Tamsulosin Doc Generici
Italy
Table of Contents
PACKAGE LEAFLET: INFORMATION FOR THE USER
TAMSULOSIN DOC Generici 0.4 mg modified-release hard capsules
Equivalent medicine
Please 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 for you only. Do not give it to other people, even if their symptoms are the same as yours, as it could be harmful.
- If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Contents of this leaflet:
- What TAMSULOSIN DOC Generici is and what it is used for
- What you need to know before using TAMSULOSIN DOC Generici
- How to use TAMSULOSIN DOC Generici
- Possible side effects
- How to store TAMSULOSIN DOC Generici
- Contents of the pack and other information
1. WHAT TAMSULOSIN DOC Generici IS AND WHAT IT IS USED FOR
The active substance of TAMSULOSIN DOC Generici is tamsulosin. Tamsulosin is a selective antagonist of α /α-adrenergic receptors which reduces muscular contraction in the prostate and urethra; this facilitates the flow of urine through the urethra and improves urination (urine expulsion - micturition). In addition, it reduces the sensation of urgency to urinate.
TAMSULOSIN DOC Generici is used in men for the treatment of lower urinary tract symptoms associated with benign prostatic hyperplasia (BPH, i.e. enlargement of the prostate gland). These symptoms may include difficulty urinating (reduced urinary stream), dribbling, urgency, and the need to urinate frequently both during the day and at night.
2. WHAT YOU SHOULD KNOW BEFORE USING TAMSULOSIN DOC Generici
Do not use TAMSULOSIN DOC Generici:
- if you are allergic to tamsulosin hydrochloride or to any of the other ingredients of this medicine (listed in section 6). Hypersensitivity or allergy to tamsulosin hydrochloride may manifest as sudden local swelling of soft body tissues (e.g. throat or tongue) and of hands or feet, difficulty in breathing and/or itching and skin rashes (angioedema).
- if you experience fainting due to a drop in blood pressure when changing position (sitting up from lying down or standing up).
- if you have severe liver problems.
Warnings and precautions
Talk to your doctor or pharmacist before using TAMSULOSIN DOC Generici.
- Periodic medical check-ups are necessary to monitor the condition for which you are being treated.
- Fainting may rarely occur during treatment with TAMSULOSIN DOC Generici, as with other medicines of this type. At the first signs of dizziness or weakness, you should sit or lie down until symptoms disappear.
- If you have severe kidney problems, inform your doctor.
- if you have experienced sudden local swelling of soft body tissues (e.g. throat or tongue) and of hands and/or feet, breathing difficulties and/or itching and skin rashes during treatment with tamsulosin, caused by an allergic reaction (angioedema), inform your doctor.
- if you are scheduled for or on a waiting list for eye surgery due to lens opacity (cataract) or increased intraocular pressure (glaucoma), inform your ophthalmologist if you have previously taken, are currently taking, or plan to take TAMSULOSIN DOC Generici, as a condition called “intraoperative floppy iris syndrome” (IFIS) may occur. The specialist can therefore adopt the most appropriate precautions regarding pharmacological treatments and surgical technique. Ask your doctor whether you should postpone or temporarily discontinue this medicine before undergoing eye surgery for lens opacity (cataract) or increased intraocular pressure (glaucoma).
Consult your doctor if you are or have previously been in any of the situations described above.
Children
Do not administer this medicine to children and adolescents under 18 years of age,
as the medicine is not effective in this population.
Other medicines and TAMSULOSIN DOC Generici
Inform your doctor or pharmacist if you are using, have recently used, or might use
any other medicines.
Taking TAMSULOSIN DOC Generici 0.4 mg together with other medicines of the same
class (α-adrenergic receptor antagonists) may cause an unintended drop in blood pressure.
Diclofenac (an anti-inflammatory medicine used to treat various types of pain) and warfarin (used to prevent blood clotting) may affect the rate at which TAMSULOSIN DOC Generici is eliminated from the body.
It is particularly important to inform your doctor if you are simultaneously taking other medicines that may reduce the elimination of TAMSULOSIN DOC Generici from the body (e.g., ketoconazole, erythromycin).
Please bear in mind that the above information may also apply to products used in the more or less recent past or to be used in the more or less near future.
TAMSULOSIN DOC Generici with food and drinks
TAMSULOSIN DOC Generici should be taken after breakfast or after the first meal of the day; taking it on an empty stomach may lead to an increase in adverse effects or in the severity of any of them.
Pregnancy, breastfeeding and fertility
TAMSULOSIN DOC Generici is not indicated for use in women.
In men, abnormal ejaculation (ejaculation disorders) has been reported. This means that seminal fluid does not exit the body through the urethra but enters the bladder (retrograde ejaculation), or that the volume of ejaculation is reduced or absent (anejaculation). This event is harmless.
Driving and using machines
To date, there has been no evidence that tamsulosin impairs the ability to drive or operate machinery.
However, you should be aware that dizziness may occur; in such a case, you should avoid activities requiring alertness.
3. HOW TO USE TAMSULOSIN DOC Generici
Take this medicine exactly as directed by your doctor. If you have
any doubts, consult your doctor or pharmacist.
This medicine is for oral use.
The recommended dose is one capsule daily, taken after breakfast or after the first
meal of the day.
The capsule should be taken while standing or sitting (not lying down) and must be swallowed
whole with a glass of water. The capsule must not be crushed or chewed,
as this would interfere with the modified release of the active substance.
TAMSULOSIN DOC Generici is usually prescribed for long-term use.
The effects on the urinary bladder and urination are maintained with long-term
treatment with tamsulosin.
Your doctor has prescribed a dose suitable for you and your condition, specifying the duration of treatment. Do not change this dose on your own initiative.
If you feel that the effect of tamsulosin is too strong or too weak, discuss it with your doctor or pharmacist.
If you take more TAMSULOSIN DOC Generici than you should
If you take more TAMSULOSIN DOC Generici than prescribed, contact your doctor or
pharmacist immediately.
Taking an excessive dose of tamsulosin may cause an unintended drop in
blood pressure and an increased heart rate, associated with a feeling of
weakness. Dizziness, weakness, vomiting, diarrhea, and fainting may also occur.
Lie down to minimize the effects of low blood pressure.
If you forget to take TAMSULOSIN DOC Generici
If you forget to take a dose of TAMSULOSIN DOC Generici after breakfast or after the first
meal of the day, you may take it as soon as you remember, provided you have already eaten. If you have missed an entire day, simply continue taking your daily dose as prescribed.
Do not take a double dose to make up for a missed dose.
If you stop taking TAMSULOSIN DOC Generici
If treatment with TAMSULOSIN DOC Generici is stopped prematurely, the initial
symptoms may reappear. Therefore, continue taking TAMSULOSIN DOC Generici for the full duration prescribed by your doctor, even if your symptoms have already disappeared. Always consult your doctor if you think this treatment should be stopped.
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.
Side effects are listed below according to how likely they are to occur:
Common side effects (occur in more than 1 in 100 patients but less than 1 in 10):
dizziness (particularly when sitting down or standing up).
Abnormal ejaculation (ejaculation disorders). This symptom means that semen does not exit the body through the urethra but enters the urinary bladder (retrograde ejaculation), or that the volume of semen is reduced or absent (failure to ejaculate). This event is harmless.
Uncommon side effects (occur in more than 1 in 1,000 patients but less than 1 in 100):
headache, palpitations (feeling the heartbeat faster than normal), irregular drop in blood pressure, for example when standing up quickly from a sitting or lying position, often associated with dizziness, stuffy or runny nose (rhinitis), constipation, diarrhoea, nausea, vomiting, skin redness (rash), itching, skin redness with raised bumps (urticaria), feeling of weakness (asthenia).
Rare side effects (occur in more than 1 in 10,000 patients but less than 1 in 1,000):
feeling faint (fainting); sudden localized swelling of soft tissues of the body (e.g. throat and tongue) and of the hands and/or feet, difficulty breathing with or without itching and skin redness (rash), as often seen in an allergic reaction (angioedema).
Very rare side effects (occur in less than 1 in 10,000 patients):
severe skin rash, inflammation, blistering of the skin and/or mucous membranes of the lips, eyes, mouth, nostrils or genitals (Stevens-Johnson syndrome); involuntary, prolonged and painful erection requiring immediate medical treatment (priapism).
Side effects with unknown frequency (frequency cannot be estimated from the available data):
blurred vision, visual disturbance, nosebleed (epistaxis), severe skin rashes (erythema multiforme, exfoliative dermatitis), dry mouth, irregular or abnormal heart rhythm (atrial fibrillation, arrhythmia, tachycardia), breathing difficulty (dyspnoea).
If you are about to undergo eye surgery for clouding of the lens (cataract) or increased eye pressure (glaucoma), and you are currently taking or have recently taken TAMSULOSIN DOC Generici, your pupil may dilate poorly and the iris (the coloured circular part of the eye) may become floppy during surgery.
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 www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects, you can help provide more information on the safety of this medicine.
5. HOW TO STORE TAMSULOSIN DOC Generici
Keep this medicine out of the sight and reach of children.
- Blister pack: store in the original packaging.
- Tablet container: keep the bottle tightly closed. Do not use this medicine after the expiry date stated on the blister, bottle, and carton after “Exp.”. The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.
6. PACKAGING CONTENTS AND OTHER INFORMATION
What TAMSULOSIN DOC Generici contains
The active substance is tamsulosin hydrochloride 0.4 mg.
The other components are:
Capsule contents: microcrystalline cellulose, methacrylic acid – ethyl acrylate copolymer (1:1), polysorbate 80, sodium lauryl sulfate, triethyl citrate, talc.
Capsule shell: gelatin, indigotine (E132), titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172), black iron oxide (E172).
Printing ink: shellac, black iron oxide (E172), propylene glycol.
Description of the appearance of TAMSULOSIN DOC Generici and packaging contents
TAMSULOSIN DOC Generici capsules are orange/olive green in colour with a black band at both ends and the imprint "TSL 0.4" in black on the capsule.
Available pack sizes are blisters or tablet containers containing 10, 14, 20, 28, 30, 50, 56, 60, 90, 100 or 200 capsules.
Not all pack sizes may be marketed.
MARKETING AUTHORISATION HOLDER
DOC Generici Srl - Via Turati 40, 20121 Milano (Italy).
MANUFACTURER
SYNTHON BV - Microweg 22 - 6545 CM Nijmegen (Netherlands).
SYNTHON Hispania S.L. - Castello 1 Poligono las Salinas - 08830 Sant Boi de Llobregat (Spain).
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