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Dolased - Analgesic Calmative

Paracetamol, Codeine Phosphate Hemihydrate and Doxylamine Succinate tablets


Consumer Medicine Information

What is in this leaflet

This leaflet answers some common questions about Dolased Analgesic - Calmative. It does not contain all the available information.

It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor or pharmacist has weighed the risks of you taking Dolased Analgesic - Calmative against the benefits this medicine is expected to have for you.

If you have any concerns about taking this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine. You may need to read it again.

What is Dolased Analgesic - Calmative

The name of your medicine is Dolased Analgesic - Calmative.

It contains the active ingredients paracetamol, doxylamine succinate and codeine phosphate hemihydrate.

Paracetamol, an analgesic with antipyretic action also reduces fever.

Doxylamine succinate is an antihistamine with pronounced sedative effects.

Codeine phosphate hemihydrate is an opioid analgesic, and in combination with paracetamol and doxylamine produces greater analgesia than any of these drugs alone and avoids the side effects associated with large doses of these components.

Dolased Analgesic - Calmative tablets contain no aspirin.

What Dolased Analgesic - Calmative is used for

Dolased Analgesic - Calmative provides temporary relief of acute moderate pain and fever.

Your doctor or pharmacist may recommend Dolased Analgesic - Calmative for another reason. If you want more information ask your doctor or pharmacist.

Before you take Dolased Analgesic - Calmative

When you must not take it

Do not take Dolased Analgesic - Calmative if:

you have an allergy to:

  • Paracetamol, codeine or doxylamine succinate, or any of the ingredients listed at the end of this leaflet
  • you have had an allergic reaction to other opioid analgesic such as morphine or pethidine
  • you have had an allergic reaction to other antihistamines

Symptoms of an allergic reaction to these medicines may include:

  • asthma, wheezing or shortness of breath
  • swelling of the face, lips or tongue which may cause difficulty in swallowing or breathing
  • hives, itching or skin rash
  • fainting

Do not take Dolased Analgesic - Calmative if you have or have had any of the following medical conditions:

  • Ultra-rapid metaboliser of CYP 2D6
  • Known intolerance to medicines used to treat or prevent pain
  • Diarrhoea caused by antibiotics or poisoning
  • Liver failure

Do not take Dolased Analgesic - Calmative if the packaging is torn or shows signs of tampering.

Do not take Dolased Analgesic - Calmative if the expiry date (EXP) printed on the pack has passed. If you take this medicine after the expiry date has passed, it may not work as well.

If you are not sure whether you should start taking Dolased Analgesic - Calmative, contact your doctor or pharmacist.

Do not give Dolased Analgesic - Calmative to a child under 12 years. The safety and effectiveness of Dolased Analgesic - Calmative in children have not been established.

Do not give to children aged between 12 - 18 years in whom respiratory function might be compromised, including post tonsillectomy and/or adenoidectomy for obstructive sleep apnoea, due to an increased risk of developing serious and life-threatening adverse reactions

Dolased is distributed to the breast milk so do not take if you are breastfeeding. However, if your doctor advises you require codeine therapy while breastfeeding, then breastfeeding should be suspended and alternative arrangements should be made for feeding the infant for any period during codeine treatment.

Before you start to take it

Tell your doctor if:

  1. you have any allergies to:
  • any other medicines or any other substances, such as foods, preservatives or dyes
  1. you are pregnant or intend to become pregnant.
Your doctor will discuss the possible risks and benefits of using Dolased Analgesic - Calmative during pregnancy.
  1. you are breast-feeding or plan to breast-feed.
Your doctor will discuss the possible risks and benefits of using Dolased Analgesic - Calmative during breastfeeding.
  1. you have or have had any medical conditions, especially the following:
  • kidney or liver disease
  • breathing problems (eg. asthma)
  • glaucoma
  • bladder problems (urinary retention)
  • prostate problems
  • stomach ulcer or other stomach problems
  1. you are a heavy drinker.

If you have not told your doctor or pharmacist about any of the above, tell them before you take any Dolased Analgesic - Calmative.

Taking other medicines

Do not take Dolased Analgesic - Calmative with other products containing paracetamol, unless advised to do so by a doctor or pharmacist.

Tell your doctor or pharmacist if you are taking any other medicines, including any that you buy without a prescription from your pharmacy, supermarket or health food shop.

Some medicines may interfere with Dolased Analgesic - Calmative. These include:

  • some drugs used to treat depression (eg. barbiturates, monoamine oxidase inhibitors)
  • medication for epilepsy
  • medications used to control fits (eg. Dilantin or Tegretol)
  • medicines to help you sleep, or relieve anxiety
  • opioid analgesics (eg. morphine or pethidine)
  • some drugs used to thin the blood (anti-coagulants)
  • alcohol
  • Paracetamol excretion may be affected and plasma concentrations altered when given with probenecide.
  • Colestyramine reduces the absorption of paracetamol if given within 1 hour of paracetamol.

These medicines may be affected by Dolased Analgesic - Calmative, or may affect how well it works. Your doctor and pharmacist may have more information on medicines to be careful with or avoid while taking Dolased Analgesic - Calmative.

If you have not told your doctor or pharmacist about any of the above, tell them before you take any Dolased Analgesic - Calmative.

How to take Dolased Analgesic - Calmative

How to take it

WARNING: Keep to the recommended dose.

Adults: Do not take this medicine for longer than a few days at a time unless advised to by a doctor.
Children and adolescent: Do not take this medicine for longer than 48 hours at a time unless advised to by a doctor.

Do not take with other medicines containing paracetamol unless advised to do so by a doctor.

How much to take

Dolased Analgesic - Calmative should be swallowed with a glass of water. They can be taken with or without food.

This medicine may cause constipation.

Adults and children over 12 years: Take 1 - 2 tablets every 4 - 6 hours as necessary.

Do not exceed 8 tablets in a 24-hour period.

Do not give to children under 12 years of age.

If you do not understand the instructions on the box, ask your doctor or pharmacist for help.

If you take too much (overdose)

If an overdose is taken or suspected, ring the Poisons Information Centre (telephone 13 11 26), or go to a hospital straight away, even if you feel well, because of the risk of delayed, serious liver damage. If you have taken too much Dolased Analgesic - Calmative you may feel drowsy, sick in the stomach, or restless.

While you are taking Dolased Analgesic - Calmative

Things you must do

If you are about to start taking any new medicine tell your doctor and pharmacist that you are taking Dolased Analgesic - Calmative.

Tell all of the doctors, dentists, and pharmacists that are treating you that you are taking Dolased Analgesic - Calmative.

If you plan to have surgery that needs a general anaesthetic, tell you doctor or dentist that you are taking Dolased Analgesic - Calmative.

Things you must not do

Do not give Dolased Analgesic - Calmative to anyone else, even if they have the same condition as you.

Do not use Dolased Analgesic - Calmative to treat any other complaints unless your doctor or pharmacist tells you to.

Do not drink alcohol.

Things to be careful of

Be careful driving or operating machinery until you know how Dolased Analgesic - Calmative affects you.

Dolased Analgesic - Calmative may cause drowsiness or light-headedness in some people and affect mental alertness. Make sure you know how you react to Dolased Analgesic - Calmative before you drive a car, operate machinery, or do anything else that could be dangerous if you are dizzy. If you drink alcohol, dizziness or drowsiness could be worse.

Codeine may be habit forming if taken frequently and over a long period of time. Please ask your doctor or pharmacist if you are concerned about this.

About 8% of people are poor metabolisers of codeine and Dolased Analgesic - Calmative may not work as well if you are one of those people.’

Side effects

Like other medicines, Dolased Analgesic - Calmative can cause some side effects. If they occur, most are likely to be minor and temporary. However, some may be serious and need medical attention.

The more common side effects of Dolased Analgesic - Calmative are:

  • skin rashes,
  • dry mouth,
  • constipation
  • sedation or drowsiness
  • dizziness,
  • nausea and vomiting,
  • stomach pain

Tell your doctor or pharmacist if you notice any of these side effects and they worry you.

After taking Dolased Analgesic - Calmative

Storage

Keep your tablets in the pack until it is time to take them. If you take the tablets out of the pack they will not keep well.

Keep the tablets in a cool dry place where the temperature stays below 30 degrees Celcius. Do not store Dolased Analgesic - Calmative or any other medicine in the bathroom or near a sink. Do not leave it in the car or on window sills. Heat and dampness can destroy some medicines.

Keep it where children cannot reach it. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Disposal

If your doctor or pharmacist tells you to stop taking Dolased Analgesic - Calmative or the tablets have passed their expiry date, ask your pharmacist what to do with any that are left over.

Product description

What it looks like

Dolased Analgesic - Calmative is a white capsule-shaped tablet. They are available in blister packs of 20 and 40 tablets.

Ingredients

Each Dolased Analgesic - Calmative tablet contains the following active ingredients:

  • Paracetamol 500mg
  • Codeine Phosphate Hemihydrate 10mg
  • Doxylamine Succinate 5.1mg

The following inactive ingredients are found in Dolased Analgesic - Calmative:

  • Crospovidone
  • Stearic acid
  • Magnesium stearate
  • Lactose
  • Glyceryl monostearate - self-emulsifying
  • Povidone.

Dolased Analgesic - Calmative contains lactose, but does not contain sucrose, gluten, tartrazine or any other azo dyes.

Manufacturer

Aspen Pharma Pty Ltd
34-36 Chandos Street
St Leonards NSW 2065
Website: www.aspencmi.com.au

The Australian Registration number for Dolased Analgesic-Calmative is AUST R 157880

This leaflet was updated in Jan 2018.

Published by MIMS June 2018

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