Package leaflet: Information for the user

Adarostin
10 mg/g, gel
Diclofenacum natricum
Please read carefully the entire leaflet 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 advised by
your doctor or pharmacist.

Keep this leaflet as you may need to read it again.
If you need advice or further information, please consult your pharmacist.
If you experience any side effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement or if your condition worsens after 7 days, consult your doctor.

Contents of the leaflet

What Adarostin is and what it is used for
Important information before using Adarostin
How to use Adarostin
Possible side effects
How to store Adarostin
Contents of the pack and other information

1. What Adarostin is and what it is used for
Adarostin is a white, smooth, homogeneous gel with a mild characteristic odour intended for topical application to the skin. The active substance, diclofenac, belongs to a group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs). Due to its aqueous-alcoholic base, Adarostin also has soothing and cooling properties.
The medicine has analgesic and anti-inflammatory effects.
Adults and adolescents over 14 years of age:
Used in local treatment of:

Mild to moderate muscle pain;
Post-traumatic pain (e.g. resulting from sprains, strains or contusions);
Back pain;
Localized inflammatory conditions of soft tissues such as tendonitis, tennis elbow, bursitis;
Adults (over 18 years of age):
Localized and mild forms of osteoarthritis.

2. Important information before using Adarostin

When not to use Adarostin
˗ If you are allergic to diclofenac or to any of the other ingredients of this medicine (listed in section 6);

If you have previously experienced wheezing or shortness of breath (asthma), skin rash with blisters or urticaria, facial or tongue swelling, or nasal mucosal inflammation (rhinitis) after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs;
If you are in the third trimester of pregnancy;
In children and adolescents under 14 years of age.

Warnings and precautions
Before starting treatment with Adarostin, discuss it with your doctor or pharmacist.

Do not apply the medicine to damaged skin, open wounds, or rashes. Discontinue use if a skin rash appears after application.
Adarostin is intended for external use only. Do not use in the mouth. Avoid contact of the gel with the eyes. If the medicine gets into the eyes, rinse thoroughly with clean water and contact your doctor or pharmacist.
Areas treated with Adarostin should not be exposed to sunlight.
Occlusive dressings, commonly used for sprains, may be used, but they must not be airtight.
Use Adarostin with caution in patients with a history of peptic ulcer, hepatic or renal insufficiency, haemorrhagic diathesis, or inflammatory bowel disease.
Adarostin should be used with caution in patients with a history of asthma or peptic ulcer.

If you have any doubts, consult your doctor or pharmacist before using Adarostin.
Children and adolescents
Due to insufficient data on efficacy and safety in children and adolescents under 14 years of age, Adarostin must not be used in this age group.
In adolescents over 14 years of age, if treatment longer than 7 days is required for pain or if symptoms worsen, the patient should consult a doctor.
Adarostin with other medicines
Inform your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
After topical application of the gel, the amount of diclofenac absorbed into systemic circulation is small; therefore, the likelihood of interactions with other medicines is low.
Information on known interactions with systemically administered diclofenac is included in the product characteristics for those formulations. Concurrent use of Adarostin and other NSAIDs may increase the frequency of adverse effects.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, suspect you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before using this medicine.
Pregnancy
Adarostin must not be used during the last three months of pregnancy, as it may harm the unborn child or cause complications during delivery.
This medicine is not recommended for use during the first six months of pregnancy.
Adarostin may be used during the first six months of pregnancy only on the advice of a doctor.
Breastfeeding
Adarostin may 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 breastfeeding women, nor to large skin areas or for prolonged periods.
If you have further doubts about using Adarostin during pregnancy or breastfeeding, consult your doctor or pharmacist.
Driving and operating machinery
Use of this medicine does not affect the ability to drive or operate machinery.
Adarostin contains propylene glycol, propyl parahydroxybenzoate, methyl parahydroxybenzoate
This medicine contains propyl parahydroxybenzoate and methyl parahydroxybenzoate, which may cause allergic reactions (including delayed-type reactions), and propylene glycol, which may cause skin irritation.

