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SERACTIL 300MG FILM-COATED TABLETS

Active substance(s): DEXIBUPROFEN / DEXIBUPROFEN / DEXIBUPROFEN

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Package leaflet: Information for the user

PIL Seractil 300
Art.Nr.:
Pharmacode.:
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Seractil
300 mg film-coated tablets
Dexibuprofen
®

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
What is in this leaflet
1. What Seractil® is and what it is used for
2. What you need to know before you take Seractil® 300 mg
film-coated tablets
3. How to take Seractil® 300 mg film-coated tablets
4. P
 ossible side effects
5. How to store Seractil® 300 mg film-coated tablets
6. Contents of the pack and other information
1. What Seractil® is and what it is used for
Dexibuprofen, the active ingredient in Seractil ®,
belongs to a family of medicines called non-steroidal
anti-inflammatory drugs (NSAIDs). NSAIDs such as
dexibuprofen are used as a painkiller and to control
inflammation. They work by reducing the amount
of prostaglandins (substances that control inflammation and pain) your body produces.

– you are older than 60;
– you need to take this medicine for long-term
treatment.
Your doctor will tell you how often you need these
check-ups.
You can get a headache if you take high doses of
painkillers for a long time (off label use). In this case
you must not take more Seractil® for the headache.

What is Seractil® used for?
Seractil® is used to relieve:
– pain and inflammation caused by osteoarthritis
(when your joints become worn);
– period (menstrual) pain;
– mild to moderate pain, such as pains in the muscles and joints and toothaches.

You should avoid taking NSAIDs if you have a varicella zoster infection (chickenpox).

2. What you need to know before you take
­Seractil® 300 mg film-coated tablets

Other medicines and Seractil®
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.

Do not take Seractil® if:
– you are allergic to dexibuprofen or any of the other
ingredients of this medicine (listed in section 6);
– you are allergic to acetylsalicylic acid or other
painkillers (your allergy may cause you to have
difficulty breathing, asthma, a runny nose, a skin
rash or swelling to your face);
– you previously had bleedings or perforations in
your gastrointestinal system caused by NSAIDs;
– you have, or have ever had, peptic ulceration
(ulcer in your stomach or duodenum) or bleeding
in your digestive tract;
– you have bleedings in the brain (cerebrovascular
bleedings) or other active bleedings;
– you currently have a flare up of an inflammatory
disease of the intestine (ulcerative colitis, Crohn’s
disease);
– you have serious heart failure or serious liver or
kidney disease;
– from the beginning of the 6th month of pregnancy.
Warnings and precautions
Talk to your doctor or pharmacist before taking
Seractil®, if
– you ever have had a stomach or duodenal ulcer;
– you have had bowel ulcers, ulcerative colitis or
Crohn’s disease;
– you have liver or kidney disease or you are
addicted to alcohol;
– you have blood clotting disorders (also see the
‘Other medicines and Seractil®” section);
– you have oedema (when fluid collects in your
body tissues);
– you have a heart disease or high blood pressure;
– you have asthma or any other breathing problems;
– you suffer from systemic lupus erythematosus (a
disease which affects joints, muscles and skin)
or mixed collagenosis (a collagen disease which
affects connective tissues).
Seractil ® 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 becoming pregnant. Your fertility will return
to normal when you stop taking Seractil®.
If you need higher doses, especially if you are over
60 or if you had stomach or duodenal ulcers, there
is an increased risk of gastrointestinal side effects.
Your doctor may consider to prescribe protective
agents together with Seractil®.
Anti-inflammatory/pain-killer medicines like dexibuprofen may be associated with a small increased
risk of heart attack or stroke, particularly when used
at high doses. Do not exceed the recommended
dose or duration of treatment.
You should discuss your treatment with your doctor
or pharmacist before taking Seractil® if you:
– have heart problems including heart failure,
angina (chest pain), or if you have had a heart
attack, bypass surgery, peripheral artery disease
(poor circulation in the legs or feet due to narrow or blocked arteries), or any kind of stroke
(including ‘mini-stroke’ or transient ischaemic
attack “TIA”).
– have high blood pressure, diabetes, high cholesterol, have a family history of heart disease or
stroke, or if you are a smoker.
Your doctor may need to give you regular checkups if:
– you have heart, liver or kidney problems;

Some patients might experience a delayed onset
of action if Seractil® is taken for a quick pain relief in
acute pain conditions, especially if taken with food
(see also section 3).

Seractil® may affect or be affected by some other
medicines. For example:
– medicines that are anti-coagulants (i.e. thin
blood/prevent clotting e.g. aspirin/acetylsalicylic
acid, warfarin, ticlopidine)
– medicines that reduce high blood pressure (ACEinhibitors such as captopril, beta-blockers such
as atenolol medicines, angiotensin-II receptor
antagonists such as losartan) may reduce the
benefits of these medicines
Some other medicines may also affect or be
affected by the treatment of Seractil®. You should
therefore always seek the advice of your doctor
or pharmacist before you use Seractil® with other
medicines. In particular you should tell your doctor
or pharmacist if you are taking any of the following
medicines in addition to those mentioned above:
You should not take the following medicines with
Seractil® unless you are under close medical supervision:
– Non-steroidal anti-inflammatory drugs (medicines for pain, fever and inflammation). There is
an increased risk of ulcers and bleedings in the
digestive system if you take Seractil® with other
NSAIDs or acetylsalicylic acid (aspirin) as a pain
killer.
– Lithium used to treat certain mood disorders.
Seractil® can increase the effect of lithium.
– Methotrexate. Seractil ® can increase the side
effects of methotrexate.
You may take the following medicines but for safety
reasons you should tell your doctor:
– Certain heart medicines called ACE-inhibitors or
Angiotensin II receptor antagonists. They may
increase the risk of kidney problems in rare cases.
– Diuretics (water tablets).
– Corticosteroids. The risk for ulcers and bleeding
may increase.
– Certain antidepressants (selective serotonin
reuptake inhibitors) may increase the risk for
gastrointestinal bleeding.
– Digoxin (a heart medicine). Seractil® can increase
the side effects of digoxin.
– Immune suppressants like ciclosporin.
– Aminoglycoside antibiotics (medicines to treat
infections)
– Medicines that increase potassium levels in the
blood. ACE inhibitors, Angiotensin-II receptor
antagonists, ciclosporin, tacrolimus, trimethoprim and heparins.
– Phenytoin used to treat epilepsy. Seractil® may
increase the side effects of phenytoin.
– Phenytoin, phenobarbital and rifampicin. Concomitant administration may lower the effects
of dexibuprofen.
– Sulfonylurea (certain oral anti-diabetic medicines)
– Pemetrexed (a medicine to treat certain forms
of cancer)
– Zidovudine (a medicine to treat HIV/AIDS)
Seractil® with food, drink and alcohol
You may take Seractil® without food, but it is better to take it with a meal, as this may help to avoid
stomach problems, particularly if you take it for
long term use.
You should limit or avoid drinking alcohol when you
are taking Seractil® as this may increase gastrointestinal side effects.
Pregnancy, breastfeeding and fertility
If you are pregnant or breast-feeding, think you may
be pregnant or are planning to have a baby, ask

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your doctor for advice before taking this medicine.
You must not take Seractil® from the beginning of
the 6th month of pregnancy, as this may seriously
harm your unborn baby, even at very low doses.
In the first five months of pregnancy you should only
use Seractil® after consulting your doctor.
You also should not take Seractil ® if you plan to
become pregnant, as the medicine may make it
more difficult to become pregnant.
Only small amounts of Seractil® pass into breast
milk. However, if you are breastfeeding, you should
not take Seractil® for long periods or in high doses.
Driving and using machines
If you have side effects like feeling dizzy, drowsy,
tired or if you have a blurred vision after taking
Seractil ®, you should avoid driving or using any
dangerous machines (see section 4 Possible side
effects).
3. How to take Seractil® 300 mg film-coated
­tablets
Always take this medicine exactly as your doctor
has told you. Check with your doctor or pharmacist
if you are not sure.
You should take Seractil® with a glass of water or
some other liquid. Seractil® works faster if you take
it without food. Taking it with food is recommended
as this may help to avoid stomach problems, particularly if you take it for long term use.
Do not take more than 1 Seractil® 300 mg tablet
for a single dose.
Do not take more than 4 Seractil® 300 mg tablets
a day.
For osteoarthritis
The recommended dose is 1 Seractil® 300 mg tablet
2 to 3 times a day. For acute symptoms, your doctor may increase the dose to 4 Seractil® 300 mg
tablets a day.
For period (menstrual) pain
The recommended dose is 1 Seractil® 300 mg tablet
2 to 3 times a day.
For mild to moderate pain
The recommended dose is 1 Seractil ® 300 mg
tablet 2 times a day. If higher doses are needed
your doctor may prescribe up to 4 Seractil® 300 mg
tablets a day.
Patients with liver or kidney disease: Your doctor
may have prescribed a lower than the normal dose
of Seractil®. You must not increase the dose your
doctor has prescribed.
Elderly patients: If you are over 60 years old, your
doctor may have prescribed a lower dose than normal. If you are not having problems taking Seractil®,
your doctor may increase your dose.
Use in children and adolescents: As there is not
enough experience in children and adolescents
Seractil® should not be used below the age of 18.
If you feel that the effects of your Seractil® tablets
are too strong or too weak, talk to your doctor or
pharmacist.
If you take more Seractil® than you should
If you have accidentally taken too many tablets,
contact your doctor straight away.
If you forget to take Seractil®
Do not take a double dose to make up for a forgotten tablet.
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.
These do not happen as often when you take a
low dose or you take Seractil® for only a short time.
If you suffer from any of the following at any time
during your treatment stop taking the medicine
and seek immediate medical help:
– Pass blood in your faeces (stools/motions)
– Pass black tarry stools
– Vomit any blood or dark particles that look like
coffee grounds.
Stop taking the medicine and tell your doctor if
you experience indigestion or heartburn, abdominal pain (pains in your stomach) or other abnormal
stomach symptoms.
Also stop taking Seractil® and see a doctor,
– if you have a skin rash, severe blistering or peeling of the skin, mucosal lesions or any signs of
hypersensitivity.
– if you have symptoms like fever, sore throat and
mouth, flu like symptoms, feeling tired, nose and
skin bleed. These can be caused by a reduction of
white blood cells in your body (agranulocytosis).
– if you have severe or persistent headache.
– if you have a yellow coloration of the skin and
the whites of the eyes (jaundice).
– if you have a swollen face, tongue or pharynx,
difficulty to swallow or to breath (angiooedema).

