Leaflet: information for the user

Trandate 200 mg coated tablets

Labetalol hydrochloride

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist or nurse.
• This medicine has been prescribed for you and should not be given to others, even if they have the same symptoms of the disease, as it may harm them.
• If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet.

1. What Trandate is and for what it is used

2. What you need to know before starting to take Trandate

3. How to take Trandate

4. Possible side effects

5. Storage of Trandate

6. Contents of the pack and additional information

Trandate belongs to a group of medications known as 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 exert a harmful effect on kidney function and is particularly suitable for use in patients with hypertension and kidney dysfunction.

Do not take Trandate

- If you are allergic to hydrochloride labetalol, or to any other component of Trandate.

- If you have a second and third degree atrioventricular block (heart block).

- In case of cardiogenic shock (heart failure).

- In case of prolonged and severe hypotension (low blood pressure).

- If you suffer from severe bradycardia (decreased heart rate).

- If you have asthma or obstruction of the respiratory tract.

Be especially careful with Trandate

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

It is not necessary to suspend the 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 Trandate therapy.

Risk of anaphylactic reaction: Patients with a history of severe anaphylactic reaction to some allergen, taking β-blockers may be more sensitive to repeated exposure, whether accidental, diagnostic, or therapeutic. These patients may not respond to the usual doses of adrenaline used to treat allergic reactions.

Use of other medications

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

You should exercise special caution with the simultaneous administration of the following medications:

Tricyclic antidepressants, as it 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 channel blockers of the type verapamil.

Trandate may potentiate the hypotensive effects of halothane.

Trandate produces fluorescence in alkaline solution, so it 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 lactation

Consult your doctor or pharmacist before using any medication.

Pregnancy

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

Lactation

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

Use in children

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

Use in athletes

Inform athletes that this medication contains a component that may result in a positive analytical result in doping control.

Driving and operating machinery

No effects on the ability to drive or operate machinery have been described due to the use of this medication.

Important information about one of the components of Trandate

This medication contains lactose. If your doctor has indicated that you have an intolerance to certain sugars, consult with him before taking this medication.

This medication may cause allergic reactions because it contains yellow orange (E-110).

It may cause asthma, especially in patients allergic to acetylsalicylic acid.

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

Remember to take your medication.

If you estimate that the action of Trandate is too strong or too weak, inform your doctor or pharmacist.

Administration will be done orally. The tablets must 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 start with doses of 100 mg twice a day. If necessary, this dose can be administered progressively and increased by 100 mg, twice a day, every 2-14 days. Blood pressure in many patients is controlled with 200 mg twice a day and can reach up to 400 mg twice a day. Do not exceed a total daily dose of 800 mg.

Older adults

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

Hypertension in pregnancy

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

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

Hypertension coexisting with angina

The dose of Trandate will be the one required to control hypertension. Do not exceed a total daily dose of 800 mg.

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

Adjuvant hypotensive effects may appear if Trandate tablets are administered concurrently with other antihypertensive agents, e.g., diuretics, methyldopa, etc. In patients being treated with such drugs and are to be replaced by Trandate tablets, start with a dose of 100 mg twice a day, gradually reducing the previous therapy. It is not advisable to abruptly discontinue clonidine or beta-blockers.

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 Toxicological Information Service. Phone: 91 562 04 20. It is recommended to bring the packaging and the package insert 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 within the first hours of ingestion is justified; use a cardiac glycoside and a diuretic in case of cardiac failure; administer a β2 agonist in aerosol in case of bronchospasm. Give 0.25 to 3 mg of atropine intravenously to alleviate bradycardia.

To improve circulation, administer an initial dose of 5 to 10 mcg of noradrenaline intravenously, preferably to isoprenaline, repeating as needed. Alternatively, noradrenaline can be infused at a rate of 5 mcg per minute until a satisfactory response is obtained.

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

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

Hemodialysis eliminates less than 1% of labetalol chloride from the circulation.

If you forget to take Trandate

Do not take a double dose to compensate for the missed doses. Take a new dose as soon as possible.

Continue treatment as indicated by your doctor.

If you interrupt treatment with Trandate

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

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

Like all medications, Trandate may have side effects, although not everyone will experience them.

The majority of side effects are transient and occur during the first 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 they are increased too quickly.

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

Shakiness has been described in the treatment of hypertension during pregnancy. Retention of urine, difficulty urinating, ejaculatory failure, epigastric pain, nausea, and vomiting have also been described.

Rarely, non- disease-associated positive antinuclear antibodies have appeared, as well as rare cases of systemic lupus erythematosus and, very rarely, drug fever.

Very rarely, cases of toxic myopathy have been described.

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

Rarely, a reversible lichenoid rash has occurred.

Rare cases of elevated liver function tests, jaundice (both hepatocellular and cholestatic), hepatitis, and liver necrosis have been described. These signs and symptoms are generally reversible upon discontinuation of treatment.

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

Reversible skin rashes and/or eye dryness associated with the use of beta-adrenergic blockers have been described. The incidence is small, and in most cases, symptoms disappeared upon discontinuation of treatment. Consider gradual withdrawal of the drug if such a reaction is not otherwise explained.

Rarely, some cases of severe hepatocellular damage have been described, usually reversible, during labetalol therapy at short and long term. Necessary analytical tests should be performed at the first sign or symptom of liver dysfunction. If there is evidence of liver damage or if the patient is icteric, labetalol should be discontinued definitively.

If bronchospasm occurs after use of Trandate, it should be treated with inhalation of a β2 agonist, e.g., salbutamol (may require a higher dose than usual in asthma) and, if necessary, atropine, 1 mg, intravenously.

If you consider any of the side effects you are experiencing to be severe or if you notice any side effect not mentioned in this prospectus, inform your doctor or pharmacist.

Keep out of reach and sight of children.

Do not store at a temperature above 25°C.

Do not use Trandate after the expiration date indicated on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and medicines you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines. By doing so, you will help protect the environment.

Composition of Trandate

• The active ingredient is hydrochloride of labetalol. Each tablet contains 200 mg of hydrochloride of labetalol.
• The other components (excipients) are: lactose, microcrystalline cellulose, magnesium stearate, hypromellose, sodium benzoate (E211), titanium dioxide (E171), and yellow-orange (E110).

Appearance of the product and contents of the packaging

Coated tablets, circular, orange in color.

Packaging containing 30 tablets.

Other presentations

Trandate 100 mg tablets: Packaging with 30 tablets.

Trandate 5 mg/ml injectable solution: Packaging with 5 ampoules of 20 ml.

Holder of the marketing authorization and responsible for manufacturing

Kern Pharma, S.L.

Polígono Ind. Colón II

Venus, 72

08228 Terrassa (Barcelona)

Last review date of this leaflet: March 2024

The detailed and updated information of this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.es/.