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DIFLUCAN 10 MG/ML POWDER FOR ORAL SUSPENSION

Active substance(s): FLUCONAZOLE / FLUCONAZOLE

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Service Développement Fareva Amboise
Produit DIFLUCAN POS
Code Mock up from 8819882
Type pliee ND
Format 157 x 315 mm

NOIR
Couleur:
Minimum font size: 8 pts
Version: 8
Date: 24/03/2017

PLIEE Double-L157-5-v2

157 x 40 mm (8 volets)
Préparé par : Karine Duverger
Text only is subject to market approval.

This medicinal product is authorised in the Member
States of the EEA under the following names:
Austria
Belgium, Denmark,
Finland, Iceland,
Ireland, Italy,
Luxembourg,
Norway, Portugal,
Sweden, United
Kingdom
France
Germany

Hungary
Greece
The Netherlands
Romania
Slovakia
Slovenia
Spain

Diflucan 10 mg/ml and 40 mg/ml
Trockensaft
Diflucan

For example, a child weighing 11 kg prescribed Diflucan
3 mg/kg/day should receive 33 mg/day, equivalent to
3.3 ml of the 10 mg/ml oral suspension. The dose may be
rounded up to 3.4 ml, the nearest graduation on the oral
syringe to provide the full dose.
A maximum dose of 400 mg daily should not be exceeded
in the paediatric population (see table *).

Triflucan
Diflucan Trockensaft 10 mg/ ml
Diflucan 40 mg/ml Pulver zur
Herstellung einer Suspension zum
Einnehmen
Diflucan 10 mg/ml and 40 mg/ml
por belsőleges szuszpenzióhoz
Fungustatin
Diflucan 10 mg/ml and 40 mg/ml
Diflucan 10 mg/ml pulbere pentru
suspesie orală
Diflucan P.O.S. 10 mg/ml and
Diflucan P.O.S. 40 mg/ml
Diflucan 10 mg/ml and 40 mg/ml
prašek za peroralno suspenzij
Diflucan 10 mg/ml and 40 mg/ml
polvo para suspensión oral

This leaflet was last revised in:
UK 03/2017
IE 03/2017

The use of Diflucan 10mg/ml powder for oral suspension
is not recommended for doses > 15.0 ml (see table for
doses highlighted in grey). When doses exceed 15.0 ml, it
is recommended to use Diflucan 40mg/ml powder for oral
suspension.
Table Dosage examples:
Weight Kg
3 kg
5 kg
7.5 kg
10 kg
12.5 kg
15 kg
20 kg
25 kg
30 kg
35 kg
40 kg
45 kg

Posology (Corresponding dose in ml/day)
3 mg/kg/day 6 mg/kg/day 12 mg/kg/day
1.0 ml
1.8 ml
3.6 ml
1.6 ml
3.0 ml
6.0 ml
2.2 ml
4.6 ml
9.0 ml
3.0 ml
6.0 ml
12.0 ml
3.8 ml
7.6 ml
15.0 ml
4.6 ml
9.0 ml
18.0 ml
6.0 ml
12.0 ml
24.0 ml
7.6 ml
15.0 ml
30.0 ml
9.0 ml
18.0 ml
36.0 ml
10.6 ml
21.0 ml
40.0 ml*
12.0 ml
24.0 ml
40.0 ml*
13.6 ml
27.0 ml
40.0 ml*

Diflucan 40 mg/ml powder for oral suspension:
In children Diflucan powder for oral suspension should be
measured as closely as possible according to the following
equation:

