Lloyflu

Package leaflet: Information for the user

LLOYFLU 500 mg/12.2 mg powder for oral solution

paracetamol/phenylephrine hydrochloride
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 leaflet or as your doctor or pharmacist has told you to do.

• 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 any not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice any improvement or if you notice worsening of symptoms after 3 days.

Contents of this leaflet:

1. What LLOYFLU is and what it is used for
2. What you need to know before taking LLOYFLU
3. How to take LLOYFLU
4. Possible side effects
5. How to store LLOYFLU
6. Contents of the pack and other information

1. What LLOYFLU is and what it is used for

LLOYFLU contains paracetamol, an analgesic that relieves pain and reduces fever, and phenylephrine, a decongestant to relieve nasal congestion.
LLOYFLU is used to relieve symptoms of cold and flu, including relief from pain, headache, nasal congestion, and reduction of body temperature in adults and adolescents over 16 years of age.
Use LLOYFLU only if you have cold and flu accompanied by nasal congestion. If you do not suffer from nasal congestion, monocomponent products containing only paracetamol should be preferred.
Consult your doctor if you do not feel better or feel worse after 3 days.

2. What you need to know before taking LLOYFLU

Do not take LLOYFLU

• if you are allergic to paracetamol and phenylephrine hydrochloride or to any of the other ingredients of this medicine (listed in section 6).
• if you have severe coronary heart disease (a disorder associated with cardiac dysfunction)
• if you have high blood pressure
• if you have glaucoma (an eye disease often associated with increased pressure of the fluid inside the eye)
• if your thyroid gland is overactive (hyperthyroidism)
• if you are taking monoamine oxidase inhibitors or tricyclic antidepressants (for depression), or have taken them within the last 14 days
• if you have severe liver disease (severe hepatic insufficiency)
• if you have acute inflammation of the liver (acute hepatitis)
• if you have alcohol abuse.

Warnings and precautions
Talk to your doctor or pharmacist before taking LLOYFLU if:

• you have Raynaud's phenomenon, a disorder caused by reduced blood circulation in the fingers and toes
• you have diabetes mellitus, a disorder associated with high blood sugar levels
• you have moderate or severe renal impairment
• you have liver function disorders: mild to moderate hepatocellular insufficiency (including Gilbert's syndrome), severe hepatic insufficiency (Child-Pugh >9), acute hepatitis, or are receiving concomitant treatment with medicinal products that impair liver function
• you have haemolytic anaemia (a reduction in red blood cells that may cause the skin to appear pale yellow and lead to weakness or shortness of breath)
• you are dehydrated
• you have alcohol abuse
• you have chronic malnutrition
• you have glutathione depletion due to metabolic deficiencies
• you have asthma and are hypersensitive to acetylsalicylic acid (used to relieve pain or to thin the blood): you may also be hypersensitive to LLOYFLU
• you have an enlarged prostate
• you have a tumour of the adrenal gland (called a phaeochromocytoma).

Important:
This product contains paracetamol. Do not take other products containing paracetamol at the same time. Never take more LLOYFLU than recommended. Doses higher than recommended do not increase pain relief but may cause severe liver damage. Symptoms of liver damage usually appear only after several days. Therefore, after an overdose, it is very important to consult a doctor as soon as possible, even if you feel well. Do not start taking any other medicine for flu, cold or nasal congestion.

Children and adolescents
LLOYFLU is indicated for adults and children over 16 years of age.

Other medicines and LLOYFLU
Do not use LLOYFLU if you are taking monoamine oxidase inhibitors (MAO inhibitors, such as moclobemide or tranylcypromine) or tricyclic antidepressants (such as amitriptyline, amoxapine, clomipramine, desipramine and doxepine), used to treat depression, or if you have taken them within the last 14 days.
Since both active ingredients in LLOYFLU, phenylephrine hydrochloride and paracetamol, may negatively interact with other medicines, inform your doctor or pharmacist about all medicines you may be taking concomitantly, especially:

