TANYZ Hard modified-release capsule (2019)

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Περιεχόμενα

1. Name of the medicinal product

TANYZ 400 micrograms hard modified-release capsules.

2. Qualitative and quantitative composition

Each hard modified-release capsule contains 400 micrograms tamsulosin hydrochloride. For the full list of excipients, see section 6.1.

3. Pharmaceutical form

Hard modified-release capsule Orange/olive-green capsule. The capsules contain white to off-white pellets. Capsule dimensions: 19.3 mm x 6.4 mm.

4.1. Therapeutic indications

Lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH).

4.2. Posology and method of administration

Posology One capsule daily, to be taken after breakfast or the first meal of the day. No dose adjustment is warranted in renal impairment. No dose adjustment is warranted in patients with mild to moderate ...

4.3. Contraindications

Hypersensitivity to tamsulosin hydrochloride, including drug-induced angio-oedema, 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 ...

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 was given concomitantly with either atenolol, enalapril or theophylline. Concomitant cimetidine brings ...

4.6. Pregnancy and lactation

TANYZ 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 ejaculation ...

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 drowsiness, blurred vision, dizziness and syncope can occur. ...

4.8. Undesirable effects

The assessment of side effects is based on the following frequencies: Common (≥1/100 to <1/10), Uncommon (≥1/1,000 to <1/100), Rare (≥1/10,000 to <1/1,000), Very rare (<1/10,000), Not known (cannot be ...

4.9. Overdose

Symptoms Overdosage with tamsulosin hydrochloride can potentially result in severe hypotensive effects. Severe hypotensive effects have been observed at different levels of overdosing. Management In case ...

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: Urologicals, drugs used in benign prostatic hypertrophy ATC code: G04CA02 Mechanism of action Tamsulosin binds selectively and competitively to the postsynaptic ...

5.2. Pharmacokinetic properties

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

5.3. Preclinical safety data

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

6.1. List of excipients

Capsule contents: Microcrystalline cellulose (E460) Methacrylic acid – ethyl acrylate copolymer (1:1) dispersion 30 per cent Polysorbate 80 (E433) Sodium laurilsulfate Triethyl citrate (E1505) ...

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/PE/PVDC/Aluminium blisters in boxes containing 20, 30, 90 and 100 hard modified-release capsules. Not all pack sizes may be marketed.

6.6. Special precautions for disposal and other handling

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

7. Marketing authorization holder

Krka, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

8. Marketing authorization number(s)

PA1347/086/001

9. Date of first authorization / renewal of the authorization

Date of first authorisation: 13th August 2019

10. Date of revision of the text

14 August 2019

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