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PACKAGE LEAFLET: INFROMATION FOR THE USER

Paracetamol 1000 mg Soluble Tablets

Paracetamol

•    Medicines used to treat epilepsy (lamotrigine)

•    Medicines to treat tuberculosis (isoniazid)

•    Antibiotics like (chloramphenicol)

Effects of Paracetamol Soluble Tablets on laboratory tests

Uric acid and blood sugar tests may be affected.

Paracetamol Soluble Tablets with food and drink

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you

•    Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.Keep this leaflet. You may need to read it again.

•    Ask your pharmacist if you need more information or advice.

•    If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

•    You must talk to a doctor if you do not feel better or if you feel worse after 3 days.

The name of your medicine is “Paracetamol 1000 mg Soluble Tablets”, but will be referred to as “Paracetamol Soluble Tablets” throughout the rest of this leaflet

What is in this leaflet:

1.    What Paracetamol Soluble Tablets are and what they are used for

2.    What you need to know before you take Paracetamol Soluble Tablets

3.    How to take Paracetamol Soluble Tablets

4.    Possible side effects

5.    How to store Paracetamol Soluble Tablets

6.    Contents of the pack and other information

1. What Paracetamol Soluble Tablets are and what they are used for

Paracetamol Soluble Tablets contain Paracetamol, which relieves pain (analgesic) and reduces the body temperature in fever (antipyretic).

The tablets are recommended for use in treatment of mild to moderate pain and/or fever.

2. What you need to know before you take Paracetamol Soluble Tablets

Do not take Paracetamol Soluble Tablets

•    If you are allergic to paracetamol or any of the ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before taking Paracetamol Soluble 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.

•    If you are suffering from dehydration or chronic malnutrition.

•    If you are on paracetamol containing drugs

•    If you have fever after paracetamol therapy

•    If you suffer from glucose-6-phosphate dehydrogenase deficiency(enzyme deficiency)

Do not use paracetamol unless prescribed by your doctor if you have an addiction to alcohol or liver damage. If this concerns you do not use with alcohol. If you are already taking other pain medication containing paracetamol do not use Paracetamol Soluble Tablets without first speaking to your doctor or a pharmacist.

Never take more Paracetamol Soluble Tablets than recommended. A higher dose does not increase pain relief; instead it can cause severe liver damage. The symptoms of liver damage occur first after a few days. It is important therefore that you contact your doctor as soon as possible if you have taken more Paracetamol Soluble Tablets than recommended in this leaflet.

Do not take anything else containing Paracetamol while taking this medicine. Talk to a doctor at once if you take too much of this medicine even if you feel well. This is because too much Paracetamol can cause delayed, serious liver damage.

Children and adolescents

Do not use Paracetamol 1000 mg Soluble Tablets in children and adolescents below 16 years of age and under 50 kg body weight.

Other medicines and Paracetamol Soluble Tablets

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.

Tell your doctor before you take Paracetamol

Soluble Tablets if you are taking:

•    Drugs to thin the blood (anti-coagulant drugs e.g. warfarin)

•    Medicines used to relieve sickness (e.g. metoclopramide, domperidone)

•    Medicines used to treat high cholesterol (cholestyramine)

•    Probenecid (Medicine used to treat high levels of uric acid in the blood stream i.e gout)

•    Medicine to treat fever or mild pain (Aspirin, salicylamide)

•    Drugs such as rifampicin (drug that helps to fight infection) and some antiepileptics such as carbamazepine, phenytoin, phenobarbital, primidone (drugs used to treat or cure convulsions).

Meals will not affect how much Paracetamol gets into the body.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine.

If you are pregnant see your doctor before you take Paracetamol Soluble Tablets.

The dose of Paracetamol recommended for this product is acceptable if you are breast -feeding.

Driving and using machines

Paracetamol Soluble Tablets have no influence on the ability to drive and use machines.

Paracetamol Soluble Tablets contains Sodium

The maximum recommended daily dose of this medicinal product contains 2127.12 mg sodium (found in table salt). This is equivalent to 53.18 % of the adult recommended maximum daily dietary intake for sodium.

Talk to your doctor if you need Paracetamol Soluble Tablets on daily basis for a prolonged period of time, especially if you have been advised to have a low salt diet.

Paracetamol Soluble Tablets contains sorbitol

This medicinal product also contains sorbitol. If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicinal product.

3. How to take Paracetamol Soluble Tablets

This medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Paracetamol Soluble Tablets are for oral administration. Place the tablet in a full glass of water. Allow it to completely dissolve. Then drink the solution straight away.

If you have doubts on the correct dose of Paracetamol Soluble Tablets to use please consult your doctor.

This medicinal product is for use, only in adults and adolescents aged 16 years and above.

Adults and adolescents > 50 kg of body weight

Take one tablet (1000 mg) every four to six hours, upto a maximum of 3 tablets (3000 mg) in 24 hours.

Maximum daily dose:

•    The maximum daily dose of Paracetamol must not exceed 3 tablets (3000 mg).

•    Maximum single dose is 1000 mg (1 Soluble tablet)

The minimum time interval between two doses should be 4 to 6 hours.

If the pain persists for more than 3 days or the fever lasts for more than 3 days, or gets worse or other symptoms appear, you should stop the treatment and consult a doctor.

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Kidney problems:

In moderate kidney problems: The usual dose is 500 mg repeated every 6 hours.

In severe kidney problems: The usual dose is 500 mg repeated every 8 hours

Liver problems :

In case of problems with your liver please consult your doctor. Your doctor may decide to reduce the dose.

In chronic alcoholics, a dose of 2000 mg per day should not be exceeded

Paracetamol 1000mg tablets are not suitable for patients with renal and hepatic insufficiency when a reduced dose is required. Do not divide the 1000 mg tablet into two equal halves for the lower doses. Paracetamol tablets of lower strengths are available in the market.

