JOLASTIC 300 mg/2 mg Coated Tablet

Зміст інструкції

1. JOLASTIC 300 mg/2 mg tablets
   1. What is JOLASTIC and what is it used for
   2. What you need to know before taking JOLASTIC
   3. How to take JOLASTIC
   4. Possible side effects
   5. How to store JOLASTIC
   6. Contents of the pack and other information

JOLASTIC 300 mg/2 mg tablets

paracetamol + chlorphenamine maleate
Generic medicine

Read this leaflet carefully before taking this medicine as 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.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better or if your symptoms worsen after 3 days.

Contents of this leaflet

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

1. What is JOLASTIC and what is it used for

JOLASTIC is an analgesic (relieves pain) and an antipyretic (reduces fever) that contains the active ingredients 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 any improvement or if your symptoms worsen after 3 days.

2. What you need to know before taking JOLASTIC

Do not take JOLASTIC

• if you are allergic to paracetamol or chlorphenamine maleate or to any of the other ingredients of this medicine (listed in section 6) or to other antihistamines (substances similar to chlorphenamine, i.e. drugs used in the treatment of allergies);
• during pregnancy and breastfeeding;
• if you suffer from severe hemolytic anemia (a disease due to the destruction of red blood cells);
• if you have a deficiency of a specific enzyme called glucose-6-phosphate dehydrogenase, the lack of which can cause hemolytic anemia;
• if you suffer from severe hepatocelluar insufficiency (a disease associated with impaired liver function);
• if you suffer from glaucoma (an eye disease often associated with an increase in the pressure of the fluid inside the eye);
• in case of prostatic hypertrophy (a disease characterized by an increase in the volume of the prostate);
• in case of obstruction of the vesical neck (obstruction of the urinary bladder);
• in case of pyloric, duodenal and other tracts of the gastrointestinal tract stenosis (gastrointestinal diseases characterized by narrowing of specific parts of the digestive tract);
• in case of urogenital stenosis (narrowing at the level of the urinary and reproductive organs);
• if you are or have been in treatment with monoamine oxidase inhibitors (MAOIs) in the two weeks prior (see section “Other medicines and JOLASTIC”).

Warnings and precautions
Consult your doctor or pharmacist before taking JOLASTIC.
You should not take this medicine for more than 3 consecutive days without consulting your doctor.
After a short period of treatment without appreciable results, consult your doctor. If you have a fever for
more than three days or if your symptoms do not improve or new symptoms appear within three days or
are accompanied by high fever, rash (skin eruptions accompanied by redness of the
skin), excessive amount of mucus and persistent cough, consult your doctor who will establish the correct diagnosis.

Paracetamol
During treatment with paracetamol, before taking any other medicine, you should check
that it does not contain paracetamol, as if paracetamol is taken in high doses, serious side effects can occur (see also section “If you take more JOLASTIC than
you should”).
Also, before combining any other medicine, contact your doctor (see also section “Other
medicines and JOLASTIC”).
Before starting therapy with JOLASTIC do not take medicines whose combined use is not recommended (see
section “Other medicines and JOLASTIC”).
High or prolonged doses of the product can cause liver disease (hepatopathy) at high
risk for you (see also section “If you take more JOLASTIC than you should”) and kidney and blood alterations, even serious.
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
resulting from the use of JOLASTIC, stop treatment and consult your doctor.

Chlorphenamine maleate
JOLASTIC contains an antihistamine (chlorphenamine). At normally taken doses, antihistamines
have highly variable side effects from subject to subject and from drug to drug.
The most common side effect is sedation (physical and mental relaxation) which can manifest
with drowsiness (see also sections “Driving and using machines” and “Side
effects”).

Patients with renal or hepatic (liver) insufficiency: if you have renal insufficiency or
hepatic insufficiency, use this medicine with caution.

Elderly
Due to their greater sensitivity to the drug, the elderly should adhere to the indicated dosages. In
elderly patients treated with antihistamines, 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 the age of 18 has not been established.

Other medicines and JOLASTIC
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Tell your doctor if you are being treated with:

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

The effectiveness of JOLASTIC may decrease in case of regular use of:

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

Do not take JOLASTIC if you are being treated with:

• tricyclic antidepressants (drugs used to treat depression);
• monoamine oxidase inhibitors (another class of antidepressant drugs such as isocarboxazide, phenelzine and tranylcypromine) or within two weeks of such treatment;
• neuroleptics (drugs used to treat mental disorders such as psychoses);
• other drugs with a depressive effect on the central nervous system (drugs that have a sedative effect on the central nervous system such as barbiturates, sedatives, tranquilizers, hypnotics);
• metoclopramide (a drug that blocks vomiting).

