Package leaflet: Information for the patient

RofixDol Gola 8.75 mg tablets, lemon and honey flavour

Flurbiprofen
Please read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed.

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 your symptoms worsen after a short period of treatment.

Contents of this leaflet:

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

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

RofixDol Gola contains the active substance flurbiprofen, which belongs to a class of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). These medicines are used to relieve pain and inflammation.
RofixDol Gola is used to relieve symptoms such as irritation and/or inflammation of the mouth and pharynx (e.g. gingivitis, stomatitis, pharyngitis).
Consult your doctor if you do not feel better or if you feel worse after short periods of treatment.

2. What you need to know before taking RofixDol Gola

Do not take RofixDol Gola

if you are allergic to flurbiprofen, to other non-steroidal anti-inflammatory drugs (NSAIDs), to aspirin (acetylsalicylic acid), or to any of the other ingredients of this medicine (listed in section 6);
if you have previously experienced allergic reactions such as asthma and/or skin rashes, wheezing after taking this medicine or other medicines belonging to the category of non-steroidal anti-inflammatory drugs (NSAIDs) or aspirin (acetylsalicylic acid);
if you have suffered from bleeding due to stomach or intestinal injuries (gastrointestinal hemorrhage) or perforations caused by treatment with medicines belonging to the category of non-steroidal anti-inflammatory drugs (NSAIDs);
if you currently have or have previously had intestinal inflammation characterized by lesions (ulcerative colitis);
if you suffer from Crohn's disease, a chronic inflammatory bowel disease;
if you have had or have had two or more episodes of stomach or intestinal injuries or bleeding (recurrent peptic ulcer or gastrointestinal hemorrhage);
if you suffer from serious heart problems (severe heart failure);
if you are in the last three months of pregnancy (see "Pregnancy and breastfeeding").

Do not give this medicine to children under 12 years of age (see "Children").
Warnings and precautions
Talk to your doctor or pharmacist before taking RofixDol Gola if:

you have kidney, heart or liver problems;
you have had asthma problems (bronchial asthma);
you have suffered from stomach or intestinal injuries (peptic ulcer) or other stomach and intestinal diseases;
you are already taking other non-steroidal anti-inflammatory drugs (NSAIDs) (see "Other medicines and RofixDol Gola");
you are elderly (because you are more likely to experience adverse effects, particularly bleeding and perforation of the digestive tract, which can be life-threatening);
you have an infection – refer to the section "Infections" below.

While using RofixDol Gola:

inform your doctor of any unusual abdominal symptoms (bleeding);
stop treatment and consult your doctor, who may prescribe appropriate therapy if local irritation symptoms occur.

Do not use this medicine for prolonged periods. If there is no noticeable improvement after a short course of treatment, consult your doctor.
Infections
Non-steroidal anti-inflammatory drugs (NSAIDs) may mask signs of infections such as fever and pain. This could delay appropriate treatment of the infection, thereby increasing the risk of complications. If you take this medicine during an infection and infection symptoms persist or worsen, contact your doctor or pharmacist immediately.
Adverse effects can be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms (see "How to take RofixDol Gola").
Children
This medicine must not be given to children under 12 years of age (see "Do not take RofixDol Gola").
Other medicines and RofixDol Gola
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, if you are already taking:

aspirin (acetylsalicylic acid), as adverse effects may increase;
antiplatelet agents (used to prevent and treat blood clots);
selective serotonin reuptake inhibitors (SSRIs) (used to treat depression);
corticosteroids (used to reduce inflammation);
other NSAIDs, including selective cyclooxygenase-2 inhibitors (used for pain and inflammation).

The adverse effects of RofixDol Gola, especially those affecting the gastrointestinal tract, may be increased if taken concurrently with certain medicines.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Oral formulations (e.g. tablets) of flurbiprofen may cause adverse effects in the unborn child. It is not known whether the same risk applies to RofixDol Gola.
Do not take RofixDol Gola during the last three months of pregnancy.
Do not take RofixDol Gola during the first 6 months of pregnancy unless absolutely necessary and under medical advice. If treatment is necessary during this period, you should take the lowest dose for the shortest possible time.
Use of this medicine during pregnancy may delay the onset of labor and prolong its duration.
Breastfeeding
Administration of flurbiprofen is not recommended during breastfeeding. If you are breastfeeding, consult your doctor or pharmacist before using this medicine.
Driving and using machines
The use of this medicine does not affect or only negligibly affects the ability to drive or operate machinery.
RofixDol Gola contains glucose and sucrose
This medicine contains glucose and sucrose, two types of sugars.
If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.

3. How to take RofixDol Gola

Take this medicine exactly as stated in this leaflet or according to the instructions provided by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is: 1 tablet every 3–6 hours, as needed. Do not exceed a dose of
8 tablets in 24 hours.
Allow the tablet to dissolve slowly in the mouth.
Use in children: Do not administer to children under 12 years of age.
Use in elderly patients: No dose adjustment is necessary.
Warning: Do not exceed the recommended doses without medical advice. Use only for short-term treatment.
The lowest effective dose for the shortest duration necessary to relieve symptoms should be used. If you have an infection, contact your doctor or pharmacist immediately if symptoms (such as fever and pain) persist or worsen (refer to section 2).
Contact your doctor or pharmacist if you do not notice any improvement, if your condition worsens, or if you develop new symptoms.
If you take more RofixDol Gola than you should
Due to the low content of active substance and its local action, overdose is unlikely. Symptoms of overdose may include nausea, vomiting, and gastrointestinal disturbances (gastrointestinal irritations).
In case of accidental ingestion or overdose, contact your doctor immediately or go to the nearest hospital.
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 everyone experiences them.
The following side effects have been reported, particularly after administration of systemic formulations (oral, parenteral):

decrease in blood platelets (thrombocytopenia);
decreased production of blood cells (aplastic anaemia);
decrease in white blood cells (agranulocytosis);
severe allergic reaction (anaphylaxis) which may cause breathing difficulties or shock, skin swelling, especially around the mouth and eyes (angioedema), and allergic reaction;
dizziness and vertigo, confusion, severe headache (migraine), and hallucinations;
cardiovascular disorders, such as stroke (cerebrovascular accidents);
visual disturbances and inflammation of the optic nerve (optic neuritis);
tingling or altered sensation in limbs or other body parts (paraesthesia);
depression;
discomfort, feeling of fatigue and drowsiness;
hearing disorders, such as perception of ringing sounds in the ear (tinnitus);
difficulty breathing (asthma, bronchospasm, dyspnoea);
nausea, vomiting, diarrhoea;
increased intestinal gas (flatulence);
constipation;
digestive difficulties (dyspepsia) and abdominal pain;
presence of blood in stools or dark stools (melena);
presence of blood clots in vomit (haematemesis);
inflammation of the oral cavity with lesions (ulcerative stomatitis);
gastrointestinal bleeding and worsening of colitis (inflammation of the colon) and Crohn's disease (chronic inflammatory bowel disease);
inflammation of the stomach (gastritis);
stomach disorders characterised by lesions (peptic ulcer), perforation and ulcer bleeding;
skin irritation, such as rash, pruritus, urticaria;
skin disorder manifesting with bleeding lesions (purpura);
skin inflammations manifesting with blister formation (bullous dermatoses), including Stevens-Johnson syndrome, toxic epidermal necrolysis, and erythema multiforme;
kidney toxicity, including kidney inflammation (interstitial nephritis);
protein retention in the blood, fluid accumulation (oedema), and increased cholesterol (hypercholesterolaemia), a condition known as nephrotic syndrome.

The use of this medicine, especially if prolonged, may lead to sensitisation or local irritation phenomena, including a sensation of warmth or tingling in the oropharynx.
Following the instructions provided in this leaflet reduces the risk of side effects.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please contact 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 RofixDol Gola

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp". The expiry date refers to the last day of that month.
Do not dispose of medicines 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 RofixDol Gola contains

The active substance is: flurbiprofen. Each tablet contains 8.75 mg of flurbiprofen.
The other components are: sucrose, glucose, macrogol, potassium hydroxide, lemon flavour, levomenthol, honey.

Description of the appearance of RofixDol Gola and contents of the pack
RofixDol Gola is presented as tablets contained in blisters.
Pack sizes: 16 or 24 tablets.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Pool Pharma S.r.l. – Via Basilicata, 9 – 20098 San Giuliano Milanese (MI)
Manufacturer
DOPPEL Farmaceutici S.r.l. - Via Volturno, 48 - 20089 Quinto de’ Stampi – Rozzano (MI)
LOZY'S PHARMACEUTICALS, S.L. Campus empresarial, 1, 31795 Lekaroz (Navarra) – SPAIN