Paracetamol and Caffeine Tablets 500mg/ 65mg Taj Pharma

Paracetamol and Caffeine Tablets 500mg/ 65mg

1. Name of the medicinal product

Paracetamol and Caffeine Tablets 500mg/ 65mg Taj Pharma

2. Qualitative and quantitative composition

Each tablet contains Paracetamol Ph.Eur. 500.0 mg and Caffeine Ph.Eur. 65.0 mg.

3. Pharmaceutical form

Tablet.

Paracetamol and Caffeine are capsule shaped tablets.

4. Clinical particulars

4.1 Therapeutic indications

Paracetamol and Caffeine is a mild analgesic and antipyretic formulated to give extra pain relief. The tablets are recommended for the treatment of most painful and febrile conditions, for example, headache, including migraine, backache, toothache, rheumatic pain and dysmenorrhoea, and relief of the symptoms of colds, influenza and sore throat.

4.2 Posology and method of administration

Adults and children16 years and over:

Two tablets every 4-6 hours up to four times daily. Do not exceed 8 tablets in 24 hours.

Elderly:

As for adults.

Children and children aged 12 – 15 years:

One tablet every 4-6 hours up to four times daily. Do not exceed 4 tablets in 24 hours. Not recommended for children under 12 years.

Method of Administration:

Paracetamol and Caffeine Tablets are for oral administration only.

4.3 Contraindications

Hypersensitivity to paracetamol, caffeine or any of the other constituents.

4.4 Special warnings and precautions for use

Care is advised in the administration of paracetamol to patients with renal or hepatic impairment. The hazard of overdose is greater in those with non-cirrhotic alcoholic liver disease.

Excessive intake of caffeine (e.g. coffee, tea and some canned drinks) should be avoided while taking this product.

Do not exceed the stated dose.

Patients should be advised to consult their doctor if their headaches become persistent. Patients should be advised not to take other paracetamol-containing products concurrently. If symptoms persist consult your doctor.

Keep out of the reach and sight of children.

Pack Label:

Immediate medical advice should be sought in the event of an overdose, even if you feel well. Do not take with any other paracetamol-containing products.

Patient Information Leaflet:

Immediate medical advice should be sought in the event of an overdose, even if you feel well, because of the risk of delayed, serious liver damage.

4.5 Interaction with other medicinal products and other forms of interaction

The speed of absorption of paracetamol may be increased by metoclopramide or domperidone and absorption reduced by colestyramine. The anticoagulant effect of warfarin and other coumarins may be enhanced by prolonged regular daily use of paracetamol with increased risk of bleeding; occasional doses have no significant effect.

4.6 Pregnancy and lactation

Paracetamol-caffeine is not recommended for use during pregnancy due to the possible increased risk of lower birth weight and spontaneous abortion associated with caffeine consumption.

Caffeine in breast milk may potentially have a stimulating effect on breast fed infants.

Due to the caffeine content of this product it should not be used if you are pregnant or breast feeding.

4.7 Effects on ability to drive and use machines

None.

4.8 Undesirable effects

Adverse events from historical clinical trial data are both infrequent and from small patient exposure. Accordingly, events reported from extensive post-marketing experience at therapeutic/labelled dose and considered attributable are tabulated below by system class. Due to limited clinical trial data, the frequency of these adverse events is not known (cannot be estimated from available data), but post-marketing experience indicates that adverse reactions to paracetamol are rare and serious reactions are very rare.

Post marketing data

* There have been cases of bronchospasm with paracetamol, but these are more likely in asthmatics sensitive to aspirin or other NSAIDs.

4.9 Overdose

Immediate treatment is essential in the management of paracetamol overdose. Despite a lack of significant early symptoms, patients should be referred to hospital urgently for immediate medical attention. Gastric lavage or the administration of activated charcoal may be beneficial when performed within one hour of the overdose but can be considered for up to four hours after the overdose. Antidotes such as N-acetylcysteine (NAC) and methionine protect the liver if administered within 12 hours of overdose. NAC is effective up to and possibly beyond 24 hours. General supportive measures must be available.

Symptoms of paracetamol overdose in the first 24 hours are pallor, nausea, vomiting, anorexia and abdominal pain. Liver damage may become apparent 12 to 48 hours after ingestion. Abnormalities of glucose metabolism and metabolic acidosis may occur. In severe poisoning, hepatic failure may progress to encephalopathy, coma and death. Acute renal failure with acute tubular necrosis may develop even in the absence of severe liver damage. Cardiac arrhythmias and pancreatitis have been reported. Liver damage is possible in adults who have taken 10g or more of paracetamol. It is considered that excess quantities of a toxic metabolite (usually adequately detoxified by glutathione when normal doses of paracetamol are ingested) become irreversibly bound to liver tissue.

Overdose of caffeine may result in epigastric pain, vomitting, diuresis, tachycardia or cardia arrhythmia, CNS stimulation (insomnia, restlessness, excitement, agitation, jitteriness, tremors and convulsions).

It must be noted that for clinically significant symptoms of caffeine overdose to occur with this product, the amount ingested would be associated with serious paracetamol-related toxicity.

5. Pharmacological properties

5.1 Pharmacodynamic properties

The combination of paracetamol and caffeine is a well established analgesic combination.

5.2 Pharmacokinetic properties

Paracetamol is rapidly and almost completely absorbed from the gastro-intestinal tract, it is relatively uniformly distributed throughout most body fluids and exhibits variable protein binding. Excretion is almost exclusively renal, in the form of conjugated metabolites.

Caffeine is absorbed readily after oral administration, maximal plasma concentrations are achieved within one hour and the plasma half-life is about 3.5 hours. 65 – 80% of administered caffeine is excreted in the urine as 1-methyluric acid and 1-methylxanthine.

