DOBENDAN

DOBENDAN Direct sugar-free Flurbiprofen 8.75mg Lut

Important notes (mandatory information)

Dobendan Direct Sugar-free, Flurbiprofen 8.75 mg lozenges. Areas of application: for the relief of symptoms of sore throats such as inflammation of the pharyngeal mucosa, pain and 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 Direct Sugar-free Flurbiprofen 8.75 mg lozenges
Active ingredient: Flurbiprofen 8.75 mg

Read the entire package leaflet carefully because it contains important information for you.

• Always use this medicine exactly as described in this leaflet or exactly as directed by your doctor or pharmacist.
• Keep the package leaflet. You may want 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 leaflet. See section 4. If you do not feel better or if you feel worse after 3 days, contact your doctor.

This package leaflet contains

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

1. WHAT IS DOBENDAN DIRECT SUGAR-FREE FLURBIPROFEN AND WHAT IS IT USED FOR?

Dobendan Direct Sugar-free Flurbiprofen contains Flurbiprofen. Flurbiprofen is a non-steroidal anti-inflammatory drug (NSAID) with pain-relieving, fever-reducing and anti-inflammatory properties. Dobendan Direct Sugar-free Flurbiprofen is used in adults and children aged 12 years and over to relieve symptoms of sore throats such as inflammation of the pharyngeal mucosa, pain and swelling, and difficulty swallowing. Consult a doctor if symptoms worsen or do not improve after 3 days.

2. WHAT SHOULD YOU CONSIDER BEFORE USING DOBENDAN DIRECT SUGAR-FREE FLURBIPROFEN?

Dobendan Direct Sugar-free Flurbiprofen must not be used if you:

• are allergic (hypersensitive) to Flurbiprofen, Levomenthol or any of the other ingredients (see section 6),
• have ever had asthma, unexpected wheezing or shortness of breath, an irritated nose, swelling of the face or an itchy rash (hives) after taking acetylsalicylic acid or any other NSAID,
• have had two or more occurrences of stomach ulcers, intestinal ulcers or bleeding in the stomach/intestinal area,
• have suffered from bleeding or perforation in the stomach/intestinal area, severe colitis or blood disorders after taking NSAIDs,
• are taking high-dose acetylsalicylic acid or other NSAIDs (such as Celecoxib, Ibuprofen, Diclofenac-Sodium, etc.),
• are in the last three months of pregnancy,
• have had or have heart, severe kidney or severe liver failure.

Warnings and precautions

Talk to your doctor or pharmacist before taking Dobendan Direct Sugar-free Flurbiprofen if you:

• have ever had asthma or suffer from allergies,
• have inflamed tonsils (tonsillitis) or believe you have a bacterial throat infection (because you may need antibiotics),
• have heart, kidney or liver problems,
• have had a stroke,
• have a history of bowel disease (ulcerative colitis, Crohn's disease),
• suffer from a chronic autoimmune disease such as systemic lupus erythematosus (SLE) or mixed connective tissue disease,
• are older, as you are more likely to experience side effects listed in this leaflet,
• are in the first 6 months of pregnancy or are breastfeeding.

During the use of Dobendan Direct Sugar-free Flurbiprofen:

• Stop using the lozenges at the first signs of skin reactions (rash, peeling skin, blistering) or other signs of an allergic reaction and seek medical attention immediately.
• Inform your doctor of any unusual symptoms in the abdomen (especially bleeding).
• Talk to a doctor if you do not feel better, feel worse or if new symptoms occur.
• The use of medicines such as Dobendan Direct Sugar-free Flurbiprofen may be associated with a slightly increased risk of heart attacks (myocardial infarction) or strokes. Any risk is more likely with high doses and prolonged treatment. Do not exceed the recommended dose or duration of treatment (see section 3).

Children

This medicine should not be used in children under 12 years of age.

Use of Dobendan Direct Sugar-free Flurbiprofen with other medicines

Please tell your doctor or pharmacist if you are taking or using, have recently taken or used, or plan to take or use any other medicines. This applies in particular to the following medicines:

• Low-dose acetylsalicylic acid (up to 75 mg daily)
• Medicines for high blood pressure or heart failure (antihypertensives, cardiac glycosides)
• Diuretics (including potassium-sparing medicines)
• blood-thinning medicines (anticoagulants, platelet aggregation inhibitors)
• medicines for gout (probenecid, sulfinpyrazone)
• other NSAIDs or corticosteroids (such as Celecoxib, Ibuprofen, Diclofenac-Sodium or Prednisolone)
• Mifepristone (a medicine used for abortion)
• Quinolone antibiotics (such as Ciprofloxacin)
• Ciclosporin or Tacrolimus (to suppress the immune system)
• Phenytoin (to treat epilepsy)
• Methotrexate (to treat cancer)
• Lithium or selective serotonin reuptake inhibitors (SSRIs) (to treat depression)
• Oral antidiabetics (to treat diabetes)
• Zidovudine (to treat HIV).