• medicines that may interfere with phenylephrine, such as those used to treat high blood pressure and cardiac or circulatory disorders, including:
• sympathomimetics, including nasal or eye decongestants
• vasodilators
• alpha- and beta-blockers (e.g. propranolol) and other antihypertensives (such as guanethidine)
• medicines that may enhance the effect of phenylephrine on blood vessels, such as:
• digoxin (for heart conditions)
• tetracyclics (for depression), such as maprotiline
• antidepressants, such as phenelzine, carboxylic acid, nialamide
• medicines for Parkinson’s disease, such as selegiline
• furazolidone (for bacterial infections)
• medicines that may interfere with the hepatic metabolism of the active ingredients in LLOYFLU and increase the toxic effects of paracetamol on the liver, such as:
• alcohol
• barbiturates (sedatives)
• anticonvulsants (for epilepsy), such as phenytoin, phenobarbital, methylphenobarbital and primidone
• rifampicin (for tuberculosis)
• probenecid (for gout)
• medicines that affect the availability of paracetamol in the body, such as:
• anticholinergic medicines (such as glycopyrronium, propantheline)
• metoclopramide or domperidone (for nausea or vomiting)
• cholestyramine (to reduce blood lipid levels)
• isoniazid (for tuberculosis)
• warfarin and other coumarin derivatives (blood thinners), as their anticoagulant effect may be increased by regular, prolonged use of paracetamol, increasing the risk of bleeding; occasional doses of LLOYFLU have no significant effect.
• regular use of paracetamol may increase the toxic effects of zidovudine (AZT) (used to treat HIV)
• the duration of action of chloramphenicol may be prolonged by paracetamol.

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

LLOYFLU with food, drinks and alcohol
Do not consume alcoholic beverages (such as wine, beer, spirits) while taking LLOYFLU.
Alcohol does not enhance the effect of paracetamol, but alcohol may increase the toxic effects of paracetamol on the liver.

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.
LLOYFLU is not recommended during pregnancy and breastfeeding.

Driving and using machines
To date, no reports have been received regarding any negative effects of LLOYFLU on the ability to drive or operate machinery.

LLOYFLU contains sucrose, sorbitol, aspartame and sodium
This medicine contains 17.5 mg of aspartame (E951) per sachet.
Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot remove it properly.
This medicine contains 1 mg of sorbitol (E420) per sachet.
This medicine contains sucrose.
If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.
Each sachet contains 1.8 g of sucrose per dose. This should be taken into account in patients with diabetes mellitus.
This medicine contains less than 1 mmol of sodium (23 mg) per sachet, i.e. essentially “sodium-free”.

3. How to take LLOYFLU

Take this medicine exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is:

Please note that doses higher than those recommended may cause a risk of severe liver damage.

Method of administration
Oral administration, after dissolution in water.
Dissolve the contents of the sachet in a small cup (125 ml) of warm, but not boiling, water. Stir briefly until fully dissolved and drink the clear, lemon-flavoured solution.

Use in children and adolescents
The use of LLOYFLU is not recommended in children and adolescents under 16 years of age.

Elderly
There is no indication that the dose should be modified in elderly patients.
If symptoms persist for more than 3 days or worsen, consult a doctor.

If you take more LLOYFLU than you should
If you or someone else has taken an excessive amount of LLOYFLU, or if you suspect that a child has ingested even part of the contents of a sachet, go immediately to the nearest emergency department or contact your doctor immediately—even if you or the other person feel well—due to the risk of delayed severe liver damage. Take this patient information leaflet, any remaining sachets, and the outer packaging with you to the hospital or doctor, so that healthcare professionals can identify which medicine has been taken.

If you forget to take LLOYFLU
Do not take a double dose to make up for a forgotten dose.

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Most people will not experience any problems, but some may.
The following list includes the side effects of paracetamol and phenylephrine.

Paracetamol
At therapeutic doses, side effects of paracetamol are rare and usually mild in clinical course.

Rare (may affect up to 1 in 1,000 people)

• blood disorders, which may present as unexplained bruising, pallor, or reduced resistance to infections;
• blood dyscrasias, including platelet disorders, reduced counts of specific blood cells (agranulocytosis, leukopenia, thrombocytopenia), hemolytic anemia, pancytopenia;
• altered liver function (elevated liver transaminases);
• liver failure;
• hepatic necrosis;
• jaundice (yellowing of the skin or eyes);
• bronchospasm (difficulty breathing or wheezing);
• allergic or hypersensitivity reactions, including skin rashes, urticaria, itching, sweating, purpura (small bleedings under the skin), angioedema (sudden swelling of the skin and mucosa), anaphylaxis (severe allergic reaction causing breathing difficulties or dizziness).

