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METOJECT PEN 25 MG SOLUTION FOR INJECTION IN PRE-FILLED PEN

Active substance(s): METHOTREXATE / METHOTREXATE / METHOTREXATE

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Metoject PEN · 91300-VBGB · AA · 01.17 · Pharma-Code: 276 (Dummy)
Format: 609 x 400 mm · HKS 44 · Perforation · Corrective action: KV01_jem_23.03.17

Package leaflet: Information for the user

Metoject PEN 7.5 mg
solution for injection in pre-filled pen

Metoject PEN 10 mg
solution for injection in pre-filled pen

Metoject PEN 12.5 mg
solution for injection in pre-filled pen

Metoject PEN 15 mg
solution for injection in pre-filled pen

Metoject PEN 17.5 mg
solution for injection in pre-filled pen

Metoject PEN 20 mg
solution for injection in pre-filled pen

Metoject PEN 22.5 mg
solution for injection in pre-filled pen

Metoject PEN 25 mg
solution for injection in pre-filled pen

Metoject PEN 27.5 mg
solution for injection in pre-filled pen

Metoject PEN 30 mg
solution for injection in pre-filled pen
methotrexate

Read all of this leaflet carefully before you start
using 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 or
pharmacist.
• 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 or
pharmacist. This includes any possible side effects not
listed in this leaflet. See section 4.

Metoject PEN
solution for injection in pre-filled pen

What is in this leaflet
1. What Metoject PEN is and what it is used for
2. What you need to know before you use Metoject PEN
3. How to use Metoject PEN
4. Possible side effects
5. How to store Metoject PEN
6. Contents of the pack and other information

91300-VBGB
AA

2. What you need to know before you use Metoject PEN
Do not use Metoject PEN if you
• are allergic to methotrexate or any of the other ingredients
of this medicine (listed in section 6).
• suffer from liver or severe kidney diseases or blood
diseases.
• regularly drink large amounts of alcohol.
• suffer from a severe infection, such as tuberculosis,
HIV or other immunodeficiency syndromes.
• suffer from mouth ulcers, stomach ulcer or intestinal ulcer.
• are pregnant or breast-feeding.
• receive vaccinations with live vaccines at the same time.
Warnings and precautions
Talk to your doctor or pharmacist before taking Metoject
PEN if you:
• are elderly or if you feel generally unwell and weak.
• have problems with the way your liver works.
• suffer from dehydration (water loss).
Recommended follow-up examinations and safety
measures:
Even when Metoject PEN is administered in low doses,
severe side effects can occur. In order to detect them in
time, check-ups and laboratory tests have to be carried out
by your doctor.
Before therapy:
Before starting the treatment, blood samples will be taken
in order to check that you have enough blood cells, tests
to check your liver function, serum albumin (a protein
in the blood) and kidney function. Your doctor will also
check if you suffer from tuberculosis (infectious disease in
combination with little nodules in the affected tissue) and
a chest X-ray will be taken.
During therapy:
You will have the following tests at least once a month
during the first six months and at least every three months
thereafter:
• Examination of the mouth and throat for changes of the
mucosa.
• Blood tests.
• Check of liver function.
• Check of kidney function.
• Check of respiratory system and if necessary lung
function test.
Methotrexate may affect your immune system and
vaccination results. It may also affect the result of
immunological tests. Inactive, chronic infections (such
as herpes zoster [shingles], tuberculosis, hepatitis B or C)
may flare up. During therapy with Metoject PEN you
must not be vaccinated with live vaccines.

