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Package leaflet: Information for the user

Seractil 200 mg film-coated tablets

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 more 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.
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 ® 200 mg
film-coated tablets
3. How to take Seractil ® 200 mg film-coated tablets
4. Possible side effects
5. How to store Seractil ® 200 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.
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.
What you need to know before you take
Seractil® 200 mg film-coated tablets
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 intestines (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 have ever 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
‘Taking other medicines’ 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 plan­
ning 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®.
Medicines such as Seractil® may be associated with
a small increased risk of heart attack („myocardial infarction“) or stroke. Any risk is more likely with high
doses and prolonged treatment. Do not exceed the
recommended dose or duration of treatment.
If you have heart problems, previous stroke or think
that you might be at risk of these conditions (for example if you have high blood pressure, diabetes or
high cholesterol or are a smoker) you should discuss
your treatment with your doctor or pharmacist.
Your doctor may need to give you regular check-ups
– you have heart, liver or kidney problems;
– 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
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.
You should avoid taking NSAIDs if you have a varicella zoster infection (chickenpox).
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).
Other medicines and Seractil®
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.
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). Do not take if you
are taking aspirin at doses of above 75 mg daily.
– Warfarin or other medicines used to thin the blood
or stop blood clots. If you take this medicine with
Seractil® it can prolong bleeding time or bleeding
can occur.
– 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:
– Medicines used to treat high blood pressure or
heart problems (for example, beta blockers).
Seractil® may reduce the benefits of these medicines.
– 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.
– Drugs used to stop or prevent blood clots. ­ eractil®
may make your body take longer to stop bleeding.
– 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.
– Low dose aspirin (up to 75 mg). Seractil® may interfere with the effect of aspirin to thin the blood.
– Sulfonylurea (certain oral anti-diabetic medicines)
– Pemetrexed (a medicine to treat certain forms of
– 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 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.

PIL Seractil 200 mg film-coated tablets UK
Art.Nr.: Pharmacode.: Schrift:
8 pt
P Black C ■
offen: 148 x 420 mm,

gefalzt: 148 x 210 mm
121127 rl, txt

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® 200 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 2 Seractil® 200 mg tablets for
a single dose.
Do not take more than 6 Seractil® 200 mg tablets
a day.
For osteoarthritis
The recommended dose is 1 Seractil® 200 mg tablet up to 3 times or 2 tablets 2 times a day. For acute
symptoms, your doctor may increase the dose to 6
Seractil® 200 mg tablets a day.
For period (menstrual) pain
The recommended dose is 1 Seractil® 200 mg tablet
up to 3 times or 2 tablets 2 times a day.
For mild to moderate pain
The recommended dose is 1 Seractil® 200 mg tablet 3 times a day. For acute symptoms, your doctor
may prescribe up to 6 Seractil® 200 mg tablets a day.
The score line on the tablets (see the ‘What Seractil® looks like’ section) makes it possible for you to
split the tablets into equal doses. To divide the tablet, place it on a hard surface and press down with
the two index fingers or thumbs.
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 inchildren 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
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).
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 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 1000
– ulcers in the mouth, gastritis;
– purpura (purple bruises), itching, a raised itchy
– 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.
If you get any side effects, talk to your doctor or
pharmacist. This includes any side effects not listed
in this leaflet.
How to store Seractil ® 200 mg film-coated
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 200 mg of dexibuprofen.
– The other ingredients are
Tablet: Hypromellose, microcrystalline cellulose,
carmellose calcium, colloidal anhydrous silica,
Film coating: Hypromellose, titanium dioxide
(E171), triacetin, talc, macrogol 6000.
What Seractil® 200 mg tablets look like, and the
contents of the pack
The 200 mg tablets are white, round tablets and
have a score line on one side. Seractil® tablets are
supplied in boxes of 10 tablets.

Marketing authorisation holder and manufacturer:
Gebro Pharma GmbH, A-6391 Fieberbrunn, Austria
Genus Pharma, Park View House, 65 London Road,
Newbury, Berkshire RG14 1JN, UK
This product is authorised in the Member
States of the European Economic Area (EEA)
under the following names.
Dexibuprofen "Gebro" 200 mg
United Kingdom: Seractil ® 200 mg film-coated
Portugal: Seractil ® 200 mg comprimidos
Sweden: Tradil ® 200 mg filmdragerade
Denmark: Seractiv® 200 mg filmovertrukne
Spain: Seractil ® 200 mg comprimidos

recubiertos con película
Greece: Seractil ® 200 mg film-coated
Germany: Dolomagon ® 200 mg Filmtab letten
Norway: Seractiv® tablett, filmdrasjert

200 mg
Italy: Seractil ® 200 mg compresse

rivestite con film
This leaflet was last approved in December 2012

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.