DOXAZOSIN TEVA-RATIOPHARM 4 mg TABLETS

Introduction

Package Leaflet: Information for the User

Doxazosina Teva-ratiopharm 4 mg Tablets EFG

Contents of the pack:

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

1. What is Doxazosina Teva-ratiopharm and what is it used for

Doxazosin belongs to a group of medicines called alpha-1 blocker antihypertensives.

Doxazosin is indicated in:

• Treatment of high blood pressure (hypertension).
• Treatment of obstruction of urinary outflow and symptoms associated with an enlarged prostate (benign prostatic hyperplasia).

Doxazosina Teva-ratiopharm can be used in patients with benign prostatic hyperplasia, whether they have high blood pressure or not.

Those patients with both conditions can be treated with doxazosin as monotherapy.

2. What you need to know before you take Doxazosina Teva-ratiopharm

Do not take Doxazosina Teva-ratiopharm

• if you are allergic to doxazosin, to other quinazolines (e.g. prazosin or terazosin) or to any of the other ingredients of this medicine (listed in section 6),
• if you have suffered from low blood pressure (hypotension) when taking other medicines to treat high blood pressure,
• if you have an enlarged prostate at the same time as a urinary outflow obstruction, a chronic infection or stones in the bladder,
• if you have low blood pressure.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Doxazosina Teva-ratiopharm

• if you have liver problems, doxazosin should be used with caution,
• if you have benign prostatic hyperplasia and are hypotensive,

• if you suffer from acute heart disease (such as pulmonary edema or heart failure),
• if you are going to undergo eye surgery for cataracts, please inform your doctor before this operation if you are taking or have taken Doxazosina Teva-ratiopharm previously. This is because doxazosin may cause complications during surgery, which can be taken into account and controlled by your ophthalmologist if informed beforehand.

Prolonged and painful erectionscan occur very rarely. If this happens, consult a doctor urgently.

Before starting treatment with this medicine, your doctor may perform tests to rule out other diseases such as prostate cancer that may cause the same symptoms as benign prostatic hyperplasia.

Children and adolescents

Doxazosin is not recommended for children or adolescents under 18 years of age as the safety and efficacy have not yet been established.

Use of Doxazosina Teva-ratiopharm with other medicines

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.

Doxazosin has been administered with other antihypertensives, other medicines such as non-steroidal anti-inflammatory drugs, antibiotics, oral antidiabetics, gout medicines, anticoagulants, digoxin, warfarin, phenytoin, and indomethacin without any negative consequences. Doxazosin enhances the action of other medicines to lower blood pressure (thiazide diuretics, furosemide, beta-blockers)

Consult your doctor or pharmacist before using this medicine if you are taking any of the following medicines, as they may change the effect of Doxazosina Teva-ratiopharm:

• Medicines for erectile dysfunction (impotence) (e.g. sildenafil, tadalafil, vardenafil) with alpha-blockers like doxazosin.
• Medicines that lower blood pressure.
• Medicines to treat bacterial or fungal infections (e.g. clarithromycin, itraconazole, ketoconazole, telithromycin, voriconazole).
• Medicines used in the treatment of HIV (e.g. indinavir, nelfinavir, ritonavir, saquinavir).
• Nefazodone, a medicine used to treat depression.

Taking Doxazosina Teva-ratiopharm with food and drinks

Doxazosin can be taken with or without food.

Pregnancy, breastfeeding, and fertility

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

Doxazosin may appear in breast milk in small amounts. You should not take this medicine while breastfeeding your baby unless your doctor recommends it.

Driving and using machines

Your ability to perform activities such as driving or operating machinery may be impaired, especially at the start of treatment with doxazosin.

Doxazosina Teva-ratiopharm contains orange yellow S (azoic dye), lactose, and sodium

This medicine may cause allergic reactions.

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

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is, essentially “sodium-free”.

3. How to take Doxazosina Teva-ratiopharm

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

Do not take more tablets than prescribed by your doctor.

This medicine is administered orally.

The tablet can be divided into equal doses.

Hypertension

The usual dose is 2-4 mg once a day. It is recommended to start treatment with 1 mg of doxazosin once a day for 1 or 2 weeks.

According to the response of each patient, the doctor may gradually increase the dose to 2 mg, 4 mg, 8 mg, or up to 16 mg per day as the maximum dose, at intervals of 1 or 2 weeks between each dose increase, until blood pressure is reduced.

This medicine can be administered with other medicines that your doctor has prescribed for the treatment of hypertension.

Benign Prostatic Hyperplasia (BPH)

The usual dose is 2-4 mg once a day. It is recommended to start treatment with 1 mg once a day.

Depending on the response of each patient, the doctor may gradually increase the dose to 2 mg, 4 mg, or up to 8 mg per day as the maximum dose, at intervals of 1 or 2 weeks between each dose increase.

If you take more Doxazosina than you should

An overdose of this medicine can cause a drop in blood pressure. In this case, sit with your head down.

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 ingested.

If you forget to take Doxazosina Teva-ratiopharm

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

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

4. Possible side effects

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

Side effects vary in intensity from person to person and should be taken into account especially at the start of treatment or when changing medication, being generally mild.

Frequent (may affect up to 1 in 10 people):

• respiratory tract infection, urinary tract infection,
• dizziness, headache, tendency to sleep (somnolence),
• vertigo,
• feeling of strong or rapid heartbeats (palpitations), increased heart rate (tachycardia),
• low blood pressure and postural low blood pressure (drop in blood pressure caused by a sudden change in body position)
• bronchitis, cough, difficulty breathing (dyspnea), inflammation of the nasal mucosa (rhinitis)
• abdominal pain, indigestion (dyspepsia), dry mouth, nausea
• itching (pruritus)
• back pain, muscle pain (myalgia)
• bladder inflammation (cystitis), urinary incontinence
• fatigue (asthenia), chest pain, flu-like illness, swelling of hands, feet, or ankles (peripheral edema)

Uncommon (may affect up to 1 in 100 people):

• allergic reaction,
• abnormal loss of appetite (anorexia), gout, increased appetite,
• anxiety, depression, difficulty starting or maintaining sleep (insomnia), agitation, nervousness,
• interruption of blood supply to the brain (stroke), decreased sensitivity (hypoesthesia), temporary loss of consciousness (syncope), tremor,
• ringing in the ears (tinnitus)
• chest pain or tightness (angina pectoris, myocardial infarction),
• nosebleed (epistaxis),
• constipation, diarrhea, flatulence, vomiting, gastroenteritis,
• abnormal liver function tests,
• skin rash,
• joint pain (arthralgia),
• urination problems (dysuria), blood in urine (hematuria), and frequent urination,
• impotence,
• facial pain, facial swelling,
• weight gain

Rare (may affect up to 1 in 1,000 people):

• increased frequency of urination (polyuria).
• obstruction of the digestive tract.

Very rare (may affect up to 1 in 10,000 people):

• decrease in the number of white blood cells (leucopenia), decrease in the number of platelets in the blood (thrombocytopenia),

• postural dizziness, tingling (paresthesia),
• blurred vision,
• decreased heart rate (bradycardia), heart rhythm disorders (cardiac arrhythmias),
• hot flashes,
• breathing difficulties (bronchospasm),
• stop or suppression of bile flow (cholestasis), liver inflammation (hepatitis), yellowing of the skin (jaundice),
• hair loss (alopecia), purple-colored spots on the skin of vascular origin (purpura), red itchy rashes (urticaria),
• muscle cramps, muscle weakness,
• urination disorders, need to urinate at night (nocturia), or changes in the amount of urine (diuresis),
• increase in male breast tissue (gynecomastia),
• persistent and painful erection of the penis (priapism). Consult a doctor urgently,
• fatigue, general malaise

Frequency not known (cannot be estimated from the available data)

• Intraoperative Floppy Iris Syndrome, an eye disorder that can occur during cataract surgery,
• entry of semen into the bladder during ejaculation (retrograde ejaculation).

No differences in side effects were observed between young and elderly patients.

Reporting of side effects:

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https//:www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Doxazosina Teva-ratiopharm

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

Store in the original packaging.

Do not use this medicine after the expiry date which is stated on the packaging after the abbreviation EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Return the containers and any unused medicines to the pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Doxazosina Teva-ratiopharm 4 mg tablets

The active substance is doxazosin. Each tablet contains 4.85 mg of doxazosin mesylate equivalent to 4 mg of doxazosin.

The other ingredients are: lactose monohydrate, sodium carboxymethyl starch (type A) potato, microcrystalline cellulose, magnesium stearate, sodium lauryl sulfate, colloidal silicon dioxide, and orange yellow S (E110). See section 2 “Doxazosina Teva-ratiopharm contains orange yellow S (azoic dye), lactose, and sodium”.

Appearance and packaging

Tablets

Orange-yellow, biconvex, scored on both sides, and engraved with “DZS 4” on one side.

Each pack contains 28 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

Teva Pharma, S.L.U.

C/Anabel Segura 11, Edificio Albatros B, 1ª planta,

Alcobendas, 28108 Madrid (Spain)

Manufacturer

SYNTHON HISPANIA, S.L.

Castelló, 1. Polígono Las Salinas.

08830 - Sant Boi de Llobregat (Spain)

or

Toll Manufacturing Services, S.L.

Aragoneses, 2.

28108 – Alcobendas (Spain)

Date of last revision of this leaflet:February 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/”

You can access detailed and updated information about this medicine by scanning the QR code included in the packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/65123/P_65123.html