Very rare (may affect up to 1 in 10,000 people)

• sterile pyuria (urine containing white blood cells, cloudy urine) and renal side effects after prolonged use of high doses of paracetamol;
• acute pancreatitis (inflammation of the pancreas causing severe abdominal or back pain).

Very rare cases of severe skin reactions have been reported.

Phenylephrine

Common (may affect up to 1 in 10 people)

• loss of appetite;
• nausea and vomiting.

Rare (may affect up to 1 in 1,000 people)

• tachycardia (fast heartbeat);
• palpitations (awareness of heartbeat);
• increased blood pressure;
• allergic or hypersensitivity reactions, including skin rashes, urticaria, anaphylaxis (severe allergic reaction causing breathing difficulties or dizziness), and bronchospasm (difficulty breathing or wheezing).

Very rare (may affect up to 1 in 10,000 people)

• insomnia (difficulty sleeping);
• nervousness;
• tremors;
• anxiety;
• restlessness;
• confusion;
• irritability;
• dizziness;
• headache.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can 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 LLOYFLU

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 sachet after "Exp.". The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from light and moisture.
This medicine does not require any special storage temperature.
Stability after reconstitution in warm water: 1 hour.
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 LLOYFLU contains
The active substances are paracetamol and phenylephrine hydrochloride.
Each sachet contains 500 mg of paracetamol and 12.2 mg of phenylephrine hydrochloride
(equivalent to 10.0 mg of phenylephrine base).
The other components are: ascorbic acid, sucrose, aspartame (E951), lemon flavours
(containing: natural lemon oils and flavouring substances identical to natural ones,
maltodextrin, mannitol (E421), gluconolactone, acacia gum, sorbitol (E420), anhydrous colloidal silica, α-tocopherol (E307)), sodium saccharin, anhydrous colloidal silica, citric acid, and sodium citrate.

Description of the appearance of LLOYFLU and pack sizes
LLOYFLU is a white, free-flowing powder with a lemon odour, packed in aluminium laminated paper sachets placed in a cardboard box.
Pack sizes:
6, 10, 20 sachets
It is possible that not all pack sizes are marketed.

Marketing Authorization Holder
Sandoz S.p.A., L.go U. Boccioni 1, 21040 Origgio (VA)
Manufacturer
Hermes Pharma Ges.m.b.H, Allgäu 36, 9400 Wolfsberg, Austria
Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, Sachsen-Anhalt, 39179 Barleben, Germany

This medicinal product is authorized in the European Economic Area countries under the following names:
Northern Ireland Paracetamol/Phenylephrine Hydrochloride 500 mg/12.2 mg Powder for Oral Solution.
Paracetamol/Phenylephrine Hydrochloride 1000 mg/12.2 mg Powder for Oral Solution.
Bulgaria LEKADOL PLUS
Czech Republic LEKADOR 500 MG/12.2 MG
LEKADOR FORTE 1000 MG/12.2 MG
Estonia Swispara
Greece LEKADOL
Spain Paracetamol /Fenilefrina Sandoz 1.000 mg/12.2 mg powder for oral solution EFG
Hungary Paracetamol Fenilefrin Sandoz 500 mg/12.2 mg por belsőleges oldathoz
Paracetamol Fenilefrin Sandoz 1000 mg/12.2 mg por belsőleges oldathoz
Ireland Rosip Decongestant Cold and Flu 500 mg/12.2 mg Powder for oral solution
Rosip Max Strength Decongestant Cold and Flu 1000 mg/12.2 mg Powder for oral solution
Italy LLOYFLU
Lithuania Swispara 500 mg/12.2 mg milteliai geriamajam tirpalui
Swispara 1000 mg/12.2 mg milteliai geriamajam tirpalui
Latvia Swispara 500 mg/12.2 mg pulveris iekšķīgi lietojama šķīduma pagatavošanai
Swispara 1000 mg/12.2 mg pulveris iekšķīgi lietojama šķīduma pagatavošanai
Romania LEKADOL 500 mg/12.2 mg pulbere pentru solutie orală
LEKADOL 1000 mg/12.2 mg pulbere pentru solutie orală
Slovenia LEKADOL COMBO 500 mg/12.2 mg prašek za peroralno raztopino