Tamsulosin Zentiva Italia
Italy
Table of Contents
PACKAGE LEAFLET: INFORMATION FOR THE USER
Tamsulosin Zentiva Italia 0.4 mg modified-release hard capsules
Generic medicine
Please read this leaflet carefully before taking 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 other people, even if they have the same symptoms as you, because it could be harmful.
- If you experience any side effects, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.
Contents of this leaflet:
- What Tamsulosin Zentiva Italia is and what it is used for
- What you need to know before taking Tamsulosin Zentiva Italia
- How to take Tamsulosin Zentiva Italia
- Possible side effects
- How to store Tamsulosin Zentiva Italia
- Contents of the pack and other information
1. What Tamsulosina Zentiva Italia is and what it is used for
Tamsulosina Zentiva Italia contains the active substance tamsulosin, which reduces the tension of the muscles in the prostate and urethra. This allows urine to flow more easily through the urethra, thus facilitating urination.
Tamsulosina Zentiva Italia is used in men for the treatment of difficulties associated with benign enlargement of the prostate, such as: difficulty urinating, reduced urinary stream, strong urge to urinate, frequent urination during both night and day.
2. What you need to know before taking Tamsulosina Zentiva Italia
Do not take Tamsulosina Zentiva Italia
- if you are allergic to tamsulosin or to any of the other ingredients of this medicine (listed in section 6).
- if you have experienced angioedema after taking certain medicines (swelling due to an allergic reaction).
- if you have severe liver problems.
- if you suffer from dizziness when sitting or standing up from a lying position.
Warnings and precautions
Talk to your doctor or pharmacist before taking Tamsulosina Zentiva Italia.
Regular medical check-ups are necessary during long-term treatment with this medicine.
Low blood pressure has been reported infrequently during treatment with Tamsulosina Zentiva Italia. If you feel dizzy, you should sit or lie down until symptoms disappear.
Caution is advised if you have severely impaired kidney function, as there are insufficient data from clinical studies in patients with severe renal impairment.
Angioedema (swelling caused by an allergic reaction) has been reported rarely after using tamsulosin (the active substance in Tamsulosina Zentiva Italia). If angioedema occurs, seek immediate medical attention and discontinue Tamsulosina Zentiva Italia. The medicine must not be readministered.
If you are scheduled for cataract or glaucoma surgery, inform your doctor that you are currently taking or have recently taken Tamsulosina Zentiva Italia.
Your specialist may then take appropriate precautions regarding the medications and surgical techniques to be used. Ask your doctor whether you need to postpone or temporarily stop taking this medicine before undergoing eye surgery due to clouding of the lens (cataract) or increased eye pressure (glaucoma).
Caution is required if you have previously experienced discomfort during or after urination (post-micturition syncope).
Children and adolescents
Do not administer this medicine to children and adolescents under 18 years of age, as it is not effective in this population.
Other medicines and Tamsulosina Zentiva Italia
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Other medicines may interact with tamsulosin. In turn, they may affect how well tamsulosin works. Tamsulosin interacts with:
- Diclofenac, a pain-relieving and anti-inflammatory medicine. This medicine may accelerate the elimination of tamsulosin from the body, shortening the time during which tamsulosin is effective.
- Warfarin, a medicine used to prevent blood clots. This medicine may accelerate the elimination of tamsulosin from the body, shortening the time during which tamsulosin is effective.
- Other α-adrenoreceptor antagonists. The combination may reduce blood pressure, causing dizziness or lightheadedness.
- Medicines that may reduce the elimination of Tamsulosina Zentiva Italia from the body (e.g. ketoconazole, erythromycin).
Tamsulosina Zentiva Italia with food and drink
Take the capsule after breakfast or after the first main meal of the day. Swallow the capsule whole, while sitting or standing, with a glass of water. Do not open, break, or chew the capsule.
Pregnancy, breastfeeding and fertility
Pregnancy and breastfeeding
Tamsulosina Zentiva Italia is intended only for use in men; therefore, information regarding pregnancy and breastfeeding is not applicable.
Fertility
Ejaculation difficulties have been reported in association with the use of tamsulosin (see section 4).
Driving and using machines
Dizziness may occur during treatment. Therefore, activities requiring high attention should only be performed if permitted by your doctor.
Tamsulosina Zentiva Italia contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e. essentially "sodium-free".
3. How to take Tamsulosina Zentiva Italia
Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist. The recommended dose is one capsule daily. Take the capsule after breakfast or after the first main meal of the day. Swallow the capsule whole while sitting or standing, and drink a glass of water. Do not open, break, or chew the capsule.
If you take more Tamsulosina Zentiva Italia than you should
Low blood pressure may occur following an overdose. Blood pressure and heart rate return to normal if the patient lies down.
If more than the prescribed number of capsules are taken at once, or if the medicine is accidentally ingested by a child, seek immediate medical advice.
If you forget to take Tamsulosina Zentiva Italia
If you forget to take your dose at the scheduled time, take it as soon as you remember, at any time during the day. If you only remember the next day, continue with your usual dosing schedule. Do not take a double dose to make up for the missed capsule.
If you stop taking Tamsulosina Zentiva Italia
Do not stop using this medicine before the prescribed time without consulting your doctor.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone experiences them.
If you feel dizzy or weak, you should sit or lie down until these symptoms disappear.
Stop using this medicine and seek immediate medical help if you experience:
- Hypersensitivity reaction with purplish spots or skin lesions, blisters on the skin, skin peeling, fever (high), joint pain and/or eye inflammation (Stevens-Johnson syndrome).*
- Severe allergic reaction causing swelling of the face or throat (angioedema).**
The side effects that may occur are listed below, grouped according to frequency:
- Common (may affect up to 1 in 10 people): dizziness (may occur especially with sudden change in position – when moving from lying down to sitting or standing), problems with ejaculation, little or no semen ejaculated during orgasm, cloudy urine after orgasm.
- Uncommon (may affect up to 1 in 100 people): headache, awareness of heartbeat (palpitations), lightheadedness or fainting (orthostatic hypotension), nasal swelling and irritation (rhinitis), constipation, diarrhoea, feeling sick (nausea), vomiting, skin rash, itching, urticaria, feeling of weakness (asthenia).
- Rare (may affect up to 1 in 1,000 people): brief loss of consciousness (syncope), angioedema**.
- Very rare (may affect up to 1 in 10,000 people): prolonged, painful erection not related to sexual activity, requiring immediate medical attention (priapism), Stevens-Johnson syndrome*.
- Not known (frequency cannot be estimated from the available data): changes in vision, blurred vision, nosebleeds (epistaxis), skin rash with irregular red patches (erythema multiforme), skin redness and peeling (exfoliative dermatitis), irregularly abnormal heart rhythm (atrial fibrillation, arrhythmia, tachycardia), difficulty breathing (dyspnoea), dry mouth.
During eye surgery (cataract or glaucoma), intraoperative floppy iris syndrome (IFIS) may occur: the pupil may dilate poorly and the iris (the coloured part of the eye) may become floppy during surgery. For further information, see section 2.
Reporting of side effects
If you experience any side effects, talk to your doctor or pharmacist. This includes any side effect not listed in this leaflet. 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 Tamsulosin Zentiva Italia
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp".
The expiry date refers to the last day of that month.
Store below 25°C.
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 Tamsulosina Zentiva Italia contains
The active substance is tamsulosin hydrochloride in the amount of 0.40 mg per capsule, which
corresponds to 0.367 mg of tamsulosin.
The other components are: Capsule contents: Microcrystalline cellulose; methacrylic acid – ethyl acrylate copolymer (1:1) dispersion at 30%
(containing sodium lauryl sulfate, polysorbate 80); dibutyl sebacate;
hydrated colloidal silica; polysorbate 80; calcium stearate.
Capsule shell: Gelatin; titanium dioxide (E171); yellow iron oxide (E172); red iron oxide (E172); black iron oxide (E172); indigotine – FD&C Blue No. 2 (E132).
Description of the appearance of Tamsulosina Zentiva Italia and the contents of the pack
Tamsulosina Zentiva Italia modified-release capsules are hard capsules of size no. 3 with an orange body and olive-colored cap, containing white to off-white granules.
Each pack contains 10, 20, 30, 50, 90 or 100 capsules.
Not all pack sizes may be marketed.
Marketing Authorization Holder
Zentiva Italia S.r.l., Via P. Paleocapa, 7, 20121 Milano
Manufacturer
S.C. ZENTIVA S.A.,
B-dul Theodor Pallady nr 50, sector 3,
032 266 Bucharest, Romania
This medicinal product is authorized in the European Economic Area Member States and
in the United Kingdom (Northern Ireland) under the following names:
Czech Republic, Lithuania, Latvia, Poland, Slovakia: Fokusin.
France: Tamsulosine Zentiva
Austria, Denmark, Norway, Germany: Tamsulosin Zentiva
Italy: Tamsulosina Zentiva Italia
Portugal: Tansulosina Zentiva
United Kingdom (Northern Ireland): Tamsulosin hydrochloride Zentiva
Netherlands: Tamsulosine HCl Zentiva