Package leaflet: Information for the user

Cholinex Direct, 8.75 mg, hard pastilles
Flurbiprofenum
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.
Always take this medicine exactly as described in this patient leaflet or as your doctor, pharmacist, or nurse has instructed you.

Keep this leaflet. You may need to read it again.
If you need advice or more information, consult your pharmacist.
If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.
If there is no improvement after 3 days, or if you feel worse, contact your doctor.

Contents of the leaflet

What Cholinex Direct is and what it is used for
What you need to know before taking Cholinex Direct
How to take Cholinex Direct
Possible side effects
How to store Cholinex Direct
Contents of the pack and other information

1. What Cholinex Direct is and what it is used for
Cholinex Direct contains flurbiprofen. Flurbiprofen belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). These medicines work by altering the body's response to pain, swelling, and fever.
Cholinex Direct is used for the short-term relief of sore throat symptoms such as irritation, pain, swelling of the throat, and difficulty swallowing in adults and adolescents aged 12 years and older.
If there is no improvement after 3 days, or if you feel worse, consult your doctor.

2. What you need to know before taking Cholinex Direct

Do not take Cholinex Direct

if you are allergic to flurbiprofen or any of the other ingredients of this medicine (listed in section 6).
if you have asthma, unexpected breathing sounds, or difficulty breathing, nasal congestion, facial swelling, or skin rash such as hives (urticaria) after taking acetylsalicylic acid or other NSAIDs.
if you have or have had a stomach or intestinal ulcer (two or more episodes of peptic ulceration of the stomach or duodenum).
if you have experienced gastrointestinal bleeding or perforation, severe colitis, or blood disorders associated with previous treatment with NSAIDs.
if you are in the last 3 months of pregnancy.
if you have or have had severe heart, liver, or kidney failure.

Warnings and precautions
Before taking Cholinex Direct, discuss with your doctor or pharmacist:

if you have ever had asthma or allergies
if you have tonsillitis (swollen tonsils) or suspect you may have a bacterial throat infection (as antibiotic treatment may be necessary)
if you have cardiovascular, liver, or kidney disorders
if you have had a stroke
if you have a history of intestinal diseases (ulcerative colitis, Crohn's disease)
if you have high blood pressure
if you have a chronic autoimmune disease (including systemic lupus erythematosus or mixed connective tissue disease)
if you are elderly, as you may be more likely to experience the side effects listed in this leaflet
if you are in the first six months of pregnancy or are breastfeeding
if you have medication-overuse headache
if you have an infection – see section “Infections” below.

While taking Cholinex Direct

If you experience the first signs of a skin reaction (rash, peeling) or other symptoms of an allergic reaction, stop taking the medicine and consult your doctor immediately.
Report any unusual gastrointestinal symptoms to your doctor (especially bleeding). If your condition does not improve, worsens, or new symptoms appear, talk to your doctor.
Use of medicines containing flurbiprofen may be associated with a small increased risk of heart attack (myocardial infarction) or stroke. The risk is greater with higher doses and prolonged treatment.
Do not take higher than recommended doses or extend the treatment period (3 days).

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 are taking this medicine during an ongoing infection and your symptoms persist or worsen, consult your doctor or pharmacist immediately.
Children and adolescents
Do not use this medicine in children under 12 years of age.
Cholinex Direct and other medicines
Tell your doctor or pharmacist about any other medicines you are currently taking, have recently taken, or plan to take, including those obtained without a prescription.
In particular, inform your doctor if you are taking:

acetylsalicylic acid in low doses (up to 75 mg per day)
medicines used to lower blood pressure or treat heart failure (antihypertensives, cardiac glycosides)
diuretics (including potassium-sparing diuretics)
blood-thinning medicines (anticoagulants, antiplatelets)
medicines used to treat gout (probenecid, sulfinpyrazone)
other NSAIDs or corticosteroids (e.g. celecoxib, ibuprofen, sodium diclofenac, prednisolone)
mifepristone (used for medical termination of pregnancy)
quinolone antibiotics (e.g. ciprofloxacin)
cyclosporine or tacrolimus (immunosuppressive medicines)
phenytoin (used to treat epilepsy)
methotrexate (used to treat autoimmune diseases or cancer)
lithium or selective serotonin reuptake inhibitors (medicines used to treat depression)
oral antidiabetic medicines (used to treat diabetes)
zidovudine (used to treat HIV infection).

Cholinex Direct with food, drink, and alcohol
Avoid drinking alcohol while taking Cholinex Direct, as the risk of gastrointestinal bleeding may be increased.
Pregnancy and breastfeeding
Oral forms (e.g. tablets) of flurbiprofen may cause adverse effects in the unborn child. It is not known whether the same risk applies to Cholinex Direct.
If you are pregnant, breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Flurbiprofen belongs to a group of medicines that may impair fertility in women. This effect is reversible upon discontinuation of the medicine. Occasional use of pastilles is unlikely to affect fertility; however, if you have difficulty becoming pregnant, consult your doctor before starting treatment.
Do not use Cholinex Direct during the last 3 months of pregnancy. Do not use Cholinex Direct during the first 6 months of pregnancy unless absolutely necessary and prescribed by a doctor. If treatment is required during this period, use the lowest effective dose for the shortest possible duration.
Driving and using machines
No studies have been conducted on the effect of this medicine on the ability to drive or operate machinery. However, dizziness and visual disturbances are possible side effects of NSAIDs. If these occur, patients should not drive or operate machinery.
Cholinex Direct contains sucrose and glucose
This medicine contains sucrose and glucose. If your doctor has informed you that you have an intolerance to certain sugars, consult your doctor before taking this medicine.

3. How to take Cholinex Direct

This medicine should always be taken exactly as described in this patient information leaflet or as directed
by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Recommended dose: Adults and adolescents aged 12 years and above:

1 tablet every 3–6 hours, if needed.
Do not take more than 5 tablets per day.
Take 1 tablet and allow it to dissolve slowly in the mouth.
The tablet should always be moved around the mouth while dissolving.

Use in children:
Do not give these tablets to children under 12 years of age.
The hard tablets are intended for short-term use only. Use the lowest effective dose for the shortest duration necessary to relieve symptoms. In case of infection, consult a doctor or pharmacist immediately if symptoms (such as fever and pain) persist or worsen (see section 2).
If irritation in the mouth occurs, discontinue use of flurbiprofen.
Do not use Cholinex Direct for longer than 3 days unless otherwise advised by a doctor.
If there is no improvement or symptoms worsen, or if new symptoms appear, consult your doctor or pharmacist.
Taking more than the recommended dose of Cholinex Direct
Seek immediate medical advice from a doctor or pharmacist, or go to the nearest hospital. Symptoms of overdose may include: nausea, vomiting, stomach pain, and less commonly diarrhoea. Tinnitus (ringing in the ears), headache, and gastrointestinal bleeding may also occur.
If you have any further doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
STOP USING this medicine and contact your doctor immediately if any of the following symptoms occur:

Signs of allergic reactions, such as: asthma, unexpected wheezing or shortness of breath, itching, runny nose, skin rash, etc.
Swelling of the face, tongue or throat causing difficulty in breathing, rapid heartbeat and drop in blood pressure leading to shock (these may occur even after the first dose of the medicine).
Severe skin reactions such as: peeling, blistering or shedding of the skin.

If any of the following symptoms occur, or if any symptoms not listed in this leaflet appear, inform your doctor or pharmacist.
Other possible adverse reactions include:
Common (may occur in fewer than 1 in 10 people):

dizziness
headache
sore throat
mouth ulcers or mouth pain
throat pain
oral discomfort (e.g. burning or warm sensation in the mouth, tingling, pricking, etc.)
nausea and diarrhoea
skin tingling and itching

Uncommon (may occur in fewer than 1 in 100 people):

drowsiness
sleepiness or difficulty sleeping
worsening of asthma, wheezing or breathing difficulties
blistering in the mouth or throat
throat numbness
dryness of the oral mucous membrane
burning sensation in the mouth
taste disturbances
bloating
stomach pain
flatulence
constipation
indigestion
vomiting
reduced throat sensation
fever
pain
skin rash, itchy skin

Rare adverse reactions (may occur in fewer than 1 in 1,000 people):

anaphylactic reaction

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

anaemia
thrombocytopenia (low platelet count, which may lead to excessive bruising and bleeding)
oedema
high blood pressure
heart failure or heart attack
severe forms of skin reactions such as: blistering skin lesions, including Stevens-Johnson syndrome, Lyell's syndrome (toxic epidermal necrolysis), and toxic epidermal necrolysis
hepatitis

Reporting of adverse reactions
If any adverse reactions occur in the patient, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department for Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Cholinex Direct

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack following "EXP".
The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use.
This helps protect the environment.
Do not store above 30°C.

6. Contents of the pack and other information

What Cholinex Direct contains
The active substance is flurbiprofen. One hard pastille contains 8.75 mg of flurbiprofen.
The other ingredients are:
Sucrose
Liquid glucose
Macrogol 300
Peppermint oil
Levomenthol

What Cholinex Direct looks like and contents of the pack
Cholinex Direct 8.75 mg, hard pastilles, are round, transparent to yellowish pastilles with a diameter of 19±1 mm.
The hard pastilles are available in PVC/PVDC/Aluminium blister packs in a cardboard carton.
Pack sizes: 8, 16 or 24 hard pastilles.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany

Manufacturer
Lozy’s Pharmaceuticals, S.L.
Campus Empresarial s/n
31795 Lekaroz Navarra
Spain
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany
Centrafarm Services B.V.
Van de Reijtstraat 31-E
4814 NE Breda
The Netherlands

This medicinal product is authorised in the European Economic Area under the following names:
Spain: Buccostad flurbiprofeno 8.75 mg pastillas para chupar sabor menta
Netherlands: Kruidvat flurbiprofen mint 8.75 mg, zuigtabletten
Belgium: Flurbiprofen EG 8.75 mg zuigtabletten
Luxembourg: Flurbiprofen EG 8.75 mg pastilles
Germany: Flurbiprofen AL 8.75 mg Lutschtabletten
Italy: NITENS GOLA
Poland: Cholinex Direct

For further information, please contact the Marketing Authorisation Holder:
Stada Pharm Sp. z o.o.
ul. Krakowiaków 44
02-255 Warszawa
Tel. +48 22 737 79 20