500 mg film-coated tablets 
paracetamol

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

Always use this medicine exactly as described in this leaflet or as directed by your doctor, pharmacist, or nurse.

  • Save this information, you may need to read it again.
  • Contact the pharmacy staff if you need more information or advice.
  • If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. See section 4.
  • You must talk to your doctor if your symptoms worsen or do not improve within 3 days in case of fever and 5 days in case of pain (see section 3 How to use Alvedon Novum).

In this leaflet you will find information about: 
1. What Alvedon Novum is and what it is used for 
2. What you need to know before you use Alvedon Novum 
3. How to use Alvedon Novum 
4. Possible side effects 
5. How to store Alvedon Novum 
6. Other information

What Alvedon Novum is and what it is used for

Alvedon Novum contains paracetamol which is analgesic and antipyretic.

Alvedon Novum is used to treat temporary fever and pain conditions of a mild nature, such as fever in colds, headaches, toothaches, menstrual cramps, muscle, and joint pain.

Alvedon Novum can be used by people with sensitive stomachs or ulcers and people with an increased tendency to bleed.

2. What you need to know before using Alvedon Novum

Do not use Alvedon Novum

– 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

Alvedon Novum contains paracetamol. If you are taking other painkillers that contain paracetamol, do not use Alvedon Novum without talking to your doctor or pharmacist first.

Never take Alvedon Novum more than what is stated in the dosing instructions or what your doctor has prescribed. Higher doses than those recommended do not provide better pain relief but instead entail a risk of very serious liver damage. The symptoms of liver damage usually come only after a few days. Therefore, it is important that you contact a doctor immediately if you have taken too large a dose, even if you are feeling well.

Do not use Alvedon Novum without a doctor’s prescription if you have alcohol problems or liver damage, and do not use Alvedon Novum with alcohol. The intoxicating effect of alcohol does not increase with the addition of Alvedon Novum.

Talk to your doctor before using Alvedon if you:

  • have impaired liver or kidney function.
  • has asthma and at the same time is sensitive to acetylsalicylic acid.
  • is deficient in an enzyme called glucose -6-phosphate dehydrogenase.
  • is malnourished or underweight due to an inadequate diet or improper diet or if you have a serious infection such as blood poisoning. This is due to an increased risk of:
    • liver damage
    • 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.

Use of other medicines and Alvedon Novum

Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines. Alvedon Novum may affect or be affected by certain medicines, (traditional) herbal medicines or herbal medicines. Therefore, consult your pharmacist or doctor before using Alvedon Novum with any of the following medicines. 

  • metoclopramide (antiemetic an antiemetic).
  • blood-thinning drugs (eg warfarin and other coumarins). Contact your doctor if you take more than 2 tablets of Alvedon Novum (500 mg) per day for 5 consecutive days. There is a risk that the effect of warfarin will be affected.
  • probenecid (anti-gout).
  • certain antiepileptic drugs:
    • phenytoin
    • phenobarbital
    • carbamazepine
  • rifampicin (remedy for tuberculosis ).
  • cholestyramine (means for high blood fats). The medication should be taken at least one hour apart.
  • chloramphenicol for injection (means for bacterial infections). (However, chloramphenicol against infection in your eye and Alvedon Novum can be used at the same time.)
  • St. John’s wort extract (included in some (traditional) herbal and herbal medicines).

Alvedon Novum with food, drink, and alcohol

Alvedon Novum can be taken with or without food. Do not use Alvedon Novum with alcohol, see section “Warnings and precautions”.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, 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, Alvedon can be used during pregnancy. However, you should use the lowest possible dose that relieves your pain and/or fever and use it for the shortest possible time. Contact your doctor or midwife if the pain and/or fever does not decrease or if you need to take the medicine more often.

Transfers to breast milk, but is unlikely to affect breastfed infants. However, consult a physician if more than temporary use of Alvedon Novum during breast-feeding.

Driving and using machines

Alvedon Novum does not affect your ability to drive or use machines.

