SolpaOne 1000mg Effervescent SolpaOne 1000mg Effervescent

Do not take SolpaOne® Effervescent Tablets.

• • If you are allergic to paracetamol or any of the ingredients of this medicine.

Warnings and precautions.

Talk to your doctor, pharmacist or nurse before taking SolpaOne ® Effervescent Tablets:

• • If you are suffering from kidney problems.
• • If you are suffering from liver problems including liver problems due to excessive alcohol consumption.
• • If you have Gilbert’s syndrome (mild jaundice).
• • If you have hemolytic anemia (abnormal breakdown of red blood cells).
• • If you are an asthmatic and sensitive to aspirin (acetylsalicylic acid).
• • If you are suffering from dehydration or chronic malnutrition.
• • If you are on paracetamol containing medicines.
• • If you have fever after paracetamol therapy.
• • If you suffer from glucose-6-phosphate dehydrogenase deficiency (enzyme deficiency).

Other important information.

Do not drink alcohol (e.g. wine, beer, spirits) whilst taking this medicine.This medicine is not suitable for patients weighing less than 50 kg.

Do not use paracetamol unless prescribed by your doctor if you have an addiction to alcohol or liver damage. If this applies to you, you must not take these tablets with alcohol.

If you are already taking other pain medication containing paracetamol do not take these tablets without first speaking to your doctor or a pharmacist.

Never take more SolpaOne ® Effervescent Tablets than recommended.

Children and adolescents

Do not use SolpaOne ® Effervescent Tablets in children and adolescents below 16 years of age and under 50 kg body weight.

Other medicines and SolpaOne ® Effervescent Tablets

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.Tell your doctor before you take SolpaOne ® Effervescent Tablets if you are taking:

Effects of SolpaOne® Effervescent Tablets on laboratory tests

Uric acid and blood sugar tests may be affected.

SolpaOne® Effervescent Tablets with food

There is no significant effect on absorption of Paracetamol when taken with meal.

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 any medicine.

If necessary, SolpaOne ® Effervescent Tablets can be used during pregnancy. You should use the lowest possible dose that reduces your pain and/or your fever and use it for the shortest time possible. Contact your doctor if the pain and/or fever are not reduced or if you need to take the medicine more often.

Paracetamol passes into breast milk.

Therapeutic doses of Paracetamol can be administered during breast-feeding.

Driving and using machines

SolpaOne ® Effervescent Tablets have no influence on the ability to drive and use machines.

SolpaOne® Effervescent Tablets contain sodium and aspartame.

This medicine contains 533.51 mg sodium (main component of cooking/table salt) in each effervescent tablet. This is equivalent to 26.68% of the recommended maximum daily dietary intake of sodium for an adult.

Like all medicines this medicine can cause side effects, although not everybody gets them.

You should stop taking SolpaOne® Effervescent Tablets and see your doctor immediately if you experience symptoms like:

• • Swelling in the face, tongue or throat, difficulty swallowing, red and itchy swellings on the skin and difficulty in breathing.
• • Serious skin reactions causing rash; or skin peeling or sores or blisters.

Other side effects includes:

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

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

• • Damage caused to the liver.
• • Immediate severe allergic reaction (hypersensitivity reaction requiring discontinuation of treatment).
• • Low levels of glucose in the blood.
• • Cloudy urine and kidney disorders.
• • Allergic reaction of the skin.
• • Accumulation of fluid in the voice box.
• • Decrease in red blood cells.
• • Severe kidney impairment.
• • Kidney disorder.
• • Blood in urine.
• • Inability to urinate.
• • Uneasiness.

1. This medicine is reserved for use in adults and in adolescents aged 16 years and above.
2. Always take this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse has told you. Check with your doctor, pharmacist or nurse if you are not sure.
3. SolpaOne ® Effervescent Tablets are for oral administration and may be taken with or without food. Place the tablets in a full glass of water. Allow it to completely dissolve.
4. Then drink the solution straight away.
5. If you have doubts on the correct dose of SolpaOne ® Effervescent Tablets to use, please consult your doctor.

The active substance is paracetamol. Each effervescent tablet contains 1000 mg of paracetamol.

The other ingredients are: Citric acid (anhydrous) (E330), povidone, sodium bicarbonate (E500), sodium saccharin (E954), sodium carbonate (anhydrous) (E500), simeticone (E900), polysorbate 80 (E443), aspartame (E951).