treatment should start with 100mg twice daily. In patients already being treated with antihypertensives and in those of low body weight this may be sufficient to control blood pressure. In others, increases in dose of 100mg twice daily should be made at fortnightly intervals. Many patients' blood pressure is controlled by 200mg twice daily and up to 800mg daily may be given as a twice daily regimen. In severe, refractory hypertension, daily doses up to 2400mg have been given. Such doses should be divided in to a three or four times a day regimen.

Elderly

In elderly patients, an initial dose of 50mg twice daily is recommended. This has provided satisfactory control in some cases.

In the hypertension of pregnancy

The initial dose of 100mg twice daily may be increased, if necessary, at weekly intervals by 100mg twice daily. During the second and third trimester, the severity of the hypertension may require further dose titration to a three times daily regimen, ranging from 100mg to 400mg three times a day. A total daily dose of 2400mg should not be exceeded. Hospital in-patients with severe hypertension, particularly of pregnancy, may have daily increases in dosage.

General

If rapid reduction of blood pressure is necessary, labetalol injection should be used. If long-term control of hypertension following the use of labetalol injection is required, oral therapy with labetalol tablets should start with 100mg twice daily.

Additive hypotensive effects may be expected if labetalol tablets are administered together with other antihypertensives e.g. diuretics, methyldopa etc. where the hypotensive effects will be additive. When transferring patients from such agents, labetalol tablets should be introduced with a dosage of 100mg twice daily and the previous therapy gradually decreased. Abrupt withdrawal of clonidine or beta-blocking agents is undesirable.

Angina co-existing with hypertension

In patients with angina pectoris co-existing with hypertension, the dose of labetalol will be that required to control the hypertension.

Paediatric population

The safety and efficacy of labetalol in children has not been established.

Method of administration

Labetalol tablets should be taken orally with food.

4.3. Contraindications

• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

• Hypotension.

• Cardiogenic shock.

• Bradycardia of less than 45-50 beats per minute.

• Second or third degree heart block.

• Uncontrolled, incipient or digitalis-refractory heart failure.

• History of wheezing or asthma.

• Prinzmetal's angina.

• Severe peripheral circulatory disturbances.

• Sick sinus syndrome (including sino-atrial block).

• Untreated phaeochromocytoma.

• Metabolic acidosis.

4.4. Special warnings and precautions for use

There have been reports of skin rashes and/or dry eyes associated with the use of beta-adrenoceptor blocking drugs. The reported incidence is small and in most cases the symptoms have cleared when the treatment was withdrawn. Gradual discontinuance of the drug should be considered if any reaction is not otherwise explicable.

The occurrence of intraoperative floppy iris syndrome (IFIS, a variation of Horner's syndrome) has been observed during cataract surgeries in some patients who were being treated with tamsulosine, or have been treated with tamsulosine in the past. IFIS has also been reported when other alpha-1-blockers were being used, and the possibility of a class effect cannot be excluded. Since IFIS can lead to a higher chance of complications during cataract surgeries, the ophthalmologist needs to be informed if alpha-1-blockers are currently being used, or have been used in the past.

There have been rare reports of severe hepatocellular injury with labetalol therapy. The hepatic injury is usually reversible and has occurred after both short and long-term treatment. Appropriate laboratory testing should be performed at the first sign or symptom of liver dysfunction. If there is laboratory evidence of liver injury or the patient is jaundiced, labetalol therapy should be stopped and not restarted.

Due to negative inotropic effects, special care should be taken with patients whose cardiac reserve is poor and heart failure should be controlled before treatment is initiated.

Patients, particularly those with ischaemic heart disease, should not interrupt/discontinue abruptly labetalol therapy. The dosage should be gradually reduced, i.e. over 1-2 weeks, if necessary at the same time initiating replacement therapy, to prevent exacerbation of angina pectoris. In addition, hypertension and arrhythmias may develop.

It is not necessary to discontinue labetalol therapy in patients requiring anaesthesia but the anaesthetist must be informed and patient should be given intravenous atropine prior to induction. During anaesthesia labetalol may mask the compensatory physiological responses to sudden haemorrhage (tachycardia and vasoconstriction). Close attention must therefore be paid to blood loss and the blood volume maintained. If beta-blockade is interrupted in preparation for surgery, therapy should be discontinued for at least 24 hours pre-op. Anaesthetic agents causing myocardial depression (e.g. cyclopropane, trichloroethylene) should be avoided. Labetalol may enhance the hypotensive effects of halothane.

In patients with peripheral circulatory disorders (Raynaud's disease or syndrome, intermittent claudication), beta-blockers should be used with great caution as aggravation of these disorders may occur.

Beta-blockers may induce bradycardia. If the pulse rate decreases to less than 50-55 beats per minute at rest and the patient experiences symptoms related to bradycardia, the dosage should be reduced.

