TRANDATE 100 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Trandate 100 mg Film-Coated Tablets

Labetalol Hydrochloride

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet.

Contents of the Package Leaflet:

1. What is Trandate and what is it used for
2. What you need to know before you take Trandate
3. How to take Trandate
4. Possible side effects
5. Storage of Trandate
6. Contents of the pack and other information

1. What is Trandate and what is it used for

Trandate belongs to a group of medicines called alpha- and beta-blockers.

Trandate is indicated for the treatment of:

• Hypertension (high blood pressure)
• Hypertension in pregnancy
• Angina pectoris (chest pain) with coexisting hypertension.

Trandate does not have a harmful effect on kidney function and is particularly suitable for use in hypertensive patients with kidney dysfunction.

2. What you need to know before you take Trandate

Do not take Trandate

• If you are allergic to labetalol hydrochloride or any other component of Trandate.
• If you have second- or third-degree atrioventricular block (cardiac block).
• In case of cardiogenic shock (heart failure).
• In case of prolonged and severe hypotension (low blood pressure).
• If you have severe bradycardia (slow heart rate).
• If you have asthma or respiratory tract obstruction.

Be cautious with Trandate

Special care should be taken in patients with poor cardiac reserve (the heart's ability to function above its normal level) and heart failure. These cases should be controlled with a cardiac glycoside (a medicine to control heart rate) and a diuretic (a medicine to increase fluid elimination) before starting therapy with Trandate.

It is not necessary to discontinue treatment with Trandate tablets before anesthesia, although patients should receive atropine intravenously before induction.

Patients, especially those with ischemic heart disease, should not interrupt or abruptly discontinue therapy with Trandate.

Risk of anaphylactic reaction: Patients with a history of severe anaphylactic reaction to any variety of allergens, who are taking beta-blockers, may be more sensitive to repeated exposure, either accidental, diagnostic, or therapeutic. These patients may not respond to the usual doses of adrenaline used to treat allergic reactions.

Use of other medicines

Tell your doctor or pharmacist if you are using, or have recently used, any other medicines, including those obtained without a prescription, as it may be necessary to discontinue treatment or adjust the dose of one of them.

Be cautious when administering Trandate simultaneously with the following medicines:

Tricyclic antidepressants, as they may increase the incidence of tremors.

Cimetidine, as it may increase the bioavailability of labetalol, and caution should be exercised with the oral dosage of the same.

Class I antiarrhythmic agents or calcium antagonists of the verapamil type.

Trandate may potentiate the hypotensive effects of halothane.

Trandate produces fluorescence in alkaline solution, which may interfere with the evaluation of certain fluorescent substances, including catecholamines.

Use of Trandate with food and beverages

Trandate tablets should be taken with food.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

Pregnancy

Trandate should only be used in the first trimester of pregnancy if the potential benefit outweighs the potential risk.

Breastfeeding

Trandate is excreted in breast milk, although no adverse effects have been reported in breastfed infants. Cases of pain and Raynaud's phenomenon in the nipples have been reported (see section 4).

Use in children

The safety and efficacy of this medicine have not been established in children.

Use in athletes

Athletes are informed that this medicine contains a component that may result in a positive analytical result in doping control.

Driving and using machines

No effects on the ability to drive or use machines have been reported due to the use of this medicine.

Important information about some of the components of Trandate

This medicine contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

This medicine may cause allergic reactions because it contains orange yellow (E-110). It can cause asthma, especially in patients allergic to acetylsalicylic acid.

3. How to take Trandate

Follow the administration instructions of Trandate indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

Remember to take your medicine.

If you think the action of Trandate is too strong or too weak, tell your doctor or pharmacist.

Administration will be oral. The tablets should be taken with a sufficient amount of liquid (a glass of water).

Your doctor will indicate the duration of treatment with Trandate.

Hypertension

Treatment should be started with a dose of 100 mg twice a day. If necessary, this dose can be progressively increased by 100 mg, twice a day, every 2-14 days. The blood pressure of many patients is controlled with 200 mg twice a day, and up to 400 mg twice a day may be given. The total daily dose should not exceed 800 mg.

Elderly patients

An initial dose of 50 mg twice a day is recommended. Lower maintenance doses than those required for younger patients may satisfactorily control blood pressure.

Hypertension in pregnancy

If necessary, the initial dose of 100 mg twice a day may be increased at weekly intervals.

The severity of hypertension may require a regimen of three times a day. The total daily dose should not exceed 800 mg.

Coexisting hypertension with angina

The dose of Trandate will be that required to control hypertension. The total daily dose should not exceed 800 mg.

For long-term control of hypertension after the use of Trandate injectable, oral therapy with Trandate tablets should be started with 100 mg twice a day.

Additive hypotensive effects may occur if Trandate tablets are administered with other antihypertensives, e.g., diuretics, methyldopa, etc. In patients who are being treated with such drugs and are to be replaced by Trandate tablets, treatment should be started with a dose of 100 mg twice a day, gradually reducing the previous therapy. Abrupt withdrawal of clonidine or beta-blockers is not recommended.

If you take more Trandate than you should

If you have taken more Trandate than you should, consult your doctor or pharmacist immediately, or the Toxicology Information Service. Telephone: 91 562 04 20. It is recommended to take the package and leaflet of the medicine to the healthcare professional.

Deep cardiovascular effects such as excessive postural hypotension and, sometimes, bradycardia are expected. Patients should remain lying down in a supine position with their legs raised. Gastric lavage or induction of vomiting is justified within the first few hours of ingestion; a cardiac glycoside and a diuretic should be used in case of heart failure; in case of bronchospasm, a beta-2 agonist should be administered by inhalation, e.g., salbutamol (a higher dose than usual in asthma may be required), and, if necessary, atropine, 1 mg, intravenously.

To improve circulation, an initial dose of 5 to 10 mcg of noradrenaline should be administered intravenously, preferably to isoprenaline, repeated as necessary. Alternatively, noradrenaline can be infused at a rate of 5 mcg per minute until a satisfactory response is achieved.

In severe overdose, glucagon should be administered intravenously, preferably. An initial dose of 5 to 10 mg in glucose or saline should be administered, followed by an intravenous infusion of 5 mg/hour or as needed to maintain cardiac output.

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

Hemodialysis removes less than 1% of labetalol hydrochloride from the circulation.

If you forget to take Trandate

Do not take a double dose to make up for forgotten doses. Take a new dose as soon as possible.

Then continue treatment as indicated by your doctor.

If you stop taking Trandate

Do not stop treatment before it is indicated, especially if you have ischemic heart disease (lack of oxygen in the heart cells).

If you have any other questions about the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Trandate can cause side effects, although not everybody gets them.

Most side effects are transient and occur during the first few weeks of treatment. They include headache, fatigue, dizziness, depression, and lethargy, nasal congestion, sweating, and rarely, ankle edema.

Postural hypotension is rare except at very high doses or if the dose is increased too rapidly.

At the beginning of treatment, some patients may experience a sensation of tingling in the scalp, usually transient.

Tremors have been described in the treatment of hypertension in pregnancy. Acute urinary retention, difficulty in urination, ejaculatory failure, epigastric pain, nausea, and vomiting have also been described.

Rarely, positive antinuclear antibodies not associated with the disease, as well as rare cases of systemic lupus erythematosus, and very rarely, drug fever, have been described.

Very rare cases of toxic myopathy have been described.

Among the rare cases of hypersensitivity: rash, pruritus, angioedema, and dyspnea.

A reversible lichenoid eruption has rarely occurred.

Rare cases of elevated liver function tests, jaundice (both hepatocellular and cholestatic), and hepatitis and liver necrosis have been reported. These signs and symptoms are usually reversible when treatment is discontinued.

Blurred vision, eye irritation, and cramps have been described, although they were not necessarily associated with Trandate.

Some cases of bradycardia and cardiac block have been described.

With an unknown frequency (cannot be estimated from the available data), pain in the nipples has been described: intermittent decrease in blood flow to the nipples, which can cause numbness, paleness, and pain in the nipples (Raynaud's phenomenon).

Skin rashes and/or dry eyes associated with the use of beta-adrenergic blocking agents have been described. The incidence is small, and in most cases, the symptoms disappeared when treatment was discontinued. A gradual withdrawal of the drug should be considered if such a reaction is not otherwise explainable.

Rare cases of severe hepatocellular injury, usually reversible, have been described during short- and long-term therapy with labetalol. The necessary analytical tests should be performed at the first sign or symptom of liver dysfunction. If there is analytical evidence of liver damage or if the patient is jaundiced, labetalol should be definitively discontinued.

If bronchospasm occurs after the use of Trandate, it should be treated by inhalation of a beta-2 agonist, e.g., salbutamol (a higher dose than usual in asthma may be required), and, if necessary, atropine, 1 mg, intravenously.

If you think any of the side effects you are experiencing is serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.

5. Storage of Trandate

Keep out of the reach and sight of children.

Do not store above 25°C.

Do not use Trandate after the expiry date indicated on the package after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the package and any unused medicines in the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of the package and any unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Trandate

• The active ingredient is labetalol hydrochloride. Each tablet contains 100 mg of labetalol hydrochloride.
• The other components (excipients) are: lactose, microcrystalline cellulose, magnesium stearate, hypromellose, sodium benzoate (E211), titanium dioxide (E171), and orange yellow (E110).

Appearance of the product and contents of the pack

Orange, circular, film-coated tablets.

Package containing 30 tablets.

Other presentations

Trandate 200 mg tablets: Package with 30 tablets.

Trandate 5 mg/ml solution for injection: Package with 5 ampoules of 20 ml.

Marketing authorization holder and manufacturer

Kern Pharma, S.L.

Polígono Ind. Colón II

Venus, 72

08228 Terrassa (Barcelona)

Date of the last revision of this leaflet: March 2024

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.es/.