Ultrafastin

Package Leaflet: Information for the Patient

ULTRAFASTIN, 25 mg/g (2.5%), gel

Ketoprofen lysinate

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Ultrafastin and what is it used for
• 2. Important information before using Ultrafastin
• 3. How to use Ultrafastin
• 4. Possible side effects
• 5. How to store Ultrafastin
• 6. Package contents and other information

1. What is Ultrafastin and what is it used for

Ultrafastin is a topical medicine. The active substance, ketoprofen in the form of lysine salt, belongs to the group of non-steroidal anti-inflammatory drugs (NSAIDs) with anti-inflammatory and analgesic effects. Ketoprofen is well absorbed through intact skin. It does not tend to accumulate in the body. The medicine is metabolized in the liver and excreted in the urine in the form of inactive metabolites.

Ultrafastin is intended for the treatment of:

• post-traumatic muscle and joint pain;
• tendinitis.

2. Important information before using Ultrafastin

When not to use Ultrafastin:

• if the patient is allergic to ketoprofen or any of the other ingredients of this medicine (listed in section 6);
• if the patient is allergic to acetylsalicylic acid and other non-steroidal anti-inflammatory drugs, tiaprofenic acid, fenofibrate, UV filters, or perfumes;
• if the patient has allergic skin diseases;
• if the patient has infectious diseases with skin changes;
• if the patient has burns;
• if the patient has damaged skin;
• in children and adolescents under 15 years of age; if the patient is in the last 3 months of pregnancy. The treated skin area should not be exposed to sunlight (even on cloudy days) or UV rays in a solarium during treatment and for 2 weeks after stopping the medicine.

Stop using the medicine immediately if skin reactions occur, including skin reactions after concurrent use of products containing octocrylene (octocrylene is one of the auxiliary substances used to delay decomposition under the influence of light in various cosmetics and hygiene products such as shampoo, aftershave products, shower gels and bath products, skin creams, lip balms, anti-wrinkle creams, makeup removers, hair lacquers).

Warnings and precautions

Exposure to sunlight (even on cloudy days) or UVA rays on skin areas where Ultrafastin has been applied may cause severe skin reactions (photosensitivity). Therefore, it is necessary to:

• protect the treated skin areas by wearing clothing during treatment and for 2 weeks after stopping the medicine to avoid the risk of photosensitivity. During treatment and for 2 weeks after its completion, avoid exposure to sunlight (including solarium);
• wash hands thoroughly after each application of Ultrafastin, unless the hands are the treatment area.

Treatment should be stopped immediately if any skin reactions occur after applying Ultrafastin.

Protect the eyes and mucous membranes from contact with Ultrafastin.

Do not apply the medicine to large areas of the body.

Do not use the medicine under occlusive dressings.

During prolonged massage into the skin, it is recommended to wear protective gloves.

Do not exceed the recommended treatment period due to the increasing risk of contact dermatitis and hypersensitivity reactions with prolonged use.

Caution should be exercised in patients with chronic asthma in combination with chronic rhinitis, sinusitis, and (or) nasal polyps. These patients have a higher risk of allergic reactions to acetylsalicylic acid and (or) NSAIDs than the rest of the population.

Using Ultrafastin in patients with circulatory failure, renal or hepatic impairment

Ketoprofen should be used with caution in patients with circulatory failure, renal or hepatic impairment, as individual cases of systemic adverse reactions consisting of renal function disorders have been reported.

Children and adolescents

The safety of using the medicine in children has not been established.

Do not use Ultrafastin gel in children and adolescents under 15 years of age.

Ultrafastin and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.

Ketoprofen used topically is absorbed in small amounts, so the occurrence of interactions with other medicines is unlikely.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before using this medicine.

Do not use Ultrafastin if you are in the last 3 months of pregnancy.

In the first 6 months of pregnancy, do not use Ultrafastin unless your doctor considers it absolutely necessary. If treatment is necessary during this period, the smallest possible dose should be used for the shortest possible time.

Oral forms (e.g., tablets) of ketoprofen may cause adverse reactions in the unborn child. It is not known whether the same risk occurs with the use of Ultrafastin on the skin.

