BENACTIVDOL 8.75 MG Оральный мукозный спрей, раствор

Содержание инструкции

1. Benactivdol Gola 8.75 mg/dose Oral Mucosal Spray, solution
   1. What is Benactivdol Gola and what is it 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

Benactivdol Gola 8.75 mg/dose Oral Mucosal Spray, solution

Flurbiprofen

Read this leaflet carefully before using this medicine as it contains important
information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or
pharmacist have told you.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better or if your symptoms worsen 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. Contents of the pack and other information.

1. What is Benactivdol Gola and what is it 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 to relieve the symptoms of sore throat such as throat inflammation,
pain, difficulty swallowing and swelling for short-term treatment in adults aged 18 years or
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 had allergic reactions after taking Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) or acetylsalicylic acid; for example asthma, wheezing, itching, runny nose, skin rashes, swelling.
• You have or have had 2 or more episodes of gastric or intestinal ulcers or bleeding.
• You have ever had severe colitis (inflammation of the intestine).
• You have ever had problems with blood coagulation 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 the age of 18 years.

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 think you have a bacterial inflammation of the throat (as antibiotics may be necessary).
• You are elderly (as you are more likely to experience undesirable effects).
• You have or have had episodes of asthma or suffer from allergies.
• You suffer from systemic lupus erythematosus or mixed connective tissue disease.
• You suffer from hypertension (high blood pressure).
• You have intestinal diseases (ulcerative colitis, Crohn's disease).
• You have problems with your heart, kidneys or liver.
• You have had a stroke.
• You are in the first 6 months of pregnancy or if you are breastfeeding.

During the use of Benactivdol Gola

• At the first sign of any skin reaction (rash, peeling, blisters) or other evidence of an allergic reaction, immediately stop using the spray and consult a doctor immediately.
• Tell your doctor about any unusual abdominal symptoms (bleeding in particular).
• See a doctor if you do not notice any improvement or if you notice a worsening or if you develop new symptoms.
• Drugs such as Flurbiprofen may be associated with a modest increase in the risk of heart attack or stroke. Any risk is more likely with higher doses or prolonged treatments. 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 the age of 18 years.

Other medicines and Benactivdol Gola
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine, including over-the-counter medicines. 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 bleeding in the stomach or intestines
• warfarin, acetylsalicylic acid and other blood-thinning or anticoagulant medicines
• ACE inhibitors, angiotensin II receptor antagonists (blood pressure medicines)
• Diuretics (medicines that increase urine production) including potassium-sparing diuretics
• SSRIs (selective serotonin re-uptake inhibitors) for depression
• cardiac glycosides such as digoxin (for heart problems)
• cyclosporine (to prevent rejection after organ transplantation)
• 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 (immunosuppressant used after organ transplantation)
• zidovudine (for HIV)

Benactivdol Gola with food, drinks and alcohol
The consumption of alcohol should be avoided during treatment with this medicine, as it can
increase the risk of bleeding in the stomach and intestines.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, or if you are
breastfeeding, ask your doctor or pharmacist for advice before taking this
medicine.

• Do not use this medicine if you are in the last 3 months of pregnancy.
• Avoid using this medicine in the first 6 months of pregnancy or if you are breastfeeding, unless prescribed by your doctor. This product belongs to a group of medicines (NSAIDs) that can affect female fertility. This effect is reversible when the medicine is stopped.

Driving and operating machinery
This medicine has no effects 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 parahydroxybenzoate (E218) and Propyl parahydroxybenzoate
(E216).
May cause allergic reactions (including delayed reactions).

3. How to use Benactivdol Gola

Use this medicine following exactly as described 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:
A dose of 3 sprays directed to the affected area of the throat every 3-6 hours as needed. Do not take more than 5 doses within 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 use on the oral mucosa only

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

Benactivdol Gola is indicated only for short-term treatments.
You should use a few doses as needed for the shortest possible time to relieve your symptoms. If the mouth becomes irritated, treatment with flurbiprofen should be discontinued.

Do not use this medicine for more than 3 dayswithout the advice of your doctor.
Consult your doctor or pharmacist if you do not notice any improvement or if you notice a worsening or if you develop new symptoms.

Activating the dispenser
When using the dispenser for the first time (or after a long period of non-use of the product), it is necessary to prime the pump beforehand.
Point the dispenser away from your body, and spray at least 4 times until a uniform and consistent mist is released. The dispenser is then activated and ready for use. If the product has not been used for a long time, point the dispenser away from your body, and spray at least 1 time until a uniform and consistent mist is released.
Always ensure that the mist is uniform and consistent before using the product.

