DOBENDAN

DOBENDAN Direkt Flurbiprofen Spray 8.75 mg/dose orally

Important notes (mandatory information)

Dobendan Direkt Flurbiprofen Spray. Areas of application: for the short-term relief of symptoms of sore throats such as inflammation of the pharyngeal mucosa, pain, swelling and difficulty swallowing.

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

Dobendan Direkt Flurbiprofen Spray, for use in the oral cavity, for adults
Active ingredient: Flurbiprofen 8.75 mg

Read the entire package leaflet carefully before you start using this medicine, because it contains important information.

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

What this leaflet contains

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

1. WHAT IS DOBENDAN DIREKT FLURBIPROFEN SPRAY AND WHAT IS IT USED FOR?

The active ingredient is Flurbiprofen. Flurbiprofen belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). These medicines work by affecting the body's response to pain, swelling and fever. Dobendan Direkt Flurbiprofen Spray is used for the short-term relief of symptoms of sore throats such as inflammation of the pharyngeal mucosa, pain, swelling and difficulty swallowing.

2. WHAT SHOULD YOU CONSIDER BEFORE USING DOBENDAN DIREKT FLURBIPROFEN SPRAY?

Dobendan Direkt Flurbiprofen Spray must not be used if you:

• are allergic to Flurbiprofen, other non-steroidal anti-inflammatory drugs (NSAIDs), acetylsalicylic acid, methyl-4-hydroxybenzoate (Ph.Eur.) (E218), propyl-4-hydroxybenzoate (Ph.Eur.) (E216) or any of the other ingredients listed in section 6,
• have previously had an allergic reaction after taking a non-steroidal anti-inflammatory drug (NSAID) or acetylsalicylic acid, such as asthma, shortness of breath, itching, a runny nose, rashes, swelling,
• have a stomach/intestinal ulcer or bleeding (two or more occurrences of stomach ulcers),
• have ever had severe colitis,
• have ever suffered from blood clotting disorders or bleeding after taking NSAIDs,
• are in the last three months of your pregnancy,
• have severe heart, kidney or liver failure.

Warnings and precautions

Talk to your doctor or pharmacist before using Dobendan Direkt Flurbiprofen Spray if you:

• are already taking another non-steroidal anti-inflammatory drug (NSAID) or acetylsalicylic acid,
• have inflamed tonsils (tonsillitis) or believe you have a bacterial throat infection (because you may need antibiotics),
• are elderly (as you are more likely to experience side effects),
• have asthma or have ever had asthma or suffer from allergies,
• have a skin condition called systemic lupus erythematosus or mixed connective tissue disease,
• have high blood pressure,
• have a history of bowel disease (ulcerative colitis, Crohn's disease),
• have heart, kidney or liver problems,
• have had a stroke,
• are in the first 6 months of pregnancy or are breastfeeding.

While using Dobendan Direkt Flurbiprofen Spray:

• Stop using the spray at the first signs of skin reactions (rash, peeling skin, blistering) or other signs of an allergic reaction and see a doctor immediately.
• Tell your doctor if you experience any unusual symptoms in your abdomen (especially bleeding).
• Talk to a doctor if you do not feel better, if you feel worse or if new symptoms occur.
• The use of medicines containing Flurbiprofen may be associated with a small increased risk of heart attacks (myocardial infarction) or strokes. Any risk is more likely with high doses and long-term treatment. Do not exceed the recommended dose or duration of treatment (see section 3).

Children and adolescents:
This medicine should not be used in children and adolescents under 18 years of age.