The use of the product is not advisable if you are being treated with anti-inflammatory drugs.
Like all preparations containing antihistamines, JOLASTIC can mask the first signs of ototoxicity
(harmful effects on the ear) of certain antibiotics.

Interference with laboratory tests
If you are going to have blood tests, keep in mind that the administration of paracetamol may interfere
with the determination of the amount of uric acid (uricemia) and the amount of sugar (glycemia) in
the blood.

JOLASTIC with food, drinks and alcohol
The product may interact with alcohol, therefore you should not take JOLASTIC at the same time
as consuming alcohol.

Pregnancy, breastfeeding and fertility

Pregnancy and breastfeeding
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding with breast
milk, you should not use JOLASTIC.

Fertility
No studies have been conducted with JOLASTIC to evaluate the effects on fertility in men.

Driving and using machines
JOLASTIC can cause drowsiness; you should be aware of this if you are driving vehicles or if
you think you are going to perform operations that require attention and vigilance.

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 following exactly the instructions in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.
The recommended dose is:

Adults: 1 tablet 2 times a day. For oral use.
JOLASTIC should be taken with water after meals. The tablet should be swallowed whole.
Caution:

• do not exceed the indicated doses without the advice of your doctor;
• use this medicine only for short periods of treatment. If the fever persists or symptoms do not improve after 3 days of treatment, consult your doctor;
• consult your doctor if the condition occurs repeatedly. Elderly: particularly the elderly must adhere to the indicated dosages.

If you take more JOLASTIC than you should
In case of taking an excessive dose of the medicine, the following may occur: drowsiness, lethargy
(a state of deep sleep with reduced response to normal stimuli), respiratory depression (reduction
in respiratory activity).
In case of taking an excessive dose of the medicine, the paracetamol contained in JOLASTIC may
cause liver cytolysis (destruction of liver cells) which could lead to massive necrosis
(death of liver cells). N-acetylcysteine (a substance that purifies the liver), administered
within hours of ingestion of an excessive dose of paracetamol, is effective
in limiting liver damage.
In case of ingestion of an excessive amount of tablets, it is advisable to induce vomiting or
possibly undergo gastric lavage (a procedure that must be performed in hospital by
specialized personnel), furthermore, you must be kept under observation and follow a supportive therapy
established by the doctor.
In case of accidental ingestion of an excessive dose of JOLASTIC, immediately inform your doctor
or go to the nearest hospital.

If you forget to take JOLASTIC
Do not take a double dose to make up for a missed dose.
If you have any questions about 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.
For the following side effects, the frequency cannot be defined on the basis of available data.
If you experience any of the following symptoms, STOP usingJOLASTIC immediately and
consult a doctor or the nearest hospital where you will be given appropriate and specific
treatment:

• severe skin reactions that manifest with skin rash, some of which are fatal (including Stevens-Johnson syndrome and toxic epidermal necrolysis, acute 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 (reduction in the number of platelets in the blood);
• leukopenia (reduction in the number of white blood cells in the blood);
• anemia (decrease in the amount of hemoglobin and red blood cells);
• agranulocytosis (decrease in the number of granulocytes in the blood);
• pancytopenia (reduction in the number of all cells present in the blood).

Disorders of the nervous systemsuch as:

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

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

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

Other side effects may be:

• blurred vision;
• thickening of bronchial secretions (more dense mucus);
• gastrointestinaldisorders such as dry mouth and nausea;
• alterations in liverfunction and hepatitis (liver inflammation);
• alterations affecting the kidney: acute renal failure (reduction in kidney function), interstitial nephritis (kidney inflammation), hematuria (presence of blood in the urine), anuria (absence of urine), urinary retention (difficulty in passing urine).

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform
your doctor or pharmacist. You can also report side effects directly through
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 which is stated on the pack after "Exp.". The expiry
date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What JOLASTIC contains

• the active ingredients are: paracetamol 300 mg; chlorphenamine maleate 2 mg equivalent to chlorphenamine 1.41 mg;
• the other excipients are: corn starch, microcrystalline cellulose, povidone, magnesium stearate, sodium carboxymethylcellulose.

Description of the appearance of JOLASTIC and contents of the pack
JOLASTIC is available in tablet form.
The pack contains 20 tablets, packaged in 2 blisters.

Marketing authorisation holder and manufacturer
Abiogen Pharma S.p.A.
Via Meucci, 36 – Ospedaletto, Pisa (PI)
Italy