ATLIMARBAI 10 mg /G Gel

Зміст інструкції

1. Atlimarbai 10 mg/g gel
   1. What is Atlimarbai and what is it 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

Atlimarbai 10 mg/g gel

diclofenac (as diclofenac diethylamine)
For adults and adolescents aged 14 years and over

Read this leaflet carefully before using this medicine as it contains important
information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or
pharmacist has told you.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better 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 is Atlimarbai and what is it used for

Atlimarbai contains the active ingredient diclofenac, which belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).

For adults
For the symptomatic treatment of local pain:

• associated with acute muscle strains, sprains or bruises resulting from impact trauma;
• 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 in the elbow area, also known as tennis elbow or golfer's elbow);
• in acute muscle pain, for example in the back.

For adolescents aged 14 years and over
For short-term treatment.
For the symptomatic treatment of local pain associated with acute muscle strains, sprains or bruises resulting from impact trauma.

2. What you need to know before using Atlimarbai

Do not use Atlimarbai

• if you are allergic to diclofenac or any of the other ingredients of this medicine (listed in section 6).
• if you have ever developed breathing 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 (NSAIDs) (for example ibuprofen);
• on open wounds, inflammation or skin infections, on eczema or mucous membranes;
• in the last trimester of pregnancy (see “Pregnancy”);
• in children and adolescents under 14 years of age.

Warnings and precautions
Consult your doctor or pharmacist before using Atlimarbai.
If you suffer from asthma, hay fever, swelling of the nasal mucosa (so-called nasal polyps) or chronic obstructive pulmonary disease, chronic respiratory infections (particularly associated with symptoms similar to hay fever) or hypersensitivity to other painkillers and rheumatic medicines of any type, you are more likely than other patients to experience asthma attacks (so-called analgesic/asthma intolerance), local skin or mucous membrane swelling (so-called angioedema) or urticaria.
In these patients, Atlimarbai can only be used with certain precautions (preparation for emergencies) and under direct medical supervision. The same applies to patients who are also allergic to other substances and experience, for example, skin reactions, itching or urticaria.
When Atlimarbai is applied to a large area of skin and for a prolonged period, the possibility of systemic adverse effects associated with the application of Atlimarbai cannot be excluded. Therefore, the gel should be used with caution in patients with reduced kidney function, reduced heart function or reduced liver function as well as in patients with active peptic ulcers in the stomach or duodenum.
Apply Atlimarbai only to intact, healthy skin without wounds. Avoid contact with eyes and mucous membranes. The gel must not be taken orally.
Atlimarbai can be used with a permeable (non-occlusive) bandage, but not with an occlusive bandage that does not allow air to pass through.
Consult your doctor if the gel is used in acute conditions associated with severe redness, swelling or overheating of the joints, prolonged joint pain or severe back pain that radiates to the legs and/or is 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 should be discontinued if you develop a skin rash.
If you are exposed to direct or artificial sunlight, there is a risk of skin reactions. You should avoid direct or artificial sunlight during treatment and for two weeks after stopping treatment.
Precautions must be taken to prevent children from touching the area to which the gel has been applied.

Children and adolescents
This medicine should 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 to be associated with the intended cutaneous use of diclofenac.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before using this medicine.
Pregnancy
Atlimarbai must not be usedduring the last trimester of pregnancy because it could harm the fetus or cause problems at the time of delivery. If you are planning a pregnancy or during the first and second trimester of pregnancy, Atlimarbai can only be used after consulting your doctor.
Breastfeeding
Atlimarbai during breastfeeding can only be used after medical advice, as diclofenac passes into breast milk in small amounts. If you are breastfeeding, do not apply Atlimarbai to the breast or elsewhere on large areas of skin and for a prolonged period of time.

Driving and operating machinery
Atlimarbai does not impair or impairs negligibly the ability to drive vehicles or operate 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 following exactly as described in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.

Adults and adolescents aged 14 years and over
Apply Atlimarbai 3-4 times a day.
Depending on the size of the area to be treated, an amount of gel varying in size between a cherry and a walnut, corresponding to 1-4 g of gel, is required.
The maximum daily dose is 16 g of gel.

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

Impairment of renal or hepatic function
No dose reductions are necessary.

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

Before using the medicine for the first time, open it as follows:

• 1. Unscrew the cap from the tube. To open the safety seal of the tube, turn 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 leaflet. Do not use the medicine if the seal is broken.

How to apply:
Atlimarbai is for external use.
Apply a thin layer of gel to the affected parts of the body and massage gently into the skin.
Afterwards, the hands must be cleaned with a tissue and then washed unless they are the area to be treated.
If too much gel is applied accidentally, the excess gel must be cleaned with a tissue.
The tissue should be disposed of in household waste to prevent unused medicine from reaching the aquatic environment.
Before applying a bandage, the gel should be allowed to dry on the skin for a few minutes.

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

If you use more Atlimarbai than you should
An overdose is unlikely if you use more Atlimarbai than you should, as absorption into the bloodstream is low when the medicine is used on the skin. If the recommended dose is significantly exceeded when applied to the skin, the gel should be removed (e.g. with a tissue) and washed away with water.
If you accidentally ingest Atlimarbai, contact your doctor. They will decide what measures to take.

If you forget to use Atlimarbai
Do not use a double dose to make up for a missed application.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Some side effects are rare and very rare and can be serious.
If you experience any of the following signs of allergy, stop using Atlimarbai and tell your
doctor or pharmacist immediately.

• Blistering skin rash; hives (may affect up to 1 in 1,000 people).
• Wheezing, shortness of breath or a feeling of 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 are possible:

Common side effects(may affect up to 1 in 10 people):
Skin rash, itching, redness, eczema, dermatitis (skin inflammation), including
contact dermatitis.

Uncommon side effects(may affect up to 1 in 100 people):
Scaling, skin dehydration, swelling (edema).

Very rare side effects(may affect up to 1 in 10,000 people):
Skin rash with pustules, gastrointestinal disorders, hypersensitivity reactions (including hives),
light sensitivity with the appearance of skin reactions following exposure to sunlight.

Side effects with unknown frequency(frequency cannot be estimated based on available data)
Burning sensation at the application site, dry skin.
When Atlimarbai is applied to a large area of skin and for a prolonged period, the possibility of
systemic side effects (e.g., renal, hepatic or gastrointestinal side effects, systemic hypersensitivity
reactions) that can occur after systemic administration of medicines containing diclofenac cannot be
completely excluded.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please tell your
doctor or pharmacist. You can also report side effects directly through the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects you 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 which is stated on the pack and the tube. The expiry date refers to the last day of that month.
This medicine does not require any particular storage temperature.
Store in the original tube to protect the medicine from light.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Atlimarbai contains

• The active substance is diclofenac.
• 1 g contains 11.6 mg of diclofenac diethylamine corresponding to 10 mg of diclofenac sodium.
• The other components are carbomer, caprylic/capric triglyceride, 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, from white to almost white, packaged in laminated aluminum tubes, sealed with a PE seal
and PP screw caps, available in the following pack sizes: 30 g, 50 g, 60 g, 100 g, 120 g and
150 g tube
Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer
Marketing authorisation 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 authorised in the Member States of the European Economic Area under the
following designations:
DE: Atlimarbai 10 mg/g Gel
IT: Atlimarbai