MOBILAT

MOBILAT Intens Muscle and Joint Ointment 3% Cream

Important notes (mandatory information)

Mobilat Intense Muscle and Joint Ointment 3% Cream. Active ingredient: Flufenamic acid. Areas of application: for the supportive symptomatic treatment of pain in inflammatory soft tissue rheumatic diseases such as tendonitis and tenosynovitis.

For risks and side effects, read the package leaflet and consult your doctor or pharmacist!


PACKAGE LEAFLET: INFORMATION FOR THE USER

Mobilat Intense Muscle and Joint Ointment 3% Cream
Active ingredient: Flufenamic acid

Read the entire package leaflet carefully before you start using this medicine, as it contains important information. Always use this medicine exactly as described in this package leaflet or exactly as directed by your doctor or pharmacist.

• Keep the package leaflet. You may need to read it again later.
• Ask your pharmacist if you need more information or advice.
• If you experience any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. See section 4.
• If you do not feel better or if you feel worse after 3 days, contact your doctor.

What this package leaflet contains

1. WHAT IS MOBILAT INTENSE AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE USING MOBILAT INTENSE?
3. HOW TO USE MOBILAT INTENSE?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE MOBILAT INTENSE?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS MOBILAT INTENSE AND WHAT IS IT USED FOR?

Mobilat Intense is an antirheumatic that has anti-inflammatory and pain-relieving effects when applied externally. Mobilat Intense is used for the supportive symptomatic treatment of pain in inflammatory soft tissue rheumatic diseases such as tendonitis and tenosynovitis. If symptoms worsen or persist unabated for more than three days, a doctor should be consulted.

2. WHAT SHOULD YOU CONSIDER BEFORE USING MOBILAT INTENSE?

Mobilat Intense must not be used:

• if you are allergic to flufenamic acid, rosemary oil or any of the other ingredients of this medicine listed in section 6 or if you react to other pain and rheumatism medicines (non-steroidal anti-inflammatory drugs), such as acetylsalicylic acid (e.g. aspirin) with asthma attacks, skin reactions or allergic rhinitis.
• if you are hypersensitive to the preservative sorbic acid.
• on open injuries, inflammations or infections of the skin as well as on eczema, on mucous membranes or on the eyes.
• if you are pregnant.
• if you are breastfeeding.

Since there is no sufficient experience to date, Mobilat Intense must not be used in children and adolescents under 18 years of age.

Warnings and precautions

Please talk to your doctor or pharmacist before using Mobilat Intense, especially:

• Patients who suffer from asthma, hay fever, swelling of the nasal mucosa (so-called nasal polyps) or chronic obstructive airway diseases or chronic respiratory infections (especially coupled with hay fever-like symptoms), and patients with hypersensitivity to pain and rheumatism medicines of all kinds have an increased risk of asthma attacks (so-called analgesic intolerance/analgesic asthma), local skin and mucous membrane swelling (so-called Quincke's edema) or hives (urticaria) than other patients when using Mobilat Intense. In these patients, Mobilat Intense may only be used under certain precautions and direct medical supervision. The same applies to patients who are also hypersensitive (allergic) to other substances, e.g. with skin reactions, itching or hives.
• if you suffer from a congenital disorder of porphyrin metabolism (e.g. acute intermittent porphyria).

Please make sure that children do not come into contact with the skin areas rubbed with the medicine with their hands.

Use of Mobilat Intense together with other medicines

Tell your doctor or pharmacist if you are using, have recently used or intend to use any other medicines. Interactions between Mobilat Intense and other medicines are not known.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you suspect you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine. There is insufficient data on the use of Mobilat Intense in pregnant women. You must not use Mobilat Intense if you are pregnant. Flufenamic acid is excreted in small amounts in breast milk. You must not use Mobilat Intense if you are breastfeeding. If your treating doctor considers the use of Mobilat Intense to be absolutely necessary, you must stop breastfeeding.

Driving and using machines

No special precautions or measures are required when Mobilat Intense is used once or for a short period of time.

Mobilat Intense contains sorbic acid

Sorbic acid can cause local skin irritation (e.g. contact dermatitis).

3. HOW TO USE MOBILAT INTENSE?

Always use this medicine exactly as described in this package leaflet or exactly as agreed with your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure.

The recommended dose is

Apply a strand of approx. 10 cm of cream (corresponding to approx. 3 g of cream) to the affected area 3 times a day. The treated area should not be larger than approx. 30 x 30 cm. The maximum total daily dose is 9 g of cream, corresponding to 270 mg of flufenamic acid.

Method of administration

Cream for application to the skin. For external use only! Do not ingest! Mobilat Intense is applied thinly to the affected body parts and rubbed in gently. Mobilat Intense is also suitable for dressings. Before applying a dressing, Mobilat Intense should be allowed to dry on the skin for a few minutes. Application under tightly occlusive dressings is not recommended.

Duration of use

As a rule, an application of 2 weeks is sufficient. The therapeutic benefit of an application beyond this period has not been proven.

Please talk to your doctor if you have the impression that the effect of Mobilat Intense is too strong or too weak.

If you have used more Mobilat Intense than you should

If the recommended dosage is exceeded when applied to the skin, the cream should be removed and washed off with water. If significantly too large amounts are used or Mobilat Intense is accidentally ingested, please notify your doctor. He can decide on the necessary measures depending on the type and severity of the symptoms.

If you have any further questions on the use of this medicine, ask your doctor and pharmacist.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

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

The following frequency information is used to evaluate side effects:
Very common:	more than 1 in 10 treated persons
Common:	1 to 10 in 100 treated persons
Uncommon:	1 to 10 in 1,000 treated persons
Rare:	1 to 10 in 10,000 treated persons
Very rare:	less than 1 in 10,000 treated persons
Not known:	frequency cannot be estimated from the available data.

Immune system disorders:

• Uncommon: hypersensitivity reactions, or local allergic reactions (contact dermatitis/allergic conjunctivitis).

Nervous system disorders:

• Uncommon: dizziness, migraine.

Respiratory, thoracic and mediastinal disorders:

• Uncommon: shortness of breath (dyspnoea).
• Very rare (including isolated cases): airway narrowing (bronchospasm).

Gastrointestinal disorders:

• Uncommon: diarrhea, stomach pain, nausea.

Skin and subcutaneous tissue disorders:

• Common: local skin reactions such as skin redness, itching, burning, rash, also with pustules or wheals.

General disorders and administration site conditions

If Mobilat Intense is applied to a large area of the skin and used over a longer period of time, the occurrence of side effects that affect a specific organ system or even the entire organism, as may occur after systemic use of flufenamic acid-containing medicines, cannot be ruled out.

If side effects occur, you should stop using Mobilat Intense. In general, the symptoms will then disappear on their own.

In appropriately sensitized patients, the application of rosemary oil to the upper body can trigger hypersensitivity reactions (including shortness of breath).

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Dept. of Pharmacovigilance, Kurt-Georg-Kiesinger Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE MOBILAT INTENSE?

Keep out of reach of children. Do not use the medicine after the expiry date which is stated on the folding box and tube.

Storage conditions

Do not store above +25°C.

Note on shelf life after first opening

Shelf life after first opening: 12 months.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Mobilat Intense contains

The active ingredient is: Flufenamic acid. 100 g of cream contain 3 g of flufenamic acid. The other ingredients are bentonite, glycerol-(mono/di/tri) (stearate/palmitate)-sodium cetylstearyl sulfate mixture (90:10), 2-propanol (Ph.Eur.), hydrochloric acid 25%, sorbic acid (Ph.Eur.), tetradecan-1-ol, medium-chain triglycerides, purified water, citronella oil, lemon oil, rosemary oil.

What Mobilat Intense looks like and contents of the pack

Mobilat Intense is a white to slightly greenish cream and is available in original packs of 50 g, 100 g and 150 g cream.

Pharmaceutical entrepreneur

Stada Consumer Health Deutschland GmbH
Stadastraße 2 - 18
61118 Bad Vilbel
Telephone: 06101 603-0
Telefax: 06101 603-259
Internet: www.stada.de

Manufacturer

Mobilat Produktions GmbH
Luitpoldstraße 1
85276 Pfaffenhofen

This package leaflet was last revised in September 2019.

Source: Information from the package leaflet
Status: 10/2020
Active ingredient: Flufenamic acid. Areas of application: for the supportive symptomatic treatment of pain in inflammatory soft tissue rheumatic diseases such as tendonitis and tenosynovitis.