Dolomax 40 mg/ml solucion para pulverizacion cutanea
Introduction
Prospect: information for the user
Dolomax 40 mg/ml skin spray solution
diclofenaco sódico
Read this prospect carefully before starting to use this medicine because it contains important information for you.
Follow exactly the administration instructions of the medicine contained in this prospect or those indicated by your doctor, pharmacist or nurse.
- Keep this prospect, as you may need to read it again.
- If you need advice or more information, consult your pharmacist.
- If you experience adverse effects, consult your doctor or pharmacist even if they are not listed in this prospect. See section 4.
- You should consult a doctor if it worsens or does not improve after 7 days.
1.What is Dolomax and for what it is used
2.What you need to know before starting to use Dolomax
3.How to use Dolomax
4.Possible adverse effects
5.Storage of Dolomax
6. Contents of the package and additional information
1. What is Dolomax and what is it used for
Spraymik contains the active ingredient diclofenac sodium, 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 after an acute contusion of small and medium-sized joints and surrounding structures.
2. What you need to know before starting to 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, for example ibuprofen, associated with difficulty breathing, skin rash, and rhinorrhea (nasal secretion).
- If you are in the last three months of pregnancy – see the section on pregnancy and breastfeeding.
- In 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 old.
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 any 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 bandages.
Do not use near an open flame, lit cigarette, or some devices (for example, hair dryers).
The possible occurrence of systemic adverse effects related to the use of Dolomax cannot be ruled out if this medication is used on extensive skin areas for a long period of time.
Adverse effects can be reduced by using the minimum effective dose for the shortest possible time.
Use of Dolomax with other medications
Inform your doctor or pharmacist if you are taking, have taken recently, or may take other medications.
Inform 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 NSAID, for example ibuprofen.
The use of another NSAID (for example 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 medication.
If you are pregnant or breastfeeding, think you may be pregnant, or intend 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. Dolomax should not be used 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 should be used for the shortest possible time.
Oral forms (for example tablets) of Dolomax may cause adverse effects in the fetus. The same risk may not apply to Dolomax when used on the skin.
Dolomax should only be used under medical advice during breastfeeding, as diclofenac sodium passes in small amounts into breast milk. Dolomax should not be applied to the breasts of breastfeeding mothers or to other extensive skin areas or for a prolonged period.
Driving and operating machinery
The topical application of Dolomax does not affect the ability to drive vehicles or operate machinery.
Dolomax contains
- propylene glycol (E1520), which in some people may cause mild local skin irritation;
- 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, equivalent to (3.3% p/p). It may cause a burning sensation on damaged skin
3. How to use Dolomax
Use this medication strictly following the instructions of your doctor or pharmacist. In case of doubts, consult your doctor or pharmacist.
- Remove the protective cap.
- Keep 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 amount 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 to be treated.
- Wait for Dolomax to be absorbed before covering the area with clothing or bandages. Be careful as the aerosol 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 improvements are 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, go immediately to a medical center or call the Toxicological Information Service (91 562 04 20), indicating the medication and the amount ingested.
If you forgot to use Dolomax
- Use the aerosol 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 compensate for a missed dose.
If you have any doubts about the use of this medication, consult your doctor or pharmacist.
4. Possible Adverse Effects
Like all medicines, this medicine may cause side effects, although not everyone will experience them.
- Stop treatment with this medicine if a skin rash appears. After topical application (skin application) of preparations containing diclofenac, skin reactions at the application site have been frequently reported, such as rash, itching, redness, burning sensation, or skin peeling.
- If you experience one of these allergy signs,STOPthe treatment with this medicine and immediately inform your doctor or pharmacist:
- Skin rash associated with blister formation (very 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), pruritus*.
- 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 pruritus, inflammation, and blisters.
- Acne-like rash.
- Some side effects have unknown frequency(cannot be defined with available data):
- Reaction at the application site, skin dryness, 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 a day (120 patients) or with placebo (116 patients) for 14 days.
If this medicine is used for a prolonged period and/or applied to large areas of the skin, systemic side effects may occur, such as stomach pain and gastrointestinal disorders, heartburn, liver or kidney problems, and hypersensitivity reactions.
Reporting of side effects
If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.
5. Dolomax Conservation
Keep this medication out of the sight and reach of children.
Do not use this medication after the expiration date that appears on the label, in the box or packaging after “CAD”. The expiration date is the last day of the month indicated.
Conserve the medication in its original packaging.
Do not use Spraymik after 6 months from the first opening.
Medications should not be thrown down the drains or in the trash. Dispose of the containers and medications you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.
6. Contents of the packaging and additional information
Composition of Dolomax
The active ingredient is diclofenac sodium. Each gram of the solution for pulverization contains 40 mg of diclofenac sodium.
The other components are: isopropyl alcohol, soy lecithin, ethyl alcohol, dodecahydrate disodium phosphate, dihydrate sodium phosphate, disodium edetate, propylene glycol (E1520), peppermint essence, ascorbyl palmitate, 10% (p/p) hydrochloric acid or 10% (p/p) sodium hydroxide (for pH adjustment) and purified water.
Appearance of the product and contents of the package
Dolomax is a transparent, yellow-gold solution that becomes gelatinous after application. Each package contains 10 ml, 15 ml, and 30 ml of cutaneous spray solution.
Only some package sizes may be commercially available.
Marketing Authorization Holder
Apotheke Laboratorios S.L.
Paseo de la Castellana nº40, 8th floor
28046 Madrid
Spain
Responsible for manufacturing
Pharbil Waltrop GmbH,
Im Wirrigen 25
45731 Waltrop
Germany
This medicine is authorized inthe member states of the European Economic Area with the following names:
United Kingdom | Diclofenac Sodium Spray Gel 4% cutaneous spray, solution |
Northern Ireland | Difene 4% Spray Gel |
Germany | DicloSpray 40 mg/g Spray for application on the skin, solution |
Estonia | DicloFlex, 40mg/g, cutaneous spray, solution |
Italy | Fastuadvance 4%, Cutaneous spray solution |
Latvia | DicloFlex 4% for external use dermal spray, solution |
Hungary | Doloflex 4% external use oldatos spray |
Slovenia | DicloFlex 40 mg/g dermal spray, solution |
Spain | Dolomax 40 mg/ml cutaneous spray solution |
Last review date of this prospectus: October 2024
Detailed and updated information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/
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