CONTIFLO XL Prolonged release capsule (2022)

Βιβλιογραφική αναφορά

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Περιεχόμενα

1. Name of the medicinal product

Contiflo XL 400 micrograms capsules.

2. Qualitative and quantitative composition

Each prolonged release capsule contains as active ingredient 400 micrograms of tamsulosin hydrochloride. Excipients with known effect: One prolonged release capsule contains 0.0353 mg of sunset ...

3. Pharmaceutical form

Prolonged release capsule. Brown/Orange size 2 capsules imprinted with R on cap and TSN400 on body in black. The capsules contain white to off-white granules.

4.1. Therapeutic indications

Lower urinary tract symptoms (LUTS) associated with Benign Prostatic Hyperplasia (BPH).

4.2. Posology and method of administration

Posology Oral use. One capsule daily, to be taken after breakfast or the first meal of the day. The capsule must be swallowed whole and should not be crunched or chewed, as this interferes with the modified ...

4.3. Contraindications

Hypersensitivity to the active substance, including drug-induced angioedema, or to any of the excipients listed in section 6.1. A history of orthostatic hypotension. Severe hepatic insufficiency.

4.4. Special warnings and precautions for use

As with other α1-adrenoceptors antagonists, a reduction in blood pressure can occur in individual cases during treatment with tamsulosin, as a result of which, rarely, syncope can occur. At the first signs ...

4.5. Interaction with other medicinal products and other forms of interaction

Interaction studies have only been performed in adults. No interactions have been seen when tamsulosin hydrochloride was given concomitantly with either atenolol, enalapril or theophylline. Concomitant ...

4.6. Fertility, pregnancy and lactatio

Tamsulosin is not indicated for use in women. Ejaculation disorders have been observed in short and long term clinical studies with tamsulosin. Events of ejaculation disorder, retrograde ejaculation and ...

4.7. Effects on ability to drive and use machines

No studies on the effects on the ability to drive and use machines have been performed. However, patients should be aware of the fact that blurred vision, dizziness and syncope can occur.

4.8. Undesirable effects

The adverse reactions are described by frequency and system organ class (SOC) in the table below. System Organ Class Common >1/100, <1/10 Uncommon >1/1.000, <1/100 Rare >1/10.000, <1/1.000 ...

4.9. Overdose

Symptoms Overdosage with tamsulosin hydrochloride can potentially result in severe hypotensive effects, dizziness and malaise. Severe hypotensive effects have been observed at different levels of overdosing. ...

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: Alpha-adrenoreceptor antagonists. ATC code: G04CA02 Preparations for the exclusive treatment of prostatic disease. Mechanism of action Tamsulosin binds selectively ...

5.2. Pharmacokinetic properties

Absorption Tamsulosin hydrochloride is absorbed from the intestine and is almost completely bioavailable. Absorption of tamsulosin hydrochloride is reduced by a recent meal. Uniformity of absorption can ...

5.3. Preclinical safety data

Single and repeat dose toxicity studies were performed in mice, rats and dogs. In addition, reproduction toxicity in rats, carcinogenicity in mice and rats, and in vivo and in vitro genotoxicity were examined. ...

6.1. List of excipients

Capsule contents: Cellulose microcrystalline PH101 Magnesium stearate Methacrylic acid-ethyl acrylate copolymer (1:1) dispersion Sodium hydroxide Triacetin Titanium dioxide (E171) Purified talc ...

6.2. Incompatibilities

Not applicable.

6.3. Shelf life

3 years.

6.4. Special precautions for storage

This medicinal product does not require any special storage conditions.

6.5. Nature and contents of container

PVC/PVdC/Alu blisters. Packs of 1, 2, 4, 7, 10, 14, 20, 28, 30, 50, 56, 60, 90, 98, 100 or 200 prolonged release capsules. Not all packs sizes may be marketed.

6.6. Special precautions for disposal and other handling

No special requirements.

7. Marketing authorization holder

SUN PHARMA UK LIMITED, 6-9 The Square, Stockley Park, Uxbridge, UB11 1FW

8. Marketing authorization number(s)

PL 14894/0466

9. Date of first authorization / renewal of the authorization

04/11/2010

10. Date of revision of the text

08/11/2022

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