Terazosin Kern Pharma 5 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Terazosin Kern Pharma 5 mg tablets EFG

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

• Keep this leaflet as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet.

:Contents of the leaflet

1. What Terazosin Kern Pharma is and what it is used for
2. What you need to know before taking Terazosin Kern Pharma
3. How to take Terazosin Kern Pharma
4. Possible adverse effects
5. How to store Terazosin Kern Pharma
6. Contents of the pack and other information

1. What Terazosina Kern Pharma is and what it is used for

Terazosin is a medicine that improves urinary symptoms in patients who have difficulty urinating due to an enlarged prostate, while at the same time lowering blood pressure.

Terazosina Kern Pharma is used for the treatment of symptoms of benign prostatic hyperplasia and for the treatment of high blood pressure (hypertension).

2. What you need to know before starting Terazosin Kern Pharma

Do not take Terazosin Kern Pharma

• if you are allergic to terazosin or to similar substances (quinazoline derivatives) or to any of the other ingredients of this medicine (listed in section 6),
• if you have a history of dizziness or fainting during urination.

Warnings and precautions

Talk to your doctor or pharmacist before starting Terazosin Kern Pharma.

• When taking the first dose, as it may cause a marked drop in blood pressure, manifested by dizziness, drowsiness, and palpitations.
• When resuming treatment after interruption, a similar effect may occur.

To minimize these effects as much as possible, take the first dose at bedtime and be cautious if you need to get up during the night. Do not increase the prescribed dose under any circumstances.

• Dizziness, lightheadedness, or even fainting may also occur when standing up from a sitting or lying position. Getting up slowly may help reduce these symptoms.

If you begin to feel dizzy, lie down to avoid fainting, then get up slowly to prevent dizziness from returning.

If, despite these recommendations, dizziness, drowsiness, or palpitations persist or are bothersome, consult your doctor.

If you are scheduled for cataract eye surgery, please inform your doctor before the procedure if you are currently taking or have previously taken Terazosin Kern Pharma. This is because Terazosin Kern Pharma may cause complications during surgery, which can be anticipated and managed by your ophthalmologist if they are informed in advance.

Use in children: The use of Terazosin Kern Pharma is not recommended in children, as the safety and efficacy of this medicine in children have not been established.

Use in elderly: Caution is necessary when administering the first dose, increasing the dose, or restarting treatment after interruption, as elderly patients are more sensitive to the effects of the medicine.

Taking Terazosin Kern Pharma with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

If you are taking another medicine to lower blood pressure (antihypertensive), consult your doctor so they can adjust the dose accordingly.

Some patients receiving an alpha-blocker for the treatment of high blood pressure or benign prostatic hyperplasia may experience dizziness or fainting, which may be caused by a drop in blood pressure when sitting or standing up quickly. Some patients have experienced these symptoms when taking medicines for erectile dysfunction (impotence) together with alpha-blockers such as TERAZOSIN KERN PHARMA 5 mg tablets. To reduce the likelihood of these symptoms occurring, you should already be on a regular daily dose of the alpha-blocker before starting treatment for erectile dysfunction.

Taking Terazosin Kern Pharma with food and drink

Terazosin Kern Pharma may be taken with or without food. Take your dose with a glass of water.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

Consult your doctor or pharmacist before using any medicine.

The safety of Terazosin Kern Pharma during pregnancy has not been established. Terazosin Kern Pharma should be used during pregnancy only if your doctor considers that the potential benefits justify the risk to the fetus.

Breastfeeding

Consult your doctor or pharmacist before using any medicine.

If you are breastfeeding, it is not recommended that you take Terazosin Kern Pharma. It is not known whether terazosin is excreted in breast milk.

Driving and using machines

Terazosin may cause dizziness, especially at the beginning of treatment, so it should be used with caution in patients who drive or operate heavy machinery.

Do not drive during the first 12 hours after starting treatment, as Terazosin Kern Pharma may impair your ability to drive safely.

Do not use any tools, dangerous machinery, or engage in risky activities where a lack of attention could put you or others at risk of death or serious injury.

Terazosin Kern Pharma contains lactose

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

3. How to take Terazosina Kern Pharma

Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again. Remember to take the medicine.

