Benactivdolmed

Package leaflet: Information for the user

Benactivdolmed 8.75 mg/dose Oral Mucosa Spray, solution

Flurbiprofen
Please read this leaflet carefully before using this medicine because it contains important information for you.
Use this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice improvement or if you notice worsening of symptoms after 3 days.

Contents of this leaflet:

1. What Benactivdolmed is and what it is used for
2. What you need to know before using Benactivdolmed
3. How to use Benactivdolmed
4. Possible side effects
5. How to store Benactivdolmed
6. Contents of the pack and other information

1. What Benactivdolmed is and what it is used for

The active substance is flurbiprofen. Flurbiprofen belongs to a group of medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), which work by modifying the body's response to pain, swelling, and fever.
Benactivdolmed is indicated for the relief of sore throat symptoms such as throat inflammation, pain, difficulty swallowing, and swelling, for short-term treatment in adults aged 18 years and over.

2. What you need to know before using Benactivdolmed

Do not use Benactivdolmed if:

• you are allergic to flurbiprofen, or to other Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), aspirin (acetylsalicylic acid), or to any of the excipients listed in section 6.
• you have previously had allergic reactions after taking Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) or aspirin (acetylsalicylic acid); for example, asthma, wheezing, itching, runny nose, skin rashes, swelling.
• you currently have or have previously had two or more episodes of stomach ulcers or bleeding, or intestinal ulcers.
• you have ever had severe colitis (inflammation of the intestine).
• you have ever had blood clotting problems or bleeding problems after taking NSAIDs.
• you are in the last 3 months of pregnancy.
• you have severe heart, kidney, or liver failure.
• you are a child or adolescent under 18 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before using Benactivdolmed if:

• you are already taking other Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) or aspirin.
• you suffer from tonsillitis (inflamed tonsils) or think you may have a bacterial throat infection (since you may need to take antibiotics).
• you are elderly (as you are more likely to experience side effects).
• you have or have had asthma episodes or suffer from allergies.
• you suffer from a skin condition called systemic lupus erythematosus or mixed connective tissue disease.
• you suffer from high blood pressure (hypertension).
• you have intestinal disorders (ulcerative colitis, Crohn's disease).
• you have heart, kidney, or liver problems.
• you have had a stroke.
• you are in the first 6 months of pregnancy or are breastfeeding.

During use of Benactivdolmed

• At the first sign of any skin reaction (rash, peeling, blisters) or other signs of an allergic reaction, stop using the spray and consult a doctor immediately.
• Inform your doctor of any unusual abdominal symptoms (especially bleeding).
• Consult your doctor if you do not notice improvement, if symptoms worsen, or if you develop new symptoms.
• Medicines such as flurbiprofen may be associated with a small increased risk of heart attack or stroke. Any risk is more likely with higher doses or prolonged treatment. Do not exceed the recommended dose or duration of treatment (see section 3).

Children
This medicine must not be used in children or adolescents under 18 years of age.
Other medicines and Benactivdolmed
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines without a prescription. In particular:

• other Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), including selective cyclooxygenase-2 inhibitors used for pain or inflammation, as these may increase the risk of stomach or intestinal bleeding
• warfarin, aspirin (acetylsalicylic acid), and other blood thinners or anticoagulant medicines
• ACE inhibitors, angiotensin II antagonists (medicines that lower blood pressure)
• diuretics (medicines that increase urine production), including potassium-sparing diuretics
• SSRIs (selective serotonin reuptake inhibitors) used for depression
• cardiac glycosides such as digoxin (for heart problems)
• cyclosporine (to prevent organ transplant rejection)
• corticosteroids (to reduce inflammation)
• lithium (for mood disorders)
• methotrexate (for psoriasis, arthritis, and cancer)
• mifepristone (used to terminate a pregnancy). NSAIDs must not be used for 8–12 days after taking mifepristone, as they reduce the effect of mifepristone
• oral antidiabetic medicines
• phenytoin (for epilepsy)
• probenecid, sulfinpyrazone (for gout and arthritis)
• quinolone antibiotics (for bacterial infections) such as ciprofloxacin, levofloxacin
• tacrolimus (an immunosuppressant used after organ transplant)
• zidovudine (for HIV).

Benactivdolmed with food, drinks, and alcohol
Alcohol intake should be avoided during use of this medicine, as it may increase the risk of stomach or intestinal bleeding.
Pregnancy, breastfeeding, and fertility
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.

• 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, consult your doctor or pharmacist before taking this medicine.

Flurbiprofen belongs to a group of medicines (NSAIDs) that may affect female fertility. This effect is reversible when the medicine is discontinued.
Driving and using machines
This medicine has no effect on the ability to drive or operate machinery. However, dizziness and visual disturbances are possible side effects following the use of NSAIDs. If these occur, do not drive or operate machinery.
Benactivdolmed contains Methyl 4-hydroxybenzoate (E218) and Propyl 4-hydroxybenzoate (E216).
May cause allergic reactions (including delayed reactions).

3. How to use Benactivdolmed

Use this medicine exactly as stated in this leaflet or according to the instructions given by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Recommended dose
Adults over 18 years of age:
One dose of 3 sprays directed at the back of the throat every 3–6 hours as needed, up to a maximum of 5 doses within 24 hours.
One dose (3 sprays) contains 8.75 mg of flurbiprofen.
Do not use this medicine in children and adolescents under 18 years of age.
For oral mucosa use only

• Spray only onto the back of the throat.
• Do not inhale during administration of the product.
• Do not administer more than 5 doses (15 sprays) within 24 hours.

Benactivdolmed is indicated only for short-term use.
You should use the lowest number of doses necessary, for the shortest possible time, to relieve your symptoms. If mouth irritation occurs, treatment with flurbiprofen should be discontinued.
Do not use this medicine for more than 3 days without medical advice.
Consult your doctor or pharmacist if you do not notice any improvement, if your symptoms worsen, or if new symptoms appear.
Pump activation
When using the spray for the first time (or after a long period without using the product), you must first activate the pump.
Point the spray nozzle away from your body and press the pump at least four times until a fine, uniform mist is released. The pump is now activated and ready for use. If the product has not been used for a long time, point the spray nozzle away from your body and spray at least once until a fine, uniform mist is released.
Before each use, always ensure that the spray produces a fine and uniform mist.
How to use the spray
Direct the spray nozzle towards the back of the throat.
Correct Incorrect

Press the pump three times with a quick, steady motion, making sure to fully depress the pump with each spray. Remove your finger from the top of the pump between each spray.

Do not inhale the product during administration.
If you use more Benactivdolmed than you should
Consult a doctor, pharmacist, or go to the nearest hospital immediately. Symptoms of overdose may include feeling unwell or general malaise, stomach ache, or more rarely, diarrhoea. Other possible symptoms include tinnitus (ringing in the ears), headache, and gastrointestinal bleeding.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
If you experience any of the following side effects, STOP TAKING THIS MEDICINE and contact your doctor immediately:

• severe skin reactions such as blistering rashes, including Stevens-Johnson syndrome and toxic epidermal necrolysis (rare medical conditions caused by serious adverse reactions to treatment or infection, resulting in severe skin and mucous membrane reactions). Frequency: not known (frequency cannot be estimated based on available data).
• signs of anaphylactic shock characterized by swelling of the face, tongue, or throat, causing breathing difficulties, rapid heartbeat, drop in blood pressure leading to shock (these effects may occur even with the first use of the medicine). Frequency: rare (may affect up to 1 in 1,000 people).
• signs of hypersensitivity and skin reactions such as redness, swelling, exfoliation, blisters, peeling, or ulceration of the skin and mucous membranes. Frequency: uncommon (may affect up to 1 in 100 people).
• signs of an allergic reaction such as asthma, unexplained wheezing or shortness of breath, itching, runny nose, or skin rash. Frequency: uncommon (may affect up to 1 in 100 people).

Inform your doctor or pharmacist if you notice any of the following side effects or any other side effect not listed below:

Common (may affect up to 1 in 10 people)

• dizziness, headache
• sore throat
• mouth ulcers, mouth pain or numbness
• sore throat
• oral discomfort (sensation of heat, burning, or tingling)
• nausea and diarrhoea
• tingling and itching sensations in the skin

Uncommon (may affect up to 1 in 100 people)

• drowsiness
• blisters in the mouth or throat, throat numbness
• bloated stomach, abdominal pain, flatulence, constipation, indigestion, malaise
• dry mouth
• burning sensation in the mouth, taste disturbances
• fever, pain
• drowsiness or difficulty sleeping
• worsening of asthma, wheezing, shortness of breath
• reduced sensitivity of the throat

Not known (frequency cannot be estimated based on available data)

• anaemia, thrombocytopenia (decreased platelet count in the blood which may cause bruising and bleeding)
• swelling (oedema), high blood pressure, heart failure or heart attack
• hepatitis (liver inflammation)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or pharmacist.
You can also report side effects directly via 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 Benactivdolmed