perforations in the digestive system (for symptoms
see “stop taking Seractil® and see a doctor” above).
Other side effects are:
Common: affect 1 to 10 users in 100
– feeling exhausted or drowsy, dizziness, headaches;
– a skin rash.
Uncommon: affect 1 to 10 users in 1,000
– ulcers in the mouth, gastritis;
– purpura (purple bruises), itching, a raised itchy
rash;
– swelling of the face or throat (angioedema);
– problems with sleeping, restlessness, anxiety,
blurred vision, buzzing or ringing in the ears (tinnitus);
– runny nose, difficulties breathing.
Rare: affect 1 to 10 users in 10,000
– A strong allergic reaction;
– psychotic reactions, depression, feeling irritable;
– feeling confused, disoriented or agitated;
– hearing problems;
– wind, constipation, an inflamed oesophagus, flare
up of diverticular disease (small pouches in your
bowels that may become infected or inflamed),
colitis or Crohn’s disease;
– problems with your liver, hepatitis (inflamed liver)
and jaundice (yellowing of the skin or eyes);
– blood disorders, including disorders that reduce
the number of white or red blood cells or platelets.
Very rare: affect less than 1 user in 10,000
– Hypersensitivity reactions, including symptoms
like fever, a rash, pain in the abdomen, headaches, feeling sick and vomiting;
– photosensitivity;
– aseptic meningitis (symptoms are headache,
fever, stiff neck, and generally feeling ill), serious
allergic reactions (difficulty breathing, asthma, a
fast heartbeat, low blood pressure and shock),
allergic reaction with inflamed small blood vessels;
– reddened skin, mucous membranes or throat;
– blistering hands and feet (Stevens-Johnson syndrome);
– peeling skin (epidermal necrolysis);
– hair loss;
– inflamed kidney, kidney disease or kidney failure;
– systemic lupus erythematosus (auto immune
disease);
– very rare bacterial infections, which attack the
tissue covering the muscle can be aggravated.
Oedema (swollen limbs), high blood pressure and
heart failure may occur with NSAID treatment.
Medicines such as Seractil® may be associated with
a small increased risk of heart attack ("myocardial
infarction") 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 national reporting system:
United Kingdom
Yellow Card Scheme
Website: 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 Seractil® 300 mg film-coated
tablets
Keep this medicine out of the sight and reach of
children. Do not store above 25 °C. Do not use
this medicine after the expiry date which is stated
on the carton.
6. Contents of the pack and other information
What Seractil® contains
– The active substance is dexibuprofen. One filmcoated tablet contains 300 mg of dexibuprofen.
– The other ingredients are
Tablet: Hypromellose, microcrystalline cellulose,
carmellose calcium, colloidal anhydrous silica,
talc.
Film coating: Hypromellose, titanium dioxide
(E171), triacetin, talc, macrogol 6000.
What Seractil® 300 mg tablets look like, and the
contents of the pack
The 300 mg tablets are white, round
tablets. Seractil® tablets are supplied in
boxes of 60 tablets.
Marketing Authorisation Holder and Manufacturer:
Gebro Pharma GmbH, A-6391 Fieberbrunn, Austria
This leaflet was last revised in August 2017.

The most frequent side effects are of gastrointestinal nature like indigestion, stomach ache, diarrhoea,
being sick or feeling sick.
Some gastrointestinal side effects can be serious, although they do not effect many people, like
ulcers and bleeding in the stomach or intestines and
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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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