3. How to use Adarostin

This medicine should always be used exactly as described in this patient leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

Adarostin should be applied topically to the skin, three or four times daily, gently rubbed in. Apply a thin layer of gel to the painful area: 2 g to 4 g of Adarostin (in the form of a round mass approximately 2.0–2.5 cm in diameter). After application, wash your hands unless the hands are the area being treated.

Use only on intact skin.

Avoid contact of the gel with eyes and mucous membranes.

The area where Adarostin has been applied may be covered with a bandage, but do not use air-tight dressings (so-called occlusive dressings).

Do not use the medicine for longer than:

In adults and adolescents over 14 years of age, when used without prior consultation with a doctor, do not use for longer than 14 days for strains and inflammatory conditions of soft tissues.
In adults (over 18 years of age): for pain associated with degenerative joint disease, without prior consultation with a doctor, do not use for longer than 21 days.

Medical evaluation is recommended after 7 days of treatment if there is no improvement, or immediately if symptoms worsen.

Use in children (under 14 years of age): Adarostin is contraindicated in children under 14 years of age, as there are no studies confirming its safety and efficacy in this patient group.
Use in adolescents (over 14 years of age): In adolescents over 14 years of age, if treatment longer than 7 days for pain is required, or if symptoms worsen, the patient should contact a doctor.

Use in patients with liver or kidney disease:

Caution is advised when administering Adarostin to patients with liver or kidney disease (see section 2 - Warnings and precautions).

If pain and swelling do not improve within 7 days or worsen, consult a doctor.

Use of more than the recommended dose of Adarostin
If an excessive amount of Adarostin has been applied, remove the excess.
Seek immediate medical advice if Adarostin is swallowed.

Missed dose of Adarostin
Do not apply a double dose to make up for a missed dose.

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

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Some adverse reactions occurring rarely and very rarely may be serious.
If any of the following symptoms occur, which may be symptoms of an allergic reaction, discontinue use of the medicine and seek medical advice as quickly as possible:

Skin rash with blisters, urticaria (common: occurs in less than 1 in 10 to fewer than 1 in 100 people using the medicine)
Bullous dermatitis (rare: occurs in less than 1 in 1,000 to fewer than 1 in 10,000 people using the medicine)
Wheezing, shortness of breath or feeling of tightness 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 adverse reactions that may occur during treatment with Adarostin are usually mild and transient. If any of the following symptoms occur, discontinue use of the medicine and inform your doctor or pharmacist:

Itching, redness, burning sensation of the skin, skin inflammation (including contact dermatitis), swelling or nodules (common: occurs in less than 1 in 10 to fewer than 1 in 100 people using the medicine)
Photosensitivity – manifesting as sunburn with itching, swelling and blistering (very rare: occurs in less than 1 in 10,000 people using the medicine). Prolonged use of Adarostin over relatively large skin areas may lead to systemic adverse reactions such as nausea, vomiting, diarrhoea, epigastric pain.

If any of the adverse reactions worsen or if any adverse reactions not listed in this leaflet occur, inform your doctor or pharmacist.
Reporting of adverse reactions
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Adarostin

Keep this medicine out of the sight and reach of children.
Store below 25°C. Do not store in a refrigerator or freeze.
Keep in the original packaging to protect from light.
Do not use this medicine after the expiry date stated on the pack following: EXP.
The expiry date refers to the last day of the stated month.
Period of use after first opening of the tube: 1 year.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the packaging and other information

What Adarostin contains
˗ The active substance is sodium diclofenac. 1 g of Adarostin product contains 10 mg of
sodium diclofenac (Diclofenacum natricum).
The other ingredients 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 contents of the pack
A white, smooth, homogeneous gel with a slight, characteristic odour, for topical application to the skin.
Adarostin is available in an aluminium tube with a membrane coated internally with epoxy-phenolic varnish, fitted with a cap made of HDPE and equipped with a piercing device, packed in an outer carton box.
The tube contains 100 g of gel.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
MEDICOFARMA S.A.
ul. Sokołowska 9 lok. U19
01-142 Warszawa
Telephone 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