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.
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.
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.
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.
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.
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.