DOLOMAX 40 MG/ML CUTANEOUS SPRAY SOLUTION

2. What you need to know before starting to use Dolomax

Do not use Dolomax

• If you are allergic to diclofenac sodium, 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 any other NSAID, such as ibuprofen, associated with difficulty breathing, skin rash, and runny nose.
• • 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 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 stomach ulcers, liver or kidney problems, bleeding tendency, or inflammatory bowel disease.
• If you have had bronchial asthma or allergies.
• Do not apply this medication to the eyes, nose, or mouth, or to open wounds or infected skin areas. In case of accidental application to the eyes, rinse with clean water and inform your doctor.
• Do not ingest Dolomax.
• Do not take sun or use UV lamps during treatment with this medication.
• If you experience skin rashes, discontinue treatment with Dolomax.
• Do not cover the treated area with occlusive dressings (waterproof or non-breathable) or band-aids.

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

The possible appearance of systemic side effects related to the use of Dolomax cannot be excluded if this medication is used on extensive skin areas for a long period.

Side effects can be reduced by using the minimum effective dose for the shortest possible time.

Using Dolomax with Other Medications

Tell your doctor or pharmacist if you are taking, have recently taken, or may take other medications.

Tell your doctor before using this medication:

• If you are taking tablets, capsules, or using suppositories for pain, including any medication that contains diclofenac sodium, acetylsalicylic acid (aspirin), or any other anti-inflammatory medication, such as ibuprofen.

Using another NSAID (e.g., acetylsalicylic acid or ibuprofen) with Dolomax may increase the risk of side effects.

Pregnancy and Breastfeeding

Consult your doctor or pharmacist before taking any medication.

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

Do not use Dolomax if you are in the last three months of pregnancy. You should not use Dolomax during the first six months of pregnancy unless clearly necessary and advised by your doctor. If you need treatment during this period, use the lowest dose for the shortest possible time.

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

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

Driving and Using Machines

Topical application of Dolomax does not affect the ability to drive vehicles or use machinery.

Dolomax Contains

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

3. How to Use Dolomax

Use this medication strictly following the doctor's or pharmacist's instructions. In case of doubts, consult your doctor or pharmacist.

• Remove the protective cap.
• Hold the container in a vertical position with the dispenser directed towards the painful or inflamed area.
• Apply the recommended amount of product.

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

• To promote the 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 careful, as the spray may stain clothing.
• Discontinue treatment when symptoms (pain and inflammation) have improved.

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

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

If You Use More Dolomax Than You Should

• If you apply more medication than indicated, remove the excess Dolomax with a cloth.
• In case of overdose or accidental ingestion, immediately go to a medical center or call the Toxicology Information Service (91 562 04 20), indicating the medication 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 forgotten dose.

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

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

• Discontinue treatment with this medication if any skin rash appears. After topical application (skin application) of preparations containing diclofenac, the frequent appearance of reactions at the application site has been reported, such as rash, itching, redness, burning sensation, or skin peeling.
• If you experience one of these signs of allergy, DISCONTINUEtreatment with this medication and inform your doctor or pharmacist immediately:
• 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 chest tightness (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 side effects are common(may affect up to 1 in 10 people):
• Skin rash, eczema, skin redness, dermatitis (including contact dermatitis), itching *.

• Some side effects are very rare(may affect up to 1 in 10,000 people):
• The skin may be more sensitive to the sun. Some signs are sunburn associated with itching, inflammation, and blisters.
• Pustular rash.

• Some side effects have an unknown frequency(cannot be defined with the available data):
• Reaction at the application site, dry skin, burning sensation.

*Itching has been 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 a day (120 people) or with placebo (116 people) for 14 days.

If this medication is used for a prolonged period and/or if it is applied to large skin areas, systemic side effects may occur, such as stomach pain and gastrointestinal disorders, stomach acid, liver or kidney problems, and hypersensitivity reactions.

Reporting Side Effects

If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this package leaflet. You can also report them directly through the Spanish Medication Pharmacovigilance System for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Dolomax

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date stated on the label, carton, or container after "EXP". The expiration date is the last day of the month indicated.

Store the medication in its original container.

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

Medications should not be disposed of through wastewater or household waste. Place the containers and medications you no longer need in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Dolomax

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

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

Appearance of the Product and Package Contents

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

Only some package sizes may be marketed.

Marketing Authorization Holder

Apotheke Laboratorios S.L.

Paseo de la Castellana nº40, 8ª planta

28046 Madrid

Spain

Manufacturer

Pharbil Waltrop GmbH,

Im Wirrigen 25

45731 Waltrop

Germany

This Medication is Authorized inthe Member States of the European Economic Area under the Following Names:

Date of the Last Revision of this Package Leaflet: October 2024

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/