Enelfa 125 suppositories

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

PARACETAMOL

Available from:

Dolorgiet GmbH & Co. KG Otto-von-Guericke-Str. 1, 53757 Sankt Augustin / Bonn, Germany

ATC code:

N02BE01

INN (International Name):

PARACETAMOL 125 mg

Pharmaceutical form:

SUPPOSITORY

Composition:

PARACETAMOL 125 mg

Prescription type:

OTC

Therapeutic area:

ANALGESICS

Authorization status:

Withdrawn

Authorization date:

2006-11-24

Patient Information leaflet

 
1
Package Insert 

FOR THE TREATMENT OF PAIN AND FEVER 

ENELFA® SUPPOSITORIES 125/250 

Active Ingredient: Paracetamol 

Composition:  ENELFA® 125: 1 suppository contains: 

_Active ingredient: paracetamol 125 mg. _
_  Excipient: _
_solid _
_fat _

ENELFA® 250: 1 suppository contains: 

_Active ingredient: paracetamol 250 mg. _
_  Excipient: _
_solid _
_fat _

PHARMACOTHERAPEUTIC GROUP: Pain-relieving and antipyretic agent. 

INDICATIONS: 
Mild to moderate pain and fever. 
Enelfa® suppositories should not be used over a prolonged
period or at increased doses 
without advice of a physician or dentist. 

CONTRAINDICATIONS: 
This drug must not be administered in cases of known
hypersensitivity to the active ingredient 
paracetamol or to any of the excipients. Patients suffering from
renal or hepatic insufficiency 
(e. g. due to chronic abuse of alcohol, hepatitis) or Gilbert´s
syndrome (Meulengrachts´s 
disease) should use Enelfa® only upon medical advice and
in reduced doses or at prolonged 
administration intervals. Same applies to newborn. 

PREGNANCY AND LACTATION: 
Enelfa® should be administered during pregnancy only under
strict consideration of the 
benefit-risk-ratio. During pregnancy, paracetamol suppositories
should not be administered 
over a prolonged period, at high doses or in combination with other
drugs, since safety of 
administration has not been established in these cases. Paracetamol
penetrates into the 
mother´s milk. Since negative effects for the infant
have not become known so far, nursing 
needs normally not be discontinued. 

SIDE EFFECTS: 
In rare cases erythema and very seldom allergic reactions with
exanthema. In extremely rare 
cases dyshaematophoiesis (thrombocytopenia, leucopenia,
in individual cases agranulocytosis, 
pancytopenia). In individual cases bronchospasm with dyspnoea
(analgesics asthma) in 
predisposed patie

Summary of Product characteristics

Page 1 of 7

SUMMARY OF PRODUCT CHARACTERISTICS 

1. 
NAME OF THE MEDICINAL PRODUCT 

Enelfa® 125, suppositories 

Enelfa® 250, suppositories  

Active ingredient: Paracetamol 

2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

ENELFA® 125, SUPPOSITORIES 

1 suppository contains 125 mg of paracetamol 

ENELFA® 250, SUPPOSITORIES 

1 suppository contains 250 mg of paracetamol 

For a full list of excipients, see section 6.1 

3. PHARMACEUTICAL 
FORM 

 Suppositories 

4. CLINICAL 
PARTICULARS 

4.1 THERAPEUTIC 
INDICATIONS 

-  mild to moderate pain 
-  fever  

4.2  POSOLOGY AND METHOD OF ADMINISTRATION 

ENELFA® 125, SUPPOSITORIES: for nurslings up to 1 year of age 

ENELFA® 250, SUPPOSITORIES: for children as from 1 – 6 years
of age 

4.3 CONTRAINDICATIONS 

    Enelfa suppositories must not be used in case of known
hypersensitivity to the active 
ingredient,  

    paracetamol or to the excipient. 

4.4  SPECIAL WARNINGS AND PRECAUTIONS FOR USE 

Patients suffering from 

-  renal or hepatic insufficiency (e. g. due to chronic abuse
of alcohol, hepatitis), 
-  Gilbert´s syndrome (Meulengracht´s disease) 

Page 2 of 7

should use Enelfa® only upon medical advice and in reduced doses or
at prolonged 
administration intervals.  

Same applies to newborn. 

4.5  INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION 

Simultaneous administration of drugs causing a so-called
enzyme induction in the liver, e. g. 
certain sleeping agents and anti-epileptics (among others
phenobarbital, phenytoin, 
carbamazepine) as well as rifampicin may cause hepatic damage even
at paracetamol standard 
doses. Same applies to the abuse of alcohol. 

Combination with chloramphenicol may lead to a distinct delay in
the elimination of 
chloramphenicol, thus increasing the toxicity of this drug. 

Interac