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DICLOFENAC 1% GEL

Active substance(s): DICLOFENAC DIETHYLAMINE

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S1403 LEAFLET Voltarol 20120919

PATAIENT INFORMATION LEAFLET

VOLTAROL EMULGEL
(diclofenac sodium)
Your medicine will be referred to as Voltarol Emulgel throughout the
remainder of the leaflet.
Read all of this leaflet carefully 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 or
pharmacist.



This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if their symptoms are the same
as yours.



If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or
pharmacist.

Taking other medicines
Please tell your doctor or pharmacist if you are taking, or have
recently taken, any other medicines, including those obtained
without a prescription.
Do not use Voltarol Emulgel if you are already taking diclofenac
tablets or other NSAID pain/inflammation tablets (e.g. aspirin or
ibuprofen).
Pregnancy and breast-feeding
Voltarol Emulgel should not be used if you are pregnant or breastfeeding.
Ask your doctor or pharmacist for advice before taking any
medicine.
Driving and using machines
Voltarol Emulgel, when used as directed, is not expected to have
any effect on your ability to drive or use machines.
Important information about some of the ingredients of
Voltarol Emulgel
Propylene glycol is an ingredient in this medicine which may cause
a mild localised skin irritation in some people.

In this leaflet:
1. What Voltarol Emulgel is and what it is used for

3. HOW TO USE VOLTAROL EMULGEL

2. Before you use Voltarol Emulgel



Always use Voltarol Emulgel exactly as your doctor has told
you.



The gel is for external use only. Do not use it in your mouth.
Inform your doctor immediately in case of accidental
swallowing.



Do not put Voltarol Emulgel in your eyes. If this happens, rinse
your eyes well with clean water. See your doctor or pharmacist
if any discomfort persists.

3. How to use Voltarol Emulgel
4. Possible side effects
5. How to store Voltarol Emulgel
6. Further information
1. WHAT VOLTAROL EMULGEL IS AND WHAT IT IS USED
FOR
Voltarol Emulgel contains the active substance diclofenac which
belongs to a group of medicines called non-steroidal antiinflammatory drugs (NSAIDs).
It is specially formulated for rubbing into the skin and is used to
relieve pain and reduce inflammation and swelling in painful
conditions affecting the joints and muscles. Voltarol Emulgel can be
used to treat:


muscle and joint injuries (e.g. sprains, strains, bruises,
backache, sports injuries)



tendonitis (e.g. tennis elbow)



osteoarthritis.

2. BEFORE YOU USE VOLTAROL EMULGEL
DO NOT use Voltarol Emulgel if you have:


an allergy (hypersensitivity) to any of the ingredients in the
product (see Section 6 ‘What Voltarol Emulgel contains’).



ever had an allergic reaction to diclofenac or other medicines
used to treat pain, fever or inflammation, such as aspirin,
ibuprofen or acetylsalicylic acid. Symptoms of an allergic
reaction to these medicines may include: asthma, wheezing or
shortness of breath; skin rash or hives; swelling of the face or
tongue; runny nose.

Adults
1. Take the tube out of the carton. Before first use, pierce the
sealing membrane of the tube with the spiked top of the cap. Do
not use if seal is broken.
2. Gently squeeze out a small amount of gel from the tube and
apply to the painful or swollen area 3 to 4 times a day, slowly
rubbing into the skin. The amount needed will vary depending
on the size of the painful or swollen area; an amount ranging in
size from a 1 penny to a 2 pence piece will usually be sufficient.
You may notice a slight cooling effect when you rub the gel in.
3. Do not rub the gel into cuts, open wounds or any other area
where the skin is abnormal. After rubbing the gel into the skin,
do not cover with bandages or sticking plaster.
4. Be careful not to get the gel in your eyes. If this happens, rinse
your eyes with clean water and tell your doctor.
5. Wash your hands after rubbing in Voltarol Emulgel, unless your
hands are the site being treated. Replace the cap.
6. Allow at least four hours between applications of the gel. Do not
apply more than 4 times in any 24 hour period.
This medicine is not recommended for use in children under 14
years of age.
Do not use Voltarol Emulgel for more than:

This medicine is not recommended for use in children under 14
years of age.
Take special care with Voltarol Emulgel


Do not apply the gel to skin that has (i) a rash or eczema (ii)
cuts or open wounds.



