TERAZOSIN KERN PHARMA 5 mg TABLETS

Introduction

Package Leaflet: Information for the User

Terazosina Kern Pharma 5 mg Tablets EFG

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

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

Contents of the Package Leaflet

1. What is Terazosina Kern Pharma and what is it used for
2. What you need to know before you 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 other information

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

Terazosin is a medicine that improves urinary symptoms in patients with difficulty urinating due to an enlarged prostate, while also lowering blood pressure.

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

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

Do not take Terazosina 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 while urinating.

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 marked decrease in blood pressure, which is manifested by dizziness, drowsiness, and palpitations.
• When resuming treatment after interruption, a similar effect to the previous one may occur.

To prevent these effects as much as possible, take the first dose when lying down and be careful not to get up suddenly. Do not increase the prescribed doses in any way.

• Dizziness, feeling of dizziness, or even fainting may also appear when getting up from a sitting or lying position. Getting up slowly can 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 precautions, dizziness, drowsiness, or palpitations persist or are a cause of discomfort, consult your doctor.

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

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

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

Use of Terazosina Kern Pharma with Other Medicines

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

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

Some patients who are receiving an alpha-blocker for the treatment of high blood pressure or prostatic hyperplasia may experience dizziness or fainting that can be caused by a decrease in blood pressure when sitting or standing up quickly. Some patients have experienced these symptoms when taking medicines for erectile dysfunction (impotence) with alpha-blockers like TERAZOSINA KERN PHARMA 5 mg tablets. To minimize 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 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 Terazosina Kern Pharma during pregnancy has not been established. Terazosina Kern Pharma should only be used during pregnancy when the doctor considers that the potential benefits justify the risk to the fetus.

Breastfeeding

Consult your doctor or pharmacist before using any medicine.

It is not recommended to take Terazosina Kern Pharma if you are breastfeeding a baby. It is not known if terazosin is excreted in breast milk.

Driving and Using Machines

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

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

Do not use any tool, machine, or engage in hazardous activities where a lack of attention may put you or others at risk of death or serious harm.

Terazosina Kern Pharma contains Lactose

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

3. How to Take Terazosina Kern Pharma

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

Your doctor will indicate the duration of treatment with Terazosina Kern Pharma. Do not stop treatment before achieving the expected results. Similarly, do not use it for longer 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 terazosin). The 5 mg tablets of Terazosina Kern Pharma are not indicated for initial treatment.

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

Benign Prostatic Hyperplasia

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

Subsequent doses: After 3-4 days, and according to your response to treatment, your doctor may increase the dose to 1 tablet of Terazosina 2 mg tablets (2 mg of terazosin) once a day at bedtime until the end of the pack. Then, the dose can be gradually increased to reach the maintenance dose suitable for your needs. The usual 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 terazosin) per day. If a different maintenance dose is prescribed for you, 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 terazosin) once a day at bedtime.

Subsequent doses: Your doctor may gradually increase the daily dose 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 terazosin) 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 Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount taken.

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

If you forget to take Terazosina Kern Pharma

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

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

If you stop taking Terazosina Kern Pharma

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

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

4. Possible Side Effects

Like all medicines, Terazosina Kern Pharma can cause side effects, although not everybody gets them.

The following side effects have been described:

• Systemic effects: asthenia (weakness) and headache.
• Cardiovascular system: palpitations, postural hypotension (feeling of 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 (feeling of shortness of breath), rhinitis, nasal obstruction.
• Urogenital system: impotence and retrograde ejaculation. In postmenopausal women, urinary incontinence.
• Senses: blurred vision.

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

Thrombocytopenia (decrease in platelet count), atrial fibrillation (heart arrhythmia), and priapism (persistent and painful erection of the penis) have also been described.

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

If you experience side effects, talk to your doctor or pharmacist, even if it is a side effect not listed in this package leaflet.

5. Storage of Terazosina 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 which is stated on the packaging 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 packaging and any unused medicine in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the Pack and Other Information

Composition of Terazosina Kern Pharma

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

Appearance of the Product and Contents of the Pack

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

Marketing Authorization Holder and Manufacturer

Kern Pharma, S.L.

Pol. Ind. Colón II, C/Venus, 72

08228 Terrassa (Barcelona)

Spain

Date of Last Revision of this Package Leaflet: October 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.gob.es/