5.3 Preclinical safety data

There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

6. Pharmaceutical particulars

6.1 List of excipients

Starch pregelatinised, maize starch, polyvinyl pyrrolidone, potassium sorbate, purified talc, stearic acid, croscarmellose sodium, water, hypromellose (6CPS) and triacetin

6.2 Incompatibilities

None

6.3 Shelf life

60 months

6.4 Special precautions for storage

Store below 25°C

6.5 Nature and contents of container

Opaque PVC 250µm / aluminium foil 30µm blister strips packed into cardboard cartons, containing 8, 12, 16, 24, 30 or 32 tablets; or opaque PVC 250µm/aluminium foil 30µm blisters in a round, wallet style pack containing 12 tablets.

6.6 Special precautions for disposal and other handling

None

7. Manufactured in India by:
   TAJ PHARMACEUTICALS LTD.
   Mumbai, India
   Unit No. 214.Old Bake House,
   Maharashtra chambers of  Commerce Lane,
   Fort, Mumbai – 400001
   at:Gujarat, INDIA.
   Customer Service and Product Inquiries:
   1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
   Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
   E-mail: tajgroup@tajpharma.com

Paracetamol and Caffeine Tablets 500mg/ 65mg

PATIENT INFORMATION LEAFLET

Paracetamol + Caffeine

Please read right through this leaflet before you start using this medicine.

This medicine is available without prescription, but you still need to use Paracetamol and Caffeine tablets carefully to get the best results from them.

• Keep this leaflet, you may need to read it again.
• If you have any questions, or if there is anything you do not understand, ask your pharmacist.

In this leaflet:

1. What Paracetamol and Caffeine does
   2. Check before you take Paracetamol and Caffeine
   3. How to take Paracetamol and Caffeine
   4. Possible side effects
   5. How to store Paracetamol and Caffeine
   6. Further information
2. What Paracetamol and Caffeine does

Paracetamol and Caffeine can provide extra relief from headache including migraine.

They can also relieve backache, rheumatic and muscle pain, toothache, sore throat, period pain, and relieve the fever, aches and pains of colds and flu.

The tablets contain two active ingredients. Paracetamol is a painkiller and also reduces your temperature when you have a fever. Caffeine acts to further help the effectiveness of paracetamol.

2. Check before you take Paracetamol and Caffeine

Do not take Paracetamol and Caffeine:

• if you have ever had an allergic reaction to paracetamol, caffeine or to any of the other ingredients (listed in Section 6)
• if you are taking other medicines containing paracetamol.

Ask your doctor before you take this medicine:

• if you have liver or kidney disease, including alcoholic liver disease.

If you are taking other medicines

Talk to your doctor or pharmacist before taking these tablets if you are taking any prescribed medicines; particularly metoclopramide or domperidone (for nausea [feeling sick] or vomiting [being sick]) or colestyramine (to lower blood cholesterol). If you take blood thinning drugs (anticoagulants e.g. warfarin) and you need to take a pain reliever on a daily basis, talk to your doctor because of the risk of bleeding. But you can still take occasional doses of Paracetamol and Caffeine at the same time as anticoagulants.

Pregnancy and breast feeding

Due to the caffeine content of this product it should not be used if you are pregnant or breast feeding.

3. How to take Paracetamol and Caffeine

Adults and children aged 16 years and over:

Swallow 2 tablets every 4-6 hours as needed.

Do not take more frequently than every 4 hours.

Do not take more than 8 tablets in 24 hours

Children aged 12 – 15 years:

Swallow 1 tablet every 4-6 hours as needed.

Do not take more frequently than every 4 hours.

Do not take more than 4 tablets in 24 hours.

• Do not take more than the recommended dose.
• Do not give to children under 12 years.
• Avoid too much caffeine in drinks like coffee and tea.

High caffeine intake can cause difficulty sleeping, shaking and an uncomfortable feeling in the chest.

If you take too many tablets

Immediate medical advice should be sought in the event of an overdose, even if you feel well, because of the risk of delayed, serious liver damage.

If your symptoms continue or your headache becomes persistent, see your doctor.

4. Possible side effects

Like all medicines, Paracetamol and Caffeine can have side effects, but not everybody gets them. A small number of people have had side effects.

Stop taking the medicine and tell your doctor immediately if you experience:

• Allergic reactions which may be severe such as skin rash and itching sometimes with swelling of the mouth or face or shortness of breath
• Skin rash or peeling, or mouth ulcers
• Breathing problems. These are more likely if you have experienced them before when taking other painkillers such as ibuprofen and aspirin
• Unexplained bruising or bleeding
• Nausea, sudden weight loss, loss of appetite and yellowing of the eyes and skin.

If you do get any side effects, even those not mentioned in this leaflet, tell your doctor or pharmacist

5. How to store Paracetamol and Caffeine

Keep out of the reach and sight of children.

Do not use this medicine after the ‘EXP’ date shown on the pack.

Store below 25°C.

6. Further information

Active ingredients: Each tablet contains Paracetamol 500 mg and Caffeine 65 mg.

Other ingredients: Starch pregelatinised, maize starch, polyvinyl pyrrolidone, potassium sorbate, purified talc, stearic acid, croscarmellose sodium, hypromellose and triacetin.

Packs of Paracetamol and Caffeine contain 16 tablets.

7. Manufactured in India by:
   TAJ PHARMACEUTICALS LTD.
   Mumbai, India
   Unit No. 214.Old Bake House,
   Maharashtra chambers of  Commerce Lane,
   Fort, Mumbai – 400001
   at:Gujarat, INDIA.
   Customer Service and Product Inquiries:
   1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
   Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
   E-mail: tajgroup@tajpharma.com