natgillin/translations-raw huggingface dataset:
%
The difference in mean improvement between the two active treatment arms was not significant.
26%..
The corresponding figures for at least 50% pain reduction were 50% and 26% respectively.
CYP2D6), $
5.2 Pharmacokinetic properties
32%
The absolute oral bioavailability of duloxetine ranged from 32% to 80% (mean of 50%).
$(96%
Duloxetine is approximately 96% bound to human plasma proteins.
11%). +
The pharmacokinetics of duloxetine in patients who are poor metabolisers with respect to CYP2D6 has not been specifically investigated.
CYP2D6, CYP1A2 / 4 -. in vitro
Limited data suggest that the plasma levels of duloxetine are higher in these patients.
(Child Pugh Class B),
The elimination half-life of duloxetine ranges from 8 to 17 hours (mean of 12 hours).
(45
45 Special populations:
mg/ kg /
As a general recommendation, caution should be exercised when treating the elderly (see sections 4.2 and 4.4).
,
Pharmacokinetic data on duloxetine is limited in patients with mild or moderate renal impairment.
)
The pharmacokinetics of duloxetine and its metabolites have not been studied in patients with mild or severe hepatic insufficiency.
(AUC).
Nursing mothers:
(AUC).
5.3 Preclinical safety data
$/.
In prenatal/ postnatal toxicity studies in the rat, duloxetine induced adverse behavioural effects in the offspring at exposures below maximum clinical exposure (AUC).
6. 1
6.
+ /
6.1 List of excipients
+ / / $(: &
Capsule content:
% + + (E171) +.
Hypromellose.
/ + 30 mg:
30 mg:
(E132) 4
Gelatin Sodium Lauryl Sulfate Titanium Dioxide (E171) Indigo Carmine (E132) Edible Green Ink
(E172)
Edible Green Ink contains:
6. 3, & +
6.2 Incompatibilities
30°C.
Not applicable.
(PVC),%
6.3 Shelf life
(PCTFE) $
6.4 Special precautions for storage
,
Store in the original package in order to protect from moisture.
ARICLAIM 30 mg
Do not store above 30 C.
7, 28
6.5 Nature and contents of container
98
Polyvinylchloride (PVC), Polyethylene (PE), and Polychlorotrifluoroethylene (PCTFE) blister sealed with an aluminum foil.
.
ARICLAIM 30 mg is available in packs of 7, 28 and 98 capsules.
$
Not all pack sizes may be marketed.
$.
6.6 Special precautions for disposal
() 6 7 6.
MARKETING AUTHORISATION NUMBER(S)
EU/ 1/ 04/ 283/ 008 EU/ 1/ 04/ 283/ 009 EU/ 1/ 04/ 283/ 010
EU/ 1/ 04/ 283/ 008 EU/ 1/ 04/ 283/ 009 EU/ 1/ 04/ 283/ 010
9.
47 9.
/ 6 7
10.
6
DATE OF REVISION OF THE TEXT
51 1.
48 1.
ARICLAIM 60 mg
ARICLAIM 60 mg hard gastro-resistant capsules
(duloxetine) (
Each capsule contains 60 mg of duloxetine (as hydrochloride).
17, 2 mg.
Excipients: sucrose 17.2 mg.
‘ 9542 ’
PHARMACEUTICAL FORM
’ 60 mg ’
Hard gastro-resistant capsule.
4.
Opaque green body, imprinted with ‘ 60 mg’ and an opaque blue cap, imprinted with ‘ 9542’.
4. 1
4.
"
Treatment of diabetic peripheral neuropathic pain in adults.
#
4.2 Posology and method of administration
.
For oral use.
4. 2
Hence, some patients that respond insufficiently to 60 mg may benefit from a higher dose.
2
The medicinal product response should be evaluated after 2 months’ of treatment.
"ARICLAIM $
Elderly Diabetic Peripheral Neuropathic Pain:
$
Children and adolescents There is no experience in children (see section 4.4).
(
Hepatic impairment ARICLAIM should not be used in patients with liver disease resulting in hepatic impairment (see sections 4.3 and 5.2).
4. 3
49 Renal insufficiency No dosage adjustment is necessary for patients with mild or moderate renal dysfunction (creatinine clearance 30 to 80 ml/ min).
30
ARICLAIM should not be used in patients with severe renal impairment (creatinine clearance < 30 ml/ min; see section 4.3).
ARICLAIM
4.3 Contraindications
4. 3).
Concomitant use of ARICLAIM with nonselective, irreversible Monoamine Oxidase Inhibitors (MAOIs) is contraindicated (see section 4.5).
$$
Liver disease resulting in hepatic impairment (see section 5.2).
(
ARICLAIM should not be used in combination with fluvoxamine, ciprofloxacin or enoxacine (i. e. potent CYP1A2 inhibitors) since the combination results in elevated plasma concentrations of duloxetine (see section 4.5).
;
The initiation of treatment with ARICLAIM is contraindicated in patients with uncontrolled hypertension that could expose patients to a potential risk of hypertensive crisis (see sections 4.4 and 4.8).
.
4.4 Special warnings and precautions for use
:
Mania and seizures ARICLAIM should be used with caution in patients with a history of mania or a diagnosis of bipolar disorder, and/ or seizures.
+
Mydriasis Mydriasis has been reported in association with duloxetine, therefore, caution should be used when prescribing ARICLAIM to patients with increased intraocular pressure, or those at risk of acute narrow-angle glaucoma.
$
In patients with uncontrolled hypertension duloxetine should not be initiated (see section 4.3).
$
50 Renal impairment Increased plasma concentrations of duloxetine occur in patients with severe renal impairment on haemodialysis (creatinine clearance < 30 ml/ min).
ARICLAIM,
For patients with severe renal impairment, see section 4.3.
$
In particular the combination with selective reversible MAOIs is not recommended.
(
St John’ s wort Undesirable effects may be more common during concomitant use of ARICLAIM and herbal preparations containing St John’ s wort (Hypericum perforatum).
4. 4
If a decision to initiate antidepressant pharmacological therapy is taken, the gradual discontinuation of ARICLAIM is recommended (see Section 4.2).
4. 8).,
In addition, long-term safety data in children and adolescents concerning growth, maturation and cognitive and behavioural development are lacking.
$
Caution is advised in patients taking anticoagulants and/ or medicinal products known to affect platelet function, and in patients with known bleeding tendencies.
.
They usually occur within the first few days of discontinuing treatment, but there have been very rare reports of such symptoms in patients who have inadvertently missed a dose.
5. 2).
Generally these symptoms are self-limiting and usually resolve within 2 weeks, though in some individuals they may be prolonged (2-3 months or more).
ARICLAIM (
In patients who develop these symptoms, increasing the dose may be detrimental.
.,
The use of more than one of these products concomitantly should be avoided.
$
Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrose-isomaltase insufficiency should not take this medicine.
$CYP1A2),
4.5 Interaction with other medicinal products and other forms of interaction
%
Consequently, caution is advised when ARICLAIM is taken in combination with other centrally acting medicinal products and substances including alcohol and sedative medicinal products (e. g. benzodiazepines, morphinomimetics, antipsychotics, phenobarbital, sedative antihistamines).
(
Based on the half-life of duloxetine, at least 5 days should be allowed after stopping ARICLAIM before starting an MAOI (see section 4.3).
, $
However, the concomitant use of ARICLAIM with selective, reversible MAOIs is not recommended (see section 4.4).
4. 5).
Caution is advisable if 52 ARICLAIM is used concomitantly with serotonergic antidepressants like SSRIs, tricyclics like clomipramine or amitriptyline, St John’ s wort (Hypericum perforatum), venlafaxine or triptans, tramadol, pethidine and tryptophan.
% $
The pharmacokinetics of theophylline, a CYP1A2 substrate, were not significantly affected by co-administration with duloxetine (60 mg twice daily).
ARICLAIM, (
Medicinal products metabolised by CYP2D6:
.
Specific in vivo drug interaction studies have not been performed.
$
Effects of other medicinal products on duloxetine Antacids and H2 antagonists: co-administration of duloxetine with aluminium- and magnesium- containing antacids or duloxetine with famotidine had no significant effect on the rate or extent of duloxetine absorption after administration of a 40 mg oral dose.
$
4.6 Pregnancy and lactation
.
Women should be advised to notify their physician if they become pregnant, or intend to become pregnant, during therapy.
53
53 Breast feeding Duloxetine is very weakly excreted into human milk based on a study of 6 lactating patients, who did not breast feed their children.
$/
4.7 Effects on ability to drive and use machines
$$
Patients should be instructed that if they experience sedation or dizziness they should avoid potentially hazardous tasks such as driving or operating machinery.
ARICLAIM $
4.8 Undesirable effects
$MAO -
The most commonly observed adverse reactions in patients with diabetic neuropathic pain treated with ARICLAIM were: nausea; headache, dry mouth and somnolence.
ARICLAIM
Adverse reactions Frequency estimate:
. +
Very
- $
Common
). +
Uncommon
- $/
Very Rare
.
Frequency not
4. 8). #
common
.,
known
ARICLAIM,,
Investigations
ARICLAIM (
Weight decrease
4. 2).
Blood cholesterol increased
$-,
Palpitations
$($.,
Tachycardia
/ $
Supra- ventricular arrhythmia, mainly atrial fibrillation
,
Nervous System
, $
Disorders
(SSRIs)
Headache (13.8%) Somnolence (10.7%) Eye Disorders
-
Dizziness Tremor Lethargy Paraesthesia
/
Blurred vision
/
Visual disturbance Mydriasis
(SNRIs).
Glaucoma
,
Ear and Labyrinth Disorders
54
54
, *).
Very
4. 8).
Common
23%
Rare
SSRI’ s
Very Rare
SRNI’ s
Frequency not
4. 8). $
common
ARICLAIM
Vertigo Ear pain
(MAO - (
known
, ARICLAIM
Respiratory, thoracic and mediastinal disorders
ARICLAIM 4. 4).
Epistaxis Throat tightness
SSRIs,
Gastrointestinal
ARICLAIM
Disorders
(Hypericum perforatum),
Nausea (21.7%) Dry mouth (13.2%)
CYP1A2:
Haematochezia Breath odour
CYP2D6 (
Muscle twitching
[+1, *]
Trismus
(
Endocrine disorders Hypo- thyroidism Metabolism and Nutrition Disorders
in vitro
Decreased Appetite
,
Hyperglycemia (reported especially in diabetic patients)
CYP3A..
Dehydration SIADH Hypo-natremia
%
Infections and infestations Laryngitis Vascular Disorders
'% 40 mg
Flushing
CYP1A2:
Syncope2 Orthostatic
CYP1A2 ARICLAIM
Hypertensive crisis
$$
55
CYP1A2, $
Very
CYP1A2,
Common
(100 mg
Uncommon
77%
Rare
AUC0- t 6
Very Rare
, ARICLAIM
Frequency not
4. 3).
known
56
hypotension2 Blood pressure increase Peripheral coldness
CYP1A2:, 50%
Hypertension
-
General Disorders and Administration Site Conditions
$
Feeling hot Malaise Gait disturbance Feeling abnormal Feeling cold Thirst Chills
0, 14% $$
Chest pain
5. 2). + ARICLAIM
Immune system disorders Hepato-biliary disorders
ARICLAIM
Hyper- sensitivity disorder
ARICLAIM,
Anaphylactic reaction
HbA1
3 See section 4.4
$
56 4 Cases of suicidal ideation and suicidal behaviours have been reported during duloxetine therapy or early after treatment discontinuation (see section 4.4) 5 Cases of aggression and anger have been reported particularly early in treatment of after treatment discontinuation.
60
It is therefore advised that when duloxetine treatment is no longer required, gradual discontinuation by dose tapering should be carried out (see sections 4.2 and 4.4).
(
5.
%
5.1 Pharmacodynamic properties
N06AX21
N06AX21.
$
The pain inhibitory action of duloxetine is believed to be a result of potentiation of descending inhibitory pain pathways within the central nervous system.
$$
The primary outcome measure was the weekly mean of 24-hour average pain, which was collected in a daily diary by patients on an 11-point Likert scale.
(5- HT)
The difference in mean improvement between the two active treatment arms was not significant.
10
Food delays the time to reach the peak concentration from 6 to 10 hours and it marginally decreases the extent of absorption (approximately 11%).
CYP2D6 CYP1A2
Duloxetine binds to both albumin and alpha-l acid glycoprotein.
/ 4 -. in vitro%
Limited data suggest that the plasma levels of duloxetine are higher in these patients.
,. 2
The elimination half-life of duloxetine ranges from 8 to 17 hours (mean of 12 hours).
22
After an intravenous dose the plasma clearance of duloxetine ranges from 22 l/ hr to 46 l/ hr (mean of 36 l/ hr).
6
Pharmacokinetic data on duloxetine is limited in patients with mild or moderate renal impairment.
(Child Pugh Class B),
Hepatic impairment: moderate liver disease (Child Pugh Class B) affected the pharmacokinetics of duloxetine.
: & 12 -
Nursing mothers:
(144 mg/ kg / $
5.3 Preclinical safety data
),
In prenatal/ postnatal toxicity studies in the rat, duloxetine induced adverse behavioural effects in the offspring at exposures below maximum clinical exposure (AUC).
63 +.
Hypromellose.
3
Capsule shell:
:
60 mg:
(E132) 3 ('172) 4
59 Gelatin Sodium Lauryl Sulfate Titanium Dioxide (E171) Indigo Carmine (E132) Yellow Iron Oxide (E172) Edible White Ink
$
Edible White Ink contains:
+ (E171)
Titanium Dioxide (E171) Propylene glycol Shellac Povidone.
(PE)
6.4 Special precautions for storage
%
Store in the original package in order to protect from moisture.
(PCTFE) $
Do not store above 30 C.
ARICLAIM 60 mg
6.5 Nature and contents of container
,
Polyvinylchloride (PVC), Polyethylene (PE), and Polychlorotrifluoroethylene (PCTFE) blister sealed with an aluminum foil.
28
ARICLAIM 60 mg is available in packs of 28 and 98 capsules.
98
Not all pack sizes may be marketed.
EU/ 1/ 04/ 283/ 011 EU/ 1/ 04/ 283/ 012
EU/ 1/ 04/ 283/ 011 EU/ 1/ 04/ 283/ 012
65 II
60 ANNEX II
()
B.
6
61 A MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
7 6
Name and address of the manufacturer(s) responsible for batch release
Avda. de la Industria Nº 30, 28108 Alcobendas Madrid!
Avda. de la Industria Nº 30, 28108 Alcobendas Madrid Spain
.
B CONDITIONS OF THE MARKETING AUTHORISATION
6
• CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON THE MARKETING AUTHORISATION HOLDER
7 6
Medicinal product subject to medical prescription
.
• CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
..
Not applicable.
•
• OTHER CONDITIONS
67 III
62 ANNEX III
6
LABELLING AND PACKAGE LEAFLET
68 A.
63 A.
40 MG
LABELLING
7
64 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
-
CARTONS FOR 40 MG HARD GASTRO-RESISTANT CAPSULES
ARICLAIM 40 mg Duloxetine
Duloxetine
..
2.
