Read all of this leaflet carefully before you start taking this
medicine because it contains important information for you.
* Keep this leaflet. You may need to read it again.
* If you have any further questions, ask your doctor or
pharmacist.
* This medicine has been prescribed for you only.
Do not pass it on to others. It may harm them, even if their
signs of illness are the same as yours.
* If you get any side effects talk to your doctor or pharmacist.
This includes any possible side effects not listed in this leaflet.
WHAT INFORMATION DOES THIS LEAFLET PROVIDE?
1 .What is PARAFLEX and what is it used for?
2.What do you need to know before you take PARAFLEX?
3.How to take PARAFLEX?
4.What are the Possible side effects of PARAFLEX?
5.How to store PARAFLEX?
6.Further information about PARAFLEX tablets
1.WHAT PARAFLEX IS AND WHAT IS USED FOR?
PARAFLEX 500mg tablet is an analgesic and antipyretic
(Painkiller) medication available over the counter. It is used for the
temporary relief of mild to moderate pain, including headaches,
migraines, toothaches, menstrual cramps, and musculoskeletal pain.
Additionally, it is used to reduce fever associated with cold and flu
symptoms. To ensure its effectiveness and avoid any complications, it
is crucial to take this medicine only as directed and not exceed the
recommended dosage without consulting a healthcare professional.
2.WHAT DO YOU NEED TO KNOW BEFORE YOU TAKE PARAFLEX?
Avoid taking PARAFLEX:
•If you are allergic to the active ingredient or any of the other
ingredients in your medicine listed in section 6.
•If you are currently taking any medicine, whether it's prescription or
non-prescription, that contains paracetamol, please be aware and
inform your healthcare provider.
WARNINGS AND PRECAUTIONS
-Hepatic and Renal Considerations:
Administer paracetamol judiciously in patients manifesting hepatic
impairment, active liver diseases, or renal complica tions, given that
paracetamol undergoes metabolism in the liver and subsequent
renal excretion.
-Glutathione-Depleted States:
Exercise caution when prescribing paracetamol to patients in a
glutathione-depleted state, such as those with sepsis or severe
infections. There is an elevated risk of metabolic acidosis in these
patients. If patients exhibit symptoms like rapid, deep breathing
coupled with nausea, vomiting, or loss of appetite, medical
consultation is imperative.
-Recommended dosage limits:
Do not exceed the maximum recommended daily dose of
paracetamol (4g/day).
-Contraindications:
Hypersensitivity to Paracetamol or any of the constituents.
-Contact a doctor immediately:
If you get a combination of these symptoms .You may need to avoid
using this product altogether or limit the amount of paracetamol that
you take.
-PARAFLEX and Other medicine:
Please tell your doctor or pharmacist if you are taking or have recently
taken any other medicines. This is due to the potential interactions of
paracetamol with other medicinal substances, which may influence
their efficacy or how paracetamol functions.
-While taking PARAFLEX You should not take any other medicines
which contain paracetamol:
This includes some painkillers, and cough and cold remedies.
-Please inform your doctor if you are taking any of the following
medicines:
•Flucioxacillin (antibiotic); due to a serious risk of blood and fluid
abnormality (High Anion Gap Metabolic Acidosis) HAGMA, the risk may
be greater in patients with additional risk factors: severe renal
impairment, sepsis, malnutrition, and chronic alcoholism.
•Metoclopramide or domperidone (Prokinetic drug); used to stop you
from feeling sick (nausea) or being sick (vomiting).
•Cholestyramine for lowering blood cholesterol levels; the effect is
minimal if cholestyramine is administered one hour after paracetamol.
•If you are taking anticoagulants like warfarin (blood thinner);
paracetamol may enhance the anticoagulant effect of vitamin K
antagonist.
-Paracetamol with alcohol:
The concomitant use of paracetamol with alcohol may enhance the
hepatotoxic effect of paracetamol.
-Pregnancy and breast-feeding:
Tell your healthcare provider if you are pregnant or plan to become
pregnant. If necessary, paracetamol can be used during pregnancy.
Paracetamol can be taken if you are breastfeeding. Small amounts of
paracetamol pass into breast milk.
Use the lowest possible dose that reduces your pain and/or fever and
use it for the shortest time possible. Contact your doctor or midwife if
the pain and/or fever are not reduced or if you need to take this
medicine more often.
3.HOW TO TAKE PARAFLEX?
Do not take more than the recommended dose.
If you need to use this medicine for more than 3 days at a time, see
your doctor.
Should not be given to children under 10 years of age. Contact your
healthcare professional if your symptoms get worse or do not
improve.
Direction for use:
•For Oral Use Only.
•Swallow the tablets with a whole drink of water.
Adults and children aged 16 years old and over.
•The usual dose of paracetamol is 2 tablets every 4-6 hours.
•Do not take more than 8 tablets within 24 hours. Children aged 10 to 16
years old.
•Give 1 tablet every 4 to 6 hours when necessary to a maximum of 4
tablets in 24 hours.
If you take more paracetamol than you should:
•Immediate medical advice should be sought in the event of an
overdose even if you feel well. This is because too much paracetamol
can cause delayed, serious liver damage.
•Early symptoms may include pallor, nausea, vomiting, diaphoresis
(increased sweating), and general malaise.
The recommended treatment in such cases is:
•Giving the patient activated charcoal if the overdose has been
ingested within the previous hour.
•Giving the patient N-acetylcysteine or methionine within 10-12 hours
of ingestion.
•Instituting supportive treatment that includes maintaining fluid and
electrolyte balance.
If you forgot to take PARAFLEX
If you forgot to take a dose at the right time, take it as soon as you
remember. However, do not take a double dose to make up a
forgotten dose. Remember to leave at least 4 hours between doses.
4.WHAT ARE THE POSSIBLE SIDE EFFECTS OF PARAFLEX?
Paracetamol is generally well tolerated when taken within the
recommended dosage. But like all medicines, this product can cause
side effects, although not everybody gets them.
An allergic reaction (very rare); symptoms may include skin rash,
breathing problems, angioedema (swelling of the hands, feet, ankles,
lips, tongue, throat, or face), Steven Johnson syndrome, unexplained
bruising or bleeding.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet. By reporting
side effects, you can help provide more information on the safety of
this medicine.
5. HOW TO STORE PARACETAMOL?
•Keep out of reach of children.
•Store below 30°C.
•Keep your medicine in a cool dry place and away from light in
the original package to protect it from moisture.
•Do not use this medicine after the expiry date which is stated on
the outer packaging. The expiry date refers to the last day of that
Date of Revision: 11 February 2025 month.
•Do not use this medicine if you notice any visible signs of
deterioration.
•Do not throw away any medicines via wastewater. Ask your
pharmacist how to throw away medicines you no longer use. These
measures will help protect the environment.
6. FURTHER INFORMATION ABOUT PARAFLEX TABLETS
PARAFLEX are white oblong, secable tablets
with UBSA engraved on one side.
Each tablet contains 500mg of paracetamol.
Excipients: Pregelatinized Starch, Polyvinyl Pyrrolidone K-30,
Croscaramellose sodium, Magnesium Stearate.
PARAFLEX tablets are packed in PVC/Alu blisters.
Box of 20 tablets.
Box of 1000 tablets.
Date of Revision: April 23, 2025
Paracetamol 500 mg Tablets
Analgesic, Antipyretic
Marketing Authorisation Holder,
Manufacturer
PARAFLEX 500mg 20 tablets Reg. N°: 114725/1
PARAFLEX 500mg 1000 tablets Reg. N°: 114625/1
This is a medicine:
- A medicine is a product which
affects your health and its consumption
contrary to instructions is dangerous for
you.
- Follow strictly the doctor's prescription,
the method of use and the instructions of
the pharmacist who dispensed the
medicine.
- The doctor and the pharmacist are the
experts in medicine, their benefits and
risks.
- Do not by yourself interrupt the period
of treatment prescribed.
- Do not repeat the same prescription
without consulting your doctor.
- Keep all medicines out of reach of
children.
Council of Arab Health Ministers
Union of Arab pharmacists
PI034/01
