Pavacol-D
pholcodine
Read all of this leaflet carefully before you start taking this medicine.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist if you need more information or advice.
- You must contact a doctor if your symptoms worsen or do not improve after 5 days.
- If you notice any side effects (see section 4) or any side effects not mentioned in this leaflet, talk to your doctor or pharmacist.
In this leaflet:
1. What Pavacol-D is and what it is used for
2. Before you take Pavacol-D
3. How you take Pavacol-D
4. Possible side effects
5. How to store Pavacol-D
6. Further information
What Pavacol-D is and what it is used for
Pavacol-D is a dark brown liquid that contains the active ingredient pholcodine. Pholcodine is one of a group of medicines called anti-tussives (help to prevent coughing).
Pavacol-D is a cough suppressant for relief of acute non-productive cough associated with upper respiratory tract infection.
For children aged 6 to 12 years: simple treatments should be tried first before you give this medicine. Further information on treating coughs and colds in children can be found at the end of this leaflet.
Before you take Pavacol-D
Do not give to children under 6 years of age.
You should not take Pavacol-D if you:
- are allergic to pholcodine or any other ingredients of Pavacol-D (these are listed in Section 6).
- have liver disease
- have a very serious breathing problem (ventilatory failure)
- have chronic bronchitis (inflammation of the airways)
- have bronchiectasis (abnormal widening of one or more airways)
- have or may have any problems with your airways such as chronic obstructive pulmonary disease (COPD), or other breathing problems
- are taking or have taken MAOIs in the last 2 weeks (MAOIs [monoamine oxidase inhibitors] are a type of antidepressant such as phenelzine, isocarboxazid, tranylcypromine or moclebemide).
Take special care with Pavacol-D and tell your doctor if you have any of the following conditions:
- kidney disease
- a history of drug abuse
- if you suffer from a chronic or persistent cough
Tell your doctor if you still have a cough after 5 days.
Ask a doctor before use if you suffer from a chronic or persistent cough, if you have asthma, are suffering from an acute asthma attack or where the cough is accompanied by excessive secretions.
Taking other medicines/alcohol
Do not take Pavacol-D if you are taking any other cough or cold medicines.
Tell you doctor or pharmacist about any other medicines, including medicines you are taking at the same time, particularly the following:
Antidepressants, antihistamines, sleeping tablets or sedatives strong painkillers, medicines to treat epilepsy, as Pavacol-D may make you feel more sleepy.
Avoid consumption of alcohol as this may also increase drowsiness if taken with Pavacol-D.
Also tell your doctor or pharmacist if you are taking any of the following medicines:
Diuretics (water tablets), antihypertensives (blood pressure tablets) as Pavacol-D can lower your blood pressure.
Tell your doctor or pharmacist if you are due to have or have recently had a general anaesthetic.
Pregnancy and breast-feeding
You should not take Pavacol-D during the first three months of pregnancy unless you doctor tells you to. Always speak to your doctor or pharmacist for advice before taking any medication.
Driving and using machines
Pavacol-D may cause sleepiness. Make sure you are not affected before you drive or operate machinery.
Important information about some of the ingredients of Pavacol-D
- If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking Pavacol-D.
- May have a mild laxative effect. Calorific value 2.6 kcal/g sorbitol.
- Pavacol-D also contains small amounts of ethanol (alcohol), less than 100 mg per 5 ml.
- The propyl and methyl hydroxybenzoates in Pavacol-D may cause allergic reactions (possibly delayed).
How you take Pavacol-D
Dosage
Adults and the elderly
One or two 5 ml spoonfuls as required. The dose may be increased to three 5 ml spoonfuls if necessary. No more than 60 ml (12 x 5 ml spoonfuls) should be taken in 24 hours.
Children
From 6 to 12 years: one 5 ml spoonful four to five times daily. No more than 25 ml (5 x 5 ml spoonfuls) should be taken in 24 hours.
Do not use for more than 5 days without the advice of a doctor.
Seek medical attention if the child's condition gets worse during treatment.
Do not give to children under 6 years of age.
Do not exceed the stated dose.
If you take more Pavacol-D than you should
Contact your doctor or go to your nearest hospital immediately. Symptoms of overdose include feeling sick, sleepiness, restlessness, excitement, co-ordination problems, and shallow breathing.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Pavacol-D Side Effects
Like all medicines, Pavacol-D can cause side-effects, although these do not affect everyone. If you experience any of the following stop taking Pavacol-D immediately and talk to your doctor or pharmacist.
sudden wheeziness
difficulty in breathing
severe allergic reactions including swelling of the eyelids, face or lips, rash or itching, especially affecting your whole body
The following side effects have also been reported occasionally:
- feeling sick (nausea)
- congestion (sputum retention)
- constipation
- mild laxative effect
- drowsiness
- dizziness
- excitation
- confusion
- vomiting
If any of the side effects becomes severe, or if you notice any side effects not listed in this leaflet, please tell you doctor or pharmacist.
How to store Pavacol-D
Pavacol-D should be kept out of the reach and sight of children.
Do not store above 25ºC and protect from light.
Do not use Pavacol-D after the expiry date as indicated on the box after "EXP". The expiry date refers to the last day of the month.
Medicines should not be disposed of via waste-water or with household waste. Ask your pharmacist what you should do with medications you no longer need. These measures will help protect the environment.
Further information
What Pavacol-D contains
The active substance is pholcodine 5 mg in 5 ml. The other ingredients are:
Tolu balsam, ethanol 96%, anise oil, clove oil, peppermint oil, capsicum tincture, strong ginger tincture, sorbitol solution, saccharin, sodium hydroxyethylcellulose, treacle flavour, caramel, menthol, methyl hydroxybenzoate, propyl hydroxybenzoate, and purified water.
What Pavacol-D looks like and contents of the pack
Pavacol-D is available as 50 ml, 100 ml, 150 ml, 250 ml, 300 ml, and 1000 ml round amber glass bottles with an aluminium cap.
Not all pack sizes may be marketed.
Treating cough and cold in children
It's normal for children to get 8 or more colds in a year. Gradually they build up immunity and get fewer colds. Most colds will get better within a few days and you may not need to do more than keep your child comfortable until they get over it. Because colds are caused by viruses, not bacteria, antibiotics don't help. Here are some simple steps to help your child who has a cough or cold:
1. If they are hot/feverish:
Increase the amount of fluid your child normally drinks. Lower their temperature with a paracetamol or ibuprofen medicine which has doses for children. (Paracetamol is not for children under 2 months. Ibuprofen is not for children under 3 months).
2. For coughs:
Although it is distressing to hear your child cough, in fact coughing serves a purpose. It helps clear phlegm on the chest or mucus from the nose. Give the child plenty or warm clear fluids to drink.
3. To help with breathing:
Plain saline nose drops, available from your pharmacy, can help babies with blocked noses who are having trouble feeding.
Marketing Authorisation Holder and Manufacturer
The product licence holder is:
Pavacol-D is manufactured by:
This leaflet was last revised in May 2009
Pavacol-D is a registered trademark of Alliance Pharmaceuticals Limited. Alliance and associated devices are registered trademarks of Alliance Pharmaceuticals Limited.
© Alliance Pharmaceuticals Ltd 2009.
No comments:
Post a Comment