Leaflet: information for the user

Terazosina Kern Pharma 5 mg tablets EFG

Read this 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only; do not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet.

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

2. What you need to know before starting to take Terazosina Kern Pharma

3. How to take Terazosina Kern Pharma

4. Possible side effects

5. Storage of Terazosina Kern Pharma

6. Contents of the pack and additional information

Terazosina is a medication that improves urinary symptoms in patients with difficulty urinating due to an enlarged prostate, while also 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).

Do not take Terazosina Kern Pharma

• if you are allergic to terazosina or to similar substances (quinazolidin derivatives) or to any of the other components of this medication (listed in section 6),
• if you have a history of dizziness or fainting during urination.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Terazosina Kern Pharma.

• When taking the first doses, as it may cause a significant drop in blood pressure, which manifests as dizziness, drowsiness, and palpitations.
• When resuming treatment after its interruption, a similar effect may occur.

To prevent these effects as much as possible, take the first dose at bedtime and watch if you need to get up during the night. Do not increase the prescribed doses by your doctor at all.

• Dizziness, feeling of dizziness, or even fainting can also occur when getting up when sitting or lying down. Getting up slowly may help reduce these symptoms.

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

If, despite these guidelines, dizziness, drowsiness, or palpitations persist or cause discomfort, consult your doctor.

If you are about to undergo eye surgery for cataracts, please inform your doctor before the operation if you are taking or have taken Terazosina Kern Pharma previously. This is because Terazosina Kern Pharma may cause complications during the operation, which can be taken into account and controlled by your ophthalmologist if you have been informed in advance.

Use in children:The use of Terazosina Kern Pharma is not indicated in children, as the safety and effectiveness of this medication in children have not been determined.

Use in the elderly:Care should be taken when administering the first dose, when increasing the dose, or when initiating the dose after a treatment interruption, as elderly patients are more sensitive to the effects of the medication.

Use of Terazosina Kern Pharma with other medications

Inform your doctor or pharmacist that you are using, have used recently, or may need to use any other medication.

If you are taking another medication to lower blood pressure (anti-hypertensive), consult your doctor to adjust the dose.

Some patients receiving an alpha-blocker for the treatment of high blood pressure or prostate hypertrophy may experience dizziness or fainting caused by a drop in blood pressure when sitting or standing up quickly. Some patients have experienced these symptoms when taking medications for erectile dysfunction (impotence) with alpha-blockers such as TERAZOSINA KERN PHARMA 5 mg tablets. To reduce the likelihood of these symptoms, you should be receiving your daily dose of alpha-blocker regularly before starting treatment for erectile dysfunction.

Use of Terazosina Kern Pharma with food and drink

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

Pregnancy and breastfeeding

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

Pregnancy

Consult your doctor or pharmacist before using any medication.

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

Breastfeeding

Consult your doctor or pharmacist before using any medication.

It is not recommended to take Terazosina Kern Pharma while breastfeeding. It is not known if terazosina is excreted in breast milk.

Driving and operating machinery

Terazosina may cause dizziness, especially at the beginning of treatment, so it should be administered with caution to patients who must drive or operate heavy machinery.

Do not drive for the first 12 hours after starting treatment, as Terazosina Kern Pharma may prevent you from driving safely.

Do not use any tools, hazardous machinery, or perform high-risk activities where a lack of attention may put you or others at risk of death or serious injury.

Terazosina Kern Pharma contains lactose

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

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again. Remember to take the medication.

Your doctor will indicate the duration of treatment with Terazosina Kern Pharma. Do not suspend the treatment before, as the expected results will not be obtained. Similarly, do not use it for a longer period than indicated by your doctor.

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

If you estimate that the medication's action is too strong or too weak, inform your doctor or pharmacist.

Benign prostatic hyperplasia

Initial dose: half a tablet of Terazosina 2 mg tablets (1 mg of terazosina) once a day at bedtime.

Following doses: After 3-4 days, and according to your response to treatment, your doctor may increase your dose to 1 tablet of Terazosina 2 mg tablets (2 mg of terazosina) once a day at bedtime until the package is finished. Subsequently, the dose may be increased gradually to reach the appropriate maintenance dose for your needs. The recommended maintenance dose is 1 tablet of Terazosina Kern Pharma 5 mg once a day.

However, your doctor may prescribe higher doses up to a maximum of 2 tablets of Terazosina Kern Pharma (10 mg of terazosina) per day. If a different maintenance dose is prescribed, the number of tablets you take will be different. Check your doctor's instructions to remember how many tablets you need to take.

Hypertension

Initial dose: half a tablet of Terazosina 2 mg tablets (1 mg of terazosina) once a day at bedtime.

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

If you take more Terazosina Kern Pharma than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

The symptoms are those of acute hypotension (sudden drop in blood pressure). Wait for the doctor to lie down or sit down, being careful not to get up suddenly.

If you forgot to take Terazosina Kern Pharma

Do not take a double dose to compensate for the missed doses.

If you have forgotten to take several doses, consult your doctor to indicate the dosage schedule to follow until you reach your maintenance dose.

If you interrupt treatment with Terazosina Kern Pharma

If treatment is interrupted for several days, its resumption will always be made with the recommended initial dose, according to the initial administration regimen.

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

Like all medications, Terazosina Kern Pharma can produce adverse effects, although not everyone will experience them.

The following adverse effects have been described:

• Systemic Effects: asthenia (fatigue or weakness) and headache.
• Circulatory System: palpitations, postural hypotension (dizziness when standing up), syncope, and tachycardia.
• Metabolic Disorders: peripheral edema (swelling of the extremities) and weight gain.
• Nervous System: fainting, vertigo, decreased libido, and drowsiness.
• Respiratory System: dyspnea (shortness of breath), rhinitis, nasal obstruction.
• Urinary System: impotence and retrograde ejaculation. In postmenopausal women, urinary incontinence.
• Sensory Organs: blurred vision.

Of all these, the most common symptoms are: asthenia (fatigue or weakness), blurred vision, vertigo, postural hypotension (dizziness when standing up), nausea, peripheral edema (swelling of the extremities), impotence, and drowsiness, usually of medium or moderate intensity.

There have also been reports of thrombocytopenia (low platelet count), atrial fibrillation (heart arrhythmia), and priapism (persistent and painful erection of the penis).

If any of these reactions or other discomforts appear during treatment, you should inform your doctor as soon as possible.

If you experience adverse effects, consult your doctor or pharmacist, even if they do not appear in this prospectus.

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

No special storage conditions are required.

Do not use this medication after the expiration date that appears on the packaging after “CAD.” The expiration date is the last day of the month indicated.

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

Composition of Terazosina Kern Pharma

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

Appearance of the product and contents of the packaging

Terazosina Kern Pharma 5 mg tablets are presented in the form of oral tablets in packaging with 30 round white tablets.

Holder of the marketing authorization and responsible for manufacturing

Kern Pharma, S.L.

Pol. Ind. Colón II, C/Venus, 72

08228 Terrassa (Barcelona)

Spain

Last review date of this leaflet: October 2024

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