Description
Instructions for medical use of
Relief®
Trade name:
Relief®
International nonproprietary name
Phenylephrine
Dosage form
Suppositories rectal
Composition
1 suppository contains
Active substance:phenylephrine hydrochloride 5 mg;
Adjuvants: cocoa butter (theobromine oil), methyl parahydroxybenzoate, propyl parahydroxybenzoate, corn starch.
Description
Suppositories evenly opaque, colored from pale white to light yellow, torpedo-shaped.
Pharmacotherapeutic group
Vasoprotectors. Drugs for the treatment of hemorrhoids and anal fissures to use locally. Other drugs for the treatment of hemorrhoids and anal fissures for local use.
Code ATC C05АХ
Pharmacological properties
Pharmacokinetics
The drug effects locally; it does not have a general resorptive action.
Pharmacodynamics
Phenylephrine hydrochloride is an alpha-adrenomimetic, produces local vasoconstrictor effect helping to reduce tissue exudation and swelling, bleeding and blood filling of hemorrhoidal veins, itching, serous secretions at hemorrhoids and other diseases of the perianal zone.
The drug Relief calms at itching, burning, discomfort associated with hemorrhoids.
Indications
– external and internal hemorrhoids
– cracks, erosion and microtrauma of the anus
– symptomatic therapy of itching, burning and anal discomfort.
Dosage and methods of use
To use the drug after hygienic procedures. To enter it into the rectum per 1 suppository up to 4 times a day (morning, night and after each bowel emptying). The maximal daily dose includes 4 suppositories. The duration of treatment makes 7-14 days.
Adverse reaction
- possible allergic reactions
– irritation at the site of application (allergic dermatitis)
– arrhythmia, increased blood pressure
– hyperthyroidism exacerbation
– tremor, insomnia, nervousness
Contraindications
– increased individual sensitivity to the ingredients of the drug
– thromboembolic disease
– granulocytopenia
– children under 12 years old
Drug interaction
In some cases, phenylephrine can result to severe hypertension (due to the stimulation of alpha-adrenergic receptors). It is not recommended to use this drug simultaneously with antihypertensive drugs. The drug should not be administered simultaneously with MAO inhibitors, tricyclic antidepressants. The pharmacological effect of phenylephrine can be enhanced at simultaneous use of MAO inhibitors, as the phenylephrine metabolism changes.
Special indications
Use with caution if patients ill with cardiovascular and cerebrovascular diseases, thyroid diseases (hyperthyroidism), with angle-closure glaucoma. Phenylephrine can cause heartbeat, tachycardia, increased blood pressure, nervousness, anxiety in these patients. Patients with diabetes should use the drug with caution, as phenylephrine may increase blood glucose concentration. These phenomena are usually transient and insignificant; therefore, the recommended daily dose should not be exceeded.
The individuals who have difficulty urinating due to hypertrophy or prostate tumor should use the drug with caution:phenylephrine can cause difficulty urinating in patients with prostate enlargement at the expense of contraction in the smooth muscles of the bladder neck through irritation of alpha-1-adrenoreceptors.Local use of phenylephrine may result to hypertension in some patients by stimulation of alpha-1-adrenergic receptors, which should be considered at use of this drug simultaneously with antihypertensive drugs.
The drug should not be used simultaneously with MAO inhibitors, which can result to increased blood pressure.To minimize systemic side effects, the recommended daily dose should not exceed unless prescribed by a physician.
If the state of health worsens or is not improved within 7 days after administration of the drug, the patients should visit a doctor for a consultation in due time.
The drug contains propyl parahydroxybenzoate and methyl parahydroxybenzoate, which may cause allergic reactions (possibly delayed).
Pregnancy and lactation
As safety of the drug has not been determined in pregnant and lactating women, this product should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
During pregnancy and lactation, the drug should be used strictly according to the doctor's prescription.
Features of the drug effect upon the ability to drive a car or potentially dangerous mechanisms.
It does not effect.
Overdosage
Symptoms: anxiety, nervousness may be observed in cases of excessive overdosage against the recommended doses.
Treatment: symptomatic.
Form of output and packing
Per 6 suppositories in a contour cell package made of polyvinyl chloride / polyethylene film.
Per 2 contour packing together with the instruction on medical use in the state and Russian languages placed in a cardboard pack.
Storage conditions
Do not store above 25 °C.
Keep out of the reach of children!
Shelf live
2 years
Do not use after the expiration date.
Conditions for drug supply
Without a prescription.
Name of the firm-manufacturer, country, and address:
Istituto De Angeli S. R. L.,
50066 Reggello (Florence), Locke. Prulli 103/s, Italy
Name and country of the Registration Certificate holder
Bayer Consumer Care AG, Switzerland
Name, address and contact details of the organization in the territory of the Republic of Kazakhstan accepting claims (offers) from consumers concerning the drug quality:
“Bayer KAZ” LLP.
Timiryazev Street, 42, Pav. 15, office 301
050057 Almaty, Republic of Kazakhstan
Tel: +7 727 258 80 40
Fax.: +7 727 258 80 39
e-mail: kz.claims@bayer.com
Address of the organization receiving claims from consumers regarding the quality of products (goods) on the territory of the Republic of Kazakhstan and responsible for post-registration supervision over the drug safety:
“Bayer KAZ” LLP.
Timiryazev Street, 42, „Expo City“Business Center, Pav. 15
050057 Almaty, Republic of Kazakhstan
Tel: +7 701 715 78 46 – 24 hours
Tel.: +7 727 258 80 40 (106) – during working hours
Fax.: +7 727 2588 039
e-mail: pv.centralasia@bayer.com
