In this leaflet:

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

Falcol sobres
Aceclofenac

The active substance of Falcol is aceclofenac. Each one contains 100 mg of aceclofenac.
The other ingredients (excipients) are: sorbitol, sodium saccharin, aspartame (E-951), colloidal anhydrous silica, hypromellose, titanium dioxide (Ep-171), milk aroma, caramel aroma and cream aroma.

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 sobres IS AND WHAT IT IS USED FOR
Falcol sobres is a medicine for oral administration. It is presented in containers of 20 or 40 sachets.
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 sobres
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 antiinflamatories.
- 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 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.

Important information about some of the ingredients of Falcol sobres
Falcol sobres contains 2.64 g of sorbitol as excipient per sachet. It may cause stomach complaint and diarrhoea. It should not be used in patients with hereditary fructose intolerance.
Falcol sobres contains aspartame as excipient. People with phenylketonuria should know that each sachet contains 5.61 mg of phenylalanine.

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 antiinflamatories or cyclosporins.

3. HOW TO TAKE Falcol sobres
Follow these instructions unless told to do otherwise by your doctor.
Remember to take your medicine.
Dissolve the contents of the sachets in half a glass of water and take it immediately.
The recommended dose is 200 mg a day, in other words two sachets, one in the morning and another at night (1 sachet 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 sachet/day.
Long-term treatment
If you take Falcol for a long period of time, your doctor must performed quarterly controls, for example of the kidney, liver and 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, 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 pancreas 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 (dyspnea, stridor), anemia 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 sobres
Keep Falcol out of the reach and sight of children.
No special storage conditions are required.

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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