Dolomax 40 mg/ml cutaneous spray solution

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Dolomax 40 mg/ml cutaneous spray solution

sodium diclofenac

Read the entire leaflet carefully before you start using this medicine because it contains important information for you.

Follow exactly the instructions for use provided in this leaflet or those given by your doctor, pharmacist, or nurse.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
• You should consult a doctor if your condition worsens or if you do not improve after 7 days.

Contents of the leaflet

1. What Dolomax is and what it is used for
2. What you need to know before using Dolomax
3. How to use Dolomax
4. Possible adverse effects
5. How to store Dolomax
6. Contents of the pack and other information

1. What Dolomax is and what it is used for

Spraymik contains the active substance sodium diclofenac, which belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). Spraymik is indicated for the local symptomatic relief of mild to moderate pain and inflammation following acute injury of small and medium joints and surrounding structures.

2. What you need to know before using Dolomax

Do not use Dolomax

• If you are allergic to sodium diclofenac, peanuts, soy, or any of the other components of Dolomax (listed in section 6).
• If you have had an allergic reaction to aspirin (acetylsalicylic acid) or to any other NSAID, for example ibuprofen, associated with difficulty breathing, skin rash, or rhinorrhea (nasal discharge).
  • If you are in the last three months of pregnancy – see the section on pregnancy and breastfeeding.
  • On open wounds, inflamed or infected skin, as well as on atopic dermatitis or mucous membranes.
  • If the patient is a child or adolescent under 14 years of age.

Warnings and precautions

Consult your doctor or pharmacist before using Dolomax:

• If you have or have had gastric ulcers, liver or kidney problems, a tendency to bleeding, or any inflammatory bowel disease.
• If you have suffered from bronchial asthma or allergies.
• Do not apply this medicine to the eyes, nose, or mouth, or on open wounds or infected skin areas. In case of accidental contact with the eyes, rinse thoroughly with clean water and inform your doctor.
• Do not ingest Dolomax.
• Avoid sun exposure or UV lamps during treatment with this medicine.
• If you develop skin rashes, stop treatment with Dolomax.
• Do not cover the treated area with occlusive dressings (waterproof or non-breathable) or adhesive plasters.

Do not use near an open flame, a lit cigarette, or certain devices (e.g., hair dryers).

The possibility of systemic adverse effects related to the use of Dolomax cannot be ruled out if this medicine is used on extensive skin areas over a prolonged period.

Adverse effects can be minimized by using the lowest effective dose for the shortest possible duration.

Use of Dolomax with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Inform your doctor before using this medicine:

• If you are taking tablets, capsules, or using suppositories for pain, including any medicine containing sodium diclofenac, acetylsalicylic acid (aspirin), or any other anti-inflammatory medicine, for example ibuprofen.

The use of another NSAID (e.g., acetylsalicylic acid or ibuprofen) together with Dolomax may increase the risk of adverse effects.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before taking any medicine.

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Do not use Dolomax during the last three months of pregnancy. Do not use Dolomax during the first six months of pregnancy unless clearly necessary and advised by your doctor. If treatment is needed during this period, the lowest dose for the shortest possible time should be used.

Oral forms (e.g., tablets) of Dolomax may cause adverse effects on the fetus. It is unknown whether the same risk applies to Dolomax when used on the skin.

Dolomax should only be used during breastfeeding on medical advice, as sodium diclofenac passes into breast milk in small amounts. Dolomax should not be applied to the breasts of nursing mothers or to other extensive skin areas or for prolonged periods.

Driving and using machines

Topical application of Dolomax does not impair the ability to drive or operate machinery.

Dolomax contains

• propylene glycol (E1520), which may cause mild local skin irritation in some individuals;
• peppermint essence, which may cause allergic reactions;
• soy; if you are allergic to peanuts or soy, do not use this medicine.
• 33.3 mg of alcohol (ethanol) per gram, equivalent to (3.3% w/w). May cause a burning sensation on damaged skin.

3. How to use Dolomax

Use this medicine exactly as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

• Remove the protective cap.
• Hold the container in an upright position with the dispenser directed toward the painful or inflamed area.
• Apply the recommended amount of product.

Adults and adolescents over 14 years of age: the recommended dose is 4–5 sprays of Dolomax applied 3 times daily at regular intervals. The number of sprays depends on the size of the area to be treated. The maximum number of sprays is 15 per day. The maximum single dose should not exceed 5 sprays.

• To promote absorption of Dolomax, gently massage the skin. Wash your hands after application, unless they are the area being treated.
• Wait for Dolomax to be absorbed before covering the area with clothing or bandages. Be aware that the spray may stain fabrics.
• Discontinue treatment once symptoms (pain and inflammation) have improved.

Do not use this medicine for more than 7 days without consulting your doctor.

• If no improvement is seen after 3 days of use, or if symptoms worsen, consult your doctor.

If you use more Dolomax than you should

• If you apply more than the recommended amount, wipe off the excess Dolomax with a cloth.
• In case of overdose or accidental ingestion, go immediately to a medical center or call the Toxicology Information Service (91 562 04 20), indicating the medicine and the amount ingested.

If you forget to use Dolomax

• Use the spray as soon as you remember, but do not apply more than the recommended amount at one time. Then continue treatment as before.
• Do not use a double dose to make up for a missed dose.

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

• Discontinue treatment with this medicine if a skin rash occurs. Reactions at the site of application, such as rash, itching, redness, burning sensation, or skin peeling, have been frequently reported after topical application (application to the skin) of preparations containing diclofenac.

• If you experience any of the following signs of allergy, STOP TREATMENT WITH THIS MEDICINE AND IMMEDIATELY CONTACT YOUR DOCTOR OR PHARMACIST:

• Skin rash associated with blister formation (rare: may affect up to 1 in 1,000 people); hypersensitivity (including urticaria) (very rare: may affect up to 1 in 10,000 people).

• Wheezing, difficulty breathing, or tightness in the chest (asthma) (very rare: may affect up to 1 in 10,000 people).

• Swelling of the face, lips, tongue, or throat (very rare: may affect up to 1 in 10,000 people).

• Some adverse effects are common (may affect up to 1 in 10 people):

• Skin rash, eczema, redness of the skin, dermatitis (including contact dermatitis), pruritus*.

• Some adverse effects are very rare (may affect up to 1 in 10,000 people):

• Skin may become more sensitive to sunlight. Signs may include sunburn accompanied by itching, inflammation, and blisters.

• Pustular rash.

• Some adverse effects have unknown frequency (cannot be estimated from the available data):

• Reaction at the application site, dry skin, burning sensation.

*Pruritus was reported with a frequency of 0.9% in a clinical study in which 236 patients with ankle sprains were treated with 4–5 sprays of Spraymik three times daily (120 patients) or with placebo (116 patients) for 14 days.

If this medicine is used for a prolonged period and/or applied over large areas of skin, systemic side effects may occur, such as stomach pain and gastrointestinal disturbances, heartburn, liver or kidney problems, and hypersensitivity reactions.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Dolomax

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the label, carton, or container, following “EXP”. The expiry date refers to the last day of the month indicated.

Store the medicine in its original packaging.

Do not use Spraymik after 6 months from the first opening.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Dolomax

The active substance is sodium diclofenac. Each gram of spray solution contains 40 mg of sodium diclofenac.

The other components are: isopropyl alcohol, soybean lecithin, ethyl alcohol, disodium phosphate dodecahydrate, sodium dihydrogen phosphate dihydrate, edetate disodium, propylene glycol (E1520), peppermint flavor, ascorbyl palmitate, hydrochloric acid 10% (w/w) or sodium hydroxide 10% (w/w) (to adjust pH), and purified water.

Appearance of the product and contents of the container

Dolomax is a clear, golden-yellow solution that becomes gel-like after application. Each container holds 10 ml, 15 ml, or 30 ml of cutaneous spray solution.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Apotheke Laboratorios S.L.

Paseo de la Castellana No. 40, 8th floor

28046 Madrid

Spain

Manufacturer

Pharbil Waltrop GmbH

Im Wirrigen 25

45731 Waltrop

Germany

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of the most recent review of this leaflet: October 2024

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/