Diclofenac Apteo Med

Leaflet attached to the packaging: patient information

Diclofenac APTEO MED, 10 mg/g, gel

Diclofenacum natricum

You should carefully read the contents of the 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 directed by your doctor or pharmacist.

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, you should ask your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.
• If after 7 days there is no improvement or you feel worse, you should contact your doctor.

Table of 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 packaging 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 of the medicine – diclofenac sodium – belongs to a group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs). Due to the water-alcohol base of Diclofenac APTEO MED, it also has a soothing and cooling effect.

The medicine acts as a pain reliever, anti-inflammatory, and anti-swelling agent.

It is used for local treatment of:

Adults and adolescents over 14 years of age:

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

Adults (over 18 years of age):

• limited and mild forms of degenerative joint disease.

2. Important information before using Diclofenac APTEO MED

When not to use Diclofenac APTEO MED:

• during the last three months of pregnancy,
• in children under 14 years of age.

Warnings and precautions

Before starting to use Diclofenac APTEO MED, you should discuss it with your doctor or pharmacist.

• You should not apply it to damaged skin, open wounds, or skin eruptions. You should stop using the medicine if a skin rash appears after its use.
• You should avoid using the medicine on large areas of skin or for a longer period than the approved duration of use, unless advised by your doctor.
• The medicine is intended for external use only. You should not use it in the mouth. After use, you should wash your hands, unless they are the area being treated.
• You should avoid contact between the gel and your eyes. If the medicine gets into your eyes, you should rinse them with clean water and contact your doctor or pharmacist.
• In case of sprains, you can use simultaneous bandaging, but not with airtight bandages.
• You should not expose the areas where the medicinal product Diclofenac APTEO MED is applied to sunlight.

Children and adolescents

Since the data on the efficacy and safety of using Diclofenac APTEO MED in children and adolescents under 14 years of age are insufficient, you should not use the medicine in this age group.

In adolescents over 14 years of age, if it is necessary to use the medicine for more than 7 days to treat pain or if the symptoms worsen, the patient should contact their doctor.

Diclofenac APTEO MED and other medicines

You should tell your doctor or pharmacist about all the medicines you are currently taking, as well as any medicines you plan to take.

Pregnancy, breastfeeding, and fertility

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

You should not use Diclofenac APTEO MED during the last three months of pregnancy. During the first six months of pregnancy, you should not use Diclofenac APTEO MED unless it is necessary and advised by your doctor. If use is necessary, you should use the smallest dose for the shortest possible time.

After oral administration of diclofenac (e.g., tablets), side effects may occur in the unborn child. It is not known if the same risk applies to Diclofenac APTEO MED when used on the skin.

During breastfeeding, Diclofenac APTEO MED may be used only on the advice of a doctor, as diclofenac passes into breast milk in small amounts. You should not apply the medicine to the breasts of nursing women or to large areas of skin or for extended periods.

In case of any further doubts about using Diclofenac APTEO MED in pregnant or breastfeeding women, you should consult your doctor or pharmacist.

Driving and using machines

Using the medicine does not affect the ability to drive or operate machines.

Important information about some ingredients of Diclofenac APTEO MED

Diclofenac APTEO MED contains propylene glycol, which may cause skin irritation. For this reason, you should not use the medicine on open wounds or large areas of damaged or injured skin (e.g., burned skin) without consulting your doctor or pharmacist.

Diclofenac APTEO MED also contains methyl parahydroxybenzoate and propyl parahydroxybenzoate. The medicine may cause allergic reactions (possible late-type reactions).

3. How to use Diclofenac APTEO MED

This medicine should always be used exactly as described in this patient leaflet or as directed by your doctor or pharmacist. If you have any doubts, you should ask your doctor or pharmacist.

Diclofenac APTEO MED should be used locally on the skin, three or four times a day, gently rubbing it in. The amount of gel should be adjusted to the size of the affected area:

from 2 to 4 g of Diclofenac APTEO MED (an amount corresponding to the size of a cherry to a walnut) is sufficient to treat an area of about 400 to 800 cm². After applying the medicine, you should wash your hands, unless they are the area being treated.

You should 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 bruises) and tendonitis.
• Adults (over 18 years of age): 21 days in case of pain associated with degenerative joint disease, unless otherwise advised by your doctor.

If the pain and swelling do not subside within 7 days or worsen, you should contact your doctor.

Using a higher dose of Diclofenac APTEO MED than recommended

You should immediately contact your doctor if you use more Diclofenac APTEO MED than recommended or accidentally swallow it.

Missing a dose of Diclofenac APTEO MED

You should not use a double dose to make up for a missed dose.

4. Possible side effects

Like all medicines, Diclofenac APTEO MED can cause side effects, although not everybody gets them.

Some side effects that occur rarely or very rarely can be serious.

If you experience any of the following symptoms, which may be symptoms of an allergic reaction, you should stop using the medicine immediately, contact your doctor, or go to the nearest hospital:

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

Other side effects

Other side effects that may occur when using Diclofenac APTEO MED are usually mild and temporary. If you experience any of the following symptoms, you should inform your doctor or pharmacist as soon as possible.

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

If any of the side effects get worse or you notice any side effects not listed in this leaflet, you should tell your doctor or pharmacist.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should 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 the medicine.

5. How to store Diclofenac APTEO MED

The medicine should be stored out of sight and reach of children.

Store in a temperature below 25°C. Store in the original packaging to protect from light.

Do not store in the refrigerator or freeze.

After first opening 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 month stated.

Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Diclofenac APTEO MED contains

The active substance of the medicine is diclofenac sodium.

One gram of the medicine contains 10 mg of diclofenac sodium (Diclofenacum natricum).

The other ingredients of the medicine are: propylene glycol, sodium hydroxide, triglycerides of medium-chain fatty acids, carbomer, hydroxyethylcellulose, propyl parahydroxybenzoate (E 216), methyl parahydroxybenzoate (E 218), purified water.

What Diclofenac APTEO MED looks like and contents of the packaging

White, smooth, homogeneous gel, with a mild characteristic odor, for application to the skin.

Aluminum tube with a membrane, internally coated with epoxy-phenolic lacquer, with an HDPE cap and a piercer, in a cardboard box.

Packaging size: 60 g of gel or 100 g of gel.

Marketing authorization holder

Synoptis Pharma Sp. z o.o.

ul. Krakowiaków 65

02-255 Warsaw

tel. 607 696 231

e-mail: [email protected]

Manufacturer

Laboratórios Basi – Indústria Farmacêutica, S.A.

Parque Industrial Manuel Lourenço Ferreira, Lotes 8, 15 e 16

3450-232 Mortágua

Portugal

Date of last revision of the leaflet: