Coldaway Plus

For the relief of pain eg, headache, dental pain, period pain, rheumatic pain, muscular pain and backache.

Coldaway Plus relieves fever eg, fever associated with cold and flu.

Also indicated for the relief of inflammation of muscles and joints in rheumatic disease including juvenile arthritis and other muscular skeletal disorder.

Ibuprofen (Coldaway Plus) is nonsteroidal anti-inflammatory drugs (NSAID) that reduces hormones that cause inflammation and pain in the body.

Pseudoephedrine (Coldaway Plus) is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).

The combination of Coldaway Plus is used to treat stuffy nose, sinus congestion, cough, and pain or fever caused by the common cold or flu.

Coldaway Plus may also be used for purposes not listed in this medication guide.

Caplet: 200 mg: Adults and Children >12 years: Initial Dose: 2 caplets, then if necessary, 1 or 2 caplets every 4 hrs.

400 mg: Adults and Children >12 years: Initial Dose: 1 caplet, then if necessary, 1 caplet every 4 hrs.

It is recommended not to exceed 1,200 mg daily for minor ailments (eg, fever and headache) but can be used up to a maximum of 2,400 mg daily, if prescribed by the doctor.

Syrup: Coldaway Plus for Children is suitable for babies and children from 3 months (weighing >5 kg), to be given orally. Daily Dose: 20-30 mg/kg body weight in divided doses.

Post-Immunisation Fever: Can be given to babies from 3 months old (weighing >5 kg), on the advice of a physician. Initial Dose: 2.5 mL followed by a further 2.5 mL 6 hrs later, if necessary. Not >5 mL in 24 hrs. Pain and Fever: Infants 3-6 months: 2.5 mL 3 times daily. Infants 6-12 months: 2.5 mL 3-4 times daily. Children 1-3 years: 5 mL 3 times daily. Children 4-6 years: 7.5 mL 3 times daily. Children 7-9 years: 10 mL 3 times daily. Children 10-12 years: 15 mL 3 times daily. Doses should be given approximately every 6-8 hrs, (or with a minimum of 4 hrs between each dose if required). Not suitable for children <3 months unless advised by physician.

Administration: Coldaway Plus should be taken with or after food.

Coldaway Plus should be used at the lowest effective dose for shortest possible time.

See also:
What is the most important information I should know about Coldaway Plus?

Hypersensitivity to aspirin, Ibuprofen (Coldaway Plus) or other nonsteroidal anti-inflammatory drugs (NSAIDs) or to any of the excipients of Coldaway Plus. Patients in whom aspirin and other NSAIDs induce the symptoms of asthma, rhinitis and/or urticaria. Patients with severe heart failure and for the treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery. History of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy; active or history of recurrent peptic ulcer/haemorrhage.

See also:
What other drugs will affect Coldaway Plus?

Ibuprofen (Coldaway Plus) should be avoided in combination with:

Aspirin: Unless low-dose aspirin (not above 75mg daily) has been advised by a doctor, as this may increase the risk of adverse reactions.

Experimental data suggest that Ibuprofen (Coldaway Plus) may inhibit the effect of low dose aspirin on platelet aggregation when they are dosed concomitantly. However, the limitations of these data and the uncertainties regarding extrapolation of ex-vivo data to the clinical situation imply that no firm conclusions can be made for regular Ibuprofen (Coldaway Plus) use, and no clinically relevant effect is considered to be likely for occasional Ibuprofen (Coldaway Plus) use.

Other NSAIDs as these may increase the risk of adverse effects.

Ibuprofen (Coldaway Plus) should be used with caution in combination with:

Anticoagulants: NSAIDs may enhance the effects of anti-coagulants, such as warfarin.

Antihypertensives and diuretics: NSAIDs may diminish the effect of these drugs. Diuretics can increase the risk of nephrotoxicity of NSAIDs.

Corticosteroids: may increase the risk of adverse reactions in the gastrointestinal tract

Anti-platelet agents and selective serotonin reuptake inhibitors (SSRIs): increased risk of gastrointestinal bleeding( see section 4.4)

Cardiac glycosides: NSAIDs may exacerbate cardiac failure, reduce GFR and increase plasma glycoside levels.

Lithium: there is potential increase in plasma levels of lithium.

Methotrexate: there is a potential for an increase in plasma methotrexate.

Ciclosporin: increased risk of nephrotoxicity.

Mifepristone: NSAID should not be used for 8-12 days after mifepristone administration as NSAIDs can reduce the effect of mifepristone.

Tacrolimus: possible increased risk of nephrotoxicity when NSAIDs are given with tacrolimus.

Zidovudine: there is evidence of an increased risk of haemarthroses and haematoma in HIV (+) haemophiliacs receiving concurrent treatment with zidovudine and Ibuprofen (Coldaway Plus).

Quinolone antibiotics: animal data indicate that NSAIDs can increase the risk of convulsions associated with quinolone antibiotics. Patients taking NSAIDs and quinolones may have an increased risk of developing convulsions.

Pseudoephedrine (Coldaway Plus)

Pseudoephedrine (Coldaway Plus) may interact with the actions of other sympathomimetic drugs and the antibacterial agent furazolidone. The action of Pseudoephedrine (Coldaway Plus) may be reduced by guanethidine, reserpine or methyldopa and may be reduced or enhanced by tricyclic antidepressants. Pseudoephedrine (Coldaway Plus) may reduce the action of guanethidine and may increase the possibility or arrhythmias in patients taking digitalis, quinidine or tricyclic antidepressants

See also:
What are the possible side effects of Coldaway Plus?

Coldaway Plus is generally well tolerated by the majority of people, however, the following adverse effects, where observed, are usually of a mild and transient nature: Stomach discomfort or pain, nausea, gastrointestinal intolerance and bleeding, stomach ulcer, activation of peptic ulcer, black tarry stools, rashes or worsening of asthma, liver and kidney problems [cystitis, haematuria, acute renal failure, interstitial nephritis and nephritic syndrome (caplet only)], headache, dizziness and hearing disturbance, and very rarely, skin peeling and easy bruising.