Be careful when sunbathing or using sun lamps as your skin
may be more sensitive to sunlight.



If you have a stomach or duodenal ulcer (or a history of), tell
your doctor or pharmacist before using the gel.



2 weeks for muscle and joints injuries (e.g. sprains, strains,
bruises) or tendonitis.



If you are using the gel for arthritis, your doctor may wish to
review your treatment regularly.

If symptoms do not improve within this time, or they get worse,
consult your doctor. In children aged 14 years and over, if this
product is required for more than 7 days for pain relief or if the
symptoms worsen the patient/parents of the adolescent is/are
advised to consult a doctor.
If you use more Voltarol Emulgel than you should
If you or a child accidentally swallows Voltarol Emulgel, contact
your doctor or accident and emergency department immediately.

If you forget to use Voltarol Emulgel

5. HOW TO STORE VOLTAROL EMULGEL

If you miss your application of Voltarol Emulgel at the correct time,
apply it as soon as you remember then carry on as normal. Do not
apply a double quantity to make up for a forgotten application.



KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Do not store above 30°C.

If you have any further questions on the use of this product, ask
your pharmacist.



Do not use after the expiry date printed on the carton or tube
label.



If your doctor tells you to stop using the gel, please take it back
to the pharmacist for safe disposal. Only keep the gel if your
doctor tells you to.

Like all medicines, Voltarol Emulgel can cause side effects,
although not everybody gets them.



If you experience any of the following signs of an allergic reaction
(likely to affect fewer than 1 person out of 10,000) stop using
Voltarol Emulgel and tell your doctor or pharmacist
immediately:

If the gel becomes discoloured or shows any signs of
deterioration, you should ask your doctor or pharmacist before
using it.



Medicines should not be disposed of via wastewater of
household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help to
protect the environment.

4. POSSIBLE SIDE EFFECTS



Skin rash with blisters, hives



Wheezing, shortness of breath or asthma/feeling of tightness in
the chest



Swelling of the face, lips, tongue or throat that may cause
difficulty in swallowing, breathing or speaking.
Other side effects which may occur are usually mild, passing and
harmless (if you are concerned, tell your doctor or pharmacist as
soon as you can):


Skin rash, itching, reddening or smarting (sharp, stinging pain)
of the skin are common after use (likely to affect 1 to 10 people
out of 100).



In very rare cases, your skin may be more sensitive to the sun.
Possible signs are sunburn with itching, swelling and blistering
(likely to affect fewer than 1 person out of 10,000).

If any of the side effects get serious or if you notice any side
effects not listed in this leaflet, STOP USING the gel and tell
your doctor or pharmacist immediately.

6. FURTHER INFORMATION
What Voltarol Emulgel contains


Voltarol Emulgel contains the active ingredient, diclofenac
sodium (as the diethylammonium salt): each 100g contains the
equivalent of 1g diclofenac sodium.



Voltarol Emulgel also contains the following: diethylamine,
carbopol, cetomacrogol, cetiol LC, isopropanol, liquid paraffin,
perfume, propylene glycol and water.

What Voltarol Emulgel looks like and contents of the pack
Voltarol Emulgel is a white, pleasant smelling, nongreasy gel
Voltarol Emulgel is available as tubes of 100g.
Product Licence holder
Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Ltd, Chemilines House, Alperton
Lane, Wembley, HA0 1DX.
Manufacturer
Voltarol Emulgel is manufactured by


Novartis Pharma GmbH, Wehr, Germany.



Novartis Consumer Health SA, Switzerland.

POM

PL No. 19488/1403

Leaflet revision date: 19 September 2012
Voltarol is a registered trademark of Novartis AG, Switzerland.
S1403 LEAFLET Voltarol 20120919

S1403 LEAFLET Voltaren 20120919

PATIENT INFORMATION LEAFLET

VOLTAREN EMULGEL 100G
(diclofenac sodium)
Your medicine is called Voltaren Emulgel 100g but will be referred
to as Voltaren Emulgel throughout the remainder of the leaflet.
Read all of this leaflet carefully 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 or
pharmacist.



This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if their symptoms are the same
as yours.



If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or
pharmacist.

Taking other medicines
Please tell your doctor or pharmacist if you are taking, or have
recently taken, any other medicines, including those obtained
without a prescription.
Do not use Voltaren Emulgel if you are already taking diclofenac
tablets or other NSAID pain/inflammation tablets (e.g. aspirin or
ibuprofen).
Pregnancy and breast-feeding
Voltaren Emulgel should not be used if you are pregnant or breastfeeding.
Ask your doctor or pharmacist for advice before taking any
medicine.
Driving and using machines
Voltaren Emulgel, when used as directed, is not expected to have
any effect on your ability to drive or use machines.
Important information about some of the ingredients of
Voltaren Emulgel
Propylene glycol is an ingredient in this medicine which may cause
a mild localised skin irritation in some people.

In this leaflet:
1. What Voltaren Emulgel is and what it is used for

3. HOW TO USE VOLTAREN EMULGEL

2. Before you use Voltaren Emulgel



Always use Voltaren Emulgel exactly as your doctor has told
you.



The gel is for external use only. Do not use it in your mouth.
Inform your doctor immediately in case of accidental
swallowing.



Do not put Voltaren Emulgel in your eyes. If this happens, rinse
your eyes well with clean water. See your doctor or pharmacist
if any discomfort persists.

3. How to use Voltaren Emulgel
4. Possible side effects
5. How to store Voltaren Emulgel
6. Further information
1. WHAT VOLTAREN EMULGEL IS AND WHAT IT IS USED
FOR
Voltaren Emulgel contains the active substance diclofenac which
belongs to a group of medicines called non-steroidal antiinflammatory drugs (NSAIDs).
It is specially formulated for rubbing into the skin and is used to
relieve pain and reduce inflammation and swelling in painful
conditions affecting the joints and muscles. Voltaren Emulgel can
be used to treat:


muscle and joint injuries (e.g. sprains, strains, bruises,
backache, sports injuries)



tendonitis (e.g. tennis elbow)



osteoarthritis.

2. BEFORE YOU USE VOLTAREN EMULGEL
DO NOT use Voltaren Emulgel if you have:


an allergy (hypersensitivity) to any of the ingredients in the
product (see Section 6 ‘What Voltaren Emulgel contains’).



ever had an allergic reaction to diclofenac or other medicines
used to treat pain, fever or inflammation, such as aspirin,
ibuprofen or acetylsalicylic acid. Symptoms of an allergic
reaction to these medicines may include: asthma, wheezing or
shortness of breath; skin rash or hives; swelling of the face or
tongue; runny nose.

This medicine is not recommended for use in children under 14
years of age.
Take special care with Voltaren Emulgel


Do not apply the gel to skin that has (i) a rash or eczema (ii)
cuts or open wounds.



Be careful when sunbathing or using sun lamps as your skin
may be more sensitive to sunlight.



If you have a stomach or duodenal ulcer (or a history of), tell
your doctor or pharmacist before using the gel.

