Olbas Oil

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

PEPPERMINT OIL; CAJUPUT OIL; EUCALYPTUS OIL; CLOVE OIL; METHYL SALICYLATE; JUNIPER BERRY OIL; LEVOMENTHOL

Available from:

G. R. Lane Health Products Limited

ATC code:

R05X

INN (International Name):

PEPPERMINT OIL; CAJUPUT OIL; EUCALYPTUS OIL; CLOVE OIL; METHYL SALICYLATE; JUNIPER BERRY OIL; LEVOMENTHOL

Pharmaceutical form:

INHALATION VAPOUR, LIQUID

Composition:

PEPPERMINT OIL 35.45 % (W/W); CAJUPUT OIL 18.5 % (W/W); EUCALYPTUS OIL 35.45 % (W/W); CLOVE OIL 0.1 % (W/W); METHYL SALICYLATE 3.7 % (W/W); JUNIPER BERRY OIL 2.7 % (W/W); LEVOMENTHOL 4.1 % (W/W)

Prescription type:

OTC

Therapeutic area:

COUGH AND COLD PREPARATIONS

Authorization status:

Authorised

Authorization date:

2005-12-23

Patient Information leaflet

READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT 
CONTAINS IMPORTANT INFORMATION FOR YOU.
This medicine is available without prescription. However, you
still 
need to use Olbas Oil carefully to get the best results from it.
r
  Keep this leaflet. You may need to read it again.
r
  Ask your pharmacist if you need more information or advice.
r
  You must contact a doctor if your symptoms worsen or do
  not improve after 7 days.
r
   If any of the side effects become serious, or if you notice 
any side effect not listed in this leaflet, please tell your
doctor  
or pharmacist.
In this leaflet:
1.
 What Olbas Oil is and what it is used for
2.
 Before you use Olbas Oil
3.
 How to use Olbas Oil 
4.
 Possible side effects
5.
 How to store Olbas Oil 
6.
 Further information
!  Do not put drops directly into nose or mouth. If Olbas Oil 
  is accidentally swallowed, seek immediate medical advice.
!   If Olbas Oil comes into direct contact with the surface of the
eye, 
wash thoroughly and seek immediate medical advice.
!  Avoid contact with plastic and other delicate materials.
4.  POSSIBLE SIDE EFFECTS 
Like all medicines, Olbas Oil can cause side effects, although not 
everybody gets them.
You may notice any of the following mild side effects if the oil
comes 
into contact with skin:
r
  hypersensitivity reactions such as skin rash
r
  stinging sensation which lasts only a short while.
If any of the side effects become serious, or if you notice any
side  
effect not listed in this leaflet, please tell your doctor or
pharmacist.
5.  HOW TO STORE OLBAS OIL
Keep out of the reach and sight of children.
Do not use Olbas Oil after the expiry date which is stated  
on the packaging. 
Do not store above 25ºC. 
Do not use if cap seal is broken or if fitted plastic dropper  
is missing from bottle neck. 
6. FURTHER INFORMATION
What Olbas Oil contains
The active substances (w/w) are:
Cajuput
Oil .............................................................18.5%
Clove

Summary of Product characteristics

Page 1 of 10 

1.

TRADE NAME OF THE PHARMACEUTICAL PRODUCT 
NORMOLOSE  tablet 

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION   
NORMOLOSE  50 mg Captopril / Tablet  

For excipients, (see Section 6.1 List of excipients) 

3.

PHARMACEUTICAL FORM 
Tablet 
NORMOLOSE  50 mg Captopril / Tablet: White, flat tablets 8 mm in diameter 

4.

CLINICAL PARTICULARS  
4.1.

THERAPEUTIC INDICATIONS  
HYPERTENSION : NORMOLOSE is indicated for the treatment of hypertension. 
CARDIAC  FAILURE  :  NORMOLOSE,    is  indicated  for  the  treatment  of  chronic  heart  failure, 
with reduced ventricular systolic function, in combination with diuretics,  and in combination 
with digitalis and beta-blockers, when it is indicated. 
MYOCARDIAL INFARCTION: 
-  Short  term  (4  weeks  duration):  NORMOLOSE  is  indicated  for  the  treatment  of  patients 
whose clinical condition has been stable within the first 24 hours after myocardial infarction.  
-  Long  term  prophylaxis  of  symptomatic  heart  failure  :  NORMOLOSE  is  indicated  for 
patients  with  asymptomatic  left  ventricular  dysfunction  (ejection  fraction  ≤  40%)  when  in 
stable clinical condition. 
Type  I  diabetic  nephropathy  :  NORMOLOSE    is  indicated    for  the  treatment  of    Type  I 
diabetic  patients  with  macroglobulinaemic  diabetic  nephropathy  (see  Section  5.1 
Pharmacodynamics)  
4.2.  POSOLOGY AND MODE OF ADMINISTRATION 
The  dose  should  be  individualized  according  to  patient  clinical  picture  (see  Section  4.4 
Special  warnings  and  special  precautions  on  use)  and  blood  pressure  response.  The 
recommended  maximum  daily  dose  is  150  mg.  NORMOLOSE  may  be  admi