1. What Metoject PEN is and what it is used for

Metoject PEN
solution for injection in pre-filled pen
91300-VBGB
AA

Metoject PEN is indicated for the treatment of
• active rheumatoid arthritis in adult patients.
• polyarthritic forms of severe, active juvenile idiopathic
arthritis, when the response to nonsteroidal antiinflammatory drugs (NSAIDs) has been inadequate,
• severe recalcitrant disabling psoriasis, which is not
adequately responsive to other forms of therapy such as
phototherapy, PUVA, and retinoids, and severe psoriatic
arthritis in adult patients,
• mild to moderate Crohn’s disease in adult patients
when adequate treatment with other medicines is not
possible.
Rheumatoid arthritis (RA) is a chronic collagen disease,
characterised by inflammation of the synovial membranes
(joint membranes). These membranes produce a fluid which
acts as a lubricant for many joints. The inflammation causes
thickening of the membrane and swelling of the joint.
Juvenile arthritis concerns children and adolescents less
than 16 years. Polyarthritic forms are indicated if 5 or more
joints are affected within the first 6 months of the disease.
Psoriasis is a common chronic skin disease, characterised
by red patches covered by thick, dry, silvery, adherent scales.
Psoriatic arthritis is a kind of arthritis with psoriatric
lesions of the skin and nails, especially at the joints of
fingers and toes.
Metoject PEN modifies and slows down the progression of
the disease.
Crohn’s disease is a type of inflammatory bowel disease
that may affect any part of the gastrointestinal tract causing
symptoms such as abdominal pain, diarrhoea, vomiting or
weight loss.

Radiation-induced dermatitis and sun-burn can reappear
under methotrexate therapy (recall-reaction). Psoriatic
lesions can exacerbate during UV-irradiation and
simultaneous administration of methotrexate.
Enlarged lymph nodes (lymphoma) may occur and if this is
the case, therapy must be stopped.
Diarrhoea can be a possible side effect of Metoject PEN
and requires an interruption of therapy. If you suffer from
diarrhoea please speak to your doctor.
Certain brain disorders (encephalopathy/
leukoencephalopathy) have been reported in cancer
patients receiving methotrexate. Such side effects cannot
be excluded when methotrexate is used to treat other
diseases.
Other medicines and Metoject PEN
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines. Please
note that this also applies to medicines that you will take in
the future.
The effect of the treatment may be affected if Metoject PEN
is administered at the same time as certain other medicines:
• Antibiotics such as: tetracyclines, chloramphenicol,
non-absorbable broad-spectrum antibiotics, penicillines,
glycopeptides, sulphonamides, ciprofloxacin and
cefalotin (medicines to prevent/fight certain infections).
• Non-steroidal anti-inflammatory drugs or salicylates
(medicines against pain and/or inflammation such as
acetylsalicylic acid, diclofenac and ibuprofen or pyrazole).
• Probenecid (medicine against gout).
• Weak organic acids like loop diuretics (“water tablets”).
• Medicines, which may have adverse effects on the bone
marrow, such as trimethoprim-sulphamethoxazole (an
antibiotic) and pyrimethamine.

• Other medicines used to treat rheumatoid arthritis
such as leflunomide, sulphasalazine and azathioprine.
• Mercaptopurine (a cytostatic agent).
• Retinoids (medicine against psoriasis and other
dermatological diseases).
• Theophylline (medicine against bronchial asthma and
other lung diseases).
• Some medicines against stomach trouble such as
omeprazole and pantoprazole.
• Hypoglycaemics (medicines that are used to lower the
blood sugar).

Under no circumstances should you try to inject Metoject
PEN yourself before you have received such training.

Instructions for use

You can also find guidance on how to use Metoject PEN in
the section “Instructions for use” at the end of this leaflet.
Please note that all of the contents have to be used.

Recommendations

Carefully read the instructions below before starting your

injection.

Always use the injection technique advised by your doctor,

pharmacist or nurse.

Vitamins containing folic acid may impair the effect of your
treatment and should only be taken when advised by your
doctor.

Methotrexate should not come into contact with the surface
of the skin or mucosa. In the event of contamination, the
affected area must be rinsed immediately with plenty of water.

Vaccination with live vaccine must be avoided.

If you use more Metoject PEN than you should
If you use more Metoject PEN than you should, talk to your
doctor immediately.

Metoject PEN with food, drink and alcohol
Alcohol as well as large amounts of coffee, caffeinecontaining soft drinks and black tea should be avoided
during treatment with Metoject PEN.
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 or
pharmacist for advice before taking this medicine.
Do not use Metoject PEN during pregnancy. There is a risk
of harm to the foetus and miscarriage. Men and women
should use an effective method of birth control during
treatment and during a further six months after treatment
with Metoject PEN has been discontinued.
In women of child-bearing age, any existing pregnancy
must be excluded with certainty by taking appropriate
measures, such as pregnancy test, prior to therapy.
As methotrexate can be genotoxic, all women who wish
to become pregnant are advised to consult a genetic
counselling centre, if possible, already prior to therapy.
Men should seek advice about the possibility of sperm
preservation before starting therapy.
Stop breast-feeding prior to and during treatment with
Metoject PEN.
Driving and using machines
Treatment with Metoject PEN may cause adverse reactions
affecting the central nervous system, such as tiredness
and dizziness. Thus the ability to drive a vehicle and/or to
operate machines may, in certain cases, be compromised.
If you feel tired or drowsy do not drive or use machines.
Metoject PEN contains sodium
This medicine contains less than 1 mmol sodium
(23 mg) per dose; i.e. essentially “sodium-free”.

3. How to use Metoject PEN
Always use this medicine exactly as your doctor has told
you. Check with your doctor or pharmacist if you are not
sure.
Your doctor decides on the dose, which is adjusted
individually to you. Usually it takes 4 – 8 weeks before there
is any effect of the treatment.
Metoject PEN is administered subcutaneously (under
the skin) by or under the supervision of a physician or
healthcare staff as an injection once a week only. Together
with your doctor you decide on a suitable weekday each
week on which you receive your injection.
Use in children and adolescents
The doctor decides on the appropriate dose in children and
adolescents with polyarthritic forms of juvenile idiopathic
arthritis.
Metoject PEN is not recommended in children less than
3 years of age due to insufficient experience in this age
group.
Method and duration of administration
Metoject PEN is injected once weekly!
The duration of the treatment is determined by the treating
physician. Treatment of rheumatoid arthritis, juvenile
idiopathic arthritis, psoriasis vulgaris, psoriatic arthritis
and Crohn’s disease with Metoject PEN is a long-term
treatment.
At the start of your therapy, Metoject PEN will be injected
by medical staff. However, your doctor may decide that you
are able to learn how to inject Metoject PEN under the skin
yourself. You will then receive appropriate training.

The manner of handling and throwing away of the medicine
and pre-filled pen must be in accordance with local
requirements. Pregnant health care personnel should not
handle and/or administer Metoject PEN.

If you forget to use Metoject PEN
Do not take a double dose to make up for a forgotten dose.
If you stop using Metoject PEN
If you stop using Metoject PEN, talk to your doctor
immediately.
If you have the impression that the effect of Metoject PEN is
too strong or too weak, talk to your doctor or pharmacist.

Additional information
The manner of handling and throwing away of the medicine and
pre-filled pen must be in accordance with local requirements.
Pregnant healthcare personnel should not handle and/or administer
Metoject PEN.
Methotrexate should not come into contact with the surface of the
skin or mucosa. In the event of contamination, the affected area
must be rinsed immediately with plenty of water.
What you need in order to administer your injection using the
Metoject PEN pre-filled pen
You need:
• 1 Metoject PEN pre-filled pen
• 1 alcohol pad
Metoject PEN pre-filled pen components:
Injection button
Handling area

4. Possible side effects
Transparent control zone
Like all medicines, this medicine can cause side effects,
although not everybody gets them.
The frequency as well as the degree of severity of the side
effects depends on the dosage level and the frequency of
administration. As severe side effects may occur even at
low dosage, it is important that you are monitored regularly
by your doctor. Your doctor will do tests to check for
abnormalities developing in the blood (such as low white
blood cells, low platelets, lymphoma) and changes in the
kidneys and the liver.
Tell your doctor immediately if you experience any of
the following symptoms, as these may indicate a serious,
potentially life-threatening side effect, which require urgent
specific treatment:
• persistent dry, non-productive cough, shortness of
breath and fever; these may be signs of an inflammation
of the lungs [common]
• symptoms of liver damage such as yellowing of the
skin and whites of the eyes; methotrexate can cause
chronic liver damage (liver cirrhosis), formation of scar
tissue in the liver (liver fibrosis), fatty degeneration of
the liver [all uncommon], inflammation of the liver (acute
hepatitis) [rare] and liver failure [very rare]
• allergy symptoms such as skin rash including red
itchy skin, swelling of the hands, feet, ankles, face,
lips, mouth or throat (which may cause difficulty in
swallowing or breathing) and feeling you are going to
faint; these may be signs of severe allergic reactions or
an anaphylactic shock [rare]
• symptoms of kidney damage such as swelling of
the hands, ankles or feet or changes in frequency of
urination or decrease (oliguria) or absence of urine
(anuria); these may be signs of kidney failure [rare]
• symptoms of infections, e.g. fever, chills, achiness,
sore throat; methotrexate can make you more
susceptible to infections. Severe infections like a certain
type of pneumonia (Pneumocystis carinii pneumonia) or
blood poisoning (sepsis) may occur [rare]
• symptoms such as weakness of one side of the
body (stroke) or pain, swelling, redness and unusual
warmth in one of your legs (deep vein thrombosis);
this may happen when a dislodged blood clot causes
blockage of a blood vessel (thromboembolic event)
[rare]
• fever and serious deterioration of your general
condition, or sudden fever accompanied by a sore
throat or mouth, or urinary problems; methotrexate
can cause a sharp fall in certain white blood cells
(agranulocytosis) and severe bone marrow suppression
[very rare]
• unexpected bleeding, e.g. bleeding gums, blood in
the urine, vomiting blood or bruising, these can be
signs of a severely reduced number of blood platelets
caused by severe courses of bone marrow depression
[very rare]
• symptoms such as severe headache often in
combination with fever, neck stiffness, feeling sick,
vomiting, disorientation and sensitivity to light may
indicate an inflammation of the membranes of the brain
(acute aseptic meningitis) [very rare]

Cap

a) With cap before injection
b) After cap removal before injection
c) After injection

What you need to do before administering your injection
1. Wash your hands very carefully.
2. Remove the system from its packaging.
3. Check the Metoject PEN pre-filled pen before using it:
If the Metoject PEN pre-filled pen appears
to be damaged do not use it. Use another
one and contact your doctor, pharmacist or
nurse.
In case a small air bubble is visible through
the transparent control zone, this will not
affect your dose nor will it harm you.
If you are not able to see or to check the
system correctly prior to injection, ask
someone around you for assistance.
4. Set the Metoject PEN pre-filled pen on a clean flat surface
(such as a table).
Where you should administer the injection
The most appropriate zones for your
injection are:
• upper thighs,
• abdomen except around the navel.
• If someone around you administers the
injection for you, the person may also use
the top of the zone at the back of the arm,
just below the shoulder.
• Change the injection area with each
injection. This will minimize any reactions
at the injection site.
• Never inject into areas where the skin is
tender, bruised, red or hard or where you
have scars or stretch marks. If you have
psoriasis, you should not try to inject
directly into any raised, thick, red or scaly
skin patches or lesions.

Metoject PEN · 91300-VBGB · AA · 01.17 · Pharma-Code: 276 (Dummy)
Format: 609 x 400 mm · HKS 44 · Perforation · Corrective action: KV01_jem_23.03.17

How to prepare the injection
5.
6.


7.




Clean your skin in the chosen injection
zone using the enclosed alcohol pad.
Hold the Metoject PEN pre-filled pen
with one hand in the handling area.
Do not remove the cap before you are
ready to administer the injection.

Use your other hand to pull the cap
straight off. The small needle shield
comes off with the cap automatically.
If not, use another pen and contact your
doctor, pharmacist or nurse.
Do not press the button until you are
ready to inject.
If you are unable to remove the cap,
ask someone around you for assistance.

Note: Once you have removed the cap, perform your injection
without delay.
8. With your free hand, build a skin fold by
gently squeezing the area of the cleaned
skin at the injection site.
• The fold must be held pinched until the
Metoject PEN pre-filled pen is removed
from the skin after the injection.

9. Position the uncapped transparent
end of Metoject PEN pre-filled pen
perpendicular to the fold of skin.
10. Without pressing the button, push the
Metoject PEN pre-filled pen firmly onto
your skin in order to unlock the button.
• If you are unable to push the Metoject
PEN pre-filled pen to the stop-point,
ask someone around you for assistance.
How to administer the injection:
11. While holding the Metoject PEN pre-filled
pen firmly against the skin, now press
the button with your thumb.
12. You will hear a click which indicates the
start of the injection. Keep holding the
pen against the raised skin until all of the
medicine is injected. This can take up to
5 seconds.
Note:
Do not remove the Metoject PEN pre-filled pen from the skin before
the end of the injection to avoid incomplete injection.
If the injection is not triggered, release the button, make sure that
the Metoject PEN pre-filled pen is pressed firmly against the skin
and push hard on the button.
If you have troubles with your hearing, count 5 seconds from the
moment you have pressed the button and then lift the Metoject PEN
pre-filled pen from the injection site.
13. Remove the Metoject PEN pre-filled pen
from the injection site, perpendicular to
the skin (pull up).
14. The protective shield automatically
moves into place over the needle.
The protective shield is then locked and
the needle is protected.
15. In case of a slight bleeding use a plaster.
Before throwing away the Metoject PEN pre-filled pen, check
visually that there is no liquid left in the pen, at the bottom of the
transparent control zone. If there is liquid left in the pen, not all
of the medicine has been injected correctly and you should consult
your doctor.
Note
To avoid any injury, never insert your fingers in the opening of
the protective tube covering the needle. Do not destroy the pen.
Whom should you contact in case of need

For any problem or question, contact your doctor, pharmacist

or nurse.

If you or someone around you is injured by the needle, consult

your doctor immediately and throw away the Metoject PEN
pre-filled pen.

• certain brain disorders (encephalopathy/
leukoencephalopathy) have been reported in cancer
patients receiving methotrexate. Such side effects cannot
be excluded when methotrexate therapy is used to treat
other diseases. Signs of this kind of brain disorders may
be altered mental state, movement disorders (ataxia),
visual disturbances or disturbances of memory
[not known]
• severe skin rash or blistering of the skin (this can
also affect your mouth, eyes and genitals); these may
be signs of conditions called Stevens Johnson syndrome
or burned skin syndrome (toxic epidermal necrolysis/
Lyell’s syndrome) [very rare]
In the following, please find the other side effects that may
occur:
Very common: may affect more than 1 in 10 people
• Inflammation of the mouth lining, indigestion, feeling sick,
loss of appetite, abdominal pain.
• Abnormal liver function tests (ASAT, ALAT, bilirubin,
alkaline phosphatase).
Common: may affect up to 1 in 10 people
• Mouth ulcers, diarrhoea.
• Rash, reddening of the skin, itching.
• Headache, tiredness, drowsiness.
• Reduced blood cell formation with decrease in white
and/or red blood cells and/or platelets.
Uncommon: may affect up to 1 in 100 people
• Throat inflammation.
• Inflammation of the bowels, vomiting, inflammation of
pancreas, black or tarry stools, gastrointestinal ulcers
and bleeding.
• Increased sensitivity to light, loss of hair, increased
number of rheumatic nodules, skin ulcer, shingles,
inflammation of blood vessels, herpes-like skin rash,
hives.
• Onset of diabetes mellitus.
• Dizziness, confusion, depression.
• Decrease in serum albumin.
• Decrease in the number of all blood cells and platelets.
• Inflammation and ulcer of the urinary bladder or vagina,
reduced kidney function, disturbed urination.
• Joint pain, muscle pain, reduction of bone mass.
Rare: may affect up to 1 in 1,000 people
• Inflammation of gum tissue.
• Increased skin pigmentation, acne, blue spots on the skin
due to vessel bleeding (ecchymosis, petechiae), allergic
inflammation of blood vessels.
• Decreased number of anti-bodies in the blood.
• Infection (incl. reactivation of inactive chronic infection),
red eyes (conjunctivitis).
• Mood swings (mood alterations).
• Visual disturbances.
• Inflammation of the sac around the heart, accumulation
of fluid in the sac around the heart, obstruction of cardiac
filling due to fluid in the sac around the heart.
• Low blood pressure.
• Formation of scar tissue in the lung, shortness of breath
and bronchial asthma, accumulation of fluid in the sac
around the lung.
• Stress fracture.
• Electrolyte disturbances.
• Fever, wound-healing impairment.
Very rare: may affect up to 1 in 10,000 people
• Acute toxic dilatation of the gut (toxic megacolon).
• Increased pigmentation of the nails, inflammation of the
cuticles (acute paronychia), deep infection of hair
follicles (furunculosis), visible enlargement of small blood
vessels.
• Pain, loss of strength or sensation of numbness or
tingling in arms and legs, changes in taste (metallic taste),
convulsions, paralysis, meningism.
• Impaired vision, non-inflammatory eye disorder
(retinopathy).
• Loss of sexual drive, impotence, male breast
enlargement, defective sperm formation (oligospermia),
menstrual disorder, vaginal discharge.
• Enlargement of lymphatic nodes (lymphoma).
Not known: frequency cannot be estimated from the
available data
• Increased number of certain white blood cells.
• Nosebleed.
• Proteins in urine.
• Feeling of weakness.
Subcutaneous application of methotrexate is locally well
tolerated. Only mild local skin reactions (such as burning
sensations, erythema, swelling, discolouration, severe
itching, pain) were observed, decreasing during therapy.

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 via the
Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more
information on the safety of this medicine.

5. How to store Metoject PEN
Keep this medicine out of the sight and reach of children.
Store below 25 °C.
Keep the pre-filled pens in the outer carton in order to
protect from light.
Do not use this medicine after the expiry date stated on the
carton and pre-filled pen after EXP. The expiry date refers
to the last day of that month.
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.

This medicinal product is authorised in the Member
States of the EEA under the following names:
Austria, Bulgaria, Czech Republic, Finland, Greece,
Hungary, Netherlands, Romania, Slovak Republic,
Slovenia, Spain, United Kingdom:
Metoject PEN
Iceland, Sweden:
Metojectpen
Germany:
metex PEN
Estonia, Latvia, Lithuania, Norway:
Metex
Poland, Portugal:
Metex PEN
Denmark:
Metex Pen
Belgium:
Metoject
This leaflet was last revised in 01/2017.

6. Contents of the pack and other information
What Metoject PEN contains
• The active substance is methotrexate.
1 pre-filled pen with 0.15 ml solution contains 7.5 mg
methotrexate.
1 pre-filled pen with 0.2 ml solution contains 10 mg
methotrexate.
1 pre-filled pen with 0.25 ml solution contains 12.5 mg
methotrexate.
1 pre-filled pen with 0.3 ml solution contains 15 mg
methotrexate.
1 pre-filled pen with 0.35 ml solution contains 17.5 mg
methotrexate.
1 pre-filled pen with 0.4 ml solution contains 20 mg
methotrexate.
1 pre-filled pen with 0.45 ml solution contains 22.5 mg
methotrexate.
1 pre-filled pen with 0.5 ml solution contains 25 mg
methotrexate.
1 pre-filled pen with 0.55 ml solution contains 27.5 mg
methotrexate.
1 pre-filled pen with 0.6 ml solution contains 30 mg
methotrexate.
• The other ingredients are sodium chloride, sodium
hydroxide and hydrochloric acid for pH adjustment and
water for injections.
What Metoject PEN looks like and contents of the pack
This medicinal product is presented as a solution for
injection in pre-filled pen.
The solution is clear, yellow-brown.
The following pack sizes are available:
Metoject PEN is available in packs of 1, 2, 4, 5, 6, 10, 11, 12,
14, 15, and 24 pre-filled pens. Alcohol pads are included in
the package.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
medac Gesellschaft für klinische Spezialpräparate mbH
Theaterstr. 6
22880 Wedel
Germany
Tel.: +49 4103 8006-0
Fax: +49 4103 8006-100

Expand Transcript

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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