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Package Leaflet: Information for the user

Barcan 100 mg film-coated tablets


Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

What is in this leaflet

What Barcan is and what it is used for

What you need to know before you take Barcan

How to take Barcan

Possible side effects

How to store Barcan

Contents of the pack and other information

What Barcan is and what is used for

Barcan belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). These drugs have anti-inflammatory and painkiller properties. The active ingredient of Barcan is aceclofenac.

Barcan is used to relieve pain and inflammation if you suffer from different types of inflammation of the joints (rheumatic diseases such as: osteoarthritis, rheumatoid arthritis or ankylosing spondylitis).

What you need to know before you take Barcan

Do not take Barcan:

Warnings and precautions

Talk to your doctor before taking Barcan:

  • gastrointestinal disorders of the upper or lower tract

  • inflammatory bowel disease (ulcerative colitis)

  • chronic inflammatory bowel disease (Crohn’s disease)

  • a history suggestive of stomach ulcer, bleeding or perforation

  • blood disorders

if you have, or have ever had problems with the circulation of the blood to your brain.

Medicines such as Barcan may be associated with an increase risk of ulcers and digestive bleeding (combination therapy with protective agents should be considered) and/or an increased risk of heart attack (”myocardial infarction”). Side effects may be minimised by using the lowest effective dose for the shortest duration necessary. Do not exceed the recommended dose or duration of the treatment.

Hypersensitivity reactions, including angioedema (skin swelling mainly around eyes and lips), can occur without earlier exposure to the drug. Serious skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported very rarely in association with the use of medicines like Barcan. The risk is higher in the first month of treatment. Stop the treatment and tell your doctor immediately at the first onset of a skin rash, injuries of mucous membrane or any signs of hypersensitivity (see section 4).

If you are elderly, you are more likely to experience serious side-effects, especially gastrointestinal bleeding or a puncture (perforation). If your doctor prescribes Barcan for you, you will be given the lowest effective dose over the shortest duration.

Children and adolescents

Do not give Barcan to children and adolescents.

Other medicines and Barcan

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

Please tell your doctor if you are taking:

any other non-steroidal anti-inflammatory drugs (NSAID) (such as aspirin, ibuprofen, naproxen)

Barcan with food and drink

Barcan can be taken with food.

Pregnancy, breast-feeding and fertility

You should inform your doctor if you are planning to become pregnant or if you have problems becoming pregnant. NSAIDs may make it more difficult to become pregnant.

Do not take Barcan during the last three months of pregnancybecause of an increased risk of complications for mother and child.

Treatment during any part of pregnancy should only occur following a doctor's prescription.In that case, follow exactly what your doctor has told you.

It is not known if this medicine passes into breast milk. It is not recommended for use during breastfeeding unless considered essential by your doctor.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Do not use any tools or machines if you experience dizziness, drowsiness, tiredness or any visual disturbances while taking this medicine.

How to take Barcan

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

You will be prescribed the lowest effective dose over the shortest duration to reduce side effects.

Do not exceed the stated daily dose.

Adults: The highest recommended dose is 200 mg (two tablets). One 100 mg tablet should be taken in the morning and one 100 mg tablet in the evening.

For patients with liver impairment the recommended initial dose is 100 mg.

Tablets should be swallowed whole with a glass of water and can be taken with food.

If you take more Barcan than you should

If you accidentally take too many Barcan tablets, contact your doctor immediately or go to your nearest hospital casualty department. Please take this leaflet or the box the Barcan tablets came in, with you to the hospital so that they will know what you have taken.

Symptoms of an overdose can include nausea, vomiting, stomach pain, dizziness, drowsiness and headache.

If you forget to take Barcan

If you miss a dose, do not worry, just take the next dose at the usual time. Do not take a double dose to make up for a forgotten dose.

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

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you experience any of the following side effects, stop the treatment and tell your doctor immediately:

Rare (may affect up to 1 in 1,000 people):

swelling of the face, tongue or throat, difficulty swallowing, nettle rash and bronchospasm (angioedema), visual disturbances, high blood pressure, worsening of high blood pressure, heart failure, shortness of breath

severe stomach pain or any sign of bleeding in the stomach or intestines, bleeding of the gastrointestinal tract (blood in the stools or black coloring of the stools)

Very rare (may affect up to 1 in 10,000 people):

Stop taking the medicine and tell your doctor as soon as possible if you experience:

Common (may affect up to 1 in 10 people):

The following side effects have also been reported:

Common (may affect up to 1 in 10 people):

Uncommon (may affect up to 1 in 100 people):

Rare (may affect up to 1 in 1,000 people):

Very Rare (may affect up to 1 in 10,000 people):

In rare cases, serious skin infections occur in association with chickenpox.

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 listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

How to store Barcan

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 outer carton and blister after “EXP”. The expiry date refers to the last day of that month.

Do not store above 30ºC.

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 to protect the environment.

Contents of the pack and other information

What Barcan contains

The active substance is aceclofenac 100 mg.

The other ingredients (excipients) are:

Tablet core:microcrystalline cellulose, croscarmellose sodium, povidone and glyceryl palmitostearate.

Coating material:hypromellose, microcrystalline cellulose, macrogol 40 stearate and titanium dioxide.

What Barcanlooks like and contents of the pack

Barcan 100 mg film-coated tablets are white, round film-coated tablets with a diameter of 8 mm

Barcan tablets are available in blister packs containing 10, 20, 30, 50, 60, 100 or 600 (30 x 20) tablets. Each strip contains 10 or 15 tablets

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Almirall S.A.

General Mitre 151

08022 Barcelona



Industrias Farmacéuticas Almirall, S.A.

Ctra. Nacional II, km 593

08740 Sant Andreu de la Barca



This medicinal product is authorised in the Member States of the EEA under the following names:


Cartrex 100 mg comprimé pelliculé


Beofenac 100 mg Filmtablette


Barcan 100 mg filmdragerad tablett

This leaflet was last revised in2014-07-04