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack and on the bottle after "Exp." The expiry date refers to the last day of that month.
Do not refrigerate or freeze.
Do not use this medicine for more than 6 months after first use.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Benactivdolmed contains
The active substance is flurbiprofen. One dose (3 sprays) contains 8.75 mg of flurbiprofen,
corresponding to 16.2 mg/mL of flurbiprofen.
The other components are: Betadex, Dibasic sodium phosphate dodecahydrate, Citric acid monohydrate,
Methyl p-hydroxybenzoate (E218), Propyl p-hydroxybenzoate (E216), Sodium hydroxide, Honey flavour
(containing flavouring substances, Flavouring preparation and Propylene glycol (E1520)), Lemon
flavour (containing flavouring substances, Flavouring preparation and Propylene glycol (E1520)),
N,2,3-Trimethyl-2-isopropylbutanamide, Sodium saccharin, Hydroxypropylbetadex and Purified water.

Description of the appearance of Benactivdolmed and package contents
The oral mucosa spray, solution is a clear, colourless to slightly yellow solution with a honey and lemon flavour.
Benactivdolmed consists of a solution in a white opaque HDPE bottle with a multi-component pump and a protective cap made of polypropylene. Each bottle contains 15 mL of solution, providing approximately 83 sprays.

Marketing Authorization Holder and Manufacturer
Reckitt Benckiser Healthcare (Italia) S.p.A., Via G. Spadolini 7, 20141 Milano
Manufacturer
Reckitt Benckiser Healthcare International Ltd, Thane Road, Nottingham, Nottinghamshire, NG90 2DB, United Kingdom
RB NL Brands B.V., Schiphol Boulevard 207, Schiphol 1118BH, Netherlands

This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Netherlands: Strepfen Kers- en Munt 8,75 mg keelspray
Belgium: Strepfen spray met kers- en muntsmaak 8,75 mg/dose spray voor oromucosaal gebruik, oplossing
Bulgaria: Стрепсилс Интензив мед и лимон 8,75 mg/доза спрей за устна лигавица, разтвор
Strepsils Intensive Honey and Lemon 8,75 mg/dose oromucosal spray, solution
Croatia: Strepfen za odrasle s okusom meda i limuna 8,75 mg po dozi, sprej za usnu sluznicu, otopina
Cyprus: Strepfen Direct Honey & Lemon
Czech Republic: Strepfen Sprej Med a Citron
Denmark: Strefzap honning og citron
Estonia: Strepsils Intensive Honey & Lemon
Finland: Strefen Hunaja & Sitruuna, 16,2 mg/mL sumute suuonteloon, liuos
Germany: Dobendan Direkt Flurbiprofen Spray Honig- und Zitronengeschmack
Greece: Streflam
Hungary: Strepfen DIREKT méz és citrom ízű 16,2 mg/mL szájnyálkahártyán alkalmazott oldatos spray
Iceland: Strefen Honung & Citron 16,2 mg/mL munnholsúði, lausn
Ireland: Strepsils Intensive Honey & Lemon 8.75 mg/dose Oromucosal Spray
Italy: Benactivdolmed 8.75 mg/dose Spray for oral mucosa, solution
Latvia: Strepsils Intensive Honey and Lemon 16,2 mg/mL aerosols izsmidzināšanai mutes dobumā, šķīdums
Lithuania: Stepfen Direct Honey and Lemon
Luxembourg: Strepfen Spray Miel & Citron 8,75 mg/dose solution pour pulvérisation buccale
Norway: Strefen 8,75 mg/dose munnspray, oppløsning med peppermynte- og kirsebærsmak
Poland: Strepsils Intensive o smaku wisni i miety
Portugal: Strepfen Spray Mel e Limão
Romania: Strepsils Intensiv Miere si Lamaie 8,75 mg/doza spray bucofaringian, solutie
Austria: Strepsils® Honig & Zitrone 8,75 mg/Dosis Spray zur Anwendung in der Mundhöhle, Lösung
Slovakia: Strepfen strej Med a Citrón 8,75 mg/dávka orálna roztoková aerodisperzia
Slovenia: Strepfen za odrasle z okusom medu in limone 8,75 mg/odmerek oralno pršilo, raztopina
Spain: Strefen Spray 8.75 mg/dosis solución para pulverización bucal sabor miel y limón
Sweden: Strefen Honung & Citron 16,2 mg/mL munhålespray, lösning
United Kingdom: Strefen Honey and Lemon Flavour 8.75 mg/dose oromucosal spray