Atlimarbai

Package leaflet: Information for the patient

Atlimarbai 10 mg/g gel

diclofenac (as diethylamine salt of diclofenac)
For adults and adolescents aged 14 years and older
Please read this leaflet carefully before using this medicine because it contains important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Contact your doctor if you do not notice any improvement or if your symptoms worsen after 3–5 days.

Contents of this leaflet:

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

1. What Atlimarbai is and what it is used for

Atlimarbai contains the active substance diclofenac, which belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).
For adults
For the local symptomatic treatment of pain:

• associated with acute muscle strains, sprains or bruises following impact injuries;
• of soft tissues adjacent to the joint (e.g. bursae, tendons, tendon sheaths, ligaments, muscle insertions and joint capsules) in osteoarthritis of the knee and finger joints;
• in epicondylitis (inflammation of tendon insertions around the elbow, also known as tennis elbow or golfer’s elbow);
• in acute muscle pain, for example in the back.

For adolescents aged 14 years and older
For short-term treatment.
For the local symptomatic treatment of pain associated with acute muscle strains, sprains or bruises following impact injuries.

2. What you need to know before using Atlimarbai

Do not use Atlimarbai

• if you are allergic to diclofenac or to any of the other ingredients of this medicine (listed in section 6);
• if you have ever developed respiratory problems (asthma, bronchospasm), skin reactions (urticaria), runny nose, or swelling of the face or tongue after taking or using acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (e.g. ibuprofen);
• on open wounds, inflamed or infected skin, on eczema, or on mucous membranes;
• during the last trimester of pregnancy (see "Pregnancy");
• in children and adolescents under 14 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before using Atlimarbai.
If you suffer from asthma, hay fever, nasal mucosa swelling (so-called nasal polyps), chronic obstructive pulmonary disease, or chronic respiratory tract infections (particularly associated with hay fever-like symptoms), or if you are hypersensitive to other painkillers and rheumatism medicines of any kind, you may be more likely than other patients to experience asthma attacks (so-called analgesic intolerance/analgesic-induced asthma), local skin or mucosa swelling (so-called Quincke's edema), or urticaria.
In such patients, Atlimarbai should only be used with specific precautions (emergency preparedness) and under direct medical supervision. The same applies to patients who are allergic to other substances and who may experience, for example, skin reactions, itching, or urticaria.
When Atlimarbai is applied over a large skin area and for prolonged periods, the possibility of systemic adverse effects associated with the application of Atlimarbai cannot be ruled out. Therefore, the gel should be used with caution in patients with impaired renal function, impaired cardiac function, or impaired liver function, as well as in patients with active peptic ulcers of the stomach or duodenum.
Apply Atlimarbai only to intact, healthy, and undamaged skin. Avoid contact with eyes and mucous membranes. The gel must not be taken orally.
Atlimarbai may be used with a permeable (non-occlusive) dressing, but not with an occlusive dressing that does not allow air passage.
You should consult your doctor if the gel is used under acute conditions associated with severe redness, swelling, or overheating of the joints, prolonged joint pain, or severe back pain radiating to the legs and/or associated with neurological deficits (e.g., numbness, tingling).
If symptoms worsen or do not improve after 3–5 days, consult your doctor.
The use of Atlimarbai must be discontinued if you develop a skin rash.
If you are exposed to direct sunlight or artificial light, there is a risk of skin reactions. You must avoid direct sunlight or artificial light during treatment and for two weeks after stopping treatment.
Precautions must be taken to ensure that children do not touch the area where the gel has been applied.

Children and adolescents
This medicine must not be used in children and adolescents under 14 years of age.

Other medicines and Atlimarbai
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
To date, no interactions are known with the intended cutaneous use of diclofenac.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before using this medicine.

Pregnancy
Atlimarbai must not be used during the last trimester of pregnancy because it could harm the fetus or cause problems during childbirth. If you are planning a pregnancy or during the first and second trimesters of pregnancy, Atlimarbai may be used only after consulting your doctor.

Breastfeeding
Atlimarbai may be used during breastfeeding only on medical advice, as diclofenac passes into breast milk in small amounts. If you are breastfeeding, do not apply Atlimarbai to the breast or to large areas of skin for prolonged periods.

Driving and using machines
Atlimarbai does not affect or affects negligibly the ability to drive vehicles or use machinery.

Atlimarbai contains propylene glycol (E1520)
This medicine contains 50 mg of propylene glycol in 1 g of gel.

Atlimarbai contains fragrances
This medicine contains a fragrance with benzyl alcohol (0.15 mg/g, E1519), citral, citronellol, coumarin, eugenol, farnesol, geraniol, d-limonene, and linalool, which may cause allergic reactions.
In addition, benzyl alcohol may cause mild local irritation.

3. How to use Atlimarbai

Use this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.

