TAMSULOSIN RATIOPHARM 0.4 mg PROLONGED-RELEASE TABLETS

2. What you need to know before taking Tamsulosin ratiopharm

Do not take Tamsulosin ratiopharm

• if you are allergic (hypersensitive) to tamsulosin or any of the other components of this medication (listed in section 6). Hypersensitivity may present as sudden local swelling of the body's soft tissues (e.g., 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 Tamsulosin ratiopharm:

• If you experience fainting or dizziness, especially when standing up. Tamsulosin may decrease 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 going to undergo or have undergone eye surgery due to cataracts or glaucoma. Please inform your ophthalmologist if you have taken, are taking, or will take tamsulosin hydrochloride. The specialist can then take the necessary precautions regarding medication and surgical techniques. Consult your doctor if you should or should not postpone or temporarily suspend taking this medication if you are going to undergo eye surgery due to cataracts or glaucoma.

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

Tamsulosin ratiopharm is a specially designed tablet from which the active substance is gradually released after the tablet is ingested. You may observe remains of the tablet in the stool. Since the active substance of the tablet has already been released, there is no risk that the tablet will be less effective.

Children and adolescents

Do not give this medication to children or adolescents under 18 years of age, as it is not effective in this population.

Taking Tamsulosin ratiopharm with other medications

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

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

• Diclofenac,analgesic and anti-inflammatory medication. This medication may accelerate the elimination of tamsulosin from the body, thereby reducing the duration of the effectiveness of tamsulosin.
• Warfarin,medication to prevent blood clotting. It may accelerate the elimination of tamsulosin from the body, thereby reducing the duration of the effectiveness of tamsulosin.
• other alpha-1 adrenergic receptor blockers.The combination may decrease your blood pressure, causing dizziness or fainting.
• Especially, it is important that you inform your doctor if you are being treated at the same time with medications that may decrease the elimination of tamsulosin hydrochloride from your body (e.g., ketoconazole, erythromycin).

Taking Tamsulosin ratiopharm with food and beverages

Tamsulosin can be taken with or without food.

Pregnancy, lactation, and fertility

The use of tamsulosin is not indicated in women.

In men, abnormal ejaculation (ejaculation disorder) has been reported. This means that the semen does not exit through the urethra but instead enters the bladder (retrograde ejaculation), or the volume of the ejaculation is reduced or absent (failure to ejaculate). This phenomenon is harmless.

Driving and using machines

There is no evidence that tamsulosin affects the ability to drive or use machines. However, you should keep in mind that dizziness may occur. Only drive or use machines if you feel well.

3. How to take Tamsulosin ratiopharm

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

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

The tablet should be swallowed whole. It is important that you do not break or chew the tablet, as this may affect the action of tamsulosin.

Normally, tamsulosin is prescribed for long periods of time. The effects on the bladder and urination are maintained during long-term treatment with tamsulosin.

Use in children and adolescents

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

If you take more Tamsulosin ratiopharm than you should

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

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 medication and the amount ingested.

If you forget to take Tamsulosin ratiopharm

If you have forgotten to take tamsulosin as recommended, you can take your daily dose later on the same day. If you have missed a dose for a day, you can simply continue taking your daily tablet as prescribed. Do not take a double dose to make up for the missed doses.

If you stop taking Tamsulosin ratiopharm

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

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

4. Possible side effects

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

Severe adverse reactions are rare. Consult your doctor immediately if you suffer a severe allergic reaction that causes swelling of the face or throat (angioedema).

Common(may affect up to 1 in 10 people)

• Dizziness, especially when sitting or standing up

Abnormal ejaculation (ejaculation disorder). This means that the semen does not exit through the urethra but instead enters the bladder (retrograde ejaculation), or the volume of the ejaculation is reduced or absent (failure to ejaculate). This phenomenon is harmless.

Uncommon(may affect up to 1 in 100 people)

• Headache,
• rapid heartbeat and palpitations,
• decrease in blood pressure when standing up, which may cause dizziness, drowsiness, or fainting (orthostatic hypotension),
• nasal congestion and irritation (rhinitis),
• constipation, diarrhea,
• nausea or vomiting,
• skin rash, itching, and hives (urticaria),
• weakness (asthenia).

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

• Fainting (syncope).

• Widespread 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 skin disorder with blisters on the skin, mouth, eyes, and genitals (Stevens-Johnson syndrome).

Frequency not known(cannot be estimated from available data)

• Abnormal heart rhythm (atrial fibrillation, arrhythmia, tachycardia)
• difficulty breathing (dyspnea),
• vision problems (e.g., blurred vision, vision loss),
• nasal bleeding (epistaxis),
• dry mouth
• inflammatory skin disorder, pink spots with itching (erythema multiforme),
• redness and peeling of the skin (exfoliative dermatitis).

During eye surgery due to a condition called "Intraoperative Floppy Iris Syndrome" (IFIS), the following may occur: the pupil may not dilate properly, and the iris (the colored part of the eye) may become flaccid during surgery. For more information, see section 2 Warnings and precautions.

Reporting side effects:

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medicines Agency's website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Tamsulosin ratiopharm

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

Do not use this medication after the expiration date stated on the package after the abbreviation EXP. 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 wastewater or household waste. Deposit the packaging and medications you no longer need at the pharmacy's SIGRE point. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Tamsulosin ratiopharm

• The active substance 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, colloidal anhydrous silica, red iron oxide (E172), magnesium stearate.

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

Appearance of the product and package contents

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

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

Not all pack sizes may be marketed.

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 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 medication is authorized in the member states of the European Economic Area under the following names:

Netherlands: Tamsulosine HCl ratiopharm 0.4 mg, tabletten met verlengde afgifte

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 comprimidos de liberación prolongada EFG

France: Tamsulosine ratiopharm® L.P. 0.4 mg, comprimé pelliculé à libération prolongée

Hungary: Tamsulosin Teva ER 0.4 mg

Norway: Tamsulosin ratiopharm

Slovakia: Tamsulosin Teva ER 0.4 mg

Date of the last revision of this package leaflet:September 2023

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/