Ref: DF 16_1
----------------------------------------------------------------------------child’s weight (kg) * prescribed dosage (mg/kg)
Dose in ml/day =
The following information is intended for healthcare
product strength (mg/ml)
professionals or for patients (where the pharmacist does
The graduations of the oral syringe are in increments of
not reconstitute this product):
0.2 ml. Therefore for intermediate weights and dosages,
Instructions to make up the suspension:
the dose to be given in ml should be calculated then
The reconstituted suspension will provide a white to offrounded up or down to the nearest graduation of the oral
white orange-flavoured suspension after reconstitution.
syringe.
10 mg/ml or 40 mg/ml powder for oral suspension
For example, a child weighing 23 kg prescribed Diflucan
in 60 ml capacity bottle: 35 ml suspension after
6 mg/kg/day should receive 138 mg/day, equivalent to
reconstitution
3.45 ml of the 40 mg/ml oral suspension. The dose may
1. Tap the bottle to release the powder.
be rounded down to 3.4 ml, the nearest graduation on the
2. Add a small quantity of still water and shake it
oral syringe to provide the full dose.
vigorously. Add water up to the level marked () on the
A maximum dose of 400 mg daily should not be exceeded
bottle (this corresponds in total to adding the required
in the paediatric population (see table *).
24 ml of water).
The use of Diflucan 40 mg/ml powder for oral suspension
3. Shake well for 1 to 2 minutes to obtain a well mixed
is not recommended for weights under 15 kg. For weights
suspension.
under 15 kg, it is recommended to use Diflucan 10 mg/ml
4. After reconstitution there will be a usable volume of
powder for oral suspension.
35 ml.
5. Write the expiry date of the reconstituted suspension
on the bottle label (the shelf life of the reconstituted
suspension is 28 days). Any unused suspension should
not be used after this date and should be returned to
your pharmacist.
10 mg/ml powder for oral suspension in 175 ml
capacity bottle: 100 ml suspension after
reconstitution:
1. Tap the bottle to release the powder.
2. Add a small quantity of still water and shake it
vigorously. Add water up to the level marked () on the
bottle (this corresponds in total to adding the required
66 ml of water).
3. Shake well for 1 to 2 minutes to obtain a well mixed
suspension.
4. After reconstitution there will be a usable volume of
100 ml.
5. Write the expiry date of the reconstituted suspension
on the bottle label (the shelf life of the reconstituted
suspension is 28 days). Any unused suspension should
not be used after this date and should be returned to
your pharmacist.

Weight Kg
15 kg
20 kg
25 kg
30 kg
35 kg
40 kg
50 kg

Posology (Corresponding dose in ml/day)
3 mg/kg/day 6 mg/kg/day 12 mg/kg/day
1.2 ml
2.2 ml
4.6 ml
1.6 ml
3.0 ml
6.0 ml
1.8 ml
3.8 ml
7.6 ml
2.2 ml
4.6 ml
9.0 ml
2.6 ml
5.2 ml
10.0 ml*
3.0 ml
6.0 ml
10.0 ml*
3.8 ml
7.6 ml
10.0 ml*

Package leaflet: Information for the user

Diflucan® 10 mg/ml
powder for oral suspension
Diflucan® 40 mg/ml
powder for oral suspension
fluconazole
Read all of this leaflet carefully before you start
taking this medicine because it contains important
information for you.
-- Keep this leaflet. You may need to read it again.
-- If you have any further questions, ask your doctor,
pharmacist or nurse.
-- This medicine has been prescribed for you only. Do not
pass it on to others. It may harm them, even if their signs
of illness are the same as yours.
-- If you get any side effects, talk to your doctor, pharmacist
or nurse. This includes any possible side effects not listed
in this leaflet. See section 4.
What is in this leaflet:
1. What Diflucan is and what it is used for
2. What you need to know before you take Diflucan
3. How to take Diflucan
4. Possible side effects
5. How to store Diflucan
6. Contents of the pack and other information
1. What Diflucan is and what it is used for
Diflucan is one of a group of medicines called “antifungals”.
The active substance is fluconazole.

Diflucan 10 mg/ml powder for oral suspension:
In children Diflucan powder for oral suspension should be
measured as closely as possible according to the following
equation:
child’s weight (kg) * prescribed dosage (mg/kg)
Dose in ml/day =
product strength (mg/ml)
The graduations of the oral syringe are in increments of
0.2 ml. Therefore for intermediate weights and dosages,
the dose to be given in ml should be calculated then
rounded up or down to the nearest graduation of the oral
syringe.
Mock up from 8819882

