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NAPROXEN ORION 25 MG/ML ORAL SUSPENSION

Active substance(s): NAPROXEN

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Package leaflet: Information for the user

Naproxen 25 mg/ml
oral suspension
Naproxen

Warnings and precautions
Talk to your doctor before taking Naproxen, if
you
• have heart, kidney or liver failure
• have coronary artery disease
• have blood circulation disorders in the
extremities or brain
• have uncontrolled or poorly treated high
blood pressure
• have unexplained stomach pain or anaemia
(low blood haemoglobin) or if you have
noticed blood in your stools or your stools
are black
• have a gastrointestinal disease, such as
ulcerative colitis (colitis ulcerosa) or Crohn’s
disease
• have an autoimmune condition, such as
systemic lupus erythematosus (SLE)
• have blood coagulation disorder, bleeding
disorder or if you are taking medicines that
prevent blood coagulation and formation of
blood clots
• have asthma or allergies or have had swelling
of the face, lips, eyes or tongue in the past
• have rhinitis or a history of nasal polyps
• are an older person.
The use of anti-inflammatory analgesics, such
as Naproxen, may be associated with a slightly
increased risk of a heart attack (“myocardial
infarction”) or stroke. All risks are increased at
high doses in long-term use. Do not exceed the
recommended dose and duration of treatment.
If you have a heart disease or if you have
had a stroke, or if you have risk factors
(e.g. high blood pressure, diabetes, high
blood cholesterol level or smoking habit)
predisposing to these diseases, you should
discuss your treatment with a doctor or
pharmacist.
If you develop visual disturbances during
Naproxen treatment, you should stop the
treatment and have an ophthalmological
examination.
Please tell your doctor if you have any other
diseases or allergies.
Other medicines and Naproxen
Tell your doctor if you are taking, have recently
taken or might take any other medicines.
This applies to prescription-only medicines,
over-the-counter medicines, herbal medicinal
preparations and natural remedies.
The efficacy of certain medicines or Naproxen
may change or you may experience
adverse effects if you use these medicines
concomitantly. Such medicines include e.g.:
• medicines that prevent blood coagulation
and formation of blood clots (e.g. warfarin,
heparin or clopidogrel), because
concomitant use increases the risk of
bleeding. Combination use should be
avoided.

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.
Naproxen should not be taken in the third
trimester of pregnancy. During the first and
second trimester of pregnancy naproxen
should be taken only if your doctor considers it
to be absolutely necessary.
Naproxen is excreted in very small amounts
in breast milk. The use of naproxen is not
recommended during breast-feeding.
Naproxen may make it more difficult to become
pregnant. You should inform your doctor if you
are planning to become pregnant or if you have
problems to become pregnant.
Driving and using machines
Naproxen does not usually affect the ability
to drive or use machines. Some patients may
experience tiredness, visual disturbances or
lack of concentration after using this medicine.
If these symptoms occur, driving a car and
using machines should be avoided.
Naproxen contains methyl
parahydroxybenzoate, propyl
parahydroxybenzoate and sorbitol
Naproxen oral suspension contains methyl
parahydroxybenzoate (E218) and propyl
parahydroxybenzoate (E216) which may cause
allergic reactions (possibly delayed).
This medicine contains 400 mg/ml sorbitol.
Daily doses as per instructions yield 1.6 g – 20 g
sorbitol. Sorbitol may have a mild laxative
effect. The energy content is 2.6 kcal/g sorbitol.
If your doctor has told you that you have an
intolerance to some sugars, discuss with your
doctor before taking this medicine.
3. How to take Naproxen
Always take this medicine exactly as your
doctor has told you. Check with your doctor or
pharmacist if you are not sure.
Naproxen oral suspension should preferably
be taken with or after food. Ingestion of small
amount of another liquid is recommended after
taking the medicine.
Adults:
The recommended dose is 250–500 mg
(10–20 ml) twice a day based on the individual
need.
For arthritis (e.g. morning stiffness): a single
dose of 500–750 mg (20–30 ml) in the evenings
may be adequate.
For acute gout: the recommended dose is
750 mg (30 ml) at once then 250 mg (10 ml)
every 8 hours until the attack has passed.
For muscle joint or tendon problems and
period pain: the recommended starting dose is
500 mg (20 ml), followed by 250 mg (10 ml) at
6–8 hour intervals as needed, with a maximum
daily dose after the first day of 1250 mg.
Children over 5 years with rheumatoid arthritis:
The recommended daily dose is 10 mg/kg
divided into two doses. Patients weighing over
50 kg may be administered the adult dosage.
body
daily dose body
daily dose
weight
weight
20–24 kg 4 ml x 2
35–40 kg 7 ml x 2
25–29 kg 5 ml x 2
40–44 kg 8 ml x 2
30–34 kg 6 ml x 2
45–49 kg 9 ml x 2
The elderly and people with liver and kidney
problems:
Your doctor will decide your dose, it will usually
be lower than that for other adults.

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Do not take Naproxen, if you
• have a history of asthma, rhinitis, nasal
polyps or rashes associated with the use of
acetylsalicylic acid (aspirin) or other NSAIDs
• you are allergic to naproxen, acetylsalicylic
acid or other anti-inflammatory analgesics or
any of the other ingredients of this medicine
(listed in section 6).
• have gastric or duodenal ulcer
• have a history of gastric or duodenal ulcer or
bleeding that have recurred at least once
• have a history of gastrointestinal perforation
or bleeding (e.g. black or bloody stools,
blood in vomit, anaemia) in connection with
the use of anti-inflammatory analgesics
• have a condition predisposing to
gastrointestinal bleedings
• are in your last three months of pregnancy
• have severe kidney, liver or heart failure.

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2. What you need to know before you take
Naproxen

Naproxen with food, drink and alcohol
You should refrain from alcohol consumption
while taking NSAIDs.
Naproxen oral suspension should preferably
be taken with or after food. Ingestion of a small
amount of another liquid is recommended after
taking the medicine.

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Jesse S.
13.1.2016
Orion Oyj

1. What Naproxen is and what it is used for
Naproxen oral solution contains as an active
substance naproxen which is a ‘Non-Steroidal
Anti Inflammatory Drug’ or NSAID. Naproxen
alleviates inflammation and pain by reducing
the formation of mediators causing pain and
inflammation in the body.
Therapeutic uses of this medicine
Naproxen is used in the treatment of
inflammation and pain in the following
diseases and conditions: rheumatoid arthritis,
ankylosing spondylitis, osteoarthrosis, acute
gout, acute musculoskeletal disorders, and
menstrual pain.
This medicine may also have been prescribed
by a doctor for some other diseases than those
mentioned in this package leaflet.

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

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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 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.

• certain antidepressants (e.g. citalopram,
fluoxetine, paroxetine, sertraline) which
belong to the so-called selective serotonin
reuptake inhibitors
• acetylsalicylic acid (aspirin) and other antiinflammatory analgesics. If you use a low
daily dose of acetylsalicylic acid (e.g. 100 mg)
for prevention of blood clots, the dose must
be taken at least one hour before you take
Naproxen.
• lithium (for bipolar disorder)
• digoxin (for heart diseases)
• corticosteroids taken by mouth
(e.g. prednisolone or dexamethasone for
alleviation of inflammation)
• methotrexate (for rheumatic and cancer
diseases)
• certain immunosuppressive medicines
(e.g. ciclosporin and tacrolimus)
• certain antibiotics (e.g. aminoglycosides,
quinolones)
• probenecid (for gout)
• zidovudine (for HIV and AIDS)
• mifepristone (used to end pregnancy or to
bring on labour if the baby has died)
• hydantoin medicines (e.g. phenytoin, for
epilepsy)
• sulfonamide medicines
(e.g. hydroclorothiazide, acetazolamide,
indapamide for diuretic treatment and
sulfonamide antibiotics for infections)
• sulfonylurea medicines (e.g. glimepiride or
glipazide, for diabetes)
• bisphosphonates (for prevention and
treatment of bone loss)
• certain antihypertensive medicines
(e.g. betablockers like propranolol, ACE
inhibitors like enalapril and angiotensin
receptor antagonists like candesartan or
losartan)
• water tablets (diuretics, e.g. furosemide).

Important!
Shake the bottle well before each dose.
If you experience stomach complaints during
the naproxen treatment, stop using this
medicine and contact your doctor. See also the
section “Possible side effects”.
If you take more Naproxen than you should
Contact immediately a doctor, hospital, or
Poison Information Centre, if you take, or
somebody else, for example a child, takes
by mistake too high a dose of this medicine.
Possible symptoms of overdose include nausea,
vomiting, stomach pain, drowsiness, loss of
consciousness, or convulsions.
Take this medicine pack with you if you go to a
doctor’s office or a hospital.
If you forget to take Naproxen
Take the missed dose as soon as possible. If it
is almost time to take the next dose, skip the
missed dose. Do not take a double dose or two
doses successively.
4. Possible side effects
Like all medicines, this medicine can cause side
effects, although not everybody gets them.
Debilitated patients, patients with other
diseases and elderly patients are more
susceptible to the adverse effects. The risk of
serious adverse effects increases at high
doses in long-term use and is multiplied if
other anti-inflammatory analgesics are used
at the same time.
Important side effects to look out for:
Stop taking naproxen and tell a doctor
straight away if any of the following side
effects happen. You may need urgent
medical treatment:
Serious stomach or gut problems, signs
include:
• Bleeding from the stomach, seen as vomit
which has blood in it, or bits that look like
coffee grounds.
• Bleeding from your back passage (anus),
seen as passing black sticky bowel motions
(stools) or bloody diarrhoea.
• Ulcers or holes forming in your stomach or
gut. Signs include upset stomach, stomach
pain, fever, feeling or being sick.
Allergic reactions, signs include:
• Sudden swelling of your throat, face, hands
or feet.
• Difficulty breathing, tightness in your chest.
• Skin rashes, blisters or itching.
Severe skin rashes, signs include:
• A severe rash that develops quickly, with
blisters or peeling of your skin and possibly
blisters in your mouth, throat or eyes. Fever,
headache, cough and aching body may
happen at the same time.
Other side effects
Very common (may affect more than one patient
out of 10):
• upper stomach pain, heartburn, nausea,
constipation.
Common (may affect less than one patient out
of 10):
• headache, tiredness, light-headedness,
dizziness
• visual disturbances
• ear ringing and buzzing (tinnitus), hearing
disorders
• worsening of heart failure (swellings,
shortness of breath)
• inflammation of the mouth, diarrhoea,
vomiting, digestion problems
• skin symptoms (e.g. itching, nettle rash, red
spots, bruises), increased sweating.
Uncommon (may affect less than one patient out
of 100):
• increased potassium level
• mood changes, depression, impaired ability
to concentrate, sleep disorders, disorders of
memory and thinking (cognitive disorders)
• palpitations
• gastrointestinal bleedings or ulcers, blood in
vomit, blood in stools, bowel obstruction
• increased liver enzyme values, jaundice
• menstrual disorders.
Rare (may affect less than one patient out of
1,000):
• hypersensitivity reactions, intense systemic
allergic reaction (anaphylaxis), sudden
swelling of the neck, lips, tongue and
possibly arms and legs (angioedema)
• hearing impairment
• worsening of asthma
• inflammation of the liver
• hair loss, photosensitivity, skin alterations
and blistering (pseudoporphyria)
• muscle pain, muscle weakness.
Very rare (may affect less than one patient out of
10,000):
• anaemia, clotting problems, changes to the
number of white blood cells
• hallucinations, confusion
• meningitis, worsening of Parkinson’s disease,
convulsions, paraesthesia (tingling or ‘pins
and needles’), inflammation of the optic
nerve
• eye disorders
• vertigo
• inflammation of the blood vessels
• inflammation of the lungs, shortness of
breath, wheezing
• swelling of salivary glands, inflammation of
the pancreas
• severe skin or mucosal reactions with
peeling or blistering (e.g. Stevens-Johnson’s
syndrome), erythema multiforme,
exacerbation of skin diseases (e.g. lichen
planus, erythema nodosum)
• blood in urine, adverse kidney effects
(e.g. kidney failure and inflammation of the
kidneys), increased creatinine level
• female infertility
• drowsiness, thirst, fever, fatigue or sickness.

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The use of anti-inflammatory analgesics, such
as Naproxen, may be associated with a small
increased risk of a heart attack or stroke.
Reporting of side effects
If you get any side effects, talk to your doctor
or pharmacist. 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 Naproxen
This medicine does not require any special
storage conditions.
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 label or carton. 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.
6. Contents of the pack and other
information
What Naproxen contains
- The active substance is naproxen. One
millilitre contains 25 mg naproxen.
- The other ingredients are sorbitol, methyl
parahydroxybenzoate (E218), propyl
parahydroxybenzoate (E216), anhydrous
citric acid, sodium citrate, glycerol 85%,
xanthan gum, microcrystalline cellulose,
sodium carboxymethyl cellulose, polysorbate
80, sucralose (E955), purified water and
chocolate flavour.
- Chocolate flavour contains ethyl vanillin,
vanillin, isoamyl phenylacetate, heliotropine,
2,3,5-trimethyl pyrazine, maltol, cinnamon
aldehyde, propylene glycol (E1520), triacetin
(E1518).
What Naproxen looks like and contents of
the pack
White or off-white suspension.
Pack sizes: 100 ml and 200 ml (plastic bottle)
including a dosing syringe.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder
Orion Corporation
Orionintie 1
FI 02200 Espoo
Finland
Manufacturer
Orion Corporation Orion Pharma
Orionintie 1
FI 02200 Espoo
Finland
This leaflet was last revised in December
2015.

13.1.2016 11.08

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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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