Use of Dobendan Direct Sugar-free Flurbiprofen with food, drinks and alcohol

You should not drink alcohol during treatment with Dobendan Direct Sugar-free Flurbiprofen, 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 pregnancy. If you are in the first 6 months of pregnancy or are breastfeeding, talk to your doctor before using this medicine. Dobendan Direct Sugar-free Flurbiprofen belongs to a group of medicines that can impair fertility in women. 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 trouble getting pregnant.

Driving and operating machinery

There are no studies on the effect on driving and operating machinery. However, dizziness and visual disturbances are possible side effects after taking NSAIDs. Do not drive or operate machinery if you are affected.

Important information about certain other ingredients of Dobendan Direct Sugar-free Flurbiprofen

Please take Dobendan Direct Sugar-free Flurbiprofen only after consulting your doctor if you know that you have an intolerance to certain sugars. 1 lozenge contains 2034 mg Isomalt (E953) and 508.5 mg Maltitol solution (E965), corresponding to approx. 0.21 bread units (BE). If you are on a diabetic diet, you should take this into account. The calorific value is 2.3 kcal/g Isomaltitol or Maltitol solution. Isomaltitol or Maltitol solution may have a slightly laxative effect after several doses per day.

3. HOW TO USE DOBENDAN DIRECT SUGAR-FREE FLURBIPROFEN?

Always use this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure. Recommended dosage: For adults and children aged 12 years and over: Take 1 lozenge and let it dissolve slowly in your mouth. Move the lozenge around in your mouth while sucking. The lozenge should start to work within 30 minutes. Afterwards, take 1 lozenge every 3 to 6 hours if necessary. Do not take more than 5 lozenges within 24 hours. Do not use in children under 12 years of age. These lozenges are for short-term use only. Use as few lozenges as possible for as short a time as necessary to relieve your symptoms. If irritation occurs in the oral cavity, treatment with Flurbiprofen should be discontinued. Do not use Dobendan Direct Sugar-free Flurbiprofen for more than 3 days unless prescribed by your doctor. If you do not feel better or even worse, or if new symptoms occur, talk to your doctor or pharmacist.

If you have taken more Dobendan Direct Sugar-free Flurbiprofen than you should

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

If you forget to use Dobendan Direct Sugar-free Flurbiprofen

Do not take a double dose to make up for a forgotten dose.

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 seek medical attention immediately if any of these side effects occur:

• Signs of an allergic reaction, such as asthma, unexpected difficulty breathing in and/or out, 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 can also occur with the first use of the medicine).
• Severe skin reactions such as peeling skin, blistering or scaling skin.

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
• Irritation in the throat
• Ulcers or pain in the mouth
• Sore throat
• Unpleasant or unusual feeling in the mouth (warmth, burning, tingling)
• Nausea and diarrhea
• Tingling and itching of the skin

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 Skin rashes, itchy skin Fever, pain.
• Tiredness or difficulty falling asleep Worsening of asthma, wheezing, shortness of breath Reduced sensation in the throat.

Rare (may affect up to 1 in 1,000 people):

• anaphylactic reactions

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

• Anemia, 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, Lyell Syndrome and toxic epidermal necrolysis
• Hepatitis (liver inflammation)

Please inform your doctor or pharmacist if any of the listed side effects affect you severely or if you notice side effects not listed in this leaflet.

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 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 DIRECT SUGAR-FREE FLURBIPROFEN?

Keep this medicine out of the reach of children. Do not use this medicine after the expiry date which is stated on the carton after .Usable until". The expiry date refers to the last day of the specified month. Store in the original carton. Do not dispose of medicines in wastewater or household waste. Ask your pharmacist how to dispose of the medicine when you stop using it. This measure helps to protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Dobendan Direct Sugar-free Flurbiprofen contains

The active ingredient is Flurbiprofen 8.75 mg. The other ingredients are: Macrogol 300, Potassium hydroxide (E515), Orange flavor, Levomenthol, Acesulfame-Potassium (E950), Maltitol solution (E965) and Isomalt (E953).

What Dobendan Direct Sugar-free Flurbiprofen looks like and contents of the pack

The lozenges are round, white to pale yellow tablets with an imprint on both sides. Dobendan Direct Sugar-free Flurbiprofen is available in blister packs of 8, 16 and 24 pieces. Not all pack sizes may be marketed.

Pharmaceutical entrepreneur

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

Manufacturer

Reckitt Benckiser Healthcare International Limited
Nottingham Site, Thane Road,
NG90 2DB, Nottingham, Nottinghamshire
United Kingdom

This leaflet was last revised in March 2015.

Source: Information from the package leaflet
Status: 10/2017
Areas of application: for the relief of symptoms of sore throats such as inflammation of the pharyngeal mucosa, pain and swelling, and difficulty swallowing.