Beta-blockers, even those with apparent cardioselectivity, should not be used in patients with asthma or a history of obstructive airways disease unless no alternative treatment is available. In such cases the risk of inducing bronchospasm should be appreciated and appropriate precautions taken. If bronchospasm should occur after the use of labetalol it can be treated with a beta2-agonist by inhalation, e.g. salbutamol (the dose of which may need to be greater than the usual in asthma) and if necessary, intravenous atropine 1mg.

Due to a negative effect on conduction time, beta-blockers should only be given with caution to patients with first degree heart block. Patients with liver or kidney insufficiency may need a lower dosage, depending on the pharmacokinetic profile of the compound. The elderly should be treated with caution, starting with a lower dosage but tolerance is usually good in the elderly.

Patients with a history of psoriasis should take beta-blockers only after careful consideration.

Risk of anaphylactic reaction: while taking beta-blockers, patients with a history of severe anaphylactic reaction to a variety of allergens may be more reactive to repeated challenge, either accidental, diagnostic or therapeutic. Such patients may be unresponsive to the usual doses of epinephrine used to treat allergic reaction. (see section 4.5).

The label will carry the following warning: 'Important warning: Do not take this medicine if you have a history of wheezing or asthma as it can make your breathing worse'.

The tablets contain lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

4.5. Interaction with other medicinal products and other forms of interaction

Concomitant use not recommended

Calcium antagonists such as verapamil and to a lesser extent diltiazem have a negative influence on contractility and atrio-ventricular conduction.

Digitalis glycosides used in association with beta-blockers may increase atrio-ventricular conduction time.

Clonidine

Beta-blockers increase the risk of rebound hypertension. When clonidine is used in conjunction with non-selective beta-blockers, such as propranolol, treatment with clonidine should be continued for some time after treatment with the beta-blocker has been discontinued.

Monoamine oxidase Inhibitors (except MOA-B inhibitors).

Use with caution

Class I antiarrhythmic agents (e.g. disopyramide, quinidine) and amiodarone may have potentiating effects on atrial conduction time and induce negative inotropic effect.

Anaesthetic drugs may cause attenuation of reflex tachycardia and increase the risk of hypotension. Continuation of beta-blockade reduces the risk of arrhythmia during induction and intubation. The anaesthesiologist should be informed when the patient is receiving a beta-blocking agent.

Anaesthetic agents causing myocardial depression, such as cyclopropane and trichlorethylene are best avoided.

Insulin and oral antidiabetic drugs may intensify the blood sugar lowering effect, especially of non-selective beta-blockers. Beta-blockade may prevent the appearance of signs of hypoglycaemia (tachycardia).

Cimetidine, hydralazine and alcohol may increase the plasma concentration of labetalol.

Other drugs/drug classes

Several different drugs or drug classes may enhance the hypotensive effects of labetalol: ACE inhibitors; angiotensin-II antagonists; aldesleukin, alprostadil; anxiolytics; hypnotics; moxisylyte; diuretics; alpha-blockers.

Several different drugs or drug classes may antagonise the hypotensive effects of labetalol: NSAIDs, corticosteroids; oestrogens; progesterones.

Take into account

Calcium antagonists, dihydropyridine derivates such as nifedipine. The risk of hypotension may be increased. In patients with latent cardiac insufficiency, treatment with beta-blockers may lead to cardiac failure.

Prostaglandin synthetase inhibiting drugs may decrease the hypotensive effects of beta-blockers.

Sympathomimetic agents may counteract the effect of beta-adrenergic blocking agents.

Concomitant use of tricyclic antidepressants, barbiturates, phenothiazines or other antihypertensive agents may increase the blood pressure lowering effect of labetalol. Concomitant use of tricyclic antidepressants may increase the incidence of tremor.

Labetalol has been shown to reduce the uptake of radioisotopes of metaiodobenzylguanidine (MIBG), and may increase the likelihood of a false negative study. Care should therefore be taken in interpreting results from MIBG scintigraphy. Consideration should be given to withdrawing labetalol for several days at least before MIBG scintigraphy, and substituting other beta or alpha-blocking drugs.

Antimalarials such as mefloquine or quinine may increase the risk of bradycardia.

Ergot derivatives may increase the risk of peripheral vasoconstriction.

4.6. Pregnancy and lactation

Pregnancy

Although no teratogenic effects have been demonstrated in animals, labetalol should only be used during the first trimester of pregnancy if the potential benefit outweighs the potential risk. Labetalol crosses the placental barrier and the possible consequences of alpha- and beta- adrenoceptor blockade in the foetus and neonate should be borne in mind. Perinatal and neonatal distress (bradycardia, hypotension, respiratory depression, hypoglycaemia, hypothermia) has been rarely reported. Sometimes these symptoms have developed a day or two after birth. Response to supportive measures (e.g. intravenous fluids and glucose) is usually prompt but with severe pre-eclampsia, particularly after prolonged intravenous labetalol, recovery may be slower. This may be related to diminished liver metabolism in premature babies.

Beta-blockers reduce placental perfusion, which may result in intrauterine foetal death, immature and premature deliveries. There is an increased risk of cardiac and pulmonary complications in the neonate in the post-natal period.

Intra-uterine and neonatal deaths have been reported with labetalol but other drugs (e.g. vasodilators, respiratory depressants) and the effects of pre-eclampsia, intra-uterine growth retardation and prematurity were implicated.

Such clinical experience warns against unduly prolonging high dose labetalol and delaying delivery and against co-administration of hydralazine.

Breast-feeding

Labetalol is excreted in breast milk. Breast feeding is therefore not recommended.

Nipple pain and Raynaud's phenomenon of the nipple have been reported (see section 4.8).

4.7. Effects on ability to drive and use machines

There are no studies on the effect of this medicine on the ability to drive.

When driving vehicles or operating machines it should be taken into account that occasionally dizziness or fatigue may occur.

4.8. Undesirable effects

Most side-effects are transient and resolve within the first few weeks of treatment with labetalol.

They include:

Blood and the lymphatic system disorders

Rare reports of positive antinuclear antibodies unassociated with disease, hyperkalaemia, particularly in patients who may have impaired renal excretion of potassium, thrombocytopenia.

Psychiatric disorders

Depressed mood and lethargy, hallucinations, psychoses, confusion, sleep disturbances, nightmares.

Nervous system disorders

Headache, tiredness, dizziness, tremor has been reported in the treatment of hypertension during pregnancy.

Eye disorders

Impaired vision, dry eyes

Cardiac disorders

Bradycardia, heart block, heart failure, hypotension.

Vascular disorders

Ankle oedema, increase of an existing intermittent claudication, postural hypotension, cold or cyanotic extremities, Raynaud's phenomenon, paraesthesia of the extremities.

Respiratory, thoracic and mediastinal disorders

Bronchospasm (in patients with asthma or a history of asthma), nasal congestion, interstitial lung disease.

Gastrointestinal disorders

Epigastric pain, nausea, vomiting, diarrhoea.

Hepato-biliary disorders

Raised liver function tests, jaundice (both hepatocellular and cholestatic), hepatitis, hepatic necrosis.

Skin and subcutaneous tissue disorders

Sweating, tingling sensation in the scalp, usually transient, may occur in a few patients early in treatment, reversible lichenoid rash, systematic lupus erythematosus, exacerbation of psoriasis.

Musculoskeletal, connective tissue and bone disorders

Cramps, toxic myopathy.

Renal and urinary disorders

Acute urinary retention, difficulty in micturition.

Reproductive system and breast disorders

Ejaculatory failure

Frequency 'not known': Nipple pain, Raynaud's phenomenon of the nipple

General disorders and administration site conditions

Hypersensitivity (rash, pruritis, angioedema, dyspnoea), drug fever, masking of the symptoms of thyrotoxicosis or hypoglycaemia, reversible alopecia.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

4.9. Overdose

Symptoms of overdosage are hypotension, bradycardia, bronchospasm and acute cardiac insufficiency.

After ingestion of an overdose or in case of hypersensitivity, the patient should be kept under close supervision and be treated in an intensive-care ward.

Absorption of any drug material still present in the gastro-intestinal tract can be prevented by gastric lavage, administration of activated charcoal and a laxative. Artificial respiration may be required. Bradycardia or extensive vagal reactions should be treated by administering atropine or methylatropine.

Hypotension and shock should be treated with plasma/plasma substitutes and, if necessary, catecholamines. The beta-blocking effect can be counteracted by slow intravenous administration of isoprenaline hydrochloride, starting with a dose of approximately 5mcg/min, or dobutamine, starting with a dose of approximately 2.5mcg/min, until the required effect has been obtained. If this does not produce the desired effect, intravenous administration of 8-10mg glucagon may be considered. If required the injection should be repeated within one hour, to be followed, if necessary, by an i.v. infusion of glucagon at an administration rate of 1-3mg/hour. Administration of calcium ions, or the use of a cardiac pacemaker may also be considered.

Oliguric renal failure has been reported after massive overdosage of labetalol orally. In one case, the use of dopamine to increase the blood pressure may have aggravated the renal failure.

Labetalol does have membrane stabilising activity which may have clinical significance in overdosage.

Haemodialysis removes less than 1% labetalol hydrochloride from the circulation.

💬 Ask about this leaflet

Ask anything about Labetalol 100 mg Film-coated Tablets. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.

Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.

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