Do not take more medicine that the label tells you to. If you do not get better, talk to your doctor.

Do not exceed the stated dose. Do not give to adolescents of 16 years of age and younger. Cap contains desiccant. Do not eat.

If you take more Paracetamol Soluble Tablets than you should:

Symptoms of paracetamol overdose in the first 24 hours may include paleness, nausea (feeling sick), vomiting, lack of desire to eat and stomach pain. If you or someone you know accidentally takes more than the stated dose (overdose) you should contact a doctor immediately even if you feel well, because there is risk of serious, delayed liver damage.

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If you forget to take Paracetamol Soluble Tablets:

If you forget to take a dose, take it as soon as you remember, unless it is almost time for your next dose. The minimum time interval between two doses should be 4 to 6 hours. Never take a double dose to make up for the one you have missed.

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

4. Possible side effects

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

You should stop taking Paracetamol Soluble 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.

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

■    Bleeding problems or clotting disorders (Platelet disorders), decreased formation of cells, severe decrease in white blood cells which may lead to severe infections (agranulocytosis), frequent infections due to poorly functioning white blood cells or decrease in white blood cells (leucopenia), reduction in blood platelets, which increases the risk of bleeding or bruising (thrombocytopenia) abnormal breakdown of red blood cells, which may cause weakness or pale skin (haemolytic anaemia), decrease in blood count (pancytopenia), reduced neutrophil count in blood (neutropenia).

■    Allergies (excluding swelling on the face, mouth, hands).

■    Depression, confusion, sensing unreal things

■    Tremor, headache

■    Abnormal vision.

■    Abnormal accumulation of fluid under the skin (oedema).

■    Stomach pain, diarrhoea, nausea (feeling sick), vomiting, bleeding (haemorrhage)

■    Abnormal liver function, liver failure, death of liver cells (hepatic necrosis), jaundice

■    Dizziness, feeling of general discomfort or uneasiness (malaise), fever, drowsiness, drug interaction.

■    Overdose and poisoning.

■    shortness of breath.

Simeticone emulsion 30% contains:

Water, polydimethylsiloxane, polyethylene glycol stearate, polyethylene glycol, glycerides C14-18 mono- and di Polyethylene glycol distearate, Polyethylene glycol palmitate, Octamethylcyclotetrasiloxane.

What Paracetamol Soluble Tablets look like and contents of the pack:

Paracetamol 1000 mg Soluble Tablets are white to off-white, round, flat faced and bevelled edged tablets, plain on both sides.

This medicinal product is available in two different types of packaging: Alu-Alu strip pack or polypropylene tubes.

Alu-Alu Strip pack:

The Soluble tablets are packed in aluminium strip foils laminated with LDPE film. Each strip has 4 tablets or 10 tablets. The strips are packed in a carton containing 4 tablets (4x1), 8 tablets (4x2), or (10 x 1) 10 tablets .

Polypropylene Tubes:

The Soluble tablets are packed in white polypropylene tube with tamper evident polyethylene cap containing an inbuilt desiccant. Each tube contains 10 tablets. One tube (1 x 10) is packed in a carton.

CAUTION:

Cap contains desiccant. Do not eat.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:

Accord Healthcare Limited,

Sage House, 319 Pinner road,

North Harrow,

Middlesex,

HA1 4 HF,

United Kingdom

The leaflet was last revised in 06/2016.

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

■    Damage caused to the liver (hepatotoxicity)

■    Immediate severe allergic reaction (hypersensitivity reaction requiring discontinuation of treatment)

■    Low levels of glucose in the blood (hypoglycemia)

■    Cloudy urine and kidney disorders.

■    Life-threatening skin disease causing rash, skin peeling and sores (epidermal necrolysis)

■    Allergic reaction of the skin (erythema multiforme)

■    Severe life-threatening skin disease causing rash, skin peeling, sores (Stevens-Johnson syndrome)

■    Accumulation of fluid in the voice box (larynx)

■    Severe allergic reaction (anaphylactic shock)

■    Decrease in red blood cells (anemia)

■    Severe kidney impairment (renal alteration)

■    Kidney disorder (nephrite interstitial)

■    Blood in urine (haematuria)

■    Inability to urinate (anuresis)

■    Stomach ulcers and bleeding (gastrointestinal effects)

■    Uneasiness.

■    Very rare cases of serious skin reactions have been reported.

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 via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Paracetamol Soluble Tablets

•    Keep this medicine out of the sight and reach of children and adolescents.

•    Do not use this medicine after expiry date which is stated on the label after EXP The expiry date refers to last day of that month.

•    For Polypropylene tube: Do not use the product after 1 month from the date of first opening.

•    For Polypropylene Tube: Store below 25°C. Keep the polypropylene tube tightly closed. Store in the original container to protect from moisture and light.

•    For Alu-Alu Strip Pack: Store below 25°C. Store in the original package in order to protect from moisture and light.

•    Do not use this medicine if you notice visible signs of deterioration, like brown or black spots, bulging of tablets or discoloration.

•    Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away of medicines you no longer used. These measures will help to protect the environment.

6. Contents of the pack and other information

What Paracetamol Soluble Tablets contains:

The active substance is Paracetamol. Each Soluble tablet contains 1000 mg of Paracetamol.

The other ingredients are;

Anhydrous Citric acid, Sorbitol E420, Sodium Carbonate Anhydrous, Sodium Hydrogen Carbonate, Povidone K 25, Simeticone emulsion (30%), Docusate sodium, Saccharin Sodium, Macrogol 6000, Monosodium glycine carbonate, Sodium Benzoate, Powdarome Lemon Premium.