Tamsulosin Almus 0.4 mg modified-release hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Tamsulosina Almus 0.4 mg modified-release hard capsules EFG

Tamsulosin hydrochloride

Read the entire 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, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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. How to store Tamsulosina Almus 0.4 mg
6. Contents of the pack and other information

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

Tamsulosin is an alpha1A-adrenoceptor blocker. It works by relaxing the muscles in the prostate and urethra.

Tamsulosin is used to relieve urinary symptoms associated with an enlarged prostate (benign prostatic hyperplasia). It improves urine flow and facilitates urination by reducing muscle tension.

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

Do not take Tamsulosin Almus 0.4 mg

• If you are allergic to tamsulosin or to any of the other components of this medicine

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

(angioedema)).

• If you have experienced drops in blood pressure upon standing, which cause dizziness, lightheadedness, or fainting.
• If you have severe liver problems.

Warnings and precautions

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

• If you experience dizziness or lightheadedness, especially when standing up, Tamsulosin Almus may

lower your blood pressure, causing these symptoms. You should sit or lie down until the symptoms have passed.

• If you have severe kidney problems. The standard dose of tamsulosin may not have the expected

effect when kidneys are not functioning normally.

• If you are scheduled for eye surgery due to clouding of the lens

(cataracts) or increased eye pressure (glaucoma). An eye condition called Intraoperative Floppy Iris Syndrome (IFIS) may occur (see section 4, Possible side effects). Inform your ophthalmologist if you are currently taking or have previously taken

tamsulosin. Your doctor can then take appropriate precautions regarding medication and surgical techniques. Consult your doctor whether you should postpone or temporarily discontinue treatment prior to scheduled eye surgery for cataracts or glaucoma.

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

Children and adolescents

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

Taking Tamsulosin Almus 0.4 mg with other medicines

Tamsulosin may affect how other medicines work in the body, and some other medicines may affect how tamsulosin works. Therefore, it is important to inform 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 pharmacist if 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

Tamsulosin Almus should be taken 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 (ejaculatory disorder) has been reported. This means that semen does not exit through the urethra but enters the bladder (retrograde ejaculation), or that the volume of ejaculate is reduced or absent (ejaculatory insufficiency).

Driving and using machines

There are no data available on the potential of tamsulosin to affect the ability to drive or operate machinery. However, you should bear in mind that tamsulosin may cause dizziness and lightheadedness.

Drive or operate machinery 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, i.e., essentially “sodium-free”.

3. How to take Tamsulosin Almus 0.4 mg

Follow exactly the instructions given by your doctor for taking this medicine.

If in doubt, consult your doctor or pharmacist again.

The usual dose is one capsule daily, taken after breakfast or the first meal of the day.

The capsule must be swallowed whole, with a glass of water, while standing or sitting (you should not be lying down). It is important not to break or chew the capsule, so as not to interfere with the modified release of tamsulosin.

If you have mild to moderate kidney or liver disease, you may take the usual 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 prescribed. You may experience dizziness, weakness or fainting, vomiting, and diarrhea. Lie down to minimize the effects of low blood pressure and contact your doctor. Your doctor will administer medications to counteract the drop in blood pressure and fluid levels, and may monitor your body functions. If necessary, your doctor may perform gastric lavage and administer a laxative to eliminate any tamsulosin not yet absorbed into the bloodstream.

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

If you forget to take Tamsulosin Almus 0.4 mg

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

If you stop taking Tamsulosin Almus 0.4 mg

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

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.

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

• Rare adverse effects (may affect up to 1 in 1,000 patients): sudden swelling of any or all of the following: hands, feet, lips, tongue, throat causing difficulty breathing and/or itching and rash due to an allergic reaction (angioedema).

• Very rare adverse effects (may affect up to 1 in 10,000 patients): rash, inflammation and erosion of the skin and/or mucous membranes of the lips, eyes, mouth, nostrils or genitals (Stevens-Johnson syndrome).

• Adverse effects with unknown frequency (frequency cannot be estimated from available data): severe inflammation and skin erosion known as erythema multiforme.

Frequent adverse effects (may affect up to 1 in 10 patients)
Dizziness • abnormal ejaculation • retrograde ejaculation • inability to ejaculate.

Uncommon adverse effects (may affect up to 1 in 100 patients)
Headache • awareness of heartbeat (palpitations) • drop in blood pressure upon standing which may cause dizziness, lightheadedness or fainting (orthostatic hypotension) • nasal inflammation and irritation (rhinitis) • constipation • diarrhoea • feeling sick (nausea) • vomiting • rash • hives (urticaria) • feeling of weakness (asthenia) • itching.

Rare adverse effects (may affect up to 1 in 1,000 patients)
Fainting (syncope).

Very rare adverse effects (may affect up to 1 in 10,000 patients)
Painful erection (priapism).

Adverse effects with unknown frequency (frequency cannot be estimated from available data)
Blurred vision • vision loss • nosebleeds (epistaxis) • dry mouth.

During eye surgery due to lens opacity (cataracts) or increased eye pressure (glaucoma), an ocular condition called Intraoperative Floppy Iris Syndrome (IFIS) may occur: the pupil dilates poorly and the iris (the coloured circular part of the eye) becomes floppy during surgery. For more information, see section 2, Warnings and precautions.

Reporting of adverse effects:

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse 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 stated on the carton and blister after EXP. The expiry date refers to the last day of the month indicated.

Store in the original packaging.

Medicines should not be disposed of via wastewater or household waste. Return empty containers and any unused medicines to the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Tamsulosin Almus 0.4 mg

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

Capsule : Microcrystalline cellulose, methylacrylic acid-ethyl 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 Tamsulosin Almus 0.4 mg and contents of the pack

Modified-release hard capsules, orange/olive green in colour. The capsules contain white or yellowish granules.

Presented in blisters containing 30 modified-release capsules.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Almus Farmacéutica, S.A.U.

Marie Curie, 54

08840 Viladecans (Barcelona), Spain

Telephone: 93 739 71 80

Email: [email protected]

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 Prague 10

Czech Republic

Date of the most recent revision of this leaflet: February 2021

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