DEXIBUPROFEN 200 MG FILM-COATED TABLETS - patient leaflet, side effects, dosage

1. what “dexibuprofen” is and what it is used for

The name of your medicine is Dexibuprofen 200 mg Film-coated Tablets (called as Dexibuprofen capsules in this leaflet). Dexibuprofen tablets contain active ingredient as “dexibuprofen”, which 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.

“Dexibuprofen” 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 dexibuprofen

Warnings and precautions

Do not take Dexibuprofen if:

• - you are allergic to dexibuprofen or any of the other ingredients in “Dexibuprofen”;

• – 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);

• – if you previously had bleedings or perforations in your gastrointestinal system caused by NSAIDs;

• – you have or previously have had recurrent a stomach or duodenal ulcers (Vomiting blood or having black bowel motions or bloody diarrhoea could be a sign that your stomach or your intestines are bleeding.);

• – 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.

Take special care with “Dexibuprofen"

Other medical problems may affect how you should use dexibuprofen. Before you take this medicine, make sure your doctor knows 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) or

• – you are having problems becoming pregnant. (In rare cases, drugs such as “Dexibuprofen” can affect a woman’s fertility. Your fertility will return to normal when you stop taking “Dexibuprofen”.)

• – you have an infection – please see heading “Infections” below.

Infections

“Dexibuprofen” may hide signs of infections such as fever and pain. It is therefore possible that “Dexibuprofen” may delay appropriate treatment of infection, which may lead to an increased risk of complications. This has been observed in pneumonia caused by bacteria and bacterial skin infections related to chickenpox. If you take this medicine while you have an infection and your symptoms of the infection persist or worsen, consult a doctor without delay.

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 “Dexibuprofen”.

Medicines such as “Dexibuprofen” 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 “Dexibuprofen” 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 “Dexibuprofen” is taken for a quick pain relief in acute pain conditions, especially if taken with food (see also section 3).

Taking other medicines

Medicines can sometimes affect the way that other medicines work. Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines without a prescription.

You should not take the following medicines with “Dexibuprofen” 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 “Dexibuprofen” with other NSAIDs or acetylsalicylic acid (aspirin). However, your doctor may allow you to take low doses of acetylsalicylic acid (up to 100 mg every day) together with “Dexibuprofen”.

• – Warfarin or other medicines used to thin the blood or stop blood clots. If you take this medicine with “Dexibuprofen” it can prolong bleeding time or bleeding can occur.

• – Lithium used to treat certain mood disorders. “Dexibuprofen” can increase the effect of lithium.

• – Methotrexate. “Dexibuprofen” 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). “Dexibuprofen” 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). “Dexibuprofen” 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. “Dexibuprofen” may make your body take longer to stop bleeding.

• – Phenytoin used to treat epilepsy. “Dexibuprofen” may increase the side effects of phenytoin.

• – Phenytoin, phenobarbital and rifampicin. Concomitant administration may lower the effects of dexibuprofen.

• – Low dose acetylsalicylic acid. Dexibuprofen may interfere with the effect of acetylsalicylic acid 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)

Taking “Dexibuprofen" with , food and drink

You may take “Dexibuprofen” 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 “Dexibuprofen” as this may increase gastrointestinal side effects.

Pregnancy and breastfeeding

Ask your doctor for advice before taking any medicine if you are pregnant.

You must not take “Dexibuprofen” 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 “Dexibuprofen” after consulting your doctor.

You also should not take “Dexibuprofen” if you plan to become pregnant, as the medicine may make it more difficult to become pregnant.

Only small amounts of “Dexibuprofen” pass into breast milk. However, if you are breastfeeding, you should not take “Dexibuprofen” 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 “Dexibuprofen”, you should avoid driving or using any dangerous machines (see section 4 Possible side effects).

3. how to take dexibuprofen

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The lowest effective dose should be used for the shortest duration necessary to relieve symptoms. If you have an infection, consult a doctor without delay if symptoms (such as fever and pain) persist or worsen (see section 2).

You should take “Dexibuprofen” with a glass of water or some other liquid. “Dexibuprofen” 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 “Dexibuprofen” 200 mg tablets for a single dose.

Do not take more than 6 “Dexibuprofen” 200 mg tablets a day.

Osteoarthritis

The usual dose is 1 “Dexibuprofen” 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 “Dexibuprofen” 200 mg tablets a day.

Menstrual _ pain

The usual dose is 1 “Dexibuprofen” 200 mg tablet up to 3 times or 2 tablets 2 times a day.

Mild to moderate pain

The usual dose is 1 “Dexibuprofen” 200 mg tablet 3 times a day. For acute symptoms, your doctor may prescribe up to 6 “Dexibuprofen” 200 mg tablets a day.

The score line on the tablets (see the ‘What “Dexibuprofen” looks like’ section) makes it possible for you to split the tablets into equal halves. To divide the tablet, place it on a hard surface and press down with the two index fingers or thumbs. The score line is only there to help you break the tablet if you have difficulty swallowing it whole and not to divide into equal doses.

Patients with liver or kidney disease: Your doctor may have prescribed a lower than the normal dose of “Dexibuprofen”. 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 “Dexibuprofen”, your doctor may increase your dose.

Children and adolescents: As there is not enough experience in children and adolescents “Dexibuprofen” should not be used below the age of 18.

If you feel that the effects of your “Dexibuprofen” tablets are too strong or too weak, talk to your doctor or pharmacist.

If you take more “Dexibuprofen” than you should

If you have accidentally taken too many tablets, contact your doctor straight away.

If you forget to take “Dexibuprofen”

Do not take a double dose to make up for a tablet you have forgotten to take. Take the next tablet as usual.

If you have any further questions on the use of this product, ask your doctor or pharmacist

4. possible side effects

Like all medicines, “Dexibuprofen” can cause side effects, although not everybody gets them.

These do not happen as often when you take a low dose, or you take “Dexibuprofen” for only a short time.

Stop taking “Dexibuprofen” and see a doctor,

• – if you have a severe stomach ache, especially when you start taking “Dexibuprofen”.

• – if you have black stool, bloody diarrhea or if you are vomiting blood.

• – 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).

Very common : affects more than 1 user in 10 – Indigestion, stomach ache.

Common : affects 1 to 10 users in 100

• – Diarrhoea, being sick or feeling sick;

• – feeling exhausted or drowsy, dizziness, headaches;

• – a skin rash.

Uncommon : affects 1 to 10 users in 1,000

• – Ulcers and bleeding in the stomach or intestines, black bowel motions, 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 : affects 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, perforations in the digestive system (symptoms are severe stomach ache, fever, feeling sick), 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 : affects 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 “Dexibuprofen” may be associated with a small increased risk of heart attack (“myocardial infarction”) or stroke.

Not known: frequency cannot be estimated from the available data – skin becomes sensitive to light.

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 Yellow Card Scheme at: or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

5. how to store “dexibuprofen”

Keep this medicine out of the sight and reach of children.

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date which is stated on the carton and blister 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.

6. contents of the pack and other information

What “Dexibuprofen” contains

• – The active substance is dexibuprofen.

• – The other ingredients are: Colloidal anhydrous silica, microcrystalline cellulose, hypromellose, croscarmellose sodium. Opadry: polyvinyl alcohol, titanium dioxide, macrogol & talc.

What “Dexibuprofen” looks like and contents of the pack

Dexibuprofen Film-coated Tablets, 200 mg

White, circular shaped, biconvex, film coated tablet with break line on one side and 200 debossed on other side. The dimension of 200mg tablet is 9.50mm ± 0.2mm.

The packs are available in blister pack of ALU-PVC/PVDC.

Package sizes: 10, 20, 30, 50, 60, 100 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Strides Pharma UK Ltd

Unit 4 Metro Centre Tolpits Lane

Watford Hertfordshire WD18 9SS

United Kingdom

This leaflet was last revised in 01/2021.

Product Name: Dexibuprofen 200 mg Film-coated Tablets – Pack insert Dimension: 114 × 600 mm

Colour: Black

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