Core Safety Profile
Active substance: Phloroglucinol
Pharmaceutical form(s)/strength: 80mg oral lyophilisate, 80mg coated tablet,
solution for injection 10mg/ml, suppository
150mg
P - RMS: FR/H/PSUR/0028/001
Date of FAR: 23.12.2010
V01530 – Annex I – Base 01/12/1993 – Rev. 10/10/1996 – 08/09/1999 – 29/10/1999 – 31/03/2003 – 21/05/2007 – 14/08/2007 – 21/10/2008 1/3
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1- NAME OF THE MEDICINAL PRODUCT
/.../, coated tablet
2- QUALITATIVE AND QUANTITATIVE COMPOSITION
Phloroglucinol hydrate............................................................................................................80.000 mg
corresponding quantity of anhydrous phloroglucinol .............................................................62.233 mg
Trimethylphloroglucinol .........................................................................................................80.000 mg
Lactose monohydrate ............................................................................................................140.000 mg
Sucrose....................................................................................................................................30.000 mg
Polyvinyl acetate.......................................................................................................................8.000 mg
Wheat starch............................................................................................................................23.767 mg
Stearic acid................................................................................................................................9.400 mg
Magnesium stearate ..................................................................................................................1.600 mg
for one 355 mg tablet core
Polyvinyl acetate.......................................................................................................................5.500 mg
Talc ........................................................................................................................................46.500 mg
Sucrose..................................................................................................................................176.500 mg
Acacia .......................................................................................................................................4.300 mg
Gelatin.......................................................................................................................................0.800 mg
Titanium dioxide (E 171)..........................................................................................................0.200 mg
Erythrosine (E 127)...................................................................................................................0.048 mg
Carnauba wax............................................................................................................................0.220 mg
for one 589.068 mg coated tablet
3- PHARMACEUTICAL FORM
Coated tablet
4- CLINICAL PARTICULARS
4.1 – Therapeutic indications
- Symptomatic treatment of pain related to functional disorders of the digestive tract and
bile ducts.
- Treatment of acute spasmodic painful disorders of the urinary tract: renal colic.
- Symptomatic treatment of acute pain in gynaecology.
- Adjuvant treatment of contractions during pregnancy in combination with rest.
V01530 – Annex I – Base 01/12/1993 – Rev. 10/10/1996 – 08/09/1999 – 29/10/1999 – 31/03/2003 – 21/05/2007 – 14/08/2007 – 21/10/2008 2/3
4.2 - Posology and method of administration
6 coated tablets per 24 hours.
4.3 - Contraindications
Hypersensitivity to one of the ingredients.
4.4 - Special warnings and precautions for use
Phloroglucinol should not be administered concomitantly with major analgesics such as
morphine or morphine derivatives due to their spasmogenic effects.
4.5 - Interaction with other medicinal products and other forms of interaction
4.6 - Pregnancy and lactation
Pregnancy
Animal studies have not demonstrated any teratogenic effect of phloroglucinol. A
malformative effect in the human species is not expected in the absence of a teratogenic effect
in animals, as, to date, substances responsible for malformations in the human species have
always been found to be teratogenic in animals during well conducted studies on two species.
The relatively widespread use of phloroglucinol in clinical practice has not revealed any risk
of malformative effects to date. However, epidemiological studies would be necessary to
confirm the absence of risk.
Consequently, the use of phloroglucinol during pregnancy must be considered only when
strictly necessary.
Lactation
In the absence of data, use of this medicinal product is not recommended while breastfeeding.
4.7 - Effects on ability to drive and use machines
4.8 - Undesirable effects
Skin and subcutaneous and allergic reactions: rash, rarely urticaria, exceptional angioedema,
hypotension, anaphylactic shock.
4.9 - Overdose
5- PHARMACOLOGICAL PROPERTIES
5.1 - Pharmacodynamic properties
MUSCULOTROPIC ANTISPASMODIC
(A: Alimentary tract and metabolism)
(G: Genito-urinary system).
Phloroglucinol relieves smooth muscle fibre spasm and relieves pain.
5.2 - Pharmacokinetic properties
V01530 – Annex I – Base 01/12/1993 – Rev. 10/10/1996 – 08/09/1999 – 29/10/1999 – 31/03/2003 – 21/05/2007 – 14/08/2007 – 21/10/2008 3/3
5.3 - Preclinical safety data
6- PHARMACEUTICAL PARTICULARS
6.1 - Incompatibilities
6.2 - Shelf life
5 years.
6.3 - Special precautions for storage
6.4 - Nature and contents of container
Blisters (PVC/Aluminium) containing 20 coated tablets
Blisters (PVC/Aluminium) containing 30 coated tablets
Blisters (PVC/Aluminium) containing 500 coated tablets (reserved for export)
6.5 - Special precautions for disposal and other handling
7- MARKETING AUTHORISATION NUMBERS
(-): Blisters (PVC/Aluminium) containing 20 coated tablets
(-): Blisters (PVC/Aluminium) containing 30 coated tablets
(-): Blisters (PVC/Aluminium) containing 500 coated tablets (reserved for export)
8- GENERAL CLASSIFICATION FOR SUPPLY
9- MARKETING AUTHORISATION HOLDER
(-)
10 - DATE OF APPROVAL/REVISION
October 2008
