Rurik

Package Leaflet: Information for the User

RURIK

0.4 mg modified-release hard capsules
Tamsulosin hydrochloride
Read this entire 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 for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, 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 taking 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 RURIK is and what it is used for

Tamsulosin is an alpha-adrenergic receptor blocker that relaxes the smooth muscle of the prostate and urinary tract.
Tamsulosin is prescribed to relieve urinary symptoms caused by prostate enlargement (benign prostatic hyperplasia). By relaxing the smooth muscle, it allows urine to pass more easily and thus facilitates urination.

2. What you need to know before taking RURIK

Do not take RURIK:

• If you are allergic to tamsulosin or to any of the other ingredients of 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 upon standing up, causing dizziness, lightheadedness or fainting;
• If you have severe liver problems.

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

• if you experience dizziness or lightheadedness, especially when standing up. Tamsulosin may lower blood pressure, causing these symptoms. In such cases, you should sit or lie down until symptoms resolve;
• if you have severe kidney problems. The standard dose of tamsulosin may not have the intended effect if kidney function is impaired;
• if you are scheduled for eye surgery due to cataracts (lens opacity) or increased intraocular pressure (glaucoma). A 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 hydrochloride. In such cases, the specialist may take appropriate precautions regarding the medication and surgical techniques. Ask your doctor whether you should delay or temporarily stop taking this medicine before undergoing surgery for cataracts or glaucoma.

Before starting treatment with tamsulosin, your doctor should examine you to confirm that your symptoms are actually 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.
Other medicines and RURIK

• Tamsulosin may affect the action of other medicines, and other medicines may affect the action of tamsulosin. Therefore, it is important to inform your doctor if you are taking:
• medicines to lower blood pressure (e.g. verapamil and diltiazem);
• medicines for the treatment of HIV (e.g. ritonavir or saquinavir);
• medicines for fungal infections (e.g. ketoconazole, itraconazole, voriconazole or fluconazole);
• medicines for blood thinning (e.g. warfarin);
• anti-inflammatory medicines (e.g. diclofenac);
• medicines for the treatment of 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.
RURIK with food and drink
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 for use in female patients.
In men, abnormalities in ejaculation (ejaculation disorders) have been reported. This means that semen does not exit through the urethra but enters the bladder (retrograde ejaculation), or the volume of ejaculate is reduced or absent (inadequate ejaculation).
Driving and using machines
There is no information available on the effects of tamsulosin on the ability to drive vehicles or operate machinery. You should bear in mind that this medicine may 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 instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.
The usual dose is one capsule daily, taken after breakfast or after the first meal of the day.
Swallow the capsule whole with a glass of water, while sitting or standing upright (not lying down).
It is important that you do not break or crush the capsule, to avoid affecting the action of tamsulosin.
If you have mild to moderate liver or kidney impairment, you may still take the normal dose of tamsulosin.

If you take more RURIK than you should
If you take more tamsulosin than recommended, 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 empty your stomach and give you a laxative to eliminate any tamsulosin not yet absorbed into 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 your usual scheduled time.

If you stop taking RURIK
If treatment with tamsulosin is stopped earlier than recommended, your original symptoms may return. Therefore, continue taking tamsulosin for the full duration indicated by your doctor, even if symptoms seem to have disappeared. Always consult your doctor if you are considering stopping the treatment.

If you have any doubts about how to use this medicine, consult 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 Tamsulosin and contact your doctor immediately if you experience any of the following side effects:

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

Uncommon side effects (may affect up to 1 in 100 people)
Headache • Awareness of heartbeat (palpitations) • Drop in blood pressure upon standing causing dizziness, feeling of emptiness in the head or fainting (orthostatic hypotension) • Nasal swelling and irritation (rhinitis) • Constipation • Diarrhea • Feeling unwell (nausea) • Vomiting • Rash • Urticaria • Feeling of weakness (asthenia) • Itching.

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

Very rare side effects (may affect up to 1 in 10,000 people)
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 not known (frequency cannot be estimated from the available data)
Blurred vision • vision loss • epistaxis • dry mouth, a severe inflammation and blistering of the skin known as erythema multiforme.

During eye surgery due to clouding of the lens (cataract) or increased eye pressure (glaucoma), a condition called Intraoperative Floppy Iris Syndrome (IFIS) may occur: the pupil may fail to dilate sufficiently and the iris (the coloured circular part of the eye) may flutter during surgery. For further information, see section 2, Warnings and precautions.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via 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 stated on the packaging and blister after 'Exp'. The expiry date refers to the last day of that month.
Store blisters in the original packaging.
Keep the container tightly closed.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What RURIK contains

• The active substance is tamsulosin hydrochloride 0.4 mg.
• The other excipients are: Capsule: microcrystalline cellulose, ethyl acrylate and methacrylic acid copolymer (1:1) 30% dispersion, polysorbate 80, sodium lauryl sulfate, triethyl citrate, talc; Capsule shell: 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 the contents of the pack
Modified-release orange/green-olive coloured capsules. The capsules contain granules which are white to off-white in colour.
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 Authorization 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.
Castelló 1 Polígono Las Salinas 08830 Sant Boi de Llobregat (Spain)

This medicinal product is authorized in EEA Member States under the following names:
Italy: RURIK 0.4 mg modified-release hard capsules
Finland: Tamsu-Anlini 0.4 mg prolonged-release capsule, hard
Poland: Tamur
Spain: TAMSULOSINA ALMUS 0.4 mg modified-release hard capsules EFG

This Patient Information Leaflet was last revised on