8
Each capsule contains 40 mg duloxetine (as hydrochloride)
8
Contains sucrose See leaflet for further information
28 56 98 140
28 hard gastro-resistant capsules 56 hard gastro-resistant capsules 98 hard gastro-resistant capsules 140 hard gastro-resistant capsules
2
METHOD AND ROUTE(S) OF ADMINISTRATION
.
Oral use.
4
Keep out of the reach and sight of children.
44
EXP {MM/ YYYY}.
4
SPECIAL STORAGE CONDITIONS
70 10.
Store in the original package.
11.
Do not store above 30 °C.
6
65 10.
7 6
11.
Eli Lilly Nederland BV, Grootslag 1- 5, NL- 3991 RA, Houten, 0
Eli Lilly Nederland BV, Grootslag 1-5, NL-3991 RA, Houten, The Netherlands.
EU/ 1/ 04/ 283/ 002- 005
EU/ 1/ 04/ 283/ 002-005
8:
Lot:
#.
Medicinal product subject to medical prescription.
6 6
16.
ARICLAIM 40 mg
ARICLAIM 40 mg
71
66 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
,
CARTON FOR 98 CAPSULES (40 MG) AS INTERMEDIATE PACK / COMPONENT OF A MULTIPACK (WITHOUT BLUE BOX)
98
1.
(40 MG)
NAME OF THE MEDICINAL PRODUCT
ARICLAIM 40 mg Duloxetine
ARICLAIM 40 mg hard gastro-resistant capsules Duloxetine
8
Each capsule contains 40 mg duloxetine (as hydrochloride).
98.
Contains sucrose.
2 (
4.
2
98 capsules Component of a multipack comprising 2 packs, each containing 98 capsules.
6.
5.
2 2
6.
{MM/ 4 4}.
EXP {MM/ YYYY}
72 10.
Store in the original package.
6
67 10.
EU/ 1/ 04/ 283/ 004
EU/ 1/ 04/ 283/ 004
73
68 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER WRAPPER LABEL ON MULTIPACKS (2X98 CAPSULES, 40 MG) WRAPPED IN FOIL (INCLUDING BLUE BOX)
8
1.
, 40 MG),
NAME OF THE MEDICINAL PRODUCT
2
Multipack comprising 2 packs, each containing 98 capsules.
4
Oral use Read the package leaflet before use.
44
EXP {MM/ YYYY}
74 10.
Store in the original package.
6
69 10.
EU/ 1/ 04/ 283/ 006
EU/ 1/ 04/ 283/ 006
ARICLAIM 40 mg
INSTRUCTIONS ON USE
75
16.
(40 mg +
ARICLAIM 40 mg
, (1
70 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS (40 mg hard gastro- resistant capsules)
Lilly
Lilly
{MM/ 4 4}.
< EXP {MM/ YYYY}.
2
BATCH NUMBER
76
Lot:
.
71 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
20
CARTONS FOR 20 MG HARD GASTRO-RESISTANT CAPSULES
MG
1.
ARICLAIM 20 mg Duloxetine
ARICLAIM 20 mg, hard gastro-resistant capsules.
20 mg
Each capsule contains 20 mg duloxetine (as hydrochloride).
.
Contains sucrose.
28
28 hard gastro-resistant capsules 56 hard gastro-resistant capsules.
56
5.
5.
6.
2
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE REACH AND SIGHT OF CHILDREN
.
Keep out of the reach and sight of children.
77 10.
Store in the original package.
6
72 10.
ARICLAIM 20 mg
INSTRUCTIONS ON USE
78
16.
(20 mg +
ARICLAIM 20 mg
, (1
73 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS (20 mg hard gastro- resistant capsules)
ARICLAIM 20 mg Duloxetine
ARICLAIM 20 mg hard gastro-resistant capsules Duloxetine
79
Lot:
.
74 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
30
CARTONS FOR 30 MG HARD GASTRO-RESISTANT CAPSULES
ARICLAIM 30 mg Duloxetine
ARICLAIM 30 mg, hard gastro-resistant capsules.
7 28 98
LIST OF EXCIPIENTS
-
Contains sucrose See leaflet for further information
- -
4.
,
7 hard gastro-resistant capsules, 28 hard gastro-resistant capsules 98 hard gastro-resistant capsules
,,
5.
4
EXP
*
Store in the original package.
30°C
Do not store above 30°C
6
75 10.
ARICLAIM 30 mg
ARICLAIM 30 mg
81
76 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 30 mg hard gastro-resistant capsules
.
1.
30 mg + (1
NAME OF THE MEDICINAL PRODUCT
ARICLAIM 30 mg Duloxetine
ARICLAIM 30 mg hard gastro-resistant capsules Duloxetine
82
OTHER
,
77 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
.
CARTONS FOR 60 MG HARD GASTRO-RESISTANT CAPSULES
60
1.
MG
NAME OF THE MEDICINAL PRODUCT
7
ARICLAIM 60 mg, hard gastro-resistant capsules.
ARICLAIM 60 mg Duloxetine
Duloxetine
8
Each capsule contains 60 mg of duloxetine (as hydrochloride)
28,
28, hard gastro-resistant capsules 98, hard gastro-resistant capsules.
6
78 10.
ARICLAIM 60 mg
INSTRUCTIONS ON USE
84
16.
60 mg + (1
ARICLAIM 60 mg
- '*
79 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 60 mg hard gastro-resistant capsules
+ '
1.
ARICLAIM 60 mg Duloxetine
ARICLAIM 60 mg hard gastro-resistant capsules Duloxetine
8:
4.
:
Lot:
.
5.
ARICLAIM 40 mg + (1
OTHER
- '* +
80 B.
+ ', / & #
PACKAGE LEAFLET
ARICLAIM 20 mg + (1
81 PACKAGE LEAFLET:
+ ', / & #
INFORMATION FOR THE USER
) (Duloxetine (
ARICLAIM 40 mg hard gastro-resistant capsules ARICLAIM 20 mg hard gastro-resistant capsules Duloxetine (as hydrochloride)
hydrochloride))
Read all of this leaflet carefully before you start taking this medicine.
. +
- Keep this leaflet.
2.
You may need to read it again.
(
- If you have any further questions, ask your doctor or pharmacist.
ARICLAIM ARICLAIM
Do not pass it on to
4.
- others.
(
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
ARICLAIM 6.
please tell your doctor or pharmacist.
ARICLAIM
In this leaflet:
6
1.
ARICLAIM ARICLAIM
Before you take ARICLAIM 3.
(! ").
How to take ARICLAIM 4.
ARICLAIM
How to store ARICLAIM 6.
ARICLAIM
Further information
$.
1.
$
ARICLAIM is a medicine to be taken by mouth to treat Stress Urinary Incontinence (SUI) in women or to treat a condition called diabetic neuropathic pain in adults.
,
Stress urinary incontinence is a medical condition in which patients have accidental loss or leakage of urine during physical exertion or activities such as laughing, coughing, sneezing, lifting, or exercise.
$
ARICLAIM is believed to work by increasing the strength of the muscle that holds back urine when you laugh, sneeze, or perform physical activities.
,
The efficacy of ARICLAIM is reinforced when combined with a training program called Pelvic Floor Muscle Training (PFMT).
$
There may be loss of feeling in the affected area, or sensations such as touch, heat, cold or pressure may cause pain.
ARICLAIM 1
The effect of ARICLAIM may be noticeable in many patients with diabetic neuropathic pain within 1 week of treatment.
$
2.
ARICLAIM
BEFORE YOU TAKE ARICLAIM
(* ARICLAIM -
Do not take ARICLAIM
,
- If you are allergic (hypersensitive) to duloxetine or any of the inactive ingredients of
ARICLAIM. -
ARICLAIM.
,
- If you are taking or have taken within the last 14 days, another medicine known as a monoamine
14
oxidase inhibitor - MAOI (see section below ‘ Taking other medicines’).
- MAO -
- If you have liver disease.
$
- If you are taking fluvoxamine which is usually used to treat depression, ciprofloxacin or
(
enoxacine which are used to treat some infections.
- -
82
,,
- If you have severe kidney disease.
$$
- If you suffer from uncontrolled high blood pressure.
$
Take special care with ARICLAIM The following are reasons why ARICLAIM may not be suitable for you.
+ ARICLAIM ARICLAIM
If any of them apply to you, talk to your doctor before you take the medicine:
$
- You are taking other medicines to treat depression.
.
John’ s Wort (Hypericum perforatum).
-.
- You have kidney disease.
(Hypericum perforatum)..
- You have had seizures (fits).
- -
- You suffer from or have suffered from mania or bipolar disorder.
).
- You have eye problems, such as certain kinds of glaucoma (increased pressure in the eye).
$
- You have a history of bleeding disorders (tendency to develop bruises).
,
- You are at risk of low sodium levels.
((
- You have high blood pressure.
).
- You are currently being treated with another medicine which may cause liver damage.
- - -
- You are taking other medicines containing duloxetine.
ARICLAIM (
- You have intolerance to some sugars (see below).
.
- You are considering stopping ARICLAIM (see section 3).
3).
You should tell your doctor if this happens to you.
ARICLAIM
You may be more likely to think like this:
$
- If you have previously had thoughts about killing or harming yourself.
. +,
- If you are a young adult.
25
behaviour in adults aged less than 25 years with psychiatric conditions who were treated with an antidepressant.
18
Use in children and adolescents under 18 years of age ARICLAIM should not be used for children and adolescents under the age of 18 years.
/
Check with your doctor if you are already taking other medicines containing duloxetine.
18
Also, you need to wait at least 5 days after you stop taking ARICLAIM before you take an MAOI.
. + $%
Inform your doctor if you are taking any of these medicines.
$
Serotonin syndrome: you should tell your doctor if you are taking any of the medicines that act in a similar way to duloxetine.
ARICLAIM,
Examples of these medicines include: triptans, tramadol, tryptophan, certain antidepressants:
ARICLAIM
Oral -anticoagulants:
ARICLAIM $.
These medicines might increase the risk of bleeding.
M,) - MAO -, /
Taking ARICLAIM with food and drink ARICLAIM may be taken with or without food.
ARICLAIM.
You should take extra care if you drink alcohol while taking ARICLAIM.
)
You should use ARICLAIM only after discussing the potential benefits and any potential risks to your unborn child with your doctor.
(ARICLAIM + 0 ARICLAIM
You should ask your doctor or pharmacist for advice if you are breast-feeding.
ARICLAIM.
The use of ARICLAIM while breastfeeding is not recommended.
ARICLAIM. + $ARICLAIM
Ask your doctor or pharmacist for advice before taking any medicine.
7 - ARICLAIM ARICLAIM.
Driving and using machines ARICLAIM may make you feel sleepy of dizzy.
)
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
ARICLAIM, $
HOW TO TAKE ARICLAIM
.
You should check with your doctor or pharmacist if you are not sure.
,
The usual dose of ARICLAIM for the treatment Neuropathic pain is 60 mg once a day, but your doctor will prescribe the dose that is right for you.
ARICLAIM
ARICLAIM is for oral use.
,
Do not stop taking ARICLAIM without talking to your doctor.
%
If you take more ARICLAIM than you should Call your doctor or pharmacist immediately if you take more than the amount of ARICLAIM prescribed by your doctor.
.
If you forget to take ARICLAIM Do not take a double dose to make up for forgotten doses.
ARICLAIM,
If you miss a dose, take it as soon as you remember.
$
If you stop taking ARICLAIM Do not stop taking your capsules without the advice of your doctor even if you feel better.
, 2
If your doctor thinks that you no longer need ARICLAIM he will ask you to reduce your dose over 2 weeks.
. +
4.
, ARICLAIM $
POSSIBLE SIDE EFFECTS