original Cilnidipine 10 mg

ATELEC Tablets 10mg (Cilnidipine)

PHARMACOLOGICAL PROPERTIES

The calcium channel blocking antihypertensive. A single oral dose of cilnidipine showed a gradual and long-lasting hypotensive action.

INDICATIONS

ATELEC is indicated for the treatment of hypertension.

DOSAGE AND ADMINISTRATION

Dosage Usually, for adults, 5 to 10mg is administered as cilnidipine for orally once a day after breakfast. The dosage may be adjusted according to the patient’s age and symptoms. The dose can be increased up to 20 mg once a day, if a sufficient response does not appear. For adults with severe hypertension, ATELEC should be administered 10 to 20 mg once a day for oral use after breakfast.
Method of administration Oral use.

CONTRAINDICATIONS

ATELEC is contraindicated in the following patients; Patients with hypersensitivity to the active substance or to any of the excipients. Pregnant women or women having possibilities of being pregnant (See “Use During Pregnancy, Delivery, or Lactation” section).

PRECAUTIONS

Read carefully the instructions before use. For further information please consult your doctor. This drug is used upon doctor’s prescription only.
INTERACTION WITH OTHER DRUGS AND OTHER FORMS OF INTERACTIONS ATELEC is chiefly metabolized by the drug-metabolizing enzyme CYP3A4 and in part by CYP2C19.

USE DURING PREGNANCY, DELIVERY, OR LACTATION

ATELEC should not be administered to pregnant women or women having possibilities of being pregnant. [It has been reported that ATELEC prolongs the gestation period and delivery time in animal experiments (in rats).] It is advisable to avoid the administration of ATELEC to nursing mothers. However, if the administration is indispensable, the patient should be instructed to discontinue lactation. *Transfer of this drug to mother’s milk has been reported in animal experiments (in rats).]

EFFECTS ON ABILITY TO DRIVE AND OPERATE MACHINE

The symptoms, such as dizziness may occur because of the hypotensive action from this drug. Give warning against engaging in hazardous activities requiring alertness, such as working at a height, operating machinery or driving motor vehicles.

ADVERSE REACTIONS

Adverse reactions, including abnormalities in laboratory data, Hepatic function disorder and jaundice accompanied with increased AST (GOT), ALT (GPT) and γ-GTP may occur. Therefore, close observation should be made, and if any abnormality is observed, appropriate measures, such as discontinuation of ATELEC, should be taken.

OVERDOSES AND TREATMENT

Overdosage of ATELEC may cause excessive reduction in blood pressure. If reduction in blood pressure is remarkable, appropriate measures such as lifting lower extremities, fluid therapy and administration of vasopressors should be taken. Hemodialytical removal of the drug is not effective because of its high rate of protein binding.

SHELF-LIFE

36 months from manufacturing date.

STORAGE

Store below 30ºC, protect from light. PACKING SIZE ATELEC Tablets 10 : Box of 10
blisters x 10 tablets Keep out of reach of children. Do not use the medicine after the expiry date stated on the package.