DICLOFENAC APTEO MED

Package leaflet: Information for the patient

Diclofenac APTEO MED, 10 mg/g, gel
Diclofenacum natricum
Please read the entire 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 so that it can be read again if necessary.
• If advice or additional information is needed, please consult a pharmacist.
• If the patient experiences any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform a doctor or pharmacist. See section 4.
• If there is no improvement after 7 days of treatment, or if the patient feels worse, consult a doctor.

Contents of the leaflet

1. What is Diclofenac APTEO MED and what is it used for
2. Important information before using Diclofenac APTEO MED
3. How to use Diclofenac APTEO MED
4. Possible side effects
5. How to store Diclofenac APTEO MED
6. Contents of the pack and other information

1. What is Diclofenac APTEO MED and what is it used for

Diclofenac APTEO MED is a white gel intended for rubbing into the skin. The active substance, sodium diclofenac, belongs to a group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs). Due to its water-alcohol base, Diclofenac APTEO MED also has a soothing and cooling effect.
The medicine has analgesic, anti-inflammatory and anti-edematous properties.
It is used locally for the treatment of:
Adults and adolescents over 14 years of age:

• traumatic inflammatory conditions of tendons, ligaments, muscles and joints (e.g. resulting from sprains, strains or contusions),
• back pain,
• localized inflammatory conditions of soft tissues such as: tendonitis, tennis elbow, bursitis, periarthritis.

Adults (over 18 years of age):

• localized and mild forms of osteoarthritis.

2. Important information before using Diclofenac APTEO MED

When not to use Diclofenac APTEO MED:

• if the patient is allergic to diclofenac or propylene glycol, or any of the other ingredients of this medicine (listed in section 6),
• if the patient has symptoms of hypersensitivity to the medicine such as wheezing or shortness of breath (asthma), blistering skin rash or urticaria, swelling of the face or tongue, inflammation of the nasal mucosa (rhinitis),
• if the patient has ever previously experienced an allergic reaction (e.g. rash, difficulty breathing or coughing attack) after taking medicines containing acetylsalicylic acid or ibuprofen or other medicines used to treat joint and muscle pain,
• during the last three months of pregnancy,
• in children under 14 years of age.

Warnings and precautions
Before starting to use Diclofenac APTEO MED, discuss it with your doctor or pharmacist.

• Do not apply to damaged skin, open wounds or rashes. Discontinue use if a skin rash appears after application.
• Avoid applying the medicine to large areas of skin or for longer than the approved duration of use, unless otherwise directed by a doctor.
• This medicine is for external use only. Do not use in the mouth. Hands should be washed after use. Avoid contact of the gel with eyes. If the medicine gets into the eyes, rinse thoroughly with clean water and contact your doctor or pharmacist.
• In cases of sprains, simultaneous bandaging may be used, but only breathable bandages should be applied (not airtight bandages).
• Do not expose areas treated with Diclofenac APTEO MED to sunlight.

Children and adolescents
As data on efficacy and safety in children and adolescents under 14 years of age are insufficient, Diclofenac APTEO MED must not be used in this age group.
In adolescents aged over 14 years, if treatment longer than 7 days for pain is required, or if symptoms worsen, the patient should contact a doctor.

Diclofenac APTEO MED and other medicines
Tell your doctor or pharmacist about all medicines currently being taken, as well as any medicines the patient plans to take.

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.
Do not use Diclofenac APTEO MED during the last three months of pregnancy. During the first six months of pregnancy, Diclofenac APTEO MED should not be used unless necessary and recommended by a doctor. If use is necessary, the lowest dose for the shortest possible duration should be administered.
Adverse effects on the unborn child have been reported after oral administration of diclofenac (e.g. tablets). It is not known whether the same risk applies to Diclofenac APTEO MED when applied to the skin.
During breastfeeding, Diclofenac APTEO MED may be used only on medical advice, as diclofenac passes into breast milk in small amounts. The medicine should not be applied to the breasts of nursing women or to large areas of skin or for prolonged periods.
If there are any further doubts regarding the use of Diclofenac APTEO MED in pregnant or breastfeeding women, consult a doctor or pharmacist.

Driving and operating machinery
Use of this medicine does not affect the ability to drive or operate machinery.

Important information about certain ingredients of Diclofenac APTEO MED
Diclofenac APTEO MED contains propylene glycol, which may cause skin irritation. Therefore, do not use the medicine on open wounds or large areas of injured or damaged skin (e.g. burned skin) without consulting a doctor or pharmacist.
Diclofenac APTEO MED also contains methyl parahydroxybenzoate and propyl parahydroxybenzoate. The medicine may cause allergic reactions (including delayed-type reactions).

3. How to use Diclofenac APTEO MED

This medicine should always be used exactly as described in this patient information leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Diclofenac APTEO MED should be applied topically to the skin three or four times daily, gently rubbed in. The amount of gel should be adjusted according to the size of the affected area:
2 to 4 g of Diclofenac APTEO MED (an amount corresponding to the size of a cherry up to a walnut) is sufficient to treat an area of approximately 400 cm^2 to 800 cm^2. After applying the medicine, hands should be washed unless they are the area being treated.
Do not use the medicine for longer than:

• Adults and adolescents over 14 years of age: 14 days in case of muscle and joint injuries (sprains, strains or contusions) and tendon inflammation.
• Adults (over 18 years of age): 21 days in case of pain associated with degenerative joint disease, unless otherwise advised by a doctor.

If pain and swelling do not improve within 7 days or if symptoms worsen, consult a doctor.
Use of more than the recommended dose of Diclofenac APTEO MED
Seek immediate medical advice in case of overdose or accidental ingestion of Diclofenac APTEO MED.
Missed application of Diclofenac APTEO MED
Do not apply a double dose to make up for a missed dose.

4. Possible adverse reactions

Like all medicines, Diclofenac APTEO MED can cause adverse reactions, although not everyone experiences them.
Some adverse reactions occurring rarely or very rarely may be serious.
If any of the symptoms listed below, which may indicate an allergic reaction, occur, stop using the medicine immediately and contact your doctor or go to the nearest hospital:

• Rare (occur in less than 1 to 10 out of 10,000 people using the medicine): skin rash with blisters, urticaria.
• Very rare (occur in less than 1 out of 10,000 people using the medicine): wheezing, shortness of breath, or feeling of tightness in the chest (asthma), swelling of the face, lips, tongue, or larynx.

Other adverse reactions
Other adverse reactions that may occur during treatment with Diclofenac APTEO MED are usually mild and temporary. If any of the symptoms listed below occur, inform your doctor or pharmacist as soon as possible.

• Common (occur in less than 1 to 10 out of 100 people using the medicine): skin rash, itching, redness, or burning sensation of the skin.
• Very rare (occur in less than 1 out of 10,000 people using the medicine): increased sensitivity of the skin to sunlight. Symptoms of photosensitivity include sunburn with itching, swelling, and blisters.
• Frequency not known (cannot be estimated from available data): burning sensation at the site of application, dry skin.

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 any adverse reactions occur, including any adverse reactions not listed in this leaflet, tell your doctor, pharmacist, or nurse.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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 Diclofenac APTEO MED

Keep this medicine out of sight and reach of children.
Store below 25°C. Keep in the original packaging to protect from light.
Do not store in the refrigerator or freeze.
After first opening of the immediate packaging: 6 months.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Medicines must 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. Contents of the packaging and other information

What Diclofenac APTEO MED contains
The active substance is sodium diclofenac.
One gram of gel contains 10 mg of sodium diclofenac (Diclofenacum natricum).
Other ingredients are: propylene glycol, sodium hydroxide, medium-chain triglycerides, carbomer, hydroxyethylcellulose, propyl parahydroxybenzoate (E 216), methyl parahydroxybenzoate (E 218), purified water.

What Diclofenac APTEO MED looks like and contents of the pack
A white, smooth, homogeneous gel with a slight characteristic odour, for topical application.
Aluminium tube internally coated with epoxy-phenolic varnish, fitted with a HDPE cap with puncture device (60 g and 100 g pack sizes) or a PP cap with puncture device (180 g pack size), in a cardboard box.
Pack sizes: 60 g gel, 100 g gel or 180 g gel.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Synoptis Pharma Sp. z o.o.
ul. Krakowiaków 65
02-255 Warszawa
tel. 22 321 62 40

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