Package leaflet: Information for the user

JOLASTIC 300 mg/2 mg tablets

paracetamol + chlorpheniramine maleate
Equivalent medicine
Please read all of this leaflet carefully before you take 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 advised you.

Keep this leaflet. You may need to read it again.
If you need more advice or information, consult your pharmacist.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
Contact your doctor if you do not notice any improvement or if your symptoms worsen after 3 days.

Contents of this leaflet

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

1. What JOLASTIC is and what it is used for

JOLASTIC is an analgesic (relieves pain) and antipyretic (reduces fever) containing the active substances paracetamol and chlorphenamine maleate.
JOLASTIC is used for the treatment of symptoms of influenza and the common cold in adults.
Consult your doctor if you do not notice improvement or if you notice worsening of symptoms after 3 days.

2. What you need to know before taking JOLASTIC

Do not take JOLASTIC

if you are allergic to paracetamol or to maleate chlorpheniramine or to any of the other ingredients of this medicine (listed in section 6) or to other antihistamines (substances similar to chlorpheniramine, i.e. medicines used in the treatment of allergies);
during pregnancy and breastfeeding;
if you suffer from severe haemolytic anaemia (a disease caused by the destruction of red blood cells);
if you have a deficiency of a specific enzyme called glucose-6-phosphate dehydrogenase, the lack of which may cause haemolytic anaemia;
if you suffer from severe hepatocellular insufficiency (a disease associated with impaired liver function);
if you have glaucoma (an eye disease often associated with increased pressure of the fluid inside the eye);
in case of prostatic hypertrophy (a disease characterised by an enlarged prostate);
in case of bladder neck obstruction (obstruction of the urinary bladder);
in case of pyloric, duodenal or other gastrointestinal tract stenosis (gastrointestinal diseases characterised by narrowing of specific parts of the digestive system);
in case of urogenital stenosis (narrowing of the urinary and reproductive organs);
if you are currently being treated or have been treated in the previous two weeks with monoamine oxidase inhibitors (MAOIs) (see section “Other medicines and JOLASTIC”).

Warnings and precautions
Talk to your doctor or pharmacist before taking JOLASTIC.
You must not take this medicine for more than 3 consecutive days without consulting your doctor.
If, after a short period of treatment, there is no noticeable improvement, consult your doctor. If you have a fever lasting
for more than three days, or if symptoms do not improve or new symptoms appear within three days, or if symptoms are
accompanied by high fever, exanthema (skin rashes with reddening of the skin), excessive mucus production, or persistent cough, consult your doctor who will establish the correct diagnosis.
Paracetamol
During treatment with paracetamol, before taking any other medicine, you must check whether it contains paracetamol, as serious adverse effects may occur if paracetamol is taken in excessive doses (see also section “If you take more JOLASTIC than you should”).
In addition, before combining with any other medicine, contact your doctor (see also section “Other medicines and JOLASTIC”).
Before starting treatment with JOLASTIC, do not take medicines whose combined use is not recommended (see section “Other medicines and JOLASTIC”).
High or prolonged doses of this product may cause liver disease (liver disease) that poses a high risk to you (see also section “If you take more JOLASTIC than you should”) and serious adverse effects on the kidney and blood.
Since severe allergic reactions to paracetamol have been observed (e.g. anaphylactic shock, see also section “Possible side effects”), at the first signs of an allergic reaction following the use of JOLASTIC, stop treatment and consult your doctor.
Maleate chlorpheniramine
JOLASTIC contains an antihistamine (chlorpheniramine). At normally prescribed doses, antihistamines may cause side effects that vary considerably from person to person and from drug to drug.
The most frequent side effect is sedation (physical and mental relaxation), which may manifest as drowsiness (see also sections “Driving and use of machines” and “Side effects”).
Patients with renal or hepatic (liver) impairment: if you have renal or hepatic impairment, use this medicine with caution.
Elderly
Due to their increased sensitivity to the drug, elderly patients should strictly follow the recommended dosages. In elderly patients receiving antihistamines, side effects such as dizziness, sedation, confusion and hypotension may occur more frequently. Elderly patients are particularly sensitive to the anticholinergic side effects of antihistamines, such as dry mouth and urinary retention (especially in men).
Children and adolescents
The safety and efficacy of JOLASTIC in patients under 18 years of age have not been established.
Other medicines and JOLASTIC
Inform your doctor or pharmacist if you are taking, have recently taken or might take any other medicine.
Inform your doctor if you are being treated with:

rifampicin (an antibiotic);
cimetidine (a medicine used in the treatment of gastric ulcer);
antiepileptic drugs (medicines used to treat epilepsy such as glutethimide, phenobarbital, carbamazepine);
normally harmless doses of paracetamol may cause liver damage if taken together with these medicines. The same applies to substances that are potentially hepatotoxic and in cases of alcohol abuse;
probenecid (a medicine used to treat gout);
oral anticoagulants (medicines used to reduce or block blood clot formation);
chloramphenicol (an antibiotic);
zidovudine (a medicine used to treat HIV patients);
other substances with anticholinergic action (medicines that block the effects of acetylcholine, a substance involved in nerve impulse transmission);
phenytoin (a medicine used to treat seizures);
flucloxacillin (an antibiotic), due to a serious risk of blood and fluid disorders (metabolic acidosis with high anion gap) which must be treated urgently and which may occur particularly in cases of severe renal impairment, sepsis (when bacteria and their toxins circulate in the blood causing organ damage), malnutrition, chronic alcoholism, and when maximum daily doses of paracetamol are used.

The effectiveness of JOLASTIC may be reduced with habitual use of:

anticonvulsant medicines (medicines used to treat seizures, such as in epilepsy);
oral contraceptives (the pill);
colestyramine (a medicine used to treat high cholesterol);
medicines that slow gastric emptying, such as propantheline, as they reduce the rate of paracetamol absorption and delay the onset of its effect.

Do not take JOLASTIC if you are being treated with:

tricyclic antidepressants (medicines used to treat depression);
monoamine oxidase inhibitors (another class of antidepressants such as isocarboxazid, phenelzine and tranylcypromine) or within two weeks after such treatment;
neuroleptics (medicines used to treat mental disorders such as psychosis);
other medicines with central nervous system depressant action (medicines that have a sedative effect on the central nervous system, such as barbiturates, sedatives, tranquillisers, hypnotics);
metoclopramide (a medicine that prevents vomiting).

The use of this product is not recommended if you are being treated with anti-inflammatory medicines.
Like all preparations containing antihistamines, JOLASTIC may mask the early signs of ototoxicity (harmful effects on the ear) of certain antibiotics.
Interference with laboratory tests
If you need to undergo blood tests, bear in mind that administration of paracetamol may interfere with the measurement of uric acid levels (uricemia) and blood sugar levels (glycaemia).
JOLASTIC with food, drinks and alcohol
This product may interact with alcoholic beverages; therefore, you must not take JOLASTIC at the same time as consuming alcohol.
Pregnancy, breastfeeding and fertility
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, you must not use JOLASTIC.
Fertility
No studies have been conducted with JOLASTIC to evaluate effects on fertility in humans.
Driving and use of machines
JOLASTIC may cause drowsiness; you should be aware of this if you drive or perform tasks requiring attention and alertness.
JOLASTIC contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per unit of volume, i.e. it is essentially “sodium-free”.

3. How to take JOLASTIC

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:
Adults: 1 tablet twice daily. For oral use.
JOLASTIC should be taken with water after meals. The tablet must be swallowed whole.
Caution:

do not exceed the stated doses without medical advice;
use this medicine only for short-term treatment. If fever persists or symptoms do not improve within 3 days of treatment, consult your doctor;
consult your doctor if the condition occurs repeatedly. Elderly patients: elderly people should particularly adhere to the stated dosage recommendations.

If you take more JOLASTIC than you should
If you take too much of this medicine, symptoms may include: drowsiness, lethargy (a state of deep sleep with reduced response to normal stimuli), and respiratory depression (reduced breathing activity).
In case of overdose, the paracetamol contained in JOLASTIC may cause hepatic cytolysis (destruction of liver cells), which could lead to massive necrosis (death of liver cells). N-acetylcysteine (a substance that detoxifies the liver), if administered within the first few hours after paracetamol overdose, is effective in limiting liver damage.
In case of ingestion of an excessive amount of tablets, induction of vomiting is recommended or, alternatively, gastric lavage (a procedure which must be performed in hospital by trained personnel). Furthermore, you must be kept under medical observation and receive supportive therapy as directed by a doctor.
If you accidentally ingest an excessive dose of JOLASTIC, contact your doctor immediately or go to the nearest hospital.

If you forget to take JOLASTIC
Do not take a double dose to make up for the forgotten dose.
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 everybody gets them.
For the following side effects, frequency cannot be estimated from the available data.
If you experience any of the following symptoms, STOP taking JOLASTIC IMMEDIATELY and contact your doctor or go to the nearest hospital, where you will be given appropriate and specific treatment:

severe skin reactions presenting as skin rash, some of which have been fatal (including Stevens-Johnson syndrome and toxic epidermal necrolysis, generalized exanthematous pustulosis);
allergic reactions such as:
angioedema (sudden swelling of the skin and mucous membranes);
laryngeal edema (swelling of the larynx);
anaphylactic shock (severe allergic reaction).

Side effects affecting the blood:

thrombocytopenia (reduced number of platelets in the blood);
leucopenia (reduced number of white blood cells in the blood);
anaemia (reduced haemoglobin levels and red blood cells);
agranulocytosis (reduced number of granulocytes in the blood);
pancytopenia (reduced number of all blood cells).

Disorders of the nervous system such as:

drowsiness;
asthenia (weakness);
dizziness;
headache;
inability to concentrate.

With the use of paracetamol, various types and severities of skin reactions have been reported, including cases of:

urticaria (appearance of red patches on the skin);
erythema multiforme (skin inflammation);
photosensitivity (allergic skin reaction following exposure to light).

Other possible side effects may include:

blurred vision;
thickening of bronchial secretions (thicker mucus);
gastrointestinal disorders such as dry mouth and nausea;
changes in liver function and hepatitis (inflammation of the liver);
changes affecting the kidney: acute renal failure (reduced kidney function), interstitial nephritis (inflammation of the kidneys), haematuria (presence of blood in urine), anuria (absence of urine), urinary retention (difficulty passing urine).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or pharmacist. You may also report side effects directly via 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 JOLASTIC

No special storage precautions are required.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after "Exp.". The expiry date refers to the last day of that month.
Do not dispose of any medicine 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 JOLASTIC contains

The active substances are: paracetamol 300 mg; chlorphenamine maleate 2 mg equivalent to chlorphenamine 1.41 mg;
The other excipients are: maize starch, microcrystalline cellulose, povidone, magnesium stearate, sodium carmellose.

Description of the appearance of JOLASTIC and pack contents
JOLASTIC is available in the form of tablets.
The pack contains 20 tablets, packaged in 2 blisters.
Marketing Authorization Holder and Manufacturer
Abiogen Pharma S.p.A.
Via Meucci, 36 – Ospedaletto, Pisa (PI)
Italy