Using the Spray
Direct the dispenser towards the back of the throat.
Correct Incorrect
Press the dispenser 3 timeswith a quick movement, making sure that each press on the dispenser is complete with each spray. Release your finger from the dispenser between sprays.
Do not inhale the product during delivery.

If you forget to use Benactivdol Gola
Do not use a double dose to make up for a missed dose.

If you use more Benactivdol Gola than you should
Consult a doctor or pharmacist or go to the nearest hospital. Symptoms of overdose may include: feeling unwell or sick, stomach pain or rarely diarrhea. The following may also occur: ringing in the ears, headache and gastrointestinal bleeding.
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

If any of the following side effects occur, stop taking Benactivdol Gola and
immediately inform your doctor:

• severe forms of skin reactions such as blistering reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis (these are rare conditions due to severe adverse reactions to treatment or an infection in which there is a severe reaction of the skin or mucous membranes. Frequency: Not known (the frequency cannot be defined based on available data))
• signs of anaphylactic shock characterised by swelling of the face, tongue or throat causing difficulty in breathing, rapid heartbeat, drop in blood pressure to shock (side effects that can occur even with the first use of the medicine). Frequency: Rare (may affect up to 1 in 1000 people).
• signs of hypersensitivity and reactions (rashes) such as redness, swelling, skin peeling, blisters, desquamation 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 rashes. Frequency: Uncommon (may affect up to 1 in 100 people)

If any of the following side effects occur or any other side effect, tell your doctor or pharmacist:
Common(may affect up to1 in 10 people)

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

Uncommon(may affect up to1 in 100 people)

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

Not known(the frequency cannot be defined based on available data)

• anaemia, thrombocytopenia (low platelet count in the blood which can cause bruising and bleeding)
• swelling (oedema), high blood pressure, heart failure or myocardial infarction
• hepatitis (liver inflammation)

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. You can also report side effects directly through 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 which is stated on the package and bottle after
”Expiry.” 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 from first use.
Do not dispose of any medicine in waste water 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 ingredient 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 parahydroxybenzoate (E218), Propyl parahydroxybenzoate (E216), Sodium hydroxide,
Mint 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 a spray for oral mucosa, solution and appears as a solution from clear
colourless to slightly yellow in taste of cherry and mint.
Benactivdol Gola consists of a white opaque plastic bottle of solution with a dosing pump
equipped with a protective cap in polypropylene.
Each bottle contains 15 ml of solution which provides approximately 83 sprays.

Marketing Authorisation 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 medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
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 oral spray, solution
France: Strefenspray 8.75 mg Solution for buccal spray
Germany: Dobendan Direkt Flurbiprofen Spray
Hungary: Strepfen DIREKT 16.2 mg/ml oral mucosal and throat spray
Ireland: Strepsils Intensive 1.62% w/v Oromucosal Spray
Italy: Benactivdol Gola 8.75 mg/dose Spray for oral mucosa, solution
Luxembourg: Strepfen spray 8.75 mg/dose solution for buccal spray
Netherlands: Strepfen 8.75 mg throat spray
Poland: Strepsils Intensive Direct
Portugal: Strepfen Spray
Romania: Strepsils Intensiv 8.75 mg/dose bucofaryngeal spray solution
Slovakia: Strepfen sprej 8.75 mg oral solution aerosol
Spain: Strepfen Spray 8.75 mg solution for buccal spray
United Kingdom: Strefen Direct 8.75 mg Oromucosal Spray
Croatia: Strepfen for adults 8.75 mg per dose, spray for oral mucosa, solution
Cyprus: Strepfen Direct
Greece: Strepfen Direct
Denmark: Strefzap cherry and mint (mouth spray, solution 8.75 mg/3 puffs)
Finland: Strefen Kirsikka & Minttu (16.2 mg/ml spray for oral cavity, solution)
Iceland: Strefen Cherry & Mint 16.2 mg/ml mouth spray, solution
Norway: Strefen 8.75 mg/dose (mouth spray, solution with peppermint and cherry flavour)
Sweden: Strefen Cherry & Mint 16.2 mg/ml oral spray, solution
Latvia: Strepsils Intensive 16.2 mg/ml spray for oral cavity, solution
Estonia: Strepsils Intensive
Lithuania: Strefen 16.2 mg/ml oral mucosa spray (aerosol)
Slovenia: Strepfen for adults with cherry and mint flavour 8.75 mg/dose oral