Adults and adolescents aged 14 years and older
Apply Atlimarbai 3-4 times daily.
Depending on the size of the area to be treated, apply a quantity of gel ranging from the size of a cherry to a walnut, corresponding to 1-4 g of gel.
The maximum daily dose is 16 g of gel.

Elderly patients
No dose adjustment is required. If you are elderly, you should pay particular attention to possible side effects and, if necessary, consult your doctor or pharmacist.

Renal or hepatic impairment
Dose reduction is not required.

Use in children and adolescents (under 14 years of age)
Do not use this medicine in children and adolescents under 14 years of age (see section 2 “Do not use Atlimarbai”).

Before first use, open the tube as follows:

1. Unscrew the cap from the tube. To open the safety seal, twist the cap and insert it into the nozzle. Do not use scissors or other sharp objects!
2. Rotate and remove the plastic seal from the tube. Use the gel as described in this patient information leaflet. Do not use the medicine if the seal is broken.

How to apply:
Atlimarbai is for topical use only.
Apply a thin layer of gel to the affected areas of the body and gently massage into the skin.
After application, clean your hands with a paper tissue and then wash them, unless the hands are the area being treated.
If too much gel is accidentally applied, wipe off the excess gel with a paper tissue.
Dispose of the paper tissue in household waste to prevent unused medicine from entering the aquatic environment.
If a dressing is to be applied, allow the gel to dry on the skin for a few minutes before application.

Duration of treatment
The duration of use depends on the symptoms and underlying condition. Do not use Atlimarbai for more than one week without consulting your doctor.
If symptoms worsen or do not improve within 3-5 days, consult your doctor.

If you use more Atlimarbai than you should
Overdose is unlikely, as systemic absorption into the bloodstream is low when the medicine is applied to the skin. However, if the recommended dose is significantly exceeded, remove the excess gel (e.g. with a paper tissue) and wash the area thoroughly with water.
If Atlimarbai is accidentally ingested, contact your doctor immediately. The doctor will determine the necessary measures.

If you forget to use Atlimarbai
Do not apply a double dose to make up for the missed application.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some rare and very rare side effects can be serious.
If you experience any of the following signs of allergy, stop using Atlimarbai and inform your doctor or pharmacist immediately.

• Skin rash with blisters; hives (may affect up to 1 in 1,000 people).
• Wheezing, shortness of breath, or tightness in the chest (asthma) (may affect up to 1 in 10,000 people).
• Swelling of the face, lips, tongue, or throat (may affect up to 1 in 10,000 people).

Other side effects may occur:
Common side effects (may affect up to 1 in 10 people):
Skin rash, itching, redness, eczema, dermatitis (inflammation of the skin), including contact dermatitis.
Uncommon side effects (may affect up to 1 in 100 people):
Peeling, skin dehydration, swelling (oedema).
Very rare side effects (may affect up to 1 in 10,000 people):
Skin rash with pustules, gastrointestinal disorders, hypersensitivity reactions (including hives), photosensitivity with skin reactions after exposure to sunlight.
Side effects with unknown frequency (frequency cannot be estimated from the available data):
Burning sensation at the application site, dry skin.

When Atlimarbai is applied over a large skin area and for a prolonged period, the possibility of systemic side effects (e.g., renal, hepatic, or gastrointestinal side effects, systemic hypersensitivity reactions) cannot be completely ruled out. These may occur after systemic administration of medicines containing diclofenac.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Atlimarbai

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 on the tube. The expiry date refers to the last day of that month.
This medicine does not require any special storage temperature.
Store in the original tube to protect the medicine from light.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Atlimarbai contains

• The active substance is diclofenac.
• 1 g contains 11.6 mg of diclofenac diethylamine, equivalent to 10 mg of sodium diclofenac.
• The other components are carbomer, cocoile caprilocaprate, macrogol cetostearyl ether, liquid paraffin, diethylamine, isopropyl alcohol, propylene glycol (E1520), fragrance (containing citronellol, geraniol, benzyl alcohol (E1519), linalool, limonene, citral, farnesol, coumarin, eugenol), purified water.

Description of the appearance of Atlimarbai and contents of the pack
Homogeneous gel, white to almost white, packed in laminated aluminium tubes closed with a PE seal and screw caps in PP, available in the following pack sizes: 30 g, 50 g, 60 g, 100 g, 120 g and 150 g.
It is possible that not all pack sizes are marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Sigillata Limited
Inniscarra,
Main Street,
Rathcoole,
Co. Dublin D24 E029,
Ireland
Manufacturer
Merckle GmbH
Graf-Arco-Str.3,
89079 Ulm
Germany

This medicinal product is authorized in the European Economic Area countries under the following names:
DE: Atlimarbai 10 mg/g Gel
IT: Atlimarbai