1 g film-coated tablets
Paracetamol
What Paracetamol Alternova is and what it is used for
Paracetamol Alternova contains paracetamol which belongs to a group of medicines called analgesics (painkillers). Paracetamol Alternova is used for mild to moderate pain and lower fever.
Paracetamol Alternova is used for aches and pains of various kinds (eg headache, toothache, menstrual pain, muscle, and joint pain, and rheumatic pain) and fever (eg for colds).
Paracetamol Alternova can be used by people with sensitive stomachs or ulcers and people with an increased tendency to bleed.
Paracetamol contained in Paracetamol Alternova may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professionals if you have any further questions, and always follow their instructions.
What you need to know before you use Paracetamol Alternova
Do not use Paracetamol Alternova
- if you are allergic to paracetamol or any of the other ingredients of this medicine (listed in section 6).
- if you have severe hepatic impairment.
Warnings and cautions
If you are taking other painkillers that contain paracetamol, do not use Paracetamol Alternova without first talking to a doctor or pharmacist.
Never take more Paracetamol Alternova than stated in the dosing instructions. Higher doses than those recommended do not provide better pain relief but instead carry the risk of very serious liver damage. The symptoms of liver damage usually come only after a few days. Therefore, you must contact a doctor immediately if you have taken too large a dose, even if you are feeling well.
Do not use Paracetamol Alternova without a doctor’s prescription if you have alcohol problems or liver damage, and do not use Paracetamol Alternova with alcohol. The intoxicating effect of alcohol does not increase with the addition of Paracetamol Alternova.
Ask your doctor for advice before using Paracetamol Alternova:
- if you have impaired liver or kidney function
- if you have alcohol problems, do not use Paracetamol Alternova without a doctor’s prescription.
- if you are malnourished or underweight e.g. due to anorexia, insufficient dietary intake, or improper diet.
- if you are deficient in an enzyme called glucose -6-phosphate dehydrogenase
- if you use painkillers often and for a long time, as long-term use can cause severe or recurrent headaches. You should then avoid increasing the dose of one of the painkillers and instead contact your doctor for advice
- if you have asthma and are sensitive to acetylsalicylic acid
- if you have a serious infection such as blood poisoning, as this can increase the risk of so-called metabolic acidosis. Signs of metabolic acidosis include deep, rapid, strained breathing; nausea, vomiting; loss of appetite. Contact a doctor immediately if you get a combination of these symptoms.
Other medicines and Paracetamol Alternova
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Paracetamol Alternova may affect or be affected by certain medicines /
herbal medicine:
- Chloramphenicol for injection (medicine for bacterial infections). However, chloramphenicol against infection in your eye can be used.
- Metoclopramide (for nausea and vomiting), may enhance the effect of paracetamol.
- Cholestyramine (to lower cholesterol), as this may weaken the effect of paracetamol. The medication should be taken at least one hour apart.
- Warfarin (a blood thinner). Contact your doctor if you take more than 2 tablets of Paracetamol Alternova 1 gram per day for 3 consecutive days. There is a risk that the effect of warfarin will be affected.
- Probenecid (treatment of eg gout ), dose one of Paracetamol Alternova may need to be lowered.
- Medicines that may damage the liver, such as:- barbiturates or carbamazepine ( treatment of mental illness and epilepsy )- rifampicin (against bacterial infections)- phenytoin (treatment of epilepsy )- St. John’s wort ( Hypericum perforatum) (treatment of depression)
Therefore, consult your pharmacist or treating physician before using Paracetamol Alternova with any of these medicines.
Never use several different painkillers at the same time without consulting a doctor or pharmacist.
Paracetamol can affect uric acid tests and blood sugar tests.
Paracetamol Alternova with food, drink, and alcohol
Concomitant use of Paracetamol Alternova and alcohol consumption should be avoided. The intoxicating effect of alcohol is not increased by the addition of paracetamol.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
If necessary, Paracetamol Alternova can be used during pregnancy. However, you should use the lowest possible dose that relieves your pain and/or fever and use the medicine for the shortest possible time. Contact a doctor or midwife if the pain and/or fever do not decrease or if you need to take the medicine more often.
Paracetamol Alternova passes into breast milk but is unlikely to affect breastfed infants. However, consult a physician if more than temporary use of Paracetamol Alternova during breastfeeding.
Driving and using machines
No effects on the ability to drive or perform precision work have been observed.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
How to use Paracetamol Alternova
Note! Higher doses than those recommended carry a risk of very serious liver damage.
Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
Use
The tablet should be swallowed with a glass of water. The tablet can be divided into two equal doses.
The recommended dose is:
Adults and adolescents over 40 kg (over 12 years):
½ to 1 tablet (500 mg to 1 g) every 4-6 hours, a maximum of 4 tablets (4 g) per day.
Paracetamol Alternova 1 g is not intended for use in children and adolescents weighing less than 40 kg (under 12 years).
Patients with renal or hepatic impairment
The dose should be reduced or the time between doses extended in patients with impaired renal or hepatic function and patients with Gilbert’s syndrome. In patients with severe renal impairment, at least 8 hours should elapse between two doses. Consult your doctor or pharmacist.
Older
No dose adjustment is necessary.
Patients with chronic alcoholism
Chronic alcohol abuse can increase the risk of paracetamol poisoning. The time between two doses should be at least 8 hours. Do not exceed 2 g paracetamol per day.
Paracetamol Alternova film-coated tablets are provided with a film coating that becomes slippery on contact with saliva and thus makes it easier to swallow the tablet, while at the same time hiding the characteristic taste of paracetamol.
If you use more Paracetamol Alternova than you should
If you have ingested too much medicine or if e.g. a child inadvertently ingested the medicine immediately contact a doctor or hospital for risk assessment and advice.
An overdose of paracetamol can cause serious liver damage with a risk of fatal outcomes.
There is a risk of liver damage even if you feel well.
To prevent liver damage, it is important to get medical treatment as early as possible. The shorter the time between overdose and starting antidote treatment (as few hours as possible), the greater the chance that liver damage can be prevented.
If you forget to use Paracetamol Alternova
Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact a doctor immediately if the following serious side effects occur:
Rare side effects ( affects less than 1 user in 1,000):
- Liver failure, liver necrosis (liver cells die) with the following symptoms: jaundice with yellowing of the skin and eyes, feeling sick, possibly unconsciousness due to. liver failure.
- Angioedema with the following symptoms: swelling of the face, tongue, or throat, difficulty swallowing, hives, and difficulty breathing.
Very rare side effects ( affects less than 1 user in 10,000):
- Anaphylactic shock (severe allergic reaction ) with the following symptoms: sudden rash, difficulty breathing, and fainting (within minutes to hours). Can be fatal.
- Severe difficulty breathing with wheezing
- Very rare cases of severe skin reactions have been reported.
No known frequency (can not be calculated from the available data) :
- Epidermal necrolysis (severe widespread skin damage with skin detachment, a life-threatening skin disease)
- Stevens-Johnson syndrome (skin and mucous membrane changes, a serious life-threatening skin disease)
- Accumulation of fluid in the larynx
- Hepatic changes and hepatitis (inflammation of the liver) with the following symptoms: fatigue, nausea, vomiting, abdominal pain, and loss of appetite. Later, jaundice is seen with yellowing of the skin and eyes.
- Severe renal impairment. Pain, often on the side and back of the lower back, and possible blood in the urine due to kidney inflammation
Other side effects may occur:
Rare side effects ( affects less than 1 user in 1,000):
- Disorders of the platelets (affects the ability of the blood to clot), disorders of stem cell function (disorders of the cells that form in the spinal cord)
- Allergic reactions
- Depression, confusion, hallucinations
- Shaking, headache
- Visual disturbances
- Edema (abnormal accumulations of fluid under the skin)
- Stomach pain, bleeding in the stomach or intestines, diarrhea, nausea, vomiting
- Impaired liver function, jaundice (with symptoms such as yellowing of the skin and eyes)
- Skin rash, itching, sweating, hives, red spots on the skin
- Dizziness, malaise, fever, fatigue, interaction with other medicines
- Overdose and poisoning
Very rare side effects ( affects less than 1 user in 10,000):
- Changes in the blood picture (decreased number of platelets, decreased number of white and red blood cells )
- Low levels of glucose in the blood
- Damage to the liver
- Turbid urine and kidney disease
- Severe allergic reactions requiring discontinuation of treatment
No known frequency (can not be calculated from the available data):
- Erythema multiforme ( allergic reaction or infection of the skin)
- Anemia (decreased number of red blood cells )
- Kidney changes (blood in the urine, difficulty urinating)
- A disease of the stomach or intestines
- Dizziness
How to store Paracetamol Alternova
Keep this medicine out of the sight and reach of children and adolescents.
Do not use this medicine after the expiry date which is stated on the carton/can/blister after EXP. The expiration date is the last day of the specified month.
No special storage instructions.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
- The active substance is paracetamol. One film-coated tablet contains 1 g of paracetamol.
- The other ingredients are Core of the tablet: Starch, pregelatinized; corn starch, povidone, stearic acid, and talc; Film rating: Hypromellose,
What the medicine looks like and the contents of the pack
1 g: Capsule-shaped, biconvex, white film-coated tablet, 20 mm x 10 mm with break notch
The tablet can be divided into two equal doses.
Pack sizes:
Blister: 20, 30, 50 and 100 tablets.
Tablet jar: 100 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder:
Alternova A / S, Lodshusvej 11, 4230 Skælskør, Denmark
Manufacturer:
Orifarm Generics A / S, Energivej 15, 5260 Odense S, Denmark