Adults
1. Take the tube out of the carton. Before first use, pierce the
sealing membrane of the tube with the spiked top of the cap. Do
not use if seal is broken.
2. Gently squeeze out a small amount of gel from the tube and
apply to the painful or swollen area 3 to 4 times a day, slowly
rubbing into the skin. The amount needed will vary depending
on the size of the painful or swollen area; an amount ranging in
size from a 1 penny to a 2 pence piece will usually be sufficient.
You may notice a slight cooling effect when you rub the gel in.
3. Do not rub the gel into cuts, open wounds or any other area
where the skin is abnormal. After rubbing the gel into the skin,
do not cover with bandages or sticking plaster.
4. Be careful not to get the gel in your eyes. If this happens, rinse
your eyes with clean water and tell your doctor.
5. Wash your hands after rubbing in Voltaren Emulgel, unless your
hands are the site being treated. Replace the cap.
6. Allow at least four hours between applications of the gel. Do not
apply more than 4 times in any 24 hour period.
This medicine is not recommended for use in children under 14
years of age.
Do not use Voltaren Emulgel for more than:


2 weeks for muscle and joints injuries (e.g. sprains, strains,
bruises) or tendonitis.



If you are using the gel for arthritis, your doctor may wish to
review your treatment regularly.

If symptoms do not improve within this time, or they get worse,
consult your doctor. In children aged 14 years and over, if this
product is required for more than 7 days for pain relief or if the
symptoms worsen the patient/parents of the adolescent is/are
advised to consult a doctor.
If you use more Voltaren Emulgel than you should
If you or a child accidentally swallows Voltaren Emulgel, contact
your doctor or accident and emergency department immediately.

If you forget to use Voltaren Emulgel

5. HOW TO STORE VOLTAREN EMULGEL

If you miss your application of Voltaren Emulgel at the correct time,
apply it as soon as you remember then carry on as normal. Do not
apply a double quantity to make up for a forgotten application.



KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Do not store above 30°C.

If you have any further questions on the use of this product, ask
your pharmacist.



Do not use after the expiry date printed on the carton or tube
label.



If your doctor tells you to stop using the gel, please take it back
to the pharmacist for safe disposal. Only keep the gel if your
doctor tells you to.

Like all medicines, Voltaren Emulgel can cause side effects,
although not everybody gets them.



If you experience any of the following signs of an allergic reaction
(likely to affect fewer than 1 person out of 10,000) stop using
Voltaren Emulgel and tell your doctor or pharmacist
immediately:

If the gel becomes discoloured or shows any signs of
deterioration, you should ask your doctor or pharmacist before
using it.



Medicines should not be disposed of via wastewater of
household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help to
protect the environment.

4. POSSIBLE SIDE EFFECTS



Skin rash with blisters, hives



Wheezing, shortness of breath or asthma/feeling of tightness in
the chest



Swelling of the face, lips, tongue or throat that may cause
difficulty in swallowing, breathing or speaking.
Other side effects which may occur are usually mild, passing and
harmless (if you are concerned, tell your doctor or pharmacist as
soon as you can):


Skin rash, itching, reddening or smarting (sharp, stinging pain)
of the skin are common after use (likely to affect 1 to 10 people
out of 100).



In very rare cases, your skin may be more sensitive to the sun.
Possible signs are sunburn with itching, swelling and blistering
(likely to affect fewer than 1 person out of 10,000).

If any of the side effects get serious or if you notice any side
effects not listed in this leaflet, STOP USING the gel and tell
your doctor or pharmacist immediately.

6. FURTHER INFORMATION
What Voltaren Emulgel contains


Voltaren Emulgel contains the active ingredient, diclofenac
sodium (as the diethylammonium salt): each 100g contains the
equivalent of 1g diclofenac sodium.



Voltaren Emulgel also contains the following: diethylamine,
carbopol, cetomacrogol, cetiol LC, isopropanol, liquid paraffin,
perfume, propylene glycol and water.

What Voltaren Emulgel looks like and contents of the pack
Voltaren Emulgel is a white, pleasant smelling, nongreasy gel
Voltaren Emulgel is available as tubes of 100g.
Product Licence holder
Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Ltd, Chemilines House, Alperton
Lane, Wembley, HA0 1DX.
Manufacturer
Voltaren Emulgel is manufactured by


Novartis Pharma GmbH, Wehr, Germany.



Novartis Consumer Health SA, Switzerland.

