Holinex Direct

Package Leaflet: Information for the User

Cholinex Direct, 8.75 mg, Hard Lozenges

Flurbiprofen

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in this package leaflet or as directed by a doctor, pharmacist, or nurse.

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

Table of Contents of the Package Leaflet

• 1. What is Cholinex Direct and what is it used for
• 2. Important information before taking Cholinex Direct
• 3. How to take Cholinex Direct
• 4. Possible side effects
• 5. How to store Cholinex Direct
• 6. Contents of the pack and other information

1. What is Cholinex Direct and what is it used for

Cholinex Direct contains flurbiprofen. Flurbiprofen belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). These medicines work by changing the body's response to pain, swelling, and high temperature.

Cholinex Direct is used for the short-term relief of sore throat symptoms such as irritation, pain, and swelling of the throat, and difficulty swallowing in adults and adolescents over 12 years of age.

If after 3 days there is no improvement or you feel worse, consult a doctor.

2. Important information before taking Cholinex Direct

When not to 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, or if you have ever had an unexpected wheezing, coughing, shortness of breath, or runny nose after taking acetylsalicylic acid or other NSAIDs.
• if you have or have had stomach or intestinal ulcers (two or more episodes of stomach or duodenal ulcers).
• if you have had bleeding or perforation of the digestive tract, severe colitis, or blood disorders associated with previous NSAID treatment.
• 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 it with your doctor or pharmacist.

• if you have ever had asthma or allergies
• if you have tonsillitis (swollen tonsils) or think you may have a bacterial throat infection (as you may need antibiotic treatment)
• 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 there is a greater risk of side effects listed in this package leaflet
• if you are pregnant or breastfeeding
• if you have headache caused by taking painkillers
• if you have an infection - see "Infections" below.

During treatment with Cholinex Direct

• In case of the first signs of skin reaction (rash, peeling) or other symptoms of allergic reaction, stop taking the medicine and consult a doctor immediately.
• Report any unusual abdominal symptoms to your doctor (especially bleeding). If your condition does not improve, worsens, or other symptoms occur, talk to your doctor.
• Taking flurbiprofen may be associated with a small increased risk of heart attack (myocardial infarction) or stroke. Any risk is more likely with high doses and long-term treatment.
• Do not take more than the recommended dose or prolong treatment (3 days).

Infections

Non-steroidal anti-inflammatory drugs (NSAIDs) may mask the symptoms of infection, such as fever and pain.

This may delay appropriate treatment of infections, which may lead to increased risk of complications. If you are taking this medicine during an ongoing infection and your symptoms persist or worsen, consult a doctor or pharmacist immediately.

Children and adolescents

Do not give this medicine to children under 12 years of age.

Cholinex Direct with food, drink, and alcohol

Avoid drinking alcohol while taking Cholinex Direct, as the risk of stomach or intestinal bleeding may be increased.

Pregnancy and breastfeeding

Oral forms (e.g., tablets) of flurbiprofen may cause side effects in the unborn child. It is not known if the same risk applies to Cholinex Direct.

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult a doctor or pharmacist before taking this medicine.

Flurbiprofen belongs to a group of medicines that may impair fertility in women. This effect is reversible after stopping the medicine. It does not seem that occasional use of lozenges affects the chances of getting pregnant, however, if you have problems getting pregnant, consult a doctor before starting treatment.

Do not take Cholinex Direct during the last 3 months of pregnancy. Do not take Cholinex Direct during the first 6 months of pregnancy unless absolutely necessary and advised by a doctor. If treatment is necessary during this period, use the smallest dose for the shortest time.

Driving and using machines

No studies have been conducted on the effects of the medicine on the ability to drive and use machines. However, dizziness and vision 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 told you that you have an intolerance to some sugars, consult a doctor before taking this medicine.

3. How to take Cholinex Direct

Take this medicine always exactly as described in this package leaflet or as directed by a doctor or pharmacist. If you are unsure, consult a doctor or pharmacist.

