In this leaflet:

1. What Falcol comprimidos is and what it is used for
2. Before you take Falcol comprimidos
3. How to take Falcol comprimidos
4. Possible side effects
5. Storing Falcol comprimidos

Falcol comprimidos
Aceclofenac

The active substance of Falcol is aceclofenac. Each tablet contains 100 mg of aceclofenac.
The other ingredients (excipients) are: microcrystalline cellulose, sodium croscarmellose, glycerol palmitostearate, povidone, hypromellose, polyoxyl 40 stearate and titanium dioxide (E-171).

Marketing authorisation holder:
FARMA-LEPORI, S.A.
C. Osi, 7 - 08034 Barcelona

Manufacturer:
Industrias Farmacéuticas ALMIRALL PRODESFARMA, S.L. (Sant Just Desvern Plant)
C. Treball, s/n. 08960 Sant Just Desvern - Barcelona

1. WHAT Falcol comprimidos IS AND WHAT IT IS USED FOR
Falcol comprimidos is a medicine for oral administration. It is presented in boxes of 20 or 40 coated tablets.
Aceclofenac belongs to the group of the non-steroidal antiinflammatories and antirheumatics alone.
Your doctor will prescribe Falcol for the treatment of inflammatory and painful processes such as low back pain (lumbalgia), toothache (odontalgia) and joint pain (scapulohumeral periarthritis and extraarticular rheumatism). Falcol is also indicated for the chronic treatment of pain and inflammation associated with chronic joint processes: arthrosis, rheumatoid arthritis and ankylosing spondylitis.

2. BEFORE YOU TAKE Falcol comprimidos
Do not take Falcol
- If you are pregnant (or plan to be or think you might be) or if you are breastfeeding your child.
- If you are allergic to any of the ingredients of the product.
- If you have had asthma, rhinitis, urticaria or any other allergic reaction caused by acetyl salicylic acid or other non-steroidal antiinflammatories.
- If you have, think you have or have had gastrointestinal haemorrhage or stomach or duodenal ulcer.
- If you have severe renal impairment.

Be particularly careful with Falcol
- If you have a record of stomach or duodenal ulcer or gastrointestinal inflammatory disease.
- If you have a serious liver disease.
- If you have moderate renal impairment.
- If you have heart problems (heart failure).
- If you have had coagulation problems (you bleed easily).
- If you are convalescing from an important (surgical) operation.
See your doctor, even if any of the above circumstances have only happened once.

Taking Falcol with food and drink
Falcol may be taken with or without food.

Pregnancy
Ask your doctor or pharmacist for advice before taking any medicine.
Do not take Falcol if you are or think you may be pregnant.

Lactation
Ask your doctor or pharmacist for advice before taking any medicine.
Do not take Falcol if you are breastfeeding.

Driving and using machines
If you tend to faint, have vertigo or other alterations of the central nervous system, do not drive or use hazardous tools or machines while you take Falcol.

Taking other medicines
Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, even those not prescribed.
Certain medicines may interact with Falcol. In these cases it may be necessary to change the dose or interrupt the treatment with some of the medicines.
This is particularly important if you are taking lithium, digoxin, diuretics, antihypertensives, anticoagulants, glycaemia-lowering agents, methotrexate, acetyl salicylic acid or other non-steroidal antiinflammatories or cyclosporins.

3. HOW TO TAKE Falcol comprimidos
Follow these instructions unless told to do otherwise by your doctor.
Remember to take your medicine.
The tablets should be taken whole, with a little water.
The recommended dose is 200 mg a day, in other words one tablet in the morning and another at night (1 tablet every 12 hours).
The duration of the treatment will be established by your doctor. Do not interrupt the treatment before that, even if you feel well.
If you have the impression that the effect of Falcol is too strong or too weak, talk to your doctor or pharmacist.
Use in children
It is not recommended.
Use in the elderly
Your doctor will indicate the dose to take, and you must have regular controls performed.
Use in patients with renal impairment or with heart failure
Your doctor will indicate the dose to take, and you must have regular controls performed.
Use in patients with liver impairment
The dose should be reduced to 1 tablet/day.
Long-term treatment
If you take Falcol for a long period of time, your doctor must perform quarterly controls, for example of the kidney and liver, as well as blood analyses.

If you take more Falcol than you should
Consult your doctor or pharmacist immediately, go to the nearest hospital or call the Toxicology Information Service. Phone number 915 620 420. Take this leaflet with you.

If you forgot to take Falcol
Do not worry. Do not take a double dose to make up for the dose you forgot to take. Take the next dose according to the usual dosage.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Falcol can have side effects. Most are mild in intensity and disappear on stopping the medication.
Frequent adverse effects are stomach complaints (dyspepsia), abdominal pain, nausea, diarrhoea, dizziness and hepatic function test anomalies.
Rather infrequently, flatulence, gastritis, constipation, vomiting, mouth ulcers, itch and skin rash and anomalies in renal function tests have been reported.
On very rare occasions it has been associated with buccal and pancreatic inflammation, blood in stools, gastrointestinal haemorrhage, tremors, depression, vertigo, sleep alterations (drowsiness/insomnia), increased potassium in blood, oedema of the lower extremities, palpitations, cramp in the legs, redness crises, purpura, respiratory difficulty (dyspnoea, stridor), anaemia and reduction of leukocytes or platelets in blood, renal alterations (nephrotic syndrome), headache, fatigue, hot flashes, facial oedema, allergic reactions, anaphylactic shock, weight increase, sight and taste alterations.
If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

5. STORING Falcol comprimidos
Keep Falcol out of the reach and sight of children.
Store below 30ºC.

Expiry
Do not use Falcol after the expiry date indicated on the box.

This leaflet was revised in May 2005.

FARMA-LEPORI
C. Osi, 7 - 08034 Barcelona

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