In this leaflet:

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

Falcol Inyectable
Aceclofenac

The active substance of Falcol is aceclofenac. Each lyophilized vial contains 150 mg of aceclofenac.
The other ingredients (excipients) of the vial are: monopotassium phosphate and sodium hydroxide.
The ingredients of the solvent ampoule are: benzyl alcohol, propylene glycol and water for injectable solutions.

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

Manufacturer:
Industrias Farmacéuticas ALMIRALL PRODESFARMA, S.L. (Sant Andreu Plant)
Ctra. Nacional II, Km. 593 08740 Sant Andreu de la Barca Barcelona

1. WHAT Falcol inyectable IS AND WHAT IT IS USED FOR

Falcol inyectable is a medicine for intramuscular administration. It is presented in boxes containing 4 vials of lyophilized powder and 4 solvent ampoules.
Aceclofenac belongs to the group of the non-steroidal antiinflammatories and antirheumatics alone.
Your doctor will prescribe Falcol for the treatment of acute painful processes such as low back pain (lumbalgia), toothache (odontalgia), renal colic, postoperative and post-traumatic painful stages, post-episiotomy pain, acute gout attacks, sciatica, primary dysmenorrhoea and joint pain (extraarticular rheumatism).

2. BEFORE YOU USE Falcol inyectable

Do not use 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).
See your doctor, even if any of the above circumstances have only happened once.

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 inyectable
As it contains benzyl alcohol as excipient, it is contraindicated in children aged under 3 years.

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 USE Falcol inyectable

Follow these instructions unless told to do otherwise by your doctor.
Remember to take your medicine.
The recommended dose is 1 injectable solution (150 mg) once or twice daily, according to medical criteria, by the deep intragluteal route in the external superior quadrant.
The administration of Falcol inyectable for more than two days is not recommended. If it was necessary to continue the analgesic or antiinflammatory treatment, other galenic forms of Falcol should be used.
Falcol inyectable should not be combined with any of the other galenic forms of Falcol.
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 should not be used in children.

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 quarterly controls performed.

Use in patients with liver impairment
The dose should be reduced to 1 injectable solution/day (150 mg/day).

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.
Being an injectable solution, overdose is very difficult.

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 inyectable

Keep Falcol out of the reach and sight of children.
No special precautions for storage. The reconstituted solution is stable for 48 hours stored in the refrigerator (2-
8ºC).

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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