Your doctor will indicate how long you should be treated with Terazosina Kern Pharma. Do not stop treatment prematurely, as you will not achieve the expected results. Likewise, do not use it for longer than indicated by your doctor.

To avoid a sudden drop in blood pressure, treatment should always be initiated with half a Terazosina 2 mg tablet (1 mg of terazosin). Terazosina Kern Pharma 5 mg tablets are not indicated for initial treatment.

If you feel the effect of the medicine is too strong or too weak, inform your doctor or pharmacist.

Benign prostatic hyperplasia

Initial dose: half a Terazosina 2 mg tablet (1 mg of terazosin) once daily at bedtime.

Subsequent doses: After 3–4 days, and according to your response to treatment, your doctor may increase your dose to one Terazosina 2 mg tablet (2 mg of terazosin) once daily at bedtime until the pack is finished. Afterwards, the dose may be gradually increased to reach the maintenance dose appropriate to your needs. The usual recommended maintenance dose is one Terazosina Kern Pharma 5 mg tablet once daily.

However, your doctor may prescribe higher doses up to a maximum of two Terazosina Kern Pharma tablets (10 mg of terazosin) per day. If a different maintenance dose is prescribed, the number of tablets you take will vary. Check your doctor's instructions to confirm how many tablets you should take.

Hypertension

Initial dose: half a Terazosina 2 mg tablet (1 mg of terazosin) once daily at bedtime.

Subsequent doses: Your doctor may gradually increase your daily dose until the desired response is achieved. The recommended maintenance dose is half a Terazosina 2 mg tablet to one Terazosina Kern Pharma tablet (1 to 5 mg of terazosin) once daily at bedtime.

If you take more Terazosina Kern Pharma than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

Symptoms are those of acute hypotension (sudden drop in blood pressure). Wait for the doctor lying down or sitting, taking care not to stand up suddenly.

If you forget to take Terazosina Kern Pharma

Do not take a double dose to make up for missed doses.

If you have forgotten to take several doses, consult your doctor for advice on the dosing schedule to follow in order to reach your maintenance dose again.

If you stop taking Terazosina Kern Pharma

If treatment is interrupted for several days, resumption should always begin with the recommended initial dose, following the initial administration regimen.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Terazosin Kern Pharma may cause adverse effects, although not everyone experiences them.

The following adverse effects have been reported:

• Systemic effects: asthenia (weakness or lack of strength) and headache.
• Cardiovascular system: palpitations, postural hypotension (dizziness upon standing), syncope, and tachycardia.
• Metabolic disorders: peripheral edema (swelling of the extremities) and weight gain.
• Nervous system: fainting, dizziness, decreased libido, and somnolence.
• Respiratory system: dyspnea (shortness of breath), rhinitis, and nasal congestion.
• Urogenital system: impotence and retrograde ejaculation. In postmenopausal women, urinary incontinence.
• Sensory organs: blurred vision.

Among these, the most common symptoms are: asthenia (weakness or lack of strength), blurred vision, dizziness, postural hypotension (dizziness upon standing), nausea, peripheral edema (swelling of the extremities), impotence, and somnolence, generally of mild to moderate intensity.

Thrombocytopenia (reduced platelet count), atrial fibrillation (heart arrhythmia), and priapism (persistent and painful penile erection) have also been reported.

If any of these reactions occur during treatment, or if you experience any other symptoms you believe are related to the treatment, you should inform your doctor as soon as possible.

If you experience adverse effects, consult your doctor or pharmacist, even if the effects are not listed in this leaflet.

5. Storage of Terazosin Kern Pharma

Keep this medicine out of the sight and reach of children.

No special storage conditions are required.

Do not use this medicine after the expiry date stated on the packaging after "EXP.". The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Terazosin Kern Pharma

• The active substance is terazosin. Each tablet contains 5 mg of terazosin (as hydrochloride).
• The other components are: lactose, corn starch, talc (E 553b), and magnesium stearate (E 470b).

Appearance of the product and contents of the pack

Terazosin Kern Pharma 5 mg tablets are presented as white, round tablets for oral administration, in packs containing 30 tablets.

Marketing Authorization Holder and Manufacturer

Kern Pharma, S.L.

Pol. Ind. Colón II, C/Venus, 72

08228 Terrassa (Barcelona)

Spain

Date of the most recent review of this leaflet: October 2024

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/