Recommended dose: Adults and adolescents over 12 years of age:

• 1 lozenge every 3-6 hours, as needed.
• Do not take more than 5 lozenges per day.
• Take 1 lozenge and slowly dissolve it in the mouth.
• While dissolving, always move the lozenge around the mouth.

Use in children:

Do not give these lozenges to children under 12 years of age.

Hard lozenges are intended for short-term use only.Use the smallest effective dose for the shortest duration necessary to relieve symptoms. If you have an infection, consult a doctor or pharmacist immediately if symptoms (such as fever and pain) persist or worsen (see section 2).

If you experience irritation in the mouth, stop taking flurbiprofen.

Do not take Cholinex Direct for more than 3 daysunless advised by a doctor. If there is no improvement or you feel worse, consult a doctor or pharmacist.

Overdose of Cholinex Direct

Immediately consult a doctor or pharmacist or go to the nearest hospital. Symptoms of overdose may include: nausea, vomiting, stomach pain, and diarrhea. It is also possible to experience ringing in the ears, headache, and gastrointestinal bleeding.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

STOP TAKINGthis medicine and contact a doctor immediately if you experience any of the following symptoms:

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

If you experience any of the following symptoms or any other symptoms not listed in this package leaflet, tell your doctor or pharmacist.

Other side effects that may occur:

Common(may affect up to 1 in 10 people):

• dizziness
• headache
• irritation of the throat
• mouth ulcers or mouth pain
• throat pain
• discomfort in the mouth (e.g., burning, heat, tingling, numbness, etc.)
• nausea and diarrhea
• tingling and itching of the skin

Uncommon(may affect up to 1 in 100 people):

• drowsiness
• sleepiness or difficulty sleeping
• worsening of asthma, wheezing, or breathing
• blistering in the mouth and throat
• numbness of the throat
• dryness of the mouth
• burning sensation in the mouth
• disturbances of taste
• bloating
• stomach pain
• gas
• constipation
• indigestion
• vomiting
• reduced sensation in the throat
• fever
• pain
• skin rash, itching

Rare side effects(may affect up to 1 in 1000 people):

• anaphylactic reaction

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

• anemia
• thrombocytopenia (low platelet count, which may cause excessive bruising and bleeding)
• edema
• high blood pressure
• heart failure or heart attack
• severe skin reactions such as: blistering, including Stevens-Johnson syndrome, Lyell's syndrome, and toxic epidermal necrolysis
• hepatitis

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products

Al. Jerozolimskie 181C

02-222 Warsaw

Phone: +48 22 49 21 301

Fax: +48 22 49 21 309

Website: https://smz.ezdrowie.gov.pl

Side effects can also be reported to the marketing authorization holder.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Cholinex Direct

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 blister after "EXP".

The expiry date refers to the last day of the month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help 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 lozenge contains 8.75 mg of flurbiprofen.

The other ingredients are:

Sucrose

Glucose liquid

Macrogol 300

Peppermint oil

Levomenthol

What Cholinex Direct looks like and contents of the pack

Cholinex Direct, 8.75 mg, hard lozenges, are round, transparent to yellowish lozenges, 19±1 mm in diameter.

Hard lozenges are available in PVC/PVDC/Aluminum blisters in a carton box.

Pack sizes: 8, 16, or 24 hard lozenges.

Not all pack sizes may be marketed.

Marketing authorization holder

STADA Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel

Germany

Manufacturer

Lozy’s Pharmaceuticals, S.L.

Campos 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

Netherlands

This medicinal product is authorized in the Member States of 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 8,75mg zuigtabletten

Luxembourg

Flurbiprofen EG 8,75mg pastilles

Germany

Flurbiprofen AL 8,75 mg Lutschtabletten

Italy

NITENS GOLA

Poland

Cholinex Direct

To obtain more detailed information, contact the representative of the marketing authorization holder:

Stada Pharm Sp. z o.o.

ul. Krakowiaków 44

02-255 Warsaw

Phone: +48 22 737 79 20

Date of last revision of the package leaflet: