Package Insert: Information for the Patient

Tamsulosin ratiopharm 0.4 mg prolonged-release tablets EFG

tamsulosin hydrochloride

Read this package insert carefully before starting to take this medication, as it contains important information for you.

- Keep this package insert, as you may need to read it again.

- If you have any questions, consult your doctor or pharmacist.

- This medication has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.

- If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

1. What is Tamsulosin ratiopharm and what is it used for

2. What you need to know before starting to take Tamsulosin ratiopharm

3. How to take Tamsulosin ratiopharm

4. Possible adverse effects

5. Storage of Tamsulosin ratiopharm

6. Contents of the package and additional information

The active ingredient is tamsulosin. It is a selective antagonist of alpha 1A/1D adrenergic receptors.Tamsulosin reduces the tension of the smooth muscles of the prostate and the urethra, allowing urine to pass more easily through the urethra and facilitating urination.It also decreases the sensation of urgency.

Tamsulosin is used in men for the treatment of lower urinary tract symptoms associated with an enlarged prostate gland (benign prostatic hyperplasia). These symptoms may include difficulty urinating (weak urine stream), dripping, sensation of urgency, and frequent need to urinate both at night and during the day.

Do not take Tamsulosina ratiopharm

- if you are allergic (hypersensitive) to tamsulosina or to any of the other ingredients of this medication (listed in section 6). Hypersensitivity may present as sudden swelling of the soft tissues of the body (e.g. the throat or tongue), difficulty breathing and/or itching and skin rash (angioedema).

- if you have drops in blood pressure when changing position (sitting or standing), causing dizziness, drowsiness or fainting.

- if you have severe liver problems.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Tamsulosina ratiopharm:

- If you experience fainting or dizziness, especially when standing up. Tamsulosina may lower your blood pressure, causing these symptoms. You should sit or lie down until the symptoms disappear.

- If you have severe kidney problems, consult your doctor

- If you are about to undergo or have undergone eye surgery due to a clouding of the lens (cataracts) or an increase in eye pressure (glaucoma). Please inform your ophthalmologist if you have taken, are taking or are going to take hydrochloride tamsulosina. The specialist will then take the necessary precautions regarding medication and surgical techniques to be used. Consult your doctor if you should or should not postpone or temporarily suspend taking this medication if you are about to undergo eye surgery due to a clouding of the lens (cataracts) or an increase in eye pressure (glaucoma).

Regular medical check-ups are necessary to monitor the development of the disease for which you are being treated.

Tamsulosina ratiopharm is a specially designed tablet from which the active ingredient is released gradually once the tablet is ingested. You may observe remnants of the tablet in the feces. Since the active ingredient of the tablet has already been released, there is no risk that the tablet will be less effective.

Children and adolescents

Do not administer this medication to children or adolescents under 18 years old as it is not effective in this population.

Taking Tamsulosina ratiopharm with other medications

Inform your doctor or pharmacist if you are taking/using, have taken/used recently or could take/use other medications.

The effect of other medications may be affected by tamsulosina. These, in turn, may affect the mechanism of action of tamsulosina. Tamsulosina may interact with:

• Diclofenac,analgesic and anti-inflammatory. This medication may accelerate the elimination of tamsulosina from the body, thus reducing the duration of the efficacy of tamsulosina.
• Warfarin,medication to prevent blood coagulation. It may accelerate the elimination of tamsulosina from the body, thus reducing the duration of the efficacy of tamsulosina.
• other α1 adrenergic receptor blockers.The combination may lower your blood pressure, causing dizziness or fainting.
• Especially, it is essential to inform your doctor if you are being treated at the same time with medications that may reduce the elimination of hydrochloride tamsulosina from your body (e.g. ketoconazole, erythromycin).

Taking Tamsulosina ratiopharm with food and drinks

Tamsulosina may be taken with or without food.

Pregnancy, breastfeeding and fertility

The use of tamsulosina is not indicated in women.

In men, an abnormal ejaculation (ejaculation disorder) has been reported. This means that semen does not come out through the urethra, but instead enters the bladder (retrograde ejaculation), or the volume of ejaculation is reduced or absent (ejaculatory failure). This phenomenon is not harmful.

Driving and operating machines

There is no evidence that tamsulosina affects the ability to drive or operate machines. However, you should be aware that dizziness may occur. Only drive or operate machines if you feel well.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. Consult with your doctor or pharmacist if you have any doubts.

The recommended dose is 1 tablet per day. You can take tamsulosina with or without food, preferably at the same time of day.

The tablet should be swallowed whole. It is essential that you do not break or chew the tablet as it may affect the action of tamsulosina.

Tamsulosina is usually prescribed for long periods of time. The effects on the bladder and urination are maintained during long-term treatment with tamsulosina.

Use in children and adolescents

The use of tamsulosina is not indicated for children and adolescents.

If you take more Tamsulosina ratiopharm than you should

Taking too many tamsulosina tablets may lead to an undesirable decrease in blood pressure and an increase in heart rate, with a sensation of dizziness. Contact your doctor immediately if you have taken too much tamsulosina.

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.

If you forgot to take Tamsulosina ratiopharm

If you have forgotten to take tamsulosina as recommended, you can take your daily dose later in the same day. If you have missed a day's dose, you can simply continue taking your daily tablet as prescribed. Do not take a double dose to compensate for the missed doses.

If you interrupt the treatment with Tamsulosina ratiopharm

When treatment with tamsulosina is discontinued prematurely, your original symptoms may return. Therefore, take tamsulosina for the entire time your doctor prescribes, even if your symptoms have disappeared. Always consult your doctor if you decide to discontinue treatment.

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

Like all medications, tamsulosin may cause side effects, although not everyone will experience them.

It is rare for serious adverse reactions to occur. Consult your doctor immediately if you experience a severe allergic reaction that causes swelling of the face or throat (angioedema).

Frequent(may affect up to 1 in 10 people)

• Dizziness, especially when sitting or standing up

Abnormal ejaculation (ejaculation alterations). This means that semen does not release through the urethra, but rather goes to the bladder (retrograde ejaculation) or that the ejaculated volume is reduced or non-existent (ejaculatory failure). This phenomenon is harmless.

Poorly frequent(may affect up to 1 in 100 people)

• Headache,
• abnormal and palpable heart rate (palpitations),
• reduced blood pressure when standing that may cause dizziness, drowsiness, or fainting (orthostatic hypotension),
• nasal congestion and irritation (rhinitis),
• constipation, diarrhea,
• sensation of nausea or vomiting,
• skin rash, itching, and hives (urticaria),
• weakness (asthenia).

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

• Fainting (syncope).

• Generalized skin rash or urticaria with swelling of the face, lips, tongue, or throat, which may cause difficulty swallowing or breathing (angioedema)

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

• Priapism (persistent painful erection in the absence of sexual stimulation, this side effect requires immediate treatment), severe disorder with appearance of blisters on the skin, mouth, eyes, and genitals (Stevens-Johnson syndrome).

Frequency unknown(cannot be estimated from available data)

• Abnormal heart rhythm (atrial fibrillation, arrhythmia, tachycardia)
• difficulty breathing (dyspnea),
• eye problems (e.g., blurred vision, vision deterioration),
• nosebleeds (epistaxis),
• dry mouth
• inflammatory skin disorder, pink patches with itching (erythema multiforme),
• skin redness and peeling (dermatitis exfoliativa).

During eye surgery due to a condition called "Intraoperative Flaccid Iris Syndrome" (IFIS), the following may occur: the pupil may dilate poorly and the iris (the colored part of the eye), may become flaccid during the surgery. For more information, see section 2 Warnings and precautions.

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicinal Products for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

Do not use this medication after the expiration date that appears on the packaging after the abbreviation CAD. The first two digits indicate the month and the last four digits indicate the year. The expiration date is the last day of the month indicated.

Store the blister pack in the original packaging to protect it from light.

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 point of the pharmacy.Ask your pharmacist how to dispose of the packaging and medications you no longer need.This will help protect the environment.

Composition of Tamsulosina ratiopharm

- The active ingredient is 0.4 mg of tamsulosin hydrochloride, equivalent to 0.367 mg of tamsulosin.

- The other components (excipients) are:

Tablet core: microcrystalline cellulose, hypromellose, carbomer, anhydrous colloidal silica, red iron oxide (E172), magnesium stearate.

Tablet coating: microcrystalline cellulose, hypromellose, carbomer, anhydrous colloidal silica, magnesium stearate.

Appearance of the product and contents of the package

White, round tablets with the inscription “T9SL” on one side and “0.4” on the other side.

They are presented in blister packs with 10, 18, 20, 28, 30, 50, 60, 90, 98, and 100 tablets.

Only some package sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Teva Pharma, S.L.U.

C/Anabel Segura 11, Edificio Albatros B, 1st floor,

Alcobendas, 28108 Madrid, Spain

Responsible manufacturer

Synthon BV

Microweg 22,

6545 CM Nijmegen, Netherlands

Or

Synthon Hispania SL

Castelló 1, Polígono Las Salinas,

08830 Sant Boi de Llobregat (Spain)

Or

Merckle GmbH

Ludwig Merckle strasse 3,

89143 Blaubeuren, Germany

This medicine is authorized in the member states of the European Economic Area with the following names:

Netherlands:Tamsulosine HCl ratiopharm 0.4 mg, tablets with prolonged release

Austria:Tamsulosin ratiopharm 0.4 mg Retardtabletten

Bulgaria:TevaTamsin 0.4 mg prolonged release tablets

Germany:Tamsulosin-ratiopharm 0.4 mg Retardtabletten

Spain:Tamsulosina ratiopharm 0.4 mg prolonged release tablets EFG

France: Tamsulosine ratiopharm L.P. 0.4 mg, coated tablet with prolonged release

Hungary: Tamsulosin Teva ER 0.4 mg

Norway: Tamsulosin ratiopharm

Slovakia: Tamsulosin Teva ER 0.4 mg

Last review date of this leaflet:September 2023

For detailed information about this medicine, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/