CLONNIRIT

Nazione: Israele

Lingua: inglese

Fonte: Ministry of Health

Principio attivo:

CLONIDINE HYDROCHLORIDE

Commercializzato da:

RAFA LABORATORIES LTD

Codice ATC:

N02CX02

Forma farmaceutica:

TABLETS

Composizione:

CLONIDINE HYDROCHLORIDE 25 MCG

Via di somministrazione:

PER OS

Tipo di ricetta:

Required

Prodotto da:

RAFA LABORATORIES LTD, JERUSALEM

Gruppo terapeutico:

CLONIDINE

Area terapeutica:

CLONIDINE

Indicazioni terapeutiche:

Prophylaxis of migraine and recurrent vascular headache, but not acute attacks.Treatment of menopausal flushing.

Data dell'autorizzazione:

2014-11-30

Foglio illustrativo

1
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’
REGULATIONS (PREPARATIONS) – 1986
The medicine is dispensed with a doctor's prescription only
®
Clonnirit
Active ingredient:
Each tablet contains: 25
mcg Clonidine hydrochloride.
For the list of the additional ingredients, see section 6. See also
'Important information about some of
the medicine's ingredients' in section 2.
Read the entire leaflet carefully before using this medicine.
This leaflet contains concise information about the medicine. If you
have any further questions, refer
to the doctor or pharmacist.
This medicine has been prescribed for treating your illness. Do not
pass it on to others. It may harm
them, even if it seems to you that their illness is similar to yours.
1.
What is the medicine intended for?
The medicine is intended for preventing migraine attacks and recurring
headaches, that are not acute,
due to narrowing or dilation of blood vessels. In addition, the
medicine is intended for the treatment of
flushing for women in menopause.
Therapeutic group:
Anti-migraine medicines
2.
Before using the medicine
Do not use the medicine if:
•
You are sensitive (allergic) to the active ingredient or to any of the
additional ingredients the medicine
contains (for a list of the additional ingredients, see section 6).
•
You suffer from a slow heartbeat caused by a heart disease called
‘sick sinus syndrome’ or from
severe heart problems.
Special warnings regarding the use of the medicine:
•
Use of the medicine may cause dryness in the eyes; this may constitute
a problem for patients
wearing contact lenses.
•
If you are about to undergo surgery (including dental) or any
procedure requiring anesthesia, inform
the doctor and the anesthesiologist of taking this medicine.
•
If you are sensitive to any food or medicine, inform your doctor
before taking this medicine.
Before starting the treatment with Clonnirit tell the doctor if:
•
You suffer or have suffered in the past from Raynaud’s disease - a
problem with blood circulatio

Scheda tecnica

1
Clonnirit
-DL-July 2023-02
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Clonnirit
®
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains clonidine hydrochloride 25 micrograms.
Excipients:
Each tablet contains approximately 18 mg lactose.
For full list of excipients, see Section 6.1.
3. PHARMACEUTICAL FORM
Tablets
Small round pale blue tablets.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Prophylaxis of migraine and recurrent vascular headache, but not acute
attacks. Treatment of
menopausal flushing.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_ADULTS:_
Initially 2 tablets twice daily. If after two weeks there has been no
remission, increase to 3
tablets twice daily.
The duration of treatment depends upon the severity of the condition.
If symptoms continue to occur the patient should be informed that it
may take 2-4 weeks until
Clonnirit is fully effective.
_ELDERLY:_
No specific information on the use of this product in the elderly is
available.
Clinical trials have included patients over 65 years and no adverse
reactions specific to this
age group have been reported.
_PAEDIATRIC POPULATION:_
There is insufficient evidence for the application of clonidine in
children and adolescents
younger than 18 years. Therefore the use of clonidine is not
recommended in paediatric
subjects under 18 years.
_PATIENTS WITH RENAL IMPAIRMENT_
Clonnirit should be used with caution in patients with renal
insufficiency. Careful monitoring of
blood pressure is required.
Method of administration
Per Os
4.3 CONTRAINDICATIONS
Clonnirit should not be used in patients with severe bradyarrhythmia
resulting from either
sick-sinus syndrome or AV block of 2nd or 3rd degree, or in patients
with hypersensitivity to
the active substance, clonidine, or to any of the excipients listed in
section 6.1.
2
In case of rare hereditary conditions that may be incompatible with an
excipient of the product
(please refer to section 4.4 Special warnings and precautions for use)
the use of this product
is contraindicat