Package leaflet: Information for the user GENUS PHARMACEUTICALS

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.

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.    Possible 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.

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.

2.    What you need to know before you take Seractil® 300 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 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 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 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®.

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 if:

-    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 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.

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. Seractil® 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 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 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 tablets 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.

-    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.

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 rash;

6. Contents of the pack and other information What Seractil® contains

-    The active substance is dexibuprofen. One film-coated 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 Distributor:

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.

Austria:    Dexibuprofen "Gebro" 300 mg

Filmtabletten

United Kingdom: Seractil® 300 mg film-coated tablets

Portugal:    Seractil® 300 mg comprimidos

revestidos

Sweden:    Tradil® 300 mg filmdragerade

tabletter

Denmark:    Seractiv® 300 mg filmovertrukne

tabletter

Spain:    Seractil® 300 mg comprimidos

recubiertos con pelicula

Greece:    Seractil® 300 mg film-coated

tablets

Germany:    Dolomagon^® 300 mg Filmtab-

letten

Norway:    Seractiv® tablett, filmdrasjert

300 mg

Italy:    Seractil® 300 mg compresse

rivestite con film

This leaflet was last approved in June 2014

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