POM

PL No. 19488/1403

Leaflet revision date: 19 September 2012
Voltaren is a registered trademark of Novartis AG, Switzerland.
S1403 LEAFLET Voltaren 20120919

S1403 LEAFLET Diclofenac 20120919

PATIENT INFORMATION LEAFLET

DICLOFENAC 1% GEL
(diclofenac sodium)
Your medicine is called Diclofenac 1% Gel but will be referred to as
Diclofenac Gel throughout the remainder of the leaflet.
Read all of this leaflet carefully 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 or
pharmacist.



This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if their symptoms are the same
as yours.



If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or
pharmacist.

Taking other medicines
Please tell your doctor or pharmacist if you are taking, or have
recently taken, any other medicines, including those obtained
without a prescription.
Do not use Diclofenac Gel if you are already taking diclofenac
tablets or other NSAID pain/inflammation tablets (e.g. aspirin or
ibuprofen).
Pregnancy and breast-feeding
Diclofenac Gel should not be used if you are pregnant or breastfeeding.
Ask your doctor or pharmacist for advice before taking any
medicine.
Driving and using machines
Diclofenac Gel, when used as directed, is not expected to have any
effect on your ability to drive or use machines.
Important information about some of the ingredients of
Diclofenac Gel
Propylene glycol is an ingredient in this medicine which may cause
a mild localised skin irritation in some people.

In this leaflet:
1. What Diclofenac Gel is and what it is used for

3. HOW TO USE DICLOFENAC GEL

2. Before you use Diclofenac Gel



Always use Diclofenac Gel exactly as your doctor has told you.

3. How to use Diclofenac Gel



The gel is for external use only. Do not use it in your mouth.
Inform your doctor immediately in case of accidental
swallowing.



Do not put Diclofenac Gel in your eyes. If this happens, rinse
your eyes well with clean water. See your doctor or pharmacist
if any discomfort persists.

4. Possible side effects
5. How to store Diclofenac Gel
6. Further information
1. WHAT DICLOFENAC GELIS AND WHAT IT IS USED FOR
Diclofenac Gel contains the active substance diclofenac which
belongs to a group of medicines called non-steroidal antiinflammatory drugs (NSAIDs).
It is specially formulated for rubbing into the skin and is used to
relieve pain and reduce inflammation and swelling in painful
conditions affecting the joints and muscles. Diclofenac Gel can be
used to treat:


muscle and joint injuries (e.g. sprains, strains, bruises,
backache, sports injuries)



tendonitis (e.g. tennis elbow)



osteoarthritis.

2. BEFORE YOU USE DICLOFENAC GEL
DO NOT use Diclofenac Gel if you have:


an allergy (hypersensitivity) to any of the ingredients in the
product (see Section 6 ‘What Diclofenac Gel contains’).



ever had an allergic reaction to diclofenac or other medicines
used to treat pain, fever or inflammation, such as aspirin,
ibuprofen or acetylsalicylic acid. Symptoms of an allergic
reaction to these medicines may include: asthma, wheezing or
shortness of breath; skin rash or hives; swelling of the face or
tongue; runny nose.

This medicine is not recommended for use in children under 14
years of age.
Take special care with Diclofenac Gel


Do not apply the gel to skin that has (i) a rash or eczema (ii)
cuts or open wounds.



Be careful when sunbathing or using sun lamps as your skin
may be more sensitive to sunlight.



If you have a stomach or duodenal ulcer (or a history of), tell
your doctor or pharmacist before using the gel.