Alvedon Novum contains sodium

The maximum daily dose of this medicine contains 1408 mg of sodium (the main ingredient in table salt). This corresponds to 70% of the recommended maximum daily intake of sodium.

Talk to your pharmacist or doctor if you are using Alvedon Novum daily for a long period of time, especially if you have been prescribed a low-salt diet.

3. How to use Alvedon Novum

Always use this medicine exactly as described in this leaflet or as directed by your doctor, pharmacist, or nurse. If you are not sure, talk to your doctor, pharmacist, or nurse.

Note! Higher doses than those recommended carry a risk of very serious liver damage.

Never take Alvedon Novum more than what is stated in the dosing instructions. Always use the lowest possible dose that gives you relief from your symptoms, for as short a treatment time as possible.

If you have impaired liver or kidney function or have Gilbert’s syndrome, you should consult your doctor about the appropriate dose, as it may need to be adjusted downwards.

The tablets should be swallowed whole.

Alvedon Novum can be taken independently of meals.

The recommended dose is

Adults and adolescents over 40 kg (over 12 years): 1-2 tablets every 4-6 hours, maximum of 8 tablets per day.

Contact a doctor if symptoms worsen or do not improve within 3 days in case of fever and 5 days in case of pain.

Use for children under 40 kg (under 12 years)

Alvedon Novum should not be used by children weighing less than 40 kg or by children under 12 years of age.

An overdose of paracetamol can cause serious liver damage with a risk of fatal outcome. 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 that elapses between overdose and starting antidote treatment (as few hours as possible), the greater the chance that liver damage can be prevented.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Alvedon Novum can cause side effects, although not everybody

Rare (may affect up to 1 in 1,000 people):

  • Angioedema, very severe allergic reaction:
    • swelling of the face, tongue, or throat
    • difficulty swallowing
    • hives and difficulty breathing
  • Allergic reactions such as skin rash and hives. Even less severe forms of skin reactions, rashes, and itching may occur.
  • Liver effects. This can be very serious and can cause symptoms such as fatigue, nausea, vomiting, stomach upset, and loss of appetite.

Very rare (may affect up to 1 in 10,000 people):

  • Bleeding from the skin and mucous membranes and bruising, general lethargy, the tendency to inflammation ( infections ) especially sore throat and fever due to changes in the blood (decreased number of white blood cells and platelets ).
  • Severe breathing difficulties with wheezing.
  • Kidney side effects
  • Paleness, fatigue, and jaundice due to severe anemia.
  • Very rare cases of severe skin reactions have been reported.
  • Anaphylaxis: hypersensitivity reaction with fever, rash, swelling, and sometimes a drop in blood pressure.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. 

5. How to store Alvedon Novum

Keep out of sight and reach of children and young people.

Do not use this medicine after the expiry date which is stated on the carton after “EXP”. The expiration date is the last day of the specified month.

Do not use Alvedon Novum if the foil was not intact at the time of purchase. In such cases, contact the pharmacy.

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.

6. Other information

Content declaration

The active substance is paracetamol, 500 mg

The other ingredients are sodium bicarbonate, pregelatinized starch, povidone, corn starch, microcrystalline cellulose, magnesium stearate, carnauba wax, sodium starch glycolate, anhydrous silica.

Coating: Titanium dioxide (E171), polydextrose, hypromellose, glycerol triacetate, polyethylene glycol.

What the medicine looks like and the contents of the pack

White to an off-white capsule-shaped tablet without a notch, marked with “A” on one side and “-” on the other side.

8 pcs, 10 pcs, 16 pcs or 20 pcs tablets in the blister pack

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

GlaxoSmithKline Consumer Healthcare A / S

Nykær 68

2605 Brøndby

Denmark

Tel: 020–10 05 79

Email: scanda.consumer-relations@gsk.com

Manufacturer:

GlaxoSmithKline Dungarvan Ltd., Knockbrack Dungarvan, Ireland

Omega Pharma Manufacturing GmbH & Co. KG, Herrenberg, Germany

Muhammad Nadeem

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