Strepsils intensive with honey and eucalyptus flavour

Package leaflet: Information for the user

Strepsils Intensive with honey and eucalyptus flavour, 8.75 mg, hard pastilles
Flurbiprofen
Read the entire leaflet carefully before using this medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as
recommended by a doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, consult your pharmacist.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after three days or if your condition worsens, contact your doctor.

Contents of the leaflet
1 What Strepsils Intensive with honey and eucalyptus flavour is and what it is used for
2 Before using Strepsils Intensive with honey and eucalyptus flavour
3 How to use Strepsils Intensive with honey and eucalyptus flavour
4 Possible side effects
5 How to store Strepsils Intensive with honey and eucalyptus flavour
6 Contents of the pack and other information

1. What Strepsils Intensive with honey and eucalyptus flavour is and what it is used for

Strepsils Intensive with honey and eucalyptus flavour contains flurbiprofen. Flurbiprofen is a
non-steroidal anti-inflammatory drug (NSAID) with analgesic, antipyretic and anti-inflammatory
properties. Strepsils Intensive with honey and eucalyptus flavour, 8.75 mg, hard pastilles are used for
short-term relief of sore throat symptoms such as pain, tenderness, swelling and difficulty swallowing
in adults and adolescents over 12 years of age.
If there is no improvement after three days or if you feel worse, contact your doctor.

2. Before using Strepsils Intensive with honey and eucalyptus flavour
When not to use Strepsils Intensive with honey and eucalyptus flavour

• if you are allergic (hypersensitive) to flurbiprofen or any of the other ingredients of this medicine (listed in section 6),
• if you have ever experienced asthma, unexpected wheezing or shortness of breath, runny nose, facial swelling or itchy rash (urticaria) after taking acetylsalicylic acid or any other non-steroidal anti-inflammatory drugs,
• if you have or have had at least two episodes of gastric or duodenal ulcer, or gastrointestinal bleeding,
• if you have previously experienced gastrointestinal bleeding or perforation, severe colitis (inflammation of the colon), or coagulation disorders while taking non-steroidal anti-inflammatory drugs,
• if you are in the last three months of pregnancy,
• if you have severe heart, kidney or liver failure.

Warnings and precautions
Before starting to use Strepsils Intensive with honey and eucalyptus flavour, discuss this with your doctor or pharmacist

• if you have or have ever had asthma or allergies,
• if you have tonsillitis or suspect you may have a bacterial throat infection (which may require antibiotics),
• if you have an infection – see section “Infections” below,
• if you have heart, kidney or liver disease,
• if you have had a stroke,
• if you have previously had intestinal disorders (ulcerative colitis, Crohn’s disease),
• if you have a chronic autoimmune disease such as systemic lupus erythematosus or mixed connective tissue disease,
• if you are elderly, as you may be at greater risk of experiencing the adverse effects listed in this leaflet,
• if you are in the first six months of pregnancy or breastfeeding,
• if you have high blood pressure,
• if you have medication-induced headache.

Infections
Non-steroidal anti-inflammatory drugs (NSAIDs) may mask symptoms of infection such as fever and
pain. This may delay appropriate treatment of infections, potentially increasing the risk of
complications. If you take this medicine during an ongoing infection and your symptoms persist or
worsen, consult your doctor or pharmacist immediately.

While using Strepsils Intensive with honey and eucalyptus flavour

• If you experience any first signs of a skin reaction (rash, peeling, blisters) or other symptoms of an allergic reaction, stop using the medicine and consult your doctor immediately.
• Report any unusual abdominal symptoms (especially bleeding) to your doctor.
• If there is no improvement or new symptoms appear, consult your doctor.
• Use of medicines such as flurbiprofen may be associated with a small increased risk of heart attack (myocardial infarction) or stroke. The risk is greater with higher doses or prolonged use. Do not exceed the recommended dose or duration of treatment (3 days).

