TAMSULOSIN PHARMAKERN 0.4 mg PROLONGED-RELEASE HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Tamsulosin Pharmakern 0.4 mg prolonged-release hard capsules EFG

Tamsulosin hydrochloride

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

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

• If you have any questions, consult your doctor or pharmacist.

• This medication has been prescribed to you and should not be given to others, even if they have the same symptoms as you, as it may harm them.

• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet.

Contents of the package leaflet:

1. What Tamsulosin Pharmakern is and what it is used for
2. What you need to know before taking Tamsulosin Pharmakern
3. How to take Tamsulosin Pharmakern
4. Possible side effects
5. Storage of Tamsulosin Pharmakern
6. Package contents and additional information

1. What Tamsulosin Pharmakern is and what it is used for

Tamsulosin Pharmakern belongs to a group of medications called alpha-1 receptor blockers, which reduces the tension of the prostate and urethra muscles.

This medication is indicated for the treatment of symptoms associated with benign prostatic hyperplasia, such as difficulty urinating, dripping, urgent urination, and frequent need to urinate both at night and during the day.

2. What you need to know before taking Tamsulosin Pharmakern

Do not take Tamsulosin Pharmakern

• If you are allergic to tamsulosin or have had an allergic reaction to tamsulosin or any other component of this medication.
• If you have orthostatic hypotension (dizziness due to a drop in blood pressure when sitting or standing up).
• If you have severe liver failure.

Warnings and precautions

• If you have severe kidney failure.
• Although rare, the use of Tamsulosin Pharmakern may cause fainting; if you experience symptoms of dizziness and weakness, sit or lie down until they disappear.

Consult your doctor, even if any of the above circumstances have occurred to you in the past.

Taking Tamsulosin Pharmakern with other medications

Tell your doctor or pharmacist that you are using or have recently used or may need to use any other medication.

Combination with other medications in the same group may cause a drop in blood pressure.

Diclofenac (an anti-inflammatory pain reliever) and warfarin (used to prevent blood clotting) may increase the elimination of tamsulosin from the body.

Pregnancy, breastfeeding, and fertility

Consult your doctor or pharmacist before using any medication.

Tamsulosin Pharmakern is administered only to males.

Driving and using machines

Due to the possibility of dizziness, you should exercise caution when driving or operating machinery.

3. How to take Tamsulosin Pharmakern

Follow these instructions unless your doctor has given you different instructions.

Remember to take your medication.

The normal dose is one capsule per day, taken orally.

The capsule should be taken after breakfast or the first meal of the day and swallowed whole without breaking or chewing, with a glass of water, while sitting or standing still (not lying down).

If you think the effect of Tamsulosin Pharmakern is too strong or too weak, tell your doctor or pharmacist.

If you take more Tamsulosin Pharmakern than you should

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount taken. It is recommended to bring the package and package leaflet of the medication to the healthcare professional.

Theoretically, acute hypotension may occur after an overdose.

When dealing with significant amounts, gastric lavage and administration of activated charcoal and an osmotic laxative such as sodium sulfate may be performed.

If you forget to take Tamsulosin Pharmakern

If you have forgotten to take your medication after breakfast or the first meal of the day, you can take it during the same day.

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

Do not take a double dose to make up for the missed dose.

If you stop taking Tamsulosin Pharmakern

Your doctor will indicate the duration of your treatment with Tamsulosin Pharmakern. Do not stop treatment before, as it may not have the expected effect.

4. Possible side effects

Like all medications, Tamsulosin Pharmakern may have side effects, although not everyone experiences them.

The frequencies of side effects have been listed below according to the following definitions:

Very common: May affect more than 1 in 10 people

Common: May affect up to 1 in 10 people

Uncommon: May affect up to 1 in 100 people

Rare: May affect up to 1 in 1,000 people

Very rare: May affect up to 1 in 10,000 people

• Common

Nervous system disorders: dizziness

• Uncommon

Nervous system disorders: headache

Cardiac disorders: tachycardia (faster than normal heartbeat)

Vascular disorders: postural hypotension (reduction in blood pressure, for example, when standing up quickly after sitting or lying down, sometimes associated with dizziness)

Respiratory disorders: rhinitis

Gastrointestinal disorders: constipation, diarrhea, nausea, vomiting

Skin and subcutaneous tissue disorders: exanthema, pruritus, urticaria (inflammatory process of a superficial skin area)

Reproductive system and breast disorders: ejaculation disorders

General disorders: asthenia (feeling of weakness and lack of vitality)

• Rare

Nervous system disorders: syncope (sudden and transient loss of consciousness)

Skin and subcutaneous tissue disorders: angioedema (inflammatory process of a deep skin area)

• Very rare

Reproductive system and breast disorders: priapism (persistent erection of the penis in the absence of sexual excitement)

• Frequency not known

Dry mouth

If you notice side effects not mentioned in this package leaflet or if you experience any of the side effects described in a severe form, tell your doctor or pharmacist.

5. Storage of Tamsulosin Pharmakern

Keep this medication out of sight and reach of children.

Do not store above 30 °C.

Do not use Tamsulosin Pharmakern after the expiration date indicated on the package after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packages and medications you no longer need at the SIGRE point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packages and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Tamsulosin Pharmakern

• The active ingredient is tamsulosin. Each capsule contains 0.4 mg of tamsulosin hydrochloride, equivalent to 0.367 mg of tamsulosin.

• The other components (excipients) are: sodium alginate (E401), methacrylic acid and ethyl acrylate copolymer (1:1), dibehenate, maltodextrin, sodium lauryl sulfate, polyethylene glycol, polysorbate 80 (E433), sodium hydroxide (E524), simethicone emulsion, anhydrous colloidal silica, gelatin, red iron oxide (E172), titanium dioxide (E171), and yellow iron oxide (E172).

Appearance of the product and package contents

Tamsulosin Pharmakern is presented in the form of prolonged-release hard capsules. They are orange-colored gelatin hard capsules, with i-snap, containing white-yellowish granules. Each package contains 30 capsules.

Marketing authorization holder

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Manufacturer

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

or

Bluepharma – Indústria Farmacéutica S.A.

Sâo Martinho do Bispo

3045-016 Coimbra

Portugal

Date of the last revision of this package leaflet: November 2013

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