Acteze 4% cutaneous spray – patient leaflet, side effects, dosage

1.WHAT ACTEZE 4% CUTANEOUS SPRAY IS AND WHAT IT IS USED FOR

Acteze 4% Cutaneous Spray contains the active substance diclofenac sodium, which belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). It is used to relieve mild or moderate pain and swelling in and around small and medium joints such as fingers and toes, wrists and ankles, knees and elbows. It is only suitable for use following injuries that don’t break the skin such as falls, blows or impacts with blunt objects.

2. WHAT YOU NEED TO KNOW BEFORE YOU USE ACTEZE 4% CUTANEOUS SPRAY

Do not use Acteze 4% Cutaneous Spray if you: - have, or have ever had, an allergy to diclofenac, other NSAIDs (e.g., aspirin or ibuprofen), peanut, soya or any of the other ingredients of this medicine (listed in section 6). Symptoms of an allergic reaction to these substances may include: asthma, blistering, redness of the skin, burning sensation, wheezing or shortness of breath; skin rash or hives; swelling of the face or tongue; a runny nose.

• are in the last 3 months of your pregnancy (see also pregnancy and breast-feeding section). If you are breast-feeding, do not apply the spray to the breast area.

This medicine is not recommended for use in children under 14 years of age.

Warnings and precautions

Talk to your doctor or pharmacist before using Acteze 4% Cutaneous Spray if:

• you have, or have ever had, bronchial asthma or allergies, as this medicine may cause tightening of the airways which makes breathing difficult
• you have, or have ever had, stomach or duodenal ulcers, liver or kidney problems, a tendency for bleeding or inflammatory bowel disease
• you are taking any other medicine containing diclofenac or painkillers known as NSAIDs, such as aspirin or ibuprofen as there may be an increased risk of side effects

Take special care with Acteze 4% Cutaneous Spray

• Do not apply the spray to cuts, open wounds, broken skin, sunburned skin, infected skin, or other areas where the skin is abnormal. Stop the treatment if a skin rash develops after applying the product.

• Avoid applying on large areas of skin and over a

  prolonged period of time, unless under medical advice.

  • Avoid sunbathing, sunlamps or excessive exposure to sunlight, as your skin may be more sensitive to light.
  • Do not use in the eyes, nose or mouth. Do not swallow Acteze 4% Cutaneous Spray. If you accidentally get some spray into your eyes, rinse thoroughly with water and tell your doctor.
  • Do not cover the treated area with occlusive (waterproof or non-breathable) bandages or plasters.
  • Do not smoke or go near naked flames - risk of severe burns. Fabric that has been in contact with this product burns more easily and is a serious fire hazard. Washing clothing and bedding may reduce product build-up, but not totally remove it.

Other medicines and Acteze 4% Cutaneous Spray Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines, including those obtained without a prescription. NSAIDs such as diclofenac can interfere with the effects of drugs that lower blood pressure, such as enalapril or ramipril and increase the risk of side effects. Consult your doctor or pharmacist if you are using blood pressure lowering medications before using Acteze 4% Cutaneous Spray.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Acteze 4% Cutaneous Spray should only be used under the advice of your doctor during the first 6 months of pregnancy. The dose should be kept as low as possible and the length of treatment for the shortest possible duration.

Acteze 4% Cutaneous Spray must not be used during the last 3 months of pregnancy, as it could harm your unborn child or cause problems at delivery.

Acteze 4% Cutaneous Spray should only be used under medical advice during breast-feeding as diclofenac sodium passes into breast milk in small amounts. If your doctor advises you to use Acteze 4% Cutaneous Spray while breast-feeding it should not be applied on the breasts nor elsewhere on large areas of skin or for a prolonged period of time.

Driving and using machines

Acteze 4% Cutaneous Spray has no influence on the ability to drive and use machines.

Important information about some of the ingredients of Acteze 4% Cutaneous Spray

Acteze 4% Cutaneous Spray contains propylene glycol, peppermint oil and soya

Acteze 4% Cutaneous Spray contains propylene glycol, which may cause mild localised skin irritation in some people. Acteze 4% Cutaneous Spray contains peppermint oil, which may cause allergic reactions.

Acteze 4% Cutaneous Spray contains soya. If you are allergic to peanut or soya, do not use this medicine.

17.08.23

145 mm

The declarations can be applied for the front and back of the leaflet. The dimension of the leaflet needs to be considered as maximum unit of measurement!

A smaller dimension of the leaflet is okay. Paper quality: 50g/m²

ACTEZE 4 · Hualan Pharmaceuticals Limited · 16/17 College Green · Dublin D02 V078 · Ireland

Product-No.

I d e nt n u m be r

Diclofenac Sodium

Patient Information Leaflet: Information for the user

3. HOW TO USE ACTEZE 4% CUTANEOUS SPRAY

Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. You should check with your doctor or pharmacist if you are not sure.

For adults and adolescents aged 14 years and over

• The usual dose is 4 to 5 pump strokes of Acteze 4% Cutaneous Spray, to be applied 3 times daily. - The number of pump strokes you use depends on the size of the affected area.
• The maximum daily dose is equivalent to 15 pump strokes. The maximum single dose should not exceed 5 pump strokes.

Acteze 4% Cutaneous Spray is for use on the skin only. Do not use on broken skin.

Follow the instructions for use carefully: - Remove the protective cap.

• Apply the 4 to 5 pump strokes, with the bottle in an upright position, onto the painful or swollen site.
• Massage the spray gently into the skin. Wash your hands afterwards unless they are the site being treated.
• Wait until the spray has dried before covering the skin with clothes or a bandage. Whilst wet it may stain your clothes. Do not use a waterproof or non-breathable bandage.
• When the pain and swelling disappear stop using the medicine.
• Use 3 times daily at regular intervals. Do not use more than 15 pump strokes a day.
• If there is no improvement in your symptoms after 3 days, talk to a doctor.
• Do not use for more than 7 days without consulting a doctor.

If you use more Acteze 4% Cutaneous Spray than you should

• If you use more of the spray than you should, wipe the excess spray off with a tissue. - If you swallow some of the spray tell your doctor immediately or go to the nearest hospital casualty department. Take the bottle and this leaflet with you.

If you forget to use Acteze 4% Cutaneous Spray

• If you miss your application of Acteze 4% Cutaenous Spray at the correct time, apply it as soon as you remember then carry on as normal. Do not apply a double quantity to make up for a forgotten application.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Acteze 4% Cutaneous Spray can cause side effects, although not everybody gets them.

If you experience any of the following signs of allergy, STOP using Acteze 4% Cutaneous Spray and tell a doctor or pharmacist immediately: Skin rash with blisters; hives (may affect between 1 and 10 in every 10,000 people).

Wheezing, shortness of breath or feeling of tightness in the chest (asthma) (may affect less than 1 in every 10,000 people).

Swelling of the face, lips, tongue or throat (may affect less than 1 in every 10,000 people). Other side effects which may occur are usually mild, passing and harmless. If you are concerned, tell a doctor or pharmacist.

Some side effects are common (may affect between 1 and 10 in every 100 people): skin rash, itching, reddening or smarting of the skin. Some side effects are very rare (may affect less than 1 in every 10,000 people): the skin may be more sensitive to the sun. Possible signs are sunburn with itching, swelling and blistering.

Some side effects have unknown frequency (frequency of occurrence in patients cannot be estimated from available data):

application site reaction, dry skin, burning sensation.

Prolonged use of topical NSAIDs applied to areas of skin of more than the equivalent of the lower arm or the size of this leaflet can cause other side effects such as stomach pain and disorders, heartburn and kidney problems may occur. If you get any side effects which worry you (even effects not listed in this leaflet), talk to your doctor or pharmacist.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

5. HOW TO STORE ACTEZE 4% CUTANEOUS SPRAY

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the carton and bottle after EXP. The expiry date refers to the last day of that month. - Store in the original package.
• Do not use Acteze 4% Cutaneous Spray after 6 months after first opening.
• Do not throw away any medicine via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Acteze 4% Cutaneous Spray contains

• The active substance is diclofenac sodium. 1 g of Acteze 4% Cutaneous Spray contains 40 mg of diclofenac sodium. Each pump stroke delivers 8 mg of diclofenac sodium.
• The other ingredients are isopropyl alcohol, soy bean lecithin, ethanol, disodium phosphate dodecahydrate, sodium dihydrogen phosphate dihydrate, disodium edetate, propylene glycol, peppermint oil (contains menthol and cineole), ascorbyl palmitate, hydrochloric acid 10% (w/w) for pH adjustment, sodium hydroxide 10% (w/w) for pH adjustment, purified water.

What Acteze 4% Cutaneous Spray looks like and contents of the pack

Acteze 4% Cutaneous Spray is a golden-yellow, clear cutaneous solution, which turns to a gel-like consistency after administration. Each bottle contains 12.5 g or 25 g cutaneous spray. Not all pack sizes may be marketed.

Marketing Authorisation Holder

HUALAN PHARMACEUTICALS LIMITED 16/17 College Green - Dublin D02 V078 Ireland

Manufacturer

Pharbil Waltrop GmbH Im Wirringen 25 45731 Waltrop Germany

This leaflet was last approved in September 2023.

PL 52104/0009

17.08.23