Other medicines and Diflucan
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.
Tell your doctor immediately if you are taking astemizole,
terfenadine (an antihistamine for treating allergies) or
cisapride (used for stomach upsets) or pimozide (used
for treating mental illness) or quinidine (used for treating
heart arrhythmia) or erythromycin (an antibiotic for treating
infections) as these should not be taken with Diflucan (see
section: “Do not take Diflucan if you”).
There are some medicines that may interact with Diflucan.
Make sure your doctor knows if you are taking any of the
following medicines:
------

Diflucan is used to treat infections caused by fungi and may
-also be used to stop you from getting a candidal infection.
The most common cause of fungal infections is a yeast
-called Candida.
-Adults
You might be given this medicine by your doctor to treat the
-following types of fungal infections:
-- Cryptococcal meningitis– a fungal infection in the brain
--- Coccidioidomycosis– a disease of the bronchopulmonary
system
--- Infections caused by Candida and found in the blood
-stream, body organs (e.g. heart, lungs) or urinary tract
-- Mucosal thrush - infection affecting the lining of the
-mouth, throat and denture sore mouth
--- Genital thrush - infection of the vagina or penis
-- Skin infections - e.g. athlete’s foot, ringworm, jock itch,
nail infection
-You might also be given Diflucan to:
--- stop cryptococcal meningitis from coming back
--- stop mucosal thrush from coming back
-- reduce recurrence of vaginal thrush
--- stop you from getting an infection caused by Candida (if
your immune system is weak and not working properly)
-Children and adolescents (0 to 17 years old)
You might be given this medicine by your doctor to treat the
following types of fungal infections:
-- Mucosal thrush - infection affecting the lining of the
mouth, throat
-- Infections caused by Candida and found in the blood
stream, body organs (e.g. heart, lungs) or urinary tract
-- Cryptococcal meningitis – a fungal infection in the brain

-----

rifampicin or rifabutin (antibiotics for infections)
alfentanil, fentanyl (used as anaesthetic)
amitriptyline, nortriptyline (used as anti-depressant)
amphotericin B, voriconazole (anti-fungal)
medicines that thin the blood to prevent blood clots
(warfarin or similar medicines)
benzodiazepines (midazolam, triazolam or similar
medicines) used to help you sleep or for anxiety
carbamazepine, phenytoin (used for treating fits)
nifedipine, isradipine, amlodipine, felodipine and losartan
(for hypertension - high blood pressure)
ciclosporin, everolimus, sirolimus or tacrolimus (to
prevent transplant rejection)
cyclosphosphamide, vinca alkaloids (vincristine,
vinblastine or similar medicines) used for treating cancer
halofantrine (used for treating malaria)
statins (atorvastatin, simvastatin and fluvastatin or similar
medicines) used for reducing high cholesterol levels
methadone (used for pain)
celecoxib, flurbiprofen, naproxen, ibuprofen, lornoxicam,
meloxicam, diclofenac (Non-Steroidal Anti‑Inflammatory
Drugs (NSAID))
oral contraceptives
prednisone (steroid)
zidovudine, also known as AZT; saquinavir (used in HIVinfected patients)
medicines for diabetes such as chlorpropamide,
glibenclamide, glipizide or tolbutamide
theophylline (used to control asthma)
vitamin A (nutritional supplement)
ivacaftor (used for treating cystic fibrosis)
amiodarone (used for treating uneven heartbeats
‘arrhythmias’)
hydrochlorothiazide (a diuretic)

Diflucan with food and drink
Diflucan can be taken with or without food.

Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be
pregnant or are planning to have a baby, ask your doctor for
advice before taking this medicine.
You should not take Diflucan while you are pregnant unless
your doctor has told you to.
2. What you need to know before you take Diflucan
You can continue breast-feeding after taking a single dose
Do not take Diflucan
of Diflucan up to 200 mg.
-- if you are allergic (hypersensitive) to fluconazole, to other You should not breast-feed if you are taking a repeated
medicines you have taken to treat fungal infections or
dose of Diflucan.
to any of the other ingredients of this medicine (listed in
Driving and using machines
section 6). The symptoms may include itching, reddening When driving vehicles or using machines it should be taken
of the skin or difficulty in breathing
into account that occasionally dizziness or fits may occur.
-- if you are taking astemizole, terfenadine (antihistamine
Diflucan powder for oral suspension contains sucrose
medicines for allergies)
(sugar)
-- if you are taking cisapride (used for stomach upsets)
-- If you have an intolerance to some sugars, please
-- if you are taking pimozide (used for treating mental
contact your doctor before taking this medicine.
illness)
-- Doses of 10 ml contain 5.5 g or more of sugar. This
-- if you are taking quinidine (used for treating heart
should be taken into account if you have diabetes.
arrhythmia)
-- May be harmful to teeth if used for periods of longer than
-- if you are taking erythromycin (an antibiotic for treating
2 weeks.
infections)
You might also be given Diflucan to:
-- stop you from getting an infection caused by Candida (if
your immune system is weak and not working properly).
-- stop cryptococcal meningitis from coming back

Dose conversion of the powder for oral suspension
from mg/ml to ml/kg body weight (BW) for paediatric
patients:



Warnings and precautions
Talk to your doctor or pharmacist before taking Diflucan
-- if you have liver or kidney problems
-- if you suffer from heart disease, including heart rhythm
problems
-- if you have abnormal levels of potassium, calcium or
magnesium in your blood
-- if you develop severe skin reactions (itching, reddening of
the skin or difficulty in breathing)
-- if you develop signs of ‘adrenal insufficiency’ where the
adrenal glands do not produce adequate amounts of
certain steroid hormones such as cortisol (chronic, or
long lasting fatigue, muscle weakness, loss of appetite,
weight loss, abdominal pain)

3. How to take Diflucan
Always take this medicine exactly as your doctor has told
you. Check with your doctor or pharmacist if you are not
sure.
It is best to take medicine at the same time each day.
The recommended dose of this medicine for different
infections are below:
Adults
Condition
To treat cryptococcal
meningitis

To stop cryptococcal
meningitis from coming
back
To treat
coccidioidomycosis

Dose
400 mg on the first day then
200 mg to 400 mg once daily
for 6 to 8 weeks or longer if
needed. Sometimes doses are
increased up to 800 mg
200 mg once daily until you are
told to stop

Elderly
The usual adult dose should be given unless you have
kidney problems.
Patients with kidney problems
Your doctor may change your dose, depending on your
kidney function.
Instructions to make up the suspension:
It is recommended that your pharmacist makes up Diflucan
powder for oral suspension before giving it to you. However
where the pharmacist does not reconstitute this product,
instructions are provided at the end of this leaflet in the
section “The following information is intended for healthcare
professionals or for patients (where the pharmacist does
not reconstitute this product)”.
Instructions for use:
Shake the closed bottle of the suspension every time before
using.

Instructions to use the oral syringe:
Shake the prepared suspension well.
1. Open the bottle (safety cap);
2. Insert the adapter fitted onto the oral syringe into the
bottle neck (Figure 1);
3. Turn the bottle with the oral syringe upside down and
To treat internal fungal
withdraw the quantity of suspension prescribed by the
infections caused by
doctor (Figure 2). The marks on the oral syringe are
Candida
To treat mucosal
shown in ml.
infections affecting the
A maximum dose of 400 mg daily should not be
lining of the mouth,
exceeded in children. (see section “3. How to take
throat and denture sore
Diflucan”).
mouth
4. Remove the oral syringe from the bottle;
To treat mucosal thrush – 50 mg to 400 mg once daily for 5. The medicinal product may be given directly into the
dose depends on where 7 to 30 days until you are told
mouth from the oral syringe. The patient should remain
the infection is located
to stop
upright during administration. Point the oral syringe at the
To stop mucosal
100 mg to 200 mg once daily, or
inside of the cheek; release the suspension slowly into
infections of mouth and
200 mg 3 times a week, while
the patient’s mouth (Figure 3).
throat from coming back you are at risk of getting an
6. Rinse the oral syringe after use
infection
7. Close the bottle with the safety cap; the adapter will
To treat genital thrush
150 mg as a single dose
remain on the bottle neck.
To reduce recurrence of 150 mg every third day for a
vaginal thrush
total of 3 doses (day 1, 4 and 7)
and then once a week for 6
months while you are at risk of
getting an infection
To treat fungal skin and
Depending on the site of the
nail infections
infection 50 mg once daily,
150 mg once weekly, 300 to
400 mg once weekly for 1 to
4 weeks (Athlete’s foot may be
up to 6 weeks, for nail infection
treatment until infected nail is
replaced)
To stop you from getting 200 mg to 400 mg once daily
an infection caused by
while you are at risk of getting
Candida (if your immune an infection
For dose conversion of the powder for oral suspension from
system is weak and not
mg/ml to ml/kg body weight (BW), for paediatric patients,
working properly)
see section 6.
200 mg to 400 mg once
daily from 11 months for up
to 24 months or longer if
needed. Sometimes doses are
increased up to 800 mg
800 mg on the first day then
400 mg once daily until you are
told to stop
200 mg to 400 mg on the first
day then 100 mg to 200 mg
until you are told to stop

