Product Details

Product Information of Motusol Gel – Diclofenac 1.16% Gel

What you need to know before you use Motusol

DO NOT use Motusol: · 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), hives, runny nose, or swelling of the face or tongue after taking/using acetylsalicylic acid or another non-steroidal antiinflammatory drug (e.g. ibuprofen), · on open injuries, inflammations or infections of the skin as well as 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 Talk to your doctor or pharmacist before using Motusol. You are more likely to asthma attacks (so-called analgesic intolerance / analgesic asthma), local skin or mucous membrane swelling (so-called quincke oedema) or hives than other patients. If you suffer from asthma, hay fever, swelling of the nasal membrane (so-called nasal polyps) or chronic obstructive pulmonary disease, chronic respiratory tract infections (particularly associated with hay fever-like symptoms) or hypersensitivity to other painkillers and anti-rheumatic medicines of any kind. In these patients, Motusol may only be used under certain precautions (emergency preparedness) and REG0289391 Version 2.0 Effective Page 2 of 7 3 direct medical supervision. The same applies for patients who are also allergic to other substances e.g. with skin reactions, itching or hives. When Motusol is applied to a large area of skin and over a prolonged period, the possibility of systemic side-effects from the application of Motusol cannot be excluded. The gel should therefore be used with caution by patients with reduced kidney function, reduced heart function or reduced liver function as well as patients with active peptic ulcers in the stomach or duodenum. Apply Motusol only to intact, not diseased or injured skin. Avoid contact with eyes and mucous membranes. The gel must not be taken orally. After applying the gel on the skin you can use a permeable (non-occlusive) bandage but allow the gel to dry on the skin for a few minutes. Do not use with an airtight occlusive dressing. If the symptoms worsen or do not improve after 3 – 5 days, consult a doctor. The use of Motusol should be discontinued if you develop a skin rash. If you are exposed to direct sunlight or artificial sun there is a risk of skin reactions. You should avoid sunlight or artificial sun during treatment and for two weeks after stopping treatment. Precautions should be taken to prevent children from touching the area to which the gel is applied. Do not smoke or go near naked flames – risk of severe burns. Fabric (clothing, bedding, dressings etc) that has been in contact with this product burns more easily and is a serious fire hazard. Washing clothing and bedding may reduce product build-up but not totally remove it. Children and adolescents Do not use this medicine in children and adolescents under 14 years of age. Other medicines and Motusol Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. In intended, cutaneous use of Motusol no interactions have become known so far. Pregnancy and breast-feeding If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine. Pregnancy Do not use Motusol during the last trimester of pregnancy as it could harm your unborn child or cause problems at delivery. If you are planning a pregnancy or during the first and second trimester of pregnancy, Motusol should be used only after consultation with your doctor. Breast-feeding Motusol should only be used under medical advice during breast-feeding as diclofenac passes into breast milk in small amounts. Do not apply Motusol on the breasts if you are a nursing mother nor elsewhere on large areas of skin or for a prolonged period of time. Driving and using machines Motusol has no or negligible influence on the ability to drive or to use machines. Motusol contains Propylene glycol (E1520) This medicine contains 50 mg propylene glycol in 1 g of gel. Motusol contains fragrances REG0289391 Version 2.0 Effective Page 3 of 7 4 This medicine contains 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.