It is not recommended to use the medicine during breastfeeding.

Driving and using machines

There are no data on the adverse effects of Ultrafastin that may affect the ability to drive and use machines.

Ultrafastin contains methyl parahydroxybenzoate and propyl parahydroxybenzoate

The medicine may cause allergic reactions (possible late reactions).

3. How to use Ultrafastin

Always use this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

Gel for topical use, on the skin.

Adults:

2 to 3 times a day, apply a small amount of gel to the skin in the painful area and massage for a few minutes. After applying the gel, wash your hands, unless your hands are the treatment area.

Treatment should not last longer than 1 week.

Using a higher dose of Ultrafastin than recommended

Overdose of ketoprofen used topically is unlikely. If too much gel is applied to the skin, the excess should be rinsed off with water.

Consider the possibility of adverse reactions.

If the medicine is accidentally ingested, consult a doctor or pharmacist immediately.

If the gel is accidentally ingested, the following may occur: drowsiness, nausea, and vomiting, depending on the amount of substance ingested. Ingestion of large doses may cause respiratory depression, coma, convulsions, gastrointestinal bleeding, increased or decreased blood pressure, and acute renal failure.

If the overdose occurred no more than 1 hour earlier, the doctor will perform gastric lavage and provide symptomatic treatment.

Missing a dose of Ultrafastin

If a dose is missed, continue treatment by applying and massaging the recommended amount of gel into the skin.

Do not use a double dose to make up for a missed dose.

If you have any further doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Ultrafastin can cause side effects, although not everybody gets them.

After using Ultrafastin, the following side effects have been observed:

Uncommon side effects (in less than 1 in 100 patients):local skin reactions such as redness, rash, itching, and burning sensation.

Rare side effects (in less than 1 in 1,000 patients):(dermatological disorders) photosensitivity and urticaria. Severe reactions such as bullous or erythematous rashes, which may spread or become generalized.

Very rare side effects (in less than 1 in 10,000 patients):worsening of existing renal failure.

Frequency not known (cannot be estimated from the available data):anaphylactic shock, angioedema, hypersensitivity reactions.

Other reactions (effect on the gastrointestinal tract, kidneys) resulting from the absorption of the active substance through the skin are dependent on the amount of gel used, the treated skin surface, the degree of absorption into the tissue, the duration of therapy, and the use or non-use of occlusive dressings.

In patients allergic to acetylsalicylic acid and other NSAIDs, an asthma attack may occur.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, tell your doctor or pharmacist.

Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products

Al. Jerozolimskie 181C

02-222 Warsaw

Tel.: +48 22 49 21 301

Fax: +48 22 49 21 309

Website: https://smz.ezdrowie.gov.pl

Side effects can also be reported to the marketing authorization holder.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ultrafastin

Keep the medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging.

The expiry date refers to the last day of the month stated.

The inscription on the packaging after the abbreviation EXP means the expiry date, and after the abbreviation Lot/LOT, it means the batch number.

Store below 25°C.

After first opening the package, the medicine should be used within 6 months.

Medicines should not be disposed of via wastewater or household waste containers.

Ask your pharmacist how to dispose of medicines that are no longer needed.

This will help protect the environment.

6. Package contents and other information

What Ultrafastin contains

• The active substance is ketoprofen lysinate. 1 g of gel contains 25 mg of ketoprofen lysinate.
• The other ingredients are: macrogol 200, troloxamine, carbomer 980, methyl parahydroxybenzoate, propyl parahydroxybenzoate, purified water.

What Ultrafastin looks like and what the package contains

The medicine is a light yellow, slightly opalescent gel. The carton contains an aluminum membrane tube with a piercing cap, containing 50 g of gel.

Marketing authorization holder

Zakłady Farmaceutyczne POLPHARMA S.A.

ul. Pelplińska 19, 83-200 Starogard Gdański

tel. +48 22 364 61 01

Manufacturer

Zakłady Farmaceutyczne POLPHARMA S.A.

Oddział Medana w Sieradzu

ul. Władysława Łokietka 10, 98-200 Sieradz

Date of the last revision of the leaflet: