Leaflet: information for the user

Tamsulosina Almus 0.4 mg modified-release hard capsules EFG

Tamsulosin hydrochloride

Read this leaflet carefully before you start taking this medicine because

it contains information for you.

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

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

- This medicine has been prescribed for you only. Do not pass it on to others even if they have the same symptoms as you, as it may harm them.

- If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What Tamsulosina Almus 0.4 mg is and what it is used for

2. What you need to know before taking Tamsulosina Almus 0.4 mg

3. How to take Tamsulosina Almus 0.4 mg

4. Possible side effects

5. Storage of Tamsulosina Almus 0.4 mg

6. Contents of the pack and additional information

Tamsulosina is an alpha1A-adrenoreceptor blocker.It acts by relaxing the muscles of the prostate and the urethra.

Tamsulosina is used to relieve urinary symptoms associated with an enlarged

prostate (benign prostatic hyperplasia).It facilitates urine flow through the urethra and urination by reducing muscle tension.

Do not take Tamsulosina Almus 0.4 mg

·If you areallergic to tamsulosina or any of the other componentsof this medication

(including those listed in section 6) (symptoms may include:swelling of the face and throat

(angioedema)).

·If you have experiencedlow blood pressure when standing up, which causesvertigo, dizziness, or fainting.

·If you havesevere liver problems.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Tamsulosina Almus 0.4 mg.

·If you experiencevertigo or dizziness, especially when standing up, Tamsulosina Almus may

reduce blood pressure, causing these symptoms. You should sit or lie down until they have disappeared.

·If you havesevere kidney problems. The normal dose of tamsulosina may not have the expected effect when the kidneys do not function normally.

·If you are to undergo eye surgery due to opacity of the lens

(cataracts) or increased pressure in the eye (glaucoma). It may cause an eye condition called Intraoperative Flaccid Iris Syndrome (see section 4, Possible side effects).

Inform your ophthalmologist if you are being treated or have previously been treated with tamsulosina. Your doctor will then take the necessary precautions regarding medication and surgical techniques. Consult your doctor if you should postpone or interrupt treatment temporarily when you have a scheduled eye surgery

programmed for lens opacity (cataracts) or increased pressure in the eye (glaucoma).

Before starting therapy with tamsulosina, your doctor should examine you to confirm that the symptoms are actually caused by an increase in the size of the prostate.

Children and adolescents

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

Use of Tamsulosina Almus 0.4 mg with other medications

Tamsulosina may affect the way other medications work in our body and some other medications may affect the way Tamsulosina acts. Therefore, it is

important to inform your doctor if you are taking:

·blood pressure-lowering medications (e.g. verapamil and diltiazem);

·medications to treat HIV (e.g. ritonavir or saquinovir);

·medications to treat fungal infections (e.g.: ketoconazol, itraconazol, voriconazol or fluconazol);

·blood-thinning medications (warfarina);

·anti-inflammatory medications (e.g. diclofenaco);

·medications to treat infections (e.g. eritromicina, claritromicina);

·immunosuppressants (e.g. ciclosporina).

Inform your doctor or pharmacistif you are taking, have taken recently, or may take

any other medication, including those acquired without a prescription.

Taking Tamsulosina Almus 0.4 mg with food and drinks

It is recommended to take Tamsulosina Almus with a glass of water after breakfast or after the first meal of the day.

Pregnancy, breastfeeding, and fertility

Tamsulosina Almus is not indicated for use in women.

In men, abnormal ejaculation (alteration in ejaculation) has been reported. This means that semen does not release through the urethra, but goes to the bladder (retrograde ejaculation) or that the ejaculated volume is reduced or non-existent (ejaculatory insufficiency).

Driving and operating machinery

No data are available on the possibility that tamsulosina may affect the ability to drive and operate machinery. You should be aware that tamsulosina may cause dizziness and vertigo.

Drive or operate machinery only if you feel well.

Tamsulosina Almus 0.4 mg contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per capsule, which is essentially “sodium-free”.

Follow exactly the administration instructions for this medication as indicated by your doctor.

In case of doubt, consult your doctor or pharmacist again.

Theusual doseis one capsule per day, takenafter breakfastor the first meal of the day.

The capsule should be swallowedwhole, with a glass of water, while standing or sitting (do not lie down). It is essential that

you do not break or chew the capsule

, to avoid interfering with the modified release of tamsulosina.

If you have mild to moderate kidney or liver disease, you can take the usual dose of tamsulosina.

If you take more Tamsulosina Almus 0.4 mg than you should

Your blood pressure may drop suddenly if you take more tamsulosina than you should. You may experience dizziness, weakness, or fainting, vomiting, and diarrhea. Lie down to minimize the effects of the drop in blood pressure and contact your doctor. Your doctor will give you medications to counteract the drop in blood pressure and fluid levels, and may monitor your bodily functions. When necessary, your doctor will perform a gastric lavage and administer a laxative to eliminate amounts of tamsulosina that have not yet been absorbed into the blood.

In case of overdose or accidental ingestion, go to the nearest hospital or consult the Toxicological Information Service, phone 915 620 420, indicating the medication and the amount ingested. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

If you forgot to take Tamsulosina Almus 0.4 mg

Do not take a double dose to compensate for the missed dose, simply take the next dose as prescribed.

If you interrupt treatment with Tamsulosina Almus 0.4 mg

When treatment with Tamsulosina Almus 0.4 mg is discontinued prematurely, your original symptoms may return. Therefore, take Tamsulosina Almus 0.4 mg 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 medication, ask your doctor or pharmacist.

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

Discontinue treatment with Tamsulosina and contact your doctor immediately if you experience any of the following symptoms:

·Rare side effects (may affect up to 1 in 1,000 patients): sudden swelling of any or all of the following: hands, feet, lips, tongue, throat, which causes

difficulty breathing and/or itching and rash, caused by an allergic reaction (angioedema).

·Very rare side effects (may affect up to 1 in 10,000 patients): rash,

inflammation and abrasion of the skin and/or mucous membranes of the lips, eyes, mouth, nasal passages, or genitals (Stevens-Johnson syndrome).

·Side effects of unknown frequency (frequency cannot be estimated from available data): severe inflammation and abrasion of the skin known as erythema multiforme.

Frequent side effects(may affect up to 1 in 10 patients)

Dizziness • abnormal ejaculation • retrograde ejaculation • inability to ejaculate.

Infrequent side effects(may affect up to 1 in 100 patients)

Headache • palpitations • reduction in blood pressure upon standing that may cause dizziness, dizziness, or fainting (orthostatic hypotension) • swelling and irritation in the nasal passages (rhinitis) • constipation • diarrhea • nausea • vomiting • rash • hives (urticaria) • feeling of weakness (asthenia) • itching.

Rare side effects(may affect up to 1 in 1,000 patients)

Fainting (syncope).

Very rare side effects(may affect up to 1 in 10,000 patients)

Painful erection (priapism)

Side effects of unknown frequency(frequency cannot be estimated from available data)

Blurred vision • loss of vision • nasal bleeding (epistaxis) • dry mouth.

During eye surgery due to cataracts or an increase in eye pressure (glaucoma) may cause a visual alteration called Intraoperative Iris Flaccidity Syndrome (SIFI): the pupil dilates weakly and the iris (the colored part of the eye) becomes flaccid during the procedure. For more information, see section 2, Warnings and precautions.

Reporting of side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute toproviding 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 and blister after CAD. The expiration date is the last day of the month indicated.

Store in the original packaging.

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 pointofthe 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 Almus 0.4 mg

·The active ingredient is tamsulosin hydrochloride 0.4 mg.

·The other components are:

Capsule: Microcrystalline cellulose, methacrylic acid-acrylate copolymer (1:1) dispersion 30 percent, polysorbate 80, sodium lauryl sulfate, triethyl citrate, talc.

Capsule shell: Gelatin, indigo carmine (E 172), titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E 172), black iron oxide (E 172).

Appearance of Tamsulosina Almus 0.4 mg and content of the container

Hard capsules with modified release of orange-green olive color. The capsules contain white or yellowish granules.

It is presented in blisters with 30 modified release capsules.

Holder of the marketing authorization and responsible manufacturer

Holderof the marketing authorization

Almus Farmacéutica, S.A.U.

Marie Curie, 54

08840 Viladecans (Barcelona), Spain

Phone: 93 739 71 80

Email: [email protected]

Responsible manufacturer

Synthon Hispania S.L.

Castelló, 1

Polígono las Salinas

08830 Sant Boi de Llobregat

Spain

Synthon BV

Microweg 22,

6545 CM Nijmegen

Netherlands

Quinta-Analytica s.r.o.

Prazska 1486/18 c -102 00 Praga 10

Czech Republic

Last review date of this leaflet: February 2021

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