Adolescents from 12 to 17 years old
Follow the dose prescribed by your doctor (either adults or
children posology).

For adult patients, please calculate the dose in ml to
administer according to the posology in mg recommended
and the product strength.

Children to 11 years old
The maximum dose for children is 400 mg daily.

If you take more Diflucan than you should
Taking too much Diflucan may make you unwell. Contact
your doctor or your nearest hospital casualty department
at once. The symptoms of a possible overdose may include
hearing, seeing, feeling and thinking things that are not
real (hallucination and paranoid behaviour). Symptomatic
treatment (with supportive measures and gastric lavage if
necessary) may be adequate.

The dose will be based on the child’s weight in kilograms.
Condition
Daily dose
Mucosal thrush and
3 mg per kg of body weight
throat infections caused
(6 mg per kg of body weight
by Candida – dose and
might be given on the first
duration depends on the
day)
severity of the infection and
on where the infection is
located
Cryptococcal meningitis or 6 mg to 12 mg per kg of
internal fungal infections
body weight
caused by Candida
To stop children from getting 3 mg to 12 mg per kg of
body weight
an infection caused by
Candida (if their immune
system is not working
properly)
Use in children 0 to 4 weeks of age
Use in children of 3 to 4 weeks of age:
The same dose as above but given once every 2 days.
The maximum dose is 12 mg per kg of body weight every
48 hours.
Use in children less than 2 weeks old:
The same dose as above but given once every 3 days.
The maximum dose is 12 mg per kg of body weight every
72 hours.

If you forget to take Diflucan
Do not take a double dose to make up for a forgotten
dose. If you forget to take a dose, take it as soon as you
remember. If it is almost time for your next dose, do not take
the dose that you missed.
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects,
although not everybody gets them.
A few people develop allergic reactions although serious
allergic reactions are rare. If you get any side effects, talk to
your doctor or pharmacist. This includes any possible side
effects not listed in this leaflet. If you get any of the following
symptoms, tell your doctor immediately.

-- sudden wheezing, difficulty in breathing or tightness in
the chest
-- swelling of eyelids, face or lips
-- itching all over the body reddening of the skin or itchy
red spots
-- skin rash
-- severe skin reactions such as a rash that causes
blistering (this can affect the mouth and tongue).
Diflucan may affect your liver. The signs of liver problems
include:
-- tiredness
-- loss of appetite
-- vomiting
-- yellowing of your skin or the whites of your eyes
(jaundice)
If any of these happen, stop taking Diflucan and tell your
doctor immediately.
Other side effects:
Additionally, if any of the following side effects gets serious,
or if you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
Common side effects (may affect up to 1 in 10 people) are:
-- headache
-- stomach discomfort, diarrhoea, feeling sick, vomiting
-- increases in blood tests of liver function
-- rash
Uncommon side effects (may affect up to 1 in 100 people)
are:
-- reduction in red blood cells which can make skin pale
and cause weakness or breathlessness
-- decreased appetite
-- inability to sleep, feeling drowsy
-- fit, dizziness, sensation of spinning, tingling, pricking or
numbness, changes in sense of taste
-- constipation, difficult digestion, wind, dry mouth
-- muscle pain
-- liver damage and yellowing of the skin and eyes
(jaundice)
-- wheals, blistering (hives), itching, increased sweating
-- tiredness, general feeling of being unwell, fever
Rare side effects (may affect up to 1 in 1,000 people) are:
-- lower than normal white blood cells that help defend
against infections and blood cells that help to stop
bleeding
-- red or purple discoloration of the skin which may be
caused by low platelet count, other blood cell changes
-- blood chemistry changes (high blood levels of
cholesterol, fats)
-- low blood potassium,
-- shaking
-- abnormal electrocardiogram (ECG), change in heart rate
or rhythm
-- liver failure
-- allergic reactions (sometimes severe), including
widespread blistering rash and skin peeling, severe skin
reactions, swelling of the lips or face
-- hair loss
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist
or nurse. This includes any possible side effects not listed
in this leaflet. You can also report side effects directly (see
details below). By reporting side effects you can help
provide more information on the safety of this medicine.

