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SPC, UK: NORPROLAC Tablet (2019)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

NORPROLAC 25 micrograms Tablets. Quinagolide 25 micrograms Tablets.

Qualitative and quantitative composition

Quinagolide, as the hydrochloride, 25 micrograms.

Pharmaceutical form

Tablet for oral administration.

Therapeutic indications

Hyperprolactinaemia (idiopathic or originating from a prolactin-secreting pituitary microadenoma or macroadenoma).

Posology and method of administration

Since dopaminergic stimulation may lead to symptoms of orthostatic hypotension, the dosage of NORPROLAC should be initiated gradually with the aid of the starter pack, and given only at bedtime. Adults ...

Contraindications

Hypersensitivity to the drug. Impaired hepatic or renal function. For procedure during pregnancy, (see section 4.6 Pregnancy and lactation).

Special warnings and precautions for use

Fertility may be restored by treatment with NORPROLAC. Women of child-bearing age who do not wish to conceive should therefore be advised to practice a reliable method of contraception. Since orthostatic ...

Interaction with other medicinal products and other forms of interaction

No interactions between NORPROLAC and other drugs have so far been reported. On theoretical grounds, a reduction of the prolactin-lowering effect could be expected when drugs (e.g. neuroleptic agents) ...

Pregnancy and lactation

Pregnancy Animal data provide no evidence that NORPROLAC has any embryotoxic or teratogenic potential, but experience in pregnant women is still limited. In patients wishing to conceive, NORPROLAC should ...

Effects on ability to drive and use machines

Since, especially during the first days of treatment, hypotensive reactions may occasionally occur and result in reduced alertness, patients should be cautious when driving a vehicle or operating machinery. ...

Undesirable effects

Frequency estimate: very common ≥10%, common ≥1% to <10%, uncommon≥0.1% to <1%, rare ≥0.01% to <0.1%, very rare <0.01%. The adverse reactions reported with the use of NORPROLAC are characteristic for dopamine ...

Overdose

Symptoms Acute overdosage with NORPROLAC tablets has not been reported. It would be expected to cause severe nausea, vomiting, headache, dizziness, drowsiness, hypotension and possibly collapse. Hallucinations ...

Pharmacodynamic properties

Pharmacotherapeutic group: prolactin inhibitors ATC code: G02CB04 Quinagolide, the active ingredient of NORPROLAC, is a selective dopamine D<sub>2</sub>-receptor agonist not belonging to the chemical classes ...

Pharmacokinetic properties

After oral administration of radiolabelled drug, quinagolide is rapidly and well absorbed. Plasma concentration values obtained by a non-selective radio-immunoassay (RIA), measuring quinagolide together ...

Preclinical safety data

Acute toxicity The LD<sub>50</sub> of quinagolide was determined for several species after single oral administration: mice 357 to >500 mg/kg; rats >500 mg/kg; rabbits >150 mg/kg. Chronic toxicity Decreased ...

List of excipients

Iron oxide Red, silica, colloidal anhydrous Magnesium stearate Methylhydroxypropylcellulose Maize starch Cellulose Microcrystalline Lactose

Incompatibilities

Not applicable.

Shelf life

Shelf life: The shelf life is 5 years. The expiry date is printed on the box. On the blister the expiry date is marked with the letters EXP.

Special precautions for storage

The expiry date refers to original unopened boxes, which were stored below 25°C. No special warning with respect to light sensitivity or humidity is necessary because the tablets are protected by the packaging. ...

Nature and contents of container

The starter pack (NORPROLAC 25/50) consists of 3 tablets of 25 micrograms and 3 tablets of 50 micrograms. These tablets are packed in an aluminium PVC/PVDC blister which is sealed in a moisture proof aluminium ...

Special precautions for disposal and other handling

None.

Marketing authorization holder

Aspire Pharma Ltd, Unit 4 Rotherbrook Court, Bedford Road, Petersfield, Hampshire, GU32 3QG, United Kingdom

Marketing authorization number(s)

PL 35533/0062

Date of first authorization / renewal of the authorization

15<sup>th</sup> December 2004

Date of revision of the text

24/12/2019

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