Tamsulosin

• Relieves urinary symptoms of an enlarged prostate gland
• Intended solely for use in men
• Swallow capsule whole
• Not suitable for use in children

Tamsulosin is a type of medicine called an alpha-1 blocker. It works by relaxing the muscles in the prostate gland and the urethra. When the prostate enlarges, it places pressure on the bladder and the urethra. Relaxing these muscles allows urine to flow freely through the urethra, reducing the constant need to pass urine.

This medicine is used to treat lower urinary tract symptoms as a result of an enlarged prostate gland (benign prostatic hyperplasia, BPH). These symptoms include:

• Difficulty passing urine( weak or intermittent stream).
• Dribbling of urine after urinating.
• Urge to urinate after urinating.
• Increased need to urinate (during the day and at night).

This medicine is not suitable for use in children and adolescents under 18 years of age.

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Long-term use will be necessary in most cases for the beneficial urinary effects to be retained.

Dosage

The usual dose is one capsule once a day to be taken after breakfast or after the first meal of the day. Swallow the capsule whole with a drink of water while in an upright position (do not lie down). Do not crush or break the capsules.

Alcohol/driving

You should know that Tamsulosin may make you drowsy or dizzy. Do not drive a car, operate machinery or perform dangerous tasks until you know how this medicine affects you. Alcohol may intensify dizziness.

If you take more or less Tamsulosin than you should

If you take too many capsules by mistake, contact your doctor, pharmacist or your nearest hospital emergency department immediately. Take the package, any remaining capsules and the package leaflet with you, so that the medical staff know exactly what you have taken. Symptoms of overdose may include dizziness, fainting and headache.

If you miss a dose of Tamsulosin, take the missed dose after your next meal of the day. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule the next day. Do not take a double dose to make up for a forgotten dose.

Always consult your doctor before stopping the treatment.

Tamsulosin is not suitable for everyone. Do not take this medicine if:

• You are allergic to the active substance tamsulosin or any other ingredient in this medicine (see section 'What Tamsulosin contains').
• You have serious liver problems.
• You suffer from orthostatic hypotension, which is a form of low blood pressure that happens when standing after sitting or lying down, causing dizziness.

When should this medicine be used with extreme caution?

Do not use Tamsulosin without consulting a doctor first if:

• You suffer from severe kidney problems.
• You need to have cataract or glaucoma surgery. Be sure to tell your doctor that you are taking, will be taking or have taken Tamsulosin. Tamsulosin may cause complications during surgery. Your surgeon will take this into account.

Other warnings associated with the use of Tamsulosin:

• Your doctor will need monitor the symptoms you are being treated for.
• In rare cases, this medicine may cause lightheadedness and fainting, especially when you get up too quickly from a lying position. If you feel dizzy or weary, remain lying down until these symptoms have completely gone.
• Before you start taking this medicine it is important that your doctor examines you. The doctor can rule out other health problems with similar symptoms as BPH.

Pregnancy and breastfeeding

In principle, this medicine is not intended for use in women. Only use this medicine with your doctor’s approval if you are pregnant, planning to conceive or breastfeeding.

Other medicines and Tamsulosin

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines alongside Tamsulosin.

Be sure to consult your doctor or pharmacist if:

• You are taking medication for high blood pressure, such as verapamil or diltiazem.
• You are taking HIV medication, such as ritonavir or indinavir.
• You are taking medication for a fungal infection, such as ketoconazole or itraconazole.
• You are taking other alpha blockers, such as doxazosin, indoramin, prazosin or alfuzosin.
• You are taking an antibiotic called erythromycin for an infection.

Tamsulosin is known to interact with these medicines.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Some side effects can be serious. If you experience any of the following rare symptoms, call your doctor or hospital immediately as you may be having an allergic reaction:

Skin irritation, itching and red skin (especially if over the whole body), swelling of the face, tongue, lips, throat, difficulty breathing and swallowing (angioedema).
The side effects reported in association with the use of Tamsulosin include:

Common (may affect up to 1 in 10 people):

• Dizziness.
• Ejaculation problems.

Less common (may affect up to 1 in 100 people):

• Headache.
• Palpitations.
• Orthostatic hypotension (form of low blood pressure that happens when standing after sitting or lying down, causing dizziness).
• Runny nose or nasal congestion (rhinitis).
• Nausea and vomiting, diarrhoea, constipation.
• Allergic reactions, such as skin irritation, itching, local infections.
• Weakness or loss of strength.

Rare (may affect up to 1 in 1000 people):

• Fainting.
• Skin rash (over the whole body).

For a full list of the side effects reported with Tamsulosin, please see the package leaflet. If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

The active substance is tamsulosin hydrochloride. Each capsule contains 0.4 mg tamsulosin hydrochloride.

The other ingredients are:

Capsule content

Microcrystalline cellulose (E460), ethyl acrylatemethyl methacrylate copolymer (2:1), methacrylic acid-ethyl acrylate copolymer (1:1), polysorbate 80 (E433), sodium lauryl sulfate, talc (E553b), anhydrous colloidal silicon dioxide (E551).

Capsule shell

Gelatin, patent blue V (E131), titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172), black iron oxide (E172).
The manufacturers of Tamsulosin HCL Sandoz are:

Lek Pharmaceuticals d.d. Verovškova 57,
1526 Ljubljana
Slovenia

Salutas Pharma GmbH Otto-von-Guericke Allee 1
39179 Barleben
Germany

Lek S.A. Ul. Domaniewska 50C
02-672 Warsaw
Poland

Read the package leaflet before use. The official package leaflet of Tamsulosin is available for download here.