6. Contents of the pack and other information
What Diflucan contains
-- The active substance is fluconazole. 1 ml of reconstituted
suspension contains 10 mg or 40mg fluconazole.
-- The other ingredients are: sucrose, silica colloidal
anhydrous, titanium dioxide (E 171), xanthan gum,
sodium citrate, citric acid anhydrous, sodium benzoate
and natural orange flavour (containing orange oil and
maltodextrin).
What Diflucan looks like and contents of the pack:
10 mg/ml powder for oral suspension in 60 ml capacity
bottle: 35 ml suspension after reconstitution
10 mg/ml powder for oral suspension in 175 ml capacity
bottle: 100 ml suspension after reconstitution
-- Diflucan 10 mg/ml powder for oral suspension comes in
two bottle sizes
-- a 60 ml capacity bottle which contains 24.4 g powder.
After reconstitution, the volume of the suspension is
35 ml or
-- a 175 ml capacity bottle which contains 67.1 g powder.
After reconstitution, the volume of the suspension is
100 ml
-- Diflucan 10 mg/ml powder for oral suspension is a dry
white to off-white powder. After adding water to the
powder (as instructed in this leaflet below) a white to offwhite orange flavoured suspension is produced.
-- In each bottle the mixture of powder and water makes
35 ml or 100 ml of suspension.
-- The 35 ml suspension comes with a 5 ml graduated oral
syringe with a press‑in bottle adaptor to measure the
correct dose.
-- The 100 ml suspension comes with a measuring cup
and a 5 ml graduated oral syringe with a press-in bottle
adaptor to measure the correct dose.
40 mg/ml powder for oral suspension in 60 ml capacity
bottle: 35 ml suspension after reconstitution
-- Diflucan 40 mg/ml powder for oral suspension comes as
a 60 ml capacity bottle which contains 24.4 g powder.
After reconstitution, the volume of the suspension is
35 ml.
-- Diflucan 40 mg/ml powder for oral suspension is a dry
white to off-white powder. After adding water to the
powder (as instructed in this leaflet below) a white to offwhite orange flavoured suspension is produced.
-- In each bottle the mixture of powder and water makes
35 ml of suspension.
-- A 5 ml graduated oral syringe with a press‑in bottle
adaptor is provided to measure the correct dose.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Pfizer Limited
Ramsgate Road
Sandwich
Kent
CT13 9NJ
United Kingdom
Manufacturer

Fareva Amboise
Zone Industrielle
29 route des Industries
United Kingdom
37530 Pocé-sur-Cisse
Yellow Card Scheme website: www.mhra.gov.uk/yellowcard. France
Ireland
HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2;
Tel: +353 1 6764971; Fax: +353 1 6762517.
Website: www.hpra.ie; E-mail: medsafety@hpra.ie.
5. How to store Diflucan
-- Keep this medicine out of the sight and reach of children.
-- Do not use this medicine after the expiry date which is
stated on the bottle and the outer carton after EXP. The
expiry date refers to the last day of that month.
Powder for oral suspension:
-- Store below 25°C. Keep the bottle tightly closed.
-- Once reconstituted, store the suspension below 30°C, do
not freeze.
-- The shelf life of the reconstituted suspension is 28 days.
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw away
medicines you no longer use. These measures will help
protect the environment.

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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