Using Dobendan Direkt Flurbiprofen Spray with other medicines

Please tell your doctor or pharmacist if you are taking/using or have recently taken/used any other medicines, even if they are non-prescription medicines. This applies in particular to the following medicines:

• other non-steroidal anti-inflammatory drugs (NSAIDs) including selective cyclooxygenase-2 inhibitors for pain or inflammation, as these may increase the risk of stomach or intestinal bleeding,
• Warfarin, acetylsalicylic acid and other blood-thinning or anticoagulant medicines,
• ACE inhibitors, angiotensin II antagonists (medicines to lower blood pressure),
• diuretics (water tablets) including potassium-sparing diuretics,
• selective serotonin reuptake inhibitors (SSRIs) (for treating depression),
• cardiac glycosides such as Digoxin (for heart conditions),
• Ciclosporin (to prevent organ rejection after a transplant),
• corticosteroids (to reduce inflammation),
• Lithium (for mood disorders),
• Methotrexate (for treating psoriasis, arthritis and cancer),
• Mifepristone (a medicine used for a termination of pregnancy). NSAIDs should not be used for 8-12 days after taking Mifepristone, as they may reduce the effect of Mifepristone,
• Oral antidiabetics (for treating diabetes),
• Phenytoin (for treating epilepsy),
• Probenecid, Sulfinpyrazone (for gout and arthritis),
• Quinolone antibiotics such as Ciprofloxacin, Levofloxacin (for bacterial infections),
• Tacrolimus (an immunosuppressant after organ transplants),
• Zidovudine (for treating HIV).

Using Dobendan Direkt Flurbiprofen Spray with food, drink and alcohol

You should not drink alcohol while being treated with Dobendan Direkt Flurbiprofen Spray, as this may increase the risk of stomach or intestinal bleeding.

Pregnancy, breastfeeding and fertility:

• Do not use this medicine if you are in the last 3 months of your pregnancy.
• If you are in the first 6 months of your pregnancy or are breastfeeding, talk to your doctor before using this medicine.

Flurbiprofen belongs to a group of medicines that can impair female fertility. The effect is reversible after discontinuation of the medicine. Occasional use of this medicine is unlikely to affect your ability to become pregnant. However, talk to your doctor before taking this medicine if you are having problems becoming pregnant.

Driving and using machines

This medicine should not affect your ability to drive or operate machines. However, dizziness and visual disturbances are possible side effects after taking NSAIDs. Do not drive or operate machines if you are affected.

Dobendan Direkt Flurbiprofen Spray contains methyl-4-hydroxybenzoate (Ph.Eur.) (E218) and propyl-4-hydroxybenzoate (Ph.Eur.) (E216)

Methyl-4-hydroxybenzoate (Ph.Eur.) (E218) and propyl-4-hydroxybenzoate (Ph.Eur.) (E216) may cause hypersensitivity reactions, including delayed reactions.

3. HOW TO USE DOBENDAN DIREKT FLURBIPROFEN SPRAY?

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The recommended dose is: Adults aged 18 and over Spray one dose of 3 sprays into the back of the throat as needed every 3-6 hours. Do not use more than 5 doses in a 24-hour period. One dose (3 sprays) contains 8.75 mg Flurbiprofen. Do not use this medicine in children or adolescents under 18 years of age.

For use in the oral cavity only:

• Spray only into the back of the throat.
• Do not inhale while spraying.
• Do not use more than 5 doses (15 sprays) in 24 hours.

Dobendan Direkt Flurbiprofen Spray is for short-term use only. Use the lowest possible dose for the shortest possible time necessary to relieve your symptoms. If irritation of the mouth occurs, Flurbiprofen treatment should be discontinued. Do not use this medicine for more than 3 days unless your doctor has told you to. If you do not feel better or if you feel worse, or if new symptoms occur, talk to a doctor or pharmacist.

Preparing the spray pump

When using the spray pump for the first time (or after prolonged storage), you must first prepare it. Point the nozzle away from you and spray at least four times until a fine, even spray is produced. The spray pump is then prepared and ready to use. If the medicine has not been used for a long time, point the nozzle away from you and spray at least once to make sure a fine, even spray is produced. Always make sure a fine, even spray is produced before dosing the spray.

Using the spray

Point the spray nozzle towards the back of the throat. Press the spray pump down three times with a light, quick motion. Make sure to press the pump all the way down for each spray and to remove your finger from the top of the pump between sprays. Do not inhale while spraying.

If you have used more Dobendan Direkt Flurbiprofen Spray than you should

Talk to your doctor or pharmacist or go to the nearest hospital immediately. Symptoms of overdose may include nausea, vomiting, stomach pain or, less commonly, diarrhea. Ringing in the ears, headache and gastrointestinal bleeding are also possible.

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

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, this medicine can cause side effects, although not everybody gets them. Stop using this medicine and see your doctor immediately if any of these side effects occur:

• Signs of an allergic reaction, such as asthma, unexpected wheezing and/or shortness of breath, shortness of breath, itching, runny nose or rashes.
• Swelling of the face, tongue or throat causing difficulty breathing, rapid heartbeat, drop in blood pressure to the point of shock (these may also occur when the medicine is used for the first time).
• Signs of hypersensitivity and skin reactions such as redness, swelling, peeling skin, blistering, detachment or skin and mucous membrane ulcers.

Talk to your doctor or pharmacist if you notice any of the following side effects or side effects not listed:

Common (may affect up to 1 in 10 people):

• Dizziness, headache
• Throat irritation
• Mouth ulcers, pain or numbness in the mouth
• Sore throat
• Discomfort when used in the mouth (burning or warmth)
• Nausea and diarrhea
• Skin tingling and itching

Uncommon (may affect up to 1 in 100 people):

• Drowsiness
• Blisters in the mouth or throat, numbness in the throat
• Bloated stomach, abdominal pain, flatulence, constipation, indigestion, nausea
• Dry mouth
• Burning in the mouth, altered sense of taste
• Rashes, itchy skin
• Fever, pain
• Tiredness or difficulty falling asleep
• Worsening of asthma, wheezing and/or shortness of breath
• Reduced sensation in the throat

Rare (may affect up to 1 in 1000 people):

• Anaphylactic reaction

Not known (frequency cannot be estimated from the available data):

• Anemia (low red blood cell count), thrombocytopenia (low platelet count, which can lead to bruising and bleeding)
• Swelling (edema), high blood pressure, heart failure or heart attack
• Severe skin reactions such as blistering, including Stevens-Johnson syndrome and toxic epidermal necrolysis (rare conditions due to severe side effects of medicines or infections, in which a severe reaction of the skin and mucous membranes is triggered).
• Hepatitis (liver inflammation)

Reporting of side effects:
If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this 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 DOBENDAN DIREKT FLURBIPROFEN SPRAY?

Keep this medicine out of the reach of children. Do not use this medicine after the expiry date which is stated on the bottle after: "Use by" and on the outer carton after "Usable until". The expiry date refers to the last day of the specified month. Do not refrigerate or freeze. Do not use this medicine for more than 6 months after opening. Do not dispose of medicines in wastewater or household waste. Ask your pharmacist how to dispose of the medicine when you no longer use it. You help to protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Dobendan Direkt Flurbiprofen Spray contains

The active ingredient is Flurbiprofen. One dose (3 sprays) contains 8.75 mg Flurbiprofen, which corresponds to 16.2 mg/ml Flurbiprofen. The other ingredients are: Betadex, sodium monohydrogen phosphate dodecahydrate (Ph.Eur.), citric acid monohydrate, methyl-4-hydroxybenzoate (Ph.Eur.)(E218), propyl-4-hydroxybenzoate (Ph.Eur.)(E216), sodium hydroxide, mint flavor, cherry flavor, N,2,3-trimethyl-2-(propan-2-yl)butanamide, saccharin sodium, hydroxypropylbetadex 0.62 and purified water.

How Dobendan Direkt Flurbiprofen Spray looks and contents of the pack
Spray for use in the oral cavity, solution. The spray is a clear, colorless to slightly yellowish solution with mint and cherry flavor. Pack size: 15 ml spray for use in the oral cavity, solution.

Pharmaceutical entrepreneur

Reckitt Benckiser Deutschland GmbH
Darwinstraße 2-4
69115 Heidelberg
Germany
Tel.: (06221) 9982-333
www.dobendan.de

Manufacturer:
Reckitt Benckiser Healthcare International Limited
Nottingham Site
Thane Road
Nottingham
NG902DB
Great Britain

This leaflet was last revised in January 2015.

Source: Information from the package leaflet
Status: 10/2017
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