ADAROSTIN 10 mg /G Gel

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
2. Adarostin
   1. Read the leaflet carefully before using the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
3. What is Adarostin and what is it used for
4. Important information before using Adarostin
   1. When not to use Adarostin
   2. Warnings and precautions
   3. Children and adolescents
   4. Adarostin and other medicines
   5. Pregnancy and breastfeeding
   6. Driving and using machines
   7. Adarostin contains propylene glycol, propyl parahydroxybenzoate, methyl parahydroxybenzoate
5. How to use Adarostin
   1. Use in children (under 14 years of age)
   2. Use in adolescents (over 14 years of age)
   3. If the pain and swelling do not subside within 7 days or worsen, the patient should consult their doctor.
   4. Using more than the recommended dose of Adarostin
   5. Missing a dose of Adarostin
6. Possible side effects
   1. If the following symptoms occur, which may be symptoms of an allergic reaction, the patient should
   2. If any of the side effects worsen or any side effects not listed in this leaflet occur, the patient should inform their doctor or pharmacist.
   3. Reporting side effects
7. How to store Adarostin
8. Package contents and other information
   1. What Adarostin contains
   2. What Adarostin looks like and what the package contains
   3. Marketing authorization holder and manufacturer
   4. Marketing authorization holder:
   5. Manufacturer:
   6. Date of the last update of the leaflet:

Leaflet attached to the packaging: patient information

Adarostin

10 mg/g, gel
Diclofenac sodium

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

This medicine should always be used exactly as described in this patient leaflet or as directed by a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.
• If after 7 days there is no improvement or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

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

1. What is Adarostin and what is it used for

Adarostin is a white, smooth, homogeneous gel with a mild characteristic odor for topical use. The active substance of the medicine, diclofenac, belongs to a group of medicines known as nonsteroidal anti-inflammatory drugs (NSAIDs). Due to its water-alcohol base, Adarostin also has a soothing and cooling effect.
The medicine has analgesic and anti-inflammatory effects.
Adults and adolescents over 14 years of age:
It is used for local treatment of:

• mild to moderate muscle pain;
• post-traumatic pain (e.g., resulting from sprains, strains, or bruises);
• back pain;
• limited inflammatory conditions of soft tissues such as tendonitis, tennis elbow, bursitis; Adults (over 18 years of age):
• limited and mild forms of degenerative joint disease.

2. Important information before using Adarostin

When not to use Adarostin

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Warnings and precautions

Before starting to use Adarostin, the patient should discuss it with their doctor or pharmacist.

• The medicine should not be applied to damaged skin, open wounds, or skin eruptions. The use of the medicine should be stopped if a skin rash appears after its use.
• Adarostin is intended for external use only. It should not be used in the mouth. Contact with the eyes should be avoided. If the medicine gets into the eyes, they should be rinsed with clean water and the patient should consult a doctor or pharmacist.
• The areas treated with Adarostin should not be exposed to sunlight.
• Bandaging, usually used in the case of sprains, may be used, but it should not be an airtight bandage.
• Adarostin should be used with caution in patients with stomach or intestinal ulcers, liver or kidney failure, bleeding disorders, or a history of non-specific intestinal inflammation.
• Adarostin should be used with caution in patients with asthma and stomach ulcers in their medical history.

In case of any doubts, the patient should consult their doctor or pharmacist before using Adarostin.

Children and adolescents

Since there is insufficient data on the efficacy and safety of using Adarostin in children and adolescents under 14 years of age, the medicine should not be used in this age group.
In adolescents over 14 years of age, if the medicine needs to be used for more than 7 days to treat pain or if the symptoms worsen, the patient should consult their doctor.

Adarostin and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
After applying the gel to the skin, the amount of diclofenac that is absorbed into the general circulation is small, so the likelihood of interactions with other medicines is low.
Information on known interactions with systemically used diclofenac is contained in the characteristics of medicinal products for those forms. Concomitant use of Adarostin and other NSAIDs may increase the frequency of side effects.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.
Pregnancy
Adarostin should not be used during the last three months of pregnancy, as it may have a harmful effect on the unborn child or cause difficulties during delivery.
The medicine is not recommended for use in women during the first six months of pregnancy.
Adarostin should only be used during the first six months of pregnancy on the advice of a doctor.
Breastfeeding
Adarostin can be used during breastfeeding only on the advice of a doctor. Diclofenac, like other NSAIDs, passes into breast milk in small amounts. The medicine should not be applied to the breast of a breastfeeding woman or to large areas of skin or for extended periods.
In case of any further doubts about using Adarostin in pregnant or breastfeeding women, the patient should consult their doctor or pharmacist.

Driving and using machines

Using the medicine does not affect driving or operating machinery.

Adarostin contains propylene glycol, propyl parahydroxybenzoate, methyl parahydroxybenzoate

The medicine contains propyl parahydroxybenzoate and methyl parahydroxybenzoate, which may cause allergic reactions (possible late reactions), and propylene glycol, which may cause skin irritation.

3. How to use Adarostin

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist. In case of doubts, the patient should consult their doctor or pharmacist.
Adarostin should be applied topically to the skin three or four times a day, gently rubbing it in.
A thin layer of the gel should be applied to the painful area: 2 g to 4 g of Adarostin (in the form of a round mass with a diameter of about 2.0 - 2.5 cm). After application, the hands should be washed, unless they are the area being treated.
It should be applied only to undamaged skin.
Contact with the eyes and mucous membranes should be avoided.
The area where Adarostin is applied can be covered with a bandage, but airtight bandages (so-called occlusive dressings) should not be used.
Do notuse the medicine for longer than:

• In adults and adolescents over 14 years of age, if the medicine is used without consulting a doctor, it should not be used for more than 14 days in the case of sprains and soft tissue inflammation.
• In adults (over 18 years of age): in the case of pain associated with degenerative joint disease, without consulting a doctor, the medicine should not be used for more than 21 days.

Medical supervision is recommended after 7 days of using the gel if there is no improvement in treatment or if the symptoms worsen.

Use in children (under 14 years of age)

Adarostin is contraindicated for use in children under 14 years of age, as there are no studies that confirm its safety and efficacy in this patient group.

Use in adolescents (over 14 years of age)

In adolescents over 14 years of age, if the medicine needs to be used for more than 7 days to treat pain or if the symptoms worsen, the patient should consult their doctor.
Use in patients with liver or kidney disease:

• Cautious use is recommended when administering Adarostin to patients with liver or kidney disease (see section 2 - Warnings and precautions).

If the pain and swelling do not subside within 7 days or worsen, the patient should consult their doctor.

Using more than the recommended dose of Adarostin

In case of using an excessive amount of Adarostin, the excess should be removed.
The patient should immediately consult their doctor if they swallow Adarostin.

Missing a dose of Adarostin

The patient should not use a double dose to make up for a missed dose.
In case of any further doubts about using this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Adarostin can cause side effects, although not everybody gets them.
Some side effects that occur rarely and very rarely can be serious.

If the following symptoms occur, which may be symptoms of an allergic reaction, the patient should

stop using the medicine and consult their doctor as soon as possible:

• skin rash with blisters, hives (frequent: occurs in less than 1 in 10 people using the medicine
• blistering skin inflammation (rare: occurs in less than 1 in 1000 people using the medicine),
• wheezing, shortness of breath or feeling of pressure in the chest, swelling of the face, lips, tongue, or throat, (very rare: occurs in less than 1 in 10,000 people using the medicine).

Other side effects that may occur when using Adarostin are usually mild and transient. If the following symptoms occur, the patient should stop using the medicine and inform their doctor or pharmacist:

• itching, redness, burning of the skin, skin inflammation (including contact dermatitis), swelling or lumps (frequent: occurs in less than 1 in 10 people using the medicine),
• photosensitivity - manifested by sunburn with itching, swelling, and blisters (very rare; occurs in less than 1 in 10,000 people using the medicine). Prolonged use of Adarostin on a relatively large area may cause systemic side effects, such as: nausea, vomiting, diarrhea, abdominal pain.

If any of the side effects worsen or any side effects not listed in this leaflet occur, the patient should inform their doctor or pharmacist.

Reporting side effects

If side effects occur, including any side effects not listed in the leaflet, the patient should tell their doctor or 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.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Adarostin

The medicine should be stored out of sight and reach of children.
Store at a temperature below 25°C. Do not store in the refrigerator or freeze.
Store in the original packaging to protect from light.
Do not use this medicine after the expiry date stated on the packaging after: EXP.
The expiry date refers to the last day of the month.
Shelf life after first opening the tube: 1 year.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Adarostin contains

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The active substance of the medicine is diclofenac sodium. 1 g of Adarostin contains 10 mg of diclofenac sodium (Diclofenacum natricum).
The other ingredients of the medicine are: propylene glycol, sodium hydroxide, medium-chain triglycerides, carbomer 980, hydroxyethylcellulose, propyl parahydroxybenzoate (E 216), methyl parahydroxybenzoate (E 218), purified water.

What Adarostin looks like and what the package contains

Adarostin is a white, smooth, homogeneous gel with a mild characteristic odor for topical use.

Adarostin is available in an aluminum tube with a membrane coated with an epoxy-phenolic lacquer from the inside, with a HDPE cap equipped with a piercer, in an outer packaging: a cardboard box.
The tube contains 100 g of gel.

Marketing authorization holder and manufacturer

Marketing authorization holder:

MEDICOFARMA S.A.
ul. Sokołowska 9 lok. U19
01-142 Warsaw
Phone number: +48 22 654 77 70

Manufacturer:

Laboratórios Basi – Indústria Farmacêutica, S.A.
Parque Industrial Manuel Lourenço Ferreira, Lotes 8, 15 e 16
3450-232 Mortágua
Portugal

Date of the last update of the leaflet: