TOP
PARACETAMOL NIDERAN
500mg tablets
PARACETAMOL
This leaflet contains important information for you. Read it carefully. This medicine can be acquired with no medical prescription. Nevertheless, you must carefully take Paracetamol Nideran to obtain the due outcome.
Keep this leaflet. You may need to read it again.
If you need any clarification or advice, ask your pharmacist.
If the symptoms worsen or persist, after 5 days for children or 7 days for adults, go to your doctor.
If any of the side effects worse or persists or if you notice any side effects not mentioned on this leaflet, tell your doctor or pharmacist.
1. WHAT PARACETAMOL NIDERAN IS AND WHAT IT IS USED FOR
2. BEFORE YOU TAKE PARACETAMOL NIDERAN
3. HOW TO TAKE PARACETAMOL NIDERAN
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE PARACETAMOL NIDERAN
6. OTHER INFORMATION
1. WHAT PARACETAMOL NIDERAN IS AND WHAT IT IS USED FOR

Paracetamol NIDERAN is used on the treatment of clinical situations which require an analgesic (use to eliminate or relieve pain) and/or an antipyretic (used to reduce fever).
Thus, this medicine may be used on the treatment of:
flus or colds
light to moderate pain, such as muscle pain, headaches, toothaches and sore throats
fever with a duration inferior to 3 days.

2. BEFORE YOU TAKE PARACETAMOL NIDERAN

BEFORE YOU TAKE PARACETAMOL NIDERAN, YOU MUST READ THIS SECTION AND EXPOSE ANY DOUBTS YOU MIGHT HAVE TO YOUR DOCTOR OR PHARMACIST.

DO NOT TAKE PARACETAMOL NIDERAN
This medicine is contraindicated on the following situations:
if you’re allergic to paracetamol, the active substance of this medicine, or to any of the ingredients of Paracetamol Nideran
if you suffer from any liver disease
if you suffer from any severe hereditary disease characterized by a dehydrogenase glucose-6-fosfate deficiency.
Don’t take this medicine if any of the above-mentioned situations applies to you. If you are unsure, talk to your doctor or pharmacist first, before taking Paracetamol Nideran.

TAKE SPECIAL CARE WITH PARACETAMOL NIDERAN
if you suffer from a kidney or liver failure
if you suffer from Gilbert’s syndrome (rare metabolic hereditary disease)
if you have a fever for more than 3 days, high fever (higher than 39ºC) or recurrent fever
if you are taking other medicine which contains paracetamol
if you regularly and continuously consume great quantities of alcohol (alcoholism).
If any of the above-mentioned situations applies to you, talk to your doctor or pharmacist before you take Paracetamol Nideran.

TAKING PARACETAMOL NIDERAN WITH OTHER MEDICINES
Tell your pharmacist if you are taking any of the following medicines:
sedatives
antiepileptics (used for epiclesis)
oral anticoagulants (used to thinner the blood)
rifampicin (used for the treatment of tuberculosis)
chloramphenicol (antibiotic)
cholestyramine (used to control cholesterol). Take Paracetamol Nideran 1 hour before or 4 hours after taking cholestyramine
zidovudine (used on the treatment of viral diseases)
medicine which increase the gastric emptying, such as metoclopramide or domperidone.

The administration of these medicines with Paracetamol Nideran may increase the occurrence of side effects or influence the therapeutic effect of paracetamol or of the mentioned medicines.

Tell your doctor or pharmacist if you are taking or have recently taken other medicines, including medicines obtained with no medical prescription.

TAKING PARACETAMOL NIDERAN WITH FOOD AND DRINKS
Taking Paracetamol Nideran after meals delays the onset of action of this medicine

PREGNANCY AND BREASTFEEDING
Consult your doctor or pharmacist before you take any medicine.

PREGNANCY
You shouldn’t take Paracetamol Nideran during your pregnancy without talking to your doctor first.

BREASTFEEDING
You may take Paracetamol Nideran while breastfeeding. Paracetamol Nideran is excreted on the breast milk, but on insignificant amounts for the baby being breastfed.

DRIVING VEHICLES AND USING MACHINES
You may drive vehicles and use machines during the treatment with this medicine.

3. HOW TO TAKE PARACETAMOL NIDERAN

Always take Paracetamol Nideran exactly as described in this leaflet. Talk to your doctor or pharmacist if you have any doubts.
Swallow the full tablet or dissolved on a glass of water.

ADULTS AND CHILDREN OVER 12 YEARS OLD:
The usual dose is 1 to 2 tablets, 3 to 4 times a day with minimum intervals of 4 hours.
The maximum dose is 8 tablets per day.
CHILDREN BETWEEN 10 AND 12 YEARS OLD:
The usual dose is 1 tablet, 1 to 4 times a day with minimum intervals of 4 hours.
The maximum dose is 4 tablets per day.
Talk to your doctor or pharmacist if you think that Paracetamol Nideran is too strong or too weak.

DURATION OF THE TREATMENT
Paracetamol Nideran must not be taken for more than 5 days by children or 7 days by adults, without medical advice.

IF YOU TAKE MORE PARACETAMOL NIDERAN THAN YOU SHOULD
Immediately contact the emergency service of the closest hospital if you have accidentally taken too many tablets or if other person or child took your medicine, even if they do not show any symptom. Take the package of Paracetamol Nideran with you.
In the case of overdose, the following symptoms may occur:
nausea
vomiting
transpiration
drowsiness
discomfort
strong abdominal pain

IF YOU FORGET TO TAKE PARACETAMOL NIDERAN
Never take a double dose to compensate a dose you missed. If you forgot to take a dose, take it as soon as you remember and then continue the medicine as usual. Nevertheless, if it is almost time for the next dose, don’t take the missing dose and follow the normal schedule.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Paracetamol Nideran may cause side effects, although not everybody gets them.

In rare cases, this medicine may cause a severe allergic reaction characterized by:
located swelling
muscle spasms on the respiratory tract
breathing difficulties
transpiration
nausea
blood pressure drop.
If you feel any of these symptoms, stop taking Paracetamol Nideran and go to the closest hospital’s emergency.

Frequent side effects (1 to 10 in 100 people treated):
nausea
vomiting.

Infrequent side effects (1 to 10 in 1.000 people treated):
burning sensation on the pharynges
diarrhea
abdominal pain
constipation.

Rare side effects (1 to 10 in 10.000 people treated):
skin allergies, with itchiness, spots and inflammation
skin redness.

Very rare side effects (less than 1 in 10.000 people treated):
disturbances on blood formation, such as thrombocytopenia, leucopenia, isolated cases of agranulocytosis and pancytopenia
bronchospasm (analgesic asthma).

If any of the side effects worsen or if you notice any side effects not mentioned on this leaflet, tell your doctor or pharmacist.

5. HOW TO STORE PARACETAMOL NIDERAN
Keep this medicine out of the sight and reach of children.
No special storage conditions are required.
Do not use this Paracetamol Nideran after the expiry date which is stated on the package. The expiry date refers to the last day of that month. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. OTHER INFORMATION

WHAT PARACETAMOL NIDERAN CONTAINS
The active substance of this medicine is paracetamol. Each Paracetamol Nideran tablet contains 500 mg of paracetamol.
The other components are: gelatinized starch, povidone and stearic acid.

WHAT PARACETAMOL NIDERAN LOOKS LIKE AND THE CONTENTS OF THE PACK
Paracetamol Nideran is presented as tablets, available on packages of 10 or 20 tablets. It is possible that not all presentations are sold.

MARKETING AUTHORIZATION HOLDER
toLife - Produtos Farmacêuticos, S.A.
Av. do Forte, 3, Edif. Suécia IV, Piso 0
2794-093 Carnaxide
Portugal

MANUFACTURER
Generis Farmacêutica, S.A.
Rua João de Deus, 19
2700-487 Amadora

Detailed and updated information on this medicine is available through the scan of the 2D code included on the package with a smartphone. The same information is also available on the following URL: https://www.tolifeotc.com/nideran.

This leaflet was last approved on May 2019.