TAMSULOSIN ALMUS 0.4 mg MODIFIED-RELEASE HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Tamsulosin Almus 0.4 mg Modified Release Hard Capsules EFG

Tamsulosin Hydrochloride

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

1. What is Tamsulosin Almus 0.4 mg and what is it used for
2. What you need to know before you take Tamsulosin Almus 0.4 mg
3. How to take Tamsulosin Almus 0.4 mg
4. Possible side effects
5. Storage of Tamsulosin Almus 0.4 mg
6. Contents of the pack and further information

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

Tamsulosin is an alpha-1A adrenoceptor blocker. It works by relaxing the muscles in the prostate and the urethra.

Tamsulosin is used to relieve the urinary symptoms associated with an enlarged prostate (benign prostatic hyperplasia). It helps to improve the flow of urine and make it easier to urinate by reducing the tension in the muscles.

2. What you need to know before you take Tamsulosin Almus 0.4 mg

Do not take Tamsulosin Almus 0.4 mg

• If you are allergic to tamsulosin or any of the other ingredients of this medicine (listed in section 6) (symptoms may include: swelling of the face and throat

  (angioedema)).

• If you have had low blood pressure when standing up, which has caused dizziness, lightheadedness, or fainting.
• If you have severe liver problems.

Warnings and precautions

Talk to your doctor or pharmacist before taking Tamsulosin Almus 0.4 mg.

• If you experience dizziness or lightheadedness, especially when standing up, Tamsulosin Almus may cause a sudden drop in blood pressure, leading to these symptoms. You should sit or lie down until the symptoms have gone.
• If you have severe kidney problems. The normal dose of tamsulosin may not have the expected effect when the kidneys are not working properly.
• If you are going to have eye surgery due to cataracts or increased pressure in the eye (glaucoma). A condition called Intraoperative Floppy Iris Syndrome (IFIS) may occur. Inform your ophthalmologist if you are being treated with or have previously been treated with tamsulosin. Your doctor may take precautions with regard to the medication and surgical techniques used. Ask your doctor whether you should postpone or temporarily stop treatment when you have scheduled eye surgery for cataracts or increased pressure in the eye (glaucoma).

Before starting treatment with tamsulosin, your doctor should examine you to confirm that your symptoms are caused by an enlarged prostate.

Children and adolescents

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

Using Tamsulosin Almus 0.4 mg with other medicines

Tamsulosin may affect the way other medicines work, and some other medicines may affect the way tamsulosin works. Therefore, it is important to tell your doctor if you are taking:

• medicines that lower blood pressure (e.g., verapamil and diltiazem);
• medicines for treating HIV (e.g., ritonavir or saquinavir);
• medicines for treating fungal infections (e.g., ketoconazole, itraconazole, voriconazole, or fluconazole);
• medicines to prevent blood clotting (warfarin);
• anti-inflammatory medicines (e.g., diclofenac);
• medicines for treating infections (e.g., erythromycin, clarithromycin);
• immunosuppressants (e.g., cyclosporine).

Tell your doctor or pharmacistif you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.

Taking Tamsulosin Almus 0.4 mg with food and drink

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

Pregnancy, breastfeeding, and fertility

Tamsulosin Almus is not indicated for use in women.

In men, abnormal ejaculation (alteration in ejaculation) has been reported. This means that semen is not released through the urethra but instead goes into the bladder (retrograde ejaculation) or that the ejaculated volume is reduced or absent (ejaculatory failure).

Driving and using machines

No data are available on whether tamsulosin affects the ability to drive or use machines. You should be aware that tamsulosin may cause dizziness and lightheadedness.

Drive or use machines only if you feel well.

Tamsulosin Almus 0.4 mg contains sodium

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

3. How to take Tamsulosin Almus 0.4 mg

Take this medicine exactly as your doctor has told you.

If you are not sure, ask your doctor or pharmacist.

The usual doseis one capsule a day, taken after breakfastor after the first meal of the day.

Swallow the capsule wholewith a glass of water, while standing or sitting (do not lie down). It is important that you do not crush or chew the capsule, as this may interfere with the modified release of tamsulosin.

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

If you take more Tamsulosin Almus 0.4 mg than you should

Your blood pressure may drop suddenly if you take more tamsulosin 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 medication to counteract the drop in blood pressure and fluid levels and may monitor your body functions. If necessary, your doctor may perform a gastric lavage and administer a laxative to eliminate any tamsulosin that has not yet been absorbed into the bloodstream.

In case of overdose or accidental ingestion, go to the nearest hospital or contact the Toxicology Information Service, telephone 915 620 420, indicating the medicine and the amount taken. It is recommended to take the packaging and the leaflet of the medicine to the healthcare professional.

If you forget to take Tamsulosin Almus 0.4 mg

Do not take a double dose to make up for a forgotten dose. Simply take the next dose as prescribed.

If you stop taking Tamsulosin Almus 0.4 mg

If you stop taking Tamsulosin Almus 0.4 mg prematurely, your original symptoms may return. Therefore, take Tamsulosin Almus 0.4 mg for as long as your doctor prescribes it, even if your symptoms have disappeared. Always consult your doctor if you decide to stop treatment.

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.

Stop taking Tamsulosin and contact your doctor immediately if you experience any of the following symptoms:

• Rare side effects (may affect up to 1 in 1,000 people): sudden swelling of the hands, feet, lips, tongue, throat, which may cause difficulty breathing and/or itching and rash, caused by an allergic reaction (angioedema).

Rare side effects (may affect up to 1 in 10,000 people): rash, inflammation, and blistering of the skin and/or mucous membranes of the lips, eyes, mouth, nasal passages, or genitals (Stevens-Johnson syndrome).

• Side effects with frequency not known (frequency cannot be estimated from the available data): severe inflammation and blistering of the skin known as erythema multiforme.

Common side effects(may affect up to 1 in 10 people)

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

Uncommon side effects(may affect up to 1 in 100 people)

Headache • palpitations • low blood pressure when standing up, which may cause dizziness, lightheadedness, or fainting (orthostatic hypotension) • swelling and irritation inside the nose (rhinitis) • constipation • diarrhea • nausea • vomiting • rash • hives • feeling weak (asthenia) • itching.

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

Fainting (syncope).

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

Painful erection (priapism)

Side effects with frequency not known(frequency cannot be estimated from the available data)

Blurred vision • loss of vision • nosebleeds (epistaxis) • dry mouth.

During eye surgery due to cataracts or increased pressure in the eye (glaucoma), a condition called Intraoperative Floppy Iris Syndrome (IFIS) may occur: the pupil dilates weakly, and the iris becomes floppy during the procedure. For more information, see section 2, Warnings and precautions.

Reporting of side effects:

If you experience any side effects, talk to your doctor or pharmacist. This includes any 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 Tamsulosin Almus 0.4 mg

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

Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of the month shown.

Store in the original package.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and further information

Composition of Tamsulosin Almus 0.4 mg

• The active substance is tamsulosin hydrochloride 0.4 mg.
• The other ingredients are:

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

Body of the capsule: 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 Tamsulosin Almus 0.4 mg and contents of the pack

Modified release hard capsules, orange/greenish in color. The capsules contain white or yellowish granules.

Available in blisters of 30 modified release capsules.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Almus Pharmaceutical, S.A.U.

Marie Curie, 54

08840 Viladecans (Barcelona), Spain

Phone: 93 739 71 80

Email: farmacovigilancia@almusfarmaceutica.es

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

Date of last revision of this leaflet: February 2021

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/