Fisiodar
Italy
Table of Contents
Package leaflet: Information for the patient
FISIODAR 50 mg hard capsules
Diacerein
Please read this leaflet carefully before taking this medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any questions, consult your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
- If you experience any adverse reactions, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.
Contents of this leaflet:
- What FISIODAR is and what it is used for
- What you need to know before taking FISIODAR
- How to take FISIODAR
- Possible side effects
- How to store FISIODAR
- Contents of the pack and other information
1. What FISIODAR is and what it is used for
FISIODAR is a medicinal product containing diacerein, which belongs to a group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs), which fight inflammation.
FISIODAR is used to relieve the symptoms of osteoarthritis (a disease causing disorders affecting bones,
muscles, tendons and nerves) of the hip and knee in adults.
The effect of FISIODAR starts after some time.
Therefore, if you suffer from a rapidly progressive (worsening) form of hip osteoarthritis, your doctor
will not prescribe FISIODAR, as you may derive less benefit from this treatment.
Contact your doctor if you do not feel better or if you feel worse.
2. What you need to know before taking FISIODAR
Do not take FISIODAR
- if you are allergic to diacerein or to any of the other ingredients of this medicine (listed in section 6),
- if you have or have previously had liver disease.
If you are pregnant or breastfeeding, see section 2. “Pregnancy and breastfeeding”.
Warnings and precautions
Talk to your doctor or pharmacist before taking FISIODAR if you:
- have intestinal disorders, particularly affecting the terminal portion of the intestine (enterocolitis),
- have previously had liver disease,
- consume alcohol or suffer from alcohol dependence (alcoholism) (see section 2. FISIODAR and alcohol).
Consult your doctor if you develop soft stools or diarrhoea after taking FISIODAR, as this may also lead to
dehydration and low blood potassium levels. If diarrhoea occurs during treatment with this
medicine, stop taking FISIODAR and consult your doctor to discuss which alternative treatments
may be appropriate for you (see section 4. “Possible side effects”).
Do not take laxatives during treatment with FISIODAR (see section 2. “Other medicines and
FISIODAR”).
Laboratory tests and FISIODAR
After taking diacerein, you may experience liver problems, including increased liver enzymes (substances involved in liver function) in the blood, and hepatitis (liver inflammation). Your doctor may ask you to have blood tests to monitor liver function.
The medicine may cause a bright yellow discoloration of the urine.
Children and adolescents
Do not give FISIODAR to children and adolescents aged 0 to 18 years.
Other medicines and FISIODAR
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, inform your doctor if you are taking diuretic medicines (usually used to lower blood pressure), as taking them together with FISIODAR may slightly increase their effect.
Do not take laxatives during treatment with FISIODAR (see section 2. “Warnings and
precautions”).
FISIODAR with food, drinks and alcohol
Consuming alcohol during treatment with FISIODAR may increase the risk of liver damage. Limit alcohol consumption during treatment with FISIODAR.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning a pregnancy, or breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Do not take FISIODAR during pregnancy or while breastfeeding, unless specifically prescribed by your doctor.
Driving and using machines
FISIODAR does not affect the ability to drive or operate machinery.
FISIODAR contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars (lactose), contact him/her before taking this medicine.
3. How to take FISIODAR
Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended starting dose is 1 capsule taken in the evening for the first 2-4 weeks.
Thereafter, the dose may be increased to 2 capsules per day.
Depending on your doctor's judgment, you may take FISIODAR also for prolonged periods.
Method of administration
Take FISIODAR with food, the first dose at breakfast and the other at dinner. Swallow the capsules whole, without opening them, with a glass of water.
Use in the elderly
Diacerein is not recommended in patients over 65 years of age.
If you are an elderly patient, your doctor will carefully determine the appropriate dose for you, possibly considering a reduction of the above-mentioned amounts.
If you take more FISIODAR than you should
If you take or ingest an excessive dose of FISIODAR, inform your doctor immediately or go to the nearest hospital.
Symptoms
Symptoms of overdose include loss of body fluids and substances contained therein (hydro-electrolytic losses) due to very loose stools (diarrhoeic effect) that may occur.
Treatment
Your doctor may perform standard overdose management procedures (e.g. gastric lavage) or treat symptoms with specific therapies. Additionally, your doctor will closely monitor the levels of certain substances in your body fluids to check their balance (electrolyte balance).
If you forget to take FISIODAR
Do not take a double dose to make up for the forgotten capsule.
If you stop taking FISIODAR
If you have any doubts about using this medicine, consult your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone experiences them.
If during treatment with FISIODAR you experience the following reaction:
- unusually loose or watery stools (diarrhoea), STOP treatment and contact your doctor immediately. In some cases, diarrhoea may be severe, with life-threatening complications such as fluid loss and imbalances in certain substances in the body fluids (electrolyte disturbances).
If during treatment with FISIODAR you experience the following reactions:
- abdominal pain
- jaundice (yellowing of the eyes or skin)
- changes in consciousness
- skin itching, contact your doctor immediately, as these may be signs of a serious condition, such as liver disease.
Other side effects that may occur are listed below by frequency.
Very common (may affect more than 1 in 10 people treated):
- abdominal pain
Common (may affect up to 1 in 10 people treated):
- frequent bowel movements
- increased gas formation in the stomach and intestine (flatulence)
- itching, skin rash, eczema (red, itchy skin rash)
Uncommon (may affect up to 1 in 100 people treated):
- increased levels of liver enzymes in blood tests
Not known (frequency cannot be estimated from the available data):
- change in colour (darkening) of urine. If you have any doubts, consult your doctor.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist.
You can also report side effects directly via the website
www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store FISIODAR
Store below 30°C.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after EXP.
The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of
medicines no longer in use. This will help protect the environment.
6. Package contents and other information
What FISIODAR contains
- The active substance is diacerein 50 mg.
- The other components are lactose and magnesium stearate (see section 2, “FISIODAR contains lactose”). The components of the capsule shell are yellow iron oxide, gelatin, titanium dioxide.
Description of the appearance of FISIODAR and pack contents
FISIODAR is presented as hard capsules.
It is available in packs containing:
- blisters of 30 hard capsules of 50 mg,
- blisters of 50 hard capsules of 50 mg.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
ABIOGEN PHARMA S.p.A.
Via Meucci, 36
Ospedaletto - PISA