Siduro 2.5% ketoprofen Gel
What Is Siduro, And What Is Siduro Used For?
Siduri belongs to a group of non-steroidal anti-inflammatory / anti-rheumatic medicines ( NSAIDs ). It is a topical drug used on the skin to relieve pain and reduce inflammation locally where the damage is.
Siduro is used for mild to moderate pain in connection with muscle and joint injuries, such as sports injuries.
The ketoprofen in Siduro Gel may also be approved for treating conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or healthcare professional for further questions, and always follow their instructions.
What Do You Need To Know Before Using Siduro?
Do Not Use Siduro Gel
- If you are allergic to Siduro ketoprofen or any of the other ingredients of this medicine (listed in section 6).
- If you have had a hypersensitivity reaction (such as symptoms of asthma, hay fever, or hives ) to medicines containing ketoprofen, fenofibrate, thiaprofenic acid, acetylsalicylic acid, or other anti-inflammatory medicines.
- If you have eczema (scaly, itchy, rash), acne, infection, or open sores in the area you want to treat.
- If you have a known skin allergy to ketoprofen, thiaprofenic acid, fenofibrate, UV blockers, or perfumes. Stop using Siduro immediately if you get any skin reactions, including skin reactions after concomitant use of products containing octocrylene (octocrylene is one of the ingredients in several cosmetics and hygiene articles to protect against light degradation, such as shampoo, aftershave, shower, and harmful gels, skin creams, lipsticks, anti-wrinkle creams, makeup removers, and hair sprays).
- If you have ever had an abnormal skin reaction to sunlight.
- Do not expose the treated area to sunlight or UV light from the solarium during treatment and 2 weeks afterward.
- If you are in any of the last three months of pregnancy.
Do not use this medicine if any of the above apply to you. If unsure, talk to your doctor or pharmacist before using Siduro.
Warnings And Cautions:
Talk to your doctor or pharmacist before using Siduro:
- A small proportion of the active substance reaches the blood circulation if you have impaired liver or kidney function or heart weakness.
- Suppose you have asthma in combination with chronic inflammation of the nasal mucosa ( rhinitis ), chronic sinusitis, or nasal polyps. In that case, you have an increased risk of acetylsalicylic acid and NSAID allergy.
Gel one must not come into contact with mucous membranes and eyes. Exposure to the sun (including sun ice) or UV light in areas in contact with Siduro may cause skin reactions that may be serious (light hypersensitivity).
It is, therefore, necessary to protect treated areas by wearing clothing during treatment and two weeks afterward to avoid the risk of photosensitivity.
Treatment should be discontinued immediately in case of signs of skin reactions or other hypersensitivity reactions after using Siduro (see section 4, Undesirable effects ).
The gel must not be used under tight-fitting (occlusive) dressings.
The risk of side effects increases over time. Therefore, the treatment should not exceed one week.
Hands should be washed thoroughly after each application.
Children And Young People:
Siduro is not recommended for use in children.
Other Medicines And Siduro:
Tell your doctor or pharmacist if you have recently taken or might take any other medicines.
Pregnancy And Breastfeeding:
If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Pregnant women should not use Siduro during the last three months of pregnancy.
Pregnant women should avoid the use of Siduro. Treatment during any part of the pregnancy should only be done after a doctor’s prescription.
It is unknown whether breastfed babies can be affected by breast milk. Therefore, consult a doctor before treatment during breastfeeding.
Driving And Using Machines:
No effects on the ability to drive and use machines have been observed.
Siduro Contains Ethanol:
This medicine contains 267 mg of alcohol ( ethanol ) per gram of gel. It can cause a burning sensation on damaged skin.
How To Use Siduro?
- Always use this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
- Siduro should only be used externally. Apply gel one so that the painful or inflamed area is covered twice to thrice daily.
- Massage gel one into the skin thoroughly for a few minutes. The amount of gel is adjusted so that it covers the painful area. Wash your hands after the treatment.
- Do not use more gel than 15 g per day (7.5 g corresponds to about 14 cm gel string).
- Do not treat for more than a week in a row. Then consult a doctor if the symptoms do not improve.
If You Use More Siduro Than You Should:
If you have ingested too much medicine or if, e.g., a child inadvertently ingested the medicine, immediately contact a doctor or hospital for risk assessment and advice.
If You Forget To Use Siduro:
If you forget a treatment, treat it as soon as you remember. If it is close to the next treatment opportunity, skip the missed treatment.
Do not take a double dose to make up for forgotten treatment. Ask your doctor or pharmacist if you have any further questions about using this product.
Possible Side Effects Of Siduro:
This medicine can cause side effects like all medicines, although not everybody gets them. Stop taking Siduro and contact a doctor immediately if you experience any of the following symptoms of angioedema or anaphylactic shock (which occurs in an unknown number of users):
- Swelling of the face, tongue, or throat
- Difficulty swallowing
- Hives and difficulty breathing
- Fever or drop in blood pressure
If you get a skin reaction, stop treatment and consult a doctor (which may affect up to 1 in 100 people).
Other side effects may also occur: Uncommon (may affect up to 1 in 100 people):
- Allergic skin reactions include:
- Redness
- Itching
- Burning sensation
- Eczema
Rare (may affect up to 1 in 1,000 people):
- Severe skin reactions when exposed to sunlight or hives, reactions such as bullous or volatile eczema ( eczema with blisters) that may spread or become common.
Very rare (may affect up to 1 in 10,000 people):
- Impact on the kidneys
How To Store Siduro?
- Keep this medicine out of sight and reach of children.
- Do not store above 25 ° C. Screw on the tube’s cover after use.
- Do not use this medicine after the expiry date stated on the carton.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer required. These measures will help to protect the environment.
Contents Of The Packaging And Other Information:
Content Declaration
- The active substance in Siduro 2.5% gel is ketoprofen. One gram of gel contains 25 mg of ketoprofen.
- The other ingredients are ethanol (96%) 285 mg, carboxy polymethylene, triethanolamine, and purified water.
What Does The Medicine Looks Like, And What Are The Contents Of The pack?
- Aluminum tube
- 1 x 100 g
- Not all pack sizes may be marketed.
Marketing Authorisation Holder
Meda AB
Box 906
170 09 Solna
Tel: 08-630 19 00
Email: info@medasverige.se
Manufacturer:
Chemineau Laboratories
BP 16, 93 Route de Monnaie
F 372 10 Vouvray, France