BUTAPIRAZOL 50 mg /G Ointment

Contents of the leaflet

1. Package Leaflet: Information for the User
2. Butapirazol, 50 mg/g, Ointment
   1. Read the package leaflet carefully before using the medicine, as it contains important information for the patient.
   2. Table of Contents of the Leaflet:
3. What is Butapirazol and what is it used for
4. Important information before using Butapirazol
   1. When not to use Butapirazol
   2. Warnings and precautions
   3. Butapirazol and other medicines
   4. Using Butapirazol with food, drink, and alcohol
   5. Pregnancy, breastfeeding, and fertility
   6. Driving and using machines
   7. Butapirazol contains butylhydroxytoluene
5. How to use Butapirazol
   1. Use in children and adolescents
   2. Using a higher dose of Butapirazol than recommended
   3. Missing a dose of Butapirazol
6. Possible side effects
   1. Common side effects
   2. Reporting side effects
7. How to store Butapirazol
8. Package contents and other information
   1. What Butapirazol contains
   2. What Butapirazol looks like and what the package contains
   3. Marketing authorization holder
   4. Manufacturer

Package Leaflet: Information for the User

Butapirazol, 50 mg/g, Ointment

Phenylobutazone

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

1. What is Butapirazol and what is it used for

Butapirazol ointment has:

• anti-inflammatory,
• analgesic effects.

Butapirazol ointment is used as an adjunct in the treatment of inflammatory conditions and pain in:

• rheumatoid arthritis,
• ankylosing spondylitis,
• soft tissue inflammation,
• discopathy,
• acute gout attack,
• phlebitis.

2. Important information before using Butapirazol

When not to use Butapirazol

• if the patient is allergic to phenylbutazone or any of the other ingredients of this medicine (listed in section 6),
• do not use in children under 14 years of age,
• if the patient is taking chemotherapeutic agents or other medicines that affect bone marrow function at the same time,
• do not use on damaged skin.

Warnings and precautions

Before using Butapirazol, tell your doctor if you have:

• mucous membrane inflammation of the gastrointestinal tract,
• stomach and/or duodenal ulcer disease,
• salivary gland enlargement,
• circulatory failure,
• hypertension,
• edema,
• liver failure,
• kidney failure,
• thyroid disease,
• blood morphology changes,
• asthma.

You should also discuss with your doctor if you:

• are elderly,
• are taking insulin or sulfonylurea derivatives, anticoagulants, or other non-steroidal anti-inflammatory drugs at the same time.

If the medicine gets into the bloodstream as a result of improper use, the same side effects may occur as with the use of Butapirazol with systemic action (e.g., suppositories).

Butapirazol and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have taken recently, as well as any medicines you plan to take. This also applies to over-the-counter medicines.
During intensive, prolonged (more than 7 days) use of Butapirazol ointment, interactions may occur, as with the use of Butapirazol with systemic action (e.g., suppositories).
Butapirazol ointment may increase the effect of:

• oral anticoagulants from the coumarin group,
• oral antidiabetic drugs from the sulfonylurea group,
• insulin,
• sulfonamides.

Concomitant consumption of alcohol, treatment with glucocorticoids increases the risk of gastrointestinal disorders, bleeding, and perforation (rupture of the wall) of the gastrointestinal tract. Butapirazol increases the toxic effect of methotrexate (a medicine used to treat cancer), reduces the effect of spironolactone (a medicine used to treat hypertension and heart disease). Probenecid (a medicine used to treat gout), sulfinpyrazone (an anti-inflammatory and analgesic medicine), and barbiturates (sedatives) weaken the effect of Butapirazol. Concomitant use of Butapirazol and other non-steroidal anti-inflammatory drugs may cause allergic reactions and increase the risk of other side effects. Do not use Butapirazol at the same time as gold salts (medicines used to treat rheumatoid arthritis).

Using Butapirazol with food, drink, and alcohol

Butapirazol can be used regardless of meals.
Consuming alcohol during the use of Butapirazol increases the risk of stomach and intestinal disorders, bleeding, and perforation of the gastrointestinal tract.

Pregnancy, breastfeeding, and fertility

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 during pregnancy.
Do not use during breastfeeding.
The medicine may make it harder to get pregnant. If you plan to get pregnant or have problems getting pregnant, tell your doctor.

Driving and using machines

The medicine does not affect psychophysical abilities, the ability to drive vehicles, and operate machines.

Butapirazol contains butylhydroxytoluene

Butapirazol contains butylhydroxytoluene and may cause local skin reactions (e.g., contact dermatitis) or eye and mucous membrane irritation.
Protect your eyes from contact with the medicine.

3. How to use Butapirazol

For topical use only.
This medicine should always be used as directed by your doctor. In case of doubts, consult a doctor or pharmacist.
Before using Butapirazol in patients with sensitive skin, a test should be performed with a minimal amount of ointment.
Squeeze a strip of about 5 cm from the tube. Usually, 2 or 3 times a day, apply a thin layer of ointment to the painful areas. To enhance the therapeutic effect, the ointment can be rubbed into the skin. Do not use intensive rubbing in case of phlebitis.
Butapirazol ointment should not be used for more than 7 days. During treatment lasting more than 5 days, consult a doctor and monitor blood morphology parameters.

Use in children and adolescents

Butapirazol should not be used in children and adolescents under 14 years of age.

Using a higher dose of Butapirazol than recommended

In case of using a higher dose of the medicine than recommended, contact a doctor or pharmacist immediately.

Missing a dose of Butapirazol

Do not use a double dose to make up for a missed dose.
Continue using the medicine.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Butapirazol ointment may cause local irritation, inflammatory reactions may occur at the site of application.
In case of improper use and absorption of significant amounts of Butapirazol ointment into the bloodstream, symptoms may occur, such as with the use of a medicine with systemic action (e.g., suppositories).

Common side effects

May occur less often than in 1 in 10patients:

• nausea, vomiting, abdominal pain, diarrhea.

May also occur other side effects, but their frequency is not known:

• allergic reactions,
• edema,
• skin rashes,
• generalized reactions such as: erythema multiforme, Stevens-Johnson syndrome, Lyell's syndrome
• toxic epidermal necrolysis, exfoliative dermatitis
• dizziness and headaches,
• optic neuritis,
• vision disorders,
• gastrointestinal ulcers (with bleeding),
• salivary gland enlargement,
• kidney inflammation and failure,
• hematuria,
• circulatory failure,
• hypertension,
• increased blood glucose levels,
• hepatitis,
• jaundice,
• benign prostatic hyperplasia,
• decreased blood coagulability,
• agranulocytosis (decreased number of certain white blood cells, which may manifest as inflammation of mucous membranes (oral cavity and throat, anus and rectum, genital organs), pharyngitis, fever, and bleeding),
• thrombocytopenia (decreased platelet count, which may manifest as increased tendency to bleeding and petechiae on the skin and mucous membranes),
• bone marrow disorders.

Systemic use of such medicines as Butapirazol may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.
With the use of systemic non-steroidal anti-inflammatory drugs, edema, hypertension, and heart failure have been reported.
In case of improper use and absorption of significant amounts of Butapirazol ointment into the bloodstream, side effects may occur, such as with the use of a medicine with systemic action (e.g., suppositories).

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the 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 Butapirazol

Store at a temperature below 25°C.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and tube after: EXP.
The expiry date refers to the last day of the month stated.
The batch number of the medicine is stated on the carton and tube after: Lot.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Butapirazol contains

The active substance of the medicine is phenylbutazone.
One gram of ointment contains 50 mg of phenylbutazone.
The other ingredients of the medicine are: ascorbyl palmitate, butylhydroxytoluene, low molecular weight polyethylene, liquid paraffin.

What Butapirazol looks like and what the package contains

Butapirazol ointment is a greasy mass of white to creamy color with a uniform consistency without palpable solid particles.
The package contains 30 grams of ointment.

Marketing authorization holder

GSK PSC Poland sp. z o.o.
ul. Grunwaldzka 189
60-322 Poznań

Manufacturer

Delpharm Poznań Spółka Akcyjna
ul. Grunwaldzka 189
60-322 Poznań
To obtain more detailed information, please contact the representative of the marketing authorization holder.

Date of leaflet approval:June 2022