Children
Do not use this medicine in children under 12 years of age.
Strepsils Intensive with honey and eucalyptus flavour and other medicines
Inform your doctor or pharmacist about any medicines you are currently taking, have recently taken, or plan to take. In particular, inform your doctor or pharmacist if you are taking the following medicines:

• low-dose acetylsalicylic acid (aspirin) (up to 75 mg per day),
• medicines used to treat high blood pressure or heart failure (antihypertensives, cardiac glycosides),
• diuretics (including potassium-sparing diuretics),
• anticoagulants (blood thinners, antiplatelet agents),
• medicines for gout (probenecid, sulfinpyrazone),
• other non-steroidal anti-inflammatory drugs, including selective cyclooxygenase-2 inhibitors or corticosteroids (e.g. celecoxib, ibuprofen, diclofenac or prednisolone),
• mifepristone (used to terminate pregnancy),
• quinolone antibiotics (such as ciprofloxacin),
• cyclosporine or tacrolimus (used to suppress the immune system),
• phenytoin (used to treat epilepsy),
• methotrexate (used to treat autoimmune diseases or cancer),
• lithium or selective serotonin reuptake inhibitors (used for depression),
• oral antidiabetic medicines (used to treat diabetes),
• zidovudine (used to treat HIV).

Strepsils Intensive with honey and eucalyptus flavour with food, drink and alcohol
Avoid alcohol during treatment, as it increases the risk of gastrointestinal bleeding.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant or plan to become pregnant, consult your doctor or pharmacist before using this medicine.
Do not take this medicine if you are in the last trimester of pregnancy. If you are in the first or second trimester of pregnancy or if you are breastfeeding, talk to your doctor before using this medicine.
Flurbiprofen belongs to a group of medicines that may adversely affect female fertility. This effect is reversible after stopping the medicine. It is unlikely that occasional use of this medicine will affect your chances of becoming pregnant. However, inform your doctor before using this medicine if you have difficulty becoming pregnant.
Driving and using machines
No studies have been performed on the effect on the ability to drive and use machines. However, dizziness and visual disturbances are possible adverse effects after taking non-steroidal anti-inflammatory drugs. If such symptoms occur, do not drive or operate machinery.
Strepsils Intensive with honey and eucalyptus flavour contains isomalt (E 953), liquid maltitol (E 965)
and flavour containing anise alcohol, benzyl alcohol, benzyl benzoate, cinnamyl cinnamate, benzyl
salicylate, cinnamon, cinnamyl alcohol, citral, geraniol, limonene and linalool.
Strepsils Intensive with honey and eucalyptus flavour contains 2032.18 mg of isomalt (E 953) and 509.03 mg of liquid maltitol (E 965) per hard pastille.
The medicine may have a mild laxative effect.
The caloric value of maltitol and isomalt is 2.3 kcal/g.
If you have previously been diagnosed with intolerance to certain sugars, consult your doctor before taking this medicine.
Anise alcohol, benzyl alcohol, benzyl benzoate, cinnamyl cinnamate, benzyl salicylate, cinnamon, cinnamyl alcohol, citral, geraniol, limonene and linalool may cause allergic reactions.
This medicine contains 0.00169 mg of benzyl alcohol in each hard pastille.
Patients with liver or kidney disease, pregnant or breastfeeding women (see “Pregnancy, breastfeeding and fertility”) should consult their doctor or pharmacist, as large amounts of benzyl alcohol may accumulate in their bodies and cause adverse effects (so-called metabolic acidosis).
Benzyl alcohol may cause mild, local irritation.

3. How to use Strepsils Intensive with honey and eucalyptus flavour
This medicine should always be used exactly as described in this patient leaflet or as recommended by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Recommended dose: Adults and adolescents over 12 years of age

• Place one pastille in the mouth and suck slowly.
• Move the pastille around in the mouth while sucking.
• The pastille should start to work within 30 minutes.
• Then take one pastille every 3-6 hours as needed.
• Do not take more than 5 pastilles in 24 hours.

Do not use this medicine in children under 12 years of age.
This medicine is intended for short-term use only. Use the lowest effective dose for the shortest duration necessary to relieve symptoms. If you have an infection, consult your doctor or pharmacist immediately if your symptoms (such as fever and pain) persist or worsen (see section 2). If oral irritation occurs, discontinue treatment with flurbiprofen.
Do not use Strepsils Intensive with honey and eucalyptus flavour for longer than 3 days, unless otherwise advised by a doctor. If there is no improvement, if you feel worse, or if new symptoms appear, contact your doctor or pharmacist.
Taking more than the recommended dose of Strepsils Intensive with honey and eucalyptus flavour
Contact your doctor or pharmacist immediately or go to the nearest hospital.
Symptoms of overdose include: nausea or vomiting, abdominal pain or, less commonly, diarrhoea.
Tinnitus, headache and gastrointestinal bleeding may also occur.
If you have any further doubts about using this medicine, consult your doctor or pharmacist.
Missing a dose of Strepsils Intensive with honey and eucalyptus flavour
Do not take a double dose to make up for a missed dose.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Stop taking the medicine and contact your doctor immediately if any of the following occur:

• symptoms of allergic reactions, e.g. asthma, unexplained wheezing or shortness of breath, itching, runny nose, skin rash and others,
• swelling of the face, tongue or throat causing difficulty breathing, palpitations and drop in blood pressure leading to shock (may occur even with first use of the medicine),
• severe skin reactions such as blistering and peeling of the skin.

If any of the following symptoms or any adverse effects not listed in this leaflet occur, consult your doctor or pharmacist.
Common (may affect less than 1 in 10 people)

• dizziness, headache
• throat irritation
• oral ulceration or pain in the mouth
• sore throat
• discomfort or unusual sensations in the mouth (such as warmth, burning, tingling, stinging, etc.)
• nausea and diarrhoea
• skin stinging and itching

Uncommon (may affect less than 1 in 100 people)

• drowsiness
• blisters in the mouth or throat, throat numbness
• abdominal distension, abdominal pain, flatulence, constipation, indigestion, vomiting
• dryness in the mouth
• burning in the mouth, taste disturbances
• skin rashes, skin itching
• fever, pain
• feeling drowsy or difficulty sleeping
• worsening of asthma, wheezing, shortness of breath
• reduced sensation in the throat

Rare (may affect less than 1 in 1000 people)

• anaphylactic reaction

Frequency not known (frequency cannot be estimated from available data)

• anaemia, thrombocytopenia (low platelet count, which may cause bruising and bleeding)
• oedema, high blood pressure, heart failure or myocardial infarction
• severe skin reactions, such as blistering reactions, including Stevens-Johnson syndrome and Lyell’s syndrome, and toxic epidermal necrolysis
• hepatitis.

Reporting of adverse effects
If you experience any adverse effects, including any not listed in this leaflet, inform your doctor, pharmacist or nurse.
Adverse effects can also be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C,
02-222 Warsaw,
tel.: 22 49-21-301,
fax: 22 49-21-309,
website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps provide more information on the safety of the medicine.

5. How to store Strepsils Intensive with honey and eucalyptus flavour

• Keep the medicine out of sight and reach of children.
• Do not use this medicine after the expiry date stated on the carton and blister pack after EXP. The expiry date refers to the last day of the stated month.
• Store below 25°C.

Do not dispose of medicines via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information
What Strepsils Intensive with honey and eucalyptus flavour contains
The active substance (the ingredient responsible for the medicine’s action) is flurbiprofen 8.75 mg. The other ingredients are: macrogol 300, potassium hydroxide (E 525), ammonium caramel (E 150c), curcumin (E 100) (containing propylene glycol (E 1520) and polysorbate 80), honey and eucalyptus flavour (containing flavouring preparations, natural flavouring substances, flavouring substances, glyceryl tricetate (E 1518), propylene glycol (E 1520), anise alcohol, benzyl alcohol, benzyl benzoate, cinnamyl cinnamate, benzyl salicylate, cinnamon, cinnamyl alcohol, citral, geraniol, limonene and linalool), potassium acesulfame (E 950), liquid maltitol (E 965) and isomalt (E 953).

What Strepsils Intensive with honey and eucalyptus flavour looks like and contents of the pack
The hard pastilles are round, with an embossed brand logo, and are light brown to yellow in colour, packed in opaque white PVC/PVDC/Aluminium blisters, and contained in cardboard cartons.
The pack contains 8, 16, 24, 32 or 36 hard pastilles. Not all pack sizes may be marketed.
Marketing authorisation holder
Reckitt Benckiser (Poland) S.A.
ul. Okunin 1
05 – 100 Nowy Dwór Mazowiecki
tel. (22) 211 26 92
Importer
RB NL Brands B.V.
Schiphol Boulevard 207
1118BH Schiphol, The Netherlands
This medicine is authorised for sale in the European Economic Area countries under the following names: