Leaflet: information for the user

Tamsulosina Pharmakern 0.4 mg modified-release hard capsules EFG

Tamsulosin hydrochloride

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

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

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

• This medicine has been prescribed for 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 any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet.

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

2.What you need to know before you start taking Tamsulosina Pharmakern

3.How to take Tamsulosina Pharmakern

4.Possible side effects

5.Storage of Tamsulosina Pharmakern

6.Contents of the pack and additional information

Tamsulosina Pharmakern belongs to a group of medicines called alpha blockers?1which reduces the tension of the muscles of the prostate and of the urethra.

This medicine is indicated for the treatment of the discomforts proper to benign prostatic hyperplasia such as: difficulties in urination, dribbling, urgent urination and the need to urinate frequently both at night and during the day.

Do not take Tamsulosina Pharmakern

• If you are allergic to tamsulosina or have had any allergic reaction to tamsulosina or to 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 rarely, the use of Tamsulosina Pharmakern may cause fainting, if you experience dizziness and weakness, sit or lie down until the symptoms have disappeared.

Consult your doctor, even if any of the circumstances mentioned above have occurred at any time.

Taking Tamsulosina Pharmakern with other medications

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

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

Diclofenac (a pain-relieving anti-inflammatory) and warfarin (used to prevent blood clotting) may increase the elimination of tamsulosina from the body.

Pregnancy, breastfeeding, and fertility

Consult your doctor or pharmacist before using any medication.

Tamsulosina Pharmakern is administered only to males.

Driving and operating machinery

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

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

Remember to take your medication.

The usual dose is one capsule per day. It should be 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 remaining still (do not lie down).

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

If you take more Tamsulosina Pharmakern than you should

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

Theoretically, an acute hypotension could 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 proceeded with.

If you forgot to take Tamsulosina Pharmakern

If you forgot 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, simply continue taking your daily capsule as prescribed.

Do not take a double dose to compensate for the missed dose.

If you interrupt treatment with Tamsulosina PharmakernPharmakern

Your doctor will inform you of the duration of your treatment with Tamsulosina Pharmakern. Do not discontinue treatment beforehand, as it may not have the expected effect.

Like all medications, Tamsulosina Pharmakern may have adverse effects, although not everyone may experience them.

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

Very frequent: May affect more than 1 in 10 people

Frequent: May affect up to 1 in 10 people

Infrequent: 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

• Frequent

Nervous system disorders: dizziness

• Infrequent

Nervous system disorders: headache

Cardiac disorders: tachycardia (heart rate is faster than normal)

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

Respiratory disorders: rhinitis

Gastrointestinal disorders: constipation, diarrhea, nausea, vomiting

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

Reproductive and breast disorders: ejaculation disturbances

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

• Rare

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

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

• Very rare

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

• Unknown frequency

Dry mouth

If you notice any adverse effects not mentioned in this leaflet or if you experience any of the adverse effects described severely, inform your doctor or pharmacist.

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

Do not store at a temperature above 30 °C.

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

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection point at the pharmacy.If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need.By doing so, you will help protect the environment.

Composition of Tamsulosina Pharmakern

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

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

Appearance of the product and contents of the packaging

Tamsulosina Pharmakern is presented in the form of hard, modified-release capsules. They are hard gelatin capsules of orange color, coni-snap, containing white-yellowish granules. Each package contains 30 capsules.

Holder of the marketing authorization

Kern Pharma, S.L.

Venus, 72 - Pol. Ind.Colón II

08228 Terrassa - Barcelona

Spain

Responsible for manufacturing

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

Last review date of this leaflet: November 2013

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