Benactivdol for sore throat

Package leaflet: Information for the user

Benactivdol Gola 8.75 mg/dose Oral spray, solution

Flurbiprofen
Please read all of this leaflet carefully before you start 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 told you to do.

• 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 effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice any improvement or if you notice worsening of symptoms after 3 days.

Contents of this leaflet:

1. What Benactivdol Gola is and what it is used for.
2. What you need to know before using Benactivdol Gola.
3. How to use Benactivdol Gola.
4. Possible side effects.
5. How to store Benactivdol Gola.
6. Package contents and other information.

1. What Benactivdol Gola is and what it is used for

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

2. What you need to know before using Benactivdol Gola

Do not use Benactivdol Gola if:

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

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

• You are already taking other Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) or acetylsalicylic acid.
• You suffer from tonsillitis (inflammation of the tonsils) or suspect you have a bacterial throat infection (as antibiotic treatment may be necessary).
• You are elderly (as you may be more likely to experience adverse effects).
• You have or have had asthma episodes or suffer from allergies.
• You suffer from systemic lupus erythematosus or mixed connective tissue disease.
• You have high blood pressure (hypertension).
• You have intestinal diseases (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 if you are breastfeeding.

During use of Benactivdol Gola

• At the first sign of any skin reaction (rash, peeling, blisters) or other signs of an allergic reaction, stop using the spray immediately and consult a doctor promptly.
• Inform your doctor of any unusual abdominal symptoms (especially bleeding).
• Contact your doctor if you notice no improvement, if symptoms worsen, or if new symptoms develop.
• 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 and adolescents
This medicine must not be used in children and adolescents under 18 years of age.
Other medicines and Benactivdol Gola
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription. In particular:

• other Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), including selective cyclooxygenase-2 inhibitors for pain or inflammation, as they may increase the risk of stomach or intestinal bleeding
• warfarin, acetylsalicylic acid, and other blood thinners or anticoagulant medicines
• ACE inhibitors, angiotensin II antagonists (antihypertensive medicines)
• diuretics (medicines that increase urine production), including potassium-sparing diuretics
• SSRIs (selective serotonin reuptake inhibitors) for depression
• cardiac glycosides such as digoxin (for heart problems)
• cyclosporine (to prevent organ transplant rejection)
• corticosteroids (to reduce inflammation)
• lithium (for behavioral disorders)
• methotrexate (for psoriasis, arthritis, and cancer)
• mifepristone (used to terminate a pregnancy). NSAIDs should not be used for 8–12 days after taking mifepristone, as they reduce its effect
• 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 transplantation)
• zidovudine (for HIV)

Benactivdol Gola with food, drinks, and alcohol
Alcohol intake should be avoided during treatment with this medicine, as it may increase the risk of stomach and intestinal bleeding.
Pregnancy, breastfeeding, and fertility
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or are 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.
• Avoid using this medicine during the first 6 months of pregnancy or while breastfeeding, unless prescribed by your doctor. This product belongs to a group of medicines (NSAIDs) that may affect female fertility. This effect is reversible upon discontinuation of the medicine.

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.
Benactivdol Gola contains Methyl hydroxybenzoate (E218) and Propyl hydroxybenzoate (E216).
It may cause allergic reactions (including delayed reactions).

3. How to use Benactivdol Gola

Use this medicine exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Recommended dose:
Adults aged 18 years and over:
One dose of 3 sprays applied to the affected area of the throat every 3–6 hours as needed. Do not use more than 5 doses in a 24-hour period.
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.

Benactivdol Gola is intended only for short-term treatment.
Use the minimum number of doses necessary for the shortest duration possible to relieve your symptoms. If irritation of the mouth occurs, treatment with flurbiprofen should be discontinued.
Do not use this medicine for more than 3 days without consulting your doctor.
Contact your doctor or pharmacist if you do not notice improvement, if your symptoms worsen, or if you develop new symptoms.
Activating the spray pump
When using the spray pump for the first time (or after a long period without using the product), it is necessary to prime the pump.
Point the spray nozzle away from your body and spray at least 4 times until a uniform and consistent mist is released. The spray pump is now primed and ready for use. If the product has not been used for a long time, point the nozzle away from your body and spray at least once until a uniform and consistent mist is released.
Before each use, always ensure that the spray produces a uniform and consistent mist.
How to use the spray
Direct the spray nozzle towards the back of the throat.
Correct Incorrect

Press the spray pump 3 times rapidly, ensuring each press is fully completed. Release your finger from the pump between each spray.

Do not inhale the product during administration.
If you forget to use Benactivdol Gola
Do not use a double dose to make up for the forgotten dose.
If you use more Benactivdol Gola than you should
Consult a doctor, pharmacist, or go to the nearest hospital immediately. Symptoms of overdose may include: feeling unwell or malaise, stomach ache, or rarely diarrhea. Other possible symptoms include tinnitus, 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 everybody will experience them.
If you experience any of the following side effects, stop taking Benactivdol Gola and
contact your doctor immediately:

• severe forms of skin reactions such as bullous reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis (these are rare conditions caused by serious adverse reactions to treatment or to an infection, in which there is a severe reaction of the skin or mucous membranes). Frequency: Not known (frequency cannot be estimated from the available data)
• signs of anaphylactic shock characterized by swelling of the face, tongue or throat causing difficulty in breathing, rapid heartbeat, drop in blood pressure up to shock (side effects that may even occur with the first use of the medicine). Frequency: Rare (may affect up to 1 in 1,000 people)
• signs of hypersensitivity and skin reactions (rashes) such as redness, swelling, peeling of the skin, blisters, desquamation or ulceration of the skin and mucous membranes. Frequency: Uncommon (may affect up to 1 in 100 people)
• signs of allergic reaction such as asthma, unexplained shortness of breath or difficulty breathing, itching, runny nose or skin rash. Frequency: Uncommon (may affect up to 1 in 100 people)

If you experience any of the following side effects or any other side effect, inform your doctor or
pharmacist:
Common ( may affect up to 1 in 10 people)

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

Uncommon ( may affect up to 1 in 100 people)

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

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

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

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or pharmacist. You may 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 Benactivdol Gola

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and 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 Benactivdol Gola 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 excipients are: Betadex, Disodium phosphate dodecahydrate, Citric acid monohydrate,
Methyl 4-hydroxybenzoate (E218), Propyl 4-hydroxybenzoate (E216), Sodium hydroxide,
Peppermint flavour (contains flavouring substances and preparations, Propylene glycol (E1520) and Glycerol
triacetate (Triacetin) (E1518)), Cherry flavour (contains flavouring substances and preparations,
Propylene glycol (E1520), and water), N,2,3-Trimethyl-2-isopropylbutanamide, Sodium saccharin,
Hydroxypropylbetadex and Purified water.

Description of the appearance of Benactivdol Gola and contents of the pack
This medicine is an oromucosal spray, solution, and is presented as a clear, colourless to slightly yellow solution with a cherry and mint flavour.
Benactivdol Gola consists of an opaque white plastic bottle containing the solution with a metered pump dispenser and a protective cap made of polypropylene.
Each bottle contains 15 ml of solution, providing approximately 83 sprays.

Marketing Authorization Holder
Reckitt Benckiser Healthcare (Italia) S.p.A., Via G. Spadolini 7, 20141 Milano

Manufacturer
Reckitt Benckiser Healthcare International Ltd, Thane Road, Nottingham, NG90 2DB,
Nottinghamshire, United Kingdom
RB NL Brands B.V., Schiphol Boulevard 207, Schiphol 1118BH, Netherlands

This medicine is authorized in the European Economic Area Member States under the following names:
Austria: Strepsils 8.75 mg Spray
Belgium: Strepfen Spray 8.75 mg/dose spray for oromucosal use, solution
Bulgaria: Стрепсилс Интензив Спрей 8,75 mg спрей за устна лигавица, разтвор
Czech Republic: Strepfen sprej 8,75 mg orální sprej, roztok
France: Strefenspray 8.75 mg Solution for buccal spray
Germany: Dobendan Direkt Flurbiprofen Spray
Hungary: Strepfen DIREKT 16,2 mg/ml szájnyálkahártyán és garatban alkalmazott spray
Ireland: Strepsils Intensive 1.62% w/v Oromucosal Spray
Italy: Benactivdol Gola 8.75 mg/dose Spray for oromucosal use, solution
Luxembourg: Strepfen spray 8.75 mg/dose solution pour pulvérisation buccale
Netherlands: Strepfen 8.75 mg keelspray
Poland: Strepsils Intensive Direct
Portugal: Strepfen Spray
Romania: Strepsils Intensiv 8.75 mg/doză bucofaringian spray solution
Slovakia: Strepfen sprej 8,75 mg orálna roztoková aerodisperzia
Spain: Strepfen Spray 8.75 mg solución para pulverización bucal
United Kingdom: Strefen Direct 8.75 mg Oromucosal Spray
Croatia: Strepfen za odrasle 8,75 mg po dozi, sprej za usnu sluznicu, otopina
Cyprus: Strepfen Direct
Greece: Strepfen Direct
Denmark: Strefzap kirsebær og mint (mundhulespray, opløsning 8,75 mg/3 pust)
Finland: Strefen Kirsikka & Minttu (16,2 mg/ml sumute suuonteloon, liuos)
Iceland: Strefen Körsbär & Mint 16,2 mg/ml munnholsúði, lausn
Norway: Strefen 8.75 mg/dose (munnspray, oppløsning med peppermynte- og kirsebærsmak)
Sweden: Strefen Körsbär & Mint 16,2 mg/ml munhålespray, lösning
Latvia: Strepsils Intensive 16,2 mg/ml aerosols izsmidzināšanai mutes dobumā, šķīdums
Estonia: Strepsils Intensive
Lithuania: Strefen 16.2 mg/ml burnos gleivinės purskalas (tripalos)
Slovenia: Strepfen za odrasle z okusom češnje in mete 8.75 mg/odmerek oralno