RURIK 0.4 мг Капсулы с модифицированным высвобождением

Содержание инструкции

1. RURIK
   1. What is RURIK and what is it used for
   2. What you need to know before you take RURIK
   3. How to take RURIK
   4. Possible side effects
   5. How to store RURIK
   6. Contents of the pack and other information

RURIK

0.4 mg modified-release hard capsules
Tamsulosin hydrochloride

Read this leaflet carefully before using this medicine because it contains
important information for you

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed only for you. Do not give it to other people, even if their symptoms are the same as yours, as it could be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See Section 4.

Contents of this leaflet:

• 1. What RURIK is and what it is used for
• 2. What you need to know before you take RURIK
• 3. How to take RURIK
• 4. Possible side effects
• 5. How to store RURIK
• 6. Contents of the pack and other information

1. What is RURIK and what is it used for

Tamsulosin is an alpha-adrenergic receptor blocker that relaxes the muscles of the prostate and
the urinary tract.
Tamsulosin is prescribed to relieve urinary symptoms caused by prostate enlargement
(benign prostatic hyperplasia). By relaxing the muscles, it allows for easier passage
of urine and therefore facilitates urination.

2. What you need to know before you take RURIK

Do not take RURIK:

• If you are allergic to tamsulosin or any of the other ingredientsof this medicine(listed in section 6) (symptoms may include: swelling of the face and throat(angioedema));
• If you have a history of low blood pressure when changing to an upright position, causing dizziness, lightheadedness or fainting;
• If you have severe liver disorders.

Warnings and precautions:
Talk to your doctor or pharmacist before using RURIK

• if you experience dizziness or lightheadedness, especially after moving to the
  upright position. Tamsulosin can lower blood pressure, causing these symptoms. In this case, you should sit or lie down until the symptoms disappear;
• if you suffer from severe kidney disorders. The normal dose of tamsulosin may not have the expected effect if the kidneys do not have normal function;
• if you are going to have eye surgeryfor cataracts (clouding of the lens) or glaucoma (increased pressure inside the eye). A condition affecting the eyes called iris flag syndrome may occur (see section 4, Possible sideeffects); inform your ophthalmologist if you are using or have used tamsulosin hydrochloride in the past. In this case, the specialist may take appropriate precautions regarding the medication and surgical techniques to be used. Ask your doctor if you should postpone or temporarily interrupt taking this medicine before undergoing surgery for cataracts (clouding of the lens) or glaucoma (increased pressure inside the eye).

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

Children and adolescents
Do not give this medicine to children or adolescents under 18 years of age because it is not effective on
this population.

Other medicines and RURIK

• Tamsulosin can affect the action of other medicines and these, in turn, can affect the action of tamsulosin. Therefore, it is important to inform your doctor if you are taking:
• medicines for lowering blood pressure (e.g. verapamil and diltiazem);
• medicines for the treatment of HIV (e.g. ritonavir or saquinavir);
• medicines for the treatment of fungal infections (e.g. ketoconazole, itraconazole, voriconazole or fluconazole);
• medicines for blood clotting (e.g. warfarin);
• anti-inflammatory drugs (e.g. diclofenac);
• medicines for the treatment of infections (e.g. erythromycin, clarithromycin);
• immunosuppressants (e.g. cyclosporine)

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

RURIK with food and drink
You should take tamsulosin with a glass of water after breakfast or after the first meal
of the day.

Pregnancy, breastfeeding and fertility
Tamsulosin is not indicated in female patients.
In men, abnormalities in ejaculation (ejaculation disorders) have been detected. This means
that semen does not come out through the urethra but through the bladder (retrograde ejaculation) or the
volume of ejaculate is reduced or absent (insufficient ejaculation).

Driving and using machines
There is no information on the effects of tamsulosin on the ability to drive vehicles and operate
machinery. You should consider that this medicine can cause dizziness and confusion,
therefore drive or operate machinery only if you feel well.
RURIK contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e. essentially
“sodium-free”.

3. How to take RURIK

Always take this medicine exactly as your doctor has instructed. If you have any doubts, consult your doctor or pharmacist.
The usual doseis one capsule a day to be taken after breakfastor after the first
meal of the day.
Swallow the capsule wholewith a glass of water, in a sitting or upright position (not lying down).
It is important that you do not break or crush the capsule, in order not to affect the action of tamsulosin.
If you suffer from mild to moderate hepatic or renal insufficiency, you can take the normal dose of
tamsulosin.

If you take more RURIK than you should
If you take more tamsulosin than you should, your blood pressure may drop suddenly and
you may experience dizziness, weakness, fainting, vomiting and diarrhea. Lie down to minimize the
effects of low blood pressure and consult your doctor, who may administer
medicines to restore your blood pressure and fluid levels, and monitor your
body functions. If necessary, your doctor may have your stomach emptied and administer a
laxative to eliminate all the tamsulosin that has not yet entered the bloodstream.

If you forget to take RURIK
Do not take a double dose to make up for a missed dose. Simply take the
next dose at the usual time.

If you stop taking RURIK
When treatment with tamsulosin is stopped prematurely, the original disorders
may recur. Therefore, use tamsulosin for the entire time indicated by your doctor even if the
disorders may already seem to have disappeared. Always consult your doctor if you think about stopping the
therapy.
If you have any further questions about 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.
Do not take Tamsulosina and contact your doctor immediately if you experience the following effects:

Common side effects(may affect up to 1 in 10 people)
Dizziness • Abnormal ejaculation; retrograde ejaculation; missing ejaculation.

Uncommon side effects(may affect up to 1 in 100 people)
Headache • Feeling of noticing the heartbeat (palpitations) • Lowering of blood
pressure when standing up which causes dizziness, lightheadedness or fainting (orthostatic
hypotension) • Nasal congestion and irritation (rhinitis) • Constipation • Diarrhea • Feeling sick (nausea) • Vomiting • Skin rash • Hives • Feeling of weakness (asthenia) • Itching.

Rare side effects(may affect up to 1 in 1,000): sudden swelling of one
or all of the following parts: hands, feet, lips, tongue, throat which can cause difficulty in
breathing and/or itching, rash, due to an allergic reaction (angioedema);
Fainting (syncope).

Very rare side effects(may affect up to 1 in 10,000)
Pain during erection (priapism). 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 unknown frequency(frequency cannot be estimated from available data)
Blurred vision• loss of vision •nosebleed •dry mouth, a severe inflammation and blistering of the skin known as erythema multiforme.
During an eye surgery due to clouding of the lens (cataract) or
increased pressure in the eye (glaucoma) a condition called
iris flag syndrome (IFIS) may occur: the pupil may dilate insufficiently and the iris (the colored part
of the eye) may flutter during the operation. For further information,
see section 2, Warnings and precautions.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. You can also report side effects directly through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the safety
of this medicine .

5. How to store RURIK

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 packaging and on the blister after
'Exp'. The expiry date refers to the last day of that month.
Store the blisters in the original packaging.
Keep the container tightly closed.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What RURIK contains

• The active ingredient is tamsulosin hydrochloride 0.4 mg.
• The other excipients are: Capsule:microcrystalline cellulose, ethyl acrylate and methacrylic acid copolymer (1:1) dispersion 30%, polysorbate 80, sodium lauryl sulfate, triethyl citrate, talc; Capsule body:gelatin, indigo carmine (E132), titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172), black iron oxide (E172).

Description of the appearance of RURIK and contents of the pack
Modified-release capsules of orange/olive-green color. The capsules contain granules of
color from white to off-white.
They are supplied in packs with blisters or containers containing 10, 14, 20, 28, 30, 50, 56, 60, 90, 100 or 200
modified-release capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
S.F. Group S.r.l.
Via Tiburtina, 1143
00156 Rome
Italy

Manufacturer
SYNTHON BV
Microweg 22, 6545 CM Nijmegen (Netherlands)
SYNTHON HISPANIA S.L.
Castell ó 1 Pol í gono Las Salinas 08830 Sant Boi de Llobregat (Spain)

This medicinal product is authorised in the member states of the EEA under the following
names:
Italy: RURIK 0.4 mg modified-release hard capsules
Finland: Tamsu-Anlini 0.4 mg säädellysti vapauttava kapseli, kova
Poland: Tamur
Spain: TAMSULOSINA ALMUS 0.4 mg cápsulas duras de liberación modificada EFG