Adults
1. Take the tube out of the carton. Before first use, pierce the
sealing membrane of the tube with the spiked top of the cap. Do
not use if seal is broken.
2. Gently squeeze out a small amount of gel from the tube and
apply to the painful or swollen area 3 to 4 times a day, slowly
rubbing into the skin The amount needed will vary depending
on the size of the painful or swollen area; an amount ranging in
size from a 1 penny to a 2 pence piece will usually be sufficient.
You may notice a slight cooling effect when you rub the gel in.
3. Do not rub the gel into cuts, open wounds or any other area
where the skin is abnormal. After rubbing the gel into the skin,
do not cover with bandages or sticking plaster.
4. Be careful not to get the gel in your eyes. If this happens, rinse
your eyes with clean water and tell your doctor.
5. Wash your hands after rubbing in Diclofenac Gel, unless your
hands are the site being treated. Replace the cap.
6. Allow at least four hours between applications of the gel. Do not
apply more than 4 times in any 24 hour period.
This medicine is not recommended for use in children under 14
years of age.
Do not use Diclofenac Gel for more than:


2 weeks for muscle and joints injuries (e.g. sprains, strains,
bruises) or tendonitis.



If you are using the gel for arthritis, your doctor may wish to
review your treatment regularly.

If symptoms do not improve within this time, or they get worse,
consult your doctor. In children aged 14 years and over, if this
product is required for more than 7 days for pain relief or if the
symptoms worsen the patient/parents of the adolescent is/are
advised to consult a doctor.
If you use more Diclofenac Gel than you should
If you or a child accidentally swallows Diclofenac Gel, contact your
doctor or accident and emergency department immediately.

If you forget to use Diclofenac Gel

5. HOW TO STORE DICLOFENAC GEL

If you miss your application of Diclofenac Gel at the correct time,
apply it as soon as you remember then carry on as normal. Do not
apply a double quantity to make up for a forgotten application.



KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Do not store above 30°C.

If you have any further questions on the use of this product, ask
your pharmacist.



Do not use after the expiry date printed on the carton or tube
label.



If your doctor tells you to stop using the gel, please take it back
to the pharmacist for safe disposal. Only keep the gel if your
doctor tells you to.

Like all medicines, Diclofenac Gel can cause side effects, although
not everybody gets them.



If you experience any of the following signs of an allergic reaction
(likely to affect fewer than 1 person out of 10,000) stop using
Diclofenac Gel and tell your doctor or pharmacist immediately:

If the gel becomes discoloured or shows any signs of
deterioration, you should ask your doctor or pharmacist before
using it.



Medicines should not be disposed of via wastewater of
household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help to
protect the environment.

4. POSSIBLE SIDE EFFECTS



Skin rash with blisters, hives



Wheezing, shortness of breath or asthma/feeling of tightness in
the chest



Swelling of the face, lips, tongue or throat that may cause
difficulty in swallowing, breathing or speaking.

Other side effects which may occur are usually mild, passing and
harmless (if you are concerned, tell your doctor or pharmacist as
soon as you can):


Skin rash, itching, reddening or smarting (sharp, stinging pain)
of the skin are common after use (likely to affect 1 to 10 people
out of 100).



In very rare cases, your skin may be more sensitive to the sun.
Possible signs are sunburn with itching, swelling and blistering
(likely to affect fewer than 1 person out of 10,000).

If any of the side effects get serious or if you notice any side
effects not listed in this leaflet, STOP USING the gel and tell
your doctor or pharmacist immediately.

6. FURTHER INFORMATION
What Diclofenac Gel contains


Diclofenac Gel contains the active ingredient, diclofenac sodium
(as the diethylammonium salt): each 100g contains the
equivalent of 1g diclofenac sodium.



Diclofenac Gel also contains the following: diethylamine,
carbopol, cetomacrogol, cetiol LC, isopropanol, liquid paraffin,
perfume, propylene glycol and water.

What Diclofenac Gel looks like and contents of the pack
Diclofenac Gel is a white, pleasant smelling, nongreasy gel
Diclofenac Gel is available as tubes of 100g.
Product Licence holder
Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Ltd, Chemilines House, Alperton
Lane, Wembley, HA0 1DX.
Manufacturer
Diclofenac Gel is manufactured by


Novartis Pharma GmbH, Wehr, Germany.



Novartis Consumer Health SA, Switzerland.

POM

PL No. 19488/1403

Leaflet revision date: 19 September 2012
S1403 LEAFLET Diclofenac 20120919

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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