Prospect: Information for the patient

Tamsulosina Teva-ratiopharm 0.4 mg Modified Release Hard Capsules EFG

Read this prospect carefully before starting to take this medicine, because it contains important information for you.

-This medicine has been prescribed only for you, and you must 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 prospect. See section 4.

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

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

3. How to take Tamsulosina Teva-ratiopharm

4. Possible adverse effects

5. Storage of Tamsulosina Teva-ratiopharm

6.Contents of the pack and additional information

This medication contains hydrochloride of tamsulosin which reduces the tension of the muscles of the prostate and of the urethra allowing the passage of urine more easily.

This medication is used for the treatment of lower urinary tract discomforts associated with an enlargement of the prostate gland (benign prostatic hyperplasia).

The prostate gland surrounds the urethra (the tube by which urine passes from the bladder). If the gland enlarges, it can compress the urethra, interfering with the flow of urine.

Do not take Tamsulosina Teva-ratiopharm:

• if you are allergic to tamsulosin hydrochloride or to any other component of this medication (including in section 6). Symptoms may include swelling of the face and throat (angioedema).
• if you have a history of decreased blood pressure when standing up, which causes dizziness, mild fainting or fainting.
• if you have severe liver problems.

Warnings and precautions

Inform your doctor or pharmacist before taking Tamsulosina ratiopharm

• if you have severe kidney problems,
• if you experience dizziness or mild fainting while taking this medication. You should sit or lie down until the symptoms have disappeared. If you do not feel better, contact your doctor.
• if you experience sudden swelling of the hands or feet, swelling of the lips, tongue or throat, difficulty breathing and/or itching and skin rash, caused by an allergic reaction (angioedema) during the use of tamsulosin.
• if you are about to undergo eye surgery due to a cataract opacity, as some patients taking this medication have suffered Intraoperative Flaccid Iris Syndrome (IFIS). Your doctor may recommend that you interrupt treatment before surgery. Inform your surgeon if you have taken Tamsulosina Teva-ratiopharm before your operation.

Children and adolescents

Do not give this medication to children or adolescents under 18 years old because it does not work in this population.

Use of Tamsulosina Teva-ratiopharm with other medications

Inform your doctor or pharmacist if you are taking, have taken or may need to take any other medication. This is especially important in the case of:

• • Terazosin, doxazosin and/or any other alpha1A blocker medication (used to treat benign prostatic hyperplasia and high blood pressure). The association with these medications may cause a decrease in blood pressure.
• Diclofenac (a nonsteroidal anti-inflammatory drug) and warfarin (used to prevent blood clotting) may increase the elimination of tamsulosin from the body.
• Ketoconazole (used to treat fungal infections)

Taking Tamsulosina Teva-ratiopharm with food and drinks

Tamsulosin should be taken after the first meal of the day. If you take tamsulosin on an empty stomach, you may increase the risk of side effects, or increase the severity of these.

Fertility, pregnancy and breastfeeding

This medication is not indicated for women.

Problems with ejaculation (ejaculation failure or delayed ejaculation) have been reported.

Driving and operating machines

There is no evidence that tamsulosin affects the ability to drive or operate tools or machines. However, dizziness may occur, in which case, you should not perform activities that require concentration.

Tamsulosina Teva-ratiopharm contains sodium

This medication contains less than 23 mg of sodium (1 mmol) per capsule; that is, it is essentially "sodium-free".

Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

• The recommended dose is one capsule (0.4 mg of tamsulosina hydrochloride) per day, after the first meal of the day.
• The capsule should be taken while standing or sitting upright (not lying down) and should be swallowed whole with a glass of water.
• The capsule should not be chewed.

Your doctor has prescribed the appropriate dose for you and your condition, and has specified the duration of treatment. You should not change the dosage.

If you estimate that the effect of this medication is too strong or too weak, consult your doctor or pharmacist.

If you take more Tamsulosina Teva-ratiopharm than you should

Consult your doctor, pharmacist, or call the Toxicological Information Service, phone 91.562.04.20, indicating the medication and the amount taken.

If you forgot to take Tamsulosina Teva-ratiopharm

Do not take a double dose to compensate for the missed dose.If you forgot to take your daily capsuleafter the first meal of the day, you can take it on the same day.

If you have omitted a dose one day, simply continue taking your daily capsule as prescribed.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

If you experience any of the following allergic reactions, stop taking this medicine and immediately inform your doctor or go to the nearest hospital:

• Difficulty breathing
• Swelling of the face, tongue, or throat (angioedema)
• Itching and skin rash

Frequent (may affect up to 1 in 10 people)

• Dizziness, especially when sitting or standing up
• Sexual function disorders, including delayed ejaculation (ejaculation in the bladder) and inability to ejaculate

Occasional (may affect up to 1 in 100 people)

• Headache.
• Fast or irregular heartbeat (palpitations)
• Low blood pressure,
• Runny or blocked nose (rhinitis).
• Constipation,
• Diarrhea,
• Nausea,
• Vomiting,
• Skin rash,

• Itching,
• Redness, itching, or inflamed skin rash (urticaria),
• Feeling of weakness (asthenia)

Rare (may affect up to 1 in 1000 people)

• Syncope
• Swelling of hands or feet and soft body tissues (e.g., the throat or tongue)
• Difficulty breathing and/or itching and skin rash (angioedema)

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

• Persistent painful erection of the penis in the absence of sexual excitement (priapism).
• Severe inflammatory skin rash and mucous membrane lesions, due to an allergic reaction to medicines and other substances (Stevens-Johnson syndrome)

Frequency not known (cannot be estimated from available data)

• Nasal bleeding
• Blurred vision, vision problems.
• Dry mouth
• Severe skin rashes (erythema multiforme, exfoliative dermatitis)

If you are to undergo eye surgery due to a cataract opacity and are already taking or have taken tamsulosin during the surgery, the pupil may dilate slightly and the iris (the colored part of the eye), may become flaccid (see section 2).

In addition to the side effects mentioned earlier, the following adverse reactions associated with the use of tamsulosin have been reported:

•Irregular heartbeat

•Abnormal heart rhythm

•Fast heart rate

•Difficulty breathing

Since these reactions have been reported spontaneously from post-marketing experience worldwide, the frequency of these events and the role of tamsulosin in their causality cannot be determined with reliability.

Reporting of adverse reactions:

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is an adverse reaction that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: http://www.notificaram.es. By reporting adverse reactions, you can contribute to providing more information on the safety of this medicine.

Keep this medicationout of the sight and reach of children.

Do not use this medication after the expiration date that appears inthe box after CAD. The expiration date is the last day of the month indicated.

Blister: Store in the original packaging.

Keep the packaging perfectly closed.

Medications should not be thrown down the drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection pointof 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 Tamsulosina Teva-ratiopharm

• The active ingredient is hydrochloride of tamsulosina. Each modified-release hard capsule contains 0.4 mg of hydrochloride of tamsulosina.
• The other components are: microcrystalline cellulose, copolymer of methacrylic acid and ethyl acrylate (1:1), polysorbate 80, sodium lauryl sulfate, triethyl citrate, and talc.

The capsule body contains: gelatin, indigotin (E132), titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172), and black iron oxide (E172).

Appearance of the product and contents of the packaging

Tamsulosina Teva-ratiopharm 0.4 mg modified-release hard capsules are orange/green olive-colored capsules.

They are presented in blister packs or bottles with 10, 20, 28, 30, 50, 60, 90, 98, and 100 capsules.

Only some sizes of packaging may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Teva Pharma, S.L.U.

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

Alcobendas 28108 Madrid (Spain)

Responsible for manufacturing

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:

Austria: Tamsulsoin “ratiopharm”retard 0.4 mg-Kapsel

Denmark: Cepalux

Finland: Tamsumin 0.4 mg depotkapseli, kova

Germany: Tamsulosin-ratiopharm 0.4 mg Hartkapseln mit veränderter Wirkstofffreisetzung

Luxembourg: Tamsulosin-ratiopharm 0.4 mg Hartkapseln mit veränderter Wirkstofffreisetzung

Norway: Cepalux

Spain: Tamsulosina Teva-ratiopharm 0.4 mg modified-release hard capsules EFG

Last review date of this leaflet: December 2020

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