Tamsulosin Almus
Italy
Table of Contents
PACKAGE LEAFLET: INFORMATION FOR THE USER
TAMSULOSIN ALMUS
0.4 mg modified-release hard capsules
Generic medicine
Please read this leaflet carefully before using this medicine.
- 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. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
- If any of the side effects worsen, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.
Contents of this leaflet:
- What Tamsulosin Almus is and what it is used for
- Before you take Tamsulosin Almus
- How to take Tamsulosin Almus
- Possible side effects
- How to store Tamsulosin Almus
- Further information
1. WHAT TAMSULOSIN ALMUS IS AND WHAT IT IS USED FOR
The active substance of Tamsulosin Almus is tamsulosin, a selective antagonist of α / α-adrenoceptors, which reduces muscular tension in the prostate and urethra. This allows urine to pass more easily through the urethra, facilitating urination. Additionally, it reduces the sensation of urinary urgency.
Tamsulosin Almus is used in men for the treatment of lower urinary tract symptoms associated with benign prostatic enlargement (benign prostatic hyperplasia). These symptoms may include difficulty urinating (reduced urine flow), dribbling, urgency, and increased frequency of urination both during the day and at night.
2. BEFORE USING TAMSULOSIN ALMUS
Do not use Tamsulosin Almus
- If you are allergic (hypersensitive) to tamsulosin or to any of the excipients of Tamsulosin Almus. Hypersensitivity may manifest as sudden local swelling of soft body tissues (e.g. throat or tongue), breathing difficulties and/or itching and skin rash (angioedema).
- If you have severe liver problems.
- If you experience fainting due to a drop in blood pressure when changing position (e.g. sitting up from lying down or standing up). Exercise particular caution with Tamsulosin Almus
- Regular medical check-ups are necessary to monitor the condition for which you are being treated.
- Fainting may rarely occur during treatment with Tamsulosin Almus, as with other medicines of this type. At the first signs of dizziness or weakness, you should sit or lie down until symptoms resolve.
- If you have severe kidney problems, inform your doctor.
- If you are scheduled for, or are on a waiting list for, eye surgery due to lens opacity (cataract), inform your ophthalmologist if you have previously taken, are currently taking, or plan to take Tamsulosin Almus. The specialist may then adopt the most appropriate precautions regarding the medicine and the surgical technique to be used. Ask your doctor whether you should postpone or temporarily discontinue treatment with this medicine before undergoing cataract surgery. Children Do not administer this medicine to children or adolescents under 18 years of age, as it is not effective in this population. Taking Tamsulosin Almus with other medicines
Concomitant use of Tamsulosin Almus with other medicines of the same class (α-adrenergic receptor antagonists) may cause an unintended drop in blood pressure.
It is particularly important to inform your doctor if you are simultaneously being treated with medicines that may reduce the elimination of Tamsulosin Almus from the body (e.g. ketoconazole, erythromycin).
Inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including those without a prescription.
Taking Tamsulosin Almus with food and drinks
Tamsulosin Almus should be taken after breakfast or after the first meal of the day.
Pregnancy and breastfeeding
Tamsulosin Almus is not indicated for use in women. Driving and using machines
Tamsulosin Almus has not been shown to impair the ability to drive vehicles or operate machinery or equipment. However, you should bear in mind the possibility that dizziness may occur; in such a case, you should not engage in activities requiring alertness.
3. HOW TO USE TAMSULOSIN ALMUS
Always take Tamsulosina Almus exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist. The usual dose is 1 capsule daily, taken after breakfast or after the first meal of the day, every day.
The capsule must be swallowed whole, without crushing or chewing it.
Tamsulosina Almus is normally prescribed for long-term use. The effects on the urinary bladder and urination are maintained during long-term treatment with Tamsulosina Almus.
If you take more Tamsulosina Almus than you should
Taking an excessive dose of Tamsulosina Almus may cause an unwanted drop in blood pressure and an increased heart rate, associated with a feeling of weakness.
If you have taken too many doses of Tamsulosina Almus, consult your doctor immediately.
If you forget to take Tamsulosina Almus
If you have forgotten to take a dose of Tamsulosina Almus as recommended, you may take it later on the same day. If you have missed a day, continue taking the capsule at your usual scheduled time. Never take a double dose to make up for a missed one.
If you stop taking Tamsulosina Almus
If treatment with Tamsulosina Almus is stopped prematurely, the initial symptoms may reappear. Therefore, continue taking Tamsulosina Almus for the entire duration prescribed by your doctor, even if your symptoms have already disappeared. Always consult your doctor if you think this treatment should be discontinued.
If you have any doubts about the use of Tamsulosina Almus, consult your doctor or pharmacist.
4. POSSIBLE ADVERSE REACTIONS
Like all medicines, Tamsulosin Almus may cause adverse reactions, although not everyone experiences them.
Common (less than 1 in 10, more than 1 in 100 (1-10%)):
Dizziness, particularly when sitting down or standing up.
Abnormal ejaculation. This symptom means that seminal fluid does not exit externally through the urethra but enters the urinary bladder instead. This event is harmless.
Uncommon (more than 1 in 1,000, less than 1 in 100 (0.1-1%)):
Headache, palpitations (the heart beats faster than normal and this is noticeable), reduction in blood pressure, for example when standing up quickly from a sitting or lying position, often associated with dizziness, nasal congestion or runny nose (rhinitis), diarrhoea, nausea and vomiting, constipation, weakness (asthenia), skin redness (rash), itching and urticaria.
Rare (more than 1 in 10,000, less than 1 in 1,000 (0.01-0.1%)):
Fainting and cases of sudden localized swelling of soft tissues of the body (e.g. throat and tongue), difficult breathing with or without itching and skin redness (rash), as often seen in an allergic reaction (angioedema).
Very rare (less than 1 in 10,000 (<0.01%)):
Priapism (a painful, prolonged, involuntary erection requiring immediate medical treatment). Skin rash, inflammation, blistering of the skin and/or mucous membranes of the lips, eyes, mouth, nose or genitals (Stevens-Johnson syndrome).
Abnormal heart rhythm (atrial fibrillation, arrhythmia, tachycardia), breathing difficulty (dyspnoea).
Adverse reactions not known (frequency cannot be estimated from available data):
Blurred vision, visual impairment. Nosebleeds (epistaxis). Multiple skin rashes (erythema multiforme), inflamed, dry or peeling skin (exfoliative dermatitis). Abnormal ejaculation, retrograde ejaculation, failure to ejaculate.
If you are about to undergo eye surgery for lens opacity (cataract) and you are already taking or have recently taken Tamsulosin Almus, your pupil may dilate poorly and the iris (the coloured circular part of the eye) may become floppy during the procedure.
If any of the adverse reactions worsen, or if you notice any adverse reactions not listed in this leaflet, inform your doctor or pharmacist.
5. HOW TO STORE TAMSULOSIN ALMUS
Store in the original packaging.
Keep Tamsulosin Almus out of the reach and sight of children.
Do not use Tamsulosin Almus after the expiry date stated on the blister and carton after “Exp.” (month and year). The expiry date refers to the last day of the month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
6. OTHER INFORMATION
What Tamsulosina Almus contains
The active substance is tamsulosin hydrochloride.
The excipients are: Capsule contents: microcrystalline cellulose, methacrylic acid - ethyl acrylate copolymer (1:1), polysorbate 80, sodium lauryl sulfate, triacetin, talc, calcium stearate.
Capsule shell: gelatin, titanium dioxide (E171), indigotine (E132), yellow iron oxide (E172), red iron oxide (E172), black iron oxide (E172).
Description of the appearance of Tamsulosina Almus and contents of the pack
Modified-release hard capsule – box of 20 capsules in blister packs
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
ALMUS S.r.l - Via Cesarea, 11/10 - 16121 Genoa
Manufacturer
DOPPEL FARMACEUTICI S.r.l. - Via Volturno, 48 - 20089 Quinto de’Stampi - Rozzano (Milan)
This patient information leaflet was last approved in: May 2013